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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 …

© 2012 Canadian Medical Association or its licensors CMAJ, April 3, 2012, 184 (6) 657
government or regulatory approval of new drugs and devices is sought. Again, this differs …

Over the last 60 years or so, there has been myriad guidance on the ethical conduct of
research with humans1–13 (see Table 11.1). Despite the profusion, the extant guidance …

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 …

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

Ethics and regulation of research with humans have coexisted in a somewhat uneasy
relationship in the United States for the past 60 years. Wartime atrocities committed by Nazi …

The history of clinical research is, unfortunately, filled with examples of research studies that
took advantage of and harmed research participants, to fulfill the research goals of scientists …

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 …

Created by the World Medical Association (WMA) in the wake of historical abuses and
violence committed under the guise of scientific research, the Declaration of Helsinki (DoH) …