World War II witnessed gross atrocities in the name of medical experimentation. Nazi physicians experimented on inmates of concentration camps with an absolute disregard for individual autonomy, willing participation and consent. After the war came to an end, the accused underwent a series of trials and prosecutions. One of these was the Doctor’s trial in Nuremberg, during which many German doctors involved in Nazi human experimentation and mass murder were sentenced to imprisonment or death.

Subsequently, a safeguard was developed in the form of a code of ethics, which came to be known as the Nuremberg Code of medical ethics. It was one of the first documents that laid emphasis on informed participation by human volunteers in research. Voluntary consent now became an absolute necessity, and researchers were urged to ensure that the risks involved in a study do not outweigh its potential benefits. The Nuremberg Code also asserted that participants must be able to exercise free will and withdraw from the study at any point, if they so wish. 

As history has shaped it, informed consent is a voluntary agreement to participate in research. More than a document to be signed, informed consent is a process of communication between the participant and researcher about the procedure of the study and the risks involved. Its purpose is to arm the participant with necessary information on which they can base their decision to be involved in a study. This involves the researchers disclosing the purpose of the study and its expected duration, the extent of confidentiality that would be maintained, and other factors.

Theory vs Practice

Today, obtaining informed consent from participants involved in a research study and ensuring that they have a sound comprehension of the nature of the study is a central tenet of ethical research. However, bringing such ethical guidelines into actual practice poses many challenges. These include socio-economic issues like language barriers, religious influences, and literacy levels, which often prevent volunteers from accurately understanding the study.

Owing to these factors, India finds itself in a unique and vulnerable position. With the multitude of languages that exist in our country, the accuracy of consent forms and participant information sheets may be compromised because of inadequate translation. Moreover, many people have a strong sense of community and participate in collective decision making, especially in the rural areas of the country. Therefore, the choice to be part of a study or otherwise may not completely be one’s own.

The Indian Council of Medical Research (ICMR) acknowledges the challenges to implement informed consent in the Indian scenario. To this end, they have published the National Ethical Guidelines for Biomedical and Health research involving human participants, which can be freely accessed by investigators and study participants alike. The guidelines advocate for marginally literate/​illiterate participants in clinical trials, stating that in a situation where both the participant as well as his/​her legally authorised representative (LAR) have compromised literacy, an impartial, literate person must be present as a witness while consent is being obtained. Documentation in all such cases is mandatory, whether in the form of a signature, thumb impression or in justifiable cases, verbal/​oral confirmation.

Moreover, the guidelines mandate that the participant information sheet should be translated into the local language of the community under consideration, and produced in front of an Ethics Committee for approval. To deal with the issue of community coercion, ICMR guidelines suggest the institution of a Community Advisory Group that protects the rights of the community. The CAG mediates with the researchers and ethical committees for the post-research benefits that the community at large is entitled to. However, community engagement cannot replace an individual’s informed consent, which must be kept in mind in such cases.

Who is a ​“competent” participant?

There is another layer to the challenges in obtaining appropriate informed consent, beyond the socio-economic factors hitherto discussed. A general understanding is that the person consenting to be part of a research procedure must be ​“competent”. However, a lack of clarity on who is or is not a competent participant breeds ambiguity in the procedure. 

For people with compromised mental faculties, neurological and psychiatric conditions, assessing their ability to consent needs scientific measures. Standardised scales that discern capable from incapable subjects in consent-giving capacity do exist, especially for neuropsychiatric conditions like Alzheimer’s disease. The current research practice in India, however, lacks the use of such objective measures. Deeming a patient to be incompetent without a sound rationale can justify coercive treatment, and hence this matter must be dealt with great sensitivity.

A research procedure may also involve children with varying cognitive levels, or in some cases, psychiatric conditions. Situations such as these call for special measures of consent. A child’s agreement to participate in a research is called assent. If a child objects to participating, i.e., dissents, the wish must be respected, even if he/​she does not completely understand the nature of the study. The National Ethics Guidelines for Bio-Medical Research involving Children was issued by ICMR in 2017 in this respect. It states that for any research procedure, an oral assent is mandatory for children between 7 – 12 years of age under direct supervision of their parents, and a written assent for children of 13 – 18 years of age. 

A phase IV clinical trial conducted by PATH in 2009 is illustrative of malpractices that may occur while obtaining assent from children. 30,000 tribal girls from Andhra Pradesh and Vadodara, all aged between 10 – 14, were administered the Human Papilloma Virus (HPV) vaccines — Gardasil and Cervarix. Ethical norms were openly flouted, as wardens of residential schools signed most of the consent forms without bringing it to the parent’s knowledge. Even in cases where the parents were involved, the students were handed the consent forms and asked to obtain signatures or thumbprints from their guardians (who were illiterate in many cases) without a direct intervention by the researchers themselves in counselling the participants. Therefore, legal protection for children must be contended for, to complement the newly released ICMR guidelines for research involving children.

The road ahead

A definitive idea that emerges from a critical analysis of ethical issues in research is that a participant has the right to choose whether to be part of a study or not. To exercise this right, he/​she must have a sound understanding of the research procedure, and formalize his/​her agreement in the form of appropriately documented informed consent. Some ideas emerged in a discussion with Manthan Janodia from Manipal College of Pharmaceutical Sciences, who has previously written about the issues and challenges involved in obtaining informed consent in India.

Janodia is of the opinion that awareness is the key to cultivate a mindset of executing the process of informed consent, and this holds true both for researchers and participants. ​“The content of what is communicated to the participants is of utmost importance,” he said, ​“The participants need to know more than the technical details of the drug they will be administered. Encapsulating one’s message in the right set of words is a people’s skill that must be instilled in young researchers, starting from their undergraduate days. Including the practice of taking an informed consent in the curriculum of research-oriented courses would be a good start.”

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