"How much do you get paid if I volunteer?" Suggested institutional policy on reward, consent, and research.
Pharmaceutical companies often ask practicing physicians to conduct phase IV or postmarketing research on new drugs. Companies pay physicians to enroll their patients and report dosage and side-effect information. Postmarketing research embraces a multibillion dollar effort at promotion and familiarization, but subjects' informed consent to it normally does not include physician reward. Improving investigators' financial status while increasing medical risks to phase IV subjects is ethically unsound, especially if subjects are unaware of investigators' rewards. We suggest a model policy and guidelines that affirm subjects' need for informed consent, investigators' need for recognition and support, and institutions' need to protect patients from undisclosed risk and relations.
Lutheran General Hospital, Park Ridge, IL.
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La Puma
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Kraut
D017327:Clinical Trials, Phase IV as Topic / Q000191:economics / Q000592:standards*; D016265:Conflict of Interest; D030881:Disclosure; D028744:Ethics Committees, Research; D004991:Ethics, Institutional; D017408:Guidelines as Topic; D006801:Humans; D007221:Industry / Q000592:standards; D007258:Informed Consent; D007373:Interinstitutional Relations; D008505:Medical Staff, Hospital / Q000191:economics / Q000592:standards*; D016134:Organizational Policy; D011050:Policy Making; D035842:Research Subjects; D012109:Research Support as Topic / Q000592:standards; D012941:Social Responsibility; D036302:Therapeutic Human Experimentation; D035502:Trust; D014481:United States