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HSR/HRPP/IRB History & Overview
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Human Subjects Research HRPP | IRB
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Chelsea Timm, MS | HRPP Coordinator
CUNY Graduate Center
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Human Subjects Research
Human Subjects Research
Human Subjects*:
- Living individual(s)
- Identifiable private information accessed
- Through archives AND/OR
- Through intervention (physical or behavioral) or interaction (communication exchange or interpersonal contact)
*Both must be true of the subjects involved.
Research*:
- Systematic investigation - a plan to include project deveopment, testing procedures and/or evaluation methods
- Designed to enhance generalizable knowledge
*Both must be true to be considered research.
Are Oral Histories HSR?
It depends....
Are Oral Histories HSR?
Oral history activities that only document a specific historical event or the experiences of individuals without intent to draw conclusions or generalize findings would not constitute "research"
BUT
Systematic investigations involving open-ended interviews that are designed to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions, inform policy, or generalize findings) would constitute "research"
AND
Creating a repository for the purpose of providing a resource for others to do research meets the definition of “research” because it includes “research development.”
Historical Events in Human Subjects Research
Historical Events
The regulations we have to protect people in research came about after a series of events in the twentieth century in which doctors and scientists abused the trust that society placed in them.
1946
Nuremberg Doctors' Trial
The Nuremberg Doctors' Trial, in 1946, was an international military tribunal that tried and convicted Nazi doctors who conducted horrific unethical experiments on concentration camp prisoners during the Holocaust. It resulted in the Nuremberg Code, a set of international ethical guidelines for conducting research with humans.
1972
Syphilis Study in Tuskegee
1972 Syphilis Study in Tuskegee
In 1972, there was widespread media coverage of the Syphilis Study in Tuskegee, Alabama. Beginning in the 1930s and continuing for decades, U.S. government doctors studied the progression of untreated syphilis in poor African American men. The doctors did not tell the men they had syphilis, prevented them from learning their diagnosis, and did not offer treatment, even after penicillin became available.
1979
Belmont Report Created
1979 Belmont Report Created
As a result of the public outcry from publicized cases of unethical research, Congress passed a law requiring federal rules to protect people who participate in research. The rules rely on ethical principles that were laid out in the Belmont Report, which was written by an advisory committee created by Congress and published in 1979.
Belmont Report
Belmont Report
Respect for Persons
- Treat individuals as autonomous agents
- Protect persons with diminished autonomy
Beneficence
- Treat individuals ethically
- Respect decisions
- Protect from harm
- Secure well-being
Justice
- Fairly distribute research benefits and burdens
- Select subjects based on the problem being studied rather than the ease of accessibility/availablity
- Ensure outcomes proportionately benefit all intended target audiences.
1991
Common Rule Established
1991 Common Rule Established
- The Federal rules that protect people who participate in research were initially published by the Department of Health and Human Services (HHS).
- The first section of the HHS rules (Subpart A) is called the Common Rule because it was simultaneously adopted by 15 Federal departments and agencies in 1991.
- One key protection in the Common Rule is the requirement for appropriate review and approval of research by institutional review boards, or IRBs.
- The Common Rule generally requires that researchers get informed consent from volunteers who participate in research. This includes giving them information about the study, including risks and benefits.
1999
The Gelsinger Case
Jesse Gelsinger, 18, died during a gene transfer experiment at the University of Pennsylvania School of Medicine. His death - the first directly attributed to gene transfer - raised questions about adherence to research protocols, reporting of adverse events, informed consent, and financial conflicts of interest. It led to profound efforts to improve the protection of research participants.
2000s
HSR Protections Enhanced
- The Office for Human Research Protections (OHRP) was created in June 2000 to lead the Department of Health and Human Services’ efforts to protect human subjects in biomedical and behavioral research and to provide leadership for all federal agencies that conduct or support human subjects research under the Federal Policy for the Protection of Human Subjects, also known as the Common Rule.
- All institutions receiving federal funding must register their IRBs with the OHRP.
- Accountability efforts were implemented by accrediting bodies to ensure Human Research Protection Programs are operating effectively.
Human Research Protection Program
HRPP
The CUNY Human Research Protection Program (HRPP) is responsible for the protection of the rights and welfare of human subjects in research projects conducted at CUNY or by CUNY faculty, staff, and students.
