The Michigan Department of Community Health
Institutional Review Board

For the Protection of Human Research Subjects

Protecting the rights and welfare of those who participate in research is a fundamental ethical responsibility of the Michigan Department of Community Health Institutional Review Board "IRB". The Department meets this responsibility through an "Assurance of Compliance" with the Department of Health and Human Services regulations for the protection of human research subjects. The regulations are found in 45 CFR Part 46 ("Common Rule") and 21 CFR Parts 50 & 56."

These regulations are based on ethical principles established in the "Belmont Report." The Department's "Assurance of Compliance" applies to all research involving human subjects that in any way involves the Department, and not just to research that is federally funded or otherwise federally sponsored.

The referenced documents and other helpful information can be found at the Office of Human Research Protection website (http://www.hhs.gov/ohrp/).

There are two considerations to determine when IRB review is required:

1. Does the activity involve living humans?

   This would include direct involvement (e.g. an intervention or interaction with someone) or indirect involvement (e.g. use of their tissue or personal information).

   If living humans are clearly not involved in any way or any part of the activity, IRB review is not required.

2. Is the activity a systematic collection or analysis of data with the intent to generate new knowledge?

   If living humans are involved in a systematic collection or analysis of data with the intent to generate new knowledge IRB review is required. The IRB must determine if the activity constitutes human subjects research or human subjects research that is eligible for exemption from approval.

Unless there is a specific agreement in place to accept the review of another institution's IRB, MDCH IRB review is required whenever:

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.

No human subjects research is permitted without current MDCH IRB approval. Any changes to an approved study must have written MDCH 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 MDCH IRB chair (517/241-0806).

July, 2007