Toolkit Changes
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 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.
June 2021 Toolkit Changes
The following changes were made primarily to update as well as improve the process for requests and reviews related to reliance on an external IRB and single IRB (sIRB). Additional revisions were made to address feedback from the research community.
Manuals
Investigator Manual (HRP-103) (download) - Track Changes Copy of HRP-103
- Updated reliance and sIRB guidance and instructions to align with the broader Toolkit updates, including the process for requesting reliance on an external IRB, individual investigator authorization agreements, and UMN IRB as sIRB.
- Updated guidance regarding requests for determinations of not human subjects research.
- Updated guidance to distinguish between determinations of not human subjects research and exemption.
- Updated Appendix B-1 to include “yes/no” in the decision tree.
Standard Operating Procedures
Authorization Agreements (HRP-801)
- Revised SOP procedures to align with Huron Toolkit Release 4.0 and 4.3
- Updated references to reliance related toolkit documents
- Added process for individual investigator authorization agreement requests
- Replaced reliance administrator with Senior IRB Analyst
- Updated signatory roles for authorization agreements
Institutional Profile Management (HRP-802)
- Revised SOP procedures to align with Huron Toolkit Release 4.0 and 4.3
- Replaced reliance administrator with Senior IRB Analyst
- Added ability to gather information from SMART IRB for institutional profiles
- Revised SOP procedures to align with Huron Toolkit Release 4.0 and 4.3
- Replaced reliance administrator with Senior IRB Analyst
- Added use of WORKSHEET: Local Context Review for Relying on an External IRB
- Revised SOP procedures to align with Huron Toolkit Release 4.0 and 4.3
- Replaced reliance administrator with Senior IRB Analyst
Request to UMN as sIRB (HRP-806)
- Added appeals process for sIRB determinations
- Updated signatory role to IRB Assistant Director
- Clarified storage of completed checklists
Request to Rely on an External IRB (HRP-807)
- New standard operating procedure that describes the process for evaluating requests to rely on an external IRB.
- Aligned with Huron Toolkit Release 4.0 and 4.3
- Clarified process for submission and review of participating site submissions for sIRB studies where UMN IRB is serving as the sIRB
- Updated Toolkit references
Worksheets
- Added prompt for all reviews to determine whether the submission is related to a study where UMN IRB is serving as the sIRB
- Added prompt to evaluate initial reliance on an external IRB submissions for local context requirements for initial submissions
Criteria for Approval (HRP-314)
- Added prompt to consider whether the submission is related to a study where UMN IRB is serving as the sIRB
- Added considerations for reviewing studies where UMN IRB is serving as sIRB
- Added requirement for continuing review for studies where UMN IRB is serving as sIRB regardless of the level of review
Local Context Review for Relying on an External IRB (HRP-830)
- Replaced existing worksheet for pre-review and reliance updates.
- Consolidated all local context requirements into the new worksheet, including required consent language, institutional policies and procedures, and submission materials.
Individual Investigator Authorization Agreements (HRP-832)
- New worksheet to provide support for the evaluation of IIA requests
Checklists
Criteria for UMN Serving as sIRB (HRP-840)
- Restructured the checklist to provide clarity as to when the University of Minnesota will allow, not allow, or may allow reliance on an external IRB for IRB review and oversight.
Criteria for Relying on an External IRB (HRP-841)
- Restructured the checklist to provide clarity as to when the University of Minnesota will allow, not allow, or may allow reliance on an external IRB for IRB review and oversight.
Forms
Institutional Profile (HRP-815)
- A new form to gather information about external institutions in order to generate an Institutional Profile in ETHOS.
PI Attestation Form for UMN IRB Serving as sIRB (HRP-828)
- A new form that outlines the responsibilities of the PI serving as the lead PI on a multi-site or collaborative research study that requires sIRB review and oversight
- The form is signed by the UMN PI and submitted when requesting UMN IRB to serve as sIRB
PI Attestation Form for Relying on an External IRB (HRP-829)
- A new form that outlines the responsibilities of the PI when utilizing an external IRB for IRB Review
- The form is signed by the UMN PI when requesting reliance on an external IRB
Templates
Human Research Determination Form
- Added guidance regarding requesting determinations from the IRB
- Added attestation regarding request for a determination from the IRB