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Ethical issues in randomised clinical trials for adolescents who self-harm: The limits of equipoise and evidence in the cultural context of Pakistan

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). Green open access

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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.

Type: Thesis (Doctoral)
Qualification: Ph.D
Title: Ethical issues in randomised clinical trials for adolescents who self-harm: The limits of equipoise and evidence in the cultural context of Pakistan
Open access status: An open access version is available from UCL Discovery
Language: English
Additional information: Copyright © The Author 2022. Original content in this thesis is licensed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) Licence (https://creativecommons.org/licenses/by-nc/4.0/). Any third-party copyright material present remains the property of its respective owner(s) and is licensed under its existing terms. Access may initially be restricted at the author’s request.
UCL classification: UCL
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Maths and Physical Sciences
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Maths and Physical Sciences > Dept of Science and Technology Studies
URI: https://discovery.ucl.ac.uk/id/eprint/10164878
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