In India, the Guidelines for Biomedical and Health Research Involving Human Participants, issued by the Indian Council of Medical Research (ICMR), play a significant role in guiding the ethical conduct of clinical trials. These guidelines emphasize the importance of obtaining informed consent from participants. Key points related to informed consent in clinical trials include: Capacity to Give Informed Consent: The guidelines emphasize that individuals participating in clinical trials should have the capacity to give informed consent. This involves the ability to understand the information provided about the trial, ask questions, and voluntarily agree to participate. Special Considerations for Vulnerable Populations: Special considerations are given to vulnerable populations, such as minors, who may not have the legal capacity to provide consent. In such cases, the guidelines often require the involvement of parents or legal guardians, and assent may also be sought from the minor, depending on their age and maturity. Age-Appropriate Information: When obtaining consent from participants, including minors, the information provided should be age-appropriate and presented in a manner that is understandable to the participant. It's crucial to note that regulations and guidelines may evolve, and it's advisable to refer to the latest guidelines issued by the CDSCO and ICMR or consult with relevant regulatory authorities for the most current information on the legal age for consent in clinical trials in India. Additionally, individual clinical trial protocols may have specific requirements regarding participant eligibility and informed consent.