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 requests and decisions, access the Toolkit Feedback Log.

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

April 2026 Changes

Most changes are related to the Huron Consulting Toolkit Release 5.4, research community feedback, and the University’s effort to improve accessibility.

During the period of pause, we received over 300 feedback items from the research community, IRB, and HRPP stakeholders. While not all feedback was incorporated, we are grateful for the community’s continued commitment to improving our materials. Please see the Toolkit Feedback Log for information about what was or was not accepted or planned for a future update.
 

Manuals

Member Manual (HRP-100)

  • Updated instructions on using "View Differences" to instructions on using "Compare."

In alignment with Huron 5.4 Toolkit Release:

  • Corrected the reference to HRP-032 - SOP - Non-Committee Review Conduct (from HRP-302) in Q4.
  • Added content to 'How do I conduct Committee Review as a Primary Reviewer?' (Q9) re: including the approval period and risk level in the motion (consistent with activities identified in Item 17 in HRP-105).
  • Modified the statement re: loss of quorum to state "if quorum is lost and a submission cannot be voted on…" (removing reference to recusal and abstention) Q11.
  • Modified Q14 to clarify section content is limited to modifications and continuing reviews (instead of referencing follow on submissions, generally). Added a new at Q15 on the review of reports of new information. Updated the Table of Contents to include the new section on RNIs.

HRPP Manual (HRP-101)

  • Replaced Dr. Shashank Priya as the Vice President of Research and Innovation and Institutional Official with Joanne Billings as Interim VP and IO.
  • Added the term “disruption” to sections associated with the emergency/disaster planning and response per Huron Toolkit Release 5.4.

Investigator Manual (HRP-103) (Track Change Copy)

  • Updated “Who may be the principal investigator for Human Research?” to reflect the term ‘appointment’ and updated the case-by-case list to include ‘Persons who do not hold a regular, ongoing faculty position.’ Also revised the PI eligibility request process.
  • Revised “Are there any approvals I need before applying to the IRB?” to include reasons for permission letters.
  • Clarified Determination forms are not to be submitted for reliance requests in “Does my research require IRB review?”
  • Updated “How do I submit new Human Research to the IRB?” to include additional details on submission materials per Huron 5.4 Toolkit Release.
  • Updated guidance for “What if I need to request approval for a planned exception to my protocol?” to include a prompt to ask the IRB office if there are questions if something meets the criteria as a planned exception.
  • Updated guidance for “How do I submit a Modification?” to include instructions for conducting research with a pending modification.
  • Changed “will” to “may” require a new application in “Are there circumstances that would require submission of a new IRB application?”
  • Clarified materials required for modifications in “When do I submit a modification versus reportable new information?”
  • Added “I previously suspended my study.  Do I need to tell the IRB when I decide to re-open the study?”
  • Added FAQ link to “Will the UMN IRB serve as the sIRB for SBIR/STTR Human Research?”
  • Added “What if I have dual-employment (e.g. University of Minnesota and Veteran’s Affairs, HHRI, etc.)?”
  • Updated Fairview Research Administration guidance in “What potential issues will investigators be asked to consider when submitting a study that includes artificial intelligence?”
  • Clarified certification of translation requirement for non-exempt research in “What translation or certification services are acceptable or required?
  • Updated process for restricting investigators/study personnel in “Can I be restricted from submitting to the IRB?”
  • Added FAQ guidance reference for researchers conducting SBIR/STTR funded research.
  • Added “Does the University of Minnesota IRB require an Investigator Application (e.g. Advarra IRB, WCG IRB applications) for the UMN site?”
  • Updated Appendix A-11 to include additional guidance added in the Huron Toolkit Release 5.4.
     

Standard Operating Procedures

Definitions (HRP-001) 

  • Aligned the definition of "Restricted" with language included in HRP-101

In alignment with Huron 5.4 Toolkit Release:

  • Expanded the definition of Non-Committee Review to include determination re: engagement.
  • Added the definition of Artificial Intelligence, including a corresponding endnote referencing 15 USC 9401(3).

