The HRPP Toolkit Library is a set of documents primarily for use and reference by the Human Research Protection Program (HRPP), IRB staff, and IRB members. The research community is encouraged to review the documents that may pertain to their studies, including the standard operating procedures for consent processes and documentation (HRP-090, HRP-091).
These manuals detail expectations and requirements of the Human Research Protection Program, IRB members and staff, and investigators.
These policies apply to all involved in the review or conduct of research involving human participants, including principal investigators submitting protocols to the IRB.
Standard Operating Procedures
These standard operating procedures (SOPs) describe policies and procedures related to IRB review, management, or function.
IRB staff, members, and investigators use these forms as a reference or tool for IRB submissions.
IRB staff and members use these worksheets as a reference when reviewing IRB submissions to enhance compliance with federal, state, and local requirements.
IRB members and staff use these checklists to consider and document regulatory items and enhance compliance with federal, state and local requirements.
Investigators preparing IRB submissions use these templates for protocols and consent documents. Additional IRB templates are provided to promote transparency of IRB operations.
Share feedback or suggestions regarding how to improve these Toolkit documents, including the protocol and consent templates, by completing the HRPP Toolkit Feedback Form. Feedback is reviewed monthly by HRPP leadership to determine whether changes are needed. Future updates will be mentioned in the IRB monthly newsletter, with greater detail on the Toolkit Changes webpage.