Recrutement et consentement à la recherche : réalités et défis éthiques

Contribution au Colloque « Consentez-vous (toujours) à participer à ma recherche? » : processus d'obtention et de renouvellement du consentement auprès de personnes vulnérables, présenté dans le cadre du 83e Congrès de l'Acfas, à Université du Québec à Rimouski, le 28 mai 2015.Le consentement à un traitement expérimental (activité de recherche) exige la prise en compte d’informations plus exhaustives que celles exigées pour consentir à un traitement innovateur (activité clinique). D’où l’importance de déterminer adéquatement le statut auquel correspond effectivement le traitement proposé. Or les définitions visant à départager la recherche de l’innovation sont reconnues depuis longtemps pour être peu opérationnelles, entraînant des risques de confusion. Cette confusion possible a un impact direct sur le consentement, puisque la nature du consentement requis dépend du statut qu’on accorde à l’intervention concernée. Ce problème est décrié depuis plus de 15 ans par de nombreux chercheurs, cliniciens, gestionnaires et autres parties prenantes. Où en sommes-nous aujourd’hui? Pratiquement au même point. C’est ce dont il sera question ici. À partir des principaux jalons de l’itinéraire de la notion de traitement innovateur depuis sa survenue dans les documents normatifs québécois, nous dégagerons quelques lieux de confusion quant à son opérationnalisation en recherche et en clinique. Finalement, quelques pistes de solution seront proposées.Abstract: Consent to an experimental treatment calls for a more exhaustive consideration of the relevant information than that is required to agree to an innovative treatment (clinical activity). It is thus important to adequately determine the status to which the proposed treatment effectively corresponds. However, the definitions aimed at defining the difference between research and innovation have been recognized to be minimally operational for a long time, which is causing some risks of confusion. Such possible confusion has a direct impact on consent, since the very nature of the required consent depends on the status given to the intervention at stake. This problem has been decried by numerous researchers, clinicians, managers and other stakeholders for more than 15 years. Where are we at today? Practically at the same point. This is what will be discussed here. Starting with the principal itinerary milestones of the notion of innovative treatment presented at the beginning of its occurrence in normative Quebec documents, we will extract statements where the confusion has been documented with respect to the operationalization aspect in research as well as in the clinical field. Finally, a few paths of solutions will be proposed

A biobank management model applicable to biomedical research

BACKGROUND: The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. Some REBs have even rejected research projects where the use of a biobank with coded samples was an integral part of the study, the greatest fear being the lack of participant protection and uncontrolled use of biological samples or related genetic data. The risks of discrimination and stigmatization are a recurrent issue. In light of the increasing interest in biomedical research and the resulting benefits to the health of participants, it is imperative that practical solutions be found to the problems associated with the management of biobanks: namely, protecting the integrity of the research participants, as well as guaranteeing the security and confidentiality of the participant's information. METHODS: We aimed to devise a practical and efficient model for the management of biobanks in biomedical research where a medical archivist plays the pivotal role as a data-protection officer. The model had to reduce the burden placed on REBs responsible for the evaluation of genetics projects and, at the same time, maximize the protection of research participants. RESULTS: The proposed model includes the following: 1) a means of protecting the information in biobanks, 2) offers ways to provide follow-up information requested about the participants, 3) protects the participant's confidentiality and 4) adequately deals with the ethical issues at stake in biobanking. CONCLUSION: Until a governmental governance body is established in Quebec to guarantee the protection of research participants and establish harmonized guidelines for the management of biobanks in medical research, it is definitely up to REBs to find solutions that the present lack of guidelines poses. The model presented in this article offers a practical solution on a day-to-day basis for REBs, as well as researchers by promoting an archivist to a pivotal role in the process. It assures protection of all participants who altruistically donate their samples to generate and improve knowledge for better diagnosis and medical treatment

Assessing the Social Acceptability of New Technologies: Gaps and Tensions Between Science and Regulation

ArticleLes considérations éthiques concernant le développement de technologies font maintenant partie du champ de la bioéthique, concentrées en grande partie sur les interactions entre la science et le gouvernement pour établir le bien social. Depuis l’avènement des différentes formes de biotechnologies, l’analyse scientifique des risques a fait l’objet de diverses lignes de questionnement par rapport au rôle que la science quantitative joue dans la surveillance gouvernementale. Cela est d’autant plus important dans le débat actuel sur l’acceptabilité des nanotechnologies. Dans cet article, nous précisons d’abord les points forts et les limites de l’analyse scientifique de l’acceptabilité sociale des risques de la nanotechnologie. Ensuite, nous montrons les limites de l’adoption d’une approche empirique dans les sciences sociales et humaines pour prédire l’acceptabilité sociale d’une technologie. Nous soutenons que la reconnaissance des hypothèses sous-jacentes de ces deux approches quantitatives doit ouvrir une route à des approches plus réflexives par les sciences sociales et les sciences humaines.Ethical considerations regarding the development of technologies are now a standard part of the field of bioethics, focused in large part on the interactions between science and government in establishing the social good. Since the advent of different forms of biotechnology, scientific risk analysis has been subject to various lines of questioning relative to the role that quantitative science plays in government oversight. This is even more significant in the present debate on the acceptability of nanotechnology. In this article, we first specify the strengths and limitations of the scientific analysis of the social acceptability of risks in nanotechnology. Next, we demonstrate the limitations of taking an empirical approach in the social sciences and the humanities to predicting the social acceptability of a technology. We argue that recognizing the assumptions underlying these two quantitative approaches should open up a road to more reflective approaches by the social sciences and the humanities

