Expedited Review

The Panel may expedite the review of completed and timely applications for research projects involving the administration of Schedule I, Schedule II, or both, controlled substances that meet certain criteria. Studies that are expedited are reviewed and approved by Panel members outside of a regularly scheduled Panel meeting.

Applications 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.

Studies may qualify for expedited review by submitting a completed application as detailed on the Guidelines page with documentation that meets all of the following criteria:

1. Independent Peer Review

   Proof of independent peer review for scientific merit. This can be satisfied with an approval letter from one of the following:

   1. National Institutes of Health (NIH)
   2. Heffter Research Institute
   3. United States National Science Foundation (NSF)
   4. United States Department of Defense (DoD)
   5. A comparable group within an institutional setting that has previous experience with research or grant review

2. Human Subjects – IRB approval

   Approval of all relevant study documents (e.g. protocol, consent forms) from an Institutional Review Board (IRB) that has been established in accordance with all relevant federal and state laws, including the Code of Federal Regulations Title 45 Part 46, Protection of Human Subjects. Submit a copy of one of the following:

   1. IRB approval letter
   2. Letter from the IRB that indicates IRB-approval is contingent upon RAPC approval

3. Human Subjects – FDA approval

   Where approval of a New Drug Application (NDA) by the FDA is required, submit a copy of one of the following:

   1. FDA approval letter for the IND application
   2. FDA letter indicating the study may proceed
   3. Documentation that the 30-day statutory period for FDA to respond to an NDA has expired
   4. Signed copy of the IND

4. Animal Subjects – IACUC approval

   For studies that involve animal subjects, submit a copy of an approval letter from an Institutional Animal Care and Use Committee (IACUC) that has been established according to all relevant federal and state laws regarding their humane care, use, and treatment.

5. Drug Enforcement Agency (DEA) registration filing

   The study either has or is actively seeking a registration with the United States DEA for the procurement and storage of Schedule I or Schedule II controlled substances. Submit a copy of one of the following:

   1. Registration application (DEA Form 225) submitted to DEA to conduct research using a Schedule I or Schedule II controlled substance, with proof of submission
   2. Letter of conditional approval by DEA to conduct research using Schedule I or Schedule II controlled substances contingent upon RAPC approval
   3. Current registration with the DEA to conduct research using Schedule I or Schedule II controlled substances
   4. Where applicable, federal authorization to conduct research using a Schedule I or Schedule II controlled substance pursuant to the federal Controlled Substances Act