The evaluation of the risks and benefits of phase II cancer clinical trials by institutional review board (IRB) members: a case study

Journal of Medical Ethics
H E M Van LuijnA W Musschenga

Abstract

There are indications that institutional review board (IRB) members do not find it easy to assess the risks and benefits in medical experiments, although this is their principal duty. This study examined how IRB members assessed the risk/benefit ratio (RBR) of a specific phase II breast cancer clinical trial. The trial was evaluated by means of a questionnaire administered to 43 members of IRBs at six academic hospitals and specialised cancer centres in the Netherlands. The questionnaire addressed: identification and estimation of inconvenience, toxicity, psychosocial distress, and benefits of trial participation to patients; identification and estimation of benefits to future patients and medical science; assessment of the trial's RBR; and assessment of its ethical acceptability. Most IRB members expected trial participation to involve fairly or very serious inconvenience, fairly severe to sometimes life-threatening toxicity, and serious psychological and social consequences. Conversely, the perceived likelihood of benefits to patients was modest. Most regarded the study as important, and the balance between risks and benefits to be favourable, and believed that the protocol should be approved. The IRB members' final judgement...Continue Reading

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Citations

Nov 3, 2009·The American Journal of Bioethics : AJOB·Rosemarie D C BernabeJohannes J M van Delden
Apr 24, 2009·Journal of Empirical Research on Human Research Ethics : JERHRE·Elisa J Gordon, Sean Philpott
Jul 24, 2012·Drug Discovery Today·Rosemarie D C BernabeJohannes J M van Delden
Jul 12, 2011·Drug Discovery Today·Rosemarie D C BernabeJohannes J M van Delden
Sep 25, 2014·Journal of Medical Ethics·Spencer Phillips Hey
Sep 20, 2007·Accountability in Research·A W MusschengaN K Aaronson
Jul 17, 2008·Medicine, Health Care, and Philosophy·Scott Y H KimKarl Kieburtz
Aug 24, 2011·Clinical Trials : Journal of the Society for Clinical Trials·Annette Rid, David Wendler
Jun 26, 2021·Monash Bioethics Review·Boris HandalMarc Fellman

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