HRPP Newsletter February 22, 2021
This issue of the newsletter provides an overview of upcoming improvements to IRB operations developed as part of the IRB Efficiency Project (IEP). Several key improvements are expected to go live in March. We will be providing you with additional information and training in the coming months as these changes are implemented. If you have questions about these coming improvements, please email email@example.com.
New Protocol-Based Application
Coming in March, ARROW will be updated to include a new protocol-based application option. This application is significantly shorter than the current full initial review application and eliminates the duplication so researchers will no longer need to provide the same information in the application that is found in their stand-alone protocols. You should use this new application if your study has a stand-alone protocol, which includes clinical trials and most more than minimal risk studies. Additionally:
- A mockup of the protocol-based application can be found here.
- A screen shot of the new IRB application wizard that includes the protocol-based application option can be found here.
- Protocol Template options:
- You can use ICTR’s Therapeutic Clinical Trial: Drug/Device intervention template or templates from NIH or NCI.
- New protocol templates will be posted in March for studies that do not evaluate drugs or devices (see below).
- You can also continue to use your own protocol templates if they address the same relevant elements in the IRB’s protocol template.
Questions? Email Carol Pech (firstname.lastname@example.org).
Upcoming Protocol-Based Application and Templates Information Sessions
The UW-Madison IRBs are hosting two, identical information sessions to cover the following topics:
- An introduction to the IEP
- Overview of using PBAs
- New templates and tools for completing applications
Register for these sessions via the OHRD catalog:
A recording will also be made available on the IEP webpage.
Overview of Toolkit Document Types
The Toolkit is a comprehensive set of documents for use by IRB staff, board members, and study teams. The Toolkit is comprised of worksheets, SOPs, and checklists that detail criteria for IRB approval, plus the following new templates to help study teams create protocols and consent documents that meet those criteria:
- Registry and Repository Protocol Template for storage of data and/or specimens for future research use.
- Biomedical Protocol Template, primarily for biomedical research that does not evaluate drugs or devices.
- Site Supplement Protocol Template, to provide additional information when the main protocol lacks necessary information or comes from an external collaborator, coordinating center, or sponsor.
- Updated Biomedical Consent Template with and without HIPAA authorization language.
Other parts of the Toolkit include:
- Worksheets are reference documents outlining regulatory and institutional criteria for specific items (e.g., FERPA, criteria for approval, assessing recruitment materials).
- Checklists are used by Human Research Protection Program (HRPP) staff and the IRB to document regulatory determinations; checklists do NOT need to be completed by study teams.
- SOPs describe HRPP processes and help to ensure that study teams include enough detail in the protocol to address the regulatory criteria.
Investigator Manual Preview
To supplement the Toolkit documents described above, the Investigator Manual is designed to guide you through policies and procedures related to the conduct of Human Research that are specific to this institution. The manual is comprehensive and covers everything from who can serve as PI and the IRB review process, to investigator responsibilities post-approval. This manual will eventually be the sole guidance document, replacing most guidance currently found on the IRB websites.
More Changes on the Way
In the coming months, additional planned changes include:
- A new application designed for studies likely to be minimal risk and without a standalone protocol, including exempt projects. The ED/SBS IRB and HS IRBs will jointly develop this application.
- A new ancillary committee review matrix designed to help researchers identify which non-IRB approvals required for their study as well as when those should occur and who to contact.
- Restructuring of the IRBs themselves, including combining the Educational and Social/Behavioral IRB and Minimal Risk IRB into a single Minimal Risk Research board and adding “panels” for each board in order to increase meeting frequency and to ensure appropriate expertise for all types of research. The combined ED/SBS and MR board will have two panels, each meeting monthly, while the HS committee will have six panels, also meeting monthly.