A research ethics board (REB) reviews studies involving people to make sure risks are reasonable and participants are protected. In Canada, the Food and Drug Regulations require the sponsor of a drug trial to obtain an REB’s approval for each site before the trial begins there (Food and Drug Regulations, C.05.010). The same section requires written informed consent from every participant, after they have been told the risks and anticipated benefits (Food and Drug Regulations, C.05.010).
REB approval is separate from Health Canada’s review of a clinical trial application (Health Canada). Canada’s research ethics policy, the Tri-Council Policy Statement, sets out how consent should be sought and given (TCPS 2, Chapter 3).
Oversight like this is newer than psychedelic research itself. The Declaration of Helsinki, the main international code for research on people, was first adopted in June 1964, years after the first DMT studies (World Medical Association). Today, Health Canada describes clinical trials, approved by an REB, as the most appropriate way to advance research with psilocybin (Health Canada).
Sources
- Food and Drug Regulations, section C.05.010 (Justice Laws)
- Health Canada: Clinical trials and drug safety
- Tri-Council Policy Statement (TCPS 2), Chapter 3
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