Human Subjects Protection Program--Dearborn
The University of Michigan-Dearborn Human Subjects Committee, or Institutional Review Board (IRB-Dearborn) is one of nine IRB Committees at the University of Michigan. The primary goal of the IRB-Dearborn is to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the University of Michigan-Dearborn. Applications submitted to the IRB-Dearborn generally encompass social, behavioral, and educational research and that are medically non-invasive and do not entail patients or resources of the University of Michigan Health System.
IRB-Dearborn reviews all planned research involving human subjects prior to initiation of the research, approves research that meets established criteria for protection of human subjects, and monitors approved research to ascertain that human subjects are indeed protected. Through educational sessions and focused discussions, the IRB-Dearborn educates the research community on ethical and procedural issues related to human subjects protection.
About IRB Dearborn
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. For more information about the IRB or applying for approval, contact irb-dearborn.
IRB-Dearborn is authorized and organized to review any and all types of research in which human subjects are involved, including projects that are not subject to federal oversight.
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 and the Office for Human Research Protections (OHRP) under the Department of Health and Human Services (DHHS). For more information on FWAs, click here.
The review process is the same for all research involving human subjects supported or otherwise subject to regulation by any federal department or agency, sponsored by any other extramural entity, or initiated and funded within the University of Michigan.
The authority conveyed to the IRB-Dearborn includes decisions to approve, disapprove, require modifications, monitor, suspend and terminate research projects involving human subjects. Under no circumstance may a decision of the IRB-Dearborn to disapprove a project be reversed by another agency of the University of Michigan.
Certain populations of human subjects may be particularly vulnerable in a research setting: children, prisoners, pregnant women, fetuses, mentally disabled persons, economically or educationally disadvantaged persons. In undertaking its review of these subject populations, IRB-Dearborn will apply additional protective safeguards as required by federal and state law, institutional guidelines, and any other applicable agency/entity regulations.
Whether or not your research falls under the jurisdiction of the the IRB-Dearborn and thus 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?
Research (that is, research under IRB jurisdiction) means a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities." 45 CFR 46.102(d)
Generally, if you intend to publish the results of your study "outside the walls" of the University, or your study is not a single "case study," journalism, or oral histories, then your study is regulated research and under IRB jurisdiction. You will need IRB approval for your research if it involves human subjects.
Are there human subjects?
Human subject refers to 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
- A survey of individuals requesting personal information (information that is sensitive or could be damaging if made public, such as tendencies toward depression or past illegal behavior) or private information (social security number, home address, medical information).
- Measuring blood pressure and heart rate with a simple, commonly-used cuff and finger clamp.
- Having K-12 students take a pre- and post-test to evaluate the effectiveness of a particular teaching method that the investigator wishes to report on in a scholarly journal.
Is UM engaged?
The University is engaged when:
- the investigator is a UM-Dearborn faculty or staff member or a student conducting research as a degree requirement or under the supervision of a UM-Dearborn faculty member; AND
- the researcher doing any of the following activities: obtaining informed consent, conducting the research interaction or intervention, or obtaining personally identifiable private information about the subject.
All applications are taken on a rolling basis. However, unless your study contains topics or questions of a highly sensitive or illegal nature (e.g., drug use, sex, abuse, immigration status), or under certain other conditions, your study should be able to stay in the expedited path (review by a single board member). About 95% of the studies submitted to the IRB-Dearborn are able to be expedited. There are no particular deadlines for submitting expedited applications. Currently, the Dearborn IRB meets a minimum of once each month between September and June to consider applications that require Full Board Review. Please be sure to submit the application no later than 2 weeks prior to the scheduled board meeting. However, given the high volume of IRB application submissions, please plan to 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.
- How to Apply for Approval
- Go to eResearch (leave Dearborn Research website)
- Introduction to Human Subjects Research: Student Guide
- Help with an eResearch application (tips and guides)
- Help with Consent Forms
- Determining When a Classroom Project Needs IRB Approval
- Human Subjects Policies (University of Michigan and Federal)
- Human Subjects Educational and Training Materials
- IRB-Dearborn Meeting Dates and Application Cutoff Dates
- Members of the IRB-Dearborn (Human Subjects Committee or Institutional Review Board