Informed consent to clinical research in India: A private law remedy

Abstract

There is a well-established common law doctrine for ascertaining information disclosure in informed consent claims within the treatment context that governs the doctor–patient relationship. But there is no such doctrine in clinical research governing the researcher–participant relationship in India. India, however, is not exceptional in this regard. Common law countries like the United States and Canada at most have sparse, non-systematised, criteria for such cases; arguably, a doctrine for research is at its nascent stage. But the adequacy of the existing criteria for settling informed consent claims in research has hardly ever been discussed. Furthermore, a specific discussion on the applicability of this ‘nascent doctrine’ to India is non-existent. This article discusses both. The article examines case law from India and other common law jurisdictions that hint at developments in this area. It suggests that Indian courts need to move abreast with other jurisdictions to better protect India’s patients and research participants.

Exploring the Influence of Decisionmaking Style and Financial Status of Cancer Patients on Varied Cultural Aspects of Decision Process

“…However, there was no significant difference between the two groups for the factor of chance or luck. Factors such as low knowledge and awareness among patients belonging to low financial status (Sahu et al, 2020; Singh et al, 2016), reduced agency in choosing healthcare facilities (Ram Prakash & Lingam, 2021) and a high reliance on doctors’ authority (Bhakuni, 2020; Subramani, 2019) could probably explain such an external locus of control—wherein god and doctors are attributed higher decision responsibility than patients and family caregivers.…”

“…Bhakuni (2020) makes a cogent argument that the Supreme Court of India has cited poverty and trust in doctors as reasons to adopt a paternalistic view of informed consent, such that the doctors determine the amount of information to be given to the patient. Further, researchers like Gopichandran (2019), Subramani (2017, 2019), and Bhakuni (2020) have also commented upon the role of trust in defining the boundaries of doctor–patient relationship, emphasising how such trust is often at intersection of prevailing sociolegal conditions and the various social identities of the patient.…”

“…Though there are many studies that have linked such decisions with positive patient outcomes and patient satisfaction (Entwistle et al, 2012; Gillman & Ferrer, 2021; Sankar et al, 2018), there is less research on the practicality and feasibility of such an approach (Ozdemir & Finkelstein, 2018), specifically, in India (Gopichandran, 2019; Sankar et al, 2018). There are certain unique aspects that define doctor–patient relationship in India, such as reverence towards authority (Panda, 2023; Subramani, 2019), paternalistic family dynamics (where often the decision-maker is the head of the family) (Gopichandran, 2019; Subramani, 2019), lower agency of female patients than their male counterparts (Bhakuni, 2020; Gopichandran, 2019), power distance between doctors and patients (Jacob, 2014), substantially low levels of cancer awareness among public (Chandra et al, 1998), among others. Research exploring how doctors and patients communicate to reach shared and informed decisions during the treatment process given such conditions is conspicuously deficient (Bhakuni, 2020; Gopichandran, 2019; Panda, 2023; Sankar et al, 2018).…”

“…There are certain unique aspects that define doctor–patient relationship in India, such as reverence towards authority (Panda, 2023; Subramani, 2019), paternalistic family dynamics (where often the decision-maker is the head of the family) (Gopichandran, 2019; Subramani, 2019), lower agency of female patients than their male counterparts (Bhakuni, 2020; Gopichandran, 2019), power distance between doctors and patients (Jacob, 2014), substantially low levels of cancer awareness among public (Chandra et al, 1998), among others. Research exploring how doctors and patients communicate to reach shared and informed decisions during the treatment process given such conditions is conspicuously deficient (Bhakuni, 2020; Gopichandran, 2019; Panda, 2023; Sankar et al, 2018). The doctor–patient communication is also not immune to the sociocultural influences, such as beliefs of the patients and the family caregivers regarding full disclosure of information, attribution of decision responsibility to metaphysical factors, and the extent of trust in the medical fraternity (Chaturvedi et al, 2009; Chittem et al, 2021; Mathew et al, 2021; Victor et al, 2018).…”

“…3. Summary of model and interpretation: After checking the model and making necessary changes, the LMM analysis was conducted using lme4 package (Bates et al, 2023) and car package (Fox et al, 2023). The output and interpretation would be discussed in the results section.…”