IRB: Ethics & Human Research

Evaluating the Risks and Benefits of Phase II and III Clinical Cancer Trials: A Look at Institutional Review Board Members in the Netherlands

This study examined the opinions of Dutch institutional review board members about the assessment of the risk-benefit ratio in phase II and phase III clinical cancer trials.  We conducted interviews with 53 members of IRBs from four academic hospitals and two specialized cancer centers in the Netherlands.  Lack of evaluation criteria, uncertainty concerning the benefits to patients, and insufficient information about the study rationale were mentioned frequently as difficult aspects when assessing the risk-benefit ratio in phase II and III cancer protocols.  More than half of the IRB members expressed interest in obtaining more information and education to make these assessments.  Many also believed that better insight into patients’ perspectives could aid them.  However, only a minority favor actually including patients on IRBs.

Key words/concepts:  clinical cancer trials, risk-benefit ratio, ethics review, The Netherlands