Investigator's Guidelines

Download Investigators Guidelines (PDF)

 

The purpose of this manual is to assist investigators planning to conduct research involving human subjects in designing their research and submitting it for approval. Investigators are urged to read this manual carefully in order to avoid unnecessary delay in obtaining approval for their research.

 

Introduction

Frequently Asked Questions

WHAT is human subjects research?

WHY must it be reviewed?

WHO reviews It?

WHO must submit it?

HOW is it submitted?

WHEN does it have to be submitted?

HOW will it be reviewed?

WHERE can I get assistance?

Planning a Research Project

Educational Requirements

Determining Human Subjects Involvement

Exempt Research Criteria and Guidelines

Expedited Research Criteria and Guidelines

Full Board Review Research and Guidelines

Review Forms

Submission Materials

Protocol Evaluation

Initial Review

Continuing Review

Modifications

Review Procedures

Exempt/Expedited Research

Full Committee Review

Scientific Evaluation

Full Committee Actions

Student Research

Recruiting Study Subjects

Students

Recruiting Subject over the internet

Advertising

Maintaining Records

Conditions of Approval

Continuing Review

Modifications to Approved Research

Protocol Title Changes and Grant Applications

Unanticipated Problems/Adverse Events/Complaints

Reportable Events

Definitions

Review of Reports

 

Introduction

Binghamton University, State University of New York, investigators and their research staff, and the Human Subjects Research Office, musty share a collaborative responsibility and commitment to maintain the highest ethical standards in our research endeavors.

Throughout history scientific research has produced substantial social benefits versus troubling ethical questions. Reported abuses first received public attention during the Second World War, Nuremberg War Crimes Trials. Federal Regulations have been passed that reflect the issues brought up in these trials, as well as, other trials that have brought into question ethical treatment of human subjects.

In 1974 the National Research Act (Pub. L. 93-348) was made into law, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission for the Protection of Human Subjects completed their study and review and published the Belmont Report in 1979. This report details ethical principles and applications to ensure that research is conducted in an ethical manner. The Code of Federal Regulations Title 45 Part 46 contains rules that all Internal Review Boards must follow. Binghamton University incorporates both documents in their review and assessment of risk in human subject’s research.

Binghamton University offers these guidelines to investigators to educate all researchers on policies and procedures that incorporate the ethical standards in conducting human subject’s research. This includes all research conducted at Binghamton University and research involving university faculty, staff or students. Research at Binghamton University adheres to all local, state, federal and, when warranted, international guidelines.

This manual also assists investigators planning to conduct research involving human subjects in designing their research and submitting it for approval. Investigators are urged to read this manual carefully in order to avoid unnecessary delay in obtaining approval for their research. Below are listed some frequently asked questions concerning human subjects research along with brief answers.


Frequently Asked Questions

WHAT is human subjects research?

Research involving "human subjects" means any activity that either:

  • Meets the Department of Health and Human Services (DHHS) definition of “research” and involves “human subjects” as defined by DHHS; or
  • Meets the Food and Drug Administration (FDA) definition of “research” and involves “human subjects” as defined by FDA.

 

DHHS Definitions:

Research: a systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge [45 CFR 46.102(d)]

Human Subject: a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [45 CFR 46.102(f)]

  • “Intervention” as defined by DHHS regulations means both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. [45 CFR 46.102(f)]
  • “Interaction” as defined by DHHS regulations means communication or interpersonal contact between investigator and subject. [45 CFR 46.102(f)]
  • “Private information” as defined by DHHS regulations means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). [45 CFR 46.102(f)]
  • “Identifiable information” as defined by DHHS means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).

 

FDA Definitions:

Research: any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations [21 CFR 50.3(c), 21 CFR 56.102(c)]

  • “Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act” means any use of a drug other than the use of an approved drug in the course of medical practice. [21 CFR 312.3(b)]
  • “Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act” means any activity that evaluates the safety or effectiveness of a device. [21 CFR 812.2(a)]
  • “Any activity in which results are being submitted to or held for inspection by FDA as part of an application for a research or marketing permit is considered to be FDA-regulated research. [21 CFR 50.3(c), 21 CFR 56.102(c)]”

Human Subject: means an individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR 50.3(g), 21 CFR 56.102(e)] A human subject includes an individual on whose specimen a medical device is used. [21 CFR 812.3(p)]


Binghamton University Definitions:

Systematic Investigation: One utilizing the observation of phenomena, the formulation of a hypothesis concerning the phenomena, experimentation to demonstrate the truth or falseness of the hypothesis, and a conclusion that validates or modifies the hypothesis.

