Committee for the Protection of Human Subjects IRB Consulting Services

Background
The California Health and Human Services Agency (CalHHS), through its Committee for the Protection of Human Subjects (CPHS), is seeking proposals for Institutional Review Board (IRB) consulting services. The goal of this contract is to enhance the policies and procedures associated with the CPHS IRB to ensure compliance with federal regulations set forth by the U.S. Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP).
This initiative aligns with CalHHS's mission to protect human subjects involved in research.

Work Details
The contractor will provide consulting services that include:
1. Reviewing and evaluating current CPHS IRB policies and procedures.
2. Developing a Report of Findings that identifies applicable federal and state regulations, gaps in compliance, and recommendations for enhancements.
3. Creating an IRB Roster tool/template to ensure compliance with membership composition requirements.
4. Providing knowledge transfer of past work products to CPHS leadership, including a Knowledge Transfer and Lessons Learned Report.
5. Preparing a Workplan with milestones, timelines, and deliverables for all tasks outlined in the Statement of Work.

Period of Performance
The contract will have a term of 12 months, commencing on June 27, 2025, and concluding on June 26, 2026.

Place of Performance
Services will primarily be performed at the California Health and Human Services Agency office located at 1215 O Street, Sacramento, CA 95814, with potential remote work as approved by the State Engagement Manager.

Bidder Requirements
Bidders are encouraged to be certified Small Businesses (SB) or Microbusinesses (MB) and must commit to subcontracting at least 25% of their net bid price to certified SB or MB firms. Additionally, bidders must comply with various certifications including DVBE participation requirements, insurance coverage stipulations, and adherence to state contracting laws.