Risks and Benefits

This chapter explores a variety of issues related to managing risks and benefits in research with human subjects, including defining risks and benefits; minimizing risks; the relationship between scientific study design issues and risks and benefits; assessing risks and benefits; balancing risks and benefits; the role of empirical evidence and intuition in risk/benefit decision-making; social benefits and risks; harms to communities, family members, and other third parties; the ethics of randomly assigning patients to different treatment groups; the use of placebos in research; the relevance of equipoise to clinical trial design and problems with the equipoise concept; challenge studies involving healthy human subjects; phase I clinical studies on healthy volunteers and cancer patients; limits for risks in studies involving healthy volunteers; controversies concerning the definition of minimal risk; alternative study designs, such as uncontrolled trials; sharing individualized results with research participants; providing ancillary medical care to research participants; post-trial access to medications; and fair sharing of the benefits of research.