Generalizable Knowledge: Information that is gathered to draw general conclusions beyond the context and/or subjects from which the data is gathered
Some research on specimens derived from living individuals may be considered human subjects research under both the DHHS and FDA regulations

 

Some research on specimens derived from living individuals may be considered human subjects research under both the DHHS and FDA regulations.

WHY must it be reviewed?

It is University policy to ensure that the rights and welfare of human subjects are adequately protected in research conducted under its auspices. Federal and state laws require this protection. In order for the University to fulfill its responsibility, all human subjects research conducted under University auspices must receive appropriate review and approval.

WHO reviews It?

The University has established the Human Subjects Research Review Committee (HSRRC) as the institutional review board (IRB) responsible for the institution’s obligations to review research involving human subjects. The HSRRC is composed of individuals of diverse backgrounds, which include a non-scientist, a community advocate, a clergy member, a physician, an attorney and other scientific members who have expertise in the areas of research that are conducted at Binghamton University.

WHO must submit it?

Binghamton University’s policy requires all research projects involving human subjects conducted by University faculty, staff and students or done under the sponsorship and auspices of the institution must be reviewed and approved by the HSRRC.

HOW is it submitted?

Human subjects research projects are submitted via COEUS. The link is available here: http://binghamton.edu/research/compliance/humansubjects/coeuscontact.html

WHEN does it have to be submitted?

When submitting projects, sufficient time should be allowed for adequate review. The HSRRC meets monthly during the academic year, and as needed at other times. For projects requiring full review, proposals must be submitted ten days preceding a meeting to be included on the agenda for that meeting. Projects eligible for exempt or expedited review may submit their protocols at any time and will generally be reviewed within three to five days. Please contact the HSRRC Office for scheduled meetings.

HOW will it be reviewed?

The review of human subjects research includes reviewing the procedures affecting the rights and welfare of human subjects. The review also focuses on such issues as risk to subjects, voluntary participation, informed consent, and confidentiality. Evaluation is also made of the content or scientific merit of research projects that submit subjects to an increased level of risk. In this case the risk/benefit ratio of the project will be reviewed.

WHERE can I get assistance?

The Human Subjects Research Review Office Staff, at 607-777-3818 or hsrrc@binghamton.edu


Planning a Research Project

When an investigator plans to conduct research involving human subjects, he/she would be advised to read through the Investigators Guidelines and contact the Human Subjects Research Review Committee (HSRRC) Office at (607) 777-3818 or hsrrc@binghamton.edu if you have any additional questions. Aspects of the project that may be problematic can be discussed and alternative procedures suggested. At this point, the research often can be designed in a way that
will facilitate approval.

Student Classroom Projects/Quality Improvement/Program Evaluations

Students conducting class room assignments, students faculty and staff which have been contacted to perform Quality Improvements or Program Evaluations which will be gathering information about people through interventions or interactions with those individuals and/or the gathering of private identifiable information about individuals must be reviewed by this office.

Please contact the HSRRC office. Please submit a Determination of Human Subjects Research application for review. The HSRRC Office will make a determination whether the activity is human subject research as defined in "What is Human Subjectst Research?" Conducting initial review, Exempt and Expedited Review or may request additional information to make this determination. You will receive a Notice of Determination of Human Subject Research via email.

It is the faculty members responsibility to ensure that any activity that is "research" involving "human subjects" as defined in IX.A, require HSRR review and approval before the project starts. Federal regulations can be confusing, rather than risk conducting research without HSRRC approval, and be out-of-compliance, it is strongly suggested that you contact our office for assistance in determining if your activity involves human subjects research.

Educational Requirements

All investigators, research personnel, faculty supervisors, and all other individuals involved in human participants research must complete a Human Subjects Research Training Program. Investigators submitting new protocols, as well as those who may be continuing previously HSRRC approved research, must complete the course. The course can be found here. The training program should be completed prior to the submission of your protocol.

Re-certification is required every three years.


Determining Human Subjects Involvement

Principal Investigators should contact the Human Subjects Research Review Office if they are unsure if their research actually involves "Human Subjects". All research projects involving human subjects conducted by University faculty, staff and students or done under the sponsorship or auspices of the institution must be reviewed and approved by the Human Subjects Research Review Committee (HSRRC). This includes research involving subjects from outside the university and research which is not funded. This includes the following types of research, (this is not an exhausted list)

  • All surveys and questionnaires distributed on-campus for research purposes
  • Behavioral and social science research
  • Clinical research
  • Human genetic research
  • Pilot studies

Once it has been determined that an activity is to be considered human subjects research, it will be reviewed under one of three categories: Exempt, Expedited or Full Board Review. The review procedures for each of these are described below. Final authority for making this determination rests with the HSRRC.

