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.
March 2023 Changes
The following changes were made primarily to update the UMN Toolkit to complete the alignment with the Huron Toolkit Release (4.5) as well as revisions based on feedback from the research community.
Manuals
Investigator Manual (HRP-103) - Track Changes Copy of HRP-103
- Added a new requirement for a two-year effective date that will go into effect July 1, 2023 for studies determined exempt in “What are my obligations after receiving an Exempt determination?”
- Added “What if I want to send biospecimens outside of the University or receive biospecimens from an outside organization?”
- Updated guidance to include translation expectations for research involving children/parents in “What about participation of individuals with limited English proficiency, meaning non-English speakers?”
- Added guidance regarding international ethics review of translated materials to “What translation or certification services are acceptable or required?”
- Clarified ‘significant changes’ in “What are my obligations after receiving a Not Human Research Determination?”
- Added “If my study will be reviewed by an external IRB, when can I start my research?”
- Added “If my study relies on an external IRB, do I have to follow UMN IRB’s translation requirements?”
- Added process chart for “How do I request reliance on an external IRB for my study?”
- Restructured the guidance for updates and reporting requirements for studies relying on an external IRB
- Added local participant complaints to reporting requirements for studies relying on an external IRB
- Fixed formatting, grammar, spelling errors throughout the manual, including the appendices
- Added social media comment guidance to “How do I create recruitment material?”
- Added “abbreviated IDE” and significant and non-significant risk device to “What if I am a sponsor or sponsor-investigator of an IND or IDE?”
- Fixed broken hyperlinks throughout the manual
IRB Member Manual (HRP-100)
- Corrected section 4 to reference the scientific review checklist
- Added affiliation status for chair and vice chair roles
Protocols
Most protocols include the following changes (Access track change copy of the instructional template):
- Fixed broken hyperlinks
- Corrected formatting/functionality of the outline
- Aligned sub-sections between protocol templates, as applicable
- Added GCP applicability section to the Protocol Cover Page
- Added University Health and Safety Compliance – Controlled Substances Program compliance to ancillary review matrix
- Added guidance about plans for data safety and monitoring in Provisions to Monitor the Data to Ensure the Safety of Participants’ section
- Added guidance about primary and secondary endpoints
- Added reference to MHealth Fairview Recruitment Guidelines in ‘Recruitment Methods’ section
- Added guidance about data analysis to ‘Statistical Considerations’ section
- Added guidance in Health Information and Privacy Compliance section
- Added Health Science Technology (HST) HIPAA Compliant Devices and Data section
- Added translation requirement previously communicated in HRP-103 to the non-English speaking participants section
HRP-503 - Determination Form
- Added section for quality improvement / quality assurance / program evaluation projects
- Added guidance and updated hyperlink about de-identified data
Worksheets
HRP-302 - Approval Intervals
- Added new requirement that will go into effect July 1, 2023 for studies determined exempt
HRP-308 - Pre-Review
- Added OMHDD requirement for Department of Psychiatry clinical drug trials
HRP-309 - Ancillary Review Matrix (Access Track Change Copy)
- Updated guidance regarding ancillary review access for quality improvement/assurance projects
- Added ‘Significant modifications as determined by pre-review or committee review’ for HRPP scientific assessment and Gillette scientific assessment
- Corrected font for consistency
HRP-312 - Exempt Determinations and Limited IRB Review
- Added new requirement for a two-year effective date that will go into effect July 1, 2023 for studies determined exempt
- Corrected exemption category numerical references
HRP-830 - Local Context Review
- Added guidance for local context review for studies where UMN is only serving as the data coordinating center
- Added Certificate of Confidentiality as part of the local context review for consent language
- Clarified local context review of consent language for studies relying on Advarra IRB or NCI CIRB
- Clarified guidance for local context review where the reliance agreement is executed in an online submission system (e.g. SMART IRB, IREX)
Checklists
HRP-417 - Adults with Impaired Decision-Making Capacity
- Corrected grammar in Section 3
HRP-841 - Request for Reliance on an External IRB
- Added documentation practice for situations where the reliance agreement is executed in an online submission system (e.g. SMART IRB, IREX)
Forms
HRP-823 - Advarra IRB Cover Page
- Added “not applicable” check boxes to facilitate the completion of the form
- Added study type section
- Removed section related to Department of Psychiatry clinical drug trials
Consent Templates
The consent templates (HRP-582, HRP-592) generally include all of the following edits (Access Track Change Copy):
- Added language regarding the 21st Century Cures Act requirements to “What happens to the information collected for the research?”
- Updated mandatory reporting language to align with MN state law
- Revised “A description of this clinical trial will be available at http://www.ClinicalTrials.gov, as required by U.S. Law” to include “or other guidelines.”
HRP-583 - Assent Template
- Added language for boys that have reached reproductive age
HRP-585 - Parental Permission Template
- Corrected hyperlink for research participants
HRP-588 – Combined HIPAA and Consent
- Revised “What about more sensitive health information?” to include not applicable options and instructions for usage of the new template
- Added guidance references for Minnesota’s Reportable Disease Rule
- Updated “Secondary (future) research without identifiers” to include information regarding situations where there will only be UMN use
- Added “or other guidelines” to ClinicalTrials.gov statement
- Updated “Whom do I contact if I have questions, concerns or feedback about my experience?” to align with other consent templates
- Updated ClinCard content in “Will I be compensated for my participation?” to align with other consent templates
- Updated “Optional research activity” to include not applicable options and instructions for usage
Standard Operating Procedures
HRP-024 - SOP - New Information
- Removed double negative from section 5.7.2
HRP-090 - SOP - Informed Consent Process for Research
- Added translation requirement previously communicated in HRP-103 to 5.2.10, corrected formatting.
HRP-091 - SOP - Written Documentation of Informed Consent
- Added translation requirement previously communicated in HRP-103 to 5.2.7
HRP-801-SOP-Authorization Agreements
- Updated to include Huron 4.5 Release addition for Section 3.2 and 6.9.
HRP-802-SOP-Institutional Profile Management
- Updated to include Huron 4.5 Release addition for Section 3.2
HRP-806 -SOP-Request to UMN as sIRB
- Updated to include Huron 4.5 Release addition for Section 3.2 and 3.3