California law, pursuant to Health & Safety Code Sections §11480 & §11481, requires proposed research studies using certain opioid, stimulant, and hallucinogenic drugs classified as Schedule I and Schedule II Controlled Substances as their main study drug(s), to be reviewed and authorized by the Research Advisory Panel of California in the Attorney General's Office. https://oag.ca.gov/research(link is external)
RAPC has identified 4 groups that it reviews. RAPC Guidelines for affected groups- 2024 Guidelines
Group 1: Academic human research of Schedule I or Schedule II
Group 2: Human controlled substance use disorder treatment research utilizing ANY scheduled or non-scheduled medications by an academic institution or a multicenter or single-center clinical drug trial research study sponsored by NIDA or a pharmaceutical company, or supported by a contract research organization (CRO)
Group 3: Non-human research of Schedule I controlled substances with animal models or in-vitro studies.
Group 4: Any single-center or multicenter clinical drug trial research by a pharmaceutical company/contract research organization (CRO) evaluating or comparing any Schedule I and Schedule II controlled substances.
RAP-C Regulatory Approval Pathways per Group
Each group has specific application forms are requirements.
RAP-C Regulatory Approval Pathways per Group
For application submission deadlines see: https://oag.ca.gov/research/meeting
Full Annual Progress Report Requirement
The Panel requires an Annual Progress Report (APR) sent by the end of February every year in PDF format.
Contact: RAPC@doj.ca.gov
Report should include:
- the PR# (Panel Review number) plus the name of the study
- A brief summary of research performed and findings made during the year (this requirement may be augmented by including reprints of papers or copies of reports published)
- Research plans for the upcoming calendar year (requests to approve the procurement of additional controlled substances should be sent separately as an amendment request)
- A photocopy of the controlled substances inventory log maintained at the site for record keeping (if applicable)
The Attorney General’s Office is now working with the Governor’s Office on a legislative solution to the procedural issue that has impacted RAPC’s meetings.
- RAP-C sign-on letter: This letter was circulated among California researchers and sent to the Governor, Attorney General Bonta, and California State Legislators in the beginning of this year. The letter asks officials to dissolve RAP-C.
- California State Association of Psychiatrists (CSAP) is considering taking action, so if you have researchers a part of this association I’d suggest having them engage with CSAP directly.
- News article providing further information:
- This powerful group is hurting California addiction research, scientists say. They want to kill it, SF Chronicle
- A California panel is holding up studies on psychedelics. Some researchers want it gone, LA Times
- The Obscure Advisory Panel Blocking Dozens of Psychedelic Studies in California, Psychedelic Alpha
The Drug Enforcement Administration (DEA) may require RAPC approval for research work that fall under one of the four groups listed by RAPC.
This may impact CSUA additions to existing or new department DEA registrations.