Observation of Consent Process (HRP-012)
In alignment with Huron 5.4 Toolkit Release:

  • Clarified the process end (section 1.3) and focus of observation (section 3.1.1).
  • Added reportable new information reference (section 3.1.3) and experience required for consent observer (section 3.2)

Incoming Items (HRP-020)

  • Moved the turnaround time statement from the Procedure to the Policy section in alignment with Huron 5.4 release.

Pre-Review (HRP-021)
In alignment with Huron 5.4 Toolkit Release:

  • Moved the turnaround time statement from the Procedure to the Policy section.
  • Modified the Procedures under 5.1 regarding the review of modifications to secure approval to be consistent with the HRS "Review Required Modifications" action/activity. 
  • Revised the Procedures section, under 5.1, to clarify that submissions should be sent for convened board review, when the investigator refuses to make the modifications required to secure approval. 
  • Corrected 5.3.4 to proceed to Section 5.5 for continued review.
  • Updated the name of HRP-801 - SOP - Establishing Reliance Agreements in the Procedures section, consistent with revisions to HRP-801. Added HRP-801 to the Materials section.

Emerg and Device Comp Use Review (HRP-023)
In alignment with Huron 5.4 Toolkit Release:

  • Added steps to the Procedure section at 5.4 re: the review of submissions involving a Collaborating Independent Investigator or Collaborating Institutional Investigator, with instructions to follow HRP-311 and HRP-801 to determine engagement and, if engaged, to determine whether to establish an Individual Investigator Agreement.
  • Revised "IRB" to "Designated Reviewer" in 1.2 to clarify when the process starts (consistent with the content of HRP-020 - SOP - Incoming Items).
  • Updated 5.1.1.1 to clarify that 5d reporting is not required when sufficient information is provided in advance to the IRB, consistent with FDA correspondence, and added an endnote to reference the correspondence.
  • Added "as Non-Compliance" to 5.1.1.2.
  • Updated the HRS system language to select IRB Chair concurrence for compassionate use of devices and non-emergency individual patient expanded access, consistent with HRS updates (v10.5.8).
  • Removed duplicative system step of documenting chair concurrence in the "Notes" section for determinations related to compassionate use of devices in 5.1.2.2.
  • Added 21 CFR §312.305 to Reference section (consistent with activities identified in Items 14 & 15 in HRP-105 - OHRP FDA Written Procedure Crosswalk).
  • Updated the link to FDA guidance on Form FDA 3926.

New Information (HRP-024)

  • Added 3.6 in the Policy section in regards to closed studies.

In alignment with Huron 5.4 Toolkit Release:

  • Moved the turnaround time statement from the Procedure to the Policy section. 
  • Revised 5.1 to include system steps for executing "Request Pre-Review Clarifications" or complete the "Submit RNI Pre-Review" and added references to HRP-031 - SOP - Non-Committee Review Preparation & HRP-040 - SOP - IRB Meeting Preparation.
  • Added HRP-031 & HRP-040 to Materials section. Revised the Procedure section at 5.9 re: information that does not involve serious non-compliance, etc. to clarify HRS system steps and remove reference to HRP-052.
  • Removed reference to HRP-052 in the Materials section.

Susp or Term Issued Outside of Conv IRB (HRP-026)

  • Added HRS system steps for suspension and termination. Added 'and relevant agencies' to 5.4.5 re: reporting adverse events/outcomes in alignment with Huron 5.4 Release.

Non-Committee Review Conduct (HRP-032)

  • Added 3.3, 3.7, 5.3.4, 5.4, and 5.7 to align with the Huron 5.4 Toolkit Release. References updated to include 6.2 and 6.4.

IRB Meeting Preparation (HRP-040)

  • Added 3.7, 5.4.3, 5.6 in accordance with Huron Toolkit 5.4 Release. Updated procedural workflow to align with the Huron Toolkit base file from the 5.4 Release. Corrected Reference citation for 7.2.

