Institutional Review Board (IRB) Policies and Procedures(Updated July 2020)
A. Types of Studies That Must be Reviewed
B. Authority to Disapprove, Modify, or Approve Studies
C. Authority to Oversee Ongoing Conduct of a Study
D. Authority to Suspend or Terminate Approval of a Study
D. Undue Influence
XVIII. RESEARCH WITH INVESTIGATIONAL DEVICES
XIX. PROTECTED HEALTH INFORMATION AND HIPAA
XX. DATA AND SAFETY MONITORING IN RESEARCH
Binghamton University, the State University of New York, investigators and their research staff, and the Human Subjects Research Review Committee (HSRRC), and office staff, share a collaborative responsibility and commitment to maintaining the highest ethical standards in all research endeavors. The University strives to protect the rights and welfare of human subjects who choose to participate in biomedical or socio-behavioral scientific research and has an organized and systematic program in place for doing so.
Binghamton University has established the HSRRC as the Institutional Review Board (IRB) responsible for the review of research involving human subjects under the terms and conditions set forth by the Office of Human Research Protections (OHRP) of the Federal Government Department of Health and Human Service (HHS) and the Food and Drug Administration (FDA).
OHRP provides the following definitions for Human Subjects Research:
- Research - is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
- Human subject - is a living individual about whom an investigator (whether professional or student) conducting research obtains (1) information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
All students, faculty and staff must comply with OHRP regulations, as well as state and local laws, and University policies. Failure to comply with the required rules and regulations can result in the loss of funding for human subjects research for the entire institution.
All human subjects research conducted by Binghamton University students, faculty and staff must be reviewed and approved by the IRB prior to the commencement of human subjects research if the University is considered "engaged" in the research as defined by HHS. A comprehensive list of criteria and scenarios in which an institution is considered "engaged" can be found here.
Human subjects research protections are constantly evolving and, as such, the Binghamton University research community will be notified of any regulatory or procedural changes via the IRB listserv, Dateline, and the Division of Research website. This will ensure that Binghamton University human subjects researchers stay up-to-date on the the most recent regulatory and procedural standards.
Binghamton University's IRB is guided by ethical principles, federal, state, and local laws pertaining to all research involving humans as subjects. These guiding ethical principles have been set forth by the Nuremburg Code of 1947, the Declaration of Helsinki of 1964, and the Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research of 1979.
The federal regulations applicable to human subjects research include:
- The OHRP under HHS Code of Federal Regulations (CFR) Title 45 CFR. 46 ("the common rule")
- Food and Drug Administration (FDA) Title 21 CFR 50 and 56
- Department of Education 34 CFR Part 97, 98 99, 350 and 356
- Department of Defense (DOD) and Department of Navy (DON) Title 32 CFR 219
Binghamton University has secured from the OHRP a Federal Wide Assurance (FWA00000174). The FWA is an assurance of compliance with the federal regulations for the protection of human subjects in research. The FWA defines the responsibilities of the University, the IRB administrative office and staff, and research investigators to protect human research subjects.
The University will comply with all applicable state laws regarding human subjects research. If research takes place outside the state of New York, the IRB will consult with legal counsel, as appropriate, to provide interpretation and guidance to the HSRRC. In situations where there are conflicts between federal and state, or other applicable laws, legal counsel will be consulted to advise on the appropriate resolution of the conflicts.
The primary responsibility for protecting the rights and welfare of human subjects rests with each individual who initiates, directs, or engages in research. It is the responsibility of the Binghamton University IRB to ensure that the rights and welfare of the human research subjects recruited to participate in research activities conducted under University auspices are protected.
All research studies involving human subjects conducted by University faculty, staff, and students in connection with their institutional responsibilities, or done under the sponsorship or auspices of the institution, must be reviewed and approved by the IRB prior to commencement of the research.
The IRB has jurisdiction and oversight responsibilities over human subjects research in which the University is engaged. This includes:
- Funded and non-funded research.
- Research involving subjects from outside the University.
- Research involving vulnerable populations (Binghamton University requires additional protections outlined in the federal regulations).
Given the authority that IRB's have under HHS regulations, when conducting an initial or continuing review of a research study, or a review of proposed changes to a previously approved research study, the IRB can take any of the following actions:
- Approve the research study or proposed changes as submitted without any conditions;
- Approve the research study or proposed changes as submitted with conditions (revised full board studies may be reviewed by the IRB Chair or committee member(s) designated by the IRB Chair if approved for expedited review procedures moving forward);
- Require modifications to secure approval;
- Defer or table the research study or proposed changes for further review at a future date after the required modifications are submitted by the investigator; or
- Disapprove the research study or proposed changes.
In cases where a study is disapproved or modifications are requested, the HSRRC will provide its rationale for the action taken. The investigator may request an appearance before the Committee to present arguments for reversal of the decision or propose a change in the protocol based on the advice and counsel of the Committee.
By regulation, action on protocols that require full IRB review may be taken only at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it must receive the approval of a majority of those members present. Investigators with research under full board review are invited to a convened meeting to provide justification or clarification for the proposed research endeavors.
No official within Binghamton University may approve a protocol or human subjects research activity that has not been approved by the IRB.
The IRB may require progress reports or a summary of findings from the investigator at any time. Additionally, the IRB may determine that there is a need for the committee to oversee the conduct of a study. The IRB has the authority to observe, monitor, or request that an audit be performed on approved research to ensure that proper scientific, ethical, and regulatory requirements are being followed.
Monitoring of ongoing research studies for compliance may include a review and assessment of areas such as, but not limited to the following:
- Consent processes.
- Current enrollment and verification of informed consent.
- Participant payment.
- Privacy and confidentiality issues.
- Recruitment procedures;
- Reports of adverse events.
- Research team composition and training processes.
- Screening procedures.
- Storage of study documents and data.
- Study procedures.
- Publications from the study data.
The IRB has the authority to determine if a research project should be suspended or terminated for cause. If appropriate, the action will be reported to appropriate institutional officials, the head of any supporting federal department or agency (if applicable), the OHRP under HHS, and the corporate study sponsor (if applicable). If the project that is suspended or terminated involves a drug, device, or biologic regulated by the FDA, the FDA shall also be notified of the suspension/termination.
In coordination with the Office of Sponsored Programs and the Assistant Vice President for Research Compliance/IO, the IRB Associate Director reviews any applicable contract language to confirm any obligations by a sponsor monitoring body that the organization be promptly notified of any information discovered by the sponsor’s on-site study monitors that could affect the safety of subjects, affect the willingness of subjects to continue participation, influence the conduct of the study, or alter the IRB’s approval to continue the study, when appropriate/applicable.
The purpose of this policy and process is to address noncompliance in obtaining prior approval to conduct human subjects research. The IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review and, as appropriate, approve them. There are three major types of IRB review: exempt, expedited, and full. This policy applies to all three review categories.
Federal regulations require that research on human subjects include a prior review and approval by an IRB. Noncompliance in obtaining approval prior to research commencement may result in:
- Withholding research funding.
- Unacceptance of publications including dissertation and thesis.
- Suspension and/or termination of research.
- A research misconduct inquiry and investigation.
Binghamton University complies with all applicable human subjects research regulations. The institutional IRB is responsible for:
- Investigating allegations of noncompliance in obtaining prior approval to conduct human subjects research.
- Reporting any findings of serious and/or continuing noncompliance to the Assistant Vice President of Research Compliance who serves as the Institutional Official (IO) in such matters.
The IRB Associate Director and/or the IRB Chair are the individuals to receive reports of instances of noncompliance. Such reports of noncompliance may be made by Principal Investigators (PI's) or study team members, faculty, staff, subjects in the research, students, and anonymous persons.
The IRB Associate Director and the IRB Chair will review the incidence of noncompliance to determine the legitimacy and/or seriousness of the allegation. The PI will be notified of the allegation.
Upon confirmation of noncompliance in obtaining prior approval to conduct human subjects research, the PI will be required to suspend the research immediately if the research is active. The PI will be notified that data collected prior to IRB approval shall not to be used for publication or presentation purposes. If the PI wishes to continue the research, a protocol is to be submitted within fourteen (14) calendar days to the IRB. The standard IRB process of review and approval will then be conducted.
A written report of the research that was conducted prior to IRB review and approval is to be submitted by the PI to the IRB Associate Director and the IRB Chair within seven (7) calendar days of official notice of noncompliance. This report is to be submitted regardless of the intention to continue the research with the necessary approvals. The report detailing the research conducted prior to IRB review should include a description of the procedures; the number of subjects enrolled and a description of the subject pool; all documents used for recruitment, consent, and in conducting the research (i.e. survey, questionnaires, tests); and any findings (if completed).
The Assistant Vice President for Research Compliance, who serves as the Institutional Official/Research Integrity Officer (IO/RIO) is to be notified immediately upon failure by the PI to:
- Immediately suspend the research;
- Submit a protocol to the IRB within (14) calendar days for continuance (when applicable); or
- Submit the written report to the IRB Associate Director and the IRB Chair within (7) calendar days.
The IO will notify the PI of any failure of adherence, which may result in the initiation of a Research Misconduct Inquiry as per the Binghamton University Policy on Responsible Conduct of Research.
The IRB Associate Director and the IRB Chair are to review the written report submitted by the PI within seven (7) calendar days of receipt. If the report identifies actions that may have adversely affected the subjects; or of noncompliance that was done willfully, knowingly, or intentionally; the IO is to be notified immediately upon that determination. The IO will contact the PI to discuss the findings which may result in the initiation of a Research Misconduct Inquiry as per the Binghamton University Policy on Responsible Conduct of Research.
Research Misconduct is defined as fabrication, falsification, or plagiarism or other practices in the conduct of research, scholarly, or creative activity that seriously deviate from those that are commonly accepted within the academic community for proposing, performing, or reviewing research, or in reporting research results. Not adhering to federal regulations which require that research on human subjects receive a review and approval by an IRB prior to commencement constitutes a serious deviation.
If the PI is a student, the Dean of Students will be notified by the IO of noncompliance. The IO will provide the Dean of Students any and all supporting documentation. The Dean of Students will then determine the appropriate course of action for addressing the noncompliance.
For matters relating to the execution of their duties and responsibilities, the IRB
office staff report directly to the Assistant Vice President for Research Compliance.
The IRB office staff is comprised of the IRB Associate Director (who is a voting member
of the IRB) and the IRB Coordinator.
The following information is reported by the IRB office staff to the Assistant Vice President for Research Compliance, who in turn communicates directly with the OHRP:
- Changes in IRB membership.
- Serious or continuing noncompliance with federal regulations.
- Any unanticipated problems involving risks to subjects or others.
- Reports of serious or continuing noncompliance, and unanticipated problems involving risks to subjects or others.
- Any suspension or termination of IRB approval for a project.
Notification of the suspension or termination of research by the IRB is also made to:
- The IRB as an information item in the agenda in the next scheduled meeting.
- Other federal agencies when the research is overseen by those agencies, and they require reporting separate from that to the OHRP (within 14 business days of suspension or termination of research protocol).
- The Food and Drug Administration (FDA), when the research is FDA regulated (within 14 days of suspension or termination of research protocol).
All reports include information and documentation from the convened IRB and any documentation reviewed by the IRB Chair and the IRB office staff during the initial investigation including all correspondence from the PI and any other individuals involved in the review and investigation process. A report is drafted by the IRB Chair and the IRB office staff, which is then forwarded to the IO for finalization and approval.
If needed, the IRB works in collaboration with other committees and with the campus community as a whole to ensure the appropriate protections for human subjects are in place. Below is a list of other offices and committees that the IRB may collaborate with when reviewing a research proposal. When research involved processes that fall under the purview of these committees, the IRB requires that protocol be reviewed and approved by the appropriate committee. Letters of review and approval must be received and reviewed by the IRB prior to final research approval and the commencement of study procedures.
Institutional Biosafety Committee
The National Institutes of Health (NIH) requires that universities maintain the highest level of scientific integrity and community safety in the review of research involving genetic engineering, the splicing together of DNA from different organisms, and the use of certain biologicals and hazardous materials. Strict rules have been established regarding types of experimentation allowable and under what circumstances different classes of experiments can be conducted. The Institutional Biosafety Committee reviews all such research.
Radiation Safety Committee
The use of radioactive materials on campus is governed by the New York State Department of Health. The Radiation Safety Committee advises members of the University in matters involving radiological procedures and safety; establishing procedures pertaining to the ordering, receipt, use and disposal of radioactive materials; and advises researchers on specific problems related to the use of radioactive materials in research and instruction.
Institutional Animal Care and Use Committee (IACUC)
The IACUC is responsible for oversight of animal care, supporting the animal-related needs of University researchers, and ensuring compliance with all standards mandated by federal and state laws, University policies, and accrediting bodies.
Stem Cell Research Oversight Committee
Prior to commencing research using human embryonic stem cells/cell lines or other
pluripotent stem cells/cell lines regardless of source (not limited to embryos, adult
tissues, amniotic fluid or fetal tissue), Binghamton University investigators must have
their research protocol approved by the campus Stem Cell Research Oversight Committee. Only NIH-Approved human embryonic stem cell/lines listed on the NIH Human Pluripotent Stem Cell Registry may be used at Binghamton University
Institutional Conflict of Interest Committee (ICIC)
Binghamton University follows written policies and procedures for identifying, managing, and minimizing or eliminating financial conflicts of interest of the University and individuals that could influence the conduct of research. Any Investigator who has disclosed significant financial interests that may influence proposed human subjects research, or may be perceived to influence it, will be subject to review by the ICIC to establish a Conflict of Interest Management Plan.
Cooperative activities are those in which University faculty, staff, or students obtain access to human subjects through one or more cooperating institutions, or when PIs from cooperating institutions obtain access to human subjects at Binghamton University. The Revised Common Rule requires single IRB (sIRB) review for cooperative research involving multiple institutions that are considered engaged by the federal regulations. This requirement became effective January 20, 2020.
If a non-Binghamton University site is engaged in the conduct of human subjects research, the PI should notify the IRB and provide:
- The contact information for the site.
- Specify if the site has its own IRB.
- Specify if the site has already approved the research or the plan is to defer to the Binghamton University IRB.
Depending on the Binghamton investigator(s) role in the research and target subject sample, Binghamton University's IRB can review the research as the IRB of Record and sign an Institutional Authorization Agreement (IAA)/Reliance Agreement for the other institution(s) to rely on Binghamton's review. Alternatively, Binghamton University's IRB can rely on an external IRB for review of the proposed research.
Examples of situations in which Binghamton University would serve as the IRB of Record include:
- The lead investigator is a Binghamton University faculty/staff member, or student.
- The target subject sample is Binghamton University faculty, staff, or students.
- The majority of research activities take place at Binghamton University.
Examples of situations in which Binghamton University would rely on an external IRB include:
- The lead investigator is a non a Binghamton faculty/staff member, or student.
- The target subject sample is from another institution (i.e. patients of a hospital).
- Federal regualtions, state laws, or local policies require use of a specific IRB.
When an Outside IRB is the Single IRB of Record
Even if an outside IRB will be named as the single IRB of record, Binghamton University investigators are responsible for contacting the Binghamton University IRB and providing a copy of the study approval letter, approved protocol and approved informed consent for review. An IAA/reliance agreement will only be signed once a local compliance review is complete, and any other conditions are satisfied. The Binghamton IRB will work with investigators to facilitate this process. Please contact the Binghamton University IRB office for more information. All modifications, revisions, continuing reviews, adverse events, unanticipated problems, complaints and any other correspondence that is received from the collaborating institution must be forwarded to the Binghamton University IRB.
When the Binghamton University IRB is the Single IRB of Record
If Binghamton University is the lead or coordinating institution, PI's must note this in their initial IRB application in PACS and provide the names, contact information, and training certifications for all non-Binghamton study team members. The IRB will coordinate with outside institutions to facilitate any necessary reliance agreements.
Site Permission Letters
When a Binghamton PI intends to conduct research at a site external to the University (not owned or operated by the University), the PI is responsible for ensuring that the non-Binghamton University site is willing to engage in the collaboration. If a PI is collaborating with an institution or organization that is not considered "engaged" in the research as defined by the federal regulations, a letter of agreement (permission) from an individual who has the authority at the collaborating institution/organization to sign the document may be needed (e.g., if recruiting potential participants from an elementary school, a letter of agreement from the principal or superintendent will be required). The letter should specify the role of the institution/organization in the research activies. A template is provided on the HSRRC webpage.
Binghamton University's IRB is required to communicate to federal, state, and local authorities all information that is outlined in the federal guidelines. The IRB also strives to maintain positive and productive relationships with regulatory agencies and local and state legislators.
