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  1. Individual Risk and Community Benefit in International Research.Robert C. Hughes - 2012 - Journal of Medical Ethics 38 (10):626-629.
    It is widely agreed that medical researchers who conduct studies in low- and middle-income countries (LMICs) are morally required to ensure that their research benefits the broader host community, not only the subjects. The justification for this moral requirement has not been adequately examined. Most attempts to justify this requirement focus on researchers' interaction with the community as a whole, not on their relationship with their subjects. This paper argues that in some cases, research must benefit the broader host community (...)
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  • Post-Trial Access to Study Medication: A Brazilian E-Survey with Major Stakeholders in Clinical Research.S. M. Dainesi & M. Goldbaum - 2012 - Journal of Medical Ethics 38 (12):757-762.
    Objectives To analyse the perspective of clinical research stakeholders concerning post-trial access to study medication. Methods Questionnaires and informed consents were sent through e-mail to 599 ethics committee (EC) members, 290 clinical investigators (HIV/AIDS and Diabetes) and 53 sponsors in Brazil. Investigators were also asked to submit the questionnaire to their research patients. Two reminders were sent to participants. Results The response rate was 21%, 20% and 45% in EC, investigators and sponsors’ groups, respectively. 54 patients answered the questionnaire through (...)
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  • Beyond Informed Consent: The Therapeutic Misconception and Trust.Inmaculada de Melo-Martin & A. Ho - 2008 - Journal of Medical Ethics 34 (3):202-205.
    The therapeutic misconception has been seen as presenting an ethical problem because failure to distinguish the aims of research participation from those receiving ordinary treatment may seriously undermine the informed consent of research subjects. Hence, most theoretical and empirical work on the problems of the therapeutic misconception has been directed to evaluate whether, and to what degree, this confusion invalidates the consent of subjects. We argue here that this focus on the understanding component of informed consent, while important, might be (...)
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  • Should Post-Trial Provision of Beneficial Experimental Interventions Be Mandatory in Developing Countries?Z. Zong - 2008 - Journal of Medical Ethics 34 (3):188-192.
    The need for continuing provision of beneficial experimental interventions after research is concluded remains a controversial topic in bioethics for research. Based on the principle of beneficence, justice as reciprocity, concerns about exploitation and fair benefits, participants should be able to have continuing access to benefits beyond the research period. However, there is no consensus about whether or not post-trial provision of beneficial interventions should be mandatory for participants from developing countries. This paper summarises recommendations from international and national guidelines. (...)
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  • Protecting Communities in Health Research From Exploitation.Segun Gbadegesin & David Wendler - 2006 - Bioethics 20 (5):248-253.
    Guidelines for health research focus on protecting individual research subjects. It is also vital to protect the communities involved in health research. In particular, a number of studies have been criticized on the grounds that they exploited host communities. The present paper attempts to address these concerns by providing an analysis of community exploitation and, based on this analysis, determining what safeguards are needed to protect communities in health research against exploitation. (edited).
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  • Reporting of Informed Consent, Standard of Care and Post-Trial Obligations in Global Randomized Intervention Trials: A Systematic Survey of Registered Trials.Emma R. M. Cohen, Jennifer M. O'neill, Michel Joffres, Ross E. G. Upshur & Edward Mills - 2009 - Developing World Bioethics 9 (2):74-80.
    Objective: Ethical guidelines are designed to ensure benefits, protection and respect of participants in clinical research. Clinical trials must now be registered on open-access databases and provide details on ethical considerations. This systematic survey aimed to determine the extent to which recently registered clinical trials report the use of standard of care and post-trial obligations in trial registries, and whether trial characteristics vary according to setting. Methods: We selected global randomized trials registered on http://www.clinicaltrials.gov and http://www.controlled-trials.com. We searched for intervention (...)
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  • Reasons Why Post-Trial Access to Trial Drugs Should, or Need Not Be Ensured to Research Participants: A Systematic Review.N. Sofaer & D. Strech - 2011 - Public Health Ethics 4 (2):160-184.
    Background : researchers and sponsors increasingly confront the issue of whether participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. Purpose: to systematically review reasons why drug trial participants should, or need not be ensured PTA to the trial drug (...)
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