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.
October 2025 Changes
Most changes are related to the Huron Consulting Toolkit Release 5.2 and 5.3. A recorded overview of the key changes to the Toolkit can be found in the IRB Lunch and Learn Recordings.
During the period of pause, we received over 300 feedback items from the research community, IRB, and HRPP stakeholders. Please note that we were unable to address all items for this release, but will be prioritizing updates for 2026. Please see the Toolkit Feedback Log for updates.
Manuals
- Investigator Manual (HRP-103)
Revised the job codes for professional and academic employees in “Who may be the principal investigator for Human Research?” to align with reclassifications made by the University’s Office of Human Resources - Removed an activity from “Does my research require IRB review?” since the IRB will no longer review incomplete submissions. (See “When should Just-in-Time funded projects be submitted to the IRB for review?” for further details.)
- Corrected link to HHS regulations in section “When do my screening activities require informed consent?”
- Changed “HRP-314” to “314a (Criteria for Consent)” under “How do I create a consent document?” in alignment with Huron Toolkit Release 5.2
- Updated PRIM&R’s AI Collaborative Working Group link in the section “Where can I find out more about the use of AI in research?”
- Revised “What if I applied for federal funding and received a Just-in-Time notification?” and “When should Just-in-Time funded projects be submitted to the IRB for review?” to clarify new requirements for study teams who receive a JIT notification.
- Clarified that the “Deputy Institutional Official” may also determine if a research activity constitutes experimental treatment in “What if I’m doing research involving children?”
- Added hyperlinks to guidance material in “When informed consent is obtained using the ‘short form’ written consent document, can the interpreter interpret by phone or videoconference?”
- Clarified waivers of obtaining a witness signature is not permissible in “When informed consent is obtained using the ‘short form’ written consent document, can the interpreter interpret by phone or videoconference?”
- Added guidance regarding translation and interpretation of study materials in “Must study questionnaires, instruments, information sheets, or other participant facing materials be translated into a participant’s language?”
- Revised “What are my obligations after receiving an Exempt determination?” to clarify what happens to exempt studies that remain open after 2 years
- Added the section “What happens after an Exempt project is archived by the IRB?” to explain when further action is required by the investigator following archival of an exempt project
- Added the phrase "of becoming aware of” in #8 of “What are my obligations after IRB Approval?” to clarify prompt reporting requirements in alignment with Huron Toolkit Release 5.2
- Revised instructions in “What if I need institutional certification for NIH Genomic Data Sharing?” for clarification and completion.
- In “Do I submit clinical research monitoring reports to the IRB?” clarified that “independent” study monitor reports require central filing
- Revised all iterations of "cognitively impaired adults" to "adults with impaired decision-making
capacity" to match 2018 revised language at 45 CFR §46.111(b) in alignment with Huron Toolkit Release 5.2 - Updated broken links in “What printed materials are available to enhance understanding for research participants?”
- Added institutional assurance statement for COC to Appendix A-1 in alignment with Huron Toolkit Release 5.2
- Updated the Additional Requirements for Clinical Trials appendix (A-3) to reflect revisions to ICH GCP E6(R3) in alignment with Huron Toolkit Release 5.3
- Additional DoD requirements made explicit in Appendix A-4 to be consistent with DoDI in alignment with Huron Toolkit Release 5.2
- Inserted new endnotes in appendix A-3 and A-5 in alignment with Huron Toolkit Release 5.3
- In Appendix A-11, removed the statement indicating voluntary holds during an emergency would not require IRB notification
- Updated Appendix B-4 to revise “language” to “dialect” for translation requirements for studies considered minimal risk
- Updated Appendix B-6 to reflect the process for submitting closures for studies relying on an external IRB
- Converted existing footnotes to endnotes
- Editorial revisions to correct typos and formatting
Standard Operating Procedures
Definitions (HRP-001)
- Added “or” to Conflicting Interest for IRB Members (3.16)
- Aligned definition of “Individual Investigator Agreement” (3.37) with Huron Toolkit Release 5.1
- Removed “that” from Minimal Risk definition (3.48)
- Added end note to Unanticipated Problems Involving Subjects or Others (3.78)
- Added “Cooperative Research” to align with Huron Toolkit Release 5.2. Updated End Note iv to reference End Note iii
- Editorial revisions to correct typos and formatting
Pre-Review (HRP-021)
- Double underlined "protocol exception" as a defined term (3.2)
- Added reference to HRP-040 - SOP - IRB Meeting Preparation (5.7.3)
- Added section 5.8 with a timeframe expectation for assigning incoming items (based on recommended best practice and to match Huron’s HRA analytics)
- All revisions made to align with Huron Toolkit Release 5.2
New Information (HRP-024)
- Added "IO" to "OO" reference (3.1)
- Removed "or national organization" (3.2)
- Added process for IRB staff to enter RNI if received new information outside the system (3.8)
- Added timeframe expectation for screening incoming items (based on recommended best practice and to match Huron’s HRA analytics) (5.1)
- Added missing DoD reference (7.4)
- All revisions made to align with Huron Toolkit Release 5.2
- Added Section 5.4.5 regarding review of reports associated with studies relying on an external IRB.
