WCG IRB Canada certifies that the identified clinical trial complies with Good Clinical Practices as defined by the FDA, HHS, and ICH guidelines. The Research Ethics Board (REB) confirms its membership meets regulatory requirements and that it has reviewed and approved the clinical trial protocol, informed consent form, and related materials. The study, conducted by Dr. Birgitta Woods at Qi Integrated Health in Vancouver, assesses the psychological effects of MDMA-assisted therapy in healthy volunteers. Approved documents include the investigator’s brochure, recruitment materials, participant consent forms, and study protocols. Investigators must adhere to IRB requirements, protect participants’ rights and safety, and report any protocol modifications or adverse events. The board requires that all participants consent for themselves and prohibits financial incentives for referrals. Compliance with HIPAA regulations and data monitoring requirements is essential. Continuing review reports must be submitted annually, and any site monitoring reports affecting subject safety must be reported within five days. The IRB maintains oversight, ensuring adherence to ethical and regulatory standards.
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