The Indian Council of Medical Research (ICMR) has released an addendum to the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017). This addition establishes a structured ethical framework specifically for Research in Integrative Medicine (RIM), ensuring scientific integrity and patient safety.
Encouraging Credible Research in Integrative Medicine
Emphasizing the significance of this development, Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush, stated, “The addition of these ethical guidelines marks a significant step in encouraging the scientific community to explore Integrative Medicine with greater credibility and confidence. By providing a structured ethical framework, we aim to inspire researchers to advance evidence-based integration of traditional and modern medicine, ensuring safe, effective, and scientifically validated healthcare solutions for all.”
Understanding Integrative Medicine
Integrative Medicine (IM) takes a multimodal approach, combining Ayush systems with modern/conventional medicine to enhance patient care and improve health outcomes. The addendum ensures that research in this field adheres to ethical and scientific standards, balancing traditional and modern medical practices.
Strengthening Ethical Oversight
To enhance ethical and regulatory standards, the addendum introduces key measures:
*Ethics Committees (ECs) overseeing Integrative Medicine research must include two Ayush subject-matter experts, with at least one being external to the institution. This ensures well-rounded and informed deliberations.
*Informed consent requirements have been strengthened. Researchers must provide participants with clear and tailored information about Integrative Medicine interventions, following India’s standard ethical guidelines for biomedical and clinical research.
Regulatory Compliance and Safety Measures
The addendum also clarifies regulatory requirements for medicines used in Integrative Medicine research:
*Ayush-approved medicines used in integrative research do not require additional safety trials or preclinical studies.
*Non-codified traditional medicines must undergo the complete regulatory approval process before use.
All research must comply with:
*Drugs & Cosmetics Act (1940)
*New Drugs & Clinical Trial Rules (2019)
*Good Clinical Practice (GCP) guidelines for Ayush systems
As reported by biospectrumindia.com, by implementing these ethical and regulatory enhancements, ICMR aims to foster credible and scientifically validated research in Integrative Medicine, ensuring patient safety while promoting innovation in healthcare.