“A response can be expected within 30 business days after the Panel meeting”, according to the Attorney General’s office. That’s up to six weeks without including the potential gap between submission and the next RAP-C meeting. Given that the Panel meets six times per year, there’s a baked-in limit as to how quickly it can respond to proposals.
The submission deadline can be up to 7 weeks before the meeting date, meaning the actual time between submitting an application and receiving a response can be more than a few months and often around a half-year according to those that have been through the process; assuming those meetings aren’t cancelled.
Researchers told Psychedelic Alpha that they’re increasingly expected to run studies in 12-18 months, meaning these delays are substantial.
Should RAP-C propose amendments to the research proposal, further delays ensue.
In the case of a study of MDMA-assisted therapy for anxiety associated with life-threatening illness, RAP-C requested “several changes to the protocol and Informed Consent form”, according to a MAPS Bulletin from 2014.
The study was approved by RAP-C on December 15th, 2014, three months after the study achieved IRB approval. Having tangled with RAP-C multiple times, it’s perhaps not surprising that MAPS’ founder, Rick Doblin, told us that the Panel is “more appropriately known by its former name”, referring to the acronym of California Research Advisory Panel .
Woolley, meanwhile, told us that RAP-C review has always caused ‘many months of extra delays’, postponing the commencement of studies.
It doesn’t look like these months-long delays to research commencement are new, either. A letter dated February 8th 1977 to Alexander (‘Sasha’) Shulgin demonstrates relatively slow interactions. Shulgin had promptly submitted an amendment to his research protocol on December 7, 1976, just two weeks after the Panel had sent him a letter. Two months later, the Panel denied his research protocol, citing “major deficiencies” and withdrew its approval of an earlier study . (Interactions with the Panel were described in TiHKAL by Shura, which is widely regarded to be a pseudonym for Sasha.)
Shulgin’s research wasn’t the only to come under scrutiny by the Panel. Speaking to the PsychedeRx podcast, Mark Geyer, UC San Diego Distinguished Professor of Psychiatry and Neurosciences Emeritus, explained how his Department Chair Arnold Mandell was dosing mescaline to pigeons in the mid-1970s, with a DEA license in hand.
Despite their DEA-licensed bona fides, Geyer recalls a cease and desist letter arriving at UC San Diego ordering them to stop their study. That letter came from the Research Advisory Panel which, according to Geyer, many academics didn’t even know existed at the time.
Once an application is approved, investigators or sponsors must also submit an annual progress report to the Panel in order to maintain approval of the project. In this capacity, RAP-C monitors ongoing, approved projects.
At the end of the 2022 calendar year, RAP-C was monitoring 132 research projects. For multi-site studies, the sponsor or contract research organisation (CRO) is responsible for the report’s submission, not the California trial site itself.
These delays and added administrative burden result in substantial costs. According to Woolley, these costs can add up to something in the region of $100,000 – $250,000 per study reviewed.
Given that studies submitted to RAP-C are supposedly cleared by all other agencies and boards, in many cases the disbursement of study-related overhead such as researcher and staff costs has already begun.
That money is not only coming from industry sponsors and philanthropy, but also millions of taxpayer dollars.