A component of the University of Michigan's Human Research Protection Program (HRPP) and a unit of the Office of Research, the five Institutional Review Boards of the University of Michigan Medical School (IRBMED) oversee human subjects research conducted at the Medical School and UMHS. More >>
IRBMED News and Updates
March 7, 2014 — In 2009, the Food and Drug Administration published guidance on the responsibilities of investigators conducting drug, biologic, and device trials. The new U-MIC presentation provides an overview.
February 21, 2014 — For each application it reviews—whether during a convened Board meeting or by expedited review—the IRB must make certain regulatory determinations. The latest U-MIC presentation offers a summary.
February 4, 2014 — Central IRB Information
January 23, 2014 — Central IRB Information
January 22, 2014 — Education Update
The IRBMED Education Page has been updated with a new layout for improved readability. On the new education page you will, also, find updated information regarding IRBMED’s course offerings. Courses are now scheduled through the end of 2014 and course descriptions and the course grid have been revised to reflect new offerings and more accurate descriptions.
January 15, 2014 — Specialty Informed Consent Templates
The IRBMED web site now offers two new specialty consent templates for use by study teams.
The first new template is tailored to minimal risk studies that involve a single blood or tissue sample.
The second new template is designed for eligibility screening that poses no more than minimal risk to subjects.
These specialty templates are not meant for use in studies involving genetic analysis of subjects' blood or tissue samples or when tissues or data will be submitted to a repository.
January 15, 2014 — Web Site Update
IRBMED has updated the Informed Consent Templates pages on our website in order to provider easier navigation between the Standard ICD Template and the newly added Specialty Templates.
To access the main Consent Templates page, click here.
To access the new specialty consent templates directly, click here.
January 9, 2014 — U-MIC Update
The previous U-MIC presentation offered recommendations for creating effective informed consent documents. This instructional follow-up presentation applies these principles in the revision of a problematic consent passage.
December 18, 2013 — U-MIC Update
In the first of two presentations on writing informed consent documents, IRBMED's technical writer offers some basic recommendations for crafting documents that are both readable and comprehensible to subjects.
November 1, 2013 — Holiday and Seasonal Closings
As the weather grows colder and the holiday season approaches, the IRBMED Office would like to remind you that:
- IRBMED will be closed on Thursday, November 28th and Friday, November 29th for the Thanksgiving holiday.
- Additionally, IRBMED will close at the end of business on Tuesday, December 24th and will reopen at start of business on Thursday, January 2, 2014.
November 1, 2013 — FDA INSPECTIONS OF INSTITUTIONAL REVIEW BOARDS
FDA conducts periodic, scheduled inspections of IRBs, to determine whether they are in compliance with current FDA regulations and laws and whether they are following their own written procedures. This short presentation gives an overview.
October 9, 2013 – ENROLLMENT NUMBERS AT SCHEDULED CONTINUING REVIEW
IRBs and other research administration committees at U-M are adopting a single standard definition of enrolled. In the newest U-MIC slideshow, guest presenter Lark Speyer summarizes enrollment reporting in eResearch.
October 7, 2013 — STAFF UPDATES
Cecilia Brenner, current JARA for the B2 Regulatory Team, will be taking on the role of Secondary Use and Umbrella Applications reviewer. Under this role, all new Secondary Use and Umbrella applications will be routed to Cecilia, thereby streamlining the review process for those projects. Aaron Rankin, MSW, will replace Cecilia as the JARA for the B2 team (effective October 7, 2013).
October 4, 2013 — U-MIC Update
When research subjects make reference to individuals who are not involved in the study at hand, and with whom researchers have no interaction, we call these individuals third parties. The latest U-MIC presentation offers an overview.
October 4, 2013 — STAFF UPDATES
IRBMED is pleased to announce that the position of Education Coordinator has been filled by Kate Sasamoto, JD. Kate is a current member of the IRBMED Staff, and will begin transitioning to the role of Education Coordinator on October 1, 2013.
IRBMED is also pleased to announce that Linda Cholewa, BS, has joined IRBMED as the ARA for the B1 Regulatory Team (effective September 3, 2013), and Nicole Duffy, BS, has joined as the ARA for the C1 Regulatory Team (effective September 9, 2013).
October 1, 2013 — Federal Government Shutdown
For Information Relating to the Federal Government Shutdown, specifically in regards to funding and grant applications, please see the following:
October 1, 2013 —
|On Wednesday, October 2, 2013, the Staff at IRBMED will be attending the all-day educational FDA symposium, sponsored by Regulatory Affairs. Responses to emails and phone calls may be delayed as a result.|
September 30, 2013 — Announcement Emails
Be sure to join the IRBMED Announcements Email list to receive important updates about educational opportunities, updates in guidances, or changes to templates. To sign up, click here: http://research.med.umich.edu/joinourlist
September 5, 2013 —
|Symposium on FDA-Regulated Research Don't miss this opportunity to get the "inside scoop" on the fascinating, and sometimes mysterious, world of FDA-regulated research. This symposium will feature insights from the perspectives of the clinical investigator, sponsor, IRB, and more — including a special presentation by an FDA inspector!
Please join us on Wednesday, October 2, 2013, 9 am — 4 pm, in the Rackham Amphitheater. Attendance is free, but space is limited — email email@example.com with your interest in attending.
This symposium is presented by the University of Michigan Office of the Vice President for Research and the Medical School Office of Regulatory Affairs.
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 page (click the link in the navigation column to the left) 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/
Tuesday July 30, 2013
1:00pm – 2:00pm
Judith Birk, JD
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.
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. 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.
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.
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).