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.
  

June - August 2024 Changes

The following updates highlight changes that impact the research community:

Transition to Huron's 5.0-5.2 Release
The Toolkit is currently under a transition to update files to Huron Consulting Group’s 5.0-5.2 release. As part of this transition, the HRPP is reviewing the University’s materials to determine if any local adaptations to the Toolkit should be removed or revised. The existing materials have been archived, and the revision history on files has a new statement regarding the transition to Toolkit 5.0-5.2:

  • Post-Review (HRP-052)
  • Quarterly Evaluations by the HRPP (HRP-061)
  • Response Plan for Emergencies-Disasters Impacting the HRPP (HRP-065)
  • Education and Training (HRP-066)
  • Request to Transfer IRB Authority to UMN IRB (HRP-073)
  • Reporting by the HRPP (HRP-099)
  • Confidentiality Agreement for Attendance (HRP-223)
  • Request Transfer of IRB Oversight (HRP-229)
  • Drugs (HRP-306)
  • Devices (HRP-307)
  • Pre-Review (HRP-308)
  • Advertisements (HRP-315)
  • Additional Agency Criteria (HRP-318)
  • IRB Member Addition (HRP-382)
  • IRB Member Removal (HRP-383)
  • Contracts (HRP-324)
  • Scientific Review (HRP-420) - coming soon
  • Institutional Profile (HRP-815)
  • Human Research Audit (HRP-700)
  • QA IRB Performance Audit (HRP-701)
  • Complaints, Questions, and Concerns (HRP-703)
  • CMA Observation (HRP-742)
  • CMA Observation - Exempt (HRP-743)
  • Sponsor-Investigator Policy Compliance (HRP-1897)
  • Sponsor-Investigator Responsibilities (HRP-1899) 
     

New Toolkit Documents Adopted from Huron Consulting’s Toolkit

  • Protocol Specific Emergency-Disaster Risk Mitigation Planning (HRP-351)
  • Additional Emergency-Disaster Review Considerations (HRP-352)
  • Study-Specific Emergency-Disaster Risk Mitigation Planning (HRP-108)
  • Annual Performance Evaluation Criteria for IRB Staff (HRP-328)
     

Detailed Toolkit Changes
Definitions (HRP-001)

  • Updated definition of Agent and added Engaged in Human Research to align with the Toolkit HRP-101 Manual. Minor edits to fix numbering (3.1.2), changed some use of subject to participant.
     

Review of Financial Conflicts of Interest (HRP-054)

  • Updated to include information that was accidentally deleted during the March 2024 Toolkit Release regarding conflicts of interest and external study personnel
  • Updated 3.6 to clarify UMN IRB policy that the IRB will not approve a study where external study personnel have a conflict of interest Related to the Research or internal study personnel are acting as an employee or agent of a company.
     

Ancillary Review Matrix (HRP-309)

  • Revised HIPCO information to include GDPR
  • Updated BLS information
     

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

  • Added “a. and/or b. ” to first statement “Both are true” in Section 2
  • Added Department of Defense requirement
     

Information Sheet for Exempt Research (HRP-587)

  • Updated research questions, complaints, and concerns section for clarity
  • Removed reference to “IRB approval”
  • Added Exemption ID to template footer

Parental Permission Form (HRP-585)

  • Retired
  • Study teams should use adult consent form templates. See instructional text of how to adapt the consent for parental use
     

IRB Member Manual (HRP-100)

  • Updated reference for FORM: 
    • IRB Member Assessment, and 
    • IRB Chair Assessment; 
  • Added guidance for providing notice when ending term early; 
  • Deleted appendices for 
    • Human Research determination, 
    • Exemption determination, and 
    • Engagement determination.
       

Single IRB (sIRB) Updates
The following documents have been re-numbered to align with the Huron Toolkit numbering scheme.

  • Basic Site Information (HRP-811)
  • Site Continuing Review (HRP-812)
  • Site Modification (HRP-813)
  • Site New Information (HRP-814)
  • Site Closure (HRP-817)
     

The following sIRB documents were updated to align with the Huron 5.0-5.2 release:

  • Participating Site Local Context and Institutional Requirements (HRP-810)
  • Institutional Profile (HRP-815)
     

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

  • Updated information to clarify Privacy Board requirements
     

External Team Member Form (HRP-216)

  • Aligned with Huron 5.0 format
  • Removed decision tree
  • Added clarity to exclusion criteria regarding minors and engagement
     

Minutes (HRP-501)

