Issues Of Special Concern
- Audio/Video/Photographic Recordings
- Community-Based Participatory Research (CBPR)
- Conflict of Interest
- Conflict of Interest (Institutional)
- Data Safety Monitoring Boards (DSMB)
- DNA/Genetic Research
- Informed Consent
- Archive specimen repository and bank requirements
- International Research
- Internet Research
- Investigational New Drugs (IND) and Devices (IDE)
- Multi-Site Study Requirements
- Organizational Research
- Payments to Human Subjects
- Socially Sensitive Research
- Mandatory Child Abuse Reporting
- Subject Coding
Recording the voice and/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.
The Human Subjects must be informed of the following:
- Type of recording that will be utilized
- Specific identifiers that will be recorded
- People who will have access to the recordings
- Confidentiality procedures of the recordings
- Indicate when the recordings will be destroyed – or – if they will be kept indefinitely
- Use of the recordings: educational; commercial; analysis by research; unspecified use
The Audio, Video, Photographic Recordings form can be found at the following link:
Community-based research is a research process between community members and researchers and recognizes the unique strengths that each brings. The research takes place in community settings in a collaborative approach to research that equitably involves all partners. The community partners may be derived from various sources, whether they be formally structured community-based organizations or informal groups of individual community members.
The CBPR research protocol must include the following information in the Expedited Full Board Review Application, Section G Project Proposal for the HSRRC review process:
- The community members involvement in the design and the project organization.
- The community members involvement in the implementation
- The community members involvement in the data analysis
- Group risks and harms, such as risks to identified communities;
- Research processes and outcomes should benefit the community. Community members should be hired and trained whenever possible and appropriate, and the research should help build and enhance community assets.
- Understanding the role of community member-researchers.
- Formal Letter of Agreement. Pursuant to our policies and procedures, any investigator who is not affiliated with Binghamton University must be added through a Letter of Agreement with our institution and/or a signed individual investigator agreement. In addition, the principal investigator of the study must be within our jurisdiction, and must assume responsibility for the training of all study personnel, and for the ethical conduct of the study according to the approved protocol.
- All individuals involved in human subject’s research must understand the basic principles of human subject protection before our HSRRC agree to approve their work in a research project. The community members must obtain training in Human Subjects Research. Whether this educational component is complete through the Collaborative IRB Training (CITI), if this is not appropriate, our office will help provide a comparable, certifiable training
- Community members should be part of the analysis and interpretation of data and should have input into how the results are distributed to make clear the community's views about the interpretation prior to final publication.
If the HSRRC receives a CPBR protocol that involves a community that the HSRRC does not have expertise in. the HSRRC administrator will solicit an outside consultant’s review of the complete protocol and will provide a report to the HSRRC on the design, risk and benefits of the research and the community.
Binghamton University’s policy dictates that any real, or perceived, conflict of interest of the HSRRC members or Principal Investigators must be fully disclosed to all parties concerned.
Binghamton University policy prohibits HSRRC members from reviewing, participating in the 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.
Binghamton University policy prohibits HSRRC members from reviewing, participating in the discussion of, or voting upon any research protocol when the committee member, their spouse, dependent children, or partner holds a financial interest, meaning anything of monetary value, including although not limited to, salary or other payments for services (e.g. consulting fees or honoraria); equity interests (e.g. stocks, stock options, or other ownership interest); and intellectual property rights ( e.g. patents, copyrights, and royalties from such rights)
Binghamton University HSRRC members with these types of conflicts of interest shall recuse themselves from the final discussion and vote of all such studies. All conflicted members must recuse themselves and leave the room for the vote and are not counted towards quorum. Absences of Committee members, who have a conflict, from the deliberation and the vote are noted in HSRRC minutes.
When a member, or a member’s spouse, relative or partner, is an investigator on a study to be reviewed, HSRRC members must recuse themselves from the review, discussion of, and vote on the protocol.
Consultants are considered to have a conflict of interests when they, their spouse, dependent children, or partner involved in the design, conduct, or reporting of the research.
Consultants are considered to have a conflict of interest when consultant, their spouse, dependent children, or partner holds a financial interest, meaning anything of monetary value, including although not limited to, salary or other payments for services (e.g. consulting fees or honoraria); equity interests (e.g. stocks, stock options, or other ownership interest); and intellectual property rights (e.g. patents, copyrights, and royalties from such rights).
Principal Investigators must fully disclose to all human subject participants, through the informed consent, any financial affiliation or any other monetary influence that the Principal Investigator may have with the research protocol.
Principal Investigators must also include with the initial protocol application the following Conflict of Interest Form
Binghamton University abides by the following Federal Guidelines conflict of interest requirements: Code of Federal Regulations, Title 42 Part 50 Subpart F. http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm
Title 21, Chapter 1 – Food and Drug Administration, DHHS, Part 54 – Financial Disclosure
by Clinical Investigators. Updated April 5, 1999. Access date April 25, 2001. Electronic
Code of Federal Regulations: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title21/21cfr54_main_02.tpl
Binghamton is an AAHRPP (American Association for Human Research Protection Policies) accredited University. Implementation of Institutional Conflict of Interest policies is an AAHRRP requirement.
