The Standard of Disclosure in Informed Consent Decision Making in Medical Practice in Malaysia
Ambikai S Thuraisingam
Asian Journal of Law and Governance, 10 August 2020; 2(1) pp 1-14
Abstract
This is a conceptual paper to analyse the standard of disclosure in informed consent decision making in the medical practice in Malaysia. This study reviews literature on the history of the standard applied in the informed consent requirement among patients and its consequences in healthcare practice. It aims to evaluate the crucial elements of patient centricness particularly the factors that affect the voluntariness and competency of the patient in giving consent. This paper reviews the existing literature surrounding the phenomenon of giving consent for medical treatment in the healthcare, particularly on how the concept of shared decision making affects the consent requirement. This study provides an overview of the perplexing nature of disclosure in shared decision making and the various concerns that have surrounded the topic leading to its recognition. Hence in Malaysia, there is no specific law which governs the provisions for shared decision making in informed consent in the healthcare practice. This study aims to explore the Malaysian Medical Council Guideline on Consent for Treatment of Patients by Registered Medical Practitioner (MMC Guideline on Consent) and the current Malaysian laws to determine whether they are sufficient to address the principle of shared decision making requirement patients. The study reviews the existing case laws and literature on the historical development of the elements of shared decision making, subsequently, the findings of the perusal of the MMC Guideline on Consent and the current statutory laws are presented and discussed. Finally, lack of empirical evidence is recognised in this paper and several suggestions are made for future research and recommendation for enactment of a new law pertaining to shared decision making in informed consent to medical treatment.

Informed consent for controlled human infection studies in low‐ and middle‐income countries: Ethical challenges and proposed solutions
Vina Vaswani, Abha Saxena, Seema K. Shah, Ricardo Palacios, Annette Rid
Bioethics, 10 August 2020
Abstract
In controlled human infection studies (CHIs), participants are deliberately exposed to infectious agents in order to better understand the mechanism of infection or disease and test therapies or vaccines. While most CHIs have been conducted in high‐income countries, CHIs have recently been expanding into low‐ and middle‐income countries (LMICs). One potential ethical concern about this expansion is the challenge of obtaining the voluntary informed consent of participants, especially those who may not be literate or have limited education. In some CHIs in LMICs, researchers have attempted to address this potential concern by limiting access to literate or educated populations. In this paper, we argue that this practice is unjustified, as it does not increase the chances of obtaining valid informed consent and therefore unfairly excludes illiterate populations and populations with lower education. Instead, we recommend that investigators improve the informed consent process by drawing on existing data on obtaining informed consent in these populations and interventions aimed at improving their understanding. Based on a literature review, we provide concrete suggestions for how to follow this recommendation and ensure that populations with lower literacy or education are given a fair opportunity to protect their rights and interests in the informed consent process.

Local customs and implications for informed consent process in research in African low and middle income countries. Challenges in information disclosure, understanding and voluntariness. [THESIS]
Miguel Paulo
Utrecht University Repository, Faculty of Humanities Theses, 2020
Abstract
The process of requesting informed consent for participation in research has been widely addressed in various international guidelines, such as the Belmont Report, the Nuremberg code and the Declaration of Helsinki. Currently, the Declaration of Helsinki is the predominant ethical guideline for conducting research with human subjects. It has an extensive section dedicated to informed consent, meant to embed in researchers the understanding of the importance and underlying core values of informed consent. While the predominant justification for informed consent requirement rests on respect for autonomy, I will argue for prevention of deception and coercion as the core value to substantiate informed consent in collaborative research in African low and middle income countries (henceforth LMIC). By using principlism as a framework, I will explore how the conflict between respect for autonomy and nonmaleficence provide support for my stance. In this paper, I scrutinize how local customs intertwined in the historical and socio-cultural context of LMIC in Africa, shape underlying dynamics in the informed consent communication process by disrupting information disclosure, understanding and voluntariness. Those aspects intersect with underlying pillars of autonomous choice, resulting in presumably undermined autonomy. Consequently, I argue that the researcher-research subject ought to be based on grounds of trust and trustworthiness in order to still validate the relevance of informed consent as currently applied. I end by arguing that a deliberative approach should be attained in improving the quality of informed consent in those settings. To this end, the intuitionist model by Heidt could be conducive for deliberations on identifying moral grounds for justifying informed consent requirements when meeting the presuppositions of the rational choice theory is not attainable.

Patients Perception of the Quality of Consent for Caesarean Sections in Tertiary Health Facility in Port Harcourt, Southern Nigeria
Kenneth Eghuan Okagua, Joyce Okagua
The Nigerian Health Journal, 2019; 19(4)
Open Access
Abstract
Background
Informed consent should be viewed as a process and not just a signature on a form as is commonly seen in most cases. It is very important not just to minimise conflict/medico-legal issues but as a tool for better communication between the physician and the patient on diagnosis, treatment risk, etc. In order to improve acceptance/minimise conflicts from Caesarean Deliveries, which are increasingly being performed globally, it is important to determine patients perception of the quality of consents obtained, more so, as previous studies have demonstrated poor quality of consent for various surgical procedures.
Materials and Method
A cross-sectional study was carried out in Braithwaite Memorial Specialist Hospital, between January 2016 to June 2016, using an interviewer based structured questionnaire on women who had caesarean section.
Results
Three hundred and forty eight women who had caesarean section were recruited for the study. They were aged between 20 and 42 years with a mean age of 31.74 ± 4.39 years. Majority (67.5%) of the women had tertiary level of education and 94.8% of the women were married. Of the 348 women, 220 (63.2%) had emergency caesarean section. 89.9% had knowledge of the diagnosis and the same number, were not aware of possible complications. 55.7% of the consents were obtained by a nurse. Only 52% of the women were satisfied with the consent.
Conclusion
The quality of consent for obstetric surgeries is still poor. Doctors especially consultants need to be more involved in the process to improve its quality.