Exempt Research Criteria and Guidelines

Federal Regulation 45 CFR 46.101(b) allow certain research to be exempt from
Federal Policy. The exemption status does not apply when the research activities include any of the following:

  • prisoners;
  • surveys or interviews which include children as participants

Exempt Research
Binghamton University grants exemption determinations to research activities in which the only involvement of human subjects will be in one or more of the following categories.

45CFR46.101(b)(1) Educational Strategies, Curricula or Classroom Management Methods

  • Research conducted in established or commonly accepted educational settings
  • Research involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  • Subjects (or their parents) should be provided with overview of project that contains basic elements of informed consent, but no formal written consent is obtained

45CFR46.101(b)(2) Tests, Surveys, Interviews, Observations

  • Studies involving children as subjects, only educational tests and /or passive observation of behavior is permitted; investigators cannot interact with child subjects
  • Studies involving adults as subjects, test, surveys, interviews or behavioral observations can be included if the following conditions are met
    • participation is completely anonymous
    • participation is not anonymous, and the information that will be gathered would not place participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation
  • Studies involving interviews or focus groups (of individuals age 18 or over) provided that the data collected (or topics discussed) would be unlikely to place participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation
  • Studies involving the observation of public behavior

45CFR46.101(b)(3) Tests, Surveys, Interviews, Observations

  • Human subjects are elected or appointed public officials or candidates for public office; or
  • Federal statue(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

45CFR46.101(b)(4) Existing Data, Documents, Records, Pathological Specimens, or Diagnostic Specimens

  • Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
  • All data is currently in existence and stripped of any direct identifiers or indirect identifiers
  • All data is publicly available
  • Medical records to be accessed for study are currently in existence
  • Medical records data is recorded in such a way that the respective patient cannot be identified
  • Specimens may include tissue, blood, or bodily fluid
  • Specimens were obtained independent of this research project
  • All specimens and corresponding data are recorded anonymously
  • Data are recorded in such a way that researchers cannot identify subjects

45CFR46.101(b)(5) Studies which are designed to study, evaluate, or otherwise examine existing programs

  • Research and demonstration projects which are conducted by or subject to the approval of department or agency heads (Federal Agencies), and which are 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.

The Office for Protection from Research Risks (OPRR) has determined that the following criteria (see 48 FR 9266-9270, March 4, 1983) must be satisfied to invoke the exemption for research and demonstration projects examining "public benefit or service programs" as specified under Department of Health and Human Services (HHS) regulations at 45 CFR 46.101(b)(5):

(1) The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act).

(2) The research or demonstration project must be conducted pursuant to specific federal statutory authority.

(3) There must be no statutory requirement that the project be reviewed by an Institutional Review Board (IRB).

(4) The project must not involve significant physical invasions or intrusions upon the privacy of participants.

Institutions should consult with the HHS funding agency regarding the above conditions before invoking this exemption.

45CFR46.101(b)(6) Taste and Food Quality Evaluation and Consumer Acceptance Studies

  • Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Expedited Research Criteria and Guidelines

Federal Regulations allow certain low risk research to be exempt from Federal Policy.
45 CFR 46.110 and 21 CFR 56.110.

Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

(B) The categories in this list apply regardless of the age of subjects, except as noted.

(C) The expedited review procedure may not be used where identification of the subjects
and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

(D) The expedited review procedure may not be used for classified research involving human subjects.

(E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.

(F) Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

 

Expedited Research Categories
(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

(2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as
follows:

(a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

(b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

(3) Prospective collection of biological specimens for research purposes by noninvasive
means.

Examples: (a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

(4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)

Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subjects privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)

(6) Collection of data from voice, video, digital, or image recordings made for research
purposes.

(7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

(8) Continuing review of research previously approved by the convened IRB as follows:
(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all
subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.

(9) Continuing review of research, not conducted under an investigational new drug
application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

Full Board Review

Research that involves more that minimal risk and includes the following (this is not an exhaustive list):

  • DNA
  • Manipulation
  • Children
  • Prisoners
  • Pregnant Women
  • Cognitively Impaired
  • Chemically Impaired
  • Research where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing.

Additional Guides, Form and Applications

The HSRRC has developed guidance documents, templates for submitting new protocols and Conintuing Review and Modification applications for exiting proposals. These documents can be found on-line here.

