[Ethics of research: the freedom to withdraw].
ABSTRACT Because they do not have universal access to health care, the poorest people in developing countries often have no other choice but to participate in medical research. In exchange for their contribution to a clinical trial and their adhesion to the study protocol, they receive a bare minimum of health services. Can the notion of informed and free consent be applied under these conditions? Does the provision of care actually constitute a powerful incentive to participate in biomedical research that contradicts the notion of free will? Suppressing this promise of care will not resolve issues for research participants in resource-limited countries. On the contrary the promise of care must be extended to all potential research participants who approach the investigators regardless of their participation in the research. Additionally, all participants should be able to withdraw the trial at any time when he/she considers that his/her interest is better dealt with outside the frame. An individual's consent could be continually renewed, informed by his/her experience throughout the course of the trial independently of the health services that are offered. A standard of care could be offered to those who decide to break the contract that connects them to researchers including the first day after the signature of the consent. Would the provision of care constitute an "even more powerful incentive" for participants to enter into trials and/or create a situation whereby research is no longer possible? Or would it be on the contrary a beneficial reform, forcing research to propose less restricting and heavy protocols, for the obvious potential direct benefits so that the participants would not be tempted to withdraw the programme? This article and the ideas put forward are directly inspired from dialogues presented on the EthicHIV discussion forum, set up by sidaCTlON as a part of their program on ethics in HIV-related research in developing countries.
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ABSTRACT: To describe what is known about the factors that influence cancer clinical trial decision making. PubMed database and reference lists of identified articles. Variations in research design and methods, including sample characteristics, instrumentation, time between decision made and measurement of decision making, and response rates, have effects on what is known about decision making for cancer clinical trial participation. Communication, whether in the form of education about a cancer clinical trial or as a personal invitation to join, is an important factor influencing decision making. Personal and system factors influence the outcomes of decision making for cancer clinical trials. The process of decision making for cancer clinical trials is understudied. Nevertheless, the currently available cancer clinical trial decision-making literature suggests a multitude of factors that influence the outcomes of the decision to accept or decline clinical trial participation, as well as the psychosocial consequences of decisional regret, pressures, and satisfaction. The decision-making process of cancer clinical trials is a fertile area for research and, subsequently, evidence-based interventions. Oncology nurses are in a position to facilitate the process and to relieve the pressures patients perceive regarding decision making for cancer clinical trials that will benefit individuals and, ultimately, society.Oncology Nursing Forum 11/2010; 37(6):E387-99. DOI:10.1188/10.ONF.E387-E399 · 1.91 Impact Factor
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ABSTRACT: Based upon Kenyan ethnography, this article examines the gap between the bioethics aversion to value transfers in clinical trials, and research participants' and researchers' expectations of these. This article focuses upon so-called 'transport reimbursement' (TR): monetary payments to participants that are framed as mere refund of transport expenses, but which are of considerable value to recipients. The interest in this case lies not so much in the unsurprising gap between regulatory norms and poor study subjects' lives, but in the way in which this discrepancy between bioethical discourse and materialities of survival is silenced. In spite of the general awareness that TR indeed is about the material value of research, about value calculation, and expectations of return, it is not publicly discussed as such - unless ironically, in jest, or in private. This double-blindness around 'reimbursement' has provoked discussions among ethicists and anthropologists, some of which propose that the work that generates scientific value should be recognised as labour and participants, accordingly, paid. Here, this paper argues that such a re-vision of trial participation as work rather than as a gift for the public good, risks abrogating the possibility of 'the public' that is not only a precondition of public medical science, but also its potential product. The supposedly radical solution of tearing away the veils of misrecognition that 'free' gifting ideology lays upon the realities of free labour, though analytically plausible, fails to recognise the utopian openings within clinical trial transactions that point beyond the present - towards larger forms of social association, and towards future alignments of scientific possibilities and human lives.Journal of Cultural Economy 02/2011; 4(1):45-64.