Empty ethics: the problem with informed consent

“…of the process of randomisation in clinical drug trials (Snowdon, Garcia, & Elbourne, 1997; Jan & DeMets, 1981; Cassileth, Zupkiss, Sutton-Smith et al., 1980), and as a consequence are sometimes under the misapprehension that they will be receiving an active treatment (Corrigan, 2003).”

“Ensuring that the consent process is embedded into the study in such a way as to not merely be performative “empty ethics” (Corrigan, 2003), but does, in fact, respect the autonomy of participants is therefore essential to conducting ethical qualitative research.”

“Over scrutiny on consent practices for persons with disabilities have at time overlook broader issues on fairness, dignity and justice [54, 55].”

“According to Corrigan (2003), subjects’ perceptions of risk strongly relate to the language context; for example, ‘study’ is considered more benign by participants than ‘experiment’.”

“difficult to attain than bioethics guidelines and policies imply’ ( Corrigan,2003, p.”

“This observation corroborates previous findings within clinical contexts (Corrigan, 2003; Redelmeier et al., 1993; Verheggen et al., 1998).”

“One such application is the informed consent process, where clear and effective communication is especially challenging, not only to ascertain how much information potential participants do or do not want (Corrigan, 2003), but also to establish a climate of collaboration and trust.”

“However, such codes of procedure ignore the social and cultural context in which the process of consent takes place (Corrigan, 2003), and consequently the moral life of the researcher.”

“…work that is available sidesteps the contextual complexities by using hypothetical scenarios, or involving children and families who have no experience of trials (Corrigan 2003; Miller et al. 2004; Hunfeld & Passchier 2012) and evidence is needed about decision-making in real world situations.”

“Nevertheless, understandings of the complexities of contemporary biomedical investigations cannot be assumed; the realities of scientific research may be very different to people’s expectations, and participants may be unclear regarding the scope and nature of the studies in which they are participating.(5) 6 This is…”

“Although there are several well-known limits to informed consent [4, 5], its general importance remains mainly uncontested.”

“The proliferation of ethics is viewed as an expression of particular interests, and analyzed as negotiations between unequal actors ( Corrigan, 2003; Fortun, 2001; Novas and Rose, 2004; Pa´ lsson, 2002; Pa´ lsson and Harðardo ´ ttir, 2002; Pa ´lsson and Rabinow, 2004; Scocozza, 1994; Whitt, 1999).”

“…“partly constituted by communal traditions and norms” (Friedman 2000, 41) and thus broadens discussions on informed consent from a position of decontextualised ethics to one which embeds patients in their social contexts and interpersonal relations throughout their decision-making (Corrigan 2003).”

“Yet, it is the responsibility of research staff to empower subjects, rather than subjects empowering themselves, because few subjects express interest in the content of informed consent forms (Zussman, 1997; Corrigan, 2003; Fisher, 2006).”

“Misunderstandings (Corrigan, 2003), evolving interpretations (Heaven et al.”

“[63] When there is overwhelming and detailed information, especially where the consequences may be complex and/or uncertain, the precautionary bureaucratic and legalistic provision of dense and lengthy documentation contributes little to ethical practice in reality.”

“The bioethical literature on informed consent, 1980–2000 A fundamental part of the British bioethical assemblage and the new governance of medical research it has helped to bring into being is the literature on informed consent (Corrigan, 2003; O’Neill, 2002).”

“[8] Genetic research involves sample collection, genotyping, sequencing, data analysis at various levels, and use of samples or data for future research projects which may or may not be known at the time of sample collection.”

“It is this point which I suggest signifies the ‘emptiness’ of the principle of informed consent within the current status quo of prenatal screening (Corrigan 2003).”

“40,41 This may lead to the process of informed consent being exclusionary rather than inclusive, 2,4 particularly for some individuals or communities.”

“As for non-sensitive personal data, consent is usually considered as one of the most important bases for the use of sensitive data (Corrigan 2003).”

“Furthermore, while we saw that some interviewees viewed consent as an ethical panacea (Corrigan 2003), or emphatically underlined the value of the need for consent merely to drive their own motivations and interests, our findings also reflect the biomedical and forensic biobanking literature in…”

“[17–19]), studies focusing on the actual DMC evaluation in clinical practice are rare [20].”

“Then as a result, there will be no harmony between autonomy, empowerment and awareness of patient in decision-making from one hand, and powerful paternalistic authority of medical staff on the other hand [46, 47].”

“Genetics language and concepts have been said to add another layer of complexity to the already poor understanding of medical and scientific concepts (Bjorn et al., 1999; Burgess, 2007; Condit et al., 2004; Corrigan, 2003; Miller et al., 2006; Waggoner and Mayo, 1995; Wertz, 2002).”

“Thus the ‘accountability’ offered by audit can be perfunctory, legalistic and lead to an ethics that is empty (Corrigan, 2003).”

“Corrigan, 2003; Santen et al., 2005; Williamson & Wilkie, 1997).”

“In this paper we focus on philosophical and to some extent legal understandings of consent for research; but we note that consent is sociologically constructed and that our framing only sheds light on some aspects of the consent process [31].”

“The scandal and response model sees the codification of regulatory frameworks for ethics review as an episodic process which has historically been accelerated by public dismay at scandalous research (Corrigan, 2003; Israel and Hay, 2006; Powell et al., 2012).”

“(p. 28) Like many ethnographers (see, for example, Corrigan, 2003; Murphy & Dingwall, 2007; Roberts et al., 2013), we find this rigid, biomedically informed notion of “informed consent” limiting and potentially impinging on our study process as we discuss below.”

