Memon, Rakhshi; (2023) Ethical issues in randomised clinical trials for adolescents who self-harm: The limits of equipoise and evidence in the cultural context of Pakistan. Doctoral thesis (Ph.D), UCL (University College London).

Text Memon_10164878_Thesis.pdf Download (1MB)

Abstract

This research examined the main conceptions of equipoise and applied them in a different cultural context based on a Randomised Clinical Trial (RCT) being conducted in Pakistan, which is investigating a psychological intervention YCMAP plus treatment as usual versus treatment as usual for young people at risk of self-harm or suicide. Equipoise is the moral justification for recruiting participants in an RCT, when there is uncertainty about which arm of the trial is more beneficial to the patient. The current research focused on whether the clinicians’ recruiting patients have a treatment preference and whether they regard participation in an RCT as scientifically and ethically important. Methods The study used an exploratory mixed methods approach; survey of clinicians, both involved and not involved in the trial and a discussion group with Pakistani researchers. It included an empirical study of the views and values of clinicians (N=20). The study examined the ethical considerations regarding clinical trials and human rights law. My thesis reviewed literature on Islamic approaches to research ethics, developed a community engagement tool for use by western researchers through a discussion group with Pakistani researchers and conducted semi structured qualitative interviews with the clinicians to explore the cultural context. Results Findings showed that clinicians (73.3%) consider YCMAP to be an effective treatment for young patients at risk of self-harm or suicide. Although, there was acknowledgement of individual preferences, there was greater consensus on the need to conduct an RCT for reaching an evidence-based decision. Conclusion From my research, I conclude that there was enough evidence of uncertainty and the existence of clinical equipoise as moral justification for conducting the RCT. There was a desire to gather home grown evidence base to make it more culturally relevant. Religiosity was a dominant thread across all the themes from the cultural analysis.

Download activity - last month

Export as CSVXMLJSON

Download activity - last 12 months

Export as JSONCSVXML

Downloads by country - last 12 months

Export as XMLCSVJSON

Archive Staff Only

View Item