  • Clarified working instructions in the end notes of this template
  • Revised funding sections to automatically pull information from the ETHOS submission record
     

HRPP Manual (HRP-101)

  • Added definitions for Employees/Agents, Clinical Trial, Engaged in Human Research, Human Research, Human Subjects as Defined by DHHS, Human Subjects as Defined by FDA, Investigator, Research as Defined by DHHS, Research as Defined by FDA, to align with the Huron Toolkit HRP-101 Manual.
  • Added “Any questions about whether an activity meets the regulatory definitions of Human Research should be referred to the IRB Office, who will provide a determination. The IRBs use “WORKSHEET: Human Research (HRP-310)” to guide the determination of whether an activity is Human Research.”
  • Added “This University utilizes the IRB to review and approve the use of a Humanitarian Use Device (HUD) before it can be used at a facility for clinical care (with the exception of emergency use).” To align with the Huron Toolkit HRP-101 Manual.
  • Minor revisions were made to clarify the sentence, “The University’s HRPP oversees all Human Research at this Institution, and provides IRB services for research conducted by Fairview Health Services (except Community Clinical Oncology Program [CCOP] studies), and by Gillette Children’s Specialty Healthcare.”
  • Minor revisions were made to clarify the sentence, “When multi-site or collaborative research is overseen by the UMN IRB, the UMN IRB may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoiding duplication of effort.”
  • Added the following to the Scope section to align with the Huron Toolkit HRP-101 Manual, “Research that includes processing or holding personal data of subjects residing in the European Union.”
  • Revised the Institutional Official component to streamline the content. 
  • Replaced existing “Relying on an External IRB” section with new content to align with the Huron Toolkit HRP-101 Manual.
  • Added “Serving as the IRB of Record” section to align with the Huron Toolkit HRP-101 Manual.
  • Added “in addition to the responsibilities for all members of the institution,” to Investigators and Research Staff component section.
    Added “GDPR” statement to the Office of the General Counsel component section.
  • Updated the Research Integrity and Compliance, Office of Academic Clinical Affairs, Institutes, Centers, and Committees, and Office of Biotechnology Activities Oversight, Sponsored Projects Administration, and Community Oversight Board component sections to reflect current information about this unit.
  • Updated the Quality Assurance Program component section to clarify roles and responsibilities for monitoring compliance with the University Sponsor and Sponsor-Investigator IND/IDE and FDA Pre-Submission Requirements policy and monitoring compliance with Common Rule requirements for posting consent forms.
  • Added statement regarding communication methods for sharing information with the research community.
  • Moved the National Emergency, Natural Disaster, or Pandemic Policies and Procedures section to align with the Huron Toolkit HRP-101 Manual.
  • Updated the contact information for the local IRB Office and Institutional Official.
  • Removed Department of Energy Responsibilities as it is not applicable to this institution.
     

Investigator Manual (HRP-103) (TRACK CHANGE COPY)
General edits:

  • Moved the “Investigator Manual Revision History” from the beginning of the Manual to Appendix C
  • Toolkit alignment with Huron Consulting (how Toolkit documents are referenced)
  • Fixed grammar and formatting issues throughout the document
  • Updated URLs throughout the document
     

Added the following new sections:

  • Can someone other than the principal investigator submit information, modifications or responses to committee requests? What if the PI is unavailable due to travel or illness?
  • How long does it take to obtain IRB approval?
  • Does the IRB need to know about my pre-screening or screening plans?
  • When do my screening activities require informed consent?
  • What if I want to keep information about my screening activities? 
  • What are the differences between preparatory to research activities, pre-screening activities, and screening activities when PHI is involved?
  • How do I approach questions of Gender, Sex, and Sexuality in Research?
  • What if I want to use Artificial Intelligence (AI) tools in my human research study?
  • What potential issues will investigators be asked to consider when submitting a study that includes artificial intelligence?
  • What additional information will be required for intervention-based research that includes the use of AI tools? 
  • What about data security, limitations of AI data entry, or copyright?
  • How will the IRB review research with human participants that involves artificial intelligence?
  • What do potential participants need to know about participating in a study that involves artificial intelligence
  • Where can I find out more about the use of AI in research?
  • When should JIT funded projects be submitted to the IRB for review?  
  • Can a PI enroll a family member in their research?
  • How will the IRB review my FDA mandated Long Term Follow-up Study (LTFU)?
  • What if a participant, or potential participant, is being followed by the media?
  • What happens if I receive a lapse notice from ETHOS?
  • How do I request to continue study procedures during a lapse in approval?
  • What if I receive a request for previously collected or additional research data from the external business and industry sponsor after the study has closed?
  • Can my IRB determination letter be signed?
     