All forms submittined must be typed or neatly written and all documentation must be included. Ineligible forms will be returned to investigators without being reviewed.

Students submitting materials should ask their faculty sponsor to e-mail the HSRRC confirming that they have read the materials submitted and are ready to sign off on the application. This e-mail needs to include the student investigator's name, title of the project and faculty sponsor's name and position. Student submittals will not be reviewed until this e-mail is received.


Submission Materials

The Principal Investigator must provide:

  • The Human Subjects Research Review COEUS Application
  • Research Protocol/Narrative Proposal
  • Proposed consent documents and all other documents noted in the Research Protocol/Narrative Proposal
  • Grant Abstract
  • The DHHS-approved sample consent document (when one exists)
  • The complete DHHS-approved protocol (when one exists)

Protocol Evaluation

Applications that qualify for exempt/expedited review are reviewed for approval by the chair or an experienced member of the HSRRC designated by the chair. Experience is defined as those committee members who have gained knowledge of the subject beyond that of an average person through their education, training, skill or experience.

The chair will designate experienced HSRRC members by periodically updating a list of experienced HSRRC members designated to conduct review using the expedited procedure and the HSRR staff will select reviewers from the list. If the chairman or designated member of the HSRRC questions the approval of the protocol, they will communicate their questions to the principal investigator. Comments, questions and the request for additional information will be returned to the principal investigator in writing. All comments, questions and additional information must be addressed by the principal investigator before the protocol can be approved.

The review process includes:

Initial Review:

The reviewers will review the following documents:

  • The Human Subjects Research Review COEUS Application
  • Research Protocol/Narrative Proposal
  • Proposed consent documents and all other documents noted in the Research Protocol/Narrative Proposal
  • Grant Abstract
  • The DHHS-approved sample consent document (when one exists)
  • The complete DHHS-approved protocol (when one exists)

The reviewers will review Federal Regulations 45 CFR 46.110, 21 CFR 56.110 and 45 CFR 46.101. The reviewers will also complete the Human Subjects Research Review Checklist and the 46 CFR 45 Criteria Form to ensure that the research:

  • Meets all applicability criteria
  • Represents one or more approvable categories of research.

Continuing Review:

The reviewers will review the initial protocol along with the Continuing Review application and all material that would have been reviewed by the convened HSRRC.

The reviewers will review Federal Regulations 45 CFR 46.110, 21 CFR 56.110. The reviewers will also complete the Human Subjects Research Review Checklist and the 46 CFR 45 Criteria Form to ensure that the research:

  • Meets all applicability criteria
  • Represents one or more approvable categories of research.

Modifications

The reviewers will review the initial protocol along with the Modification application and all material that would have been reviewed by the convened HSRRC.

The reviewers will review Federal Regulations 45 CFR 46.110, The reviewers will also complete the Human Subjects Research Review Checklist and the 45 CFR 46 Criteria Form to ensure that the research:

  • Meets all applicability criteria
  • Represents one or more approvable categories of research.

All expedited research, initial, continuing review and modifications are posted on the agenda and presented to the HSRRC at the next convened meeting.

 

Review Procedures

Scientific Evaluation
All expedited and full board review protocols will be reviewed by the initial reviewer and the Human Subjects Research Review Committee to evaluate all research protocols for scientific or scholarly validity by determining that:
  • The research procedures are consistent with sound research design
  • The research is likely to achieve its objectives
  • The knowledge expected to result has importance

 

Exempt/Expedited Research

If the protocol falls into one or more exemption categories and meets additional ethical criteria, it will be approved as an exempt protocol. If the protocol either (1) meets all applicability criteria for review using the expedited procedure, falls into one or more categories allowing review using the expedited procedure or (2) is a minor change to previously approved research, and in addition meets the regulatory criteria for approval it will be approved as an expedited protocol.

The principal investigator will receive an approval memo via e-mail, along with their consent form date stamped. The protocol must note that the research will last longer than one year to receive the stamp.

 

Full Committee Review

By regulation, action on protocols that require full HSRRC 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. In order for the research to be approved, it must receive the approval of a majority of those members present. In the event a quorum is lost during a meeting, the HSRRC cannot take votes until it is restored. Below is a list of materials made available to and reviewed by all of the members present at the meeting of the HSRRC.

  • The Human Subjects Research Review COEUS Application
  • Research Protocol/Narrative Proposal
  • Proposed consent documents and all other documents noted in the Research Protocol/Narrative Proposal
  • Grant Abstract
  • The DHHS-approved sample consent document (when one exists)
  • The complete DHHS-approved protocol (when one exists)

The reviewers will also complete the Criteria for Approval of Research Form to ensure that the research meets all applicability criteria

Once the project is approved, no protocol or consent changes, amendments or addenda may be made without re-review and approval by the HSRRC.