Here is a list of additional laws, regulations, and guidelines concerning the conduct of research with human participants:
- The Federal Policy for the Protection of Human Subjects (the “Common Rule”)
- U.S. Food and Drug Administration (FDA) CFR Title 21
- New York State’s Article 24-A: Protection of Human Subjects
- HIPAA Privacy Act
- Family Educational Rights and Privacy Act (FERPA)
- New York Civil Rights Law Section 79-l: Confidentiality of records of genetic tests
Department of Defense (DOD) Sponsored Research
Research sponsored or funded by the U.S. Department of Defense (DOD) must be reviewed by the IRB under an additional set of regulations (32 CFR 219) that involve special protections for research participants, as well as additional review and reporting requirements for investigators and IRBs. Researchers must meet additional DOD requirements prior to initiation of the research. The DOD follows the HHS and FDA regulations on human subjects research but also applies DOD Directive 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DOD Supported Research. Investigators should review these requirements when planning a DOD-supported research project as they may add a significant amount of time to the review and approval process of research.
The structure and composition of the IRB must be appropriate to the amount and nature of the research that is reviewed by the IRB and in compliance with federal regulations. Every effort is made to have a membership that represents and understands the areas of specialty encompassing most of the research performed at Binghamton University.
The IRB members are selected based on relevant experience, expertise, and diversity (racial, cultural, gender, and professional) to insure respect for their advice and counsel specific to safeguarding the rights and welfare of human subjects. This includes having members experienced in working with vulnerable subjects, and the inclusion of both scientific and non-scientific members. Committee members posess the professional competence necessary to ascertain the acceptability of proposals in terms of organizational commitments, regulations, applicable law, standards of professional conduct and practice, and community attitudes.
The IRB office staff will report changes in IRB membership to OHRP as required.
The Assistant Vice President for Research Compliance in collaboration with the IRB Chair and office staff will identify those areas of research for which member expertise is required. Recommendations for appointment to the IRB are requested from individuals in the University and local community. The Assistant Vice President for Research Compliance appoints the IRB members.
Length of Term/Service
Members are appointed to one-year, renewable terms. Members may resign at any time by submitting a letter of resignation to the IRB Chair.
The IRB members are responsible for:
- Completing initial and ongoing educational requirements regarding the protection of human subjects.
- Identifying any personal conflicts of interest during protocol reviews and, if one exists, removing themselves from the discussion and voting except to provide information requested by the IRB.
- Reading all material provided to them and being informed and prepared for the committee meetings.
- Conducting reviews of full board and expedited protocols as requested.
- Being an active member of the IRB and attending the meetings on time, participating
in the discussions, and casting a vote at the convened meetings.
The IRB members, upon accepting their appointment, are informed of the scheduled committee meetings on a semester-by-semester basis, and it is their responsibility to make every effort to attend each meeting. In the event that a member is not available for a period of three consecutive meetings in one semester or five meetings in a one-year period, membership on the committee will be relinquished.
The Assistant Vice President for Research Compliance may remove members from the IRB prior to the end of their appointment. The IRB member removal may occur in the event that the member does not fulfill assigned duties or responsibilities in reviewing protocols, or has displayed inappropriate behavior and has affected the conduct of IRB meetings. Members cannot be removed based on voting records, or in an attempt to alter the IRB membership to facilitate approval for protocols.
The appointment and function of alternate IRB members is the same as that for primary IRB members, and the alternate's expertise and perspective are comparable to those of a primary member. The role of the alternate member is to serve as a voting member of the IRB when a regular member is unavailable to attend a convened meeting. When an alternate member substitutes for a primary member, the alternate member will receive and review the same materials prior to the convened meeting that the primary member received or would have received. The alternate member will not be counted as a voting member unless the primary member is absent. The IRB meeting minutes will document when an alternate member replaces a primary member.
At times, the IRB may not have the necessary expertise to judge the scientific soundness or cultural appropriateness of a research protocol, or to make a fair and accurate determination of the risk-benefit ratio. In these situations the IRB will invite an ad hoc consultant for assistance in reviewing the scientific merit or to perform an in-depth review of the study.
Consultants are required to sign written confidentiality statements. Those individuals who identify that they do have a conflict of interest pertaining to the research they are being asked to review can no longer serve as consultants for the specified research.
Consultants will provide their opinions of the research protocol under review to the IRB in layman terms. This may be accomplished through a written report that will be distributed to the IRB or by attending a meeting to provide in-person feedback. If consultants attend IRB meetings, they will not be involved in the discussion and decision making except to provide information requested by the IRB. The consultant must leave the meeting before final discussion and voting.
All consultant reports will be kept on file with the IRB office and the information provided to the IRB by the consultant will be reflected in the minutes of the meetings.
IRB Chair/IRB Associate Director
The IRB Chair and the IRB Associate Director are directly responsible for mutually assuring that the IRB operates in full accordance with regulatory requirements and the highest ethical standards.
The IRB Chair works with the IRB Associate Director, the IRB Coordinator, committee members, institutional officials, and investigators to ensure that the rights and welfare of research subjects are adequately protected, and that the benefits of the research justify the risks to the research subject. The IRB Chair is appointed by the Assistant Vice President for Research Compliance and is appointed usually for a three-year term.
The IRB Chair and the IRB Associate Director play leadership roles in establishing and implementing IRB policy. As the primary representative of IRB decisions, the IRB Chair has shared authority over all IRB policies and procedures in collaboration with the Assistant Vice President for Research Compliance, the IRB Associate Director, and the IRB Coordinator.
The Chair, in conjunction with the IRB Associate Director (who may at times serve as the Chair's designee), are responsible for the following:
- Representing the IRB in discussions with other segments of the organization.
- Representing the organization in discussions with federal authorities.
- Reviewing all protocols presented to the full committee. Both the IRB Chair and the IRB Associate Director are expected to have read each full committee protocol and to communicate with other reviewers so that important IRB issues are identified or resolved before the full committee meeting.
- Directing the proceedings and discussion of the full committee meeting. This includes keeping the discussion focused on important IRB issues and seeing that the full committee meeting process is both efficient and effective.
- Voting at full committee meetings.
- Reviewing research that is under an expedited review process. At minimum, all expedited protocols are reviewed by the IRB Associate Director. This task may be shared with other committee members, as well.
- Having an in-depth understanding of the ethical issues, state laws, institutional policies, and federal research regulations that are applicable to studies that are reviewed by the IRB.
- Drafting letters from the IRB to researchers regarding IRB decisions.
- Reviewing and signing IRB response letters in a timely fashion.
- Representing the IRB in discussions with researchers who have made submissions to the IRB.
- Investigating instances of non-compliance in collaboration with the Assistant Vice President for Research Compliance and developing a plan of action to address the non-compliance and oversee monitoring of any remedial action.
- Reviewing unanticipated problems, adverse event reports, and complaint forms pertaining to active studies and taking appropriate action regarding the revision or suspension of study protocols.
- Reporting as needed to the Assistant Vice President for Research Compliance.
The IRB Chair is not expected to be the only, or ultimate, authority on compliance issues. The IRB Associate Director, the IRB Coordinator, and other members of the organization take collective responsibility for compliance verification.
The Assistant Vice President for Research Compliance has the authority to remove the IRB Chair at any time, for cause, in consultation with the President and Vice President of Research.
The IRB members are required to complete the IRB Members Basic Course through the Collaborative Institutional Training Initiative (CITI Program). The training must be completed prior to the first convened meeting that the new appointee is scheduled to attend. Those members requiring continuing education will be notified by CITI as well as the IRB office staff. This continuing education must be completed by the expiration date of 4 years from the last certification date in order to maintain active status in the committee.
Liability Coverage for IRB Members
Section 17 of the NYS Public Officers Law provides that the NYS Attorney General will defend employees should they become involved in litigation if such litigation pertains to an incident involving their duties as long as the employee(s) did not intentionally engage in wrong doing. This protection is also extended to SUNY Associates and volunteers expressly authorized to participate in a state-sponsored volunteer program. Evidence of this authorization includes a volunteer appointment record in accordance with campus procedures and an oath of office executed by the SUNY Associate or other volunteers.
The IRB office staff will provide the necessary support to facilitate the acceptance, review, approval, continuing approval, and modification of protocols submitted to the IRB. The IRB office staff will facilitate full board meetings, as well as maintain all records in accordance with University, state, and federal regulations. Full job descriptions and responsibilities of the IRB Associate Director and the IRB Coordinator will be made available upon request.
Administrative offices for the IRB are maintained in the University Innovative Technology Complex Biotechnology building with the necessary office equipment and supplies (ITC Biotechnology building rooms 2204, 2205, and 2207). Boardrooms within the ITC complex are reserved to hold full board meetings.
The IRB office staff is adequate for conducting IRB business. Personnel hires are bound by the Research Foundation of the State University of New York (SUNY) and SUNY, which encompass all Affirmative Action and Equal Employment Opportunity Requirements. The recruitment and hiring process follow the policy and procedures of the Research Foundation of SUNY and SUNY.
IRB Education Program
All IRB office staff and committee members are required to fulfill human subjects research training through the Collaborative Institutional Training Initiative (CITI). The IRB office staff maintain records to ensure that committee members stay up-to-date on all ethical training.
All IRB office staff and members are provided additional opportunities for training through online and on-site seminars or workshops. Attendance at regional and national meetings (i.e. PRIM&R) is encouraged and supported by the Division of Research for IRB office staff. IRB office staff are highly encouraged to obtain Certified IRB Professional (CIP) certification as they become eligible. Continuing education materials are distributed prior to or at each IRB meeting. All new federal regulations, policies, procedural revisions, and other departmental news that require immediate notification of the University research community are accomplished through the IRB listserv and IRB website.
If needed, the IRB consults the Binghamton University Counsel for the interpretation and application of laws for any jurisdiction where human subjects research conducted by members of the Binghamton University community is occurring.
The IRB provides training and educational materials and resources to investigators online through the IRB website as well as through individual and group meetings, workshops, and class presentations. For investigators who have questions or concerns about their studies and research subjects who have questions, complaints, or concerns regarding participation in human subjects research, the office contact information is made widely available through the IRB website and informed consent documents. If necessary, questions, comments, or concerns are documented and discussed during convened IRB meetings.
The Assistant Vice President for Research Compliance will perform evaluations of the IRB operations, committee members, and IRB office staff periodically to ensure effective performance. As a part of annual evaluation of members, the IRB office staff provide the Assistant Vice President for Research Compliance with the training status of all IRB members.
Internal audits will be performed regularly to ensure that the IRB is in compliance with federal, state, agency, and system regulations. Areas of review include:
- Review of the IRB minutes to verify that meeting discussions addressed issues relating to the regulatory requirements for approval of research as well as that quorum was met and maintained.
- Review complaints, adverse events, and unanticipated problem reports.
- Review databases, files, and meeting minutes to evaluate continuing review discussions, and to ensure that continuing reviews are reviewed on an annual basis pursuant to federal regulations.
- Review files to ensure the presence of all appropriate documentation.
- Verify IRB FWA and IRB applications with HHS.
No IRB members (regular or alternate) or consultants may participate in the review of any research project in which the member or consultant has a conflict of interest (COI), except to provide information requested by the IRB. Committee members and consultants may find themselves in any of the following COI's when reviewing research:
- The member or consultant is involved in the design, conduct, and reporting of the research.
- An immediate family member of the member or consultant is involved in the design,
conduct, and reporting of the research.
The member holds significant financial interest related to the research being reviewed.
- Any other situation where an IRB member believes that another interest conflicts with
his or her ability to deliberate objectively on a protocol.
Designated Reviewers for Expedited Review
IRB members (including experienced staff members) who have been designated by the IRB Chair or IRB Associate Director as reviewers for initial or continuing review of research protocols, reports of noncompliance, protocol deviations, unanticipated problems, and modification requests that qualify for expedited review will self-identify any COI that they may have with the research or PI. In such cases, the review responsibility will be reassigned to another experienced IRB member.
Convened IRB Meeting
Binghamton University policy prohibits IRB members and consultants from participating in the final discussion of, or voting upon any research protocol for which they, their spouse, dependent children, or partner are involved in the design, conduct, or reporting of the research or hold a financial interest, meaning anything of monetary value, including although not limited to, salary or other payments for services (i.e. consulting fees or honoraria); equity interests (i.e. stocks, stock options, or other ownership interest); and intellectual property rights (i.e. patents, copyrights, and royalties from such rights).
Should an IRB member declare involvement in any way in a research protocol under review by the IRB, or state a COI with the research protocol the following is required:
- IRB member is excluded from discussion and voting at committee meetings except to provide information requested by the IRB concerning the research.
- IRB member leaves the meeting room during discussion and voting.
IRB member is not counted towards quorum.
- IRB member with a conflict is documented in the minutes as being absent with an indication that a conflict of interest was the reason for the absence.
The IRB Chair and committee members are required to complete a Conflict of Interest Form annually. Additionally, the Conflict of Interest Form needs to be updated when a new conflict of interest is acquired that affects or has the potential to affect one's obligations to review research protocols.
The HHS regulations 45 CFR part 46 use the term "investigator" to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. For the purposes of the HHS regulations, OHRP interprets an "investigator" to be any individual who is involved in conducting human subjects research studies. Such involvement would include:
- Obtaining information about living individuals by intervening or interacting with them for research purposes;
- Obtaining identifiable private information about living individuals for research purposes;
- Obtaining the voluntary consent of individuals to be subjects in research; and
- Studying, interpreting, or analyzing identifiable private information or data for research purposes.
Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others. Some research studies are conducted by more than one investigator, and usually one investigator is designated the "principal investigator" with overall responsibilities for the study. In every human subjects research study, investigators have certain responsibilities regarding the ethical treatment of human subjects. Investigators are also referred to as researchers throughout the policy and procedures document.
According to the University Investigator COI policy, if you are a PI or senior key personnel on a sponsored program or IRB protocol, and/or have a current COI on file, you must have a completed Investigator Disclosure Statement in PACS on file at the time of an application for funding or submitting a IRB protocol. Disclosed COIs that might affect the protection of subjects must have a management plan in place. Management plans may include: partial or complete divestment, limiting involvement of the conflicted individual, additional oversight, or disclosure. Disclosure alone cannot be used to manage conflicts of interests that might affect the protection of subjects.
The IRB will review the following questions included in the study protocol narrative and evaluate whether there is conflict of interest:
- Does any investigator who is involved in the design, conduct, or reporting of the study, their spouse, or dependent children have a proprietary or financial interest related to the research? ("Financial interest" refers to any financial interest in the sponsor, product, or service being tested, or any financial interest in a competitor of the sponsor, product, or service being tested.)
- Does any investigator who is involved in the design, conduct, or reporting of the
study, their spouse, or dependent children have any ownership interest, stock options,
or other financial interest related to the research that:
- Exceeds $5,000 when aggregated?
- Is not publicly traded on stock exchange?
- Involves arrangements in which the value of the ownership interests will be affected by the outcome of the research?
- Exceeds 5% interest in any one single entity when aggregated for the spouse or dependent children?
- Does any investigator who is involved in the design, conduct, or reporting of the
study, their spouse, or dependent children have any compensation related to the research
- Exceeds $5,000 in the past year, when aggregated?
- Involves arrangements in which the amount of compensation will be affected by the outcome of the research?
If there is a definite or probable COI, the IO will review the documents and meet with the PI and investigator with a COI to educate and prepare a COI Management Plan for the research. The Management Plan will be signed by the IO and the PI or investigator with the conflict. In the event that the Management Plan is not adhered to as part of the approved protocol, the researcher will then be found noncompliant. The noncompliance will automatically be deemed "serious" and the IRB procedures for handling "Serious Non-Compliance" will be followed. All records related to disclosure and management of financial conflicts of interests and any other related correspondence and documents will be stored for a period of three years following completion of the approved research.
C. Institutional Conflict of Interests
University administrators are required to comply with the New York State Commission on Public Integrity disclosure policies that stipulate that they file at least annually a disclosure of all of their financial activities through JCOPE. Additionally, an "Institutional Conflict of Interest Financial Disclosure" is required of all Senior Officers of the University, annually, in order to be in compliance with the procedures of the Association for Accreditation of Human Research Protection Programs. The Institutional Conflict of Interest Financial Disclosure is facilitated by the Office of Research Compliance.
D. Undue Influence
Undue influence can be defined as "any pressure or influence which causes an individual to act in a manner that is favorable to an individual investigator or the institution over the welfare and safety of the research participants." Individual members of the IRB, whether employed by the institution or who are community members, as well as IRB office staff, have the right and obligation to report any undue pressure upon them during the initial and continuing review processes or when conducting or participating in other IRB related business. Reporting of undue influence is required to ensure the highest ethical standards of research conducted at Binghamton University.
Reports of Undue influence can be submitted to the following individuals:
- IRB Chair
- IRB Associate Director or IRB Coordinator
- Assistant Vice President for Research Compliance/Institutional Official (IO)
- Vice President for Research
The IO will receive all reports of undue influence. Upon review of the reports the IO will conduct an investigation or assign an investigation to an individual or a committee. In the event that the IO is involved in the report, the Vice President for Research will be informed and will decide on the investigative action.
