2026 Guidelines

Note: Researchers obtain Institutional Review Board (IRB) and FDA Investigational New Drug (IND), or Institutional Animal Care Use Committee (IACUC) approval of the study before submitting an application for review by the Research Advisory Panel of California.

Note - Expedited Review: Studies that submit a completed application and meet all of the requirements for expedited review are eligible for review and approval of their study outside of a regularly scheduled Panel meeting. See Expedited Review.

Applications for research projects that do not satisfy the criteria for Expedited Review will be reviewed by the standard review process and may be approved by the full Panel at a regularly scheduled Panel meeting.

1. Group 1 - Academic Human Research:
   
   
   1. Cover letter (list all documents in the submission)
   2. RAPC Application Form: ACADEMIC HUMAN RESEARCH W/ SCHEDULE I OR II CONTROLLED SUBSTANCE, pdf
   3. IRB-approved and FDA IND-approved (where applicable) Research Protocol, not a grant application
   4. IRB-approved Informed Consent Form(s) (ICF)
   5. Filled-out Informed Consent Form Checklist(s)
   6. Experimental Subject’s Bill of Rights with an area for the participant’s signature. See - Experimental Subject's Bill of Rights
   7. Study Drug Monograph(s) and/or Investigators Brochure(s)
   8. Copy of the IRB approval letter for the submitted documents
   9. Where applicable, a copy of the FDA IND approval letter, study may proceed letter or the submission cover letter to FDA indicating that the 30-day comment period has passed without FDA comment
   10. Completed application checklist. See – Academic Human Research Application Checklist
   11. *Expedited review: See criteria required to qualify for expedited review and approval outside of a regularly scheduled Panel meeting
   12. All application submission packets should be sent via email ONLY - in PDF format (maximum capacity is 25 MB per email) - to RAPC@doj.ca.gov


2. Group 2 – Substance Use Disorder Treatment Research:
   
   Note: For multisite studies, the sponsor/pharmaceutical company/CRO is required to submit the study application to the Panel, not the individual principal investigators (PIs) or study sites participating in the study. The Research Advisory Panel of California grants approval to the sponsor, not the individual researchers or study sites participating in the study. Please include study information: See Clinical Drug Trials.
   
   
   1. Cover letter (list all documents in the submission)
   2. Independent or Academic Substance Use Disorder Research - RAPC Application Form: SUBSTANCE USE DISORDER TREATMENT W/SCHEDULE I OR II CONTROLLED SUBSTANCE, pdf
   3. Single or multi-center clinical drug trail research - See Clinical Drug Trials
   4. IRB-approved and FDA IND-approved (where applicable) Research Protocol, not a grant application
   5. IRB-approved Informed Consent Form(s) (ICF)
   6. Filled-out Informed Consent Form Checklist(s)
   7. Experimental Subject’s Bill of Rights with an area for the participant’s signature. See - Experimental Subject's Bill of Rights
   8. Study Drug Monograph(s) and/or Investigators Brochure(s)
   9. Copy of the IRB approval letter for the submitted documents
   10. Where applicable, a copy of the FDA IND approval letter, study may proceed letter, or the submission cover letter to FDA indicating that the 30-day comment period has passed without FDA comment
   11. Completed application checklist. See - Substance Use Disorder Treatment Research Application Checklist
   12. *Expedited Review: See criteria required to qualify for expedited review and approval outside of a regularly scheduled Panel meeting
   13. All application submission packets should be sent via email ONLY - in PDF format (maximum capacity is 25 MB per email) - to RAPC@doj.ca.gov


3. Group 3 - Non-Human Research:
   
   
   1. Cover letter (list all documents in the submission)
   2. RAPC Application Form: NON-HUMAN RESEARCH W/SCHEDULE I & II CONTROLLED SUBSTANCES, pdf
   3. Complete Research Protocol, not a grant application
   4. IACUC approved (where applicable) Research Protocol
   5. Calculations for the requested quantities of Schedule I controlled substances
   6. *Expedited review: See criteria required to qualify for expedited review and approval outside of a regularly scheduled Panel meeting
   7. Completed application checklist. See - Non-Human Research Application Checklist
   8. All application submission packets should be sent via email ONLY - in PDF format (maximum capacity is 25 MB per email) - to RAPC@doj.ca.gov


4. Group 4 – Multicenter Studies and Multicenter or Single-Center, Clinical Drug Trial Research Sponsored by a Pharmaceutical Company/CRO:
   
   

   Note: For Group 4 research studies, the study Sponsor, coordinating center, or pharmaceutical company/CRO is required to submit the study application to the Panel, not the individual principal investigators (PIs) or study sites participating in the study. The Research Advisory Panel of California grants approval to the sponsor, not the individual researchers or study sites participating in the study.

