Issues and Challenges on Informed Consent in Biomedical Research Involving Human Participants: An Indian Perspective

Introduction

National and international guidelines, codes and regulations have been created in recent decades to guide the conduct of research involving human participants. Researchers and scientists need to abide by these guidelines while conducting research on human participants. Investigators are to follow various guidelines in the process of obtaining informed consent. Research scientists sometimes face the critical necessity of applying ethical principles to the process of obtaining informed consent in a multicultural society like India. While, on the one hand, they are not to violate universally applicable ethical standards, the local culture of research participants must also be considered.

Ethics Committees (ECs) play a very important role for ensuring that researchers document the informed consent process and all the relevant information in the protocol before initiation of the study. ECs review the proposals and decide whether the investigator should be allowed waiver of informed consent, verbal or written. It is the responsibility of the investigator to submit the proposal to the EC even if it is for waiver of informed consent and the EC’s Chairperson makes the final decision, in consultation with the members.

It is the responsibility of ECs to critically review the participant information sheet and informed consent document. In a multi-centric study, Regional Ethics Committees (RECs) should examine the process through which informed consent will occur, as well as the information that will be provided. RECs may waive the requirement of informed consent only when doing so is consistent with international guidelines and national standards.¹

Around 850 ECs in India have been registered by the Drug Controller General of India under the Central Drug Standard Control Organization (CDSCO) in response to the notice and regulatory requirement issued by the CDSCO for ECs in India that review clinical trials to register. The regulation of clinical trials in India is an excellent initiative. After registration, the ECs will face several challenges, one of which is not only to review the informed consent document so that they protect the rights, welfare and health of the study participants, but also to monitor the process of informed consent throughout the study.

The four basic principles of ethics—autonomy (respect for participants), beneficence, non-maleficence (to do no harm) and justice—are taken care of if the process of informed consent is conducted in accordance with national and international guidelines.

Objective

The objective of the present review is to identify the issues and challenges related to informed consent in human biomedical research and to explore the recent initiatives and efforts for improving the process of informed consent in India.

Informed Consent of Participants

For all biomedical research involving human participants, the investigator must obtain the informed consent of the prospective participant or in the case of an individual who is not capable of giving informed consent, the consent of a legal guardian. Informed consent protects the individual’s freedom of choice and respect for his autonomy, and the choice whether or not to participate is exercised voluntarily. Adequate information about the research should be provided in a simply and coherently worded document which uses unambiguous language, known as the Informed Consent Form with Participant/Patient Information Sheet (PIS).²

Informed consent is a process by which a subject voluntarily confirms his willingness to participate in a certain trial, after having been informed of all aspects of the trial that are relevant to his decision to participate. The consent is documented by means of a written, signed and dated informed consent document (ICD).³ The three requirements that are necessary to obtain informed consent include: a) providing accurate information; b) comprehension/understanding of the prospective participant about the information given; and c) voluntariness in the decision-making process. Informed consent is not restricted to sharing of information and coming to a decision. But in midst of that is an important step: the understanding of the participant.

The Process of Informed Consent

The four basic principles of ethics are accommodated only if the responsibility is taken by the ECs, researchers/investigators and the sponsors or institution in which...