The program provides oversight, administrative support, and educational training to ensure CUNY research complies with federal and state regulations, university policy, and the highest ethical standards.
HRPP Office
Human Research Protection Program Coordinators
- Provides educational opportunities for students, staff, and faculty to learn about Human Subjects Research, the Human Research Protection Program, and the Institutional Review Board
- Provides administrative support for studies involving human subjects.
- Provides initial review(s) of applications for studies involving human subjects to ensure they comply with federal and state regulations, university policy, and the highest ethical standards.
- Communicates with Institutional Review Board member(s) regarding study applications and studies up for annual review.
IRB
Institutional Review Board
The CUNY Institutional Review Boards (IRB) are groups of research experts within the HRPP who must ensure that subjects are not exposed to risks, however minimal, without scientific justification, and that the risks are reasonable in relation to benefits. The IRB members accomplish this by evaluating whether the proposed research involves sound experimental design and has the potential to yield valid results. The IRBs are made up of research experts in several fields (community health, law, biology, psychology, etc.) and include CUNY faculty and/or professionals in the community. When necessary, the IRBs may seek expert consultants to assist in the review of research that requires expertise beyond or in addition to that available on the IRBs.
IRB Manager Application
IRB Application
WHO:
- Investigators (students or faculty) who wish to conduct research that involves human subjects and CUNY is engaged in the project.
WHEN:
- Consults with your advisor to determine at which point in your academic program it is appropriate to get involved in research as a Principal Investigator
- Also consider:
- Complexity of study
- Desired timeframe for participant contact
- Time of year
The xForm
The xForm:
It's logic-based!
What to expect and include in the application!
Consent Considerations
- Communication of information
- Comprehension of information
- Translation of consent forms and recruitment materials
- Voluntary participation
- Regulations requirements
Consent Must Include
- Specific information about the study that would allow potential participants to be considered well-informed.
- All defined and described potential risks and benefits.
- A breakdown of study procedures: time it will take, where it will take place, what participants should expect, etc.
- Statements about potential direct and indirect benefits to participant, group, society, even if their are none.
- Other requirements depending on the type and/or subject of the project.
Considerations for Vulnerable Populations
Additional safeguards are in place per the regulations for these populations.
EXAMPLE - PRISONERS:
Prisoners may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research.
At least one member of the IRB shall be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity.
EXAMPLE - CHILDREN:
Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
Because children are minors, additional requirements for consent of parents/guardians and assent of the child are necessary.
Checklist for Submission
Checklist for Submission
IRB Manager Account
HSR CITI Training Certificates
Advisor Appointed/Accepts
- Principal Investigator
- Advisor
- Principal Investigator
- Advisor
- All research personnel
As Applicable
- Surveys/Interviews
- Scripts
- Consent Templates
- Screening Documents
- Recruitment Materials
Level of Review
Level of Review
NONE
determined not to be human research
EXEMPT
minimal risk projects that fall into one of the exempt categories as defined by the federal regulations; administratively reviewed
EXPEDITED
minimal risk projects that fall into at least one of the expedited categories as defined by the federal regulations; IRB Member reviewed
FULL BOARD
greater than minimal risk projects; IRB Board reviewed; Annual review required
Order of Operations for Submission
Order of Operations for Submission
8. You respond to all IRB inquiries, questions, and suggestions for revisions. Repeat 2-7 as necessary.
6. HRPP deems Exempt OR submits to IRB for approval.
2. You submit project to advisor for initial review.
4. HRPP conducts pre-review.
7. IRB conducts review.
3. Your advisor submits project to HRPP for pre-review.
1. You create IRB Manager account at https://cuny.my.irbmanager.com.
9. IRB approves project. HRPP notifies you and your advisor of IRB approval.
5. You respond to all HRPP inquiries, questions, and suggestions for revisions. Repeat 2-4 as necessary.
Questions?
?
GRADUATE CENTER HRPP
Chelsea Timm
HRPP Coordinator
ctimm@gc.cuny.edu
3300.29 | (212)817-7532
Office Hours
In-Person: Tues 10-1
Virtual: Wed 10-12
IRB MANAGER TECHNICAL SUPPORT
Travis McCarthy
Senior Research Compliance Coordinator
travis.mccarthy@cuny.edu