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.

Monthly Toolkit Meetings

Requests from the research community, IRB members, and staff are discussed at monthly Toolkit meetings. 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 Monthly Toolkit Meeting Summaries.

See below for a list of the most recent changes made to documents in the Toolkit. Access Archive of Toolkit Releases.

Toolkit Changes During Re-Accreditation

HRPP leadership will continue to monitor feedback submitted in the Toolkit Feedback Form, however minimal changes will be made during the re-accreditation process between August 2019 and December 2020.

August 2019 Toolkit Changes

The following changes were made in preparation for the renewal of the Human Research Protection Program’s accreditation and in response to feedback from the research and IRB community. Watch the recording: Town Hall: Toolkit Changes.

Manuals

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

Fixed formatting of bullets, headings, grammar, and ‘Return to Table of Contents.’
Added guidance about the development of a repository, database, or registry.
Added guidance about existing repositories and regulatory compliance.
Added guidance about what data / specimen activities require IRB review, including secondary use, collection, and sharing of.
Added IRB and HIPAA applicability matrix for data / specimen related research in Appendix B-2.
Clarified the scope of a quality improvement registry / database.
Added decision tree for prompt reporting in Appendix B-3.
Clarified the timing for review of fetal tissue research, and clarified research record retention, added reference to UMN policy about record retention.
Added guidance about tele-consent, e-consent, mail consent, electronic signatures, electronic storage of study documents.
Added guidance about research where the University of Minnesota is serving only as the coordinating center for a study.
Added references to new Registry/Database/Repository protocol (HRP-597) and HUD protocol (HRP-596).
Clarified Just-in-Time submission process.
Added guidance about the use of volunteers or “Temp/Casual” staff as study personnel.
Updated references to standard consent language templates, removing Quorum IRB review references.
Revised guidance regarding Non-Significant Risk and Significant Risk Determinations.
Replaced HRPP Scientific Assessment instructions for the Portal with ETHOS instructions.
Added guidance about long term follow-up for human gene therapy studies.
Clarified fetal tissue research review process.
Added ancillary review obligations for when relying on an external IRB.
Clarified individual patient expanded access IND guidelines from NIH to include emergency access.
Revised the instructions on how to close a study with the IRB.

IRB Member Manual (HRP-100)

Clarified process for designated reviewer appointment process.
Added Designated Reviewer training course requirement for newly appointed designated reviewers.
Added information about the independence of the IRB.
Added Deputy Institutional Official authority regarding prorating compensation.
Revised Vulnerable Populations Advisor description.

HRPP Manual (HRP-101)

Added HRPP scope for multi-site or collaborative research.
Revised the IO, Deputy IO role (collapse and revise biomedical and social-behavioral roles into one role) and responsibilities to align with revised organizational structure of VP and Associate VP.
Revised Executive HRPP Director role to remove the authority to determine what IRBs the University will rely upon and transfer the responsibility to the IO role.
Replaced EthicsPoint to Ethical Advocate, updated hyperlinks for UReport.

Policies

Minnesota Laws Affecting Human Research (HRP-112)

Added definition for experimental treatment, corrected statutory references, clarified approval requirements for fetal tissue research.

Standard Operating Procedures

Definitions (HRP-001)

Added definitions for honest broker, custodian, practicably, prospective study, and retrospective study.

New Information (HRP-024)

Added information about reporting responsibilities when DHHS support has ended, added process for review of RNI for QA Audit of ceded research, updated author from J. Thomas to F. Mroczkowski.

Designated Reviewers (HRP-030)

Clarified timing of appointment as a designated reviewer in 3.2, added communication process, added HRP-564 appointment letter reference.

Non-Committee Review Preparation (HRP-031)

Added conflict of interest statement.

Non-Committee Review (HRP-032)

Revised the turnaround time from 10 business days to 7 calendar days to align with current practice (Section 5.6), added conflict of interest statement.

IRB Review of Financial Conflicts of Interest (HRP-054)

Clarified 5.2 to clarify the process to reference a new or change in conflict of interest, updated author due to retirement of B. Shiels.

Annual HRPP Evaluations (HRP-060)

Clarified REPA evaluation process, added annual evaluation of HRPP educational program, clarified that a summary evaluation of IRB member/chair performance is shared and process of sending the IRB member appreciation letter (Section 5.6).

Daily or Frequent Tasks (HRP-062)

Clarified the frequency regarding failure to submit emergency use reports to the IRB (Removed Section 5.3, Added Section 5.10).

