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

August 21, 2014 —

RESEARCHPALOOZA!

Come join the Office of Research on Wednesday August 27th, from 11am – 2pm, on Circle Drive in front of Med Sci I. 

Researchpalooza is the perfect opportunity for colleagues and friends to have a great time and meet, mingle, and learn more about many of the organizations that offer their services to faculty, students, and staff, all at one convenient time and location.  With nearly 70 participating offices and labs, it's shaping up to be a great event!

Be sure to stop by and meet some of the IRBMED staff.  We’re looking forward to seeing you there!

For more information, click here.

August 21, 2014 —

The “Inside Scoop” on When the FDA Comes to Call

Wednesday, August 27, 2014
BSRB Kahn Auditorium
2pm – 3pm

Nancy A. Bellamy, FDA Investigator, Bioresearch Specialist, Detroit Office, will be discussing issues of importance for human subject protection, how to run an FDA-compliant clinical trial, and what “observations” of concern are most commonly found during FDA inspections.  Her presentation will be followed by liberal time for questions and answers.

This event is sponsored by UMMS Office of Regulatory Affairs.  There is no registration for this event.

Click here for a presentation flyer.

August 21, 2014 — U-MIC

In certain circumstances, IRBMED may permit the University of Michigan’s participation in a multi-site study only if U-M–specific protocol modifications are implemented. A new U-MIC presentation offers a summary of the procedures.

August 19, 2014 — Two New Specialty Informed Consent Templates

IRBMED's Specialty Consent Templates page now offers two new templates: an Emergency Use Informed Consent Template and a Survey Research Informed Consent Template. The survey consent template is availble both with instructions and in a clean version. Emergency Use guidance, including information about obtaining informed consent in emergency use situations, is available here.

July 28, 2014 — Central IRBs

The University of Michigan has finalized Master Services Agreements with four IRBs: Chesapeake IRB, Quorum Review IRB, Schulman Associates IRB, and Western IRB (WIRB). Please visit the Central IRB Information page for details about ceding IRB oversight to one of these IRBs.

July 8, 2014 — New Specialty Informed Consent Template: Compassionate Use

A newly developed Compassionate Use Informed Consent Template is now available for download on IRBMED's Specialty Consent Templates page. A Compassionate Use Information Sheet accompanies the new template, to guide and assist researchers in completing their compassionate use Informed consent document prior to submitting it to the IRBMED for review.

June 13, 2014 —

REGULATORY FLEXIBILITY:

Exemption 2A

Utilizing the flexibility within the human subject protection regulations and in accordance with our Federalwide Assurance (FWA) with OHRP,  IRBMED has expanded the definition of Exemption 2 to include minimal risk research with adults that involves a non-invasive intervention followed by data collection via survey, interview (including focus groups), test, observation, and/or recording of physiological measurements.  This expanded category is called Exemption 2a.

Non-invasive interventions include, but are not limited to:

  • Reading a story or vignette
  • Playing an economic game
  • Using a computer program or website
  • Watching a video
  • Using a robot arm or mechanical object, if it remains outside of the body
  • Being exposed to stimuli such as color, light or sound (within safe limits)

To qualify for this expanded definition of Exemption 2, the study must pose no more than minimal risk to subjects and may not include any of the following:

  • Federal funding or federal training grants (direct or prime sponsorship)
  • FDA regulated components
  • Sponsor or other contractual restrictions
  • Clinical interventions (including clinical behavioral interventions)
  • Minors as subjects
  • Prisoners as subjects
  • Receipt of an NIH issued Certificate of Confidentiality to protect identifiable research data

Initial or Scheduled Continuing Review applications meeting the criteria cited above will be reviewed by the IRB to determine that subject protections are equivalent to those required by federal regulations.  If equivalent protections are in place, and there are no additional extenuating circumstances, IRBMED may issue the new Exemption 2A. 

All other regulatory requirements pertaining to exemptions remain unchanged.

June 10, 2014 — HSIP Gift Cards

The Human Subjects Incentive Program (HSIP) has recently selected a new vendor, Vantiv, for issuing gift cards.  As part of this change, the program will now be distributing MasterCard gift cards instead of the previously distributed Visa gift cards.  IRBMED is not requiring that study teams submit amendments at this time to change this information in consent documents; rather, this change should be made with the next amendment submitted.

For more information, please see the HSIP website: http://www.finance.umich.edu/treasury/hsip

May 23, 2014 — 

IRBMED SEMINAR SERIES

Thank you to everyone that contributed their time, knowledge, and expertise in order to make the Seminar Series a success.  To everyone that was able to attend, we hope you found the sessions to be informative and beneficial.

Click on any of the following links to access the slide presentations:

May 8, 2014 — The Central IRB Information page includes a recently updated decision tree illustrating the workflow when ceding oversight to a non–UM Institutional IRB (typically an academic institution).

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).