Correspondence
What's the Price of a Research Subject?
N Engl J Med 1999; 341:1550-1552November 11, 1999
- Article
To the Editor:
In their Sounding Board article on remuneration models for research subjects (July 15 issue),1 Dickert and Grady point out that payment of subjects is a common recruitment strategy, principally in trials sponsored by the pharmaceutical industry. The authors present a cogent argument based on ethical precepts for continuing this practice with both healthy volunteers and patient subjects. On review of three models (market, wage-payment, and reimbursement) for structuring payment to subjects, the authors advocate the uniform adoption of the wage-payment model as the most equitable and ethical approach.
We propose a fourth model for consideration: the fair-share model. Unlike the market model, in which the study participant could be viewed as a commodity, or the wage-payment method, in which the subject is cast as a laborer, the fair-share model views the subject or patient as a partner in the drug-development process. Payment of the subject would be based on a percentage of the per-patient compensation to the investigator or institution. Payment is generally determined by the duration of the study, and the procedures and visits it involves. A phase 1 study may have a payment schedule of $8,000 per subject who completes the study. It would be reasonable, therefore, to base remuneration of the subject or patient on some percentage of the total (10 percent, for example). Because payment is usually based on study components such as completed visits and procedures, the study participant would receive full or partial payment (as would the investigator) according to a formula for completed components. A phase 3 study, with fewer visits and procedures, might pay the investigator $2,000, and a similar percentage would then be paid to the subject for his or her participation. All study volunteers, irrespective of the nature or design of the study, should be offered this compensation. In this model, no other incentives, to either the subject or the investigator, would be permitted. Although payment might vary somewhat from site to site for the same study, this variation would probably be minimal and would reflect actual cost differences (such as those resulting from salaries and overhead).
In contrast to the models discussed by Dickert and Grady, the fair-share model views the subject or patient as an integral member of the research team and is simple to calculate and apply. A reasonable and fair percentage of the compensation to the research subject could be derived by the Food and Drug Administration (FDA), the Office of Protection from Research Risks, and institutional review boards, and standards for local and national compliance could be promulgated.
1 ReferencesCarol A. Saunders, R.N.
Center for Clinical Research Practice, Wellesley, MA 02481Alan M. Sugar, M.D.
Boston University School of Medicine, Boston, MA 021181
Dickert N ,Grady C . What's the price of a research subject? Approaches to payment for research participation. N Engl J Med 1999;341:198-203
Full Text | Web of Science | Medline
To the Editor:
Dickert and Grady provide a careful analysis of how research subjects should be compensated for their participation in research studies. They evaluate the market, wage-payment, and reimbursement models and recommend adoption of the wage-payment model to avoid the possibility of undue inducement, to standardize payment, and to allow equal treatment of research subjects. I agree with use of a wage-payment model but think that wages and market considerations are inextricably joined. Employers pay wages to ensure that there are sufficient numbers of workers to get the job done. Wages go up when qualified workers are scarce or when the job has unavoidable risks. Researchers who employ subjects to perform the work of research must be allowed to follow similar, market-based wage considerations to recruit adequate numbers of research subjects. If the FDA and the Office of Protection from Research Risks adopt an arbitrary wage scale that is not tied to market forces, as the authors suggest, all of us who perform clinical research will have one of our most difficult tasks, the recruitment of qualified subjects, made even more arduous.
Paul D. Thompson, M.D.
Hartford Hospital, Hartford, CT 06102To the Editor:
Dickert and Grady bring needed ethical reflection to the way research subjects ought to be paid in order to encourage participation in clinical studies. The authors examine three models for cash payment of subjects. They rightly reject the market model, which allows high payments to subjects for risky or otherwise undesirable research, but fail to articulate what is, in my opinion, the most serious problem with it. When very large amounts of money are offered as an incentive to participate, research subjects may conceal factors that would make them ineligible for study participation, thereby putting themselves at undue risk. In fact, the deaths of two “healthy” volunteers in phase 1 studies resulted when they withheld such information, apparently because they needed (or wanted) the money offered.1,2