Actions of Report Findings:
All undue influence investigations require that a report be formulated and provided to the complainant and to the IRB for a full committee review. The IRB may decide to vote and report the undue influence issue and correspondence to the OHRP if it is determined, during a convened meeting, that the undue represents an unanticipated problem involving risks to subjects or others, or it has not been resolved by the University.
A. Determining if IRB Review is Required
The IRB Associate Director and the IRB Coordinator will review each application submitted through the online portal, Pre-award and Compliance System (PACS), for compliance with federal and state regulations and institutional policies. The IRB Associate Director and IRB Coordinator will first determine whether or not the proposed activity constitutes research (for HHS supported studies) or a clinical investigation (for FDA regulated studies), and whether or not human subjects are involved.
"Human Subjects Research" means any activity that meets either the HHS (Office of Human Research Protections) or FDA definitions of "research" and involves "human subjects".
HHS Definition of Human Subjects Research (45 CFR 46):
Research: Means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.
For purposes of this part, the following activities are deemed not to be research:
- Scholarly and journalistic activities (i.e. oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
- Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
Human Subject: Means a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Student Class Projects/Internships
Generally speaking, classroom projects do not require IRB review. Please contact the IRB office if you have questions about classroom assignments involving gathering information about people through interventions or interactions, or using collected data with identifiable private information. It is the responsibility of faculty members to ensure that any classroom activity that is "research" involving "human subjects" as defined by OHRP is reviewed and approved by the IRB before the project starts.
Students conducting research that falls under the purview of the IRB at an internship site outside of Binghamton University may obtain an IRB approval from the collaborating institution through a Reliance Agreement. Please contact the IRB office to discuss this process.
Quality Improvement (QI) and Program Evaluation (PE)
QI and PE generally do not require IRB oversight. However, some QI or PE activities may be considered research if they fit the definition of "research" as defined by OHRP. Please contact the IRB office to determine whether your QI or PE activity is considered research and requires IRB approval.
Types of Research Conducted at Binghamton University
The research conducted at Binghamton University is social-behavioral or biomedical in nature. The University does not participate in planned emergency research described in and covered under 21 CFR 50.54 and OHRP Guidance 97-01.
Categories of Research Subjects
Human subjects research at Binghamton University generally includes normal healthy individuals; adults and/or children. The IRB reviews and approves research proposing inclusion of vulnerable populations. The vulnerable populations most commonly included in research activities are children, prisoners, pregnant women, and decisionally impaired adults.
B. Exempt and Expedited Review
Prior to a determination of exempt, expedited, or full board review status, the following information should be submitted to the IRB office for review via PACS:
- Protocol narrative or existing data application (for secondary research).
- Informed consent/assent documents.
- Recruitment materials (i.e. flyers, emails, letters, advertising blurbs, etc.).
- Study instruments (i.e. survey, visual/auditory stimuli).
- Letter(s) of agreement / site permission letter(s) from collaborating individuals, institutions, or organizations (if applicable).
- Faculty statement if the Principal Investigator is a student.
- Grant proposal (if applicable).
- Any other supplementary documents relevant to the study.
Upon receiving documentation, an initial determination of exempt, expedited, or full board status will be made by the IRB office staff. Subsequently, applications that qualify for exempt review will be reviewed for approval by the IRB Coordinator. Applications that require expedited review will be reviewed by the IRB Associate Director and, when appropriate, the IRB Chair and/or a designated member of the IRB who has relevant educational/professional training and experience.
All comments, questions, and additional information must be addressed by the investigator(s) before the protocol can be approved.
The HHS regulations 45 CFR 46.104 define some research as exempt from IRB review. However, depending on the potential risks subjects may experience, the IRB may require a higher level of review either through the expedited process or by the IRB at a convened meeting. PIs are not allowed to make the final determination of exemption. Formal continuing review of exempt studies will not be required, but investigators will be contacted at least every three years to determine if the research is still ongoing.
Note: Regardless of exempt status, exempt studies at Binghamton University are reviewed in a similar manner to expedited studies, and any exempt study modifications must be formally submitted to the IRB via PACS. Modifications that involve a change in PI, increased risk, etc. may affect the criteria for exempt determination and, as such, will be reviewed by the IRB office staff upon submission.
If a protocol has been determined to be minimal risk it may be considered for expedited review provided that it fits one of the categories authorized by 45 CFR 46.110 for expedited review. Upon processing the study submission, the IRB Associate Director will verify the protocol is appropriate for expedited review and a designated reviewer or reviewers will be assigned. The IRB Associate Director, who is a voting member of the IRB, typically serves as the primary designated reviewer, however additional / alternate designated reviewers may be assigned if there is a conflict of interest on behalf of the IRB Associate Director or research area expertise is warranted. Designated reviewers will be experienced IRB members with demonstrated competency and that the IRB Associate Director confirms do not have any conflict of interests. At least one IRB member is provided and reviews the complete protocol, including any protocol modifications previously approved by the IRB.
Protocols that may be minimal risk but are not included on the list of activities that may undergo expedited review are reviewed at a convened meeting of the IRB. The IRB may then designate that a protocol is minimal risk and determine that the protocol may undergo an expedited review process under during its subsequent reviews for continuation.
For new studies approved via the expedited review process on or after January 21, 2019, the expedited reviewer will determine the need for continuing review. Most expedited studies will not require a continuing review, however, if a continuing review is required, the interval for continuing review will be at least once per year (not to exceed 365 days; 366 days during a leap year) but may be shorter.
Continuing review applications must be submitted through PACS prior to the expiration date to avoid any lapse in approval. PACS sends an initial reminder 90 days prior to the expiration date. Investigators need to complete the electronic form through PACS. No additional forms are required for continuing review submission. Continuing review applications for expedited research are reviewed and approved by the IRB Associate Director. Please note that the Revised Common Rule (effective January 21, 2019) does not require continuing review for expedited research, unless the IRB has determined and justified in writing that a continuing review is required to ensure protection of human subjects.
All proposed modifications must be approved before investigators can implement the changes in their study protocol. Investigators need to complete the electronic modification form through PACS and upload any relevant documents that are being modified. Modifications will be reviewed by the IRB Coordinator and/or IRB Associate Director for exempt and expedited research. The IRB Chair and Committee member with relevant expertise may be consulted depending on the modification.
Approved Consent Forms
All approved consent/assent forms are stamped with an approval/expiration date and are available in PACS under the study history. Investigators must use the stamped consent/assent forms when distributing to study subjects unless providing electronic consent (in which case the exact language from the approved consent/assent form must be utilized). If any changes need to be made to the informed consent/assent forms, investigators must submit a modification through PACS and upload the modified documents. The modified consent/assent forms will be stamped with a new approval date. Please note that the expiration date does not change. Investigators will receive a new expiration date only when the study is due for a continuing review and the continuing review application has been reviewed and approved by the IRB.
C. Full Committee Review
By regulation, action on protocols that require full IRB review may be taken only at convened meetings at which a majority of the members are present, including at least one member whose primary concerns are in nonscientific areas. Convened meetings are scheduled once every month during spring and fall semesters. There are no convened meetings during summer or winter breaks. However, in urgent cases, meetings may be scheduled during break periods as necessary to ensure the protection of human subjects.
In order for research under review by the full board to be approved, it must receive the approval of a majority of those members present at a convened meeting. In the event a quorum is lost during a meeting, the IRB cannot take a vote until it is restored.
Investigators must submit the following application materials through PACS two weeks prior to the full board meeting date listed on the HSRRC website:
- Protocol narrative or existing data application (for secondary research).
- Informed consent/assent documents.
- Recruitment materials (i.e. flyers, emails, letters, advertising blurbs, etc.).
Study instruments (i.e. survey, visual/auditory stimuli).
- Letter(s) of agreement / site permission letter(s) from collaborating individuals, institutions, or organizations (if applicable).
- Faculty statement if the principal investigator is a student.
- Grant proposal (if applicable).
- Any other supplementary documents relevant to the study.
It is highly recommended that investigators submit their protocol well before the deadline noted on the HSRRC website in case requests are made to provide more information or to revise documents. All application materials are initially reviewed by the IRB Associate Director and IRB Chair to determine whether a full committee review is required and if so, to ensure that all documents are complete and sufficiently prepared to be reviewed at the convened meeting.
All Committee members will be notified through PACS once a study is added to the meeting agenda and will be provided access to the application materials at least 7 days prior to the convened meeting. IRB members will review the materials and post their comments in PACS in preparation for the convened meeting. In the event that committee members cannot attend a full board meeting in person, they may participate through teleconference.
Investigators with studies under full board review will be invited to attend the convened IRB meeting to answer any questions and/or to provide additional information. If the investigator is a student, faculty advisors will also be invited to attend the meeting.
IRB office staff will assure members with appropriate scientific expertise, local knowledge, and other expertise specific to the protocols under review are present at the IRB meeting, along with at least one member who is knowledgeable about or experienced in working with vulnerable subjects, when research involving subjects who are vulnerable to coercion are reviewed. If a member with the appropriate expertise, knowledge, or experience cannot be present, the IRB office staff will notify the IRB Chair to defer the review to another meeting or obtain a consultant, if needed, to provide a written report of their evaluation of the protocol.
For full board reviews to be properly executed a quorum of the IRB members, which must include a non-scientist, an unaffiliated member and a prisoner representative (if research including prisoners is discussed), must be present for the entire presentation, discussion, and deliberation of the proposed study. The IRB office staff will determine if a quorum of members in present and inform the IRB Chair when quorum is met. Members not present for a substantial part of the discussion and deliberations should abstain from voting. The presence of a quorum of members is documented in the meeting minutes.
Full Committee Actions
The IRB may render one of the following determinations for each protocol reviewed at a convened meeting:
- Approved: In order to approve research, the IRB will perform an ethical and scientific review of all human subjects research to the extent necessary to determine that all of the requirements of 45 CFR 46.111, criteria for IRB approval of research, are satisfied.
- Approved with conditions (i.e. approved once more information is provided or revisions are made): In such cases, the IRB will vote whether the revised documents can be reviewed and approved by the IRB Chair, with any designated member, or by the full committee.
- Approve some components of the proposed research and defer taking action on other components: The committee may approve components of the proposed research and allow the investigator to initiate research activities only related to those approved components. In such circumstances, the committee must ensure that the approved components of the research study are scientifically valid and satisfy all criteria required for IRB approval, even if the other components are never approved and conducted.
- Disapproved: The IRB may determine that a protocol describes a research activity that is deemed to have risks which outweigh potential benefits or the protocol is significantly deficient in several major areas. In such cased the protocol and/or other documents will need to be completely re-written and re-submitted as a new submission.
Situations may arise in which the IRB considers observing the informed consent process as a method for protecting study subjects. The IRB Chair will appoint an individual from the IRB office staff or from the IRB to oversee this process. This individual will attend and observe the informed consent process between the study investigator and the subject.
PIs will be notified of full board IRB decisions through PACS within (7) business days following the convened meeting at which the study was discussed or voted on.
All study modifications to full board reviewed studies must be approved before investigators can implement the changes in their protocol. Investigators need to complete the electronic modification form in PACS and upload any relevant documents that are being modified. Modifications will be reviewed by the IRB Associate Director if previously determined by the IRB that modifcations and continuing reviews can be conducted using expedited review procedures. The IRB Chair and Committee member with relevant expertise may be consulted depending on the modification. If the modifications are substantial or pose any risk to participants, or the IRB previously determined that study modifcations should be reviewed by the full board, they will be discussed at the upcoming full board meeting.
The IRB will determine the interval for the continuing review of the research, appropriate to the degree of risks that will be experienced by subjects. The interval for continuing review will be at least once per year (not to exceed 365 days; 366 days during a leap year) for studies requiring a continuing review, but may be shorter. The following conditions are likely to require review more often than annually:
- There is a high degree of risk to subjects.
- The stage of research is such that many of the risks are unknown.
- The proposed procedures have not been used in humans.
- There have been confirmed instances of serious or continuing noncompliance.
- An IRB member believes more frequent review is required.
- Other reasons for which the IRB requests closer monitoring.
If the IRB voted to approve the expedited review of the annual continuing review, the continuing review can be reviewed and approved by the IRB Associate Director (with the IRB Chair or other committee member, if needed). If no such vote was made, the continuing review must be reviewed by the full committee. Continuing review applications must be submitted through PACS prior to the study expiration date to avoid any lapse in approval. PACS sends an initial reminder 90 days prior to the study expiration date. Investigators need to complete the electronic form through PACS.
Approved Consent Forms
All approved consent/assent forms are stamped with an approval/expiration date and
are available in PACS under the study history. Investigators must use the stamped
consent/assent forms when distributing to subjects unless providing electronic consent
(in which case the exact language from the approved consent/assent form must be utilized).
If any changes need to be made to the informed consent/assent forms, investigator
must submit a modification through PACS and upload the modified documents. The modified
consent/assent forms will be stamped with a new approval date. Please note that the
expiration date does not change. Investigators will receive a new expiration date
only when the study is due for a continuing review and the continuing review application
has been reviewed and approved by the IRB.
D. Notification of Determinations
Investigators will receive a determination letter via PACS that informs them whether their research is approved, requires a modification, or is disapproved. PACS will send an email notification to the investigators alerting them that a decision has been made. Approval and modification request letters can be accessed once they are logged into PACS. Investigators are to respond to any IRB requests via PACS unless otherwise directed.
E. Appeal of IRB Decisions
By federal regulation, organizational officials may not approve research that has not been approved by an IRB. Consequently, NIH does not have an appeal procedure if a protocol is not approved by an IRB. PIs may request an IRB reconsider a decision regarding a human subjects research activity. Investigators do not have the option to seek the reversal of an IRB decision by submitting the same protocol to another IRB.
If an IRB study application is disapproved, the reason(s) for disapproval will be conveyed to the investigator in writing via PACS. This letter will include the committee's decision and concerns regarding the study, listing the federal guidelines that the committee considered in it's decision. The investigator may request the IRB reconsider it's decision by responding in writing, and may request an opportunity to appear before the IRB.
The IRB allows investigators various levels of appeal from the time a study receives initial review through approval or disapproval. IRB decisions are contingent upon the response of the investigator. If the IRB finds that the negotiation is at an impasse, intramural or extramural independent consultant review may be requested.
F. Investigator Reporting Requirements
PIs or any individual involved in the research must report the following problems to the IRB through PACS (under the Reportable New Information tab) within five (5) business days of the occurrance of the activity.
- Adverse events that are (1) unexpected in terms of nature, severity, or frequency given the study protocol procedures and documents approved and (2) related or likely related to the research as determined by the PI.
- Information that indicates a change to the risks (physical, psychological, economic, or social) or potential benefits of the research (i.e. an interim analysis or safety monitoring report indicates that frequency or magnitude of harms or benefits may be different than initially presented to the IRB).
Examples of events that require reporting to the IRB include but are not limited to the following:
- Breaches of confidentiality.
- Changes in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol.
- Incarceration of a participant in an approved protocol.
- Specific protocol-defined events that require prompt reporting to the sponsor.
- Sponsor imposed suspension of a protocol due to possible increased risk.
- Accidental or unintentional deviations from the IRB approved protocol that place one or more subjects at increased risk or that have the potential to occur again.
- Emergency protocol deviations taken without prior IRB review to eliminate apparent immediate hazard to research participants.
- Complaints of participants that indicate unanticipated risk or which cannot be resolved by the research staff.
Failure to Report
Failure to report the above infomration is a breach of the conditions under which IRB approval is given, and could result in suspension or revocation of study approval.
Review of Reports
Upon receipt of a report, the IRB office staff will review the Reportable New Information provided by the investigator through PACS and determine the appropriate course of action using the OHRP guidance on unanticipated problems involving risks and adverse events. Reports may be handled administratively or forwarded to the IRB for review at a convened meeting.
All unanticipated problems involving risks to participants or others are handled by the convened IRB. If reviewed at a convened meeting, a copy of the investigator report, the study protocol, and any consent documents will be provided to the IRB members. Upon discussion, the IRB will determine whether the reported event does in fact represent an unanticipated problem involving risks to subjects or others. However, if after reviewing the information, the IRB determines that the event was not an unanticipated problem, the issue will be returned to the IRB office staff to be handled administratively.
Possible IRB Actions
When a research-related incident/problem requires review, the following corrective actions may be taken:
- Suspension of the research.
- Termination of the research.
- Notification of study subjects when information about the noncompliance may affect their willingness to continue participation.
- Modification of the protocol.
- Modification of the continuing review schedule.
- Modification of the informed consent process or documents.
- Providing additional information to past subjects.
- Requiring current subjects to re-consent to participate.
- Monitoring of the research or the consent process
- Referral to other organizational entities.
G. Allegations and Findings of Noncompliance
Binghamton University complies with all applicable human subjects research regulations. The IRB is responsible for investigating allegations of noncompliance and reporting any findings of serious and/or continuing noncompliance to the Assistant Vice President of Research Compliance who serves as the Institutional Official (IO) in such matters.
