The ethical demands of 21st-century clinical research

What should the ethics of clinical research look like as biomedical science advances? Debate is already underway about physicians’ responsibilities to current and future patients.

The December issue of the AMA Journal of Ethics explores the roles of physicians and patients in improving the art and science of medicine in the 21st century.

The issue features:

“Expanded access to new drugs: What physicians and the public need to know about FDA and corporate processes.” Existing treatments don’t cure some patients’ illnesses. When this happens, physicians can help patients get access to investigational drugs through the expanded access process. This article investigates what changes to this process mean for patient care.
“Patient-physician relationships and research on medical practice: Do OHRP guidelines help?” Boundaries between clinical research and practice are often blurred, but their convergence can be necessary for improving patient care. This article explores whether and when government regulations can help physicians study their own practices and impact health outcomes.
“Enrolling research participants in clinical settings: Conflicts of interest, consistency, therapeutic misconception, and informed consent.” Using a case example, this article investigates ethical predicaments physicians face when enrolling patients in clinical trials.

In the journal’s December podcast, Robert Levine, co-author of the landmark Belmont Report, discusses changes in clinical research guidelines, conflicts of interest among institutional review board members and the top ethical challenges facing clinical researchers today.

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