IRB Meeting Conduct (HRP-041)

  • Updated 3.8 to simplify the description of the worksheet, added 5.5.7-5.5.8, 5.5.8.2 to align with the Huron Toolkit 5.4 Release.

IRB Meeting Minutes (HRP-043)

  • Updated 3.3 to align with Huron Toolkit Release 5.4.

Consultation (HRP-051)

  • Corrected Reference 7.2

Annual Evaluations of the HRPP (HRP-060)
In alignment with Huron 5.4 Toolkit Release:

  • Updated Section 5.2 to directly reference HRP-065 - SOP - Continuity Planning for HRPP Disruptions. Added HRP-065 to the Materials section. 
  • Re-ordered statements to group steps in the Procedure section re: verifying IRB registration and FWA status so they are grouped accordingly. 
  • Modified statements re: IRB registration and FWA status to reference HRP-080 - SOP - IRB Formation and Registration. 
  • Added statements to verify the IRB roster is up-to-date and assess outstanding toolkit updates. Added HRP-071 and HRP-601 to the Materials section.
  • Additional editorial corrections.

Daily Tasks (HRP-062)

  • Updated statement in the Procedures section re: 5d emergency report to include 'required but', consistent with edits to HRP-023 - SOP - Emerg and Device Comp Use Review. Additional editorial correction with alignment with Huron 5.4 Release.

Response Plan for Emergencies-Disruptions Impacting the HRPP (HRP-065)
In alignment with Huron 5.4 Toolkit Release:

  • Revised SOP to more broadly address business continuity (i.e., include scenarios such as mass funding cuts and/or loss of facilities). 
  • Specific updates include: 1) Updated SOP title; 2) Expanded list of disruptive event examples in 1.1; 3) Additional content in 5.1.2 re: circumstances that may warrant postponing study activities by the IO/OO; 4) Clarification in 5.2.2.1 re: prioritization of IRB reviews; 5) Clarifications and editorial revisions throughout to accommodate the broadened scope; and 6) Updates to the Materials section consistent with remainder of the document, as well as updates to other related Toolkit documents.

IRB Removal (HRP-081)

  • Added section 5.1.6 - 5.1.7 to include electronic submission system tasks noted in the Huron 5.4 Toolkit Release.

Establishing Authorization Agreements (HRP-801)

  • Revised title to 'Establishing Reliance Agreements'. Under 5.1.2.4, removed instruction to file HRP-815 - FORM - Institutional Profile, as is duplicative with instructions in HRP-802 - SOP - Institutional Profile Management. In 5.2, revised "unaffiliated individual or individual affiliated with an organization that does not have an FWA" to "Collaborating Individual Investigator or Collaborating Institutional Investigator', consistent with OHRP guidance and the terms defined in HRP-001. 
  • Removed HRP-815 from the References section.

Review Request to Rely on External IRB (HRP-806)

  • Updated the title of HRP-801 - SOP - Establishing Reliance Agreements in the Procedure and Materials section, consistent with revisions to this SOP. 
  • Additional editorial revisions.
     

Worksheets

Review Materials (HRP-301)
In alignment with Huron 5.4 Toolkit Release:

  • In 3.1 clarified that HRP-601 indicates which members are designated reviewers and added use of HRP-601 to the Procedures. 
  • Added 3.3 to clarify designated reviewers are responsible for completing HIPAA waivers or alterations. 
  • Added 5.1.1 to clarify that all non-committee reviews can be performed by designated reviewers.
  • Remove redundant reference to executing “Assign Designated Reviewer” activity in Procedures. 
  • Added CFR reference in 7.3.

Drugs and Biologics (HRP-306) 

  • Added endnote to IND Exemption Category 1 to reference FDA guidance on IND exemptions for cancer trials in alignment with Huron Toolkit Release 5.4.

Pre-Review (HRP-308)

  • Added DMC Charter to materials list.