Suspension or Termination Issued Outside of Convened IRB (HRP-026)
- Updated 1.2 to indicate the IRB chair (of panel A) can initiate suspensions or terminations in alignment with section 3.1 and the Huron Toolkit Release 5.2.
- Updated section 3.1 to clarify that only the chair of panel A, not any IRB chair, can institute a suspension or termination.
- Revised Section 5.2 to be more specific of what is being asked from investigator so there is not a misunderstanding to provide a list of names (PHI) in alignment with the Huron Toolkit Release 5.2
Non-Committee Review Preparation (HRP-031)
- Minor format/editing corrections.
- Added reference to the expert consultation process to Section 5.1.1.
Non-Committee Review Conduct (HRP-032)
Based on Huron Toolkit Release 5.3:
- Added instructions for requesting clarifications during Non-Committee Review in Procedure section
- Clarified language related to determining review level
- Clarified system-related instructions for executing the Submit Designed Review activity
IRB Meeting Minutes (HRP-043)
- Revised “cognitively impaired adults” to “adults with impaired decision-making capacity” to match 2018 revised language at 45 CFR §46.111(b), based on Huron Toolkit Release 5.2
- Added reference to HRP-302 - WORKSHEET - Approval Intervals in procedures (Section 5.7.3) based on Huron Toolkit Release 5.3
Post-Review (HRP-052)
- Added Section 5.2.1.1 regarding DHHS-regulated research involving prisoners to align with the Huron Toolkit.
Daily Tasks (HRP-062)
- Added Section 5.4 based on Huron Toolkit Release 5.2
NIH Genomic Data Sharing (GDS) Institutional Certification (HRP-064)
- Clarified the process overview in section 1.3.
- Added the missing hyperlink in 5.2.1 based on Huron Toolkit Release 5.2.
IRB Formation (HRP-080)
- Updated Section 5.1.1.1 to align with the Huron Toolkit formatting
IRB Membership Addition (HRP-082)
- Added policy section 3.3 to meet AAHRPP ELEMENT II.1.C to align with Huron Toolkit Release 5.2
IRB Meeting Scheduling and Notification (HRP-084)
- Removed timeframe requirements (sections 1.2, 1.3 and 3.1) as these are not regulatory requirements to align with Huron Toolkit Release 5.2
- Updated ICH GCP in References (7.1) to be consistent with revisions to ICH GCPE6(R3) in alignment with Huron Toolkit Release 5.3
Establishing Authorization Agreements (HRP-801)
- Added section 5.1.3.4.3 to clarify who signs the authorization agreement when the PI is solely an employee of Fairview or Gillette to align with institutional practices
Review Request to Rely on an External IRB (HRP-806)
- Added steps in Section 5 updated in system version to match electronic IRB workflow
Worksheets
Review Materials (HRP-301)
- Revised "cognitively impaired adults" to "adults with impaired decision-making capacity" to match 2018 revised language at 45 CFR §46.111(b) to align with Huron Toolkit Release 5.2
- Added relevant worksheet references throughout the worksheet
Approval Intervals (HRP-302)
- Endnotes updated for relevancy based on Huron Toolkit Release 5.2
Communication of Review Results (HRP-303)
- Corrections to letter references in different sections for consistency such as letters moved from convened IRB table to "convened IRB, designated reviewer or other designee" table as the letters may be used for a designated review also based on Huron Toolkit Release 5.2
Quorum and Expertise (HRP-305)
- Revised End Note ii for unaffiliated members to include regulatory resources based on Huron Toolkit Release 5.3
Drugs and Biologics (HRP-306)
- Clarified that the Investigator must certify compliance with FDA sponsor requirements “in writing” in section 6 based on Huron Toolkit Release 5.2
Devices (HRP-307)
- Add endnote to section 3 (“Software as a Medical Device”) based on Huron Toolkit Release 5.2
