Ethics of Participation in Clinical Trials

A review of The Ethical Foundations of Clinical Research: Shifting the Paradigm of Participation. The Case of Phase 0 Cancer Trials, by Silvia Camporesi.

Since their inception, clinical trials have sparked intense debate over their ethical acceptability and their potential misuse. In her dissertation, Silvia Camporesi engages in this discussion with the intention to provide the community at large with an innovative approach that would overcome the standard free market vs. exploitation dilemma. Her final goal is to provide the theoretical groundwork for the construction of a new model of clinical research. To keep the scope of her dissertation more focused, Camporesi has opted to pay attention to the application of the notion of informed consent only to one specific study: the ABT-888 (Phase 0 Cancer Trial), performed at the National Cancer Institute-National Institute of Health (NCI-NIH) Center in Bethesda, United States in August 2007.

Coercion and exploitation are key elements that constantly come out in the discussions surrounding clinical trials, but Camporesi suggests that, even though vulnerability should always be taken into account, at the same time:

Vulnerability should be seen more as a state than as it currently is a label for entire groups. Special attention would need to be paid to people who find themselves in a “vulnerable state” (such as terminal cancer patients), but per se a vulnerable state would not exclude a person from participation in a clinical trial (p. 134).

Thus, even if willing to allow the defense of the vulnerable, Camporesi wants us to move on from the historical heritage coming from the Nazi atrocities during the Holocaust that led us to the stipulation of a number of codes such as the Nuremberg Code, the Belmont Report, CIOMS (Council for International Organizations of Medical Sciences) Guidelines and the Declaration of Helsinki — meant to preserve humanity from treading that path again. Surely, we must re-elaborate our stand as members of a larger global  community in a different way from that portrayed by the horrible experiments carried out in the 1932 Tuskegee Syphilis Study as well as the 1963 Jewish Chronic Disease Hospital for example, and reshape the version of informed consent that was “incorporated only from the second version onwards of the DoH [Declaration of Helsinki]” (p. 50) into something more in line with current society, and — most importantly — capable to ensure society a larger and more efficient number of clinical trials necessary for humanity to progress. In other words, we need to overcome the structural impasse that scientific progress has (rightly) entered after these deploring instances of experiments on and with humans, and use modern conceptions of morality to seek a greater benefit to the global community without undermining the need to keep in mind past mistakes committed for the “sake of science”.

The thesis is divided into four chapters. Chapter 1 explains the “problem” related to clinical trials, while Chapter 2 expands on two traditional views on the issue. After this extensive introduction to the bioethical theme and in search for a convincing solution, Chapters 3 and 4 aim at providing the foundations for it. Chapter 3 looks specifically at the Phase 0 cancer trials as “paradigmatic cases” that should help us understand the controversy more deeply. That is so, because Phase 0 trials “embody the prototype kind of clinical research that does not benefit the patient/participant directly, but society and, in the longer term, the individual through the advancement of medical knowledge” (p.9).

Finally, in Chapter 4 Camporesi puts forward suggestions for future directions of research. Those are: a) pushing individuals to participate more actively in research while counterbalancing this new attitude towards research with a change from an opt-out to an opt-in system, b) allowance for the existence of some forms of payment for the participants — especially as a “reimbursement model”, c) not excluding anyone on the grounds that they belong to a vulnerable group, but ensuring instead the possibility for everyone to participate — including terminal cancer patients such as those in the study considered, d) redefinition of the terminology use, with the consequent abandonment of the terms “coercion” and “undue inducement” in particular.

Camporesi’s work has the noble intention to overcome the unnecessary — and sometimes deeply damaging — hypocrisy that sometimes surrounds bioethical issues. It does so by making the reader realize that something has to be done to improve the human condition and we need to redirect the enterprise representing clinical trials towards the common good. In this light, we might want to see Camporesi’s suggestion has a positive input that should go beyond the field of bioethics to enter in the sphere of politics. Perhaps this is idealistic, but the virtuosity of Camporesi’s attempt to ensure a higher impact of justice in clinical trials remains a worthy goal.

Of the whole dissertation, I found Chapter 4 particularly interesting, as it is the chapter in which the main thesis brought forward by Camporesi takes its final shape. Building on the work of a number of prominent authors, Camporesi affirms that it is now time to change the whole approach to the trials by, in some sense, renegotiating our social contract in relation to clinical trials. Moving on from the historical debate that characterized clinical trials in the past, she describes in more detail the limits that an obsessive use of informed consent has created in relation to clinical research: the individual and society are the two faces of the same coin and we need to readdress this relationship more directly to facilitate the possibility for clinical trials to take place.

In conclusion, while Camporesi’s approach may be controversial, her enterprise is certainly worthy of attention. It is an engaging work, which contributes to the ongoing debate on the ethical status of clinical trials. Rather than aiming to overcome the issues that are integral to clinical trials, Camporesi’s mission is to push us to question some of the dogmas that surround our interaction with and within society; to produce a new, more inclusive and active attitude towards clinical trials that could only be beneficial to society. We must simply reconsider whom, and in what situations, we should regard persons as fully autonomous when it comes to the medical and clinical sphere. For those who find it hard to answer such questions, the importance of Silvia Camporesi’s intellectual challenge is obvious.

Mirko Garasic
Centre for Human Bioethics
Monash University
mirko.garasic@monash.edu

&

Center for Ethics and Global Politics
Libera Università Internazionale degli Studi Sociali Guido Carli (LUISS)
mgarasic@luiss.it

Theoretical Sources

– Giovanni Boniolo, Pier Paolo Di Fiore and Salvatore Pece, “Trusted Consent and Research Biobanks: Towards a ‘New Alliance’ Between Researchers and Donors,” in Bioethics 26 (2012), pp. 93-100.
– Inmaculada de Melo-Martín and Anita Ho, “Beyond Informed Consent: The Therapeutic Misconception and Trust,” in Journal of Medical Ethics 34(2008), pp. 202-205.
– Ezekiel J. Emanuel, “Undue Inducement: Nonsense on Stilts?” in The American Journal of Bioethics 5 (2005), pp. 9-13; discussion W8-11, W17.
– John Harris, “Scientific Research is a Moral Duty,” in Journal of Medical Ethics 31 (2005), pp. 242-248.
– Franklin G. Miller and Howard Brody, “A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials,” The Hastings Center Report 33 (2003), pp. 19-28.

Dissertation Information

European School of Molecular Medicine (SEMM) and University of Milan (Università degli Studi di Milano). 2011. 155 pp. Primary Advisors: Giovanni Boniolo and John Harris (University of Manchester).

 

Image: Macrophages Destroying Cancer Cells. Photograph by Susan Arnold (in public domain). Wikimedia Commons.

 

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