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 requests and decisions, access the Toolkit Feedback Log.

See below for a list of the most recent changes made to documents in the Toolkit.
  

March 2024 Changes

Transition to Huron's 5.0-5.2 Release
The Toolkit is currently under a transition to update files to Huron Consulting Group’s 5.0-5.2 release. As part of this transition, the HRPP is reviewing the University’s materials to determine if any local adaptations to the Toolkit should be removed or revised. The existing materials have been archived, and the revision history on files has a new statement regarding the transition to Toolkit 5.0-5.2.

The March 2024 release focused on standard operating procedures, worksheets, checklists, and letter templates, with changes primarily impacting IRB staff. Researchers will notice a new “look and feel” to worksheets and checklists. Changes to IRB letters will be seen in April 2024.

The following updates highlight changes that impact the research community:

Pre-Review (HRP-308)

  • Updated check for missing materials to align with current practices
  • Clarified check for completeness of protocol and/or local protocol addendum sections

Ancillary Review Matrix (HRP-309)

  • Added sponsor-investigator ancillary review

March Toolkit Release Town Hall
An overview of the March transition will be provided at the April 10 IRB Lunch and Learn. Please register to attend.

June Toolkit Release Planned
In June, the IRB will release updates to the Investigator Manual, protocol templates, and consent templates, based on community feedback. To be considered for this release, submit feedback about these materials via the Toolkit Feedback Form by May 1.

Toolkit Lock Down for AAHRPP Re-Accreditation
In preparation for AAHRPP re-accreditation, the Toolkit will be locked down from June 2024 until July 2025. Minimal changes will be made during this period. As part of the re-accreditation process, accreditors discourage changes wherever possible.