La notion de consentement éclairé : mythe ou réalité pour les pays africains
Author(s)Adiogo Dieudonné, Désiré
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AbstractR&#233;sum&#233;La question du consentement &#233;clair&#233; en Afrique est une question &#224; grand d&#233;bat entre d&#8217;une part, les tenant du respect de l&#8217;autonomie de la personne et d&#8217;autre part, les d&#233;fenseurs de l&#8217;organisation communautaire. Ces deux th&#232;se se doivent d&#8217;&#234;tre compl&#233;mentaire afin de concilier : le respect de l&#8217;autonomie de la personne participant &#224; la recherche et la pr&#233;servation de toutes les diversit&#233;s qui sont un des garant du progr&#232;s. Du fait de la faible capacit&#233; des populations &#224; se d&#233;terminer et du faible engouement des diff&#233;rents acteurs de la recherche, il est important qu&#8217;une d&#233;marche pour la pr&#233;servation des droits des sujets participant &#224; la recherche et des communaut&#233;s soit mise en &#339;uvre. Pour cela il est important de responsabiliser d&#8217;une part, les sponsors et les chercheurs et d&#8217;autre part, les comit&#233;s d&#8217;&#233;thiques qui sont les r&#233;gulateurs du processus.
The question of informed consent in Africa is an issue of great debate between the defenders of the respect of personal independence and the defenders of community organization. These two theses need to be complementary in order to reconcile: the respect of personal independence participating in research and the preservation of all diversity which are one of the guarantors of progress. Due to the weak capacity of groups to be determined and due to the weak interest of the different research players, it is important that a step towards the preservation of the rights of subjects participating in research and communities be implemented. For this, it is important to give a sense of responsibility to both sponsors and researchers and the ethics committees that regulate this process.
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Acil Tip'ta Aydinlatilmi? OnamErsoy, Nermin; Ozcan Senses, Müesser; Aydin Er, Rahime (2016-01-09)Informed consent is a prerequisite for the ethical and legal validity of the emergency intervention in emergency medicine, since it protects the fiduciary relationship between the physician and patient; the principle of honesty that grounds this relationship; the principle of autonomy that necessitates right of self-determination; and the principle of respect for persons. Informed consent in emergency medicine, which is supposed to include the nature, benefits and risks of emergency medical intervention, differentiates with respect to definite groups of patients: (1) conscious patients, (2) unconscious patients, and (3) children and mature minors. In addition, informed consent differentiates between medical, psychological and even social circumstances of the patients, referred to as valid consent, expressed-explicit consent, blanket consent, presumed consent, tacit consent, proxy consent, and parental consent. There are a few exceptions in which emergency medical intervention is administered without informed consent. In addition to the exceptions of life-saving interventions, when a patient can not decide for herself/himself, intervention of the physician in the best interest of the patient or children is based on the "therapeutic privilege" of the physician. As an ethically defensible right, since therapeutic privilege may open a door to hard paternalistic approaches, in those situations, emergency physicians should be cautious not to violate a patient's autonomy.
Informed Consent for Psychiatric Research: The Case of Medication-Free ResearchBerghmans, Ron L.P. (2016-01-08)Informed consent for research in psychiatry raises a number of ethical and legal issues. To illustrate some of the ethical problems involved, in particular issues of patient competence and proxy consent, as well as the motives of patients to become research participants, as an example the case of so-called medication-free research in schizophrenia is discussed. It is argued that an assessment of the competence of potential research subjects to consent to participation, based on explicit criteria, is necessary. In case of substituted consent it is shown that proxy decision makers may fail to protect the interests of incompetent patients in research. Finally, researchers ought to be aware that research subjects may be motivated to participate in research because they may mistakenly believe that the research project is designed to benefit them directly.
Handling ethical, legal and social issues in birth cohort studies involving genetic research: responses from studies in six countries.Ries, Nola M.; LeGrandeur, Jane; Caulfield, Timothy (2011-07-12)BACKGROUND: Research involving minors has been the subject of much ethical debate. The growing number of longitudinal, pediatric studies that involve genetic research present even more complex challenges to ensure appropriate protection of children and families as research participants. Long-term studies with a genetic component involve collection, retention and use of biological samples and personal information over many years. Cohort studies may be established to study specific conditions (e.g. autism, asthma) or may have a broad aim to research a range of factors that influence the health and development of children. Studies are increasingly intended to serve as research platforms by providing access to data and biological samples to researchers over many years.This study examines how six birth cohort studies in North America and Europe that involve genetic research handle key ethical, legal and social (ELS) issues: recruitment, especially parental authority to include a child in research; initial parental consent and subsequent assent and/or consent from the maturing child; withdrawal; confidentiality and sample/data protection; handling sensitive information; and disclosure of results. METHODS: Semi-structured telephone interviews were carried out in 2008/09 with investigators involved in six birth cohort studies in Canada, Denmark, England, France, the Netherlands and the United States. Interviewees self-identified as being knowledgeable about ELS aspects of the study. Interviews were conducted in English. RESULTS: The studies vary in breadth of initial consent, but none adopt a blanket consent for future use of samples/data. Ethics review of new studies is a common requirement. Studies that follow children past early childhood recognise a need to seek assent/consent as the child matures. All studies limit access to identifiable data and advise participants of the right to withdraw. The clearest differences among studies concern handling of sensitive information and return of results. In all studies, signs of child abuse require reports to authorities, but this disclosure duty is not always stated in consent materials. Studies vary in whether they will return to participants results of routine tests/measures, but none inform participants about findings with unknown clinical significance. CONCLUSIONS: Analysis of how cohort studies in various jurisdictions handle key ELS issues provides informative data for comparison and contrast. Consideration of these and other examples and further scholarly exploration of ELS issues provides insight on how best to address these aspects in ways that respect the well-being of participants, especially children who become research subjects at the start of their lives.