Education And Debate

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
  1. John La Puma (j-la-puma{at}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 enrol their patients and to collect dosage and effect information. Patients may receive the new drugs free; doctors may also receive payment for laboratory examinations and office visits. Yet patients may be unaware of their status as research subjects.

Methods

To understand patients' and doctors' attitudes about these arrangements, we developed structured, parallel, self administered questionnaires to gather data on attitudes about informed consent to, financial disclosure about, and participation in postmarketing research. The questionnaire for doctors was pretested and validated and then distributed to all active staff physicians (n=733) of a large, suburban, community teaching hospital.

The questionnaire for patients was pretested and validated, and then distributed by a research associate to consecutive patients (n=269) in a general medical office. Patients under 18 years of age and those who seemed to be acutely ill were excluded (n=29).

Participation was voluntary and confidentiality was assured. The institutional review board of Lutheran General Hospital approved the research protocol.

Results

Of the 733 doctors surveyed, 394 (54%) responded. Age in years (mean 45.4 (SD 11.5)) and sex distribution (79% (297) male) of respondents did not differ from that of the staff as a whole. Respondents had been in practice for 1-60 years (mean 14.6 (11.1)) and represented all clinical departments.

Of the 269 outpatients approached, 200 (74%) returned completed surveys. Respondents ranged in age from 18 to 87 years (mean 49.7 (16.9)). Most were female (64%; 123), in excellent or very good health (53%; 103), and had a regular doctor (85%; 167). Twelve (6%) had been part of a research study on a new drug.

One hundred and forty four doctors (36%) had been asked by a drug company to enrol patients in a phase IV trial. Of the 106 (27%) who had participated, 79 reported whether and how much they had received for each patient enrolled. Forty one of 79 (52%) reported that they had not been paid a fee; three wrote in the margin that a programme, institution, or employer had accepted the fee for them. Thirty eight reported that they had been paid from $5 to $5000 (median $80) for each patient enrolled.

Most doctors (64%; 240) found it acceptable to be paid a fee, while most patients (56%; 110) found a fee unacceptable (P<0.005). Proportionately fewer doctors (75%; 282) than patients (86%; 171) believed that a physician should inform a patient if the physician is paid for enrolling the patient (P<0.005) (table).

Responses to questions about investigators' financial ties to research sponsors

View this table:

Respondents who found fees acceptable were asked how much, over the direct costs, the doctor should be paid to enrol each patient. Ninety five doctors made this estimate, most frequently suggesting $100 (range $10-$2500, median $100). Patients who made this estimate (n=31) answered $10 most frequently (range $10-$100, median $15).

Most responding doctors (67%; 253) and patients (69%; 133) thought that some doctors might be influenced to enrol patients just for the fee.

Discussions

Moral questions of dual loyalty, research purpose, truth telling, and informed consent for phase IV investigators raised by these data have been explored briefly elsewhere.5 6 We know of no data which suggest that doctors actually include their remuneration for research as part of the informed consent process. Indeed, doctors who inform patients may encounter resistance to enrolment.

Conclusion

Doctors and patients disagree about whether remuneration of doctors is acceptable in phase IV research but agree that information about financial ties to the research sponsor should be part of informed consent. Such information would make explicit a part of the conflict of interest that confronts doctors who are simultaneously clinicians and phase IV investigators receiving enrolment fees. Whether disclosure is enough to extinguish doctors' conflict of interest in post-marketing research provides opportunity for further study.

These data were presented at the 16th annual Society for General Internal Medicine national meeting in Washington, DC, 1993; the 7th annual Society for Medical Decision Making national meeting in Triangle Park, North Carolina, 1993; and the 5th annual University of Chicago McClean conference in clinical medical ethics in Chicago, Illinois, 1994. The work was funded in part by the Lutheran General Hospital and the Lutheran General Medical Group. The views expressed in this paper are those of the authors and do not necessarily reflect the views of the supporting institutions.

References

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