Forty years ago, the Belmont Report counseled that a “systematic, nonarbitrary analysis of
risks and benefits” is vital to ensuring the ethical appropriateness of research with human …

Healthy volunteers in biomedical research often face significant risks in studies that offer
them no medical benefits. The US federal research regulations and laws adopted by other …

Reigning regulatory frameworks for biomedical research impose on researchers and
research ethics committees an obligation to protect research participants from risks that are …

Clinical research attempts to address a relatively straightforward, and important challenge:
how do we determine whether one medical intervention is better than another, whether it …

To characterize the range of opinions in the current debate over disclosure of individual
genetic research results, Ravitsky and Wilfond (2006) describe the opposing ends of the …

Burris and Davis (2009) raise questions regarding the potential for institutional review
boards (IRBs) to require empirical assessment of risk prior to the initiation of research, as a …

The authors of the target articles in this issue add new perspectives to decades-old debates
about payment for research participation: Under what particular circumstances is payment …

Many believe that informed consent makes clinical research ethical. However, informed
consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic …

Most ethical commentary on clinical research concerns studies involving patient-subjects.
Several reasons may account for the relative neglect of ethical appraisal of research with …

The possibility that at least some participants would find research results clinically or
personally useful should be evaluated based on the best available evidence, ie, the …