Updated guidance for:

  • Revised “How do I create an assent document?” to indicate multiple assent documents may be necessary
  • Revised “How do I create a parental permission document?” to include new instructions on tailoring the adult consent form for parental permission
  • Revised “Can I conduct consent electronically” to include new instructions on the use of the eConsent platform and capturing electronic signatures.
  • Added guidance for data collection associated with non-US residents and GDPR applicability to “Does the General Data Protection Regulation (GDPR) affect my research?
  • Updated “What is a CoC (Certificate of Confidentiality)” “What about Certificates of Confidentiality for Research not funded by NIH?” to reflect current NIH policy guidance and contact information for submitting the CoC request for non-NIH funded research.
  • Added Job Code 9340F to those eligible to serve as PI.
  • Added training requirement research teams conducting Indigenous research to “What training is required to conduct Human Research?” and to “What if I’m doing research involving Indigenous peoples, Tribal Partners/Communities, Tribal-Serving Institutions, American Indian or Alaskan Native populations?”
  • Removed reference suggesting that an HRP-216 can be used to obtain a reliance agreement under “Who is Considered Study Personnel for purposes of IRB submission?”
  • Updated “Does my research require scientific assessment?” and “What are acceptable methods for scientific assessment?” to indicate Gillette Specialty Healthcare scientific assessment process and requirement.
  • Updated “What if I’m receiving a grant award but my plans for human research are not fully defined?” to clarify that this is not in reference to JIT requests.
  • Updated “What if I applied for federal funding and received a JIT notification?” to reflect new expectations and requirements
  • Added Safety of Minors policy to “What if I’m doing research involving children?”
  • Added reference to reliance FAQ to “What are the expectations for using the short form process?”
  • Added clarity about use of non-commercial vendors to “What translation or certification services are acceptable or required?”
  • Added privacy law guidance to “What if I’m doing international research?”
  • Added additional guidance and graphics to “What documents are stamped with the IRB watermark when a study is approved?”
  • Added statement regarding new submission may be required for substantive changes made to an exempt study for “What are my obligations after receiving an Exempt determination?”
  • Updated “How do I document consent?” to align the short form section with standard operating procedures language
  • Updated “What if I need access to IRB records or rosters?” to include a hyperlink to the letter that can be given to sponsors or agencies requesting information about the IRB’s FWA and registration
  • Updated “What if I need institutional certification for NIH Genomic Data Sharing” to reflect current processes
  • Added guidance for unfunded studies to “How long do I keep or retain records?”
  • Updated “Will the UMN IRB serve as the sIRB for SBIR/STTR Human Research?” to clarify engagement for prime awardees (i.e. the company) and that UMN IRB cannot be used without a formal agreement in place prior to the initiation of the research. Removed “HRP-054” reference from this guidance to reduce confusion.
  • Added clarity about health information privacy issues to “What reportable events must I submit to the University of Minnesota IRB for a study that is approved for reliance on an external IRB?”
  • Revised “What is the difference between a research site and a research location?” to include information about automatic engagement.
  • Added engagement guidance to “In what cases will the University of Minnesota IRB consider serving as the IRB of record for an external study team member?”
  • Updated contact information listed in “What if I have questions about the IRB process or IRB review?”
     

Moved and updated content from the sIRB Manual (HRP-803) into this manual:

  • How do I create a multi-site/collaborative research protocol?
  • How do I create a multi-site/collaborative research consent form?
  • What are my obligations as the overall study PI for an sIRB study?
  • What are my obligations as investigator when relying on an external IRB?
  • When should I consult with UMN IRB when planning a study for which this IRB will be asked to serve as the IRB of record (sIRB)?
  • What if UMN IRB agrees to serve as the sIRB?
  • Will UMN charge a fee for serving as sIRB?
  • What should be considered in a budget for an sIRB study?
  • How do I develop a communication plan for multi-site/collaborative research reviewed by a sIRB?
  • What should be included in the Overall Study submission to the UMN sIRB?
  • Is a reliance agreement required for participating sites if UMN IRB serves as the sIRB?
  • What UMN policies must be adhered to by participating sites?
  • What are the responsibilities of a Participating Site Principal Investigator?
  • Will the UMN IRB serve as the Privacy Board (HIPAA) for participating sites?
  • What should be included in the participating site submission to the UMN sIRB?
  • What if there are changes to a participating site’s local context or institutional requirements?
  • Will participating site study teams have access to ETHOS?
     

