On March 27, 2015 FDA solicited comments on the future of Homeopathic Product Regulation via a Notice of Proposed Rulemaking (“NPRM”) that sought input on current enforcement policies from scientific, risk, and process perspectives. Homeopathic drugs are currently exempt from many of the requirements of non-homeopathic drugs under the Food Drug & Cosmetic Act, and FDA regulates based on the Compliance Policy Guide (CPG) 400.400, “Conditions Under Which Homeopathic Drugs May Be Marketed.”
The research community might one day see homeopathic products undergoing the same approval and labeling process as non-homeopathic drugs. If this happens, IRBs must be prepared to address the issues of informed consent and subject safety. Question #8 in the NPRM asks, “do consumers and health care providers have adequate information to make informed decisions about drug products labeled as homeopathic.” This question is at the heart of the informed consent process and IRBs reviewing studies of homeopathic drugs would apply the same elements of informed consent found in regulations at 21 C.F.R. § 50.25 as used in the informed consent process for studies of other FDA-regulated products. Any informed consent must include a description of reasonably foreseeable risks, benefits to the subject which may be reasonably expected, and disclosure of appropriate alternative procedures or courses of treatment that might be advantageous (among other required elements). Also, when IRBs approve a study protocol the Board adheres to the requirements found in 21 CFR 56.111 for “Criteria for IRB Approval of Research.” In order for research to be approved the risk to the subjects must be minimized and risk to the subjects must be reasonable in relation to anticipated benefits. Because of the untested nature of many homeopathic products, the IRB’s responsibilities for ensuring adequate informed consent and making risk-based determinations would be essential.
Ensuring that any future clinical trials involving homeopathic drugs respect the subjects’ safety and right to be fully informed through an approved informed consent may prove challenging for a previously unregulated industry, but Sterling IRB’s primary concern is the welfare of study participants in ethically sound research. If you would like to learn more about Sterling services, please contact the IRB.
Article submitted by Royce DuBiner, JD, LLM