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.
October 2023 Changes
The following changes were made to address changes associated with the ETHOS upgrade. Changes to Toolkit documents are related to processes for studies that rely on an external IRB.
Investigator Manual (HRP-103) - Track Changes Copy of HRP-103
- Replaced existing content about the requirements for submitting limited modifications for studies relying on an external IRB with new content as part of the ETHOS upgrade for, “What changes must I submit to the University of Minnesota IRB after my study for a study that is approved for reliance on an External IRB?”
- Added Appendix B-6, “Submission Requirements for Modifications and External IRB Updates for Studies Relying on an External IRB”
- Moved content regarding reportable requirements for reliance into a separate question, “What reportable events must I submit to the University of Minnesota IRB for a study that is approved for reliance on an External IRB?”
sIRB Manual (HRP-800) - Track Changes Copy of HRP-800
- Changed Toolkit number reference from HRP-803 to HRP-800
- Removed of Appendix B which is replaced with HRP-830 Communication and Responsibilities worksheet
- Update Appendix C to be labeled Appendix B with the removal of prior appendix
- Update text from p-Site to pSite per Huron 5.0 Toolkit, related to the ETHOS upgrade
Standard Operating Procedures
Prior University of Minnesota versions of these SOPs and its revision history from 2017-2024 have been archived and replaced with this version as a result of the ETHOS upgrade. These materials were part of the Huron Toolkit Release 5.0.
- HRP-801 - SOP - Establishing Authorization Agreements
- HRP-802 - SOP - Institutional Profile Management
- HRP-803 - SOP - Reliance Pre-Review
- HRP-804 - SOP - External IRB Post-Review
- HRP-805 - SOP - External IRB Updates
As part of the upgrade and transition to Huron Toolkit Release 5.0, the following SOPs were retired as the content is either no longer relevant or incorporated in the new SOPs mentioned above.
- HRP-806 - SOP - Request to UMN as sIRB
- HRP-807 - SOP - Request to Rely on External IRB
- HRP-809 - SOP - pSite Review
Communication and Responsibilities (HRP-830)
- New worksheet that was previously embedded in the sIRB manual
- Worksheet is from the Huron 5.0 Toolkit release
Local Context Review (HRP-831)
- Changed Toolkit number from HRP-830 to HRP-831
Local Compliance Assessment (HRP-833)
- New form to be completed for modifications and external updates related to studies relying on external IRB