Committee for the Protection of Human Subjects IRB Consulting Services

The California Health and Human Services Agency (CalHHS), specifically the Committee for the Protection of Human Subjects (CPHS), is seeking Institutional Review Board (IRB) consulting services through Request for Proposal (RFP) #2025-579-CDII. The procurement covers consulting services to review, evaluate, and enhance CPHS IRB policies and procedures to ensure alignment with FDA and HHS Office of Human Research Protections regulatory requirements. Key deliverables include reviewing IRB policies, developing an IRB roster tool, and conducting knowledge transfer to up to four CPHS team members, with work primarily performed remotely and occasional in-person meetings in Sacramento. Proposals must be submitted by May 28, 2025, with estimated interviews scheduled between June 2-6, 2025, and a contract start date of June 27, 2025. The evaluation process will utilize a secondary method, scoring proposals across four stages: administrative evaluation (pass/fail), bidder experience and approach (600 points), optional interviews (100 points), and cost evaluation (300 points), with a total possible score of 1,000 points. Bidders are required to submit a 6-page narrative response including work samples relevant to the statement of work, with proposals assessed on their comprehensive approach to IRB consulting services.

The RFP includes several incentive programs targeting small and disadvantaged businesses, with CalHHS committed to a 25% Small Business participation goal. Bidders can earn a 5% preference for being a Certified Small Business (SB), Microbusiness (MB), or committing to subcontracting at least 25% of the net bid price to certified SB or MB vendors. An additional 3% incentive is available for Disabled Veteran Business Enterprise (DVBE) participation. There is no incumbent contractor currently performing similar services for CPHS. The contract has a maximum value of $300,000 with a 12-month term from June 27, 2025, to June 26, 2026. The procurement seeks a consultant with expertise in reviewing research study oversight processes, preferring direct employee training or train-the-trainer approaches for knowledge transfer. The IRB roster tool is expected to be a static Microsoft Word or Excel file, and the contract anticipates flexibility in meeting frequency based on ongoing needs. The solicitation covers jurisdictions including Sacramento County and San Francisco City, with work to be primarily conducted remotely.