4 tips for IRB compliance

If your research at the University of Minnesota involves human subjects, then you’ve submitted paperwork to the Institutional Review Board (IRB). A vital component of the Human Research Protection Program (HRPP), the IRB works to ensure that subjects are not placed at undue risk and that they provide consent to participate.

The board reviews numerous projects from across the university in the areas of health, biological, social and behavioral sciences.

To ensure you’re submitting the right information in the right format, here are some notes from Moira Keane, director of HRPP. Keep the following points in mind when you apply for your next IRB review.

Consent forms must be complete

Errors with consent forms account for nearly 60 percent of all compliance issues. Write as clearly as possible, as clarifications and language issues make up the majority of concerns. Pay special attention to the details of formatting, compensation, and risks and benefits. Learn more about consent forms.

Oversee your oversights

Oversights in application submissions are the second-most common error. Roughly 10 percent of IRB approvals are delayed while researchers clear up review with their TASC billing grid; approval from a peer review or scientific review; safety monitoring; or another committee approval. The IRB cannot grant approval until the issues are satisfied. Other common compliance issues are related to:

Missed training sessions
Appendix H regarding HIPAA information
Confidentiality of the data section
Recruitment clarifications
Subject profile concerns

Make your email official

Always send your electronic applications to irb@umn.edu using an official University of Minnesota email account. Affiliated researchers, such as those from Gillette Children’s Specialty Hospital and Fairview Health Services, should use their official institutional account.

Remember to copy your adviser (for student applications) and any co-investigators associated with the research project (for all applications) using official University of Minnesota email accounts.

Include the whole package

Be sure to submit any surveys, questionnaires, recruitment materials, supporting documents and consent forms along with the application.