Convened Full Board
Research involving any of the following will likely require convened (full) board review:
- Minors, prisoners, pregnant women, impaired adults
- Illegal activities such as drug use
- Private activities such as sexual behavior
- FDA approved drugs and devices presenting more than minimal risk
- Non-FDA approved drugs and devices (applications that fit this catagory must go through IRBMED or IRB Health in Ann Arbor for review. Please contact the IRB for further instruction
Applications requiring review by the convened board must be submitted by the deadlines listed under "Full Board Meeting Schedule" (click on link below).
Please note that the study team is initially asked (Section 12 in the eResearch application) to make a judgment about their research project, classifying it as either Exempt or Expeditable. However, according to Federal Regulations, it is the responsibilty of the IRB to make final determination for each research project's status.
Once your application is processed by the IRB Office, you will be contacted via email with additional instructions.
NOTE: Research, including subject pre-screening and/or subject recruitment may not begin until formal approval is issued by the IRB.
Possible board decisions:
- Approved: You will receive an email notification when the decision is entered into our system. You will also be sent a hard copy of an approval letter by mail within a week of the decision.
- Additional Information Requested: If the committee requires clarification, additional information, or revisions to your application you will be notified by email when the decision is entered into the system. Each request is noted as a "stipulation" in the system. You must fulfill all stipulations before the committee will review your application again and issue a decision. In some cases, if the revisions are minor, the committee will allow the chair to approve the stipulations to avoid a delay in processing.
- Disapproved: If the IRB disapproves a research activity, it will provide written notification of the reasons for the decision and give the researcher an opportunity to respond in person or in writing.
The approval period for research approved by the convened board is usually one year (exceptions may apply). Federal regulations require that the IRB conduct a continuing review of human subject research at least once per year. In cases of minimal risk, non-federally funded research a 2 year approval period may be allowed, subject to IRB discretion. Several months prior to the approval expiration date, the IRB will issue reminder notices outlining the steps necessary to submit an application for scheduled continuing review. Subject recruitment, data collection, or data analysis without continuing IRB approval is prohibited past the expiration date assigned by the IRB.
For more information, call the IRB Office at (810) 762-3384 or e-mail at: email@example.com.