Citation: Ron Roizen, "Why I Oppose Drug Company Payment of Physician/Investigators on a Per Patient/Subject Basis," IRB: A Review of Human Subjects Research 10:9-10, 1988.
Drug trials typically involve "percapita physician payment"--that is, a contract between the drug company (which desires to test a new drug) and the physician/investigator (on whose patients it will be tested) calling for a fixed number of patient/subjects and paying the physician/investigator a flat fee for each one who is enrolled in and completes the study. Until recently my hospital's IRB (of which I am a non- physician member) routinely approved such percapita payment studies, with- out special inquiry into either the precise manner or the amount of physician/investigator payment. Many IRB members regarded such payment arrangements as the private concern of the physician/investigator and the sponsoring drug company.* Nor had the IRB required physician/investigators to inform patient/subjects of percapita payment in their informed consent discussions. More recently, however, percapita payment has become the focus of a thoughtful review and spirited debate in my IRB. Is percapita physician payment ethical? Should patient/subjects be informed of such arrangements?
Percapita payment, especially when it involves relatively large amounts, inevitably introduces the threat of financial bias into the research process. it may subtly incline physician/inves- tigators toward encouraging inappro- priate or marginally appropriate patient/subjects to participate in drug trials. Remuneration levels can be substantial: A physician may receive $3,000 per recruit or higher and a quota of 30 patients may be called for in the study design. Moreover, because infor- mation is not collected on these monies a number of important ques- tions have gone unaddressed: Are these funds intended to compensate the physician/investigator for the time and effort he or she devotes to the study? If so, is the level of compensation in fact appropriate to the level of effort? Is the physician/investigator already com- pensated for patient/subject treatment from other sources? In the end, what fraction of drug company compensa- tion might reasonably be regarded as simply the drug company's bonus to the physician/investigator for recruiting patients?
Doesn't the patient/subject have a right to know that the physician/investigator is paid percapita for the patient/subject's participation? Will not some patient/subjects have the reason- able expectation that their doctors' motivations are limited to (1) hopes for the patient's benefit from the drug and (2) hopes for the study's long-term contribution to medical science? The percapita pay system obviously intro- duces the potential for a third physician motivation, financial gain. Regardless of the physician's true motivations, by concealing the percapita payment scheme from the patient the physician/ investigator indulges in a tacit and self- serving deception. The physician/ investigator withholds information that deviates from and might cast a shadow upon the patient's common sense understanding of the research situation. The physician/investigator also with- holds information that might diminish the patient's trust in the doctor/patient relationship and his/her willingness to participate in the study. Would some patients be angered and disappointed on discovering how their doctors were paid? (I know I would be!) Such anger and disappointment would indicate that fuller disclosure is warranted.
It can scarcely be doubted that the patient's trust in his physician is a crucial factor in his willingness to participate in research. Spiro, for example, recently wrote.
...I could get most of my patients to participate in almost any kind of clinical study. They would swallow new drugs, receive infusions of calcium or glucagon, or even embrace esophageal or rectal catheters because they had faith in my goodwill or, I now fear, because they wanted to please me.2, p.1174
I believe that great trust alone makes it imperative that the physician not perpetrate a tacit deception. Percapita payment also harbors the vague sug- gestion of an unseemly quid pro quo between physician and drug company in which physician is marketing both his access to patients and patients' trust in his recommendations to the drug company.
A number of arguments on behalf of the current system of percapita pay- ment have been advanced in my IRB's discussions. It has been argued, for example, that if our hospital declined or excessively regulated such support then in the long run physician/inves- tigators would not always fill their patient/subject quotas and drug com- panies in turn, would in time look elsewhere for research sites. This tacitly acknowledges the existence of a tangi- ble biasing biasing factor in percapita pay- ment--while suggesting that the biasing factor can serve a valued end (contin- uing drug company funding) as well as disvalued ends.
It has been argued that even if new rules were introduced percapita pay- ment would soon be re-established by a tacit convention arising between drug company and physician/investigators. In other words, even if physician/ investigators were required, say, to accept only lump-sum grants, in due course a new tacit quid pro quo exchanging research funding for patient/subject quotas would be re- established. This argument misunder- stands the IRB's obligation to erect procedures for the protection of human subjects. It is far better to erect proce- dures that may be eluded than to permit outright a faulty procedure. Moreover, an IRB procedure would establish a symbolic standard in its own right, bringing with it the educative or suasive power of symbolic action.
Another argument asserts that only the most naive patient/subject would be unaware that his physician/investi- gator is paid for conducting research. Why, then, should the IRB take pains to require that patient/subjects are informed of the precise manner and amount of physician payment? This argument inappropriately equates any payment with the percapita payment system. Patients cannot be expected to know that physician/investigators are paid percapita, and such knowledge has the potential to alter the patient's perception of the research. Moreover, there is an important ethical distinction to be drawn between payment for research activity and payment for subject recruitment.
Finally, many point out that in many drug trials potential patient/subjects are actually clamoring to gain entry into the experiment.** In other words, the physician/investigator is confronted with an overflow supply of potential candidates and the possibility of improper recruitment is equivalently diminished. This argument is based on the facts of particular research situa- tions rather than the IRB's obligation to establish procedures appropriate to the body of all research. True, we need not worry about "best case" exemplars; but the IRB's duty is to establish procedures for "average" and "worst" cases as well.
My IRB's discussions have also resur- rected the longstanding debate over the relative place and weight of judgments of the physician/investigator's moral character versus procedural oversight of the research process.4 It has been argued, for example, that the IRB's judgment of the moral character of the physician/investigator proposing to conduct a drug trial serves to protect the patient from the risks of financial bias. The counter-argument is that the IRB's proper function is to set proce- dures for maintaining appropriate protections of human subjects. These procedures--not the IRB membership's subjective judgments of a physician/ investigator's moral character--consti- tute the stock in trade of IRB activity. The IRB's obligation, therefore, is not to define areas outside and immune from its procedural oversight and control but instead to establish proce- dural means for such oversight and control wherever the circumstances warrant.
My IRB recently considered three approaches to the percapita payment problem:
(a) Establishing regular procedures for collecting information on the manner, amounts, and uses of funds in percapita studies.
(b) Requiring physician/investiga- tors to disclose percapita payment in their informed consent forms.
(c) Working toward the establish- ment of research guidelines and regulation that disallow percapita funding in favor of lump-sum or other kinds of research support.
We voted to adopt approach (b) requiring informed consent. After considerable discussion of various alternatives, we voted to accept the following wording to be added to the informed consent:
The investigator will be reimbursed a fixed amount by (company name) __________ for each appropriate subject enrolled in the trial. Please fee free to inquire about funding arrangements and amounts if you desire.
*IRBs routinely Inquire about stock ownership or other "conflict of interest" potentials, however. IRB's reluctance to include other financial aspects of research in the human-subjects process is apparently not uncommon. Lind's1 recent survey< reported that many IRB chairpersons around the country feel similarly.
**Oversupplly of would-be patients/subjects rasies other ethical issues as well--see3, pp. 92 and 189
Ron Roizen [was a] Senior Scientist at the Alcohol Research Group of the Medical Research Institute of San Francisco and member of the Pacific Presbyterian Medical Center Joint Council on Human Research.