Documents in the HRPP Toolkit Library are changed periodically in response to feedback from the community, changes in best practices for human research protections, and institutional, local, or federal regulatory changes.
Requests from the research community, IRB members, and staff are discussed at regular Toolkit meetings. Toolkit revisions are on a semi-annual cycle (March and September) unless regulatory changes are required more immediately. Many requests for clarifications, additions, and revisions are incorporated into Toolkit documents. However, some changes, after thoughtful consideration, are not incorporated. To view all requests and decisions, access the Archive of Toolkit Meeting Summaries and the Toolkit Revision and Release Information Sheet to view feedback submitted and anticipated revision release dates.
See below for a list of the most recent changes made to documents in the Toolkit. Access the Archive of Toolkit Releases.
January 2021 Toolkit Changes
The following changes were made to address feedback from the research community, electronic consent, and reliance processes.
- Removed the question, “Can I use the short form method more than once for a non-English speaker?” as the guidance was outdated.
- Clarified and expanded guidance for the question, “What is required after obtaining consent using the short form method?”
- Clarified requirements for use of a standalone HIPAA authorization for research involving non-English speaking participants.
- Added Appendix B-4 which includes clarifications regarding short form and consent translation requirements.
- Added guidance regarding exceptions to PI eligibility criteria.
- Clarified B&I fee applicability to apply to studies that are greater than minimal risk.
- Clarified student-investigator submission process for “What if I’m teaching a research methods or “courseroom” class?”
- Corrected Toolkit reference errors for HRP-591, HRP-595, and HRP-410.
- Removed outdated guidance regarding the UMN IRB ability to serve as sIRB.
- Updated the process for IRB review of human research where an Institutional Conflicts of Interest exists to align with HRP-054.
ADVARRA Institution Cover Page (HRP-823)
- Updated to align with toolkit changes related to the Department of Psychiatry research
Ancillary Review Matrix (HRP-309)
- Added resource link for OnCore
- Updated contact information for Regulatory Review
- Added CUHCC as an ancillary review
- Added instructions for IBC ancillary review
Criteria for UMN IRB Serving as sIRB (HRP-840)
- Added exclusion criteria regarding study termination, disapproval, and studies already under UMN IRB oversight
- Added ‘N/A’ check boxes to applicable criteria
Criteria for Relying on an External IRB (HRP-841)
- Added exclusion criteria regarding study termination and disapproval
- Added information regarding Department of Psychiatry
Multi-site Master Consent Template (HRP-593)
- Releasing the sIRB Master consent template for multi-site research
IRB Meeting Minutes Template (HRP-501)
- Replaced two separate templates (cover sheet and minutes) with one template
- Revised to address AAHRPP site visit feedback regarding documentation of review of criteria for approval, conflicts of interest, and scientific assessment
- Aligned with Submit Committee Review activity in ETHOS