| Literature DB >> 10134417 |
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.Entities:
Keywords: Biomedical and Behavioral Research
Mesh:
Year: 1994 PMID: 10134417
Source DB: PubMed Journal: Hosp Health Serv Adm ISSN: 8750-3735