Ethical considerations concerning treatment allocation in drug development trials

Senn, S
October 2002
Statistical Methods in Medical Research;Oct2002, Vol. 11 Issue 5, p403
Academic Journal
journal article
It is claimed that much of the opposition to placebos is based on the misunderstanding that their use implies the withholding of effective treatments. It is also argued that the ethical feasibility of a trial must be judged by comparing the likely prognosis of patients in the trial to their expectations outside the trial. Furthermore, a longer-term perspective of the patients needs is necessary; the ethical dilemmas involved cannot be resolved at the point of sickness. Some device such as the 'original position' of the philosopher John Rawls is needed. Finally, it is argued that placebo run-ins involve a violation of consent and should be eliminated from clinical trials.


Related Articles

  • Valid consent for genomic epidemiology in developing countries. Chokshi, Dave A.; Thera, Mahamadou A.; Parker, Michael; Diakite, Mahamadou; Makani, Julie; Kwiatkowski, Dominic P.; Doumbo, Ogobara K. // PLoS Medicine;Apr2007, Vol. 4 Issue 4, pe95 

    Drawing on experience gained from ongoing research in Mali, this paper describes practical ethical challenges relating to the achievement of valid consent in genomic epidemiology.

  • Consent and discontent. Wenger, Neil S.; Shapiro, Martin F. // CMAJ: Canadian Medical Association Journal;12/15/97, Vol. 157 Issue 12, p1691 

    Examines the status of research ethics and informed consent, as of December 15, 1997. Report of the United States Advisory Committee on Human Radiation Experiments regarding tests done without participants' consent; Protection levels for subjects; Cases of scientific misconduct; Impact of...

  • When Is It Ethical to Withhold a Research Incentive? Tomlinson, Tom // IRB: Ethics & Human Research;Nov/Dec2011, Vol. 33 Issue 6, p14 

    The article presents a discussion of a hypothetical research project involving an online survey which will present survey respondents a $10 gift certificate for completing the survey. A discussion of the moral and ethical issues that are raised in withholding a research incentive in cases such...

  • Informed consent on trial. Cressey, Daniel // Nature;2/2/2012, Vol. 482 Issue 7383, p16 

    The article reports on the European Forum for Good Clinical Practice meeting held in Brussels, Belgium in January 2012, focusing on a discussion of ethics concerns regarding informed consent standards for clinical trials. Suggestions for improving consent form documents included adding summaries...

  • Next-generation sequencing: does the next generation still have a right to an open future? Bredenoord, Annelien L.; de Vries, Martine C.; van Delden, Johannes J. M. // Nature Reviews Genetics;May2013, Vol. 14 Issue 5, p306 

    The article offers the authors insights on the ethical aspects of the next-generation sequencing (NGS) which is anticipated to lead a new era in paediatric diagnosis and research. They say that NGS is a diagnostic tool that brings genetic information, but the ethical challenges is whether to...

  • Informed Consent to Treatment in Psychiatry. Neilson, Grainne; Chaimowitz, Gary; Zuckerberg, Joaquin // Canadian Journal of Psychiatry;Apr2015, Vol. 60 Issue 4, p1 

    Patients have a right to be informed and actively involved in their health care. Fundamental to a person's dignity and autonomy is the right to make decisions about their psychiatric treatment, including their right to refuse unwanted treatments, providing that the refusal is a capable one. It...

  • Protecting People Who Decline to Participate in Research: An Example from a Prison Setting. STILES, PAUL G.; EPSTEIN, MONICA; POYTHRESS, NORMAN; EDENS, JOHN F. // IRB: Ethics & Human Research;Mar/Apr2012, Vol. 34 Issue 2, p15 

    No abstract available.

  • Capacity to consent to biomedical research's evaluation among older cognitively impaired patients. A study to validate the University of California Brief Assessment of Capacity to Consent questionnaire in French among older cognitively impaired patients. Duron, Emmanuelle; Boulay, M.; Vidal, Jean-S├ębastien; Bchiri, Jamila; Fraisse, Marie-Laure; Rigaud, Anne; Hugonot-Diener, Laurence // Journal of Nutrition, Health & Aging;Apr2013, Vol. 17 Issue 4, p385 

    Context: Some studies have highlighted the difficulty for physicians to evaluate patient's ability to consent to bio-medical research in the elderly population. The University of California Brief Assessment of Capacity to Consent (UBACC) is a rapid questionnaire to assess the ability to consent,...

  • Ethical implications of consent in translational research. Moore, Helen; McSherry, Wilfred // Cancer Nursing Practice;Dec2013, Vol. 12 Issue 10, p22 

    In the UK in 2010, 325,000 people were diagnosed with cancer with one in four dying from the disease. Cancer research is therefore a healthcare priority. Over the past two decades, more people have been cured and, of those who are in the palliative stages of disease, more are living longer....

  • Ethics of Biobank Research Come Under Scrutiny. Ward, Philip // Applied Clinical Trials;Nov2011, Vol. 20 Issue 11, p18 

    The article reports on the issues concerning biobank research's ethical aspects. It states that the intense discussion on biobank research has emerged following the claim of Swedish authors that essential studies could be hampered by the need to get informed consent in using samples of left-over...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics