Why do patients cooperate with medical researchers? So asks sociologists Mary Dixon-Woods and Carolyn Grant in a study analysis appearing in the June 2009 issue of Social Science and Medicine. You might think the answer is simple: they think they will benefit; they want to contribute to medical knowledge; or, they trust researchers who invite them. These are the simple and pat answers that have dominated the research ethics literature until now. However, Dixon-Woods and Tarrant probe deeper by asking why it is that patients feel safe and justified in joining research studies.Using interviews from three different clinical studies, Dixon-Woods and Tarrant identify five recurring themes:
1- Research as Moral Act: Volunteers perceive participation as a moral act: they are willing to participate and cooperate only insofar as they are "able to defend the moral character" of their actions
2- Research as Risk: There was an awareness of risk and research scandals, and volunteers perceived a need to defend their choice to enter a study (rather than feeling like the choice was an obvious one that needed no explanation)
3- Trust in Regulation: Volunteers perceived that the research enterprise was regulated- that transgression of errant researchers would be "subject to punishment," though they had no familiarity at all with specific oversight structures
4- Signals of Trustworthiness: Participants sought "cues" and "signals" as to the values and trustworthiness of researchers. Informed consent, for example, was taken less as a substantive process than as a signal of the researcher's openness and integrity. Participants had strong expectations that researchers and affiliated institutions shared values of cooperation. And they saw the healthcare setting and affiliation of research personnel as "signaling" a kind of trustworthiness."
5- Trust of Professions: Building on item 4, participants made "swift" judgments about the trustworthiness of research personnel- not so much on the basis of their personal characteristics as their affiliation with trusted professions and institutions
The report helpfully contextualizes these findings within a broad sociological literature on giving, cooperation, and trust. Though the authors shy from offering specific prescription, two key themes emerge: oversight systems should focus on meeting these expectations; and regulation (whether external or internal to the profession), far from impeding research, creates social conditions in which patients can feel comfortable bearing risks imposed by strangers for the sake of strangers. (photocredit: Lucas 2008)
2 comments:
In my past experience enrolling patients on clinical trials, I noted two additional benefits of enhanced oversight:
1. The forms were a hassle but, almost uniformly, resulted in more i-dotting by the researchers;
2. Rules and registration serve patients by making it less likely the studies, particularly unsuccessful ones, will "get lost."
Thanks for writing this piece, and contributing this valuable blog.
Elaine-thanks for your thoughts; I agree.
I think defenders of regulations and oversight have not been as articulate about the rationale and functions of regulation as they need to be. Which leaves their arguments vulnerable to unsystematic and often emotive charges that oversight structures are causing excessive "red tape." Of course, there is such a thing as overregulation and misdirected regulatory policy, but it seems critics (and defenders) of present oversight structures would do well to hone their arguments. Your point that oversight prompts greater vigilance is an interesting one.
thanks too for your kind words on my blog.
--Jonathan
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