Each institutional financial activity that presents a potential for conflicts of interest must be disclosed and the conflict of interest must be properly identified and managed or eliminated before any contract, sponsored project, dedicated gift, or transaction is executed, any contractual relationship is initiated, or any action is taken that might be influenced or appear to be influenced by the conflict of interest.
Conflict of Interest Official
Oversight of these three policies is the responsibility of the Associate Vice President for Research, who shall function as the Conflict of Interest Official.
Institutional Conflict of Interest Committee (ICIC)
The University shall establish an Institutional Conflict of Interest Committee. The Committee shall report to the Office of the President of the University. The committee shall consist of the Conflict of Interest Official, the University Ethics Officer and the Associate Vice President for Administration. Recusal shall be required whenever any member has an actual or apparent conflict of interest with regard to any matter under review. The ICIC shall include one or more alternates to sit in place of any member who has recused himself or herself from the deliberations. The Conflict of Interest Official shall serve as administrator for the ICIC and as the liaison to the University's Institutional Review Board(s) when human participants research in involved
The ICIC is responsible for:
- Review of disclosures that present or appear to present an institutional conflict of interest.
- Development of conflict resolution plans.
- Documenting the committee's findings and the bases for the approval of conflict resolution plans, including steps to be taken to manage the conflict or minimize the potential for conflict of interest by reducing or eliminating the interest.
- Oversight of projects that are being managed with respect to conflicts of interest.
- Communication to the IRB, and to responsible institutional officials, of summary information about the nature and amount of the institutional financial interest in human subject research, along with the committee's findings.
Whenever someone has violated these policies, the ICIC shall recommend sanctions, which may include disciplinary action ranging from a public letter of reprimand to dismissal and termination of employment. If the violation results in a collateral proceeding under University policies regarding misconduct in science, then the Committee shall defer a decision on sanctions until the misconduct in science process is completed. The Committee's recommendations on sanctions shall be presented to President, who shall enforce any disciplinary action, following due process as outlined in University policy. In addition, in cases impacting federally funded sponsored projects, the University shall follow federal regulations regarding the notification of the sponsoring agency in the event an Individual has failed to comply with this policy.
Policy for Officers and Other Senior Managers of the University
- Officers and other senior managers are defined as the President, Vice Presidents, Deans, Associate Vice Presidents and the Assistant Vice President for Entrepreneurship and Innovation Partnerships.
- Officers and other senior managers of the University are required to file an annual disclosure of their significant financial interests to comply with New York State’s Public Officers Law and other laws and regulations related to Ethics in State Government by the Commission on Public Integrity. These laws require a comprehensive and detailed disclosure process by University Officers and other senior managers on an annual basis. In addition, an additional disclosure process is implemented at Binghamton University to allow for the prompt and comprehensive reporting of potential Institutional Conflict of Interests as they may arise at any time.
- If a financial interest might present a conflict on a University program that involves the use of human participants, then disclosure must be made immediately regardless of the value of such financial interest.
- The ICIC has the authority to recommend that formal recusal be required when an official or other senior manager holds a significant financial interest in an investigational product or in an entity sponsoring human participant research. The scope of this recusal should include any involvement in matters or decisions that might reasonably appear to affect the research.
- If a University official or other senior manager who holds a significant financial
interest in an investigational product or commercial research sponsor becomes aware
that he or she must take an action or participate in a decision that may affect or
reasonably appear to affect the University's human participants research, and the
official or other senior manager has not yet been directed by the ICIC to recuse himself
or herself from the matter, the official or other senior manager should be required
to disclose the circumstances to his or her superior. The superior may determine that
recusal is necessary, may decline to require recusal, or may refer the matter to the
ICIC for resolution. When the superior declines to require recusal, the ICIC shall
make a final recommendation to the President as to whether recusal is in fact necessary.
In any case, the superior should document his or her recusal determination and forward
this documentation to the ICIC.
Binghamton has established an institutional conflict of interest policy. While Binghamton University recognizes the many benefits of having its senior officials enter into relationships with outside private and public organizations it is important that such relationships are not viewed by the general public as impacting our professional judgment or the use of University resources. The method to address possible apparent conflicts is to disclose all such outside relationships and in some cases remove ourselves from decisions that could be perceived as conflicts.
Institutional Conflict of Interest Disclosures will be done annually by the President,
Vice Presidents, Deans, Associate Vice Presidents and the Assistant Vice President
for Entrepreneurship & Innovative Partnerships at the same time as the State’s Annual
Conflict of Interest Disclosure process. Any change in the information on the Disclosure
form must be reported at the time that change occurs throughout the year.
