Assessment of the risk/benefit ratio of phase II cancer clinical trials by Institutional Review Board (IRB) members

Abstract

A substantial minority of IRB members believes that trial protocols provide too little information relevant to evaluating various cost/benefit and scientific issues, and feels less than fully competent in carrying out such evaluations. IRB members are more likely to identify psychosocial benefits than physical health benefits that may accrue to patients participating in phase II trials.

Awareness and attitudes towards clinical trials among Polish oncological patients who had never participated in a clinical trial

“…Other studies have established that the most important benefits that encourage patients to participate in clinical trials are: the possibility of reducing one's chance of getting cancer and the possibility of preventing others from getting cancer in the future, the psychosocial benefits of trial participation, and also the possible benefit of treatment effectiveness. 16,17 On the one hand, clinical trials are the basis for improvements in oncologic patient care, but on the other they have significant barriers. In our study, 69.1% of patients identified the fear of side effects as the greatest barrier to clinical trial participation, and 89.1% said that during clinical trials they may experience unexpected side effects.…”

Reviews: Emerging Empirical Evidence on the Ethics of Schizophrenia Research

“…[210][211][212] Data on the risk-benefit assessments or other review criteria used by IRB members are far less plentiful. 213,214 Despite the ongoing discussions about risk, and the need to protect potentially ''vulnerable'' groups, minimal data exist about how IRBs actually arrive at their complex decisions. 215,216 IRBs take on the extraordinary challenge of reviewing myriad protocols involving patients with medical and neuropsychiatric disorders, yet there is almost no guidance about how to define terms such as ''vulnerability,'' 33 how to determine whether investigators have provided protections adequate to the risks of a study, and how to identify adequate group decision making.…”

US and UK policies governing research with humans

“…However, no federal guidance indicates how researchers and IRBs should objectively analyze a study's risk-benefit ratio. Several commentators offer various approaches to analyzing risks and benefits and their relation to each other (King 2000;Henderson and King 2001;van Luijn et al 2002).…”