In alignment with Huron 5.4 Toolkit Release:

  • Added a checkbox and corresponding endnote in the Initial Review and Modification section to confirm the protocol includes information re: the inclusion of women and minorities consistent with NIH policy (NOT-OD-25-131).
  • Revised 'funded by ED' to 'conducted or supported by ED' in the appendix re: Department of Education, consistent with 34 CFR 97.
  • Updated the title of HRP-801 - SOP - Establishing Reliance Agreements, where referenced, consistent with updates to HRP-801. Added reference to HRP-329 - WORKSHEET - HIPAA Applicability in the appendix re: OCR/HIPAA.

Ancillary Review Matrix (HRP-309)

  • Added additional email contacts for clinicaltrials.gov assistance.
  • Revised link to ancillary review form from the Office of Native American Affairs. 
  • Revised "GDPR" organization to "International Research" and added contact information for the Research Integrity and Compliance Office (RIC).

Human Research Determination (HRP-310)

  • Made formatting corrections in sections 7, 8, and 10 so boxes are now checkable.

Engagement Determination (HRP-311)  

  • Added endnote to refer to HRP-101 for the definition of engagement.
  • Removed double underline for "engaged" throughout the text

Exemption Determination and Limited IRB Review (HRP-312)

  • In Section 1, corrected DOE endnote V to include 'Chg. 1' in alignment with Huron Toolkit Release 5.4.
  • Under Section 3, added endnote VII to 3(i)(C)(ii) noting that, per OHRP correspondence, eye-tracking can be considered for data collection under this exemption in alignment with Huron Toolkit Release 5.4.
  • Further clarified endnote VII to note that wearable technology is not eligible under exempt 3. Corrected a typo.

Criteria for Consent (HRP-314a)

  • In the ICH GCP section: 1) Removed 'approval of the IRB'; 2) Combined statements re: reasonably foreseeable risks and benefits to partner, etc. into 1 sentence; and 3) Added statement re: benefits/risks of alternative procedures back into ICH-GCP section, which was removed in error in 5.3. in alignment with Huron Toolkit Release 5.4.

Additional Federal Regulatory Criteria (HRP-318)

  • Added endnote to Section 9 header to reference DoDI 3216.02, thereby clarifying source of section contents in alignment with Huron Toolkit Release 5.4.

Review of Information Items (HRP-321)

  • Added additional consideration re: no further action, when CAPA is adequate in alignment with Huron Toolkit Release 5.4.

Emergency Use (HRP-322)

  • Added 'when necessary' to references to 5d reporting requirements, consistent with updates to HRP-023 - SOP - Emerg and Device Comp Use Review, in Sections 1, 3 and 4 in alignment with Huron Toolkit Release 5.4.

Protocol-Specific Emergency-Disruption Risk Mitigation Planning (HRP-351)

  • Revised consistent with HRP-065 - SOP - Continuity Planning for HRPP Disruptions revisions in alignment with Huron 5.4 Toolkit Release.
  • Specific updates include: 1) Updated title; 2) Revised introduction to refer to HRP-108 to determine whether a risk mitigation plan is needed, note that the the list of considerations provided is intended to serve as a starting point, and that all actions taken must comply with broader institutional/HRPP requirements pertaining to the emergency; 3) Eliminated Section 1 to avoid duplication with HRP-108; 4) Added content related to modifying the DSMP & DMP, documenting impact on research records, and notification to subjects in the "General Considerations..." section; 5) Added a section on additional notification considerations; and 6) Additional editorial revisions to provide clarification, minimize duplication and improve consistency.

Additional Emergency-Disruption Review Considerations (HRP-352)

  • Revised consistent with HRP-065 - SOP - Continuity Planning for HRPP Disruptions revisions in alignment with Huron 5.4 Toolkit Release.
  • Specific updates include: 1) Updated title; 2) Removed content duplicative with HRP-411 in Section 1; 3) Added reference to Pre-Review determination in Section 3, when considering whether or not the research is covered by federal regulations; and 4) Additional editorial revisions to provide clarification.