Please check the appropriate column for each question, providing a short explanation of the circumstance for each Yes answer. Once the form is completed, sign it and forward the completed form to Dr. Michael McGoff, Campus Ethics Officer (AD 711).
Institutional Conflict of Interest Policy Statement
Each institutional financial interest that presents a potential for conflicts of interest, whether real or perceived, must be fully disclosed to the University and the conflict of interest must be properly identified and managed or eliminated before any contract, sponsored project, dedicated gift, or transaction is executed, any contractual relationship is initiated, or any action is taken that might be influenced or appear to be influenced by the conflict of interest.
The Conflict of Interest Officer shall obtain from the Binghamton Foundation at least annually (and updated as necessary):
- A list of individual and corporate donations that exceed a value of $1 million.
The Conflict of Interest Officer will review these holdings against the profile of University programs to determine if a potential conflict of interest exists in any areas. The COI Officer shall provide a "watch list" of companies to the Assistant Vice President for Sponsored Programs that research administrators should consult when processing grants and contracts from company sponsors in order to assist in the identification of potential institutional conflicts of interest. All potential conflicts shall be disclosed by the Conflict of Interest Officer to the ICIC, which shall review the disclosures and resolve potential conflicts in accordance with the steps identified within this policy.
Endowment investments are generally held in mutual funds in a “Fund of Funds” arrangement.
Therefore, decisions related to individual purchase and sales are outside University
The Conflict of Interest Officer shall obtain from the Assistant Vice President for Entrepreneurship and Innovation Partnerships a listing of companies as of the date of reporting that hold option or licensing rights to Binghamton University inventions and a listing of companies in which Binghamton University through the Research Foundation owns any equity. The date of reporting is June 30 of each year or anytime there is a change in activity.
The Conflict of Interest Officer shall review these holdings against the profile of University programs to determine if a potential conflict of interest exists in any areas, and shall notify the heads of those areas thus affected as to the potential conflict. In addition, the COI Officer shall provide a "watch list" of companies to the Assistant Vice President for Sponsored Programs who is responsible for sponsored programs that research administrators should consult when processing grants and contracts from company sponsors in order to assist in the identification of potential institutional conflicts of interest. On a case-by-case basis, when research sponsored by a private company involves the use of human research participants, the Conflict of Interest Officer shall provide to relevant University offices, including the Binghamton Foundation, University Development Office, Research Division, Deans, and the Office of Entrepreneurship and Innovation Partnerships, the name of the sponsoring company, the financial relationships, and obtain from those offices an indication of the total financial interests and any other potential conflicting relationships the University has in that company. All potential conflicts shall be disclosed by the Conflict of Interest Officer to the ICIC, which shall review the disclosures and resolve potential conflicts in accordance with the steps identified within this policy.
Equity based on intellectual property is managed by Research Foundation for SUNY central office on behalf of and independently from Binghamton University. This arrangement will provide a suitable firewall especially when:
- The equity position is significant and its value-potential very high.
- The University is involved in ongoing research in cooperation with the licensee.
- The University has significant knowledge about the product and the company's plans for commercialization.
- The product under license is a medical therapeutic, treatment, palliative, or curative that has significant medical potential or a high level of risk associated with it.
The University is strictly prohibited from using non-public information to influence or appear to influence the management of its equity share in a company. Likewise, the amount of equity the University takes in a company can be a potential institutional conflict of interest issue, especially if the company involved is a University-related start-up company. The University should ensure that its equity position in the company is not one such that the University is perceived as a major holder. As such, an independent observer might believe that the University's actions regarding the company might be influenced by its substantial holding, regardless of the kinds of firewalls the University has constructed between the management of the investment and the University Research and Technology Transfer activities the University may be engaged in. Equity positions may not exceed 10% without the review of the ICIC and subsequent approval of the Vice President for Research and then by the Vice President for Administration. Certainly, in no case should the University be involved in a company at a level greater than 49%.
When accepting equity in a start-up company the University will generally not accept any representation on a company's board of directors nor have any voting rights. However, in the event of the early stage development of a technology in a start-up company, the University may secure "observer rights" or the rights to review company financial and performance reports.
The Conflict of Interest Officer shall maintain a central repository of information about all recusal determinations related to the University's human participant’s research.
One of the research approval criteria is for the HSRRC to determine whether “risks to subjects are minimized” and “risks to subjects are reasonable in relation to anticipated benefits” 21 CFR 56.111(a)(1) and (3). Additionally, the Code of Federal Regulations stipulates that “when appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects” 45 CFR 46.111 (a)(6).
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 problem or complaints. For example, IRB’s do not have the ability to review all records of participants if research is being conducted at five (5) different sites. DSMB will have the ability to review these reports
A Data Safety Monitoring Board is defined as “a committee that is established specifically to monitor data throughout the life of a study to determine whether it is appropriate, from both scientific and ethical standpoints, to continue the study as planned” (Bankert, et al pg. 162)
The DSMB is a group of individuals who are expert in their field that are applicable to the study, individuals with statistical experience, lay representatives, and administrators. 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?