- Added endnote to section 8 (“IDE exemptions”) category #1 based on Huron Toolkit Release 5.2
- Added endnote to section 8 (“IDE exemptions”) category #2 based on Huron Toolkit Release 5.2
- Added “N/A” option to section 8 (“IDE exemptions) category #2 based on Huron Toolkit Release 5.2
- Made grammatical and formatting changes based on Huron Toolkit Release 5.2
Pre-Review (HRP-308)
- Added Appendix 1 with guidance on how to determine when particular regulatory agency oversight applies in alignment with Huron Toolkit Release 5.2
- Added “clinicaltrials.gov” Continuing Review section
Ancillary Review Matrix (HRP-309)
- Updated introductory text to remove Huron reference
- Updated Fairview contact information to remove direct phone-line
- Updated CPRC ancillary review exclusions for studies
- Added CPRC oversight applicability guidance from the CPRC Charter as an foot-note
- Added that Regulatory Review should only be assigned by IRB Staff
- Updated Gillette Ancillary Review applicability to include significant revisions
- Clarified BPIC ancillary review assignment references
- Updated AURPC ancillary review applicability
- Updated AURPC links
- Updated references to Biospecimen Support (formerly BioNet)
- Clarified ClincalTrials.Gov ancillary review applicability references and requirements
- Updated FERPA ancillary review applicability
- Added reference to GDPR guidance
- Added institutional conflict of interest to OIC - Conflict of Interest ancillary review
- Updated the Office of Native American Affairs ancillary review applicability, added Notification of Indigenous Research Form, and updated information related to the impact on IRB review
- Addressed general formatting/grammatical corrections throughout the document
Criteria for Approval (HRP-314)
- Removed consent-related sections based upon the Huron Toolkit Release 5.2
- Added references to new worksheet, HRP-314a - Criteria for Consent based upon the Huron Toolkit Release 5.2
- Added title to guidance, “Appendix A” and included reference to Appendix A in Section 2
- Corrected checklist name for HRP-417
Criteria for Consent (HRP-314a)
- New worksheet as part of Huron Toolkit Release 5.2 that includes content previously included in HRP-314 - Criteria for Approval
- Added NIH Digital Health section
- Updated to reflect ICH GCP E6(R3) requirements
Additional Agency Criteria (HRP-318)
- Updated Additional Criteria for Department of Energy Research section to reflect revisions identified in DOE Order 443.1C, Chg. 1
Certificate of Confidentiality (HRP-333)
- Added Section 3 based on Huron Toolkit Release 5.2
Checklists
Pregnant Women (HRP-412)
- Revised endnote to include DRAFT FDA/OHRP guidance on Not Otherwise Approvable Research.
- Added reference to HRP-044 - SOP - Not Otherwise Approvable Research.
Non-Viable Neonates (HRP-413)
- Added reference to HRP-044 - SOP - Not Otherwise Approvable Research.
Neonates of Uncertain Viability (HRP-414)
- Added reference to HRP-044 - SOP - Not Otherwise Approvable Research.
Prisoners (HRP-415)
- Broke apart DHHS and DOD regulated checkboxes for contacting those agencies.
- Added endnotes for certifying and awaiting approval in some categories to OHRP for DHHS oversight research with prisoners.
- Updated wording to increase clarity of prisoner representative expectations in convened review versus expedited review.
Children (HRP-416)
- Added reference to HRP-044 - SOP - Not Otherwise Approvable Research.
- Eliminated endnote regarding "children" now that the term is defined in HRP-001-SOP - Definitions.
- Updated FDA waiver reference from guidance to regulations for waiver of parental permission.
- Updated language to match HRP-410 revisions made in 5.1.1 release.
- Updated the heading in Section 6 for FDA waiver of parental permission to remove the guidance language and replace it with the regulation.