Allegations or reports of protocol deviations or noncompliance may be identified via monitoring visits or via communication by someone other than the researchers directly involved in the study. The IRB Associate Director and/or the IRB Chair are the individuals to receive reports of instances of noncompliance via e-mail, telephone, or any method of communication. Such reports of noncompliance may be made by Principal Investigators (PI's), faculty, staff, subjects in the research, students, and anonymous persons. The identity of an individual who makes a report will remain confidential unless the individual provides permission to disclose his or her identity.
Response to a Report
Upon receipt of a report or allegation of noncompliance, or upon identifying noncompliance as part of a review process, the IRB Associate Director and the IRB Chair will review the incidence of noncompliance to determine the legitimacy and/or seriousness of the allegation. If noncompliance is not found, no further action is taken.
Noncompliance that is Not Serious or Ongoing
Problems that are clearly not serious and/or continuing noncompliance may be managed by IRB Associate Director in conjunction with the IRB Chair. If the noncompliance is clearly neither serious nor continuing, and there is a corrective action plan that can be readily implemented to prevent recurrence, then the matter may be handled as a protocol deviation. If the noncompliance is neither serious nor continuing, the IRB Associate Director and the Chair work with the non-compliant parties to develop an appropriate corrective action plan. If the non-compliant parties do not work with the IRB in a collaborative effort to develop a corrective action plan, the noncompliance will then be handled as serious or continuing noncompliance.
Serious or Continuing Noncompliance
Incidents appearing to involve serious and/or continuing noncompliance with a basis in fact, or if it cannot be determined if there is a basis in fact, may be the subject of further inquiry and will be handled in line with the processes outlined in the University Policy on Responsible Conduct of Research. The IO will notify the PI of any failure of adherence, which may result in the initiation of a Research Misconduct Inquiry as per the policy. In addition to reporting allegations of serious or ongoing non-compliance to the IO, all allegations of noncompliance are included on the agenda for the upcoming IRB meeting.
Upon a determination made by the IO as part of the Policy on Responsible Conduct of Research, all actions will be reported to the applicable regulatory and sponsoring agencies according to the requirements of the IRB's Federalwide Assurance (FWA). Reports of unanticipated problem involving risks to subjects and others, incidents of serious and/or continuing noncompliance, and suspensions and terminations of research activities, will be sent to the applicable regulatory and sponsoring agencies within 30 days of the IO's determination.
Federal reports should be copied to the following individuals, as applicable:
- The Institutional Official (IO).
- OHRP (if the research is federally funded).
- FDA (if the study is subject to FDA regulations).
- Any other federal agency that may have oversight of the study.
- The PI.
- PI’s chairperson and/or dean.
- The faculty advisor, if PI is a student.
- The Office of Sponsored Programs (if the research is funded).
- The sponsor (if the research is funded).
Reports should contain the following information:
- The nature of the event (unanticipated problem involving risks to subjects and others, incident of serious and/or continuing noncompliance, or suspension or termination of research activities).
- Name of the institution conducting the research.
Title of the research protocol and/or grant proposal in which the problem occurred.
- Name of the PI.
- The number assigned to the protocol by the IRB and the number of any applicable federal award, grant, contract, or cooperative agreement.
- The IND or IDE number associated with the study, if applicable.
- A description of the problem including findings of the organization and the reasons for the IRB’s determination.
- A description of any corrective action plan approved by the IRB.
Problems that indicate a significant risk or severity will be evaluated to determine if immediate actions are necessary to ensure the ongoing protection of research subjects, and, if so, the IRB office staff will communicate directly with the PI to implement temporary measures intended to prevent harm to subjects.
If the PI is a student, the Dean of Students will be notified by the IO of noncompliance. The IO will provide the Dean of Students any and all supporting documentation.
Suspension: Temporarily or permanently withdrawing approval for some or all research procedures. Investigators must cease all research activities. Suspended research must undergo continuing review if reinstituted.
Termination: Permanently withdrawing approval for all research procedures. Terminated research is closed and does not require continuing review.
The IRB can suspend or terminate approval of research that:
- Is not being conducted in accordance with the HSRRC's requirements.
- Has been associated with unexpected serious harm to subjects.
The IRB may suspend or terminate research based on information received during its continuing review, monitoring visits, or from complaints made to the IRB.
The following individuals are authorized to suspend or terminate research, including suspension of IRB approval on an urgent basis to remove immediate hazards:
- Convened IRB
- President of the University
- Vice President of Research
- Institutional Official (IO)
- IRB Chair
The PI will be notified of the decision immediately and required to submit a response to the HSRRC.
PI Authority to Suspend or Terminate Research Activities
A PI should always be aware of subject safety issues and should suspend research activities on a study when necessary to remove immediate hazards to subjects. If it is apparent that hazards cannot be eliminated by modification of various aspects of the study (i.e. the study design or inclusion/exclusion criteria) the study should be terminated. PIs must notify the IRB in writing immediately after suspending research activities or terminating a study via PACS (the Reportable New Information tab). The notification should contain information of the facts leading to the decision for the action, a plan for notifying and safely withdrawing current subjects, if applicable (taking into account the subjects rights and welfare) and, if applicable, a plan for notifying former subjects of the suspension/termination and any follow-up that may be required to assure their ongoing safety. The IRB will review reports of PI suspensions or terminations and determine what, if any further actions are required on the part of the PI, and report the suspension/termination to the IO.
Individuals or bodies other than the convened HSRRC suspending or terminating research must report that action to the IRB for review. When the research is suspended or terminated, the convened IRB or the individual ordering the suspension or termination must take the following into consideration:
- Actions to protect the rights and welfare of currently enrolled participants, such
- Whether procedures for withdrawal of enrolled participants take into account their rights and welfare (i.e. making arrangements for medical care of a research study or transfer to another investigator).
- Whether participants should be informed of the termination or suspension.
- The need to report any adverse events or outcomes be reported to the HSRRC.
The IRB must notify PIs in writing via PACS immediately after research activities are suspended or terminated. The notification should contain information on the facts leading to the decision for the action, a plan for notifying and safely withdrawing current subjects, if applicable (taking into account the subjects rights and welfare), and, if applicable, a plan for notifying former subjects of the suspension/termination and any follow-up that may be required to assure their ongoing safety.
The following incidents require reporting to the OHRP per 45 CFR 46.103(a) and (b)(5):
- Any unanticipated problems involving risk to subjects or;
- Any serious or continuing non-compliance with this policy or the requirements or determinations of the HSRRC; and
- Any suspension or termination of HSRRC approval.
These reporting requirements apply to all nonexempt human subjects research that is conducted at Binghamton University, State University of New York. Our Federal Wide Assurance (FWA) has adopted the Common Rule for all research.
Lifting a Suspension
Only the IRB can lift a suspension using either the expedited review process or full board review. The IRB may use the expedited review process to lift a suspension that was directed under the following conditions:
- That was directed by the IRB Chair.
- That was directed by the IO.
- That was directed by the convened board when the board specifically delegates to the IRB Chair the authority to lift the suspension.
The IRB will send written notification to the PI when the suspension is lifted. The letter will be reviewed and signed by the IRB Chair, and sent out by the IRB office staff. A copy of the letter lifting the suspension will be sent to all entitites who received a copy of the notification of suspension.
Convened meetings are scheduled once every month during the fall and spring academic semesters. There are no convened meetings during summer or winter breaks. However, in urgent cases, meetings may be scheduled during breaks as necessary to ensure the protection of human subjects.
Prior to each full board meeting the IRB office staff and the IRB Chair will formulate and review the meeting agenda. Once finalized, IRB members can access the meeting materials (i.e. meeting agenda, protocol(s) to be reviewed, past meeting minutes, etc.) through PACS. All protocols and relevant documents are uploaded to PACS at least seven (7) days prior to the scheduled full board meeting. The members are informed via email that the materials are available online and asked to review the documents and post their comments in PACS. The meeting materials include:
- Meeting agenda.
- New research
- Modification requests
- Continuing review requests
- Minutes from the previous meeting.
- Adverse event / complaint reports.
- All relevant documents for protocol review.
- New business and or topics to be discussed.
A majority of the IRB members and at least one member whose primary concerns is in non-scientific areas are required to review protocols and vote at meetings. It is strongly recommended that IRB members be physically present at the meeting. If physical presence is not possible, a member may be considered present if participating through teleconferencing or videoconferencing. In this case the member must have received all pertinent material prior to the meeting and must be able to participate actively and equally in all discussions. For research to be approved, it has to receive approval of a majority of members present at the meeting.
If this requirement is not achieved or lost at a meeting due to members with conflict of interest being excused, early departures, or a loss of a non-scientist, the meeting is terminated from further votes unless the quorum can be restored. Any absence or loss of quorum should be noted in the meeting minutes.
The IRB may invite consultants with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not be involved in final discussions or vote with the IRB.
Faculty, research staff, students, research subjects, or any other individual who has a question, concern, complaint, suggestion, or input regarding the IRB, or feels that they have been subjected to coercion or undue influence regarding aspects of human subjects research, or feels that they have observed issues of concern regarding human subjects research, may contact the IRB:
Human Subjects Research Review Committee
Biotechnology Building, 2204
Any and all concerns, complaints, input, or suggestions regarding the Binghamton University human subjects research protection program and all allegations of coercion, undue influence, or noncompliance will be thoroughly investigated and, if applicable, corrective actions will be taken to rectify the situation(s). If it appears that the concern/complaint could be an incident of noncompliance, further inquiry will follow procedures previously outlined in this document.
Communication with Investigators
All IRB applications are submitted via PACS which can be accessed by going to the HSRRC website. The IRB office staff primarily communicates with researchers regarding IRB decisions and requests for additional information or clarification via PACS. At times, the IRB office staff may also contact researchers via phone or email to further discuss study related information. Major revisions or changes concerning IRB applications, IRB policies and procedures, or issues pertaining to human subjects research compliance will be communicated to researchers through the IRB listserv, Binghamton University's "Dateline" announcement, and the Division of Research website.
Communication with the Institutional Official (IO)
The IO can access all minutes of convened IRB meetings (including board voting decisions) via PACS or upon request directly to the IRB office staff. Additionally, the IRB communicates all allegations of serious or ongoing non-compliance directly to the IO.
Communication with Research Sponsors
Upon request from the Sponsored Programs office, IRB approval/determination letters or other information pertinent to research funding will be provided to the Sponsored Programs staff.
Communication with Research Subjects
In addition to providing the IRB contact information on the HSRRC website, contact information is also provided on all informed consent/assent documents. When the IRB office staff receives contact from research subjects the staff will take down the subject's name and contact information. In the event that the subject has a question regarding the research he or she is involved in, the IRB office staff will provide appropriate answers and let the subject know that the study PI will be forwarded the information and provided with the subject's name and contact information. In the event that a subject wishes to file a formal complaint, the IRB office staff will gather pertinent additional information from the subject and follow the policies and procedures outlined in this document for allegations and findings of noncompliance.
In the fall of each year, the IRB office staff will submit to the IO a copy of the IRB member roster and current curriculum vitae demonstrating the qualifications of each committee member.
Written IRB policies and procedures are contained on the Binghamton University Human Subjects Research website. Hardcopies can be downloaded or obtained by contacting the IRB office.
The IRB Coordinator will take notes during the IRB full board meetings. The minutes are recorded in sufficient detail to allow an outside observer to reconstruct protocol specific discussion and determinations. Minutes will be provided for IRB review prior to the next convened meeting and all comments will be reviewed by the IRB office staff and addressed as appropriate. A vote for approval of the final version of the minutes occurs at the subsequent convened IRB meeting.
At minimum, meeting minutes will contain the following information:
- A record of members present and absent, with consultants, guests, or other attendees listed separately.
- A record of members who left the meeting during protocol discussions and voting due to a conflict of interest.
- A record of separate deliberations for each protocol reviewed and resulting IRB actions.
- The basis for requiring changes, tabling, or disapproving research.
- Justification for any deletion or substantive modification of information concerning risks or alternative procedures contained in a approved sample consent document.
- For initial and continuing reviews, the specified approval period.
- The voting record for each protocol reflecting the number of members for, against, or abstaining from the vote and when alternate members replaced a primary member.
- A written summary of the discussion of controverted issues and their resolution.
- If applicable, summaries of deliberations of protocols for the inclusion of vulnerable populations.
- If applicable, the rationale for significant risk/non-significant risk device determinations.
- If applicable, protocol specific justifications for waivers of consent and/or research involving vulnerable populations.
All minutes will be stored in the IRB PACS system for 3 years after research is completed or otherwise terminated.
The IRB will retain all records required by the regulations (i.e. meeting minutes, correspondence between the IRB and investigators, IRB member rosters, and written procedures required by regulations) for at least three years, and retains all records relating to research that has been conducted or cancelled for at least three years after completion or cancellation of the research. If a protocol is cancelled without participant enrollment, the IRB records will be maintained for at least three years after cancellation. In the case of new drug investigations, IRB records will be maintained for two years after the marketing application is approved or, if no application is filed or if the application is not approved, until two years after the investigation is discontinued and the FDA is notified.
The IRB office staff will make records accessible for inspection and copying by authorized representatives of federal agencies or departments at reasonable times and in a reasonable manner.
In order to allow a reconstruction of a complete history of IRB actions related to the review and approval of protocols, the IRB records include copies of:
- Research applications, protocol narrative documents, consent documents, recruitment materials, investigator brochures, and all other documents submitted for review of proposed human subjects research.
- IRB meeting minutes.
- Progress reports submitted by the investigators, including significant new findings.
- Reports of injuries to participants.
- Data and safety monitoring reports, if any.
- Modifications to previously approved research.
- Records of continuing review activities.
- Unanticipated problems involving risks to subjects or others.
- Documentation of noncompliance.
- All correspondence between the IRB and researchers.
- Scientific evaluations, when provided by an entity other than the IRB.
- When applicable, the frequency for the next continuing review.
IRB records document determinations required by laws, regulations, codes, and guidance. IRB records for initial and continuing review of research by the expedited procedure include the justification for using the exempt and expedited procedure and actions taken by the reviewer.
Regulations require that all human subjects research records be retained for three years following the completion of the research unless otherwise specified by the IRB or funding agency. For research covered by the HIPAA Privacy Rule, the requirement is six years after the completion of the research. Investigators must maintain all research records (including a copy of the entire protocol, consent form, amendments, and copies of signed consent forms for each research participant, if applicable, in the approved location noted in the study protocol. These files are to be available for inspection by HHS, FDA, and the University.
Investigators Who Leave the University
If the investigator leaves Binghamton University, the records must be kept at the University in the IRB office or with a designated investigator. The IRB office must be informed of this transfer of records prior to the investigator's departure. The records will be accessible for inspection and copying by authorized representatives of HHS, FDA, and the University.
When a student graduates or otherwise leaves the University, the faculty advisor is then responsible for retaining the research records.
Closure of a protocol should occur when all of the following conditions are met:
- The research is permanently closed to the enrollment of new subjects;
- All subjects have completed all research-related interventions;
- Collection of private identifiable information is complete; and
- Analysis of identifiable information is complete.
Instructions on how to submit a Study Closure via PACS can be found on the HSRRC website.
In coordination with the Office of Sponsored Programs and the Assistant Vice President for Research Compliance/IO, the IRB Associate Director reviews any applicable contract language to confirm obligations and roles of the Researchers and Sponsors regarding the dissemination of findings from the research, when appropriate/applicable. This includes the terms by which at the conclusion of the study, the researcher and/University will be notified by the Sponsor of results that may impact participants and to determine appropriate communication of such information, when appropriate/applicable.
The IRB is responsible for reviewing all applications to ensure that all investigators have the necessary skills and qualifications to conduct the research under review. This includes ensuring that, when applicable, investigators have appropriate licensure, accreditation, or experience. In addition, the IRB will consider the facilities and equipment to be used for conducting the research and seek to maintain the rights and welfare of the research subjects.
All key personnel (PI, Co-PI, faculty advisor, students), including investigators from other institutions, originally listed or later added to a study protocol through a modification, must complete the required human subjects research training through the Collaborative Institutional Training Initiative (CITI). This includes modules relating to ethics, regulations, risk assessment, informed consent, and privacy and confidentiality. More information on the required training can be found on the HSRRC website. Protocol submissions (initial, continuing reviews, and modifications) are checked to ensure all research staff listed on the study protocol have completed CITI training. Protocol determinations, including approvals, are not made until training is complete for all investigators.
The IRB reviews all recruitment procedures associated with proposed research to ensure scientific merit, the protection of subjects from unnecessary risks, and the equitable and non-discriminatory recruitment of subjects. Subjects inclusion and criteria must be appropriate with respect to the safety and well-being of the participants. Additionally, the IRB will consider the scientific and ethical justification for exclusion of classes of persons who might benefit from the research and determine if exclusion is justifiable and allowable. There are several questions in the IRB application in which the PI must describe the proposed study population, the number of subjects to be enrolled, and the procedures to be used for recruitment.