- Protocols presenting more than minimal risk to subjects. Risk assessment should include the characteristics of the subject population.
- Is the 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?
FDA Regulations and Data Safety Monitoring Boards.
In reviewing FDA research, the HSRRC will consider the following provisions:
- What safety information will be collected, including serious adverse events.
- How the safety information will be collected (e.g., with case report forms, at study visits, by telephone calls with participants).
- The frequency of data collection, including when safety data collection starts.
- The frequency or periodicity of review of cumulative safety data.
- The plan might include establishing a data monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the sponsor, including the frequency of reporting.
- For studies that do not have or are not required to have a data monitoring committee and are blinded, have multiple sites, enter vulnerable populations, or employ high-risk interventions, the IRB or needs to carefully review the data and safety monitoring plan and determine whether a data monitoring committee is needed.
- If not using a data monitoring committee, and if applicable, statistical tests for analyzing the safety data to determine whether harm is occurring;
- Provisions for the oversight of safety data (e.g., by a data monitoring committee).
- Conditions that trigger an immediate suspension of the research, if applicable.
For more information and regarding the requirement of DSMB, please review the NIH
website or contact the HSRRC office at firstname.lastname@example.org.
Sometimes information must be withheld from subjects or false information provided to them. This may be for substantive reasons (e.g., to distinguish perceptual causes from other causes) or methodological reasons (e.g. 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.
- Deception cannot be used in any study where there is risk to subjects
- The consent document should 1) never contain anything that is untrue, or be part of the deception, and 2) 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)
- 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
- Human Subjects need to be informed about the nature of the research in a way that does not invalidate the data
- All subjects must be debriefed regarding the true nature of the research after their participation
The debriefing should:
- Explain all truths not revealed and all falsehoods told to subjects
- Address the reasons the deceptions were necessary
- Reassure subjects that their reactions to the deceptions were normal
If having incomplete or erroneous information is not likely to be harmful to subjects, the HSRR Office will consider delaying the debriefing until all subjects have completed their participation. Care should be taken in debriefing to protect the well being of the subjects.
All debriefings must be submitted as a written text document to the HSRR Office. The debriefing should always be a dialogue. Those conducting the debriefing should be trained to elicit and respond to subject concerns.
Information should not be provided that might damage subjects' self-esteem or hurt their feelings. The use of highly evaluative terms (e.g. `We tricked you." Or `We lied to you.") should be avoided in explaining deceptions to the subjects.
All genetic research must be reviewed by the full HSRRC. Genetic research is constantly evolving and more personal information is being obtained. This information can have dire consequences on the human subjects and can affect the subject’s insurability and employment opportunities. Genetic studies that generate information about subjects’ personal health risks can provoke anxiety and confusion
The following Binghamton University procedures and NYS laws must be taken into
consideration when designing a research protocol that involves the use and storage of human DNA
Each disclosure or re-disclosure of the (human subjects identified) test results requires the express informed consent of the test subject, and no general waivers are deemed informed consent.
NY Civil Rights Law Section 79-1
While informed consent is required to allow research access to specimens, explicit re-consent is not required once linked identifiers are removed.
For the researchers convenience we provide an informed consent template that addresses all of the issues concerning genetic research:Laboratory inspection
- Biosafety Committee audit
The Archive will require regular inspection (2 times per year) by Environmental Health & Safety Staff. This inspection includes the standard EH&S audit. While scheduling this, you may request that your Biosafety Committee audit is conducted at the same time. The laboratory directors will be required to forward all audit reports and compliance approvals from EH&S and the Biosafety Committee to the Human Subjects Research Review Office. To schedule a lab inspection, EH&S can be contacted at email@example.com OR X 7-2211.
- Provide security measures for the archive
- Example: key-card access with time-stamped electronic recording of personnel entering lab.
The Archive must be sufficiently secure to prevent theft, loss or destruction of valuable information. The laboratory director should be aware of all individuals with access to archive. Archive rooms should be locked and accessibly to laboratory personnel with key access. We recommend, if not already in place, that the archive be equipped with key-card access via a BU ID, so that there is an electronic time-stamped recording of personnel entering the lab.
- Storage report
- Password protected and secure
- Key coded or encrypted software
- Backed up
The protocol must include a detailed description of what type of data has been collected and how all data records are stored and kept secure. All data should be protected and backed-up (on other computers or in file cabinets, etc). All data must be kept in a secure and defined location.
- MTA through the Division of Research http://www.binghamton.edu/research/index.html
In order to function as human biological repository and specimen bank, the Archive will be required to establish an official material transfer and data use agreement for those researchers interested in obtaining samples. The Office of Technology Transfer and Innovative Partnership in the Division of Research will oversee this process. The laboratory directors will be required to forward all MTAs to the Human Subjects Research Review Office.
