Institutional Review Boards of the University of Michigan Medical School (IRBMED)

The five Institutional Review Boards of the University of Michigan Medical School (IRBMED) oversee human subjects research conducted at the Medical School and UMHS. This includes research conducted off-site by University faculty and staff when acting as University employees or in connection with their University appointments.  

IRBMED is charged with protecting the rights and welfare of participants in clinical trials and other human subjects research studies. IRBMED is responsible for monitoring compliance with federal and state laws, university policies, and ethical principles (particularly those articulated in the Belmont Report).  

For more information, including staff contacts, fees, and IRBMED office location, click here.

 

IRBMED News and Updates

 

April 3, 2013 — The latest U-MIC slide show explores lotteries as incentives for research participation, including a summary of Michigan's legal requirments.

March 25, 2013 — The newest U-MIC presentation outlines options for obtaining subjects' consent to take part in genetic sub-studies.

March 8, 2013 – UMHS has updated its disciplinary policy for protecting patient information.  This amended policy takes effect March 15, 2013.  To read more, click here: http://umhsheadlines.org/08/health-system-updates-disciplinary-policy-for-protecting-patient-information/?utm_source=HSH&utm_medium=email&utm_campaign=TopStory-health-system-updates-disciplinary-policy-for-protecting-patient-information

March 7, 2013 — IRBs maintain meeting minutes to document key elements of convened board meetings.This short presentation summarizes the requirements.

March 6, 2013 — An informed consent template for use with Humanitarian Use Devices (HUDs) is now downloadable from the IRBMED web site.

February 21, 2013 — The HIPAA Privacy Rule guards patients' protected health information (PHI) and governs how researchers may access, use, and disclose PHI in research. This slide show provides a summary.

February 19, 2013 — The help text in section 9.2 of the standard informed consent template has been revised. The new text addresses child and elder abuse reporting.

February 7, 2013 — The IRBMED web site's guidance on Humanitarian Use Devices (HUDs) has been updated.

February 7, 2013 — Federal regulations outline requirements for obtaining the assent of human subjects under 18, as well as cases in which IRBs may waive those requirements. This short presentation offers an overview.

February 5, 2013 — The IRBMED web site now includes guidance on deception and concealment in human subjects research.

Jaunary 31, 2013 — The help text in section 6.1 of the standard informed consent template has been revised. This section relates to alternatives to study participation.

January 25, 2013 — The latest U-MIC presentation outlines federal requirements for documenting subjects' consent to take part in research, as well as circumstances under which IRBs may waive the documentation requirement.

January 7, 2013 – IRBMED course offerings for February and March are now available; you may access the schedule of classes here:  http://www.med.umich.edu/irbmed/education.html.  Please note that the location for these classes has changed.

January 4, 2013 – IRBMED issues a bi-weekly email with information related to guidance updates, template modifications, staff changes, U-MIC postings, and available educational opportunities.  If you would like to receive these emails, please contact Joseph Austin at sjaustin@med.umich.edu and let him know you would like to be added.

January 3, 2012 – The IRBMED Calendar has been updated to include scheduled Board meetings, educational opportunities, and holiday closures.  You may access the calendar here: http://med.umich.edu/irbmed/StaffContactList.html#calendar

January 2, 2013 – Help text changes have been made to Sections 5.2 and 8.1 of the Informed Consent Template.  These Sections relate to subject-injury language for internal or investigator sponsored projects.  To view the help text, access the Informed Consent Template here: http://med.umich.edu/irbmed/ict.htm

November 21, 2012 –

For BLINDED research studies, where subject access to their TEST RESULTS through MyUofMHealth.org MUST NOT BE VIEWED, contact IRBMED for special procedures to follow at 734-763-4768 or at irbmed@umich.edu – or see Guidance for Blinded Studies (hotlink).