Clinical research involving pregnant women and women with reproductive health disorders presents unique ethical challenges because research interventions may affect both the mother and the developing fetus. Although Ayurveda has long been used for antenatal care, infertility, menstrual disorders, polycystic ovarian syndrome (PCOS), menopause, and postpartum recovery, robust scientific evidence supporting many interventions remains limited. Ethical research is therefore essential to establish safety and effectiveness while protecting participant rights.

Ayurvedic clinical research must integrate traditional principles with internationally accepted ethical standards. Key considerations include scientific validity, informed consent, participant autonomy, equitable selection, risk-benefit assessment, confidentiality, pharmacovigilance, and quality assurance of herbal medicines. Pregnancy requires additional safeguards because physiological changes may influence drug metabolism and fetal exposure.

International frameworks such as the Declaration of Helsinki, International Council for Harmonisation-Good Clinical Practice (ICH-GCP), Council for International Organizations of Medical Sciences (CIOMS), and the Indian Council of Medical Research (ICMR) National Ethical Guidelines provide the foundation for ethical research involving pregnant women. These principles are equally applicable to Ayurvedic clinical trials, while additional challenges such as individualized treatment, polyherbal formulations, Prakriti-based management, and herbal standardization require special consideration.

This review discusses the ethical principles, regulatory requirements, informed consent, maternal-fetal safety, herbal standardization, pharmacovigilance, and future directions for conducting responsible Ayurvedic clinical research in pregnancy and women's reproductive health.

Keywords: Ayurveda, Clinical Research, Ethics, Pregnancy, Women's Health, Prasuti Tantra, Stree Roga, Good Clinical Practice, Informed Consent, Maternal Health