- Required IF specimens are identifiable
- Requires IRB approval. Approval can be contingent upon certificate
If the specimens in the Archive are identifiable and belong to living subjects it is a requirement to obtain a Certificate of Confidentiality before sharing information. This certificate can be obtained through the National Institutes of Health. However, if data has been de-identified this may not be required, although advisable.
Please complete the DNA Archive Specimen and Data Storage application for committee review The forms are available on our website: http://binghamton.edu/research/compliance/humansubjects/coeus.html
Research in foreign countries also presents special concerns regarding the rights and welfare of human subjects. In general, the HSRRC 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 addition, the following issues apply to international human subjects’ research:
- The review of international research may fall under "exempt" and "expedited" review
- This decision requires "knowledge of local context". The reviewers must have sufficient expertise in the culture in which the research is taking place to evaluate the research - if this expertise does not exist within the HSRRC – outside consultation will be obtained by the HSRRC Administrator
- All materials, including consent forms, must have English language translations included with the protocol
- Documentation of permission from local authorities, co-investigators, or foreign institutions is required before approval can be granted
Permission to Conduct Research (Social Behavioral)
- Research that receives federal funds and is working with a foreign institution, must receive some form of review, or affirmation of the US review
- If there are no federal funds, but the research is being done in collaboration with a foreign institution, affirmation that the institution reviewed the research and approves of the protocol
- If the research is not being conducted with a foreign institution, but within a community, there is no requirement for local review
It is clear that the Internet will be used more and more in conducting human subjects research. Research on the Internet presents new concerns to the traditional human subjects issues: risk, consent, participation by minors, and confidentiality. Investigators are going to have to provide technical information on how they will deal with these issues.
The HSRR Office may require additional information on internet-based research issues. The National Institute of Mental Health has proposed suggestions for addressing such risks: http://www.nimh.nih.gov/funding/grant-writing-and-application-process/internet-based-rsch-interventions-chart-may2007_34847.pdf
Internet-Based Issues may include:
- Anonymity or false information
- Information from vulnerable populations
- Monitoring of individuals clinical status
- Lack of in person communication
- Assuring consent was informed
- Delay of appropriate treatment
- Adequate debriefing
- Limits to privacy and confidentiality
- Bias sample selection
Risk. There are two sources of potential harm to subjects from research: harm resulting from participation in the research (e.g., acute emotional reactions to certain questions), and harm resulting from breach of confidentiality. Since there is generally no direct contact with subjects participating in research over the Internet, it may be difficult or impossible to deal with individual subject reactions. As a result, some sensitive research may not be appropriate for the Internet. Breach of confidentiality is the primary source of harm in most Internet research and is dealt with below.
Consent. Since it is currently not possible to get a signed consent form over the Internet, Investigators can have subjects submit a signed consent form and send them a password to gain access to the research pages. In any event, investigators must indicate to the HSRRC how they plan to get consent from subjects.
Confidentiality. Since it is impossible to guarantee absolute data security over the Internet, sensitive research may not be appropriate for the Internet. Investigators need to address how they intend to assure confidentiality, keeping in mind that the degree of concern over confidentiality is directly related to the sensitivity of the data. Data transmitted via e-mail cannot be anonymous without the use of additional steps. Almost all forms of e-mail contain the sender's e-mail address. In order to maintain anonymity the research must use an "anonymizer" - a third party site which strips off the sender's e-mail address. (For more information on Anonmizer(s) visit: www.anonymizer.com; www.rewebber.com; wwww.mutemail.com) Data submitted over the Web can only be anonymous if software is used to store the information directly in a database without identifiers; otherwise identifiers are attached to the data. Web servers automatically store a great deal of personal information about visitors to a web site and that information can be accessed by others.
For more information on ethical internet based research, please visit the Association of Internet Researchers:
The Association of Internet Researchers is an academic association dedicated to the advancement of the cross-disciplinary field of Internet studies. It is a member-based support network promoting critical and scholarly Internet research independent from traditional disciplines and existing across academic borders. The association is international in scope.There are three types of research conducted on the Internet:
- Recruiting Subjects over the Internet
- Observation of Internet Activity
- Collecting Data Over the Internet
Recruiting Subjects Over the Internet
The use of the Internet to recruit subjects presents similar issues as with any other recruiting tool. The HSRRC needs to review information to be presented to subjects. Not only does the HSRRC 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 must see an example of what the prospective subjects will see (i.e., a "screen shot").
Observation of Internet Activity
Observation of Internet activity usually involves such activities as gathering information about the use of the Internet and/or recording user information or users' comments. Examples include: participant observation of an on-line discussion group, using "cookies" to track web sites visited, or asking visitors to a web site to provide demographic information. The human subjects issues involved in this type of research generally involve consent/disclosure issues. Investigators need to indicate to the HSRRC how they intend to obtain the subjects' consent to use this information for research. As with other types of participant observation, investigators generally must disclose their role as researchers to the group participants. The HSRRC must see an example of what the prospective subjects will see (i.e., a "screen shot").
