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.
  

December 2023 Changes

The following changes were made to address feedback received by the research community, IRB members, and IRB staff. 

Manuals

HRPP Manual (HRP-101)

  • Revised title of the Vice President for Research to Vice President for Research and Innovation.
  • Revised title of Associate Vice President for Research to Associate Vice President for Research and Innovation.
  • Added requirement for studies relying on an external IRB that are requesting a waiver or alteration of HIPAA authorization.

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

  • Replaced “Office of the Vice President for Research” with “Research and Innovation Office” throughout the manual
  • Replaced “Vice President for Research” with “Vice President for Research and Innovation”
  • Clarified Fairview PI approval requirement for “Who may be the principal investigator for Human Research?”
  • Clarified HIPAA Training requirement and enforcement and social-behavioral personnel training for “What training is required to conduct Human Research?”
  • Updated HIPCO resource links throughout the manual
  • Added HIPCO resource links for research involving non-English speaking participants
  • Added HIPCO resource links for research subject to GDPR
  • Added resource link for University guidelines for indigenous research
  • Clarified scientific assessment requirement for pending grant studies for “Does my research require scientific assessment?”
  • Added webpage resource for “What if I am the sponsor or sponsor-investigator of an IND or IDE or Abbreviated IDE?”
  • Added HIPAA applicability for “What if I need expanded access to investigational drugs, biologics, and devices?”
  • Added guidance, “How do I develop a data and safety monitoring plan?”
  • Clarified instructions for studies that have an approval lapse for “How do I Submit Continuing Review?”
  • Added FDA guidance for “When informed consent is obtained using the ‘short form’ written consent document, can the interpreter interpret by phone or videoconference?”
  • Added guidance related to translations for reliance studies to “What changes must I submit to the University of Minnesota IRB for a study that is approved for reliance on an External IRB?”
  • Added guidance, “If the local site consent form was changed and approved by the external IRB, can we proceed with consenting participants?”
  • Added guidance, “What documents need to be uploaded or updated at the time of continuing review for a study that relies on an external IRB?”
  • Revised Appendix B-6, clarifying examples of modifications and external updates for reliance submissions
  • Added guidance, “What if my study includes questions regarding suicidal ideation?”
  • Added Appendix B-7, “Considerations for studies that include questionnaires or interview questions about mental health, psychological functioning, or mood, or includes participants that are at elevated risk of suicide”

Standard Operating Procedures

HRP-066 – SOP – Education and Training

  • Updated HIPAA training reference
  • Replaced Assistant Director references with IRB leadership
  • Clarified social behavioral research training requirement

Worksheets

Ancillary Review Matrix (HRP-309)

  • Added ancillary reviews for indigenous peoples research, REDCap eConsent
  • Updated contact information for Gillette and BLS
  • Updated ancillary review applicability for Fairview Research Administration to include RNI’s for studies that include/involve Fairview resources, staff, or locations

Data and Safety Monitoring (HRP-335)

  • Added section for studies that include questionnaires or interview questions about mental health, psychological functioning, or mood, or includes participants that are at elevated risk of suicide

Indigenous Research (HRP-338)

  • New worksheet that includes considerations based on University of Minnesota guidelines for research involving indigenous peoples or communities

Local Context Review (HRP-831)

  • Added statement regarding external IRBs and Privacy Board responsibilities
  • Added prompt for HIPAA Authorization Form (standalone or combined)

Checklists

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

  • Added statement regarding external IRBs and Privacy Board responsibilities
  • Updated Toolkit references

Forms

Local Compliance Assessment (HRP-833)

  • Added “No change impacts ancillary review oversight” as an option on the form
  • Clarified the instructions and language used in the table of ancillary reviews 
  • Added ancillary reviews (indigenous research, CUHCC, REDCap)

Protocol Templates

All protocol templates (HRP-5808, HRP-580, HRP-590, HRP-595, HRP-597) were revised to include the following (Track Change Copies). New studies submitted on or after March 1, 2024 must use the updated version of the template:

  • Added ancillary reviews (indigenous research, CUHCC, REDCap)
  • Updated contact information in the ancillary review table
  • Formatting corrections to the outline headings
  • Corrected Toolkit document references
  • Separation of “Pregnant Women, Fetuses, and Neonates” into separate rows in the Vulnerable Populations section
  • Updated language for “Adults lacking capacity to consent” to remove specific examples of conditions and to include fluctuating capacity to consent in the Vulnerable Populations section
  • Added prompt for additional information for research involving Tribal collaborators, communities, Tribal natural resources, and other Tribally-controlled or Tribal-serving institutions, Indigenous Peoples, paces, and objects of cultural significance to the Vulnerable Populations section (included in the instructional versions of templates)
  • Revised the Health Information and Privacy Compliance section to include updated guidance, instructions and hyperlinks
  • Added Health Care Component section to the Health Information and Privacy Compliance protocol section
  • Added Preparatory to Research section to the Health Information and Privacy Compliance protocol section
  • Revised the Health Science Technology (HST) HIPAA Compliant Devices and Data Storage section to include updated guidance, instructions and hyperlinks
  • Added Safety Plan sub-section to the Provisions to Monitor the Data to Ensure the Safety of Participants section
  • Added prompt for a safety plan for studies that include questionnaires or interview questions about mental health, psychological functioning, or mood, or includes participants that are at elevated risk of suicide (Safety Plan sub-section)
  • Clarified guidance regarding the DSMB Charter (Data Safety Monitoring sub-section)
  • Clarified the instructions for the Research Sites sub-section of the Setting section
  • Revised the International Research sub-section of the Setting section to include prompts, updated guidance, resources, and hyperlinks

Consent Templates

All consent and assent templates were revised to include the following (Track Change Copy):

  • Updated language / word choice resources
  • Added ‘Study Consent Version’ prompt in the footer
  • Additional language for studies that include questionnaires or interview questions about mental health, psychological functioning, or mood, or includes participants that are at elevated risk of suicide

Other Templates

Referral Information Sheet for Research Participants (HRP-988) 

  • New information sheet for studies for studies that include questionnaires or interview questions about mental health, psychological functioning, or mood, or includes participants that are at elevated risk of suicide