Advertisements and Recruitment Materials
The IRB considers all forms of brochures, advertisements, and recruitment incentives as being directly related to the informed consent process and, as such, these materials must not contain any coercion or undue influence. Advertisements used to recruit research subjects should be focussed on information that a potential subject would need to determine if they are eligible and interested in participating. This includes information such as, but not limited to, the following:
- The name and address of the investigator and/or research facility;
- The purpose of the research, with reference to the fact that the study is investigational;
- A list of potential benefits, if applicable;
- Criteria for eligibility to participate;
- The time and other commitments that will be required of the participant;
- The location of the study;
- Contact information for the PI; and
- A statement similar to: “This study has been approved by The Binghamton University Institutional Board.”
The IRB must review the final copy of printed advertisements to evaluate the relative size of font type used and other visual effects and must review the script of the final audio or video taped advertisements, before study approval will be given.
In some cases a research study may require a pre-screening process in which potential subjects are asked for personal or sensitive information to determine eligibility for the study. Questions asked during this pre-screening process are subject to IRB review to determine if proper procedures are in place for protecting the privacy and confidentiality of the information collected (i.e. shredding of screening answers after pre-screening is complete). This includes evaluating whether or not the description of potential risks and benefits is presented in a fair and balanced manner.
Recruitment of Students and Staff
Binghamton University students and staff have the same rights as any other potential subject to participate in a research project, irrespective of the degree of risk, provided all of the following conditions exist:
- Recruitment should not be conducted in ways that students may reasonably perceive to be undue influence.
- The research must not bestow upon participating University subjects any competitive academic or occupational advantage over other students or staff who do not volunteer. The investigators must not impose any academic or occupational penalty on those not volunteering.
- Due to the potential for perceived or undue influence to participate, University students and staff who desire to participate in the research must not be under the direct supervision of anyone who is involved in the collection of or has access to identifiable data.
- If incentives for participation are offered (i.e. extra course credit), the incentives should not be so large as to cause undue influence. Typically this means that any credit or extra credit must be only a small portion of the total grade.
Researchers Recruiting from Their Own Courses
One circumstance that raises ethical considerations is when researchers recruit students from courses that they are teaching. Of particular concern is the potential for undue influence. Instructors have inherent power over students (i.e. through their responsibility for assigning grades). Because of this, it is likely that some students will feel pressure to comply with requests made by their instructors, regardless of if the instructors actually try to pressure the students. In the rare instances in which recruiting from one’s own class is permissible, researchers are expected to minimize the potential for students to feel pressure to participate. This can be done through a variety of ways including:
- Assigning an individual who does instruct the course or is not affiliated with course grades in any way, to oversee participant recruitment.
- Design the study so that the instructor is blind to the identity of the participants (at least until after the final grades have been assigned). For example, a researcher can run the study and keep any identifying information from the instructor. Before being asked to participate, potential subjects should be informed that the instructor will not know who did and who did not participate (at least until after the final grades have been assigned). The research should be designed so that the instructor cannot infer who participated through indirect means (e.g., by seeing who walks into the laboratory, by getting a list of who earned extra credit for participating in the study).
- If extra credit is being provided for participation in the study, instructors should providing an alternate assignment that class members not wishing to participate in the research can complete.
Whenever possible, researchers should avoid recruiting subjects from their own classes.
It is commonplace in institutions of higher education for academic departments to have subject pools that serve as a registry of individuals who are interested in participating in research and agree to be contacted for potential participation in a study. The IRB provides guidance and oversight of departmental subject pools (i.e. the Department of Psychology SONA pool), and reviews all research requesting subject pool participation. Student subject pools are typically composed of undergraduate students enrolled in particular departmental courses that provide course credit for participation in one or more research projects. All student participation in subject pool research must be completely voluntary.
Departments may provide students with incentives (usually extra credit) to participate in the subject pool. However, reimbursement for participation must not jeopardize the subject confidentiality or anonymity, and subject pools offering extra credit to participating students must provide alternative opportunities for student who do not wish to participate in research to earn the equivalent amount of extra credit.
Subject pools including subjects under 18 years-of age are required to obtain parental permission prior to their involvement in research unless those individuals are emancipated. It is up to the student to decide whether to participate in any study. Course instructors cannot mandate or require student participation.
When reviewing research protocols, the IRB is required to review both the amount of compensation proposed and the method and timing of disbursement to ensure that neither are coercive or present undue influence. What is considered "reasonable" is based upon the time involved, the inconvenience to the subject, and reimbursement for expenses incurred while participating. The amount of compensation and any prorating or scheduling of payments should be clearly described in the informed consent document. Payment to research subjects for participation is part of the recruitment incentive. If a subject withdraws early, payment may need to be prorated to reflect the time and inconvenience of the subjects participating up to that point.
In coordination with the Office of Sponsored Programs and the Assistant Vice President for Research Compliance/IO, the IRB Associate Director reviews the study protocol, any applicable contract language, and consent documents to ensure the language regarding contractual responsibility and medical care and any compensation for research participants that incur a research-related injury, when appropriate/applicable, is congruent.
When applicable, the informed consent document should include a statement that addresses any costs to subjects that may result from participation in the research. All potential participants must be fully informed of the nature and estimated extent of these costs during the consent process.
The potential invasion of privacy or loss of confidentiality resulting from participation in research should be of great concern to investigators conducting human subjects research and must be addressed in the study protocol submission. At times, the risk of serious harm resulting from loss of privacy or confidentiality may exceed the physical or other risks associated with the research. Moreover, loss of privacy or confidentiality associated with a research activity can be considered a moral wrong.
When the IRB considers whether or not a subject's privacy is adequately and appropriately protected in a particular study, consideration will be given to the following:
- The methods used to identify and contact potential participants, and the nature of the information being sought.
- The setting in which participants will be recruited and/or interacting with the investigator.
- The methods used to obtain information about and from participants.
- The nature of the information being obtained from individuals other than the direct participants (i.e. survey information about a family member).
- Whether or not the information is publicly available.
- Whether or not information about the subject is recorded in such a manner as to prevent identification.
- The methods used to limit access to data and consent forms, and if signed consent forms will be kept in a secure location separate from raw data.
Before research is initiated all measures used to ensure confidentiality of data must be understood by all research staff and, once research is initiated, all measures should be followed as outlined in the approved study protocol. Confidentiality procedures must be described in research applications that come before the IRB, including specific steps that will be taken to ensure any information linking participants to the study is maintained in confidence. The requirement of signed consent forms is often waived in sensitive studies if the consent document is the only written record linking participants to the project and a breach of confidentiality presents the principal risk of harm anticipated in that research. A request for waiver of documentation must be noted in the IRB application.
The following information will be considered when the IRB makes a determination of whether or not subject confidentiality is adequately and appropriately protected:
- The anonymity of the data.
- The methods used by the investigator to ensure that information obtained is not improperly divulged (i.e. secure storage).
- The nature and adequacy of the safeguards that will be used to ensure protection of sensitive data.
- The methods used to de-identify data (i.e. substituting codes for participant identifiers, removing names from survey instruments containing data).
- Proper disposal of identified data at the earliest possible time.
- Limiting access to data.
Use or disclosure of subjects’ Protected Health Information (PHI) is generally required to have the subject’s signed authorization (see PHI section). Even in circumstances where a waiver of the requirement for written documentation of informed consent has been approved by the IRB, a signed authorization from the research subject permitting the use and disclosure of their Protected Health Information (PHI), will still be required. The requirement for written documentation authorizing use or disclosure of PHI may also be waived by the IRB under certain circumstances (see PHI section). Confidentiality is best maintained by anonymous data collection. In the event that the HIPAA Privacy Act is more restrictive than the procedures described in the consent requirements, the more restrictive rule must be followed.
Use of Data if Participant Withdraws from a Study
For a variety of resasons, a participant enrolled in a research study may decide to withdraw from the research, or an investigator may decide to terminate a subject's participation. Investigators may retain and analyze already collected data relating to any subject who chooses to withdraw from a research study or whose participation is terminated by an investigator, provided such analysis falls within the scope of the analysis described in the IRB approved protocol. However, for research not subject to Food and Drug Administration (FDA) review, PIs can choose to honor a subject’s request to destroy data relating to the participant or exclude the data from further analysis. Additionally, PIs are encouraged to consider discussing during the enrollment process, verbally or in the consent form, the use or analysis of collected data if a subject chooses to withdraw from a research study. In deception research, subjects should be permitted to withdraw their data at the time of the debriefing.
Researchers are required to describe in the research protocol how informed consent will be sought from each prospective participant or the participant's legally authorized representative (LAR) in keeping with the criteria outlined in the OHRP regulations. Protocol descriptions should identify the setting in which consent will occur and the methods in place to allow for questions and to prevent undue influence on a potential subject. Obtaining consent is to be viewed as both a legal and ethical obligation, and must be obtained prior to enrolling subjects in a study.
Any consent form used to enroll subjects in a research protocol must be reviewed and approved by an IRB prior to enrollment. Approved consent/assent forms will be stamped by the IRB. Modifications to an existing consent/assent form must be approved prior to implementation, at which time the revised consent form will be stamped and dated by the IRB and be accompanied by a formal approval notification. In addition, the IRB may request to observe the informed consent process to ensure adequate consent when the research involves particularly vulnerable populations.
Consent/Assent Form Templates
Researchers are expected to utilize the template informed consent and assent documents provided on the HSRRC website. The consent form template contains all the required regulatory elements of consent. Information given to potential participants must be in language that is understandable to the subject or representative. If it is anticipated or known that there will be non-English speaking potential participants, the consent form must be translated for IRB review and approval.
For long-term studies, researchers are reminded that the informed consent process is ongoing and does not end with the signing of the consent form. Participants should be kept apprised of events that might affect their willingness to participate. Participants who reach the age of majority (18 or older in New York state) while continuing participation in a study, must be consented as adults before participating in any further study activities.
Documentation of Informed Consent
The IRB follows the federal and state regulations for documentation of consent. Please visit the OHRP website for more information about the federal regulations concerning documentation of consent and Article 24-A for New York state regulations concerning documentation of consent. Please contact the IRB office for any question or concern regarding the consent documentation process. At the conclusion of the consent process the person obtaining informed consent should ask the subject who agrees to sign and date the consent form and the researcher must also sign and date the document. Each study subject must be given a copy of the signed consent form.
Informed Consent for Online Research
Internet consent documents should include all the elements of a regular signed consent form. Researchers should maintain the format of the template consent document, with study specific information added, as much as possible.
Parental Permission/Child Assent
For any research involving minors (individuals under the age of 18 years) the federal regulations require the assent of the child or minor and the permission of the parent(s). Children, while not legally capable of giving informed consent, may possess the ability to assent. Similar to the consent process, the assent process should involve investigators taking the time to explain to the child what is going on in the proposed study, why the study is being done, what will be done to them, and that if they object, the research will be terminated. Assent means the potential subject’s affirmative agreement to participate in the research. Investigators are expected to utilize the template assent documents provided on the HSRRC website.
Waiver or Alteration of the Consent Process
The IRB may approve a consent procedure that does not include, or that alters some or all of the elements of informed consent, or that waives the requirement to obtain informed consent provided that the IRB finds and documents all of the following:
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research cannot practicably be carried out without the waiver or alteration;
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation; and
- The research is not FDA-regulated.
A less common set of conditions for a waiver or alteration of consent includes:
- The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or(iv) possible changes in methods or levels of payment for benefits or services under those programs; and
- The research could not practicably be carried out without the waiver or alteration.
Waiver of Documentation of Consent
The IRB may waive the requirement for the researcher to obtain a signed consent form for some or all subjects if it finds any of the following (45 CFR 46.117 (c)):
- The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.
- Each participant will be asked whether he/she wants documentation linking the subject with the research, and the subject’s wishes will govern.
- The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
- The subjects are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
In the revised Common Rule, broad consent is an alternative consent process for use only for the storage, maintenance, and secondary use of identifiable private information or identifiable biospecimens for future, yet-to-be specified research. At this time, the Binghamton University IRB will not implement the institutional use of broad consent, as the tracking requirements are too burdensome. Exempt categories 7 and 8, which rely on broad consent, will not be utilized. The IRB will continue to support investigators seeking subject permission for the collection and storage of identifiable private information/biospecimens for future secondary use research through other processes including comprehensive IRB review and consent procedures as appropriate.
Emergency Waiver of Consent
The waiver of consent may be carried out in human subjects who are in need of emergency therapy and for whom, because of the subjects' medical condition and the unavailability of legally authorized representatives of the subjects, no legally effective informed consent can be obtained. Due to special regulatory limitations relating to research involving prisoners (subpart C of 45 CFR part 46) and research involving fetuses, pregnant women, and human in vitro fertilization (subpart B of 45 CFR part 46), this waiver is inapplicable to these categories of research.
Binghamton University does not have the faculty, staff or facilities to conduct research that would require a Waiver of Emergency Consent. Binghamton University does not oversee the use of emergency uses of test articles in a life-threatening situation.
Posting of Clinical Trial Consent Forms
For each clinical trial supported by a federal department or agency, one IRB approved informed consent form used to enroll subjects has to be posted by the PI on a publicly available federal website that will be established as a repository for such forms. The form must be posted on the federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject.
Proxy Consent - Research Conducted in New York State
New York state law requires that surrogate consent, other than that of a parent or legal guardian (a legal guardian is defined as an individual who has obtained legal guardianship through the Surrogate Courts Proceedings Act §1700 ff., Domestic Relations Law §81 and Article Six of the Family Court Act), is not allowable, unless there is a legal document that specifically authorizes another to act on behalf of someone for research purposes (Public Health Law Section 2442). For example, the consent of a friend would not be allowed. Those individuals allowed to give consent to a third party include:
- Persons appointed as health care agents.
- Court appointed guardians.
- Next of kin in the following order: spouse, adult child, parent, and adult sibling when there is a legal document that specifically authorizes another to act on behalf of someone for research purposes as per Public Health Law Section 2442.
- Research conducted outside New York state.
It is the PI's responsibility to ensure that federal guideline 45 CFR 46.102(i) is followed: Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. Therefore the PI must provide to the IRB documentation of state law concerning proxy care where the research is being conducted and these laws must be incorporated in the consent process.
Research Conducted Outside of New York State
It is the PI's responsibility to determine which individuals are considered ,"children" or "guardians" outside of New York state to ensure that federal guideline 45 CFR 46.102(i) is followed: (c) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.
FDA requirements for permission by parents or guardians and for assent by children (21 CFR 50.55(e)(1)).
- Where parental permission is to be obtained, the IRB may find, if consistent with state law, that the permission of one parent is sufficient for clinical investigations to be conducted under 21 CFR 50.51 or 21 CFR 50.52.
- Where clinical investigations are covered by 21 CFR 50.53 or 21 CRF 50.54, and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child if consistent with State law.
Therefore the PI must provide to the IRB documentation of state law concerning proxy care where the research is being conducted and these laws must be incorporated in the consent process.
Researchers are responsible for informing subjects of any new information that might affect their willingness to continue participation in the research. In these cases, an amended consent form, delineating the findings and the changes to research risks/benefits, must be reviewed and approved by the IRB. Participants should then be briefed on the changes, asked if they wish to continue participation and signify their willingness to continue participation by signing the amended consent form.
Research Involving Audio, Video, and/or Photographic Recordings
Recording the voice or image of an individual creates a type of record that requires unique handling and storage, particularly if the content may be considered sensitive. Research subjects must be informed that such recordings will occur, and be provided with information about the storage, confidentiality, and future use of the recordings in the consent document. The subjects must be informed of the following:
- The type of recording that will be utilized;
- Specific identifiers that will be recorded;
- Who will have access to the recordings;
- Processes in place for protecting confidentiality of the recordings;
- When the recordings will be destroyed or if they will be kept indefinitely; and
- Purposes the recordings will be used for: educational, commercial, analysis, and/or unspecified use.
The informed consent should include an additional signature line for recording permission. If recording is required in order to participate in the research, informed consent must clearly state signing the informed consent indicates agreeing to participate in research and giving permission to be recorded.
G. Research Utilizing Surveys
Survey instruments have become some of the most used data collection tools in the social sciences and now, more than ever, researchers are using the internet for ease of survey distribution. Regardless of how surveys are distributed (in-person or online), the IRB must review the proposed research, including a final version of the survey instrument. While research involving the use of surveys is often minimal risk and able to be reviewed by an exempt or expedited process, there is always a requriement to obtain informed consent from research participants. For research utilizing surveys, approval is usually granted for an informed consent process that includes a consent document in the form of a cover letter that is presented at the beginning of the survey. In many cases the requirement for obtaining written documentation of consent (a signature) is waived as subjects agree to participate by completing the survey.
Researchers who utilize e-mail surveys should add the following information to their message:
- The message should state at the outset where the e-mail addresses were obtained.