   
   
   1. Cover letter from the coordinating center (list all documents in the submission)
   2. Study information: See Clinical Drug Trials
   3. IRB-approved and FDA IND-approved (where applicable) Research Protocol, not a grant application
   4. IRB-approved Informed Consent Form(s) (ICF)
   5. Filled-out Informed Consent Form Checklist(s)
   6. Experimental Subject’s Bill of Rights with an area for the participant's signature. See - Experimental Subject's Bill of Rights
   7. Drug Monograph(s) and/or Investigators Brochure(s)
   8. Copy of the IRB approval letter for the submitted documents
   9. Where applicable, a copy of the FDA IND approval letter, study may proceed letter, or the submission cover letter to FDA indicating that the 30-day comment period has passed without FDA comment
   10. List of each CA site with name, address and the principal's investigator’s (PI) name and contact information
   11. Completed application checklist. See - Clinical Drug Trial Application Checklist
   12. *Expedited review: See criteria required to qualify for expedited review and approval outside of a regularly scheduled Panel meeting
   13. All application submission packets should be sent via email ONLY - in PDF format (maximum capacity is 25 MB per email) - to RAPC@doj.ca.gov


5. Group 5. Human Tissue Research:
   
   Note: The application for research involving human tissues is dependent on whether informed consent is required to collect and study the human tissues. When informed consent is required, the application for human research is used. When informed consent is not required, the application for non-human research is used.
   
   
   1. Cover letter (list all documents in the submission)
   2. The source of the human tissue(s)
   3. Is Informed Consent required to obtain the samples: YES/NO
      1. YES, Informed consent is required to harvest or use the human tissues (i.e. collected from patients or known, living donors): Complete the application requirements for Human Research.
      2. NO, informed consent is not required to harvest or use the human tissues (e.g. obtained from cadavers or a commercial supplier of anonymous or deidentified specimens.). Complete the application requirements for Non-Human Research.
   4. *Expedited Review: See criteria required to qualify for expedited review and approval outside of a regularly scheduled Panel meeting
   5. Completed application checklist. See - Human Tissue Research Application Checklist
   6. All application submission packets should be sent via email ONLY - in PDF format (maximum capacity is 25 MB per email) - to RAPC@doj.ca.gov

Note:

• Obtain IRB, FDA, or IACUC approval(s) of the study BEFORE submitting the study for review by the Research Advisory Panel of California.


• Include DNA Informed Consent for human research studies that may involve DNA/genetic testing, or that collect samples for DNA/genetic testing, or that may share biological samples with others who may conduct DNA/genetic testing on the samples. DNA informed consent may be a separate consent form, attached to the main consent form, or a section in the main consent form. For guidance on drafting a valid DNA consent, see the following link: DNA/Genetic Informed Consent.


• Submit the most up-to-date drafts of the protocol and consent form(s) for RAPC review. Changes to the protocol and/or consent form(s) after an application is submitted to RAPC can result in delays in the review of the application.


• Send all application submission packets via email ONLY - in PDF format (maximum capacity is 25 MB per email) - to RAPC@doj.ca.gov **Hard copies are no longer required to be mailed to the RAPC office.**


• Report any significant study drug related serious adverse event (SAE) that may emerge during conduct of the research study to the Panel via email (PDF format) only.

The Panel reviews study applications (that have completed all submission requirements) at a Panel meeting and issues a response in PDF format to the Principal Investigator or sponsor/CRO. A response can be expected within 30 days after the Panel meeting. The Panel may take any of the following actions:

1. Issue an approval or denial
2. Require additional documentation
3. Request clarifications or changes to the protocol, consent form(s), and/or any other study documents submitted for approval in conjunction with the application
4. Review the application at a subsequent Panel meeting if the reply and resubmission by the sponsor/CRO or academic principal investigator does not adequately or clearly respond to the Panel’s concerns

Any amendments to the research project should be timely reported to the Panel for review and approval prior to their implementation.

Amendment submission packets should be sent via email ONLY - in PDF format (maximum capacity is 25 MB per email) - RAPC@doj.ca.gov.

1. Human Studies (Group 1, 2, and 4 research):
   1. Cover letter (list all documents in the submission)
   2. A summary document of the revisions to study documents, identifying for each revision, the original wording and the revised wording, along with the section and page number for each revision
   3. Copies of the revised protocol and informed consent form(s), as applicable, with changes in tracked changes
   4. Final copies of the revised protocol and informed consent form(s)
   5. Copies of all applicable approval letters (IRB, FDA, etc). Where FDA did not provide an approval letter, submit a copy of the electronically dated transmittal or cover letter to the FDA or acknowledgement of receipt. Submit after expiration of the 30-day comment period without FDA comment.


2. Non-Human Studies (Group 3 research):
   1. Cover letter (list all documents in the submission)
   2. A summary document of the revisions to the study, identifying for each revision, the original wording and the revised wording, along with the section and page number for each revision
   3. A copy of the revised protocol with changes in tracked changes
   4. A final copy of the revised protocol
   5. Calculations for any additional quantities of Schedule I Controlled Substances requested for approval
   6. A copy of the IACUC approval of the amendments, where applicable

When the research study is completed, closed, or terminated, submit a final report via email ONLY - in PDF format (maximum capacity is 25 MB per email) - to RAPC@doj.ca.gov.

1. For all study types (Group 1, 2, 3, 4, and 5 research):
   1. PR# (Panel Review number) plus the title of the study
   2. The study closure or termination date and reason for closure or termination
   3. A final summary report of research performed and findings of the study
   4. The drug usage log sheets (if applicable)