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. Access the Archive of Toolkit Releases.
March 2021 Toolkit Changes
The following changes were made to address feedback from the research community, electronic consent, and reliance processes.
Manuals
- Added Vice Chair section, “What are the roles and responsibilities of an IRB Vice Chair?”
Investigator Manual (HRP-103) - Track Changes Copy of HRP-103
- Addressed minor spelling or grammatical errors.
- Added additional guidance regarding the addition of study personnel to IRB approved submissions (see “Who is considered Study Personnel for purposes of IRB submission?).
- Added new guidance regarding participant compensation (see “How do I develop a compensation plan for research participation?”).
- Added guidance regarding the use of ETHOS to obtain the IRB approved consent form (see “How do I create a consent document?”).
- Added guidance regarding HUD submission review to “Does my research require scientific assessment?”
- Removed Clinical and Translational Science Institute (CTSI) pilot funding awards from “Does my research require scientific assessment?”
- Removed IND/IDE Regulatory Director references.
- Revised guidance regarding Just-In-Time submissions (see “What if I applied for federal funding and received a Just-in-Time notification?).
- Added guidance regarding research involving children (see “What if I’m doing research involving children?”).
- Added information regarding expectations for responding to requests from the IRB within 45 days of notices being sent (see “What will happen after IRB review?”).
- Added modification submission guidance regarding the addition of study personnel to existing protocols who plan to conduct a research study using the existing study data/specimens (see “How will the modification be reviewed?”).
- Added instructions regarding the requirement to submit reportable new information at the time of continuing review in the event of a lapsed IRB approval (see “How do I submit continuing review?”).
- Added non-compliance statement to “How do I close out a study?”
- Added “Can I be restricted from submitting to the IRB?”
- Added prompt reporting of a death of a local research participant to reporting requirements for research being reviewed by an external IRB (see “What do I submit to the University of Minnesota IRB after my study is approved for reliance on an External IRB?”).
- Added appeal process for situations where UMN IRB declines to serve as sIRB or declines a request to rely on an external IRB (see “How do I request the University of Minnesota serve as the sIRB?” and “How do I know my study is eligible for reliance on an external IRB?”).
- Clarified process information for sIRB requests (see “How do I request the University of Minnesota serve as the sIRB?”).
- Updated process for requesting reliance on an external IRB (see “What is the process for requesting reliance on an external IRB?”)
- Revised Appendix B-1 Research Involving Children to align with new guidance from the Office of the General Counsel.
Policies
Research Involving Adults Under Court Jurisdiction (HRP-111)
- Clarified Section 5.2.1 regarding experimental treatment.
Minnesota Laws Affecting Human Research (HRP-112)
- Updated statutory citations and clarification for reporting requirements in Section 5.1.2.
- Clarified Sections 5.2.2-5.2.3 regarding parental consent for minors.
- Clarified Section 5.4.2 language regarding court appointed guardians.
Standard Operating Procedures
- Added definition for the term, experimental treatment.
- Revised the definition for the terms, court-appointed guardian of a child and guardian of a child.
Legally Authorized Representatives, Children, and Guardians (HRP-043)
- Added section headings (Sections 3.1 – 3.3)
- Clarified Section 3.1.3 regarding experimental treatment.
- Clarified Section 3.2.2 by adding “only.”
- Added guidance in Section 3.3 regarding experimental treatment and recommendation for seeking guidance from the Office of General Counsel.
- Revised Sections 5.4.9 – 5.4.11 to include new procedures for calling the PI, requesting additional information prior to significant decisions, and panel review of responses.
- Removed 5.5 which is now encompassed in 5.4.9 – 5.4.11 and 5.4.12.
- Added reportable new information determinations to 5.4.12.
- Replaced five business days with two business days (Section 3.5)
- Revised to align with the TEMPLATE: Meeting Minutes (HRP-501) instructions.
- Replaced “PAR Quality Assurance Manager” with Assistant IRB Director.
- Added the role, Vice Chair.
- Corrected references to the Consultation Form (HRP-210) and Criteria for Approval (HRP-314).
- Clarified the process for identifying a consultant.
- Clarified the process for documenting the consultant’s feedback on a submission.
Annual HRPP Evaluations (HRP-060)
- Added ETHOS improvements (Section 5.1.7).
- Added review of the HRPP Employee Handbook (Section 5.8).
- Added review of non-Toolkit materials (job aids, training videos) (Section 5.9).
- Added review of billing for Fairview and Gillette IRB services (Section 5.15).