Local Context Review (HRP-831)

  • Added comment box to sections 1, 2, and 3. 
  • Added statement to section 3 to note that if the study involves children, local language should be added as applicable. 
  • Clarified that non-sponsored funded compensation includes federally funded research in the research-related injury options.
  • Revised the research participant advocate line text in section 3. Added text about adding the consent form and HIPAA authorization to a person's medical record for research taking place at MHealth Fairview. 
     

Checklists

Waiver of Alteration of Consent Process (HRP-410)

  • Added endnote to clarify that a waiver of consent cannot be granted if the research involves the review of records of nonviable neonates.

Non-Viable Neonates (HRP-413)

  • Added endnote to clarify that a waiver of consent cannot be granted if the research involves the review of records of nonviable neonates.

Capacity to Consent (HRP-417)

  • Removed reference to complete Section 4 regarding fluctuation of capacity for studies that will exclude those lacking capacity to consent. Much of Section 4 does not apply for situations where the study will exclude the individual from continued participation if capacity to consent is lost.
  • Added a text box for any comments (if needed) at the end of Section 4.

HIPAA Waiver (HRP-441)

  • Revised the purpose statement to accommodate review by either IRB or privacy board and clarify review pathways. 
  • Added endnote to reference 45 CFR 164 to sentence 2 re: waivers/alterations. In the Signature section, revised sentence 1 to generically state "The individual..." and added "or designee" in signature line.
     

Templates & Forms

Meeting Minutes Template (HRP-501)

  • Added guidance to Scientific Review section
  • Added footnote to provide instructions on “null” funding

Human Research Determination Form (HRP-503)

  • Revised form description and instructions for better guidance on when it should/should not be used. 
  • Added an ethical conduct and responsibility section on the cover page
  • Added new section (1.1) to ensure oversight congruency with funding source.
  • Section 1.2, clarified the prompts for accuracy. 
  • Section 1.3, noted that the IRB needs to see your data collection tools.
  • Section 1.4, revised instructional text to prompt completion. 
  • Section 1.5, added identifiable data elements table to help clarify what exact elements the project does or does not entail. 
  • Clarified the instructions in each section

Scientific Review (HRP-538)

  • Revised language to deemphasize "clinical trial" experience and reflect "human research" experience in general.

Site Closure (HRP-817)

  • Add statement to the instructions: "You should also use this form to report continuing review data for p-sites, and submit within each individual p-site in ETHOS.”
     

Letters

Modifications Required to Secure Approval (HRP-512a)

  • Changed the title and link for the quick guide referenced to "Respond to IRB Request for Changes as part of Continuing Review: Quick Guide."
  • "How to respond.” Corrected typo, clarified not to use "add" button for tracked-change documents, and added link to "Respond to IRB" job aids.

Suspension or Termination (HRP-515)

  • Updated leadership titles and letterhead to reflect new address for the HRPP/IRB

Information Items (HRP-519)

  • Updated leadership titles and letterhead to reflect new address for the HRPP/IRB
    Corrected grammatical errors

External Report - All Agencies NOT INCLUDING OHRP (HRP-520)

  • Updated leadership titles and letterhead to reflect new address for the HRPP/IRB

External Report wOHRP (HRP-520a)

  • Updated leadership titles and letterhead to reflect new address for the HRPP/IRB
     

Protocol Templates (Track-Change Copies)

NOTE: On July 1, 2026, researchers are expected to use the latest version of protocol templates for new study submissions.

