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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
May 8 IRBMED 2008 Education Symposium Materials are on-line. Click here.
Microsoft 2007 and eResearch
Files saved in Microsoft Office 2007 format are currently not compatible with
the eResearch - Regulatory Management system. Office 2007 files should be saved
in a previous version using the 'Save As'
function before being uploaded in eResearch.
FOR QUESTIONS OR ASSISTANCE
Contact the MAIS Help Desk 6-7000, option 6 or
emaill: maishelpdesk@umich.edu
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Important Changes
REMINDER--Update to the new IRBMED Informed Consent Document Template required on new studies, 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 |
