An Ethical Debate: Financial ties as part of informed consent to postmarketing research Attitudes of American doctors and patient

BMJ 1995; 310 doi: http://dx.doi.org/10.1136/bmj.310.6995.1660 (Published 24 June 1995)
Cite this as: BMJ 1995;310:1660

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  1. John La Puma (j-la-puma@uchicago.edu),
  2. Carol B Stocking, director of researcha,
  3. William D Rhoades, attending geriatricianb,
  4. Cheryl M Darling, clinical research associateb
  1. a Center for Clinical Medical Ethics, University of Chicago, Chicago IL 60637, USA john la puma, clinical associate professor
  2. b Lutheran General Hospital, Park Ridge, IL 60068
  1. Correspondence to: Dr La Puma, 1945 North Burling Street, Suite 1R, Chicago, IL 60614, USA.
  • Accepted 7 March 1995

Postmarketing research, often called phase IV trials, is intended to familiarise doctors and patients with newly approved drugs. La Puma and colleagues, in Chicago, studied doctors' and patients' attitudes to whether doctors should receive payment for taking part in such research. We asked for commentaries on their findings from four ethical experts, who put the study in a British context, present the views of patients, and examine some methodological assumptions.

The attitudes of doctors and patients about financial ties as part of informed consent to research have not been studied. Neither the United Kingdom's quadripartite regulations1 nor new research guidelines in the United States2 require financial disclosure to patients.

Postmarketing (phase IV) research is part of the $10.9bn the American pharmaceutical industry spends annually on research.3 Ordinarily uncontrolled observational cohort studies of outpatients,4 phase IV trials are often intended to familiarise doctors and patients with new drugs approved by the Food and Drug Administration. In the United States phase IV trials and postmarketing surveillance (seeding studies) are generally indistinguishable.

Industry sponsors pay doctors to …

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