The latest round of revisions went live at the beginning of this month. Updates to the Investigator Manual, Reliance Manual, and various templates were made. Below are some highlights of the updates:
- Protocol templates for Biomedical Studies (HRP-503) and Registries and Repositories (HRP-503a), as well as the consent template (HRP-502), have been updated to address information required as part of the IRB review of data shared under the NIH Data Management and Sharing policy, which went into effect January 25th.
- A new section addressing data and safety monitoring plans has been added to the Investigator Manual.
- A new section related to tribal research was added to the Investigator Manual. This section has helpful information and links to resources when conducting tribal research.
Additionally, updates were made to Toolkit checklists and worksheets that IRB Staff have been using to conduct reviews. As a reminder, we welcome feedback via the Toolkit Feedback Form that is linked throughout the IRB website or by email (email@example.com).