EMU Research

UHSRC Full-Board Review Procedures

Introduction

The majority of human subject applications received by the UHSRC undergo Exempt or Expedited review. Occasionally, studies require review by the full committee at a meeting. Studies requiring Full-Board review are either judged to contain greater than minimal risk* to subjects or employ procedures that are novel to the UHSRC. In addition, the UHSRC reserves the right to assign any application to a Full-Board review at its discretion.

*minimal risk means that “the probability or magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” (45 CFR 46.102(i))

Meeting Schedule

The UHSRC meets once per month, September through April. The meeting schedule is posted on the Application Process and Guidance page.

Note that the UHSRC does not meet during the summer months. If your study requires Full-Board review during the summer, you must hire an external IRB to review your study.

Full-Board Submission Processing

Full-Board submissions must be received by the Office of Research Compliance no later than 3 weeks before the meeting date. The application is shared with UHSRC members who have 2 weeks to return reviews to the UHSRC Chair. The UHSRC Chair then communicates potential issues and revisions to the Principal Investigator approximately 1 week prior to the meeting. The Principal Investigator is invited to attend the meeting to address the issues sent by the UHSRC Chair.

After the meeting, the Principal Investigator will receive an email from Cayuse IRB listing the revisions from the UHSRC meeting. The Principal Investigator must respond to the UHSRC revisions within 60 days of the post-meeting email or the study will be administratively withdrawn.

Full-Board Review Process

All research reviewed by the Full Board must be compliant with Federal Regulations outlined in 45 CFR 46. The UHSRC reviews the application in accordance with 45 CFR 46 and EMU policy to ensure protection of human subjects in research. Principal Investigators may be asked to revise or make changes to their application or supporting documents accordingly prior to approval.

The UHSRC can make the following determinations at convened meetings:

Approval: Your study has been approved as-is, and you can begin your research. Your research must be conducted exactly according to the approved application and supplemental materials. Any subsequent changes must be submitted to the UHSRC and approved prior to implementation. You will receive stamped copies of your recruitment information and consent/assent forms. You must use copies of these stamped forms.

Minor Revisions Required: Before your study can be formally approved, you need to make some minor clarifications or revisions to your application and supplemental documents. These revisions will be embedded in your Cayuse IRB application. You must address each comment in the Cayuse IRB application in order for your study to be approved. Your revisions will be reviewed by the UHSRC Chair or Vice-Chair once they are received. Once your study is formally approved, you will receive a separate approval letter via email.

Deferral: Your study cannot be approved as-is and requires some major revisions or clarifications. The revisions will be embedded in the Cayuse IRB application. You must address all comments and resubmit your application and supplemental materials accordingly. Your revisions will be reviewed by the UHSRC at the next committee meeting.

Disapproval: Your study cannot be approved. Disapproval is rare and occurs when the UHSRC is certain that adequate protection of human subjects cannot be provided. If your study is disapproved, you will not be permitted to resubmit the study for UHSRC review, but you can respond to the UHSRC in writing about the reasons given for disapproval.

Post-Approval

Once you receive your approval letter, you are all set to begin your research. Along with your approval letter, you will receive stamped copies of your consent and recruitment documents. You must use the stamped versions of these documents and actual stamped copies whenever possible (e.g., in-person consent, posting recruitment fliers, etc.).

Continuing Review: Your UHSRC approval will last for 365 days unless otherwise indicated. Your study expiration date will be printed in the letter. If you plan to continue your research beyond 365 days, you must submit for renewal in Cayuse IRB 4 to 6 weeks before your expiration date to allow for processing and review at a Full-Board meeting. If your study approval expires without renewal, you must cease and desist all human subject research activities. It is against Federal Regulation 45 CFR 46 to conduct human subject research without valid UHSRC approval.

Changes to Approved Research: If you plan to make any changes to your study during the course of your approval period, you must submit a Modification Request in Cayuse IRB and obtain UHSRC approval prior to implementation. Any changes made to already-approved documents must be highlighted or tracked using Track Changes mode in Word. Changes to a Full-Board study can undergo Expedited review provided that the changes do not represent an increase in risk to subjects.

If you have any questions about Full-Board review, contact the Office of Research Compliance at [email protected] or 734-487-3090.