Institutional Review Boards (IRBMED)

 

Guidance

 

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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 >> 

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IRBMED News and Updates

April 18, 2014 — Federal regulations and the University of Michigan Human Research Protection Program's Operations Manual address requirements for IRB membership and approval of proposed research at convened IRB meetings. The new U-MIC presentation offers a summary.

April 8, 2014 — 

SAVE THE DATE!

IRBMED SEMINAR SERIES

Ford Auditorium
May 21, 2014
1:00pm - 5:00pm

IRBMED is excited to be hosting the next installment of our Seminar Series, focusing on several contemporary issues related to conducting human subjects research.  Topics of discussion will include:

  • HIPAA: Crossing the Privacy Barrier
  • Central IRBs: Ceding IRB Oversight
  • Case Study: Managing Multi-Disciplinary Research
  • Social and Behavioral Research in the Medical Setting

The seminar will conclude with a Panel Q&A Session, with representatives from the IRBMED Co- and Vice-Chairs, Directors, and Staff.   For the full agenda, click here.

Seating is limited and registration closes on May 14th, 2014!  To save your space, be sure to register here: Seminar Series Registration

 

April 3, 2014 — In certain cases, it is possible to obtain legally effective informed consent in an urgent or emergency care setting. The new U-MIC presentation examines the variables that IRBs and researchers must consider when determining whether consenting emergency care patients for research is appropriate.

April 1, 2014 — Modification to Regulatory Oversight of Exempt Research Projects

Beginning April 1, 2014, IRB-HSBS (UM Central Campus IRB) will be taking on responsibility for processing some Exempt human research study applications submitted by UMHS or Medical School faculty.

Specifically, IRB-HSBS will review and issue the exempt determinations for Exempt Categories 1, 2, and 3, when study teams will not be accessing Protected Health Information (PHI).

IRBMED will retain oversight for Exemptions 1, 2, and 3, when the study team will be accessing PHI, and for all Exemptions 4, 5, and 6 originated by UMHS or Medical School faculty.

IMPORTANTLY, default jurisdiction for UMHS faculty is not changing: if you normally submit to IRBMED (by choosing "IRBMED" in question 1.9 of an HUM application), please continue to do so.

IRB staff will re-assign appropriate applications as necessary.  Please contact Lark Speyer, IRBMED Exempt/Not Regulated Coordinator, at larkspur@med.umich.edu with general questions. Contact the IRB "Staff Owner" with questions about any specific application.

March 20, 2014 — For minimal-risk research that falls under one of nine categories, federal regulations allow review by an IRB Chair or designee, with no vote by the full IRB. The new U-MIC presentation outlines category 5: research involving materials collected for non-research purposes.

March 11, 2014 — Central IRB Information

A new decision tree on the Central IRB Information page illustrates the workflow when ceding oversight to a non–UM Institutional IRB (typically an academic institution).

March 7, 2014 — The IRBMED web site now includes a Statements of Practice page. The first Statement—covering Approval Dates on Consent Documents and Recruitment Materials—is available here.

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

A new decision tree on the Central IRB Information page illustrates the workflow when ceding oversight to an independent/commercial IRB.

January 23, 2014 — Central IRB Information 

The Central IRB Information page has been updated. Click here to view new and revised frequently asked questions. 

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. 

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).