Local Protocol Addendum (HRP-508)
Social Template Protocol (HRP-580)
Medical Template Protocol (HRP-590)
Data or Specimen-Only Protocol (HRP-595)
Database, Repository, Registry Protocol (HRP-597)

  • Revised link to ancillary review form from the Office of Native American Affairs. 
  • Added additional email contacts for clinicaltrials.gov assistance.
  • Added instructions to the Data Security section to eliminate redundancy with HIPAA section.
  • To reduce redundancy: Removed reference to non-medical records access from recruitment section. Revised “access” sub-section in “provisions to protect privacy interests of participants” section to refer to non-medical records only. The HIPCO section captures medical-based records. 
  • Health Information and Privacy Compliance and Health Science Technology (HST) HIPAA Compliant Devices and Data Storage sections - Combined former “preparatory to research activities” subsection with another subsection on PHI options that may apply to the study. Other edits to formatting and instructional text for clarity. 
  • Addressed accessibility by altering font colors, adding alternative text where appropriate, and adjusting table headings.

Local Protocol Addendum (HRP-508)

  • In addition to the changes above, the sections of this protocol were re-ordered to align with the order of the other protocol templates.

HUD Protocol (HRP-591)

  • Updated hyperlinks to Toolkit documents
  • Updated content format for accessibility
     

Consent Templates (Track-Change Copies)

*NOTE: Researchers are expected to modify consent forms to address the revisions related to taxation. The IRB suggests modifying the consent for studies at continuing review or "next touch." Study teams should work with sponsors accordingly when making changes to consent form(s).

Consent Form Template for Social/Behavioral Research (HRP-582)

  • "Voluntary Participation and Right to Stop at Any Time" Revised language to be more explicit about no penalty or loss of benefits.
  • "Will I be compensated for my participation?" Updated to indicate that Greenphire requires the parent's date of birth in order to issue a payment to a minor. Updated name of Greenphire company. 
  • Updated language related to change to IRS tax threshold, removing the specific amount of $600.* 
  • Added instructional text to ensure any included optional elements are described in the protocol.
  • Enhanced instructions for the use of the #988 hotline. 
  • "Can I be removed from the research?" Clarified that this section should align with the "Withdrawal Circumstances" section in the protocol.
  • Under "What happens to the information collected for the research?", added disclosure statement for NIJ-funded studies involving a Privacy Certificate covered by DOJ statute (34 USC 10231(a)) in alignment with Huron 5.4 Toolkit Release.

Assent Form Template (HRP-583) 

  • Corrected broken link in instructions.
  • Added instructional guidance encouraging the use of visual aids.
  • Removed gendered language from headings. 
  • Updated Suicide Prevention Lifeline number to 988 and enhanced the instructions for its use. 
  • Removed pregnancy testing/birth control content from optional elements. 
  • Added instructional text to ensure any included optional elements are described in the protocol.

Combined HIPAA and Consent (HRP-588),
Consent Form Template for Medical Research (HRP-592), and
Multi-Site Master Consent Form (HRP-593)

  • "Voluntary Participation and Right to Stop at Any Time" Revised language to be more explicit about no penalty or loss of benefits.
  • "Will I be compensated for my participation?" Updated to indicate that Greenphire requires the parent's date of birth in order to issue a payment to a minor. Updated name of Greenphire company. 
  • Updated language related to change to IRS tax threshold.* 
  • Added instructional text to ensure any included optional elements are described in the protocol.
  • Can I be removed from the research?" Clarified that this section should align with the "Withdrawal Circumstances" section in the protocol.
  • What happens if I say “Yes, I want to be in this research”? Clarified that the CMRR procedures paragraph should be edited as applicable to the given study. 
  • Under "What happens to the information collected for the research?", added disclosure statement for NIJ-funded studies involving a Privacy Certificate covered by DOJ statute (34 USC 10231(a)) in alignment with Huron 5.4 Toolkit Release.
  • Enhanced instructions for the use of the #988 hotline. 
  • Corrected typos.
     

Other

HRP-108 - FLOWCHART - Study-Specific Emergency-Disruption Risk Mitigation Planning
In alignment with Huron 5.4 Toolkit Release:

  • Revised introduction to directly reference OHRP/FDA guidance on IRB written procedure formatting and flexibility and added a description of Toolkit components.
  • Updated corresponding Toolkit component references to provide clarity, based on feedback obtained from clients.
  • Moved the regulatory citations linked in the endnotes to the body of the document.