Guidelines
Any planned research project to be conducted in California requiring the use of a Schedule I or Schedule II Controlled Substance as its main study drug must be submitted to the Research Advisory Panel of California for review and approval prior to start-up:
- Any research, human or non-human, involving any Schedule I Controlled Substance
- Academic human research involving any Schedule I or Schedule II Controlled Substance
- Clinical drug trial protocols evaluating or comparing any Schedule II Controlled Substances
- Research for the treatment of drug addiction or abuse utilizing any drug, scheduled or not
Schedule I Controlled Substances are drugs or substances with a high potential for abuse, that have no currently accepted medical use in treatment in the United States. Examples of Schedule I Controlled Substances are: heroin, lysergic acid diethylamide (LSD), methylenedioxy-methamphetamine (MDMA), marijuana, and psilocybin. Schedule II Controlled Substances are drugs or substances with a high potential for abuse, that have a currently accepted medical use in treatment in the United States, or a currently accepted medical use with severe restrictions. Examples of Schedule II Controlled Substances are: fentanyl, methadone, methylphenidate, morphine, and oxycodone.
Applicants may check with the Panel Office or the DEA Controlled Substance listings link to determine if the planned study drugs are classified as Schedule I or Schedule II Substances.
All Panel applications have a standardized submission format which requires a completed Panel Application Form (see Applications for Research), study Protocol, study Informed Consent, and study drug information. One set of application packet without staples should be mailed via U.S. or commercial mail to Y. Jennifer Ahn, Pharm.D., the Panel’s Executive Officer. (see Contact Us section for the mailing address)
The Panel meets every other month, 6 times yearly (see Meeting and Submission Deadlines). The outcome/response of the Panel review will be going out in the letter form and it may take 5-7 days after the completion of the Panel meeting. The researches cannot be started - research subjects cannot be enrolled/screened - before the Panel's approval.
Non-Human researches using Schedule II Substances or any researches using Schedule III, IV, or V Controlled Substances as a study drug need not to be reviewed by the Research Advisory Panel.