Ethical Requirements for Research in Integrative Medicine

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 The Indian Council of Medical Research (ICMR) has published an addendum to the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) to provide a structured ethical framework for Research in Integrative Medicine (RIM). This initiative marks a significant milestone in strengthening the scientific foundation of Ayush-based integrative healthcare by ensuring ethical rigour and regulatory compliance in research that explores the integration of traditional and modern medical practices.

Integrative Medicine (IM) involves a multimodal approach, where Ayush systems are integrated alongside modern/conventional medicine to enhance patient care and improve health outcomes. With growing global interest in holistic and personalised medicine, it is observed that ethical and regulatory clarity is essential to ensure the credibility, safety, and efficacy of integrative approaches.

This addendum aims to guide researchers, institutions, Ethics Committees (ECs), and regulatory bodies involved in Integrative Medicine research, ensuring that scientific integrity and patient safety remain paramount.

The addendum introduces key measures to enhance the ethical and regulatory framework for Integrative Medicine research. Ethics Committees overseeing such research must now include two Ayush subject-matter experts, with at least one being external to the institution, ensuring well-rounded and informed deliberations. Informed consent standards have been strengthened, requiring that research participants receive clear, tailored information about Integrative Medicine interventions while adhering to India's standard ethical guidelines for biomedical and clinical research. Additionally, Ayush-approved medicines used in integrative research will not require extra safety trials or preclinical studies. However, non-codified traditional medicines must undergo the entire regulatory approval process. To ensure compliance, all research must align with the Drugs & Cosmetics Act (1940), New Drugs & Clinical Trial Rules (2019), and Good Clinical Practice (GCP) guidelines specific to Ayush systems.

SCOPE: The ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, in Section 7.13 discussed ‘Clinical trials on traditional systems of medicine’. An addendum is being made to this Guideline to facilitate and guide Research in Integrative Medicine involving human participants, by researchers in modern medicine institutions. 

Recommendations: 

1. For undertaking an ethics review of proposed Research in Integrative Medicine, the Ethics Committee (EC) shall invite two subject matter experts to the EC meeting from the relevant Ayush system(s). These Ayush experts need not be permanent members of the EC but may be co-opted when there are integrative medicine research proposals under review. They will be considered part of the EC quorum for decision-making. Like other expert members of the EC, these experts must not have any conflicts of interest related to the study under consideration. Additionally, at least one of these experts must be external to the institution. The EC should be duly registered with the Department of Health Research (DHR) and may also be registered with the Central Drugs Standard Control Organization (CDSCO) if it reviews clinical trials as defined under the Drugs & Cosmetics Act, the New Drugs & Clinical Trial Rules, 2019 or other relevant regulations. For multicentre research, a common ethics review may be conducted by the designated EC. 

2. Informed Consent should be tailored to ensure that participants fully understand the nature of the research in integrative medicine. All relevant ethical considerations and guidelines for biomedical and clinical research involving humans in India shall also apply to integrative research. 

3. If the medicinal product or modalities approved for use in clinical Ayush practice (Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa Rigpa, Homoeopathy) is being used for Research in Integrative medicine, it will not require additional evidence of safety (from animal studies or phase I/II human clinical trials).

4. Research involving non-codified traditional medicines must go through the entire prescribed regulatory approval processes as per applicable rules/regulations/guidelines and any amendments thereto

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