Include either a statement that there will be no future mailings or an “opt-out” message that directs the researcher to remove the subject’s name from future mailings.
- If there will be future e-mails, add the statement, “If you do not respond to this survey or return the “opt-out” message, you will receive repeat e-mail messages X times during the next Y weeks.
- Include the PI's contact e-mail address and telephone number.
- Use a “blind copy format” so that the list of recipients will not appear in the message header.
H. Community-Based Research
Community-based research is an important subset of research being widely conducted at Binghamton University. While "community-based research" is a term that carries many different meanings, the IRB will use the term to refer to any research that takes place in or involves a community. The degree of engagement of the community or degree of shared governance can be along a spectrum. When investigators conduct these types of research activities, theres is an intent to strengthen community partnerships and to demonstrate respect for community values. While traditional human subjects research protections have focused on the risks and benefits to individual research participants, community-based resaerch involves interactions with the community at large, and therefore requires consideration of the risks and benefits to the entire stakeholder community. Because there is a continuum of involvement between University investigators and communities, a single set of guidelines is not appropriate. However, all research involving communities should follow best practices for respectful and productive relationships.
XII. RESEARCH INVOLVING DECEPTION
Sometimes information must be withheld from research subjects or false information needs to be provided to them. This may be for substantive reasons (i.e. to distinguish perceptual causes from other causes) or methodological reasons (i.e. to ensure natural reactions or to avoid placebo effects). These circumstances inherently involve a breach of the concept of informed consent. Consequently, several serious concerns must be addressed before such research can take place.
The following are potential risks associated with deception:
- Subjects may feel that they were coerced to act against their will.
- Subjects may feel ashamed, guilty, stressed, or embarrassed because they now have knowledge about themselves that they otherwise would not have known or would not want to know.
- Subjects may feel a loss of control that will cause distrust and suspicion regarding human subjects research in general.
- The research may undermine the trust in professional standards governing human subjects research.
The following are general guidelines regarding the design, review and conduct of studies involving deception and incomplete disclosure:
- The use of deception is only acceptable for studies that are minimal risk.
- The use of deception should have no adverse effects on the well-being of the subjects.
- Subjects must be provided with sufficient information for them to decide whether to participate and, as in all other human subjects research, be allowed to withdraw at any point without penalty.
- No information can be withheld from subjects that could significantly affect their decision to participate (i.e. the subjects would likely participate anyway if they knew all the information).
- The IRB must be provided with sufficient information to determine that the value of the research outweighs the risk of waiving some aspects of the requirement for full disclosure in the informed consent process.
- There is no reasonable alternative to scientifically and effectively address the research question without the use of deception or incomplete disclosure.
- When the deception involves a falsehood told, no information can be provided to subjects that would have a harmful effect on them if the statement were believed.
- Subjects should be informed about the nature of the research in a way that does not invalidate the data.
- All subjects must be debriefed as soon as possible after their participation regarding the true nature of the research.
The debriefing process should:
- Explain all truths not revealed and all falsehoods told to research participants.
- Address the reasons the deception was necessary.
- Reassure subjects that their reactions to the deception was normal.
- Inform subjects of their right to withdraw their data if they wish.
All debriefing scripts must be submitted as part of the IRB application. The debriefing should be conducted verbally, whenever possible, and those conducting the debriefing should be trained to elicit and respond to subject concerns. If having incomplete or erroneous information is not likely to be harmful to subjects, the IRB will consider delaying the debriefing until all subjects have completed their participation.
The following Binghamton University procedures and New York state laws must be taken into consideration when designing a research protocol that involves the use and storage of human genetic materials:
- NY Civil Rights Law Section 79-L: Each disclosure or re-disclosure (human subjects identified) of the test results requires the express informed consent of the test subject, and no general waivers are deemed informed consent.
- NY Civil Rights Law Section 79-L: While informed consent is required to allow research access to specimens; explicit re-consent is not required once linked identifiers are removed.
For the purpose of this manual, "Genetic Materials" are defined as human tissue samples (saliva, blood, serum, tumor, etc.) on which genetic-related research, such as identification and location of specific genes, study of gene products, inherited human traits, or identification and analysis of DNA mutations, may be performed. Research involving genetic materials may require the Institution Biosafety Committee approval prior to beginning the research.
In the informed consent, researchers need to explain whether the collected genetic samples (de-identified or with identifiers) will be used for future research.
Prospectively Acquired Anonymous Samples
For research in which samples (blood, tissue, saliva, etc.) will be prospectively acquired without identification, the following issues must be presented in the consent document:
- How anonymity of the samples will be accomplished (some basic information, such as age and gender, may be retained with the sample);
- Ownership of the genetic material (usually the University);
- The general scope of the investigation, but new avenues of investigation in the future are permissible if this possibility is presented and explained during the consent process;
- Whether the sample or its genetic material will be shared by other investigators'
- That information specific to an individual subject cannot be shared due to sample de-identification. However, information that accrues from the study that is valuable to society will be shared through publications.
Research utilizing samples collected with identifiers must consider the following issues as appropriate:
- If genetic material is linked to the donor by specific identifiers, ownership of the material will generally remain with the institution. If a commercial use is anticipated for the genetic material, the individual must be notified.
- If identifiers are present, new experiments (not described in the original consent form) must be reviewed by the IRB and new consent obtained from the research subject regardless of the details of ownership.
- The PI may include a provision in the consent form for new experiments not requiring new consent if identifiers are irrevocably removed from the samples. If the PI anticipates future experiments without identifiers, this possibility should be presented in the original consent form. The methods for removal of identifiers must be approved by the IRB. Removal of identifiers must not be employed as a method of avoiding ownership issues.
- A satisfactory method for sharing or withholding information gained by the research
must be in the research protocol and clearly indicated in the consent form.
Details for sharing or not sharing the genetic material with other investigators must be present in the protocol and clearly indicated in the consent form.
- The length of time the genetic material will be maintained must be indicated in the consent form.
This section does not apply to PIs who collect biological fluids or other types of human tissue for analysis as a part of a specific research project. A human tissue or data repository is a collection of tissue samples or data with the intent of establishing a relatively large collection of data or tissue that will be accessed by other investigators who may or may not be located at the University.
Archived Specimen Repository Requirements
When proposing to establish an archive of biological materials, the researchers must contact University Environmental Health and Safety and the Institutional Biosafety Committee for consultation. An Archived Specimen Repository will require regular inspection by Environmental Health and Safety and Institutional Biosafety Committee approval.
The Archived Specimen Repository must be sufficiently secure to prevent theft, loss, or destruction of valuable information. The laboratory director should be aware of all individuals with access. The facility should be locked and accessible to laboratory personnel with key access. The Archived Specimen Repository should be equipped with key-card access which will provide electronic time-stamped recording of personnel entering the facility.
In order to function as human biological repository and specimen bank, the Archive will be required to establish an official material transfer agreement (MTA) and data use agreement (DUA) for those researchers interested in obtaining samples. The Office of Entrepreneurship and Innovation Partnerships-Technology Transfer unit (https://www.binghamton.edu/research/innovation/technologytransfer.html) in the Division of Research will oversee this process. Laboratory directors/PIs will be required to forward all MTAs to the IRB office.
The IRB must review and approve the procedures and conditions under which data and/or tissue specimens are collected, stored, and shared; and ensure that there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data. Documentation of informed consent should be obtained from each donor subject. The informed consent document should also contain an acknowledgement that collector-investigators and the repository are prohibited from providing recipient investigators with access to the identities of donor-subjects or to information through which the identities of donor-subjects could be readily ascertained.
If the specimens in the Archived Specimen Repository are identifiable and belong to living subjects, obtaining a Certificate of Confidentiality before sharing information may be required. This certificate can be obtained through the National Institutes of Health or other non-HHS agencies including but not limited to the CDC and FDA. The appropriate agency will be dependent on the research/repository.
For research involving vulnerable populations as participants, the IRB must consider additional safeguards to protect their rights and welfare such as: recruitment inclusion and exclusion criteria; informed consent and desire and capacity to volunteer; coercion and undue influence; and confidentiality of data. In addition to the responsibilities prescribed for IRB's under 45 CFR Part 46, Subpart A, the IRB must also follow special procedures with respect to pregnant women, fetuses, neonates of uncertain viability, prisoners, and children as specified in Subparts B, C, and D.
Research Involving Neonates
When research involves neonates of uncertain viability and nonviable neonates, the IRB determines and documents:
- Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing potential risks to neonates.
- Individuals engaged in the research have no part in determining the viability of a neonate.
- One of the following is true:
- The research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective.
- The purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there is no added risk to the neonate resulting from the research.
- The consent of either parent of the neonate is required or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective consent of either parent’s legally authorized representative is required, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.
When research involves nonviable neonates, the IRB determines and documents:
- Where scientifically appropriate, preclinical and clinical studies has been conducted and provided data for assessing potential risks to neonates.
- Individuals engaged in the research have no part in determining the viability of a neonate.
- Vital functions of the neonate are not artificially maintained.
- The research will not terminate the heartbeat or respiration of the neonate.
- There is no added risk to the neonate resulting from the research.
- The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means.
- The consent of both parents is required, except:
- If either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the consent of one parent is required.
- If the pregnancy resulted from rape or incest the consent of the father need not be obtained.
- When the research involves non-viable neonates, the IRB is not allowed to approve the consent of a legally authorized representative.
Review of Non-HHS Funded Research Involving Pregnant Women and Fetuses
For studies not greater than minimal risk and not funded by HHS, 45 CFR Part 46, Subpart B may be used as a guide, but determinations of approval for inclusion of pregnant women will predominantly be made by assuring that risks to the fetus are minimal and all criteria for approval under 45 CFR 46.111 are met.
Review of Federally-Funded Research Involving Pregnant Women and Fetuses
Federally-funded research activities requesting inclusion of pregnant women may be undertaken if all the following conditions, 45 CFR 46.204, are met:
- Where scientifically appropriate, pre-clinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses;
- The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means;
- Any risk is the least possible for achieving the objectives of the research;
- If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, the consent of the mother will be obtained in accordance with the informed consent provisions of 45 CFR 46, Subpart A unless altered or waived in accordance with 45 CFR 46.116(d);
- If the research holds out the prospect of direct benefit solely to the fetus, then the consent of the pregnant woman and the father is obtained in accordance with the informed consent provisions of 45 CFR 46, Subpart A, except that the father’s consent need not be obtained if he is unable to consent because of non-availability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest;
- Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate;
- For children as defined in 46.402(a) who are pregnant, assent and permission are obtained in accord with the provisions of 45 CFR Part 46, Subpart D.
- No inducements, monetary or otherwise, will be offered to terminate a pregnancy for the purposes of the activity;
- Individuals engaged in the research will have no part in any decisions as to timing, method, and procedures used to terminate a pregnancy; and
- Individuals engaged in the research will have no part in determining viability of the neonate.
Recognizing that prisoners may be influenced by their incarceration to participate in research and in order to ensure that their decision to participate is not coerced, research funded by HHS must adhere to Subpart C of 45 CFR Part 46.
- Prisoner means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
- Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
Composition of the IRB When Reviewing Research Involving Prisoners
- A majority of the HSRRC members (exclusive of the prisoner advocate) must have no affiliation with the prison system, apart from membership on the IRB; and
- At least one IRB member who is a prisoner, or prisoner representative, with appropriate background and experience to serve in that capacity, must be present at any meeting at which protocols including prisoners will be discussed.
Additional Duties of the IRB When Reviewing Research Involving Prisoners
In addition to all other responsibilities prescribed under 45 CFR Part 46 Subpart A, the IRB shall review and approve federally-funded research for inclusion of prisoners only if it finds the research under review represents one of the categories of research permissible in 45 CFR 46.306 (a)(2) and meets all criteria under 45 CFR 46.305(a) as follows:
- Any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired;
- The risks involved in the research are commensurate with the risks that would be accepted by non-prisoner volunteers;
- Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator (PI) provides to the IRB justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project;
- The information is presented in language that is understandable to the subject population;
- Adequate assurance exists that parole boards will not take into account a prisoner’s participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole; and
- Where the IRB finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examinations or care, taking into account the varying lengths of individual prisoner’s sentences, and for informing participants of this fact.
Permitted Research Involving Prisoners
The following biomedical or behavioral research conducted or supported by HHS may involve prisoners as subjects:
- 45 CFR 46.306(a)(2)(A) - The study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects.
- 45 CFR 46.306(a)(2)(B) - The study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects.
- 45 CFR 46.306(a)(2)(C) - Research on conditions particularly affecting prisoners as a class (i.e. vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults), provided that the study may proceed only after the Secretary of HHS has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of his/her intent to approve such research. Note: HHS Secretary consultation does not apply if research is not funded by HHS.
- 45CFR 46.306(a)(2)(D) - Research on practices, both innovative and accepted, that have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners, in a manner consistent with the protocols approved by the IRB, to control groups that may not benefit from the research, the study may proceed only after the Secretary of HHS has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of his/her intent to approve such research.
IRB Expedited Review of Research Involving Prisoners
Research involving interaction with prisoners may be reviewed by the expedited procedure if a determination is made that the research involves no greater than minimal risk for the prison population being studied. The prisoner representative must concur with the determination that the research involves no greater than minimal risk.
- The prisoner representative must review the research as a reviewer, designated by the IRB Chair. This may be as the sole reviewer or in addition to another reviewer, as appropriate.
- Review of modifications and continuing review must use the same procedure for initial
review using this expedited procedure including the responsibility of the prisoner
Research that does not involve interaction with prisoners (i.e. existing data, record review) may be reviewed by the expedited procedure if a determination is made that the research involves no greater than minimal risk for the prison population being studied.
- Review by a prisoner representative is not required.
- The prisoner representative may review the research as a reviewer or consultant if designated by the HSRRC Chair.
- Review of modifications and continuing review (if needed) must use the same procedures as initial review.
Issues Related to Consent
In a closed institution such as a prison there may be extraordinary organizational and interpersonal pressures which intrude on the decision whether or not to participate as a subject in research. This may be particularly evident in group situations and classroom environments. Wherever possible, prisoners should be given the opportunity to reflect on the decision to participate in private.
On occasion, research will be situated in a prison classroom setting assuring the structured program segment for the day. A prisoner who elects not to participate in such research should be offered an alternative program for the time in question to minimize coercion.
Some prisoners may feel they will lose privileges or be punished if they choose not
participate in research; others may hope for favorable treatment or early release if they do participate. Prisoners must be assured they will be neither punished nor rewarded for their participation, and that they can discontinue their participation at any time without an institutional penalty.
Many adult prisoners are deficient readers, many have an incomplete formal education, and many speak English poorly or not at all. Investigators must use necessary measures to assure that these populations clearly understand the nature of the research and its potential risks.
Issues Related to Confidentiality
Special care should be taken to avoid requesting information in a group setting that could jeopardize the safety of individual prisoners. Additionally, care should be taken to insure that confidential materials do not come into the possession of prison administrators, guards, and correctional officers, or other prisoners. Prisoners are much more likely than other populations to be associated with sensitive data. This could include, for example, involvement in illegal activity and HIV/AIDS. Appropriate safeguards are necessary regarding the collection, storage, and destruction of such information.
Issues Related to Research Content
Investigators must be aware that research into certain topic areas within the institution setting can be potentially dangerous for participants. For example, the mere act of interviewing a prisoner about sensitive topics such as gang activity, contraband, and prison prostitution may inadvertently label the respondent as an informant. Great care must be taken to balance the research against protection of the prisoner as subject.
The risk of suicide is an ever present concern in the penal environment. The investigator must assure that debriefing is readily available to the prisoner whenever the subject is questioned about sensitive topics that could evoke self-injury once the prisoner has returned to the privacy of his or her cell.
Research Conducted with the Bureau of Prisons
- A non-employee of the Bureau may receive records in a form not individually identifiable when advance adequate written assurance that the record will be used solely as a statistical research or reporting record is provided to the agency.
- Except as noted in the consent statement to the participant, the researcher must not provide research information that identifies a participant to any person without that participant's prior written consent to release the information. For example, research information identifiable to a particular individual cannot be admitted as evidence or used for any purpose in any action, suit, or other judicial, administrative, or legislative proceeding without the written consent of the individual to whom the data pertain.
- Except for computerized data records maintained at an official Department of Justice site, records that contain non-disclosable information directly traceable to a specific person may not be stored in, or introduced into, an electronic retrieval system.
- If the researcher is conducting a study of special interest to the Office of Research and Evaluation (ORE) but the study is not a joint project involving ORE, the researcher may be asked to provide ORE with the computerized research data, not identifiable to individual participants, accompanied by detailed documentation. These arrangements must be negotiated prior to the beginning of the data collection phase of the project.
