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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.
  

October 2022 Toolkit Changes

The following changes were made primarily to update the UMN Toolkit to align with the Huron Toolkit Release (4.5) as well as revisions based on feedback from the research community.
 

Manuals

Investigator Manual (HRP-103) (download) - Track Changes Copy of HRP-103

  • Clarified guidance and process for external study personnel additions (see In what cases will the University of Minnesota IRB consider serving as the IRB of record for an external study member?)
  • Clarified Good Clinical Practice - NIH training requirements for social and behavioral science research
  • Added “Are there any approvals I need before applying to the IRB?”
  • Added guidance regarding Data Use Agreements to “What are my responsibilities for data security?”
  • Added guidance regarding additional review for substantial changes to study designs under “Is scientific assessment required?”
  • Removed requirement for Department of Psychiatry clinical drug trials to be reviewed by an external IRB (Advarra IRB) from “What if my research is a UMN Department of Psychiatry clinical drug trial?”
  • Updated guidance for interpreter signatures on HIPAA Authorization Forms
  • Added “Are there any unique laws or rules associated with informed consent if I’m conducting genetic analysis with existing specimens?”
  • Updated link text for “What if I am the sponsor or sponsor-investigator of an IND or IDE?”
  • Added FDA guidance to “What if I’m doing research with devices?”
  • Updated guidance for “What if I need to request approval for a planned exception to my protocol?” per Huron 4.5 Toolkit Release
  • Clarified scope of continuing review and potential modifications for legacy studies (pre-ETHOS) for “What does the IRB consider when conducting a continuing review?”
  • Added guidance to “What should be reported promptly to the University of Minnesota IRB?” regarding Good Clinical Practice ‘errors’ and participant death reporting
  • Added clarification that IRB review is required for research recruitment registries.
  • Added “What documents are stamped with the IRB watermark when a study is approved?”
  • Clarified guidance regarding new study vs. modification submission requirements for “Are there circumstances that would require submission of a new IRB application?”
  • Updates to referenced text format to improve consistency of language use (e-Consent and eConsent)
  • Added AAHRPP element reference per Huron 4.5 Toolkit Release

Standard Operating Procedures

HRP-001 - SOP - Definitions

  • Added protocol exception, serious adverse events, and updated AAHRPP references. Adjusted “affiliation” guidance for non-affiliated IRB member (3.77)

HRP-021 - SOP - Pre-Review

  • Add single subject protocol exception review and AAHRPP references

HRP-052 - SOP - Post-Review

  • Updates to reporting requirements for Serious Non-Compliance; Continuing Non-Compliance; Suspension of IRB Approval; Termination of IRB Approval; and Unanticipated Problem Involving Risks to Subjects or Others to an outside agency and AAHRPP references

HRP-060 - SOP - Annual HRPP Evaluations

  • Added HRPP Emergency Preparedness review (Section 5.2), Materials (Section 6), Reference (Section 7.1) from the Huron 4.5 Toolkit Release

HRP-066 - SOP - Human Research Education

  • Update HIPAA 16 to HIPAA 19 training

Worksheets

HRP-303 - WORKSHEET - Communications

  • Removed OHRP exception from reporting to a federal agency
  • Add link to the incident form
  • Add AAHRPP elements reference footnote

HRP-308 - WORKSHEET - Pre-Review

  • Added that NIH-funded studies (regardless of whether the investigator has indicated the use of a Certificate of Confidentiality), should note the presence of a Certificate of Confidentiality in the Protocol Tracking section of the Pre-Review Checklist
  • Added AAHRPP reference footnote

HRP-309 - WORKSHEET - Ancillary Review Matrix

  • Delete Regulatory footnote: “For studies relying on an external IRB, this review will be assigned only when the UMN is the IND/IDE holder”
  • Add to CTSI eligibility criteria, “at https://ctsi.umn.edu/services/regulatory/clinical-trial-monitoring”
  • Add to Clinicaltrials.com section, “Note: For initial study submissions, ancillary review is to be completed prior to final IRB approval, not the CT.GOV# registration”
  • Add to OnCore, “Studies determined by IRB review to be Exempt do not require registration Oncore”
  • Revised on November 8, 2022, to clarify HIPCO's ancillary review scope to include all privacy laws (foreign and domestic), applicability for studies where a waiver or alteration of HIPAA Authorization is denied, and HIPAA training compliance

HRP-313 - WORKSHEET - Expedited Review

  • Removed footnotes (per Huron) regarding blood withdrawals from indwelling venous line being more than one collection
  • Added footnote (per Huron) regarding no greater than minimal risk (determination by committee) with nonsignificant risk devices, being eligible for review under Category 9

HRP-830 - WORKSHEET - Local Context Review for Relying on an External IRB 

  • Revised Funding information requirement to include the STUDY and SITE workspace information in preparation for the ETHOS upgrade in 2023

