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Tips for Getting your IRB Application Approved

#1 Pick up the phone
Please contact the IRB as you are preparing your materials if you have questions about the IRB application or the IRB process. We are happy to consult with you and answer any questions you may have. The IRB Health full board administrator is Nancy Adair Birk and she can be reached at 936-0933.

If your questions relate to the FDA regulated components of your work or you would like assistance in developing your preparing your application or informed consent materials, contact MCOHR at 998-6721.

#2 Use available resources on the web
Guidelines for the preparation of informed consent documents are available at the following site:
http://www.irb.research.umich.edu/IRB_HSBS_Shared/consent.html#guide.
This document contains all the required regulatory elements of consent, along with recommended language. Information regarding the IRBs at UM can be found at http://www.irb.research.umich.edu/. In addition, general questions about human research protections can be found at http://www.hhs.gov/ohrp/.

#3 Plan ahead
Allow at least 2-4 weeks for expedited review and 4-8 weeks for full board review. The full board schedule is found at
http://www.irb.research.umich.edu/IRB_Health/New/deadlines.html.
Studies for which the risk level is more than minimal must be reviewed by the full board. In addition, studies utilizing FDA-regulated devices or drugs are also reviewed by the full board, regardless of risk level.

#4 Complete the application fully
One of the primary reasons applications are delayed in the IRB review process is because information provided by the PI is unclear or incomplete. Consistency in all aspects of application materials is also critically important. In other words, make sure the informed consent document contains the same information as your study protocol. If you are a student, be sure that your faculty advisor conducts a thorough review of your application - it is also their responsibility to assure that your application is well-prepared and that human subjects will be adequately protected.

#5 Dealing with eResearch issues
If you are uncertain about how to navigate the technical issues of the eResearch system, contact the MAIS help desk at 936-7000 or maishelpdesk@umich.edu.

Tip #6 Keeping yourself in compliance
Once you've received an approval from IRB Health your relationship with the IRB has not ended. Unless you received an exemption approval, you must renew your application each year. The eResearch system will send you a reminder notice at 90, 60, and 30 days. We strongly urge you to submit the renewal at least 30 days prior to your expiration date. If your study's IRB approval expires, you must immediately cease all work on the project. In addition, if you find that you need to modify your protocol in any way, you must submit an amendment. Should any adverse events occur during the course of your research, you must submit an adverse event report to the IRB.

The IRB serves as a resource for you in your human subject research. As such, we are happy to assist you in all phases, from design to data analysis. In addition, if you would like IRB staff to give a presentation to your unit, contact us at 936-0933 or irbhsbs@umich.edu.

For more information, please contact:
Anna Galloro
Phone: 734 998-1435
E-mail: ashafto@umich.edu

Frequently Asked Questions about IRBMED

How long will it take for an application to be processed and reviewed once received by IRBMED?

• Investigators should allow 8-10 weeks for review of standard applications and 4 weeks for review of exemption requests.

How often does the IRBMED meet?

• There are three IRBMED board meetings every week. Two boards meet each Thursday between noon and 3 PM, excluding major holidays--A1 and A2 meet one week, B1 and B2 the next week, and the pattern is repeated throughout the year. Board C1 meets every Friday morning 9-10:30 AM. Requests to attend a meeting should be sent to IRBMED@umich.edu.

How many studies are under IRBMED oversight?

• About 3000.

 How many submission does IRBMED receive each year?

• About 5200, of which ~1000 are for new studies. The other submissions are renewals, reports, and terminations.

IRBMED website:

• http://www.med.umich.edu/irbmed/index.htm

Link to the IRBMED consent form template and instructions:

• http://www.med.umich.edu/irbmed/ict.htm

Link to information on new applications

• http://www.med.umich.edu/irbmed/forms.htm

IRBMED
517 W. William, Argus I,
Ann Arbor , MI 48103-4943
Email: irbmed@umich.edu
Phone: (734) 763 4768
FAX (734) 763 9603

For more information, please contact:
Anna Galloro
Phone: 734 998-1435
E-mail: ashafto@umich.edu