Controlled substances: research.

Plain English Breakdown

The official source material did not provide specific details about the exact criteria for federal approvals and independent peer reviews that qualify projects for expedited review.

Research on Controlled Substances

AB-1103 modifies how California reviews and approves research projects involving Schedule I or II controlled substances, allowing expedited review for certain projects until January 1, 2028.

What This Bill Does

• Requires the Research Advisory Panel to review research projects that need Schedule I or II controlled substances in California.
• Allows the panel to speed up reviews for projects with federal approvals and independent peer review until January 1, 2028.
• Lets the chair of the panel appoint other members to approve projects without a full vote by January 1, 2028.
• Gives the panel permission to cancel approval if there are reasonable reasons and gives researchers time to fix issues before cancelling.
• Extends until January 1, 2028, the ability of the Research Advisory Panel to hold private meetings for projects with sensitive information.

Who It Names or Affects

• Researchers who want to study Schedule I or II controlled substances in California.
• The Research Advisory Panel that reviews these research projects.

Terms To Know

Schedule I and II Controlled Substances

Drugs with the highest level of government control because they are considered to have a high potential for abuse and no accepted medical use in the United States.

Research Advisory Panel

A group that reviews research projects involving controlled substances in California.

Limits and Unknowns

• The bill only speeds up review processes until January 1, 2028.
• It does not specify what happens after January 1, 2028, regarding the expedited review process or private meetings for sensitive information.

Official Summary Text

AB 1103, Ward.
Controlled substances: research.
Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitations generally placed on controlled substances classified in Schedule V. Existing law creates a Research Advisory Panel, as specified, to conduct hearings on, and in other ways study, research projects concerning controlled substances. Existing law authorizes the panel to approve research projects that have been registered with the Attorney General concerning the nature and effects of cannabis or hallucinogenic drugs and the treatment of abuse of controlled substances. Existing law authorizes a person who, under federal law, is entitled to use controlled substances for the purpose of research, instruction, or analysis, to
lawfully obtain and use those controlled substances upon approval by the panel, as specified.
This bill would revise and recast these provisions to require the panel to review research projects to be conducted in this state that require the administration of Schedule I or Schedule II controlled substances. The bill would authorize the panel, until January 1, 2028, to expedite the review of projects that satisfy certain criteria, including, among others things, that have
sought or received certain federal approvals and have proof of independent peer review of the study, as described. The bill would authorize the chairperson of the panel to deputize 2 or more panel members to review the research project and to approve it, without a vote by the entire panel. The bill would authorize the panel to withdraw its approval for reasonable cause and would require the panel to provide notice and time for the concern to be cured by the project before withdrawing its approval.
Existing law, the Bagley-Keene Open Meeting Act, requires, with specified exceptions, that all meetings of a state body be open and public and all persons be permitted to attend. Existing law, until
January 1, 2027, authorizes the Research Advisory Panel to hold closed sessions for the purpose of discussing, reviewing, and approving research projects that contain sensitive and confidential information, including trade secrets, intellectual property, or proprietary information in its possession, the public disclosure of which is prohibited by law.
This bill would extend the authorization to hold closed sessions to January 1, 2028, and would additionally exempt the above-described panel members assigned to review and approve a research project from the Bagley-Keene Open Meeting Act until January 1, 2028.
Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.
This bill would make legislative findings to that effect.

Current Bill Text

Download Bill PDF