Les enjeux identitaires de l’humain dans le débat philosophique sur la robotique humanoïde et l’amélioration humaine

ArticleLes représentations identitaires de l’humain (identité humaine, distinction naturel/artificiel) font-elles encore sens dans le contexte du développement de la robotique humanoïde (par l’humanisation du robot) et de l’amélioration humaine (par la robotisation de l’humain)? Le problème est que des philosophes critiques, comme Lin et Allhoff qui ont fondé la revue NanoEthics, remettent en question ces représentations identitaires de l’humain, comme si le discours de l’évaluation éthique fondée sur ces représentations était caduc quant aux deux questions qu’ils posent dans Ethics of Human Enhancement: 25 Questions and Answers en 2009: « Does the notion of human dignity suffer with human enhancements? » et « Is the natural-artificial distinction morally significant in this debate? » Le but du présent article sera de montrer, à partir de différents textes publiés, qui constituent notre cadre d’analyse des arguments moraux, la portée et l’insuffisance des arguments critiques que Lin et Allhoff utilisent pour répondre à ces deux questions. Mais, en appliquant à ces auteurs ce cadre de référence, nous pourrons aussi montrer en quoi la question de l’identité humaine ou la distinction naturel/artificiel fait encore sens dans l’évaluation éthique.Do human identity representations (human identity, natural/artificial distinction) still make sense in the context of the development of humanoid robotics (humanizing the robot) and human enhancement (automation of the human)? The problem is that critical philosophers, like Lin and Allhoff who founded the journal NanoEthics, challenge these representations of human identity, as if the discussion of the ethical evaluation of these representations was exhausted with regards to the two issues that they raise in 2009 in Ethics of Human Enhancement: 25 Questions and Answers, i.e.: “Does the notion of human dignity suffer with human enhancements?” and “Is the natural-artificial distinction morally significant in this debate?” The purpose of this article is to show – in light of various texts that constitute our framework for analyzing moral arguments – the limits of the scope and insufficiency of the critical arguments that Lin and Allhoff use to answer these two questions. But in applying our framework to these authors, we will also show how the question of human identity or the natural/artificial distinction still makes sense in the ethical evaluation

Les comités d’éthique de la recherche sur l’humain : les chercheurs face aux enjeux d’internormativité et de gouvernance

Cet article présente les résultats d’une étude pancanadienne qui a été menée entre octobre 2007 et juin 2008 auprès de deux catégories de chercheurs canadiens, soit des médecins-chercheurs et des chercheurs académiques, dont les principaux domaines de recherche se situaient en sciences humaines, en sciences sociales, en sciences de la santé ou en sciences naturelles et génie et qui avaient soumis à un comité d’éthique de la recherche leur protocole. Par cette étude nous voulions d’une part étayer plus clairement les satisfactions et insatisfactions de chercheurs face aux comités d’éthique de la recherche et d’autre part vérifier l’hypothèse qu’il existe, en arrière-plan des insatisfactions, des enjeux plus profonds concernant la visée éthique des dispositifs actuels. Les résultats globaux de l’étude démontrent que pour répondre aux insatisfactions des chercheurs, une réflexion s’impose pour réduire l’écart entre le dispositif actuel des comités d’éthique de la recherche et les attentes normatives des chercheurs.Abstract : This article presents and discusses the results of a pancanadian study undertaken between October 2007 and June 2008, dealing with the degree of satisfaction of researchers in their dealings with Research Ethics Boards. A questionnaire was sent to medical and academic researchers who had submitted a research proposal to a REB. Through this study it was not only the writers’ intent to determine the level of satisfaction of researchers in their involvement with REBs, but also to verify the hypothesis that behind certain expressions of dissatisfaction, there exist more profound issues concerning the ethical goals fostered by the present system. The overall results of this study indicate that in order to address the complaints of researchers, some reflection is needed in order to reduce the gap between the present system governing REBs and the normative expectations of researchers

The Social and Ethical Acceptability of NBICs for Purposes of Human Enhancement: Why Does the Debate Remain Mired in Impasse?

The emergence and development of convergent technologies for the purpose of improving human performance, including nanotechnology, biotechnology, information sciences, and cognitive science (NBICs), open up new horizons in the debates and moral arguments that must be engaged by philosophers who hope to take seriously the question of the ethical and social acceptability of these technologies. This article advances an analysis of the factors that contribute to confusion and discord on the topic, in order to help in understanding why arguments that form a part of the debate between transhumanism and humanism result in a philosophical and ethical impasse: 1. The lack of clarity that emerges from the fact that any given argument deployed (arguments based on nature and human nature, dignity, the good life) can serve as the basis for both the positive and the negative evaluation of NBICs. 2. The impossibility of providing these arguments with foundations that will enable others to deem them acceptable. 3. The difficulty of applying these same arguments to a specific situation. 4. The ineffectiveness of moral argument in a democratic society. The present effort at communication about the difficulties of the argumentation process is intended as a necessary first step towards developing an interdisciplinary response to those difficulties

Accompagner du développement d’innovations technologiques : favoriser des usages responsables

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