“Of course, this is muddied by the possibility that this knowledge could cause distress, as well as the difficulty of knowing what a diagnosis actually means for the patient and their future, thus calling into question the very possibility of being ‘fully informed’ (Corrigan, 2003).”

“Bioethics has focused predominantly on consent issues (Appelbaum, Lidz, & Meisel, 1987; Caplan, 1998), and social scientists have added significantly to scholarship on challenges and limitations to informed consent as well as strategies for optimizing the process (Corrigan, 2003; Featherstone & Donovan, 2002; Morris &…”

“The assumption underpinning informed consent is that the data subject’s rights and welfare are protected by providing a space for the data subject to make free and informed decisions regarding themselves and this must form a central pillar of all informed consent processes (Corrigan 2003).”

“Instead, decisions about participating in medical research are linked to broader social and moral reasoning [42]; personal concerns and experiences [40, 44, 45]; perceptions about medical research; and trust in the institutions conducting thework [43, 46].”

“Mário’s point of view is in line with trans activists’ requests for the use of an informed consent model as they believe this is a powerful tool against autocratic and paternalistic medical approaches (Corrigan, 2003) that constrain access to trans-specific healthcare (Davy et al., 2018).”

“This shift towards person-centred care [1] has been endorsed through policy that stresses its centrality to high-quality care: paying attention to, and displaying respect for, patients’ values and preferences are framed as important guards against the dangers of paternalism and autocratic practice by professionals [2]…”

“A wealth of studies suggest that informed consent, so vital to respect patients’ and research participants’ autonomy, is extremely hard to obtain in a meaningful sense (Gray, 1975; Lidz, Meisel, Osterweis, Holden, Marx, and Munetz, 1983; Fox and Sawzey, 1984; Harth and Thong, 1995; Corrigan, 2003).”

“22 Western countries have adopted a more patient autonomous approach in consent.(23) This concept was highlighted by the four principles in healthcare ethics by Beauchamp and Childress.”

“Yet as has become apparent through analyses of the implementation of informed consent documents in the clinical setting (Burgess 2001; Corrigan 2003; Dunne and Warren 1998), and of codes of ethics for professionals and businesses (Behrman 2001; Boo and Koh 2001; Stevens 2007), policy-based approaches to guiding or sha…”

“An example in genomic healthcare is Genomics Advisor, a tool to support decision-making for genomic secondary fi ndings, based on fi ve ‘ patient pro fi les ’ identi fi ed from qualitative data [26, 27].”

“research has demonstrated the diverse ways in which ethical norms are negotiated, transgressed and 170 transformed within the constraints of institutions and according to the interests of different actors 171 (Brosnan et al., 2013; Corrigan, 2003; Hedgecoe, 2014; Heimer, 2013; Hoeyer & Tutton, 2005; Hoeyer 172 & Jense…”

“Other work has emphasized the importance of the social and clinical context of research participation, and fleshed out the social processes involved (but often ignored) in giving informed consent (Corrigan, 2003) and the dynamic process and variability over time of clinical drug trial participation (Cox, 2000).”

“Configuring the patient as clinical research subject in the UK national health service Mary Adams* and Christopher McKevitt”

“Although the process of gaining consent can be oral or written, it generally takes the form of written informed consent (Corrigan 2003).”

“Others have problematised the idea of truly informed consent (Corrigan 2003), by showing that the realities and intricacies of fieldwork (overt and covert) mean that ensuring that all participants are fully informed and that they consent all of the time is, at best,”

“Corrigan (2003) and Levy (2014) question an idealistic view of informed consent when it is considered as “an ethical panacea to counter paternalistic medical practices” [38, 39].”

“An increased emphasis on paying attention to and displaying suitable respect for patients’ values and preferences is framed as an important guard against the dangers of paternalism and autocratic practice on the part of professionals (Corrigan, 2003).”

“As debates continue around how to define ‘informed consent’ and how it can be achieved and maintained (e.g. Corrigan, 2003; Molyneux, Peshu, & Marsh, 2004), these considerations could make a valuable contribution to deepening knowledge of how people make sense of research participation.”

“These issues mean that practitioners may have to negotiate potentially conflicting factors such as clinical need, patient choice and research requirements, when discussing donation with couples (Corrigan, 2003; Mortimer, 2005; Svendsen & Koch, 2008).”

“Today, these two concepts—respect for persons and informed consent—have become increasingly intertwined so as to be virtually indistinguishable (Corrigan, 2003; Dickert, 2009).”

“This strategy, which is a requirement of most ethical review boards, rests on the assumption that potential participants understand written information and once informed can consent freely (Corrigan, 2003).”

“They also appear to be effective at describing short-term risks, such as the likely side effects that might result from consuming the investigational drug (Corrigan 2003).”

“This view of objectification of the participants during the IC process is congruent to that of Corrigan’s [74], who claimed that “patients often become objects of the bureaucratic machinery.””

“%) made no reference to informed consent; for the UK, 21/25 (84%); Canada, 19/23 (82.6%); the Netherlands, 12/20 (60%); Japan, 8/15 (53.3%); China, 11/12 (91.7%); Spain, 9/11 (81.8%).”

“The concept of ‘informed consent’ became an ‘ethical panacea’ (Corrigan, 2003) to the problem of covertness in field research.”

“This avenue for future research aligns with health movements that support informed choice and patient-centred care and aim to counter paternalistic and hegemonic medical practices (Corrigan, 2003; Hersch et al., 2017).”

“Corrigan (2003) challenged these assumptions, arguing that overemphasis on the fully informed rational individual divorces the consent process from its social context and negates the role of social networks in everyday medical encounters, risk perception and decision-making.”