Abstract
Phase I trials, which test the safety and toxicity of an investigational agent, are a vital stage of drug development. Many of these trials enroll healthy participants and recent data suggest that some of the healthy participants treat phase I research participation as a form of work. This chapter examines three facets of the shift from research participation as a form of altruism to research participation as a form of work. First, I set out three features of trial participation that support labeling healthy participants’ enrollment in phase I research as a form of work. Second, I ask: is phase I research participation similar to risky occupations such as firefighting or coal mining, or is phase I research participation similar to non-risky, low-wage occupations such as janitorial work? To answer this question, I draw upon original data from a systematic review of 475 phase I trials with healthy participants that measures the risk level of the trials. Third, once I have found the appropriate “occupational bucket” for phase I work, I briefly examine the implications for contested questions within research ethics, such as the information persons need prior to consent, rights of withdrawal and compensation for injury, and efforts to increase the transparency of trial results. I argue that conceiving of phase I research as a form of work can bolster the rights of research participants in some of these areas and that bioethicists ought to be less wary of this shift in research participants’ roles.
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Notes
- 1.
For the purposes of the present section, I am not making fine-grained distinctions between “work” versus a “job” versus an “occupation” versus a “profession.” This is in spite of our colloquial use of the words “occupation” or “profession” to denote higher-status activities than “jobs” or “work.” For simplicity’s sake, I will consistently use the word “phase I research work.”
- 2.
E.g. Rawls’ attempt to find the moral ideas implicit in the background culture of contemporary societies (Rawls 1996, 46).
- 3.
In a recent book chapter, Holly Fernandez Lynch focuses on whether research participants ought to count as employees (as opposed to volunteers or independent contractors) (Lynch 2014). Because there is a lack of U.S. case law on whether research participants can count as employees, Fernandez Lynch looks to the reasons why persons are classified as employees and given certain workplace protections. She outlines two reasons. First, the interests of the employers may diverge from the interests of the employees, meaning that employees need a greater amount of protection for their interests. Second, it is possible to identify an employer party who can be held responsible for the employee’s wellbeing. Lynch, analyzing which types of research participation satisfy these two conditions, claims that most research participants, rather than solely healthy phase I participants, display these features that the law uses to justify the classification of persons as employees. Her work offers a complementary legal definition of work. It helps translate the conceptual arguments I make in the present chapter to concrete legal claims to classify healthy phase I participants as workers under U.S. employment law.
- 4.
This first conception of work is intertwined with the time-based and meaning-based conceptions of work that I discuss later—that is, it may be morally acceptable to expect someone to perform an activity once for free (for example, helping a friend lift heavy boxes in the moving process) but morally unacceptable to expect a person to perform that activity a large number of times without compensation. Likewise, the act of receiving compensation for an activity may lead that person to view the activity as work (for example, if I am paid to edit the papers of my fellow students I may be more likely to view that editorial work as a job than if I edit those papers for free). Similarly, another characteristic that separates person A and person B in the cooking scenario is if one cooks for the sole benefit of his personal welfare (i.e., cooking daily meals for himself) versus the other cooking to enhance the welfare of others (i.e., he cooks meals for others who visit his restaurant). This distinction is at work in phase I versus phase II/III trials: for phase I trials, healthy persons participate to benefit others with a disease and are often paid for their efforts, versus for later-stage trials, sick persons participate in part to benefit their own disease and are often not paid for their efforts.
- 5.
Note this includes both trials with healthy persons and with persons with a disease, with organizations reporting little difference in payment policies across the two groups.
- 6.
For qualitative data on payment, see Abadie (2010).
- 7.
Unlike the previous criteria, this third criterion is both descriptive—what is the payment structure for phase I research participation?—and normative—what should be the payment structure for phase I participation? For instance, if someone is participating repeatedly in phase I research activities and thinks of it as a form of work, if they are not currently receiving payment, we can argue that they should be receiving payment. For a normative defense of a wage-based payment structure for phase I research participation, see Dickert and Grady (1999) or Shamoo and Resnik (2006).
- 8.
See, e.g., Branch (2011).
- 9.