Collecting data over the Internet
This type of research generally involves having subjects submit data, e.g., survey data, over the Internet and presents the most serious human subjects concerns. As in the other types of Internet research, the investigator needs to indicate how subjects' consent will be obtained and their confidentiality protected. Of particular concern with this type of research is the participation by minors and investigators must address this issue in their HSRRC protocols. The HSRRC must see an example of what the prospective subjects will see (i.e., a "screen shot").
The HSRR office staff will review all documentation submitted by the Principal Investigator to determine that when an investigator proposes to conduct research that involves a drug that one of the following is true:
The drug has an IND number and the IND number is supported by one of the following: (The Investigator Brochure may not be used for this purpose.)
Sponsor protocol imprinted with the IND number.
Written communication from the sponsor documenting the IND number.
Written communication from the FDA documenting the IND number. (Required if the investigator holds the IND.)
The drug falls into one of the categories of exemption from an IND. [See 21 CFR 312.2(b)]
The HSRR office staff will review all documentation submitted by the Principal Investigator 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 and the IDE number is supported by one of the following: (The Investigator Brochure may not be used for this purpose.)
- Sponsor protocol imprinted with the IDE number.
- Written communication from the sponsor documenting the IDE number.
- Written communication from the FDA documenting the IDE number (Required if the investigator holds the IDE.)
- The device meets the requirements for an abbreviated IDE. [See 21 CFR 812.2(b)]
- The device falls into one of the categories of exemption from an IDE. [See 21 CFR 812.2(c)]
Control of Investigational Devices
- The HSRRC will review the plan for storage, control, and dispensing of the device to evaluate whether the plan is adequate to ensure that only authorized investigators will use the device and they will use the device only in subjects who have provided consent.
All device studies require full board review. The Principal Investigator will supply the following information:
- A description of the device,
- Reports of prior investigations with the device
- The proposed investigational plan
- A description of patient selection criteria and monitoring procedures
- Any other information that the HSRRC deems necessary to make its decision
The application must include information that describes the type of device study: Significant Risk (SR), Non-Significant Risk (NSR), and exempt studies. Sponsors are responsible for making this initial determination. SR studies must fully comply with FDA regulations 21 CFR 812, and NSR studies must comply with the abbreviated requirement 21 CFR 812.2(b).
For more information please refer to the following links:
Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors, US Department of Health and Human Services, FDA Center for Devices and Radiological Health (CDRH), January 2006
FDA Code of Federal Regulations Website
Principal Investigators (Researchers) 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:
- The investigator must ensure that the investigational device is used in accordance with the HSRRC approved protocol, the Occupational Health and Safety report, the Mechanical Report, the investigational plan and applicable FDA regulations.
- The investigator must administer the investigational device only to participants under the investigator’s direct personal supervision or under the supervision of the sub-investigator directly responsible to the investigator who is listed on the Occupational Health and Safety Report as being authorized to use this equipment for the named project.
- The investigator must not supply the investigational device to any person not authorized to receive it.
- The investigator must maintain the following accurate, complete, and current records
relating to their 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.
- If the investigation is terminated, suspended, discontinued, or completed, the investigator must return any unused stock of the investigational device to the study sponsor, or otherwise provide for disposition of the unused stock as directed by the sponsor.
Research that is conducted by Binghamton University’s Faculty, Staff or Administrators that works in collaboration with another institution must obtain an IRB approval from the collaborating institution or if an IRB does not exist a letter of collaboration or permission must be obtained from the appropriate official.
If the Principal Investigator is the lead investigator in this multi-site study the Principal Investigator must provide, on a separate sheet of paper, a description of the management of information obtained in multi-site research that might be relevant to the protection of subjects, such as:
- Unanticipated problems involving risks to subjects or others.
- Interim results.
- Protocol modifications.
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 HSRRC.
Often social scientists conduct research on organizations rather than individuals. Since the information gathered in this research is not about individuals, there is often a great deal of confusion about compliance with human subjects requirements. "Organizational research" is defined as research obtaining information only about organizations, not about the individuals in or served by the organizations. Any research which gathers information about individuals (whether identified or not) must meet the human subjects requirements described in this Guidebook.
The human subjects requirements for organizational research depends on the source and nature of the information obtained. There are three categories of organizational research:
- Information about organizations obtained from publicly available - Since the University Human Subjects Policy defines human subjects research as gathering information "from or about living human beings," this type of research may be considered exempt human subjects research after HSRRC review.
- Non-sensitive information obtained through interviews or questionnaires. Since this information is obtained from individuals, it would fall under the University's definition of human subjects research and would require HSRRC review. However, this type of research may be eligible for exempt or expedited review. Investigators would have to submit a copy of the interview questions or questionnaire.
- Sensitive information obtained through interviews or questionnaires. Sensitive information is information that might be proprietary or damaging to the organization if divulged. This type of research would require documentation of organizational permission and would require review by the full HSRRC.
