Healthy Skepticism Library item: 4838

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Klanica K.
Conflicts of interest in medical research: how much conflict should exceed legal boundaries?
J Biolaw Bus 2005; 8:(3):37-45

Abstract:

This article addresses the current plague of financially conflicted research from various perspectives including the research community, the medical community, patients/subjects, the Food and Drug Administration (F.D.A.), and other government agencies. Part one lays out the current conflicts of interest within medical research. Part two explains the actual and potential effects of these conflicts, highlighting the conflict of interest associated with the death of Jesse Gelsinger. Part three describes how conflicts of interest are currently regulated by government agencies and within individual institutions. Lastly, part four concludes by recommending a system of seven balanced reform measures that protect research subjects and the scientific integrity of medical research while encouraging scientific progress.

Keywords:
Biomedical Research/economics* Biomedical Research/legislation & jurisprudence* Clinical Trials/adverse effects Clinical Trials/economics* Conflict of Interest/economics* Conflict of Interest/legislation & jurisprudence* Disclosure*/legislation & jurisprudence Disclosure*/standards Drug Industry/economics* Government Regulation* Human Experimentation/legislation & jurisprudence Human Experimentation/standards* Humans Informed Consent/standards National Institutes of Health (U.S.) Research Personnel/economics* Research Subjects Research Support* United States United States Food and Drug Administration Universities/economics