Status Updates for Research Reviewed Outside of the Full Committee

There are several determination types approving or providing clearance for the conduct of a research activity that the MDHHS IRB may make outside a full committee meeting. Those determinations include finding that an activity is not human subjects research, that an activity is exempt human subjects research, that research has been approved on an expedited basis, or that the MDHHS IRB acknowledges reliance by MDHHS on the review and approval of another reviewing IRB.

A not human subjects research determination means one or more of the following:

1. The activity does not include research,
2. The activity does not involve human subjects, or
3. MDHHS is not engaged in the activity to an extent requiring ongoing MDHHS IRB oversight.

Activities that receive a not human subjects research determination do not require ongoing MDHHS IRB oversight and do not require status updates be provided to the MDHHS IRB.

Because MDHHS is responsible for the ethical conduct of exempt and non-exempt human subjects research involving the department, and due to record keeping requirements related to human subjects research, the MDHHS IRB requests periodic status updates on human subjects research cleared or approved by the MDHHS IRB. The requirements for what to include in the update vary by the type of determination made and the regulation under which the determination was made:

1. Studies that involve MDHHS reliance on the review and approval of another IRB require only a minimal status update to ensure the research remains ongoing and in good standing at the institution providing IRB review. Use this link to access the DCH-1278-A, Status Report for Research Approved by an External IRB on which MDHHS is Relying.
2. Studies determined consistent with an exemption under a research regulation require a brief report to confirm the research is ongoing, continues to involve human subjects, and has not changed to include additional research components that may not be consistent with an exemption. Use this link to access the DCH-1279, Research Status or Closure Form.
3. Studies approved on an expedited basis under the 2018 Common Rule require a brief report to confirm the research is ongoing, continues to involve human subjects, and has not changed to include additional research components that may not be eligible for review on an expedited basis. Use this link to access the DCH-1279, Research Status or Closure form.
4. Studies approved on an expedited basis under the pre-2018 Common Rule requirements require an application for continued approval to allow for a detailed review of ongoing research activities. Use this link to access the DCH-1278, Application for Continued Approval form.

It is standard for the MDHHS IRB to request a status report annually. Prior to the status update due date, the requested report must be completed by the primary investigator (or by the MDHHS responsible department employee with assistance from the primary investigator). The form must be emailed to MDHHS-IRB@michigan.gov from the email of the MDHHS responsible department employee. A timely report is necessary for the research to remain in good standing and compliant with MDHHS IRB requirements. There is no grace period to allow for the conduct of research beyond the status update due date without submitting a status update.

Review of a status update that occurs within a month before the status update due date allows for the research to keep the original one-year status update due date for the next year's status update. For example, if the original status update due date is 12/31/24 and the continuation review and approval occurs on 12/02/24, the new expiration date can be 12/31/25.

Review of a change requested to a research protocol is not generally considered to be a review of a status update and does not typically alter the status update due date. For information on requesting changes to approved research please see: What Should I Do if I Want to Make Changes to Approved Research?

To close out any research activity approved or cleared for conduct by the MDHHS IRB, please use the DCH-1279, Research Status or Closure form.