How to submit a protocol for review by the MDH Institutional Review Board - Minnesota Dept. of Health

How to submit a protocol for review by the MDH Institutional Review Board

You must complete an application for review and submit it to the IRB administrator or IRB coordinator:

Each application should include:

  1. a detailed description of the research design and procedures as they affect human subjects;
  2. a list of precautions necessary to safeguard the welfare of subjects;
  3. a precise description of the subject population involved in the research;
  4. all consent forms to be used; and
  5. methods to be used to protect data confidentiality and subject privacy.

Three (3) unbound copies of the proposal and all appropriate forms should be sent to:

Institutional Review Board, MDH
85 East Seventh Place, Suite 300
PO Box 64882
St. Paul, MN 55164-0882

All proposals must be received by the Board two full weeks prior to the next regularly scheduled meeting (second Wednesday of each month) in order to be considered at that meeting.

After the application has been submitted, a determination will be made by the IRB Administrator as to whether the protocol is exempt from review, meets requirements for an expedited review, or needs review by the full IRB. If the latter is found to be appropriate, a primary reviewer will be assigned to review the protocol and any documents attached to it and give a brief report to the IRB concerning his/her findings.

If review by the full board is required, the principal investigator (PI) is expected to be at the meeting to present a brief overview of the project and answer questions pertaining to it. The PI will be contacted concerning the date and time.

Proposals will be reviewed at regularly scheduled IRB meetings or by expedited review. The proposal will be reviewed and assigned one of the following types of status:

  1. Approval
  2. Approval pending stipulations
  3. Disapproved

Investigators will receive written notification of the proposal’s status, including a detailed description of stipulations that must be met before “Approval” is granted. Approval status can be granted only after receipt of the investigator’s written responses to the IRB, notifying it of actions taken to address each stipulation.