Paying research subjects: historical considerations.

• Author: Hutt, Leah E.

Introduction

Paying research subjects money to participate in medical experimentation is not a recent phenomenon. In the late 1800s, for example, Walter Reed paid volunteers in his yellow fever studies $100 in gold for their participation. If they contracted yellow fever, he paid them a $100 bonus. (1) Subjects today continue to be paid, in varying amounts, to participate in research. Despite this practice's lengthy history and ubiquity, no consensus has developed about its ethical propriety. While most regulations and guidelines governing human experimentation permit some sort of monetary remuneration to research subjects, they provide little instruction on evaluating the amount of a payment. The regulations and guidelines reflect the apprehension expressed in the academic literature about the philosophical and practical ramifications of both paying and not paying research subjects.

This paper explores the historical development of the debate about paying research subjects. A review of the debate over the last 30 years reveals that payments have mainly been conceived of as a threat to voluntary consent. Further, the issues discussed in the 1970s are largely the same issues being discussed today. I suggest that a preoccupation with voluntary consent may have slowed the progress of the debate and is part of the reason why consensus remains elusive. The importance of achieving some sort of consensus is that it translates into practical and ethical guidance in evaluating the propriety of a given payment.

In recent years, there has been a slight shift in emphasis in the discussion such that issues that were historically on the periphery of the payments debate are receiving increased attention. This may signal a turning point in the debate which may lead to practical and ethically sound guidance about how to evaluate payments to research subjects.

Prison Experiments

The appropriateness of paying research subjects began to be explored in a meaningful way in the context of prison populations. During World War II, American researchers increasingly used prisoners for medical experimentation. The ability of prisoners to freely consent was challenged both during and after the war, (2) especially where rewards were offered. (3) American researchers, however, insisted that all prisoner-subjects freely chose to participate and prison research flourished in the post-war years. (4) This emphasis on voluntariness would dominate the debate about payments for the next 50 years, even after prisoners ceased to be used.

After World War II, news of illness and death associated with prison research prompted formal hearings to consider the ethics of certain prison experiments. Rather than focus on the health problems caused by the experiments, excessive reward was often seen as the key ethical concern. In particular, some feared subjects might conceal symptoms rather than risk disqualification from the experiment and the reward. Consequently, the validity of the research results was jeopardized. (5)

In the late 1940s, publicity about the terrible side-effects associated with the wartime malaria research conducted in an Illinois prison prompted the Governor of Illinois to form a committee to investigate the ethics of the research. The committee found the research conformed to ethical rules and focussed its attention on the issue of rewards to prisoners. It found a subject's sole motivation ought to be to contribute to human welfare. If that was the motive, then a reduced sentence was a reward, not an undue inducement. The Commission, however, deliberately and explicitly did not consider when a reward is excessive. Rather, it said this should be reviewed on a case-by-case basis. (6) This reluctance to identify when a reward is excessive is a trend which regulatory bodies unfortunately have continued.

By the 1960s, the pharmaceutical industry had well-established drug-testing programs in American prisons. The program in Alabama came under scrutiny in 1969 after the Montgomery-Advertiser Journal (7) published news of epidemics in the prisons and sub-standard medical care of subjects enrolled in the program. The journal raised numerous concerns about the experiments, but money was central: specifically (1) excessive profits made by investigators; and (2) large payments to prisoner-subjects which apparently caused some to give false information about their medical histories and reactions to the drugs being tested.

The committee investigating the epidemics in Alabama prisons found that most prisoners volunteered because of the money and remained in the studies despite serious side-effects simply to collect the pay. (8) In its report, the committee sent a mixed message about paying subjects. It found the pressure to volunteer because of the need for money was problematic, but at the same time noted that drug-testing programs in prisons served valuable purposes, including providing prisoners with the opportunity "to earn some extra needed money." (9)

By the 1970s, a variety of scandals had focussed attention on human experimentation in general. Well-publicized cases like the cancer experiments on senile patients in the Brooklyn Jewish Chronic Disease Hospital (10) and the Tuskegee syphilis study, (11) along with the publication of Jessica Mitford's book on prison experiments, Unkind and Usual Punishment, (12) all highlighted concerns about the use of vulnerable populations as subjects in research. (13) Mitford's book clearly brought the concept of exploitation into the discussion of payments. She highlighted the concern that amounts paid to subjects were high compared to other prison jobs, but a...