2 ReferencesCharles Weijer, M.D., Ph.D.
Dalhousie University Faculty of Medicine, Halifax, NS B3H 4H7, Canada1
Darragh A ,Kenny M ,Lambe R ,Brick I . Sudden death of a volunteer. Lancet 1985;1:93-94
CrossRef | Web of Science | Medline2
Kolata GB . The death of a research subject. Hastings Cent Rep 1980;10:5-6
Web of Science | Medline
To the Editor:
Dickert and Grady base their argument for paying clinical research subjects on the assumption that “there is no inherent reason to treat patients and healthy subjects differently with respect to payment” for participation in clinical trials. Nothing could be further from the truth. Healthy subjects gain nothing from participating in a trial. Not being ill, they cannot possibly benefit from treatment. At the other extreme, for patients with terminal cancer that has not responded to any conventional therapy, a clinical trial may represent a last (admittedly slim) chance of survival. For any seriously ill person, payment of a “working wage” is likely to be unimportant as compared with the chance of obtaining effective treatment. We will probably always have to compensate normal, healthy subjects for the time, effort, and discomfort involved in being research subjects. For patients seeking treatment, payment would not and should not be necessary.
Robert J. Yaes, M.D.
15 Quantum Pl., Gaithersburg, MD 20877Author/Editor Response
The authors reply:
To the Editor: We appreciate the suggestion of Saunders and Sugar that a fourth model for the payment of research subjects, a fair-share model, be considered. We strongly endorse the concept of the subject as an important partner in research and believe that all partners in research should be valued for the contributions they make. Our notion of a wage-payment model is consistent with this philosophy. We find the fair-share model troublesome, however, for several reasons. In the fair-share model, the amount of payment to subjects is based on a selected percentage of compensation to investigators rather than on the nature of the subject's contribution; not all clinical research is drug development, and many studies are not funded or budgeted on the basis of subjects who complete the study; variation would be common not only from site to site, as suggested, but also among studies within sites, and hence there would be no standardization; all the potential disadvantages of a market model would pertain, including the possibility of undue inducement (especially from large amounts of payment) as well as competition that favors studies with more funding. For these and other reasons, we believe a wage-payment model is a better choice than a fair-share model for calculating payment of research subjects.
Thompson notes, and we agree, that “wages and market considerations are inextricably joined.” However, we did not suggest that the FDA or the Office of Protection from Research Risks adopt an arbitrary wage scale, as Thompson states; rather, we proposed with regard to the wage-payment model that they “publish guidelines suggesting this model of payment” and that to ensure local appropriateness and standardization “institutions and institutional review boards . . . develop specific policies or guidelines” with regard to payment of subjects. These wage scales should be based on the local unskilled-labor market rather than on a market of subjects.
We wholeheartedly share Weijer's concern that large amounts of money might induce research subjects to conceal important information about themselves, jeopardizing their own safety. We noted as a disadvantage of the market model that “large total payments . . . may provide an incentive for the subject . . . to conceal important health information in order to become or remain eligible for the study.” Not only could concealment of information jeopardize the subject's safety, but it could also jeopardize the integrity of the data and thus the safety of future patients.
We agree with Yaes's point that for many “patients seeking treatment, payment would not . . . be necessary,” because of the potential for therapeutic benefit from research participation. However, some research or research procedures offer patients who are subjects little or no direct prospect of therapeutic benefit. Furthermore, although in oncology the standard is not to pay subjects, payment to patients in other types of clinical research, such as asthma and diabetes, is common. We see no convincing ethical reason why patients, simply because they are patients, should not be permitted to receive payment for research participation.
(The opinions expressed herein are our own and do not necessarily reflect those of the National Institutes of Health.)
Neal Dickert, B.A.
Christine Grady, Ph.D.
National Institutes of Health, Bethesda, MD 20892- Citing Articles (5)
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Rafael Dal-Ré, Xavier Carné. (2006) ¿Los pacientes deben recibir una remuneración económica por su participación en ensayos clínicos terapéuticos?. Medicina Clínica 127:2, 59-65
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Celia B. Fisher. (2003) Adolescent and Parent Perspectives on Ethical Issues in Youth Drug Use and Suicide Survey Research. Ethics & Behavior 13:4, 303-332
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