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
August 14, 2013 —
SAVE THE DATE
Researchpalooza is scheduled for Wednesday August 21st, from 11:00am - 2:00pm. Spend some time learning about the latest collaboration and funding opportunities, and network with faculty and staff across dozens of specialties. Also, be sure to stop by and see the IRBMED table and meet some of our team members!
August 2, 2013 — The IRBMED web site now includes information about ceding oversight to a central IRB. The Central IRB Information box in the right column of this page contains a link to the slideshow used during the July 30 information session hosted by IRBMED and Chesapeake IRB, as well as a link to some frequently asked questions.
August 1, 2013 — Join the "IRBMED Announcements" email list to receive important updates!
July 22, 2013 —
Are you interested in learning about the University of Michigan's procedures for using a central IRB for your multi-site, industry-sponsored clinical trials?
Representatives from IRBMED and from Chesapeake IRB, one of the central IRBs collaborating with the University of Michigan, are hosting an information session to discuss the application and review process for ceding IRB oversight to Chesapeake IRB. General highlights from the new UM eResearch Ceding Application and its review process will also be discussed.
To register for this event, click here: http://ttc.iss.lsa.umich.edu/ttc/sessions/upcoming/
June 28, 2013 — Humanitarian Use Devices (HUDs) are used to treat conditions that affect fewer than 4,000 Americans per year. This short slide show outlines the requirements for HUD use and research.
June 13, 2013 — The newest U-MIC presentation outlines requirements for IRB review of supporting documents at scheduled continuing review.
May 29, 2013 — For the latest U-MIC presentation, guest presenter Lark Speyer offers an overview of projects lacking immediate plans for involvement of human subjects—known as umbrella projects.
May 21, 2013 — IRBMED is moving! Beginning May 24, 2013, our new address will be:
2800 Plymouth Road
Building 520, Room 3214
Ann Arbor, MI 48109-2800
Our phone number and main email address will remain the same: 734.763.4768, firstname.lastname@example.org
Any mail directed to our current address will be forwarded to our new location.
IRBMED is NOT requesting amendments to update Informed Consent Documents (ICD) with the new address information. However, if you are submitting an amendment to modify some other aspect of the ICD, we request that you also update the address.
May 17, 2013 — The latest U-MIC presentation offers recommendations for securing electronic research data.
May 3, 2013 – Policy Change: IRBMED has a modified policy on watermarking and updating expiration dates on recruitment materials and informed consent documents at the time of scheduled continuing review (SCR). For studies where enrollment has concluded, IRBMED will no longer watermark or update expiration dates on recruitment materials at SCR. For studies where interaction/intervention with subjects has concluded, IRBMED will no longer watermark or update expiration dates on informed consent documents at SCR.
May 3, 2013 — The newest U-MIC presentation addresses unanticipated problems involving risk to subjects or others.
May 1, 2013 — The IRBMED web site now offers guidance on lotteries as incentives for research participation.
April 9, 2013 – The Standard Informed Consent Template has been updated to include modified help text and language for:
- Genetic sub-studies
- Genetic Information Non-Discrimination Act (GINA)
Additionally, Section 12 – Signatures has been revamped entirely. The help text and language has been updated for clarity and consistency, and additional information has been included regarding:
- Two-parent signatures
- Genetic sub-studies
For the most up-to-date version of the ICD Template, click here: http://med.umich.edu/irbmed/ict.htm
April 9, 2013 — 21 CFR Part 11 provides criteria under which FDA will consider electronic records to be equivalent to paper records and electronic signatures to be equivalent to traditional handwritten signatures. Click here for guidance, including certification letters and compliance checklists for MiChart, CareWeb, and eResearch.
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 email@example.com 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 firstname.lastname@example.org – or see Guidance for Blinded Studies (hotlink).