Capacity to Consent (HRP-417)
- Updated Section 2 - GTMR to separate "a and/or b" options for prospect of direct benefit and inclusion in studies that involve adults with capacity to consent. The revision clarifies the requirement for a prospect of direct benefit to allow the inclusion of adults lacking capacity to consent
- Added "protocol justification" text boxes that were missing. Clarified guidance in Footnote iv
- Removed reference to AAHRPP element II.1.A from endnotes as not applicable to this checklist based on Huron Toolkit Release 5.2
Minutes Quality Improvement Assessment (HRP-431)
- Revised "cognitively impaired adults" to "adults with impaired decision-making capacity" to match 2018 revised language at 45 CFR §46.111(b) in alignment with Huron Toolkit Release 5.2
Human Research Consent Meeting Audit - Interview/Questionnaire (HRP-743)
- Updated formatting to better align with formatting of the main audit checklist (HRP-740)
- Removed “Consent Meeting ID Number” as no number is assigned in practice
- Added “representative” to communication considerations for participants with an LAR
- Clarified that the “study team,” not necessarily the person obtaining consent, confirms the inclusion parameters
Templates & Forms
IRB Member Information Form (HRP-202)
- Revised "cognitively impaired adults" to "adults with impaired decision making capacity" to match 2018 revised language at 45 CFR §46.111(b) in alignment with Huron Toolkit Release 5.2
Meeting Minutes Template (HRP-501)
- Added guidance on how to document the absence of voting members that were originally expected to attend
- Added a discussion summary prompt for additional federal agency criteria (when applicable) to the Notes section
Institutional Profile (HRP-815)
- Updated Communications reference to state "Communication and Responsibilities" based on Huron Toolkit Release 5.1
Protocol Templates (Track-Change Copies)
Note that new study submissions submitted on or after February 1, 2026 must use the updated templates from October 2025.
Local Protocol Template with and without instructions (HRP-508)
- Revised the ancillary review table to clarify the most current processes and correct broken links
- Revised "cognitively impaired adults" to "adults with impaired decision-making capacity" to match 2018 revised language at 45 CFR §46.111(b) in alignment with Huron Toolkit Release 5.2
- Removed the word “paper” from the document storage subsection 15.7
Social Template Protocol with and without instructions (HRP-580)
- Revised the ancillary review table to clarify the most current processes and correct broken links
- Added guidance to the instructional template for Section 8: Vulnerable Populations regarding recruitment from the general population
- Corrected file name for HRP-417
Medical Template Protocol with and without instructions (HRP-590)
- Revised the ancillary review table to clarify the most current processes and correct broken links
- Added guidance to the instructional template for Section 8: Vulnerable Populations regarding recruitment from the general population
- Corrected file name for HRP-417
Data and Specimen-Only Protocol (HRP-595)
- Revised the ancillary review table to clarify the most current processes and correct broken links
- Added guidance to the instructional template for Vulnerable Populations section regarding recruitment from the general population
- Corrected file name for HRP-417
Database, Registry, and Biospecimen Repository Protocol (HRP-597)
- Corrected broken links in the instructions on page 1
- Revised the ancillary review table to clarify the most current processes and correct broken links
- Corrected the reference to the location of the sharing of results language in sections in 5.1 and 5.2.2 of part 2
- Added guidance to the instructional template for Vulnerable Populations section regarding recruitment from the general population
- Corrected file name for HRP-417
Consent Templates (Track-Change Copies)
Consent Form Template for Social/Behavioral Research (HRP-582)
- Added a section for NIH-funded research involving digital health technologies based on Huron Toolkit Release 5.2
- Revised ICH GCP language to align with ICH GCP E6 (R3) based upon Huron Toolkit Release 5.3
- Updated Suicide Hot-Line Number
Assent Form Template (HRP-583)
- Added a statement to the “Important Information for Girls” section for consistency with the “Boys” section to respect confidentiality
Information Sheet for Exempt Research (HRP-587)
- Corrected formatting error suggesting voluntary participation text was optional rather than required
Combined HIPAA and Consent (HRP-588)
- Added a section for NIH-funded research involving digital health technologies based on Huron Toolkit Release 5.2
- Updated signature blocks to align with HRP-592
- Added instructional end-note to refer to HIPCO guidance for studies approved to use the short form method of consent
- Added content previously released for studies involving suicidal ideation to align with HRP-592
- Corrected version date footer and numbering formatting
Consent Form Template for Medical Research (HRP-592)
- Added a section for NIH-funded research involving digital health technologies based on Huron Toolkit Release 5.2
- Revised ICH GCP language to align with ICH GCP E6 (R3) based upon Huron Toolkit Release 5.3
- Updated Suicide Hot-Line Number
Multi-Site Master Consent Form (HRP-593)
- Added a section for NIH-funded research involving digital health technologies based on Huron Toolkit Release 5.2
Letters
HRP-51a - Letter - Approval
- Added paragraph to address requirements for psychiatry clinical drug trials
HRP-510d - LETTER - Approval MODCR
- Added paragraph about using finalized documents that was erroneously omitted from this letter in the previous version update
HRP-520, HRP-520a, HRP-526: External Reporting Letters to Agencies
- Updated letterhead to reflect new address for the HRPP/IRB