The principal investigator will receive documentation from the HSRRC office noting the committees decision pursuant to 45 CFR 46.109 (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

Full Committee Actions

The Full Committee may act on a protocol in one of five ways:

  • It may be approved
  • It may be approved with conditions (requested modifications)
    • This option may not be used when the HSRRC requests modifications or clarification that are directly relevant to the regulatory criteria for approval
    • For modifications and clarifications that are not relevant to the regulatory criteria for approval the modifications will be reviewed by the HSRRC chair or a HSRRC member designated by the HSRRC chair.
  • It may approve some components of the proposed research study and defer taking action on other components.
    • The IRB 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 IRB 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. (OHRP Guidance November 10, 2010)
  • It may be tabled, needing substantial revisions or clarifications (such protocols will nee to be re-reviewed by the full committee).
  • It may be disapproved (in this case, the study may be re-written to address all concerns and re-submitted for full committee review).

The HSRRC will review the Criteria for Approval of Research Form to determine whether the research undergoing initial review can be approved.

Once a project is approved, no protocol or consent form changes, amendments, or addenda may be made without re-review and approval by the HSRRC.

Attached to the standard approval memo is the final approved version of the consent form with the HSRRC approval stamp.

In the event that a Committee member leaves the meeting a quorum is lost during the meeting, the HSRRC cannot take votes until the quorum is restored.

Approved Consent Form
The consent form is stamped with an approval/expiration date and an approval letter is forwarded to the principal investigator and faculty supervisor.

The expiration date on the stamped consent document is the date that the protocol has expired, i.e. the first date that the protocol is no longer approved.

The expiration date is the date of the convened meeting at which the research was approved or approved with modification plus the approval interval, not to exceed one year. The calculation of the approval period for research is based on the date of the convened meeting at which the HSRRC approved the protocol or approved the protocol with modifications.

Copies of all documents are placed in the principal investigator's file and in a chronological folder.

Student Research

Students conducting class room assignments which will be gathering information about people through intervention or interactions with those individuals and class room assignments which will be gathering private identifiable information about people must be reviewed by this office. Please submit Research Determination Application for review. The HSRRC Office will make a determination whether the activity is human subject research as defined in the Policy and Procedures Section IX.A or may request additional information to make this determination. You will be notified of this decision via email.

 

It is the faculty members’ responsibility to ensure that any activity that is “research” involving “human subjects” as defined in the Policy and Procedures Section IX.A, require HSRRC review and approval before the project starts. Federal regulations can be confusing, rather than risk conducting research with HSRRC approval, and be out- of-compliance, it is strongly suggested that you contact our office for assistance in determining if your activity involves human subjects research.

 

Recruiting Study Subjects

Students: Under the SUNY Board of Trustees policy students may not be required to participate in any research project as a subject as a course requirement or required by faculty member to serve as a subject for pilot testing research instruments. Courses that involve a research requirement must make clear that participation in research, as a subject is one of several options to fulfill the research requirement. A written explanation of all research alternatives is strongly urged. The informed consent for projects proposing to recruit student participants must make clear the voluntary nature of their participation.

Recruiting Subjects Over the Internet. The use of the Internet to recruit subjects presents similar issues as with any other recruiting tool. The HSRRC Office needs to review information to be presented to subjects. Not only does the HSRRC Office need to review the text of the recruitment, but it also has to examine the context in which the recruitment takes place (e.g., posting a message on a newsgroup or creating a web site to recruit subjects). When the Web is used to recruit subjects, the HSRRC Office must see an example of what the prospective subjects will see (i.e., a "screen shot").

Advertising: Binghamton University considers direct advertising for study subjects to be the start of the informed consent and subject selection process. Advertisement should be reviewed and approved by the HSRR Office as part of the package for initial review. However, when the clinical investigator decides at a later date to advertise for subjects, the advertising may be considered an amendment to the ongoing study. When such advertisements are easily compared to the approved consent document, the HSRRC chair, or other designated HSRRC member, may review and approve by expedited means, as provided by 21 CRF 56.110 (b)(2). When the HSRRC reviewer has doubts or other complicating issues are involved, the advertising should be reviewed at a convened meeting of the HSRRC.

