"How much do you get paid if I volunteer?" Suggested institutional policy on reward, consent, and research.

Full Abstract

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.

Author information

Author/s: La Puma, J (J); Kraut, J (J);

Affiliation: Lutheran General Hospital, Park Ridge, IL.

Journal and publication information

Publication Type: Journal Article

Journal: Hospital & health services administration (Hosp Health Serv Adm), published in UNITED STATES. (Language: eng)

Reference: 1994-; vol 39 (issue 2) : pp 193-203

Dates: Created 1994/07/18; Completed 1994/07/18; Revised 2007/11/15;

PMID: 10134417, status: MEDLINE (last retrieved date: 2/18/2009)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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