Please consult the HSRR Office for information concerning organizational research
The HSRRC requires that the Principal Investigators must provide the HSRRC accounting information that indicates the full amount for each subject enrolled full term in the study. Should a modification to the research requesting additional enrollment be submitted – the Principal Investigator must provide an updated accounting.
Payment to subjects must be allocated as outlined by the FDA guidance listed below:
Food and Drug Administration Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators: 1998 Update: Sponsorship - IRB Iterrelationships
“…Any credit for payment should accrue as the study progresses and not be contingent upon the subject completing the entire study. Unless it creates undue inconvenience or a coercive practice, payment to subjects who withdraw from the study may be made at the time they would have completed the study (or completed a phase of the study) had they not withdrawn. For example, in a study lasting only a few days, an IRB may find it permissible to allow a single payment date at the end of the study, even to subjects who had withdrawn before that date.
While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion of the study is acceptable to FDA, providing that such incentive is not coercive. The IRB should determine that the amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn. All information concerning payment, including the amount and schedule of payment(s), should be set forth in the informed consent document.”
Under the provisions of 45 CFR 46.116(a)(8), students must be free to choose not to participate in research that they have signed up for at anytime prior to the start of their involvement in the research. Furthermore, students must be free to communicate their decisions not to participate in research in whatever way they choose, including by simply not showing up for the research
OHRP offers the following two options which would not violate these regulations:
(1) Students who show up for an appointment as scheduled could be awarded a credit point, or some fraction thereof.
(2) Students who fail to show up for a scheduled appointment could have a decrease in the number of credits that can be earned through participation in research for a particular course, provided such students can still earn the same maximum number of credits by substituting an alternative non-research activity that involves a comparable amount of time and effort. For example, consider circumstances where students enrolled in a course can earn up to 3 extra credit points toward their final grade by participating in 3 separate studies (1 extra credit point per study). Under this option, if a student in the course fails to show up for an appointment for one study without cancelling by the specified deadline, the student is allowed to earn a maximum of 2 extra credit points by participating in two other research studies. However, the student must be able to earn a third extra credit point by completing an alternative non-research activity.
The Office has a complete list of all questionnaires that were previously reviewed and approved and also notes the Human Subjects audience that was involved in the research. This list is compiled for your convenience - if the questionniare is listed, it is not necessary to provide our office with copies: Questionnaires
Questionnaires are the most common research method used in human subjects research at the University. As a result, researchers often overlook some of the human subjects concerns that can hold up approval of a questionnaire study, such as consent and confidentiality.
Consent: Although most questionnaire studies do not require a written consent form, researchers must still ensure that subjects are giving informed consent to participating in the study. All questionnaires must include some form of cover sheet or instructions to subjects which provides subjects with the same information that would be included in a consent form.
In particular, subjects need to be informed:
- about the nature of the questions they are going to be asked (especially any questions on sensitive topics);
- that they can skip any question they choose not to answer (subjects should not be instructed to answer every question);
- that they may withdraw at any point without penalty;
- that procedures are in place to protect their confidentiality.
Confidentiality: In even the most innocuous questionnaire research, all research information must be kept strictly confidential. Complete anonymity is the best protection from breaches of confidentiality. Researchers must be aware that demographic information, in some circumstances, can be an identifier. Anything that allows an individual subject to be identified is an identifier and this information must be protected. The degree of protection depends on the sensitivity of the information.
Another point that is often overlooked is the collection of completed questionnaires. In some circumstances, the individuals collecting the questionnaires can identify who turned in which form. For sensitive information, it would be best if forms were returned in sealed envelopes.
In addition to the basic requirements for conducting human subjects research specific research topics present additional concerns relating to the rights and welfare of research subjects. The HSRRC has delayed or disapproved protocols in these topics until additional information or a Certificate of Confidentiality has been issued
According to the Office for Human Research Protection, Institutional Review Board Guidebook, Chapter 3, Section D. Privacy and Confidentiality, the policy states:
"Where data are being collected about sensitive issues protection of confidentiality consists of more than preventing accidental disclosures. There have been instances where the identities of subjects or research data about particular subjects have been sought by law enforcement agencies, sometimes under subpoena. Researchers can apply for a Certificate of Confidentiality through the Assistant Secretary for Health that will provide protection even against a subpoena for research data.
The policy defines sensitive research as involving the collection of information falling into any of the following categories:
(a) Information relating to sexual attitudes, preferences, or practices;
(b) Information relating to the use of alcohol, drugs, or other addictive products;
(c) Information pertaining to illegal conduct;
(d) Information that if released could reasonably be damaging to an individual's financial standing, employability, or reputation within the community;
(e) Information that would normally be recorded in a patient's medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination;
(f) Information pertaining to an individual's psychological well-being or mental health;
Information in other categories, not listed here, might also be considered sensitive because of specific cultural or other factors".Risks associated with socially sensitive information could include:
- Loss of confidentiality about the identity of the volunteers
- Loss of confidentiality about the information given by the volunteers
- Triggering internal conflicts within volunteer-respondents, (e.g., emotional reactions or needs)
- Triggering external conflicts of social, stigmatizing, or physical damage against volunteers, (e.g., assault by abusing partners or legal action by authorities, if subject participation in the study became known)
- In some research (e.g., about fetal alcohol syndrome), the people at risk include
not only the subjects of the research, but third parties (e.g., the mothers) as well.
