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.
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.
March 2022 Toolkit Changes
The following changes were made primarily in response to feedback from the research community.
- Replaced Research Compliance Office with Research Intelligence and Compliance Team
- Updated information regarding the current Institutional Official, J. Michael Oakes
- Added section, Emergency Preparedness, and updated Department of Energy Appendix based on Huron 4.5 Toolkit Release
- Clarified compensation for Vice Chair
- Added the following guidance:
“How do I protect the privacy of research participants when using Zoom or other video conferencing tools?”
“If re-consent is required, do I have to translate the revised study consent form?”
“What does the IRB consider when conducting a continuing review?”
“Will the UMN IRB serve as the sIRB for SBIR/STTR Human Research?”
- Updated guidance for “When informed consent is obtained using the ‘short form’ written consent document, can the interpreter interpret by phone or videoconference?”
- Provided a link to translated HIPAA forms in the “How do I obtain HIPAA Authorization for non-English speaking participants?”
- Removed outdated references to retired Toolkit material, HRP542b and HRP-542c.
- Added exercise guidance to “Does the IRB have guidelines regarding risk levels of common research related medical or physical procedures?”
- Revised time frame for researchers to respond to the IRB from 45 to 30 days.
- Added guidance regarding requests for extension including that additional requests for extension will only be considered with approval of the research dean, and that deferrals should follow these extension guidelines.
- Reformatted guidance regarding review of modifications to separate out the guidance regarding “Circumstances that would require submission of a new IRB application?”
- Clarified that prompt reporting should be for an unexpected death for studies relying on an external IRB.
- Fixed broken and missing hyperlinks due to Google Security Update in Summer 2021.
- Corrected typos.
- Replaced subject with participant.
- Replaced Research Compliance Office with Research Intelligence and Compliance Team (RIACT)
- Corrected all broken hyperlinks
- Clarified continuing review process
- Replaced Appendix A-1 references with HRP-828 Attestation of PI Responsibilities
Standard Operating Procedures
- Added guidance regarding interpretation of non-scientist and scientist IRB membership
- Added process for reviewing Reportable New Information submissions for ceded research
- Clarified process for the completion, review, and finalization of meeting minutes
- Replaced “Research Compliance Office” with “Research Intelligence and Compliance Team”
- Added QA program notification of for-cause audit notifications
- Aligned with Huron 4.5 Toolkit Release (e.g. AAHRPP Elements, OHRP Online Reporting)
The following worksheets were updated. The release generally included updated footnotes and regulatory guidance.
- Clarified CT.Gov ancillary review requirement
- Updated CT.Gov contact information
- Updated CMRR ancillary review applicability
Updated to align with the 4.5 Huron Toolkit Release
Clarified FDA requirement for consent language in Section 9, from “will” to “may” in the following element: “The investigator may ask a subject who is withdrawing whether the subject wishes to provide further data collection from routine medical care.”
- Clarified applicability of consent language requirements in Section 3
- Added documentation requirement regarding the reliance agreement
Clarified applicability of the checklist in the instructions to include exempt research
- Clarified exclusion criteria to include STTR funded research
- Updated instructions regarding the storage of completed checklists
The following changes were made to all protocol templates (Download Examples of Track Change Copies):
- Added “or MR at Masonic Institute for the Developing Brain (MIDB)” to CMRR in Ancillary review table
- Updated ancillary review contact information for CT.Gov
- Removed instructions from “HRP-508 no instructions Template”
- Adjusted the order of sections for studies using the Information Exchange
- Added section regarding waiver of informed consent and HIPAA Authorization requirements