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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. 

Monthly Toolkit Meetings

Requests from the research community, IRB members, and staff are discussed at monthly Toolkit meetings. 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 Monthly Toolkit Meeting Summaries.

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

Toolkit Changes During Re-Accreditation

HRPP leadership will continue to monitor feedback submitted in the Toolkit Feedback Form, however minimal changes will be made during the re-accreditation process between August 2019 and December 2020.
 

May 2020 Toolkit Changes

The following changes were made to address feedback from the research community, electronic consent, and reliance processes.

Manuals

Investigator Manual (HRP-103) - Track Changes Copy of HRP-103

  • Added guidance regarding electronic consent
  • Clarified guidance regarding PI participation in panel meetings
  • Revised guidance regarding reliance and instances where an institutional conflict of interest exists
  • Updated research participant educational resources section to include hyperlinks to the research participant brochure, legally authorized representative brochure, and participant bill of rights

Standard Operating Procedures

New Information (HRP-024)

  • Added process for regulatory reporting related to studies relying on an external IRB

IRB Meeting Conduct (HRP-041)

  • Clarified procedures related to PI attendance at IRB panel meetings

Review of Financial Conflicts of Interest (HRP-054)

  • Added reliance requirement for studies involving an institutional conflict of interest

Informed Consent Process for Research (HRP-090)

  • Added consent process requirements for electronic consent to address FDA Part 11 requirements

Written Documentation of Consent (HRP-091)

  • Added consent process requirements for electronic consent to address FDA Part 11 requirements

Forms

ADVARRA Institution Cover Page (HRP-823)

  • Updated to align with toolkit changes related to institutional conflicts of interest, ombudsman requirements, and the PREP Act

Reliance Exception Request (HRP-828)

  • Renumbered form to align with reliance toolkit numbering (HRP-228 to HRP-828) 
  • Added questions to gather additional information for exception requests
  • Streamlined instructions and formatted questions to improve usability

Worksheets

Criteria for Approval (HRP-314)

  • Updated criteria for electronic consent
  • Updated section references for elements of consent and electronic consent

Checklists

Criteria for UMN IRB Serving as sIRB (HRP-840)

  • Added protocol and PI fields
  • Added institutional conflicts of interest requirements

Criteria for Relying on an External IRB (HRP-841)

  • Renumbered from HRP-831 (worksheet) to HRP-841 (checklist)
  • Added protocol and PI fields
  • Revised criteria for external reliance to align with Huron Consulting Group toolkit release related to reliance considerations 
  • Added institutional conflicts of interest requirements
  • Updated sIRB references