Information and Instructions Regarding Research Approval

The Michigan Department of Health and Human Services (MDHHS)
Institutional Review Board (IRB) for Human Subject Research
 

This document contains only information and instructions. The "MDHHS IRB Initial Review Application" is a separate document. Submit only the actual application to request IRB review.

Completed applications may be sent electronically to MDHHS-IRB@michigan.gov. Documents are deemed signed if they are submitted electronically from the Outlook mailbox of the "Responsible Department Employee". Website: www.michigan.gov/irb.

REQUIREMENTS FOR REVIEW AND APPROVAL OF HUMAN RESEARCH ACTIVITIES 

Institutional Review Boards (IRBs) review, approve and monitor research that directly or indirectly involves living persons, their tissues or personal information, in order to protect the rights of the participants.  There are two main considerations to determine if a particular activity needs IRB review by the MDHHS IRB: 

A)   Does the activity involve the systematic collection/analysis of data, from or about living individuals, with the intent to generate new knowledge? 

This can involve an intervention or interaction with living individuals, or only involve the collection of, release of, or access to identifiable private information or biological specimens from or about living individuals.  Since the definition of research (for IRB purposes) may be difficult, the IRB should determine whether activities that involve obtaining and analyzing data to generate new knowledge constitute research in this context.  

B)   MDHHS IRB review is required for:  

         All research involving living human participants, if one or more of the following apply: 

  1. the research is sponsored by the department, or 
  2. the research is conducted by or under the direction of any employee or agent of the department in connection with his or her institutional responsibilities, or 
  3. the research is conducted by or under the direction of any employee or agent of the department using any facility of the department, or 
  4.  the research involves the use of the department's non-public information to identify, or contact, human research participants or  prospective participants. 

Research may not begin without written MDHHS IRB approval.  Any changes to an approved study must have written MDHHS IRB approval before they are implemented (except when necessary to eliminate an apparent immediate hazard to the subject). 

Any unexpected problems or changes in the research that could potentially be a human subjects concern must be reported immediately to the MDHHS IRB chair. 

The legal basis for MDHHS IRB authority is Title 45 Code of Federal Regulations Part 46.  This document and other IRB material can be found at:  http://www.hhs.gov/ohrp/. 

April 2015