The Challenges of Multiculturalism on Informed Consent in Clinical Research
Joseph Tham
Studia Universitatis Babes-Bolyai Bioethica, 2021; 65 pp 174-175
Abstract
The UNESCO Chair in Bioethics and Human Rights held its 6th international workshop to discuss the issues of Informed Consent and Clinical Research. Being part of the i-Consent consortium, a project funded by the European Union’s Horizon 2020 research and innovation program, the workshop focused on the multicultural and interdisciplinary dimension of ethical requirements of informed consent applied to translational/clinical research. Bioethical experts from Buddhism, Confucianism, Christianity, Hinduism, Islam and Judaism discussed the key challenges and the requirements of informed consent in clinical research. Some of the ethical gaps, barriers and challenges present in obtaining informed consent from patients/subjects in different, challenging cultural contexts were identified, as they represent minority groups and vulnerable populations. One of the findings is that many religious traditions do not accept the Western idealization of the autonomous self and prefer a more relational or communitarian understanding of doctorpatient/researcher-subject relationship. Western medicine and its current gold standard of informed consent that is practiced globally may not adequately address the theoretical skepticism towards the underlying principle of autonomy by different religions and cultures. This tension is becoming more pronounced with migrant and minority groups when they are asked to participate in clinical research as well as doing research in different parts of the world. A shift from individual to relational autonomy may offer a more nuanced improvement of the readability, design and obtaining process of consent forms. This shift will take into consideration the conscious and unconscious cultural biases of the investigators; multicultural and religious variables of the subjects’ understanding; cross-cultural vision of vulnerability, knowledge, communication and empathy; the need for individualized approaches to promote health protective behaviors; and framing questions for a multi-layered informed consent which includes East/West – North/South perspectives.