Literature DB >> 10134417

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

J La Puma1, J Kraut.   

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


  2 in total

1.  Physician rewards for postmarketing surveillance (seeding studies) in the US.

Authors:  J La Puma
Journal:  Pharmacoeconomics       Date:  1995-03       Impact factor: 4.981

2.  Financial ties as part of informed consent to postmarketing research. Attitudes of American doctors and patients.

Authors:  J La Puma; C B Stocking; W D Rhoades; C M Darling; R E Ferner; J Neuberger; M VandenBurg; I Dews; J S Tobias
Journal:  BMJ       Date:  1995-06-24
  2 in total

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