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.
June 2022 Toolkit Changes
The following changes were made primarily in response to feedback from the research community.
Manuals
Investigator Manual (HRP-103) (download) - Track Changes Copy of HRP-103
- Updated the following guidance for the conduct of consent electronically
- Added guidance regarding dual-role (provider-investigator) consenting
- Added information regarding the Medical School IRB Protocol Review Extension Program
- Added “What about data sharing in the Social Sciences?”
Policies
Minnesota Laws Affecting Human Research (HRP-112)
- Updated requirements for reporting prenatal use of controlled substances and alcohol
Standard Operating Procedures
Informed Consent Process for Research (HRP-090)
- Updated to include information regarding dual-role (provider-investigator) consent for research
Worksheets
Ancillary Review Matrix (HRP-309)
- Update information for the following ancillary review groups: Office of Institutional Compliance – Conflict of Interest, CT.Gov, Regulatory Review, Expert Consults, and Oncore.
- Added CTSI Monitoring as an ancillary review group.
Criteria for Approval (HRP-314)
- Updated Section 7, Consent Process, to include information regarding dual-role consenting
- Updated guidance regarding e-Consent in Section 10
Templates
The ancillary review matrix was updated in all of the protocol templates to reflect information about CTSI Monitoring as an ancillary review group.
Social Template Protocol (HRP-580) - Track Change Copy
- Updated data sharing guidance for social science research
Consent Form for Social - Behavioral Research (HRP-582)
- Updated data sharing guidance for social science research
Information Sheet for Exempt Research (HRP-587)
- Updated data sharing guidance for social science research