Administrative rewording to the following Q&A:

  • What about Institutional Conflicts of Interest?
  • Does my research require IRB review?
  • What are acceptable methods for scientific assessment?
  • Updated reference to Vulnerable Population Worksheet (changed from HRP-333 to HRP-334)
  • Reference to “Submit a Study Closure: Quick Guide” job aid
     

Consent Templates (HRP-582 – TRACK CHANGE COPY, HRP-588 – TRACK CHANGE COPY, & HRP-592 – TRACK CHANGE COPY)
All templates:

  • Changed font size for section headings and content
  • Added guidance about creating the key information section.
  • Added guidance about studies involving non-English speaking participants the ‘Appropriate Use of Interpretation and Translation Services in HIPAA”
  • Restructured and simplified statements within the Key Information Section to align with August 2023 FDA Guidance regarding key information.
  • Added voluntary participation section
  • Added instructions on how to adapt the consent form for parental permission
  • Added “What if I am not a U.S. Resident?”
  • Updated “Whom do I contact if I have questions, concerns, or feedback about my experience?” based on community feedback
  • Revised “How will my information be used in publications and presentations?”
  • Revised format of Optional Elements to Optional Research Activities
  • Aligned Optional Elements for Genetic Research
  • Added Signature Block for Parental Permission
  • Clarified Witness Block for non-professional and professional interpreter use.
     

Combined HIPAA and Consent Template (HRP-588)

  • Updated HIPAA specific content to improve readability and use for study-specific forms: 
    • What health information will be made available?” 
    • Sensitive Health information
    • May I cancel my permission for making my health information available for use and sharing?
       

Protocol Templates (HRP-580: Track Change Copy & HRP-590: Track Change Copy)
All protocol templates had the following updates:

  • Updated ancillary review matrix to align with HRP-309 – Worksheet – Ancillary Review
  • Updated broken hyperlinks
  • Added instructions to add information regarding artificial intelligence to Procedures Involved Section
  • Added guidance to Sharing of Results with Participants Section for research involving Tribal partners, Tribal communities, Tribal-serving institutions, or includes focused recruitment of Indigenous Peoples, the Tribe(s), and/or institutions.
  • Added guidance to Study Population Section regarding demographic and non-demographic factors related to inclusion and exclusion criteria.
  • Added guidance to Study Population Section regarding terminology used that reflects the constructs of interest when referencing gender, gender expression, sexual orientation, and sexual behaviors.
  • Aligned the Vulnerable Populations Section content across all protocol templates. Language was modified in this section to improve clarity.
  • Aligned the Number of Participants Section content across all protocol templates.
  • Added Recruitment Barriers and Challenges and Recruitment Monitoring and Mitigation Plans to the Local Recruitment Methods Section.
  • Added “Identify Potential Barriers to Ongoing Participation – Retention Monitoring and Mitigation Plans” to the Withdrawal of Participants Section.
  • Aligned the Potential Benefits to Participants Section across all protocol templates.
  • Aligned the Consent Process Section across all protocol templates.
     

Social Protocol (HRP-580)

  • Revised Section 3.0, Section 5.0 to replace medical terminology with social-behavioral sciences terminology.
  • Revised Section 9 and 10 to provide social-behavioral sciences relevant examples.
  • Revised Section 11 with social-behavioral sciences relevant guidance.
  • Updated Section 12 to remove biomedical study related guidance and added social-behavioral sciences relevant guidance.
  • Updated Section 16 to clarify guidance.
  • Revised Section 17 with social-behavioral sciences relevant guidance.
  • Updated Section 19 to include not applicable statement.
  • Moved Storing Data for Future Use to Section 20 and updated guidance.
  • Moved the Health Information and Privacy Compliance Section to Section 27.
  • Moved Health Science Technology (HST) HIPAA Compliant Devices and Data Storage to Section 28.
     

Reportable New Information Letter (HRP-519)

  • Restructured letter format to improve readability and provide key information regarding determinations
     

Toolkit Release Town Hall

An overview of the March transition will be provided at the August 14th IRB Lunch and Learn. Please register to attend.

Toolkit Lock Down for AAHRPP Re-Accreditation

In preparation for AAHRPP re-accreditation, the Toolkit will be locked down until July 2025. Minimal changes will be made during this period. As part of the re-accreditation process, accreditors discourage changes wherever possible.