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DISPUTING THE ETHICS OF RESEARCH: THE CHALLENGE FROM BIOETHICS AND PATIENT ACTIVISM TO THE INTERPRETATION OF THE DECLARATION OF HELSINKI IN CLINICAL TRIALS
Author(s) -
WOODS SIMON,
MCCORMACK PAULINE
Publication year - 2013
Publication title -
bioethics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.494
H-Index - 55
eISSN - 1467-8519
pISSN - 0269-9702
DOI - 10.1111/j.1467-8519.2011.01945.x
Subject(s) - declaration of helsinki , bioethics , normative , research ethics , declaration , context (archaeology) , clinical trial , perspective (graphical) , political science , population , interpretation (philosophy) , informed consent , sociology , law , medicine , alternative medicine , psychiatry , paleontology , demography , pathology , artificial intelligence , computer science , biology , programming language
In this paper we argue that the consensus around normative standards for the ethics of research in clinical trials, strongly influenced by the Declaration of Helsinki, is perceived from various quarters as too conservative and potentially restrictive of research that is seen as urgent and necessary. We examine this problem from the perspective of various challengers who argue for alternative approaches to what ought or ought not to be permitted. Key themes within this analysis will examine these claims and argue they have implications for the interests of the research subject, research governance and regulation. Using our work with TREAT‐NMD, the neuromuscular clinical trials network, we posit that there is a place for advancing the discourse of moral rights and moral duties in the context of research, especially from the perspective of patients and their families, and for including the politics of patient activism and empowerment. At the same time we remain vigilant to the danger that the therapeutic misconception and other serious vulnerabilities for the patient population in clinical trials, are at risk of being overlooked.