Checklists

HRP-401 - CHECKLIST - Pre-Review

  • Added AAHRPP reference footnote

HRP-410 Checklist - Waiver or Alteration of Consent Process

  • Added that the research does NOT involve UMN researchers obtaining genetic information about identifiable individuals
  • Corrected footnote

HRP-416 - CHECKLIST - Children

  • Added to Section 7, “Parental permission is waived under criteria in Section 11”
  • Added AAHRPP elements footnote
  • Updated CFR reference in Section 9 heading
  • Updated footnotes

HRP-418 - CHECKLIST - Non-Significant Risk Device 

  • Add that the determination is based on the use of the device and the investigation (study), not the use of the device alone and documentation from the FDA has to be related to the specific study in question
  • Add AAHRPP elements footnote

HRP-419 - CHECKLIST - Waiver of Consent Process for Emergency Research

  • Added under FDA regulation under separate investigational new drug application (IND) or investigational device exemption (IDE) that identifies protocol as including subjects who are unable to consent, that “(even if an IND for the same drug product or an IDE for the same device already exists)”
  • Added to the statement that if the IRB determines that it cannot approve a protocol they will document and provide these findings promptly in writing to the investigator and the sponsor; that this will be done within 30 days
  • Add AAHRPP elements footnote

HRP-841_checklist_-_criteria_for_relying_on_an_external_irb

  • Removed “and Institutional Checklist” from “SMART IRB Letter of Acknowledgement”

Templates - Protocols

HRP-503 - Human Research Determination Form (HRP-503 Track Changes Version)

  • Clarifies the form is only for research that has not been initiated 
  • Deleted History Revision table

HRP-508 - Local Protocol Addendum - no instructions

  • Added Department affiliation

HRP-508 - Local Protocol Addendum - With instructions

HRP-580 - Social Template Protocol - No instructions/With instructions (HRP-580 Track Changes Version)

  • Added Department affiliation

HRP-590 - Medical Template Protocol - No instructions

  • Added Department affiliation
  • Removed Individually Identifiable Health Information

HRP-590 - Medical Template Protocol - With instructions (HRP-590 Track Changes Version)

  • Added Department affiliation
  • Added information to the Data and Specimen Banking section regarding storing and sharing data.
  • Added content for data security and data sharing for future use. 
  • Added instructions for when a child becomes an adult during a study.
  • Corrected typo.

HRP-595 - Data / Specimen Only Protocol (HRP-595 Track Changes Version) 

  • Added Department affiliation

HRP-597 - Database Registry and Biospecimen Repository Protocol (HRP-597 Track Changes Version) 

  • Added Department affiliation
  • Added instructions for when a child becomes an adult during a study.
  • Added section, “Provisions to Protect the Privacy Interests of Participants.”

Templates - Consent

HRP-582-template-social-behavioral-consent-form and HRP-592 template biomedical consent (HRP-582 Track Changes Version & HRP-592 Track Changes Version) 

  • Added information regarding data sharing and repositories to Secondary (future) research without identifiers
  • Clarifications to the section “Will anyone besides the study team be at my consent meeting?”  
  • Minor clarifications to the “Whom do I contact if I have questions, concerns or feedback about my experience?” section.

HRP-583-TEMPLATE-Assent-Form (HRP-583 Track Changes Version)

  • Added instructions for when a child becomes an adult during a study.
  • Added that information collected for the study may be published or shared but the participant's identity will remain confidential. 
  • Minor clarifications to the “Whom do I contact if I have questions, concerns or feedback about my experience?” section.
  • Added information that if a child becomes an adult during a study, they will be consented as an adult. 

HRP-585 - TEMPLATE PARENTAL PERMISSION DOCUMENT (HRP-585 Track Changes Version)

  • Minor clarifications to the “Whom do I contact if I have questions, concerns or feedback about my experience?” section.
  • Added that information collected for the study may be published or shared but the participant identify will remain confidential 
  • Clarifications to the section “Will anyone besides the study team be at my consent meeting?”  

Templates - Other

HRP-501 - TEMPLATE MINUTES

  • Added to the EDUCATION/NOTES/OTHER BUSINESS section, that the meeting was conducted remotely via Zoom Meeting Teleconference
  • Changed his/hers to theirs
  • Added to Section J instructions, “Note if there is more than one protocol, consent or other document, refer to the specific document that needs to be changed (i.e. Sponsor protocol, LPA…)”

Forms

HRP-216 - Form - External Team Member Form

  • Streamlined the form to improve user experience
  • Clarified external study team personnel eligibility criteria and requirements
  • Clarified documents required for external study personnel additions
  • Added ‘Decision Tree’ to assist study teams in determining eligibility

HRP-823 - Form - Advarra IRB Cover Page

  • Moved the Fee section for billing purposes from the Department of Psychiatry section to the general information section of the form

Announcements for the UMN Research Community