The Binghamton University HSRRC requries that all recruitment material include the folllowing:

1. The name and address of the principal investigator.
2. The purpose of the research.
3. In summary form, the criteria that will be used to determine eligibility for the study.
4. A brief list of participation benefits, if any.
5. The time or other commitment required of the subjects.
6. The location of the research and the person or office to contact for further information.
7. Contact information for the Office of Human Subjects Research Review.

Maintaining Records

All human subjects' research records are to be retained for three (3) years following the completion of the research [45.115(b)].  Retention requirements of research records funded by industry or private foundations are to be maintained for three (3) years or the length of time required by the sponsor (whichever is longer).

 

HIPAA

Under the HIPAA Privacy Rule, subjects have the right to ask for an accounting of certain disclosures of their identifiable health information for a period dating six (6) years from the date of the last covered The date of the last disclosure of identifiable health information from study records, if disclosures continue after all subjects have completed the study.  [45 CFR 164.528]
 
IND
For Investigational New Drug (IND) research, the FDA requires that sponsors and investigators retain “records and reports required by this part for two (2) years after a marketing application is approved for the drug; or if an application is not approved for drug, until two (2) years after shipment and delivery of the drug for investigational use is discontinued and the FDA so notified.” [CFR Title 21 Vol. 5 1. Subchapter D Subpart D]
 
IDE
For Investigational Device Exemption (IDE) research, the FDA requires the investigator or sponsor to maintain the records “for a period of two (2) years after the latter of the following two dates: The date on which the investigation is terminated o​r completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol.” [CFR Title 21 Vol. 8. I. Subchapter H Subpart G]
 
Please contact the HSRR Office if you should have any questions on records retention for your particular research protocol.  
 
If the investigator leaves Binghamton University, the records must be kept at the University in the Human Subjects Research Review office or with a designated investigator. The HSRRC office must be informed of this transfer of records prior to the investigators departure. The records will be accessible for inspection and copying by authorized representatives of the DHHS and FDA and the university.
 
When a student graduates, or otherwise leaves the University, the faculty advisor is then responsible for retaining the human subject documentation. Students may retain the original, while a copy of all research documentation must be maintained in the areas listed above.
 
The HSRRC Office will retain all records required by the regulations (e.g. minutes, correspondence between the HSRRC office and investigators, HSRRC 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 research.  
 
The HSRR Office makes records accessible for inspection and copying by authorized representatives of federal agencies or departments at reasonable times and in a reasonable ma

Conditions of Approval

Approval of a project by the HSRRC Office applies only to the procedures submitted in the proposal. No form of recruitment, or any other aspect of the research, may commence until HSRRC approval has been issued. The investigator must secure prior approval from the HSRRC Office for any changes in the procedures that will affect the use of human subjects. The investigator must also report to the HSRRC Office any problems that arise in connection with the use of human subjects.

Approval for projects is valid for no more than one year. See below for the procedures for obtaining a continuation of approval.

Continuing Review

The HSRRC is required to continue to reevaluate research projects at intervals appropriate to the degree of risk but not less than once a year. For research involving no more than minimal risk, the approval period is generally one year. For research involving greater than minimal risk, the HSRRC will determine the appropriate approval period.

For research with a one-year approval period, investigators must request a continuation for the approval yearly if the activity lasts more than one year.

The following documents will be reviewed by the HSRRC office for continuing review:

  • Human Subjects Continuing Review Application
  • Research Protocol/Narrative Proposal
  • Proposed consent documents and all other documents noted in the Research Protocol/Narrative Proposal
  • Any proposed consent documents.

The convened HSRRC will use the Criteria for Approval of Research Form to determine whether the research undergoing continuing review can be approved.

Continuing review must occur on or before the one-year anniversary date of the previous
HSRRC Office review, even though the research activity may not begin until some time after the HSRRC Office has given approval. As a result, the HSRRC Office must receive the request for continuation sufficiently in advance of the anniversary date to allow it to conduct its review. Reminders will be sent out several weeks before the anniversary date.

If the Continuing Review application is not provided to the HSRRC or the HSRRC has not approved a protocol by the expiration date, the HSRR Office staff will provide written notification to the investigator that:

    • All research procedures related to the protocol under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection of private identifiable information.
    • If current subjects will be harmed by stopping research procedures that are available outside the research context, then these should be provided on a clinical basis as needed to protect current subjects.
    • If current subjects will be harmed by stopping research procedures that are not available outside the research context, then the investigator should immediately contact the HSRRC Chair and provide a written list of the currently enrolled subjects and why they will be harmed by stopping research procedures.
    • When the HSRRC Chair is notified by an investigator that current subjects will be harmed by stopping research procedures that are not available outside the research context, then the HSRRC Chair may allow such procedures to continue when determined to be in the best interest of subjects
  • Under no circumstances may the HSRRC Chair approve enrollment of individuals in an expired research.