- Added review of HRPP Internal Service Organization (ISO) rate (Section 5.16).
- Added Vice Chair (Section 5.3.2).
- Revised IRB formation for social behavioral sciences panel (Section 5.4) to align with the formation description for the biomedical panel (Section 5.3).
Informed Consent Process for Research (HRP-090)
- Clarified language regarding guardians in Section 3.2.3 and Section 3.6.3.
Written Documentation of Consent (HRP-091)
- Clarified language regarding guardians in Section 3.2.3 and included reference to HRP-013.
Complaints, Questions, Concerns (HRP-703)
- Added Section 5.2 regarding risk of imminent danger or harm reporting.
- Added process for ceded research (Section 5.5.5 – Section 5.5.7) and Section 5.7.
- Clarified process for addressing IRB related complaints (Section 5.8).
Worksheets
- Added sponsor or sponsor investigator and regulatory references to Section 5, “Abbreviated IDE” requirements.
- Added additional guidance to Footnote #1 per Huron 4.4 Toolkit Release due to changes to Section 3060 of the 21st Century Cures Act.
Human Research Determination (HRP-310)
- Added not applicable option to Section 1.
Exemption and Limited IRB Review (HRP-312)
- Added Department of Energy regulatory reference to Footnote #1 per Huron 4.4 Toolkit Release.
- Added consent process requirement to Section 2 regarding the inclusion of the Research Participant Advocate Line.
- Added criteria for research involving the use of MTurk to Section 1.
- Replaced “subject” with “participant” throughout the worksheet.
- Added instructions regarding ETHOS access to Section 2.
Checklists
Criteria for Relying on an External IRB (HRP-841)
- Removed Section 6 regarding exception requests.
Templates
- Clarified requirements for submitting to the IRB for student-investigators.
- Removed scientific assessment from the cover page.
Social Protocol Template – With Instructions and Without Instructions (HRP-580)
- Updated Ancillary Review table to align with the Ancillary Review Matrix (HRP-309).
- Included “Do Not Delete” for the Ancillary Review Table as it should not be removed.
- Corrected Table of Contents.
- Corrected section references in Section 10: Vulnerable Populations.
- Revised Section 18.11 regarding storage of research documents.
- Added Section 18.12 regarding the disposal of research documents.
- Added instructional text regarding who will assess capacity to consent in Section 22.6.
Biomedical Protocol Template – With Instructions and Without Instructions (HRP-590)
- Corrected Table of Contents.
- Updated Ancillary Review table to align with the Ancillary Review Matrix (HRP-309).
- Included “Do Not Delete” for the Ancillary Review Table as it should not be removed.
- Added guidance in Section 4.1 regarding studies involving an investigational device, determination of IDE Exemption, Significant Risk or Non-Significant Risk.
- Added guidance to Section 6.3 regarding parameters and process for which data may be shared for future use.
- Corrected section references in Section 9: Vulnerable Populations.
- Revised Section 16.11 regarding storage of research documents.
- Added Section 16.12 regarding the disposal of research documents.
- Added instructional text regarding who will assess capacity to consent in Section 21.6.
Data or Specimen Only Protocol (HRP-595)
- Corrected Table of Contents.
- Updated Ancillary Review table to align with the Ancillary Review Matrix (HRP-309).
- Included “Do Not Delete” for the Ancillary Review Table as it should not be removed.
- Moved sections within the protocol template to align with information needed or not captured by the BPIC Consultation Form that is required for IRB review.
- Revised Section 4.6 regarding storage of research documents.
- Added Section 4.7 regarding the disposal of research documents.
Database, Registry, and Biospecimen Repository Protocol (HRP-597)
- Updated Ancillary Review table to align with the Ancillary Review Matrix (HRP-309).
- Included “Do Not Delete” for the Ancillary Review Table as it should not be removed.
- Added Health Information and Privacy Compliance (Section 7)
- Added Section 7.9 regarding storage of research documents.
- Added Section 7.10 regarding the disposal of research documents.
- Clarified instructions for Part 1 and Part 2 completion.
Biomedical Consent Template (HRP-592)
- Added guidance for research involving investigational test articles under “Will being in this study help me in any way?”
IRB Meeting Minutes Template (HRP-501)
- Updated instructions to clarify documentation requirements for significant risk / non-significant risk device determinations and reportable new information.
- Updated instructions regarding the removal of headings in the Additional Information/Notes section.
Business and Industry Funded Study Fee (HRP-823)
- Added instructions regarding Fairview research.
- Fixed form fields.