IRB Performance (HRP-065)

Expanded SOP to include additional types of IRB Performance reviews, including addition of 5.5. Added materials list.

Education and Training (HRP-066)

Added IRB analyst responsibilities for training IRB members, revised specialist title to assistant director, added database references.

Transfer of IRB Authority to UMN (HRP-073)

New toolkit document that describes the preview and confirmation process for transferring a study to the UMN for oversight.

Forms

External, Volunteer & Temporary/Casual Team Member (HRP-216)

Revised to include additional options and instructions for including volunteer, temporary/casual and external team members in research.

Request to Transfer Form (HRP-229)

New toolkit document that is completed by investigators requesting transfer of a study to the UMN IRB for oversight.

Quorum Institution Cover Page (HRP-811)

Retired due to Quorum IRB Review’s merger with Advarra.

ADVARRA Institution Cover Page (HRP-812)

Revised to align with changes made to UMN toolkit documents.

Worksheets

Communications (HRP-303)

New Toolkit document that lists IRB communications regarding IRB review, such as decision letters.

Ancillary Review Matrix (HRP-309)

General information about ancillary reviews has been expanded and reformatted to Questions and Answers. Added impact of ancillary review completion on IRB review. Other minor content updates.

Criteria for Approval (HRP-314)

Added guidance about continuing review frequency, continuing review submission considerations, electronic consent.

Vulnerable Populations (HRP-333)

Added considerations for the use of an independent clinical monitor or independent assessment of capacity to consent to research.

Data and Safety Monitoring (HRP-335)

Added reference to stopping rules.

Creation of a Research Database, Registry, or Repository (HRP-337)

New Toolkit document to assist IRB in the review of a request to create a research database, repository, or registry.

Checklists

Pre-Review (HRP-401)

Fixed formatting.

Scientific Review (HRP-420)

Revised to separate comments/suggestions from stipulations.

Templates

Combined HIPAA Authorization and Consent (HRP-588)

New Toolkit template for investigators that propose to use a combined HIPAA authorization and consent document rather than a standalone HIPAA authorization. This new template was developed in collaboration with the Office of the General Counsel and HIPCO.
Includes revisions made to the main consent templates.

Consent Templates (HRP-582 / HRP-592)

Added content regarding genetic testing, future use of samples and data, European General Data Protection Regulation (GDPR), and additional changes that were primarily administrative in nature.
Revised to align with combined HIPAA / Consent, where applicable.

Consent Collection After Withdrawal (HRP-589)

New Toolkit document for a clinical protocol that includes plans to allow for further data collection after a participant’s withdrawal from the interventional portion of the study, the IRB will require use of an approved consent form and HIPAA authorization to obtain permission from the participant for collection of additional information.

Consent (Emergency Use) (HRP-506)

Updated Participant Advocate Line and website references.

Short Form Templates (HRP-507)

These updates were made in July 2019:

Added two documents that list certifications of translations for specific languages.
Updated witness signature blocks.
Updated Participant Advocate Line and website references.

IRB Standard Consent Language (HRP-542a-b-c)

Retired HRP-542a “Standard Consent Language (Quorum IRB Review)” due to merger with Advarra.
Updated HRP-542b (Standard Consent Language (Advarra) to align with revisions to the UMN Toolkit and Advarra instructions.
Updated HRP-542c (Standard Consent Language) to include instructions for studies that transfer to UMN for oversight.

Parental Permission Template (HRP-585)

Re-release of the template with updated contact information for complaints, questions, and concerns.

Information Sheet for Exempt Research (HRP-587)

Updated Participant Advocate Line and website references.

School Permission Template (HRP-504)

New Toolkit Document for researchers seeking permission from schools for research.

Local Protocol Addendum (HRP-508), Social - Behavioral Protocol Template (HRP-580) & Biomedical Protocol Template (HRP-590)

Added Ancillary Review Abbreviated Matrix after instructions.
Added content from the Health Information Privacy and Compliance Survey.
Added section regarding sharing of genetic test results.
Added section regarding Coordinating Centers.
Added General Data Protection Regulation (GDPR) to International Research section.
Added reference to stopping rules in the Data and Safety Monitoring section.

Data and Specimen Only Protocol (HRP-595)

Added abbreviated protocol completion option for investigators utilizing the Information Exchange (IE).
Added Ancillary Review Abbreviated Matrix after instructions.
Added content from the Health Information Privacy and Compliance Survey.

Research Database, Registry, or Repository Protocol Template (HRP-597)