Conflict of Interest in Clinical Research: Direct Payment to the Investigators for Finding Human Subjects and Health Information
Puttagunta, P. Saradhi, Caulfield, Timothy A., Griener, Glenn, Health Law Review
The recent death of teenager Jesse Gelsinger in a drug therapy trial has drawn attention to how financial conflicts of interest may compromise patient protection. While research institutions throughout the world have instituted a variety of conflict of interest guidelines, the potential conflicts associated with investigators receiving direct payment from private companies for both the recruitment of patients and the running of clinical trials in pharmaceutical research remains a relatively unexplored area. Clinical researchers undoubtedly deserve to be reasonably compensated for their participation. But these incentive mechanisms also have the potential to create conflicts of interest -- both real and perceived.
The purpose of this paper is to examine the issue of physician remuneration for patient recruitment and conducting clinical trials for pharmaceutical companies. The potential conflicts and dangers of this remuneration scheme will be examined in detail, as will be the lack of guidelines. This lack of guidelines poses a problem for research ethics boards in trying to protect patients' rights.
The authors conclude with recommendations as to which legal mechanisms can best be implemented to effectively alleviate this conflict of interest. Specifically, the authors consider:
1. full disclosure to the patient of the doctors' financial interest;
2. national/international guidelines to maintain consistency of rules and to prevent 'forum shopping' by drug companies;
3. education of clinical investigators on the issue of conflicts of interest; and
4. implementation of regulations specifying exactly how much doctors are to be paid for clinical trials.
More and more doctors in private practice are being recruited to run industry-sponsored trials. This trend arose in the last twenty years when government funding for clinical drug trials declined, and industry funding increased. For pharmaceutical companies, this accelerates the time it takes to test, approve, and put a new drug product on the market.
While doctors have a right to be reasonably remunerated for the work they perform, inappropriate remuneration raises the possibilities of:
* erosion of the patient's informed consent;
* compromise of patient confidentiality (by doctors searching other doctors' patient databases for prospective test subjects);
* enrolment of ineligible subjects or subjects on the margins of eligibility;
* marketplace pressures leading to declines in patient safety;
* a coercive enrolment environment, e.g., patients agreeing to be subjects simply because they fear losing the caregiver if they say 'no'; and
* doctors, under pressure to increase their income, being inclined to perform research that they are not qualified to do.
Past experience shows that a financial interest can bias a physician's decision-making. (1)
The Current Regime
The main players in a drug trial are Health Canada, the investigator, the patient, the sponsor, and the Research Ethics Board (REB). In Canada, REBs help protect human subjects' safety. No specific legal framework exists in Canada to govern REB practice. However, guidelines and policies do exist. These include:
1) TriCouncil Policy Statement (TCPS). This document governs all research that receives federal funding. Researchers, it states, have a fiduciary relationship with their subjects. The TCPS advocates a "proportionate" approach to conflicts: if the conflict of interest is small, the investigator need only disclose the interest. If the conflict is large, the investigator must abandon one of the interests or withdraw from the trial. (2)
As a general guide, per capita payments should be comparable to the physician's or researcher's usual professional fee. …