Ethics of Informed Consent in Medical settings: A qualitative study of clinicians managing patients presenting with self-harm in Pakistan

Abstract

Abstract Background informed consent is considered to be the standard method for respecting the autonomy of individual participants in research and is thought to be based on several conditions: 1) providing information on the purpose of the research or a specific treatment, what it will entail, 2) the participants being mentally competent to understand the information and weigh it in the balance, and 3) the participants to be free from coercion. While there are studies of informed consent in other countries, especially Low and Middle Income Countries (LMICs), this study explored the role of cultural norms in the process of obtaining informed consent by clinicians in healthcare settings in general and mental health in particular, specifically focusing on the tension between contexts of Western autonomy and collectivist values in cultures such as Pakistan. Methods Qualitative interviews with 20 clinicians in Pakistan to explore consent processes in participant recruitment in Randomised Controlled Trials (RCTs), using a topic guide to gain an understanding of the consent process in Pakistan when recruiting participants in RCTs and decision-making regarding treatments and the influence of cultural norms’ impact on attitudes and beliefs in the collectivist culture. Results The interviews revealed that shared decision making was more morally important than individual autonomy, the role of the family played a dominant part in the consent-taking procedure, the decision of the elder and/or family patriarch took prominence, and that clinicians and researchers encountered significant challenges in consent process in Pakistan. Four distinct themes emerged which were 1) Family deciding for patients, 2) Benefits of involving family in consent process, 3) Gender disparity in consent process, 4) Challenges experienced by clinicians during consent process in Pakistan. Conclusions The concept of consent is generally considered important in many cultures, however, there are two strands of understanding. There seems to be consensus that participant agreement is necessary to protect the participant but with regards to autonomy there are significant cultural differences whether it is the right for autonomy of the individual (western) or family, community, or expert authority in other cultures, in Pakistan clinician-researchers sometimes preferred one approach and sometimes the other as they appreciated the interests of the patient to be.