Dearborn Institutional Review Board
The University of Michigan - Dearborn Institutional Review Board (IRB-Dearborn) is one of nine Institutional Review Boards that are part of the University of Michigan Human Research Protection Program. The IRB oversees all of the research involving human subjects conducted by University of Michigan-Dearborn faculty, staff, and students. This program is fully accredited by the American Association of Human Research Protection Programs.
New Human Subjects Regulations
The implementation of the new Human Subject Regulations has been pushed back to January 21, 2019. The new regulations are expected to reduce the burden on researchers. Changes include eliminating Continuing Review on many Expedited studies, new categories of Exempt research, self determination of Exempt status, and changes to Informed Consent. This space will be updated as more information becomes available.
About IRB Dearborn
The mission of the IRB is to protect the rights and welfare of human subjects recruited under the auspices of the University of Michigan-Dearborn.
IRB activities include:
- review and approve studies that meet established criteria for protection of human subjects
- monitor approved research to ensure that human subjects are protected
- educate the research community on ethical and procedural issues related to human subjects protection.
The IRB-Dearborn meets monthly during the academic year and on an as-needed basis during the summer. The Chair of the IRB is Dr. Robert Hymes. Investigators seeking exempt determination, expedited approval, or full board approval for their research must complete an on-line application using eResearch.
Debra Schneider, Dearborn IRB Administrator
The IRB - Dearborn employs a review process in conformity with the Federal Policy for the Protection of Human Subjects (45 CFR 46) and the Federalwide Assurance (FWA) enacted between the University of Michigan's Human Research Protection Program and the federal Office for Human Research Protections (OHRP).
These regulations give IRB Dearborn the authority to approve, monitor, suspend, terminate, or disapprove any research project conducted by UM-Dearborn faculty, staff, and students. Under no circumstance may a decision of the IRB-Dearborn to disapprove a project be reversed by another agency of the University of Michigan.
Is my research under IRB jurisdiction?
Whether or not your research requires IRB approval, depends on three things:
1. Is the activity "regulated research"?
2. Are there "human subjects"?
3. Is the University of Michigan "engaged"?
Is it research? 45 CFR 46.102(d)
Research, is defined as a "systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge." If you intend to share or publish the results of your study "outside the walls" of the University your project will require IRB review.
Are there human subjects? 45 CFR 46.102(f)
A human subject is defined as a living individual about whom an investigator (whether professional or student) conducting research (whether funded or not) obtains:
1. data through intervention or interaction with the individual or
2. identifiable personal or private information
Examples of data collection include: surveys, interventions, and/or collections of specimens (blood, saliva, etc.)
Is UM engaged?
The University is engaged in human subjects research when the researcher is a University of Michigan Dearborn faculty, staff, or student who conducts any one of these 3 activities:
- obtain informed consent
- conduct a research interaction or intervention to obtain personal, private information about a subject
- analyze personally identifiable data
IRB Application Deadlines & Meeting Dates
Applications are taken on a rolling basis. If the study does not contain topics or questions of a highly sensitive or illegal nature (e.g., drug use, sex, abuse, immigration status) the study should be able to stay in the exempt or expedited review path (review by a single board member). There are no particular deadlines for submitting exempt or expedited applications. These studies should take from 2 weeks to a month for approval.
If the study poses more than minimal risk to the subjects, contains sensitive questions, or utilizes vulnerable populations (children or prisoners) it may require full board approval. The Dearborn IRB meets on the third Friday of the month from September through June to review studies that pose more than minimal risk to the subjects. Please submit the application 3 to 4 weeks before the scheduled meeting.
If you have questions about whether a study will require full board review please contact Deb Schneider at (734) 763-5084.