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What is an IRB?
An IRB is an independent committee made up of at least five (5) members from the academic disciplines for which it has oversight and at least one member who is not affiliated with the institution. The membership:
- Comes primarily from faculty
- May also include students, staff and members of the community
- Must have the expertise and experience to evaluate proposed research projects
- Must be diverse in terms of race, gender and cultural backgrounds
U-M HRPP Operations Manual IRB References
IRB organization, authority: Part 2, Section II, C
IRB jurisdiction: Part 5, Section I, A-D
Cindy Shindledecker, BA, CIP – Director
Mary Ramirez, MA, CIP – Assistant Director
Vicki Botek, Ed. M – Office Secretary
Mary E. Donnelly, MBA, CIP – Sr. Research Compliance Specialist, Full Board Administrator
Li Morrow, M.Ed. – Research Compliance Specialist, Assistant Full Board Administrator
Adam J. Mrdjenovich, Ph.D. – Project Manager, Education Coordinator
Wendy Peebles, MSW – Research Compliance Specialist
Deborah Schild, Ph.D. – Research Compliance Specialist
Debra T. Schneider – BBA, CIP – Intermediate Research Compliance Specialist
About the Health Sciences and Behavioral Sciences IRB (IRB-HSBS)
The Health Sciences and Behavioral Sciences Institutional Review Board (IRB-HSBS) is responsible for protecting the rights and welfare of human subjects participating in research conducted by faculty, staff and students affiliated with the University of Michigan – Ann Arbor Campus (see list of supported units).
- Reviews and oversees research to ensure that it meets ethical principles and complies with federal regulations, state laws, and university policies (see HRPP Policies)
- Assists researchers in the design and conduct of sound research in support of U-M's mission to develop and disseminate new knowledge in the public interest
The IRB-HSBS consists of two (2) boards led by the IRB Chair, Thad Polk, Ph.D., who is supported by a Vice Chair. Each board meets monthly. Designated IRB members also may conduct expedited review of applications on a rolling basis.
The IRB-HSBS regulatory compliance staff supports the operations of the two boards. As a researcher, most of your interaction with the IRB is through the staff as they assist you with questions about IRB process and regulatory requirements, as well as provide educational programming to the research community. IRB staff members:
- Conduct administrative review of new submissions
- Manage application workflow
- Manage communications between the research team and the IRB reviewer
Some qualified IRB staff members have the authority to issue exempt determinations and other decisions.
Researcher Roles & Responsibilities
Researchers at U-M are responsible for the ethical conduct of research with human subjects. In compliance with federal regulations, state laws, and university policy, the investigator's key responsibilities are to:
- Apply for IRB approval or determination of exemption before conducting any research with human subjects or their personally identifiable data via U-M's eResearch Regulatory Management system
- Designate a faculty advisor on the IRB application for research conducted by students. The faculty advisor shares responsibility with the student for the ethical conduct of the research (see Resources below).
- Complete the required ethical and regulatory training for the conduct of human subjects research (see HRPP Education Resources - PEERRS)
- Conduct the research in accordance with the approved protocol
- Submit amendments before initiating changes to the approved protocol
- Submit scheduled continuing review reports to the IRB as required, and prior to the protocol expiration date
- Report all unanticipated problems or serious adverse events involving risks to human subjects as soon as possible
- Manage research data carefully to protect subject confidentiality
Federal regulations define human subjects as a "living individual about whom an investigator conducting federal research obtains (1) data through intervention or interaction with an individual or (2) identifiable private information." ~ 45 CFR 46.102
- Data includes information or specimens collected from living subjects
- About whom indicates that the data must be personal information about an individual
- Intervention includes physical procedures, manipulations of the subject, or manipulations of a subject's environment for research purposes (e.g., taking saliva or blood samples, havin a subject view a video)
- Interaction refers to communication (e.g., face-to-face, internet, mail, phone, etc.) between the investigator and the subject
- Individually identifiable means that the subject's identity is or may be ascertained by the investigator or others
- Private information includes information about behavior that occurs in a context in which the subject can reasonably expect that no observation or recording is taking place; or, information provided for specific purposes by the subject in which the subject can reasonably expect will not be made public (e.g., medical records, academic records, personal journals).
NOT human subjects research:
- Research using data from the 1880 Census because the data isn't from living individuals
- Survey that collects data about an organization's activities because the data isn't about individuals
- Research using de-identified data sets because the data are not individually identifiable
If you can answer "yes" to the following questions, you need to submit an IRB application in eResearch for IRB review:
1. Is it research?
Research is a systematic investigation (including research development, testing, and evaluation) designed to develop or contribute to generalizable knowledge? ~ Federal definition, 45 CFR 46.102, d
- Systematic investigation is an activity designed to test a hypothesis and to draw conclusions as described in a formal protocol that sets forth an objective and procedures to reach that objective.
- Activities such as the practice of public health, medicine, counseling, or social work are not research.
- Generalizable knowledge is information expressed in theories, principles, and statements of relationships that can be widely applied (e.g, by publishing findings or presenting findings at a professional meeting).
- Studies for internal management purposes (e.g., program evaluation, quality assurance, or quality improvement) are not research because the intent is not to provide generalizable knowledge but to apply findings only to the program or activity.
2. Does the research involve human subjects?
Human subjects research is a project that involves a living individual about whom the investigator obtains data through interaction/intervention with the individual, or obtains identifiable private information? ~ Federal definition 45 CFR 46.102, f
3. Is the university engaged in the conduct of the research?
The university is "engaged" when the research is conducted by U-M faculty, staff, trainee, or other agent acting in connection to their university responsibilities. See OHRP's Guidance on Engagement of Institutions for more information and examples.
- Direct awards from federal sponsors that meet criteria #1 and #2 are always reviewed by a U-M IRB, whether or not the university is engaged in the research.
- If you answer "no" to any of these questions, you may have other obligations than IRB review. See the U-M HRPP Operations Manual Part 4, Section V for more information about regulated/non-regulated research.