When a proposed research study involves children and is supported or conducted by HHS and/or FDA, the IRB must take into consideration not only the general regulatory requirements of 45 CFR 46, subpart A, but the special regulatory requirements as prescribed in 45 CFR 46, subpart D. If the proposed research involves FDA-regulated products, then FDA's parallel regulations apply. Please visit the OHRP website for additional guidance on research involving children.
By regulatory definition, children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under applicable law of the jurisdiction in which the research will be conducted. Generally the law considers any person under 18 years old to be a child.
The IRB must consider the potential benefits, risks, and discomforts of the research involving children and assess the justification for their inclusion in the research. In assessing the risks and potential benefits, theIRB should consider the circumstances of the children to be enrolled in the study (i.e. their health status, age, and ability to understand what is involved in the research) as well as potential benefits to the participants, other children with the same disease or condition, or society as a whole.
For any protocol involving children, the IRB must determine which of the categories of research apply to that study, if any. OHRP recommends that the IRB document the rationale for this choice.
Requirements by Category of Research Involving Children
The HHS regulations at 45 CFR part 46, subpart D permit IRBs to approve three categories of research involving children as subjects:
- Research involving no greater than minimal risk with or without a potential for direct
benefit (45 CFR 46.404).
- Adequate provisions need to be made for obtaining assent of the children.
- Adequate provisions must be made to obtain permission of parents or guardians.
- Research involving greater than minimal risk but presenting the prospect of direct
benefit to to each individual subject (45 CFR 46.405).
- IRB must find that the risk is justified by the anticipated benefits.
- The relation of the anticipated benefit to risk is at least as favorable as alternative approaches.
- Adequate provisions must be made for obtaining assent of the children.
- Adequate provisions must be made to obtain permission of parents or guardians.
- Research involving greater than minimal risk and no prospect of direct benefit to
each individual subject, but likely to provide generalizable knowledge about the subject's
disorder or condition and (45 CFR 46.406):
- The risk represents a minor increase over minimal risk.
- The intervention or procedure presents experiences commensurate with those inherent in the subjects’ actual or expected medical, dental, psychological, social, or educational experience.
- The intervention or procedure yields generalizable knowledge about the subjects’ disorder or condition that is vital to understanding or ameliorating the subjects’ disorder or condition.
- Adequate provisions must be made for obtaining assent of the children.
- Adequate provisions must be made to obtain permission of parents or guardians.
- Research involving greater than minimal risk and no prospect of direct benefit to each individual subject and does not meet the conditions of 45 CFR 46.404, 46.405, or 46.406, but the research presents a reasonable opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (45 CFR 46.407).
Research must meet the following requirements:
- The IRB must find that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health and welfare of children.
- A request must be made by the PI, through the IRB, to the Secretary of HHS or the Commissioner of FDA to approve the research. The Secretary or Commissioner, after consultation with a panel of experts in pertinent disciplines and following opportunity for public comment, may approve the research.
- Adequate provisions must be made for obtaining assent of the children.
- Adequate provisions must be made to obtain permission of parents or guardians.
Assent/Permission Requirements for Research Involving Children
The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent.
- Requirements for documentation of assent depend on the age, maturity, and psychological
state of the child:
- For children under the age of 7, assent is waived or verbal assent is obtained as determined by the HSRRC.
- For children ages 7-12, a simple assent form is used and verbal assent is obtained. The child does not have to sign the assent form.
- For children ages 13-17, a simple assent form is used, verbal assent is obtained, and the child must sign the assent form.
- If the research is approvable under 45 CFR 46.404 46.405, only one parent’s signature is required.
- If the research is approvable under 45 CFR 46, 406, 46.407, both parents must sign the parental permission form, unless one parent is unavailable or not competent to consent.
- For research approved under 45 CFR 46.404, 46.405, the parents can override a child’s decision not to participate. Parents cannot override a child’s decision not to participate if the research is approvable under 45 CFR 46.406, 46.407. The IRB could waive the requirement for the child’s assent, in which case the parents could override the child’s decision to participate for all research activities.
- A legal guardian could only give permission for inclusion of a child as a research
subject if the document granting guardianship authorizes the person to give permission
for “medical care including research.”
Exceptions to Assent Requirements for Research Involving Children
When the IRB determines that assent is not a requirement for some or all children in a study, the IRB determines and documents one or more of the following:
- The children are not capable of providing assent based on their age, maturity or psychological state.
- The intervention or procedure holds the prospect of direct benefit that is important to the health or well-being of the child and is available only within the context of the research and the capability of the children is so limited that they cannot reasonably be consulted.
- Assent can be waived using the criteria for waiver of the consent process.
Waiver of Permission Requirements for Research Involving Children
If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is consistent with federal, state, or local law. Requests for a waiver of the requirement for parental permission and/or a waiver of the requirement to obtain written documentation of consent will be done on a case-by-case basis.
All research that is requesting waiver of parental permission, must be reviewed by the full board. An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research could not practicably be carried out without the waiver or alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
- Permission by parents or guardians shall be documented in accordance with and to the extent required by 46.117 of subpart A.
- When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.
Compensation to Children and/or Parents
In considering the amount of compensation to be given to a child and/or the child’s parents, PIs must take special care to ensure a child would not simply assent to participate based on the amount or type of compensation. In addition, the amount of compensation should not be so large that the parents would provide undue pressure on the child to assent to participate. The PI should consider that the type or amount of compensation may be coercive in some situations and not coercive in others and make every effort to establish a compensation amount and schedule that will not be a factor in the child’s decision to participate or the parent’s decision to give permission.
Wards - 45 CFR 46.409
Children who are wards of the state or any other agency, institution, or entity can be included in research approved under §46.406 or §46.407 only if such research is:
- Related to their status as wards; or
- Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.
Research approved for inclusion of wards under 45 CFR 46.406 or 45 CFR 46.407 shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as a guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child’s participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the PI(s), or the guardian organization.
Schools do not have the authority to give consent for children to participate in research; only parents or guardians have that authority. However, permission from the school district(s) must be obtained before conducting research in schools. The letter of permission needs to be on the official school letterhead and signed by the school official (i.e. principals or superintendents). A template is provided on the HSRRC website.
In conducting research on children, every attempt must be made to minimize coercion to participate. Researchers must remember that children are in a dependent relationship with adults and special care must be taken to ensure that the decision to participate as research subjects made by children is truly voluntary. When the investigator is unfamiliar with the population to be studied, he/she should consult experts to determine the degree of coercion in the procedures to be used. Such judgments are inevitably subjective and often result in negotiation between the IRB and investigators, who should be prepared to justify chosen study procedures.
Individuals, for a variety of reasons, may be incapacitated to the extent that their
decision-making capabilities are diminished or absent. Impaired capacity is not limited
to individuals with neurologic, psychiatric, or substance abuse problems. Conversely,
individuals with these problems should not be presumed to be cognitively impaired.
Cognitively impaired persons have a diminished capacity for judgment and reasoning due to psychiatric, organic, developmental, or other disorders that affects cognitive or emotional functions. Decision-making capacity may fluctuate.
Initially, the PI must assess whether or not the study could be performed utilizing competent subjects (those without impaired decision making capacity) and determine that competent persons are not suitable for the proposed research. PIs must demonstrate to the IRB that there is a compelling reason to include incompetent individuals or persons with impaired decision making capacity as subjects by considering the following:
- Incompetent persons or persons with impaired decision making capacity are not being proposed as subjects simply because they were readily available (they comprise the only appropriate subject population) ;
- The proposed research entails no significant risks, tangible or intangible, or if the research presents some probability of harm, there is at least a greater probability of direct benefit to the subject;
- The research does not impose a risk of injury, unless the research is intended to benefit each subject and the probability of benefit is greater than the probability of harm;
- Procedures are devised to ensure that subjects’ legally authorized representative (LAR) is well informed regarding the investigators role and obligation to protect incompetent subjects or persons with impaired decision making capacity;
- LARs will be told that their obligation is to try to determine what the prospective subject would do if competent, or if the prospective subject’s wishes cannot be determined, what they think is in the incompetent person’s best interest.
The IRB shall consider the ethical concern of how the individuals with psychiatric, cognitive, or developmental disorders, or those who are substance abusers, have the capacity to understand the information presented and their ability to make a reasoned decision about participation. Both the IRB and PI must recognize that decision-making capacity may fluctuate and require ongoing assessment throughout the course of the research.
As the level of impairment increases, along with an increase in risks and discomforts, safeguards should also increase proportionate to the severity of the impairment. The autonomy of the individual with impaired decision-making capacity should be respected. Individuals with impaired decision-making capacity may need more time to consider the information they are given regarding the research. Information should be provided incrementally to facilitate understanding. Planned waiting periods to allow potential participants to consult with family members about whether to participate or not may be useful.
Surrogate Permission with Subjects Judged Incompetent to Consent
A research subject must be competent to give informed consent; otherwise, the consent of the legally authorized representative (LAR) of the patient must be obtained. In New York state incompetent subjects include children (those individuals under 18 years of age) and the mentally disabled. If competency issues are anticipated for a study, they must be acknowledged in the research proposal and the procedures used to evaluate competency must be described in detail.
- 45 CFR 46.402(e)
- Guardian: an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.
- 45 CFR 46.102(i)
- Legally authorized representative: an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.
New York State Definition
- Legal guardian: an individual who has obtained legal guardianship through the Surrogate Courts Proceedings Act §1700 ff., Domestic Relations Law §81 and Article Six of the Family Court Act.
New York State law states that surrogate consent, other than that of a parent or legal guardian is not allowable, unless there is a legal document that specifically authorizes another to act on behalf of someone for research purposes (Public Health Law Section 2442). For example, the consent of a friend would not be allowed. Those individuals allowed to give consent to a third party include:
- Persons appointed as health care agents.
- Court appointed guardians.
- Next of kin in the following order: spouse, adult child, parent, and adult sibling when there is a legal document that specifically authorizes another to act on behalf of someone for research purposes as per Public Health Law Section 2442.
Students, employees, economically or educationally disadvantaged individuals, racial or ethnic minorities, terminally ill, and individuals with AIDS or HIV+ are also considered vulnerable subjects although the federal regulations do not provide explicit protections for subjects in these categories. When conducting research involving these populations, investigators need to take the following into consideration:
- The compensation to human subjects should not be so great as to constitute an undue inducement.
- Recruitment should be conducted in such a manner that individuals with any power or authority over subjects are not engaged in the recruitment process.
- Sensitive subjects such as health, sexual activity, or the use of illicit drugs or alcohol, and personal health information present increased confidentiality risk to subjects and they should be made aware of and protected from these risks to the greatest extent possible.
Research in foreign countries also presents special concerns regarding the rights and welfare of human subjects. All policies and procedures that are applied to research conducted domestically are applied to research conducted in other countries. It is also expected that researchers will comply with local laws and take into account the cultural context of the country in which the research will be conducted. In general, the IRB accepts the standards of the location in which the research is taking place, unless those standards grossly violate the basic principles of ethical human subjects' research. In some cases the Binghamton University IRB will rely on the foreign IRB as the IRB of record through coordination of a reliance agreement.
Special Note: If you are or will be conducting research outside of the United States, please be aware that Binghamton University has an International Travel Safety Committee that approves student, faculty, and staff travel to areas of high risk. Please contact the committee if you anticipate conducting research involving international travel.
Federal regulations for oversight of transnational research, as well as expectations of the Association for Accreditation of Human Research Protection Programs (AAHRPP) require that when conducting transnational research the researcher:
- Will provide the same or equivalent protections to human subjects in research conducted
in other countries.
- The protections need not be the same as provided in the U.S. but should be equal in function or effect.
- Subject autonomy and dignity should be respected.
- Protections should encompass the ethical principles of respect for person, beneficence, and justice.
- Is aware of local laws, regulations, political and socio-economic factors, and cultural
context in all locations where the research is conducted.
- Researchers must have sufficient knowledge of the local context to enable carrying out of the research in ways that protect the rights and welfare of subjects.
- Knowledge of the local context may influence all aspects of the research design.
- Will comply with local laws and adhere to cultural norms.
- Will demonstrate whether the University or investigator has permission to conduct research in the country by local ethics committee review and approval or by certification (approval) by the local government when there is no local ethics committee.
The Binghamton University IRB will require certain information be submitted by the investigator in order to fulfil these requirements. The following information should be addressed in the submitted study protocol:
- Whether the researcher speaks the language of the country in which participants will be enrolled and the research will be conducted. If the researcher does not speak the local language, describe how communication with the research subjects will be accomplished.
- Whether the researcher is familiar with the local customs and culture or whether a local collaborator will be used and the involvement of the local collaborator will have in the conduct of the research.
- Whether the subjects will be paid and, if paid, the amount and how it relates to the local economy and subject income.
- If consent will be obtained, how or from whom will consent be obtained along with
the following information, if applicable:
- Describe local customs/culture in which the subject might not have the autonomy to provide consent and a family member or other person will be providing consent to participate.
- How the researcher will assure that there is no coercion for participation if a person other than the subject will be providing consent.
- If written documentation of consent will be obtained, and:
- If so, a description of how or from whom the consent will be translated.
- If not, a description of how consent will be documented or if there are cultural/other prohibitions regarding use of consent forms. Describe how the privacy for the subjects and confidentiality of their research data will be assured and if there is a local custom that research data be revealed to someone other than the subject. Describe how the communications with the University IRB/local EC will be achieved for requesting amendments or reporting unanticipated problems.
- For student researchers, a description how the academic advisor/faculty sponsor will oversee conduct of the research.
All study materials submitted by the PI, including consent forms and recruitment advertisements, must be in the participants native language as well as provided in the English translation.
The review of transnational research may fall under exempt, expedited or full board review.
Risk Assessment/Involvement of External Consultant
OHRP requires that the IRB have knowledge of the local research context in order to make an accurate risk assessment. This can be accomplished through use of an outside consultant who is familiar with the proposed research site location. In such cases, external consultants who are familiar with the local context/laws of the foreigh research site will be asked to sign a confidentiality statement. Once the confidentiality statement is received, they will be given access to the study materials via PACS.
The following information should be considered by the consultant:
- Questions that might be innocuous in the U.S. could be offensive in certain foreign sites.
- Assuring and maintaining confidentiality may be difficult in other countries.
- Breach of confidentiality in the research locale could have dangerous consequences.
- Depending on political and other factors, there may be dangers to the researcher.
- The informed consent process must honor local custom.
- Some cultures may have a different authority structure for consent. The local consent structure may seem coercive and clash with the researcher’s, reviewer’s, or IRB's views on autonomy.
- Consent is best obtained using the language most familiar to the participants, taking into account some languages/dialects are not written, subjects may be unable to read, or there may be word in the foreign language that do not translate to/from English.
- If researchers are not fluent in the local language, interpreters/translators who are fluent should be used.
- Documentation of consent may be difficult because subjects are illiterate, it may be inappropriate to ask for a signature, subjects may be suspicious or distrustful of giving up their rights, or there may be legal implications when signing documents.
Consultants will be asked to write a summary assessing any risk involved in the study given its cultural context and the appropriateness of the proposed research.
National Ethics Board
Some countries require a separate national ethics board review. Please visit the OHRP website for a list of countries that require additional review from their ethics board. If you are conducting transnational research always consult the Binghamton IRB first to confirm what and to whom documentation must be submitted.
Single IRB of Record for Collaborative Projects
If a project will be conducted in collaboration with a foreign institution and the foreign institution has an FWA, the IRB can sign an Institutional Authorization Agreement (IAA) or Reliance Agreement to rely on them for review of the study. Please contact the IRB office to determine whether such an agreement can be made.
If a proposed research activity involves evaluation of an investigational drug or biological material in humans or before a Food and Drug Administration (FDA)-approved drug can be used for unapproved indications, the sponsor or researcher may need to obtain an FDA Investigational New Drug Exemption (IND). PIs should understand that by obtaining and holding an IND they assume sponsor and investigator responsibilities for the conduct of the research as described in 21 CFR 312.
The IRB office staff will review all documentation submitted by the PI to confirm that one of the following is true:
- The drug has an IND number.
- The sponsor protocol is imprinted with the IND number,
- There is written communication from the sponsor documenting the IND number;
- There is written communication from the FDA documenting the IND number (Required if the investigator holds the IND.); or
- The drug falls into one of the categories of exemption from an IND. [See 21 CFR 312.2(b)]
The FDA defines a drug as:
- An article recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
- An article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and
- An article (other than food) intended to affect the structure or any function of the body of man or other animals; and
- An article intended for use as a component of any article specified in the numbered statements 1, 2 and 3 above.
An FDA-regulated study is a study in which a PI uses a drug in one or more persons and the drug is not an approved drug in the course of medical practice and/or the data collected in the study is intended to be submitted to or held for inspection by the FDA. Some examples are:
- Study of an approved drug to determine safety and/or efficacy in a new disease state.
- A psychology professor gives people ginkgo biloba to look at its effects on learning or memory.
- The agriculture department has developed a genetically modified watermelon with high levels of vitamin A and wants to test if it can be used to treat vitamin A deficiency.
