Research is often conducted without the knowledge or consent of those whose tissues are banked and poses possible harms to social groups if information about a few members is unscientifically applied to all.
Aside from its use to rule out potential physical causes of a patient’s condition, for example a brain tumor, neuroimaging is not used in the process of psychiatric diagnosis.
Developing technologies for personalized medicine may be misused to popularize the idea that one can infer a person’s genetic makeup from observer-defined or self-reported assignment to a race or ethnic group.
Some commentators say comparative trials of FDA-approved drugs are overburdened by current Common Rule regulations and that researchers should not be required to obtain explicit consent for participation in the most innocuous of these trials.
Anne Drapkin Lyerly, MD, MA and Ruth R. Faden, PhD, MPH
Participation in a research study—in which there are rigorous standards and close monitoring—may be a safer context for the use of medications in pregnancy than the clinical setting, where the evidence base is lacking.
Addicts quickly learn the diagnoses that cannot be definitively confirmed or ruled out by examinations or test results but that elicit prescriptions for opioid pain management.
Oliver Schirokauer, PhD, MD, Thomas A. Tallman, DO, MMM, Leah Jeunnette, PhD, Despina Mavrakis, MBA, and Monica L. Gerrek, PhD
An educational initiative is described in which medical and bioethics students observe health care in an urban jail for two days and reflect on their learning.
The FDA’s expanded access pathway allows patients with no other therapeutic options to request access to investigational agents, but manufacturers do not often grant it.