title: Disputing the ethics of research: the challenge from bioethics and patient activism to the interpretation of the Declaration of Helsinki in clinical trials.
abstract: 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.
authors.affiliation: Policy, Ethics and Life Sciences Research Centre PEALS, Newcastle University, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Woods
authors.forename: Pauline
authors.initials: P
authors.lastname: McCormack
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics / Q000592:standards*; D057176:Compassionate Use Trials / Q000941:ethics*; D034462:Dissent and Disputes; D032984:Ethics, Research; D005060:Europe; D006381:Helsinki Declaration; D006801:Humans; D033181:Information Dissemination; D028681:Moral Obligations; D009468:Neuromuscular Diseases / Q000188:drug therapy; D026706:Paternalism; D010344:Patient Advocacy; D028701:Patient Rights; D011209:Power, Psychological; D035583:Rare Diseases / Q000188:drug therapy; D014837:Voluntary Health Agencies