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HRPP Toolkit Overview and Library

The HRPP (IRB) Toolkit is a comprehensive set of workflows, standard operating procedures (SOPs), checklists, worksheets and templates. All Toolkit documents will be uploaded on this web page to foster transparency throughout the review process.

HRPP (IRB) Toolkit guiding principles

  • Protect subjects
  • Be compliant
  • Be efficient
  • Provide excellent customer service
  • Simplify workflow
  • Use the regulatory criteria for approval

HRPP (IRB) Toolkit objectives

  • Increase efficiency and decrease administrative burden
  • Ensure compliance
  • Enable the D-HH HRRP (IRB) to become AAHRPP accredited
  • Avoid HRRP (IRB) scope creep
  • Reduce research team administrative work
  • Align business processes with the D-HH HRRP (IRB) electronic submission system

Toolkit components

HRPP (IRB) plan

  • Overview of HRPP (IRB) components, scope, etc.

Investigator manual

  • Researcher facing
  • Provides instruction on HRRP (IRB) submission process
  • Outlines rules and responsibilities associated with the conduct of human subjects research

Standard operating procedures (SOPs)

  • Include policy statements
  • Organized by business process (e.g., pre-review, review, post-review) rather than by topic (e.g., continuing review, drugs, and protocol deviations)
  • Cross-reference worksheets and checklists to be used; does not duplicate information
  • Most are for HRRP (IRB) staff and committee members, but some are for researchers (e.g., definitions, informed consent process and documentation)

Worksheets

  • Used to assist with regulatory decision making
  • Includes topics such as payments, advertisements, vulnerable populations, etc.
  • Used by HRRP (IRB) staff and committee reviewers; accessible to researchers for reference

Checklists

  • Regulatory decision making that must be documented
  • Need to be completed and kept in the regulatory file
  • Includes checklists for topics such as research with children (Subpart D), prisoners (Subpart C), cognitively impaired adults, etc.
  • Used by HRRP (IRB) staff and committee reviewers; accessible to researchers for reference

Template protocols and informed consent forms

  • Provides guidance for researchers to provide information that the IRB needs to evaluate the regulatory criteria for approval

Toolkit library

All materials listed on the following Toolkit library pages will be made available to the Dartmouth-Hitchcock Health (D-HH) research community in advance of HRRP (IRB) system go-live.

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