The five Institutional Review Boards of the University of Michigan Medical School (IRBMED) are charged with the oversight of human subjects research conducted by medical school faculty, students, and staff at any University of Michigan Health System (UMHS) facility or site. The purpose of an IRB is to protect the rights and welfare of human subjects in research. Guiding this process is the application of federal and state laws, university policies, ethical principles; particularly those articulated in the Belmont Report.

Investigators should not commence research involving human subjects until the IRBMED has approved the study or has determined it is exempt.

Federal OHRP* regulations define a "Human Subject" as: "[A] living individual about whom an investigator . . . conducting research obtains: (1) Data through intervention or interaction with the individual, or (2) Identifiable private information" (45 CFR 46.102[f]).  FDA* regulations use the definitions "a human . . . on whose specimen an investigational device is used . . .;"21 CFR 812.3 (p) or "an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient." 21 CFR 50.3 (g)

"Research" is defined by OHRP as:  "[A] systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" 45 CFR 46.102[d] and by FDA as " [A]ny experiment that involves a test article and one or more human subjects [or specimens]. . . the results of which are intended to be submitted to . . FDA." 21 CFR 56.102 (c)

The IRBMED office welcomes comments and suggestions from research team members. Please use our online feedback form to give us your input.

*OHRP is the U.S. Deptment of Health and Human Services Office of Human Research Protections. FDA is the U.S. Deptment of Health and Human Services Food and Drug Administration.

All 'key personnel" must complete basic human subjects education in PEERRS prior to IRB approval of a study. Click here for details.

News

NEW! Assent Template recommended for children ages 10- to 14-years-old. The assent template is posted on the webpage with informed consent templates. We expect to post assent templates for 7- to 9-year-olds and cognitively or decisonally impaired adults in the coming weeks. Click here for more information.

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Important Changes

REMINDER--Update to the new IRBMED Informed Consent Document Template required on a subset of renewals (eResearch studies must update via an amendment application) and informed consent amendments submitted after 11/1/2007

Common Errors When Updating to the New Informed Consent Template

Since November we've become aware of two informed consent mistakes that have become very common, requiring applications to be returned to the study teams for corrections and making the review process take longer than it otherwise would.Click here for more details.

Unanticipated Problems and New Adverse Event Reporting Guidance updated 10/1/2007

Federal Law Expands Clinical Trial Registration Requirement--Click here for full details about the 12/26/07 deadline.

Other News

eResearch Conversion

The term "eResearch Conversion" refers to the plan to move active studies previously approved in IRBMED's paper-application system, known as "Legacy," to the "eResearch" on-line application system. Click here to read more.

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Nominations for faculty service on IRBMED

Interested parties should send their CVs or resumes along with a letter of interest outlining their reasons for volunteering to Jan Hewett, Director, IRBMED, c/o Colleen Bouton, (Board Secretary) at cbouton@med.umich.edu