NOTE: IF APPROVAL FOR THE PROJECT LAPSES, CONDUCTING THE RESEARCH IS A VIOLATION OF UNIVERSITY POLICY AS WELL AS STATE AND FEDERAL REGULATIONS.

 
Modifications to Approved Research

Once the HSRRC has approved a project, it must be carried out exactly as planned. Any and all changes (i.e. subject population, recruitment plans, research procedures, study design, study instruments, study sites, or research personnel), must be approved by the HSRRC prior to implementation.

The HSRRC will review the following documents involving the modification using the Criteria for Approval of Research Form to determine whether modification undergoing review using the expedited procedure can be approved

  • Modification Form
  • One marked copy of the document that will be revised (all changes must be highlighted or underlined)
  • Research Protocol/Narrative Proposal
  • Proposed consent documents and all other documents noted in the Research Protocol/Narrative Proposal
  • Currently approved consent documents
  • Any proposed consent documents, with all changes highlighted or underlined
  • One clean copy of the amended consent document for the HSRRC stamp (note: the expiration date remains the same).

Minor protocol/consent changes may be approved by expedited review.

45 CFR 46.110(b)(2) allows for minor modifications to research that required convened review and approval to be approved through expedited procedures during the period of approval.

The chair, or the designated reviewer, will review the entire protocol and all information and assess whether the modification is minor. Minor changes would be defined as changes that do not adversely alter the overall risk/benefit profile of the study; would not affect the willingness of current subjects to remain in the study; and do not alter the scientific validity of the study design.

The modification will be reviewed using the Criteria for Approval of Research Form to determine whether research undergoing review using the expedited procedure can be approved

Those modifications that are excluded from expedited review are those that involve more than minimal risk, or do not fall into expedited categories outlined in 45 CFR 46 110(1)-(7).

 

Protocol Title Changes and Grant Applications

The HSRRC realizes that usually protocol titles are the same, however, this is not always possible when some protocols cover multiple projects and multiple grants.  If the funding institution requires that the IRB approved protocol title match the grant application title, then a modification must be submitted to our office changing the protocols title or a new research protocol must be submitted for this grant application.  If the funding institution does not require the same titles, then the researcher must provide to our office documentation to prove that the grant application human subjects research is the same as the approved research. Upon receipt of this documentation, then the HSRRC office can provide documentation to demonstrate a link between the HSRRC approved protocol title and the grant application title.


Unanticipated Problems/Adverse Events/Complaints

Principal Investigators or any individual involved in the research must report the following problems to the HSRRC in writing within five (5) business days.

Reportable Events:
  • Allegations or findings of non-compliance. Non-compliance is defined as: failure to follow the requirements or determinations of the HSRRC
  • Any deviations from the approved protocol should be reported in writing. Examples of a more serious nature include incidents of a person being enrolled in a study before signed consent has been obtained.
  • Change to a protocol taken without HSRRC review to eliminate an apparent immediate hazard to a subject.
  • Protocol violation (meaning an accidental or unintentional change to the HSRRC approved protocol) that harmed subjects or others or that indicates subjects or others might be at increased risk of harm.
  • Adverse events or any harm experienced by a subject or other individual regardless of whether the event meets FDA definition of “serious adverse event”, which in the opinion of the investigator are both unexpected and indicate new or increased risks to subjects
  • Information that indicates a change to the risks or potential benefits of the research. For example:
    • An interim analysis or safety monitoring report indicates that the frequency or magnitude of harms or benefits might be different from those initially presented to the HSRRC
    • A paper is published from another study that shows that the risks or potential benefits of the research might be different from those initially presented to the HSRRC.
  • Breach of confidentiality
  • Incarceration of a subject in a protocol not approved to enroll prisoners.
  • Any problems involving the conduct of the study or patient participation. For example, social and behavioral interviews may deal with sensitive issues - occasionally, research subjects will become upset because of the nature of the questions, these incidences requires reporting.
  • Any problems involving the recruitment and/or consent processes require reporting. For example, if a person who is contacted, either in writing or in person, about participating in a study becomes upset about the recruitment process, this should be reported.
  • Any other problem that the investigator considers to be unanticipated and indicates that subjects or others are at increased risk of harm.
  • Complaint of a subject when the complaint indicates unexpected risks or cannot be resolved by the research team.
  • Unanticipated adverse device effect (any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including supplemental plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
  • Change in FDA labeling or withdrawal from marketing a drug, device, or biologic used in a research protocol.
  • Event that requires reporting to the sponsor.
  • Sponsor imposed suspension for risk.