This number is based on the U.S. national standard for full-time workers of 2087 h per year divided by the standard workday of 8 h.
- 10.
From this point forward, for shorthand, I will refer to phase I research participation as a form of work as “phase I research work.”
- 11.
Abadie discusses phase I participants’ resistance to the idea that their activities are a form of volunteering instead of a form of work. He also documents the lack of identification with the goals of research among his sample (Abadie 2010).
Others find that among repeat participants, 90 % of repeated healthy participants in phase I research reported that their primary motivation for participating was financial reward. In contrast, medical students who volunteered for phase I research had a more diverse mix of motivations that included a desire to contribute to science in addition to a desire for a financial reward, see Bigorra and Baños (1990).
- 12.
Johnson, R.A., A. Rid, E. Emanuel, and D. Wendler. 2016. Risks of phase I research with healthy participants: A systematic review. Clinical Trials 13(2): 149–160.
- 13.
- 14.
Sam Arnold, in his discussion of ‘meaningful work’ and Rawlsian liberal theory, uses a related package of characteristics to evaluate the quality of an occupation: the authority a worker has, the responsibility a worker is given, and the complexity of the tasks in question. My proposal is inspired by and fully consistent with these criteria for objectively evaluating the quality of an occupation.
- 15.
This sentiment is not confined to contemporary descriptions of phase I research work. A brochure that featured the experiences of healthy participants in clinical trials in the 1959 recounts one participant’s framing of the negatives of trial participation: “it’s the discipline and boredom that get you the most.”
- 16.
For instance, a participant in Ondrusek’s study reports how certain research staff would really relish their authority and the ability to act like “drill sergeants” in regulating participant behavior, creating additional frustration at the power imbalance participants experienced between them and the overseeing staff (Ondrusek 2010, 123).
- 17.
Others have also challenged the undue inducement concept, most notably Emanuel (2005).
- 18.
In the case of work that is clearly immoral—for example, work as a mafia killer—what makes the work immoral are the bad consequences the work has on the wellbeing of others. For these jobs, the immoral aspects are not the level of payment offered but the content of the job itself.
- 19.
This is a version of the well-known argument that Richard Titmuss makes, where he argues that relying on altruistic volunteers produced a safer blood supply than relying on persons looking for financial incentives (Titmuss 1997). But this argument has been challenged in more recent work by Kieran Healy (2006). With respect to phase I trials, potential participants undergo such extensive testing to ensure that they are “healthy” and not at risk of false adverse events that the problem of financial rewards attracting a less healthy volunteer pool may be minimal. However, more data on the topic are needed.
- 20.
Another argument that I do not address in the present chapter is that a constrained wage model minimizes the impact of funding disparities between lucrative projects and valuable but non-lucrative research. This seems to be a reality of employment in general—corporate law firms can afford to hire more workers than legal aid bureaus. And it seems best corrected at the governmental level—e.g. trying to incentivize workers to join less lucrative professions through programs like graduate school loan forgiveness for those entering public service—rather than at the level of the individual trial employers making decisions about wages.
- 21.
As one participant in Abadie’s study reports, “I am pretty cynical and don’t think that the trials result in much medical benefit and most of the guinea pigs feel the same way” (Abadie 2010).
- 22.
As pointed out in the previous section, because most existing studies of healthy phase I participants have been qualitative rather than quantitative, we do not know the breakdown of altruistic volunteers versus more self-interested workers. As a result, the present chapter tries to rebut arguments that rest on the notion that all phase I participants contribute to the trials for altruistic reasons, but still leaves room for others (1) to show empirically that most phase I participants contribute for altruistic reasons, and (2) to argue normatively that the fact that these altruists make up the majority of phase I participants means that ethical analyses should center around these altruistic participants rather than the subset of more “worker-like” participants.
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Johnson, R.A. (2016). From Altruists to Workers: What Claims Should Healthy Participants in Phase I Trials Have Against Trial Employers?. In: Strech, D., Mertz, M. (eds) Ethics and Governance of Biomedical Research. Research Ethics Forum, vol 4. Springer, Cham. https://doi.org/10.1007/978-3-319-28731-7_3
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