Although IND numbers are generally required for drug studies there are several FDA exemptions from this requirement listed in 21 CFR 312.2(b). PIs must submit documentation to support an exemption and may contact an FDA consumer safety officer for confirmation that the investigation fits one of the exemptions.
Applying for and/or Filing an IND
An IND application should include the facts that satisfy the FDA that the agent may be justifiably administered to a human as proposed. If the PI wishes to apply for and hold an IND, they must give the FDA the information specified in Form FD-1571 Investigational New Drug Application. Visit the FDA website for guidance on completing and submitting an IND.
INDs go into effect 30 days after the FDA receives the IND unless the sponsor receives earlier notice from the FDA. The 30-day period can be extended if the FDA requires additional time for the sponsor to correct deficiencies.
The IRB will review the plan for storage, control, and dispensing of the drug to evaluate whether the plan is adequate to ensure that only authorized investigators will use the drug and they will use the drug only in subjects who have provided consent. When completing the application, the PI will be asked to provide a copy of the research and informational materials generated by the drug company, if applicable.
In general, investigators are responsible for the following:
- Ensuring that the clinical research is conducted according to the signed investigator statement for clinical investigations, the investigational plan and applicable regulations.
- Informing subjects, or any persons used as controls, that the drugs/biologics are being used for investigational purposes. This includes a statement in the consent form.
- Administering the study drug or biologic only to subjects under the investigator’s personal supervision or the supervision of an HSRRC approved sub-investigator.
- Not supplying the study drug or biologic to any person not authorized to receive it (patient or another investigator).
- Complying with all requirements regarding the obligations of clinical investigators and all other pertinent requirements of 21 CFR 312.
- Maintaining adequate records of the disposition of the study drug or biologic to include dates, quantity and use by subjects.
- Returning any unused supply of study drug to the sponsor upon completion, suspension, termination or discontinuation of the clinical investigation. (21 CFR 312.59 and 312.62).
- Permitting the FDA to have access to and copy and verify records or reports (generally not required to divulge subject names) made during the study. (21 CFR 312.68).
- If the investigational drug is subject to the Controlled Substances Act, taking adequate precautions, including storage of the drug in a securely locked, substantially constructed cabinet or enclosure to which access is limited to prevent inappropriate distribution. (21 CFR 312.69).
- Reading and understand information in the Investigator’s Brochure, including potential risks and side effects of the drug.
- As noted above, researchers who apply for and hold an IND are also subject to sponsor responsibilities.
- Complying with Data and Safety Monitoring in Research.
- Following the reporting requirements outlined in the IRB Policies and Procedures.
Additional Reporting Requirements
If the PI does not hold the IND and an external sponsor funds or supports the study, then the PI is responsible for notifying the sponsor of any serious adverse events or unanticipated problems. For any studies under FDA jurisdiction, it is the PI and/or sponsor’s responsibility to notify the FDA within 24 hours of any serious adverse events or unanticipated problems.
Similarly, if the study is a multi-site project and the unanticipated problem occurs at a site other than the University, then the sponsor (PI if they hold the IND) is required to inform researchers of unanticipated problems or reactions that occur at other sites. When PIs are informed of unanticipated problem(s) in sponsor safety memos or other correspondence, then the PI must notify the HSRRC as promptly as possible after receipt of the report from the sponsor
XVIII. RESEARCH WITH INVESTIGATIONAL DEVICES
The IRB office staff will review all documentation submitted by the PI to determine that when an investigator proposes to conduct research that involves evaluating the safety of effectiveness of a device that one of the following is true:
- The device has an IDE number;
- The sponsor protocol is imprinted with the IDE number;
- There is written communication from the sponsor documenting the IDE number;
- There is written communication from the FDA documenting the IDE number (Required if the investigator holds the IDE.); or
- The device falls into one of the categories of exemption from an IDE. [See 21 CFR 812.2(c)]
The regulations at 21 CFR 812.2 do not apply to investigations that fit one of the following categories:
- A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that time;
- A device, other than a transitional device, introduced into commercial distribution on or after May 28, 1976, that the FDA has determined to be substantially equivalent to a device in commercial distribution immediately before May 28, 1976, and that is used or investigated in accordance with the indications in the labeling that the FDA reviewed under Subpart E of part 807 in determining substantial equivalence;
- A diagnostic device, if the sponsor complies with applicable requirements in 21 CFR 809.10(c) and if the testing is i) non-invasive, ii) does not require an invasive sampling procedure that presents significant risk, iii) does not by design or intention introduce energy into a subject, and iv) is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure;
- A device undergoing consumer preference testing, testing of a modification or testing of a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk;
- A device intended solely for veterinary use;
- A device shipped solely for research on or with laboratory animals and labeled in accordance with 21 CFR 812.5(c);
- A custom device as defined in 21 CFR 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.
Applying for and/or Filing an IDE
An IDE application should include the facts that satisfy the FDA that the agent may be justifiably administered to a human as proposed. If the PI wishes to apply for and hold an IDE, they must provide the FDA with the information specified in the guidance for applying for an IDE.
Significant/Non-Significant Risk Determinations
If a PI or sponsor claims a device is not a significant risk, then the IRB will review research involving the investigational device at a convened meeting. The IRB will determine whether the study using the device is significant risk, within the context of the overall study, by reviewing the criteria in 21 CFR 812.3(m). A significant risk device means that the device:
- Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
- Is purported or represented to be for use supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
- Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
- Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
A non-significant risk device study is one that does not meet the definition for a significant risk device study.
If the IRB disagrees with the sponsor’s or PI’s assessment that a device study is “non-significant risk” and determines that the study using the device is “significant risk,” it will notify the PI, and where applicable, the sponsor (21 CFR 812.66) and document its determination in the IRB minutes. The study will be tabled, the sponsor or PI must apply for an IDE, and the study may not begin until the FDA approves the IDE application and the IRB approves the study. Upon receipt of FDA approval, the sponsor or PI must provide the IRB with the FDA’s approval letter or conditional approval letter as part of the re-submission process.
Investigators conducting studies in which an investigational device will be used must ensure adequate control of the device. Adequate control and handling of investigational devices include all of the following:
- Not beginning the study or obtaining informed consent of any subjects prior to HSRRC and FDA approval.
- Ensuring that the investigational device is used in accordance with the HSRRC approved protocol and, the investigational plan and any condition fo approval imposed by teh reviewing IRB and FDA.
- Supervising all testing of the device involving human subjects in accordance with 21 CFR 812.43(c)(4)(ii) and 812.110(b).
- Permiting use of an investigational device only with subjects under the supervision of the PI and supplying the investigational device only to persons authorized to receive it.
- Providing for control or taking adequate precautions, including storage of the device
in a securely locked area to which access is limited to prevent inappropriate use
of the device in accordance with 21 CFR 812.100.
- Investigational devices must be stored in a locked room designated for research or
in a locked cabinet within a room designated for research that is under the direct
control of the PI and accessible only to the PI and his/her authorized and IRB-approved
staff. If applicable, the storage area for investigational devices must be separate
from storage areas for approved devices. An investigational device or its packaging
must be labeled with the following information:
- The name and place of business of the manufacturer;
- Packer or distributor;
- The quantity of contents, if appropriate: and
- The following statement: "CAUTION - Investigational device. Limited by Federal law to investigational use." The label or other labeling must describe all relevant contraindications, hazards, adverse effects, interfering substances, or devices, warnings, and precautions.
- Investigational devices must be stored in a locked room designated for research or in a locked cabinet within a room designated for research that is under the direct control of the PI and accessible only to the PI and his/her authorized and IRB-approved staff. If applicable, the storage area for investigational devices must be separate from storage areas for approved devices. An investigational device or its packaging must be labeled with the following information:
- Maintaining accurate, complete, and current records relating to participation in the
clinical investigation. Specifically, records of receipt, use or disposition of a
device that relate to:
- The type and quantity of the device, the dates of its receipt, and the batch number or code mark.
- The names of all persons who received, used, or disposed of each device.
- Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of.
- Permitting the FDA to inspect and copy any records pertaining to the investigation, including those which may identify subjects (21 CFR 812.145).
- Preparing and submitting to the sponsor:
- Progress reports,
- A final report,
- Financial disclosure reports; and
- Any other information requested by the FDA (21 CFR 812.110).
- Returning any remaining supply of the device (or otherwise dispose of it as directed by the sponsor) upon completion or termination of the clinical investigation or the PI’s part of an investigation.
XIX. Protected Health Information AND HIPAA
In certain cases, research projects may involve the collection, disclosure, or use of Protected Health Information (PHI). Such studies raise issues of confidentiality that must be carefully addressed by the investigator and the official custodian of the records.
If authorization is not obtained initially and, depending upon the design of the study, the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) or state law may require the investigator to obtain specific authorization for the use of the PHI in that particular study.
Health Information Protected by the HIPAA Privacy Act (PHI)
With certain exceptions, HIPAA protects a subset of individually identifiable health information, known as protected health information or PHI. There are eighteen (18) elements, as defined by the HHS, that could be used to identify the individual or the individual's relatives, employer, or household members.
- Patient names
- Geographical elements (such as a street address, city, county, or zip code)
- Dates related to the health or identity of individuals (including birthdates, date of admission, date of discharge, date of death, or exact age of a patient older than 89)
- Telephone numbers
- Fax numbers
- Email addresses
- Social security numbers
- Medical record numbers
- Health insurance beneficiary numbers
- Account numbers
- Certificate/license numbers
- Vehicle identifiers
- Device attributes or serial numbers
- Digital identifiers, such as website URLs
- IP addresses
- Biometric elements, including finger, retinal, and voiceprints
- Full face photographic images
- Other identifying numbers or codes
Binghamton University as a Hybrid HIPAA Entity
The Health Insurance Portability and Accountability Act of 1996 (HIPAA), as modified by the Health Information Technology for Economic and Clinical Health Act, mandates privacy and security safeguards for information about an individual’s health status, care, or payment for care. Individuals, organizations, and agencies that meet the definition of a “covered entity” or “business associate” under HIPAA must comply with its requirements.
At some institutions, it likely that PIs will desire to use individual’s PHI, collected at that institution, for research purposes. The State University of New York has designated itself as a hybrid HIPAA entity. A hybrid HIPAA entity is a single, multidisciplinary entit at which certain departments use PHI as part of their business operations, and other departments do not. A HIPAA covered function is any function that, if performed, makes the performer a health plan, a health care provider, or a health care clearinghouse. Note that only the Binghamton University Institute for Child Development is classified as a covered entity.
How Can a Covered Entity Use and Disclose Protected Health Information (PHI) for Research and Comply with the Privacy Rule?
- De-identifying PHI under the Privacy Rule.
- Acquiring authorization for research use and disclosures.
- Requesting a waiver or alteration of the authorization requirement.
- Using a limited data set and having a data use agreement in place.
PHI can be used or disclosed for research purposes if it has been de-identified and linkage back to a specific subject would not be possible. National Institutes of Health Department of Health Regulations at 45 CFR 164.514(e) provides more details for de-identified information.
Research use or disclosure of identifiable PHI with authorization of the research subject is permitted providing that use or disclosure is for only the PHI that was originally authorized.
In order to use or disclose additional information, the PI would either have to obtain authorization or request a waiver of the requirements to obtain authorization. If the use or disclosure of PHI involves minimal risk for the subjects, a request for waiver of the requirement for signed authorizations may be requested. The IRB must review requests for waiver of the requirement for obtaining authorization for use and disclosure of PHI. If a waiver is approved, the IRB will notify the investigator in writing of its determination.
To use or disclose identifiable PHI without authorization of the research subject, the IRB must determine that the following criteria have been met by the PIs request submission:
- The use or disclosure of PHI is solely used to design a research protocol or to assess feasibility of conducting a study;
- Document that the use or disclosure is solely for research on the PHI of decedents;
- The use or disclosure of PHI involves no more than minimal risk to the research subjects;
- The alteration or waiver will not adversely affect the privacy rights and welfare of the subjects;
- The research cannot practicably be conducted without the alteration or waiver;
- The research could not practicably be conducted without access to or the use of the PHI;
- The privacy risks to individuals whose PHI is to be used or disclosed are reasonable in relation to the anticipated benefits, if any, to the individuals, and the importance of the knowledge that may reasonable be expected to result from the research;
- There is an adequate plan to protect the identifiers from improper use and disclosure;
- There is an adequate plan to destroy the identifiers at the earliest possible opportunity consistent with the conduct of the research, unless there is a health or research justification for retaining the identifiers; and
- There are adequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of PHI would be permitted by this policy.
For more information on HIPAA and personal health information (PHI) researchers are encouraged to contact the IRB Office at firstname.lastname@example.org or (607) 777-3818.
XX. DATA and SAFETY MONITORING IN RESEARCH
Federal regulations require that for any research involving human subjects, when appropriate, adequate provisions for monitoring data to ensure the safety of research participants should be made. The regulations do not specify when or how this monitoring should be accomplished. For each study, researchers and the IRB must determine the type and level of monitoring required to ensure participant safety and well-being.
Minimal Risk Studies
Much of the research conducted at Binghamton University is social and behavioral in nature, and may be considered not to be greater than minimal risk. As such, these studies will not require a Data and Safety Monitoring Plan (DSMP). However, sponsors or the IRB may require DSMPs regardless of risk. In all research, regardless of whether a formal data and safety monitoring plan is required, investigators are responsible for providing ongoing oversight to protect the safety and welfare of study participants.
Greater Than Minimal Risk
All human subjects research involving the use of drugs, biologics, or devices require a DSMP. For other types of interventional human subjects research involving greater than minimal risk, a DMSP should be strongly considered and may be required by the IRB.
Types of Data and Safety Monitoring Plans
DSMP's can range from monitoring by the researcher or a group of researchers to the establishment of a Data and Safety Monitoring Board (DSMB). The methods and amount of monitoring required are dictated, in part, by the type and magnitude of risk involved, the population to be studied, and the complexity of the research.
- Monitoring by an individual investigator: for studies that involve small numbers of research participants at a single site and interventions unlikely to lead to major changes in risks and benefits. Close, continuous monitoring by the researcher and prompt reporting of unanticipated problems to the IRB and sponsor are generally considered to be adequate.
- Monitoring by a group of investigators: for studies where assessments may require additional expertise or objectivity from individual(s) who may or may not be directly involved with the design and/or conduct of the study. Studies overseen by a monitoring group of this type are generally short-term in nature, study endpoints do not include serious events, and risks to participants can be assessed through simple comparisons.
- Data and Safety Monitoring Board (or Committee): for studies involving large numbers of research participants, particularly vulnerable populations, multiple performance sites, blinded study groups, particularly high-risk interventions or when sophisticated data monitoring/statistical analysis is required. FDA regulated studies generally require establishment of a DSMB.
Data Safety Monitoring Boards (DSMB)
Multi-site research that involves a large population may require additional oversight, allowing one group to view all data and monitor any adverse events, unanticipated problems, or complaints. A Data Safety Monitoring Board (DSMB) is a group of individuals who are experts in their field, which are applicable to the study under review. Individuals may have statistical experience, be lay representatives, administrators, etc. This group usually meets one to two times a year and reviews all adverse events reports from all of the study sites.
The DSMB has the power to recommend termination of the study based on the evaluation of these results. There are typically three reasons a DSMB might recommend termination of the study: safety concerns, outstanding benefit, and futility.
While it is important to remember that all studies require careful monitoring, it is also important to know that not all studies require a DSMB. The following questions are designed to help make a determination as to whether or not a DSMB may be needed.
- Are there multiple study sites that involve a large subject population?
- Is there more than minimal risk to subjects?
- Is the clinical trial intended to provide definitive information about effectiveness and/or safety of an intervention?
- Would it be ethically important for the trial to stop early if the primary question addressed has been definitively answered, even if secondary questions or complete safety information were not yet fully addressed?
For more information regarding the guidelines for DSMB's, please visit the NIH website or contact the IRB office at email@example.com.
In coordination with the Office of Sponsored Programs and the Assistant Vice President for Research Compliance/IO, the IRB Associate Director reviews any applicable contract language to confirm any obligations by a sponsor data and safety monitoring body that the organization be promptly notified of any information discovered by the sponsor that could affect the safety of subjects, affect the willingness of subjects to continue participation, influence the conduct of the study, or alter the IRB’s approval to continue the study, when appropriate/applicable.
Department of Defense (DOD) Sponsored Research:
- Research sponsored or funded by the U.S. Department of Defense (DOD) must be reviewed by the IRB under an additional set of regulations (32 CFR 219) that involve special protections for research participants, as well as additional review and reporting requirements for investigators and IRBs. Researchers must meet additional DOD requirements prior to initiation of the research. The DOD follows the DHHS and FDA regulations on human subjects research but also applies DOD Directive 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DOD Supported Research. Investigators should review these requirements when planning a DoD-supported research project as they may add a significant amount of time to the review and approval process of research.