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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. 

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.
  

November 2021 Toolkit Changes

The following changes were made primarily to update the UMN Toolkit to align with the Huron Toolkit Release (4.4) as well as revisions based on feedback from the research community.
 

Manuals

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

  • Fixed broken and missing hyperlinks, minor formatting, spelling, and grammatical errors
  • Clarified PI eligibility for faculty with emeritus status or who are tenured and retired
  • Clarified when sub-projects should be submitted as a separate protocol
  • Clarified that study related materials (i.e. Instruments, tests, surveys, and recruitment material) should not be appended to the study protocol but uploaded separately in ETHOS
  • Revised guidance for participant compensation
  • Clarified the submission process for electronic consent
  • Clarified processes and applicability of the Certificate of Confidentiality (CoC)
  • Clarified requirements and limitations of consent for research involving children
  • Changed subject to participant
  • Added information about translated versions of the HIPAA Authorization Form
  • Clarified policy for Using Legend and Investigational Drugs for Clinical Research and Fairview IDS identification;
  • Added Section “Does the IRB have guidelines regarding risk levels of common research related medical procedures?”
  • Clarified guidance on using IRB approved-stamped consent form
  • Provided guidance regarding title changes associated with new funding, frequent changes in personnel and funding changes
  • Clarified RNIs for changes that significantly affect research conduct but are outside the investigator’s control
  • Added requirement for Federalwide Assurance for Entities Collaborating or Participating in the Conduct of Research for which the U of M is the IRB of Record
  • Updated Appendix A-4 through A-6 to align with the 4.4 Huron Toolkit Release
  • Updated Appendix B-1 to align with revisions to HRP-013
     

Standard Operating Procedures

Legally Authorized Representatives, Children, and Guardians (HRP-013)

  • Clarified determination process for what constitutes “experimental treatment” in sections 3.1.3 and 3.3.1 and special considerations related to recruiting/enrolling children in foster care in section 3.3.2. 

Suspension or Termination Instituted Outside of the Convened IRB (HRP-026)

  • Revised 5.4 to include a Reportable New Information submission.

NIH GDS Institutional Certification (HPR-064)

  • Revised to align with the Huron 4.4 Toolkit Release.
     

Worksheets

The following worksheets were updated to align with the 4.4 Huron Toolkit Release. The release generally included updated footnotes and regulatory guidance.

Pre-Review (HRP-308)

  • Added check for an IDS number (when applicable)
  • Added check for unresolved RNI submissions as part of the pre-review for modification and continuing review submissions

Ancillary Review Matrix (HRP-309)

  • Clarified CPRC review for retrospective chart review, retrospective sample review, and prospective specimen repository studies
  • Updated information for CTSI Best Practices Integrated Informatics Core (formerly known as the Academic Health Center Information Exchange)
  • Updated contact information for the Community-University Health Care Center

Human Research Determination (HRP-310)

  • Clarified Section 4 by including the definition of human subject

Criteria for Approval (HRP-314)

  • Added prompt regarding unresolved reportable new information submissions
  • Clarified scientific assessment determinations for greater than minimal risk research
  • Removed reference to IRB Manager position
  • Updated to align with the 4.4 Huron Toolkit Release to include additional element of consent for studies involving genetic testing 

Vulnerable Populations (HRP-333)

  • Replaced “subject” with “participant”
  • Updated to align with the Vulnerable Populations section of the protocol template

Certificate of Confidentiality (HRP-334)

  • Updated to align with the 4.4 Huron Toolkit Release
  • Added clarification regarding certificate applicability for foreign sites
     

Checklists

The following checklists were updated to align with the 4.4 Huron Toolkit Release. The release generally included updated footnotes and regulatory guidance.

Adults with Impaired Decision-Making Capacity (HRP-417)

  • Removed check boxes for N/A in all sections where applicability was irrelevant
  • Added considerations for the IRB in regards to continued participation in greater than minimal risk research where there is no prospect of direct benefit to research participants
  • Replaced “subject” with “participant”
  • Removed statements regarding obtaining consent from the participant 

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

  • Added exclusion criteria for foreign institutions
  • Clarified when the local context review will take place
  • Added N/A to external submission requirements in Section 4
  • Added completion of an institutional checklist to Section 4 for agreements using the template, IRB Institutional Authorization Agreement (HRP-854)

 

Templates

Protocol Templates With and Without Instructions (Local Protocol Addendum (HRP-508), Social Template (HRP-580), Medical Template (HRP-590)) (Download Examples of Track Change Copies)

The following changes were made to all protocol templates:

  • Updated the ancillary review section for use of data from CTSI Best Practices Informatics Core (BPIC)
  • Fixed checkboxes
  • Revised the Vulnerable Population section to replace the term “targeted” to “focus” of the research
  • Updated drop-down menus to the Vulnerable Populations section
  • Added to the Vulnerable Population section a request for rational for any exclusions if the study includes a potential for direct benefit to participants
  • Added to the Cognitive Impairment section, the requirement to list who will assess capacity to consent
  • Revised the international section to clarify that international studies should complete the section
  • Added guidance to the multi-site section regarding sIRB requirements for federally funded research

Biomedical Protocol Template (with instructions) (HRP-590)

  • In addition to the other changes, the template was updated to include requirements for the IDS number (if applicable) prior to full IRB approval

Consent Templates (Social (HRP-582), (Medical (HRP-592), (Multi-Site (HRP-593) (Download Examples of Track Change Copies)

  • Added information regarding COC applicability in foreign jurisdictions
  • Updated ClinCard information to align with terms of use
  • Added “FDA” to the section on access to information in the Biomedical Consent template (HRP-592) and HIPAA Combined Consent (HRP-588)

Information Sheet (HRP-587)

  • Added section about compensation for research participation

Short Form Translations

  • Corrected Participant Advocate Line on the Spanish and Urdu translated documents