Institutional Review Board Consulting Services

The California Health and Human Services Agency (CalHHS), specifically the Committee for the Protection of Human Subjects (CPHS), has issued Request for Proposal (RFP) # 2025-556-CDII for Institutional Review Board (IRB) consulting services. The primary objective is to secure a consultant who will assist CPHS in reviewing, evaluating, and enhancing IRB policies and procedures to ensure alignment with FDA and HHS Office of Human Research Protections regulations. The contract will have an initial 12-month term with an option to extend for an additional 12 months. Key procurement dates include a written questions deadline of April 10, 2025, potential interviews scheduled between May 13-16, and an estimated contract start date of June 1, 2025. The evaluation process will be conducted using a secondary method, with proposals scored across four stages: administrative evaluation (pass/fail), bidder experience and approach (600 points), optional interview (100 points), and cost evaluation (300 points). Proposal evaluation criteria will focus on firm experience, staff qualifications, understanding of the scope of work, and total cost. Proposals are due by May 7, 2025, at 3 pm PST.

The RFP includes specific incentives and set-aside designations for small businesses and disabled veteran business enterprises (DVBE). There is a 5% preference for small businesses or those subcontracting at least 25% to certified small businesses, and a 3% incentive for DVBE participation. The state has established a 25% small business participation goal and encourages certified small businesses and microbusinesses to submit proposals. The maximum contract value is set at $150,000 per year, providing potential opportunities for qualified consulting firms specializing in IRB services. While no incumbent vendors are specified in the provided documentation, the RFP indicates a comprehensive approach to selecting a consulting partner who can provide strategic guidance and support in maintaining regulatory compliance for human subjects research protection.