All problems described above must be reported promptly. The Unanticiapted Problem/Adervse Event/Complaint form is available on-line at: http://binghamton.edu/research/compliance/humansubjects/coeus.html

Definitions:
  • Non-compliance: Failure to follow the regulations or VHA Handbook 1200.5 and failure to follow the requirements or determinations of the HSRRC.
  • Allegations of non-compliance: An unproven assertion of non-compliance.
  • Findings of non-compliance: A proven assertion of non-compliance.
  • Serious non-compliance: Non-compliance that affects the rights and welfare of participants.
  • Continuing non-compliance: A repeated pattern of non-compliance likely to recur without intervention.
  • Unanticipated Problem Involving Risks to Participants or Others: Any problem, event, occurrence or new information that is (1) unanticipated and (2) indicates that participants or others are at increased risk of harm.
  • Protocol Violation: Any unapproved deviation from the protocol, or the HSRRC policies is considered a Protocol Violation, whether or not it is intentional and whether or not it is under control of the Investigator
  • Protocol Deviation: If anyone on the research team has deviated from the protocol as written and approved by the HSRRC
    • Submit a Reportable Event Form and follow the protocol as written, or
    • Submit a Reportable Event Form and submit a modification to the HSRRC, while your modification is being written, submitted, reviewed, and approved, you must follow the current, approved protocol as it is written.

 

Review of Reports

The HSRRC Office staff review all reports and ask these three questions:

  1. Does this report involve an allegation of non-compliance?
  2. Does this report involve a finding of non-compliance?
  3. Does this report involve an unanticipated problem involving risks to participants or others?

If the answer to question 1 is yes, the report is processed as described in “Allegations of Non-compliance”.

If the answer to question 2 is yes, the report is processed as described in “Findings of Non-compliance”.

If the answer to question 3 is yes, the report is processed as described in “Unanticipated Problems Involving Risks to Participants or Others”.

If the answer to multiple questions are yes, then the multiple corresponding policies and procedures are followed.

If the answer to all questions is no, then no further action is taken.

Allegations of Non-compliance
HSRR Office staff and the HSRR chair evaluate allegations of non-compliance to determine whether it has no basis in fact or is a finding of non-compliance.

  • If the basis has a basis in fact, it is handled as described in “Findings of Non-compliance”.
  • If the allegation has no basis in fact, no further action is taken under this section of the policy.

Findings of Non-compliance
HSRR Office staff and the HSRR chair evaluate finding of non-compliance to determine whether it is serious or continuing non-compliance.

  • If the non-compliance is either serious or continuing, it is handled under the section on “Serious or Continuing Non-compliance”.
  • If the non-compliance is neither serious nor continuing, it is handled under the section on “Non-serious and Non-continuing Non-compliance.”

Non-serious and Non-continuing Non-compliance

  • HSRR office staff and the HSRR chair work with the non-compliant parties to develop an appropriate corrective action plan.
  • If the non-compliance parties do not collaborate with the HSRRC to develop a corrective action plan when asked to do so, the non-compliance is handled as continuing non-compliance under the section “Serious or Continuing Non-compliance”.

Serious or Continuing Non-compliance
All serious or continuing non-compliance is handled by the convened HSRRC under the section on “Convened HSRRC Review of Problems".

Unanticipated Problems Involving Risks to Participants or Others
All unanticipated problems involving risks to participants or others are handled by the convened HSRRC under the section on “Convened HSRRC Review of Problems”

Convened HSRRC Review of Problems
HSRR staff provides all HSRRC members with information about the problem, results of any investigation, supporting documents, and information about the consent and protocol, when the research involves a specific protocol.

The convened HSRRC considers the following actions and may take no action:

  • Suspension of the research.
  • Termination of the research.
  • Notification of participants when information about the non-compliance may affect their willingness to continue participation.
  • Modification of the protocol.
  • Modification of the information disclosed during the consent process.
  • Providing additional information to past subjects.
  • Requiring current subjects to re-consent to participate.
  • Modification of the continuing review schedule.
  • Monitoring of the research.
  • Monitoring of the consent.
  • Referral to other organizational entities.

Once the convened HSRRC’s evaluation is completed, the serious or continuing non-compliance, any suspension or termination of HSRRC approval, or unanticipated problems involving risks to participants or others will be reported to organizational officials and appropriate regulatory agencies.

Last Updated: 3/24/17