Protection of Human Research Subjects privacy and confidentiality are extensions of
the principles of autonomy (respect for persons) and beneficence from the Belmont
Privacy can be defined in terms of having control over the extent, timing, and circumstances
of sharing oneself (physically, behaviorally, or intellectually) with others.
Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure, without permission.
HSRRC review of privacy and confidentiality protections is required under both the Common Rule and the FDA regulations, as well as state and local statutes. Protections to be reviewed by the HSRRC include promises to subjects on informed consents, protections during recruitment and follow-up, and methods to be employed to protect data and samples during storage, and use, and eventual data destruction (if promised).
The HSRRC must receive this information with the protocol submission documents. Studies that obtain particularly sensitive information (e.g. HIV status, drug abuse) may be required to obtain a certificate of confidentiality (see below).
The HSRRC must decide on a case-by-case basis whether there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
The HSRRC must take into account the degree of sensitivity of the information that may be obtained in the research and the protections offered the study and study population. As with other aspects of HSRRC review, these determinations will be dependent on the circumstances of the study and subjects.
The investigator must describe sound plans to protect the subject's identity, as well as the confidentiality of the research records. Care should be taken to explain the mechanisms that have been devised; for example, the use of numbering or code systems or safely locked files in private offices. Furthermore, the investigator should describe who has access to the data and under what circumstances a code system may be broken. Without appropriate safeguards, problems may arise from long-term retention of records. In special circumstances requiring additional safeguards to prevent potential criminal prosecution of the participating human subject, the HSRRC may require the destruction of all data that can identify the subjects. Subjects should be informed whether the data collected will be retained, and if so, for what purpose, what period of time, or whether and when data will be de-identified and destroyed.
A special situation arises for video or taped data and photographs, since these media
provide additional potential means for subject identification. Investigators must
secure subject consent explicitly mentioning these practices. They should also explain
plans for final disposition or destruction of such records.
If the research concerns illegal behavior, (e.g., a study of HIV and risk factors among prostitutes), the researcher may need to have the cooperation of local legal authorities or a federal Certificate of Confidentiality (see section on Certificates of Confidentiality).
If there is a risk of triggering retribution by others, such as violence by abusing partners, the researcher must ensure that nothing given can identify a person as a respondent.
Risk to the community must be minimized, often by researchers and community agreeing
about publication, (e.g., whether to identify the community).
Researchers should also maximize benefits of the research to each volunteer and community.
They must ensure availability of services to the volunteers. For a survey of fetal
alcohol syndrome, for instance, researchers should link to established, or help establish,
real services of prevention and treatment. At the very minimum, subjects should be
provided with sources of help and support available in the community.
Research involving emotionally vulnerable subjects should avoid coercion by caregivers. Many patients who are dependent on caregivers' help may feel that refusing to take part in research will lead to loss of the care they need, in spite of the written "non-coercion disclaimer" in consent forms. One way to avoid the problem is to emphasize repeatedly the freedom to refuse. Another is to have at least the consent, and sometimes the research as well, done by people other than the caregivers.
SUNY's Mandatory Child Sexual Abuse Reporting & Prevention Policy
State University of New York Board of Trustees adopted a resolution on December 17, 2012 that created a new policy to mandate the reporting of incidents of child sexual abuse on University property at University sponsored events and to take step to prevents such incidents.
When a SUNY employee, student or volunteer has a reasonable cause to suspect that any sexual abuse of a child occurring on SUNY property or while off campus during official State University business or University-sponsored events has occurred must report to the University Police Department.
For more information, please review this link.
One method commonly used to protect confidentiality is to use subject codes rather than names or other identifiers. Care must be taken, however, to ensure that the code cannot be used as an identifier.
For example, a frequently used code is the last four digits of the subject's social security number. Unless an extremely large number of subjects are being used, this number can still be used to identify an individual subject.
Arbitrary or random codes are much better at protecting confidentiality. On the other hand, when different sets of data for a single subject must be linked, an arbitrary code is usually unsuitable because subjects will forget them. In these cases, the best method is to provide subjects with a formula that they can use to generate a unique code and which will generally result in the same code number each time the subject uses it. The following is an example of a workable formula:
First & Second letter of Your Mother's First Name
First & Second letter of Your Father's First Name
Month You Were Born
Date You Were Born
FOR EXAMPLE: If your mother's name was Sally and your father's name was George and you were born on May 1st, you would enter:
SA GE 05 01