Protection for Patients in Clinical Trials and Biomedical Research

All clinical trials in India operate as per guidelines issued by the Central Drugs Standard Control Organization, Directorate General of Health Services in India.(( Schedule Y, Drugs and Cosmetics Rules, 1945)). Some of the main guidelines for clinical trials are:

• Application for permission to conduct such a trial must be sought according to the procedure laid out by the rules. The  Licensing Authority¹ has to give permission to start the clinical trial. Further, the Ethics Committee should also give approval.(( Section 2 (1)(i), Schedule Y, Drugs and Cosmetics Rules, 1945)).
• Conducting all phases of  clinical trials for a new drugs discovered in India, which have human participants, within India itself.
• All investigators conducting the trial must possess appropriate qualifications and should have access to the investigation facilities required for the trial.
• When any physician or dentist accompanies the trial, he should be responsible for all medical or dental decisions taken in the trial.
• The investigator should ensure that proper medical care is provided to participants of the trial for any adverse events. Ancillary medical care must be provided for any illness arising during the period of the trial, even if it is unrelated to the trial.
• Investigators shall provide information about the essential elements of the clinical trial to the participants. The information provided should be easily understandable.
• Participants have a right to claim compensation in case of trial-related injury or death.
• All participants have to provide free, informed, and written consent before they join the trial. Legal representative can give consent if the patient is unable to give consent. Similarly, parents or legal guardians can give consent for children who participate in trials.

Rights of Participants of Clinical Trials

The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants was released by the Indian Council of Medical Research (ICMR) in 2017. The guidelines ensure the following rights for participants of such trials:

• Voluntary consent is paramount. Participants can choose to participate, not participate, or to withdraw from the trial at any time.
• Every trial has to provide safeguards as well as equal distribution of benefits to all participants or vulnerable groups.
• Confidentiality of the participants’ identities to protect their privacy is essential. However, this breach can happen only for medical or legal reasons, in consultation with the Ethics Committee.
• Such research should not lead to social, racial, or ethnic inequalities.
• Compensation for any direct physical, psychological, social, legal or economic harm faced by patients rights in the form of financial compensation or in any other manner.

1. Section 21 (b), Drugs and Cosmetics Rules, 1945 [↩]