|Abstract||Research involving the vulnerable sick raises difficult challenges for investigators and Institutional Review Boards. Exactly who among the ill counts as vulnerable is a matter of judgement, and involves consideration of susceptibility to harm and capacity to provide free and informed consent. A balanced approach is required when protections are considered, and the benefits as well as the risks of research participation must be carefully weighed. A variety of protections for the vulnerable sick in research are available, including enrolling subjects in a study only with a strong justification, ensuring that consent is free and comprehending, and setting limits on the risk to which they may be asked to endure. Discussion of three contemporary controversies, placebo-controlled trials in the psychiatric setting, phase I clinical trials and oncology patients, and emergency room research involving patients incapable of giving consent, highlights the little recognized prominence of risk-benefit issues in the clinical studies in the vulnerable sick|
|Keywords||No keywords specified (fix it)|
|Categories||No categories specified (fix it)|
|Through your library||Only published papers are available at libraries|
Similar books and articles
Andrew D. McRae & Charles Weijer, Lessons From Everyday Lives: A Moral Justification for Acute Care Research.
Stephanie R. Solomon (2013). Protecting and Respecting the Vulnerable: Existing Regulations or Further Protections? Theoretical Medicine and Bioethics 34 (1):17-28.
Oonagh Corrigan (ed.) (2009). The Limits of Consent: A Socio-Ethical Approach to Human Subject Research in Medicine. Oxford University Press.
Alexander Friedman, Emily Robbins & David Wendler (2012). Which Benefits of Research Participation Count as 'Direct'? Bioethics 26 (2):60-67.
Andrew McRae & Charles Weijer, U.S. Federal Regulations for Emergency Research: A Practical Guide and Commentary.
Charles Weijer & Paul B. Miller, When Are Research Risks Reasonable in Relation to Anticipated Benefits?
R. Norman, D. Sellman & C. Warner (2006). Mental Capacity, Good Practice and the Cyclical Consent Process in Research Involving Vulnerable People. Clinical Ethics 1 (4):228-233.
Philip J. Nickel (2006). Vulnerable Populations in Research: The Case of the Seriously Ill. Theoretical Medicine and Bioethics 27 (3):245-264.
James A. Anderson & Jonathan Kimmelman (forthcoming). Are Phase 1 Trials Therapeutic? Risk, Ethics, and Division of Labor. Bioethics.
Margaret Brazier & Mary Lobjoit (eds.) (1991). Protecting the Vulnerable: Autonomy and Consent in Health Care. Routledge.
Pamela Fisher (2012). Ethics in Qualitative Research: 'Vulnerability', Citizenship and Human Rights. Ethics and Social Welfare 6 (1):2-17.
Tom L. Beauchamp, Bruce Jennings, Eleanor D. Kinney & Robert J. Levine (2002). Pharmaceutical Research Involving the Homeless. Journal of Medicine and Philosophy 27 (5):547 – 564.
Added to index2010-09-08
Total downloads11 ( #99,523 of 549,088 )
Recent downloads (6 months)1 ( #63,317 of 549,088 )
How can I increase my downloads?