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.
Toolkit Meetings
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 requests and decisions, access the Toolkit Feedback Log.
See below for a list of the most recent changes made to documents in the Toolkit.
August 2026 Changes
This release is focused on updates related to RIO Leadership, ancillary reviews, and increased/new IRB review fees.
Manuals
HRPP Manual (HRP-101)
- Updated the Institutional Official section to indicate that the President will either appoint the Vice President for Research and Innovation or the Associate Vice President for Research Integrity and Compliance as the Institutional Official
- Revised MHealth to Fairview Health Services
- Corrected web address for Fairview Research Administration
- Included the role Associate Vice President for Research Integrity and Compliance to have the ability to amend and the approve HRP-101
Investigator Manual (HRP-103)
- Added the section “What if I plan to use Blackwell?” to describe what this tool is and the data it can support.
- “Can I conduct consent electronically?” - Updated the link to take readers to the latest version of the eConsent Guide for REDCap from CTSI. (Please note that the link to the guide in the protocol templates will be updated in the October 2026 toolkit release.)
- “Is there a fee for IRB review?” - Increased the fee for business-and-industry-sponsored studies reviewed by UMN’s IRB; Added a fee for local context review for studies seeking reliance on an external IRB; added submission requirements for fee-eligible studies
- “Does the IRB have guidelines regarding risk levels of common research related medical procedures?” - Added guidance on Blood Collection from Clinically-Placed Indwelling Lines
Worksheets
Pre-Review (HRP-308)
- Added prompt to identify studies where UMN IRB will be the IRB of Record or a request to rely on an external IRB
- Added prompt to identify studies eligible for IRB fees for service
Ancillary Review Matrix (HRP-309)
- Divided the Regulatory review into 2 tiers based on funding source
- Made clarifications about the CTSI Best Practices Integrated Informatics Core (BPIC) review for accuracy
- Added "Academic Support Resources" as the organization that conducts the FERPA review
- Clarified which organizations review which types of international research data
Protocol-Specific Emergency-Disruption Risk Mitigation Planning (HRP-351)
- Corrected typographical errors
Checklists
Criteria for External IRB Reliance (HRP-841)
- Revised the inclusion criteria for commercial and non-commercial IRBs to clarify when reliance can be pursued for non-federally funded or business and industry-sponsored research
Standard Operating Procedures
Daily/Frequent Tasks (HRP-062)
- Added section 5.5 to outline the procedural costs for IRB service fees
Forms
IRB Member Information (HRP-202)
- Added information regarding demographic to match the Office of Management and Budget information
- Clarified what constitutes a conflict of interest
- Updated the categories of research methodology and experience
Other Templates
Business and Industry Funded Study Fee (HRP-537)
- Updated to reflect new and increased fees
- Improved clarity of instructions