Recovering from Research: A No-Fault Proposal to Compensate Injured Research Participants

Abstract

National advisory committees have considered the obligations owed to research participants in the event of research-related injuries. These committees have repeatedly concluded that injured research participants are entitled to compensation for their injuries, that the tort system provides inadequate remedies, and that the United States should adopt no-fault compensation. But because the advisory committees have made no concrete proposals and have taken no steps toward implementing no-fault compensation, the United States continues to rely on the tort system to compensate injured research participants. This Article argues that recent legal developments and a transformation in the global research landscape make maintaining the status quo morally indefensible and practically unsustainable. Recent legal developments exacerbate the longstanding difficulties associated with the tort system as a method of compensation; nearly every injured research participant will have difficulty recovering damages, and certain classes of injured research participants--those in federal research and those abroad--are prevented from recovering altogether, resulting in substantial unfairness. In the past ten years, many of the countries substantially involved in research have mandated systematic compensation. By not mandating compensation, the United States has become a moral outlier and risks having its noncompliant research embargoed by foreign ethics committees, thereby delaying important biomedical advances. This Article examines alternative compensation mechanisms and offers a concrete no-fault compensation proposal built on systems already in place. The proposed system can be implemented in the United States and countries around the world to help harmonize various national compensation systems and to more equitably and effectively make those injured by research whole.

Appropriateness of no-fault compensation for research-related injuries from an African perspective: an appeal for action by African countries: Table 1

“…Since the tort compensation system is adversarial, researchers are also less likely to facilitate compensation for illiterate participants, whereas these features may be less prominent in a more collaborative, less adversarial, no-fault based compensation system. As Pike observes, even in the USA where the tort system has been operational for a long time, this system does not adequately serve research participants 2. Below, we sketch a model for compensation that resonates with African social, moral and political values and practices, and one that may help foster greater consensus on compensation for RRIs in global research involving the African continent.…”

“…With the no-fault system, when a research participant is injured during participation in the research, the research team only needs to establish that it is the participation in the research that has resulted in the injury ‘causality’ regardless of who was to blame or was responsible for the injury ‘fault’ 36. Despite a few challenges (like deciding what sort of injuries qualify for compensation and to what extent14), no-fault compensation is the model currently being advocated by some ethicists as probably the most equitable compensation policy, and argue that it should be adopted by the US government as a federal regulation 1 2 9. This system is enshrined in the ABPI guidelines and a lot of countries in Europe have a no-fault compensation policy as a legal requirement before approval of any clinical trial.…”

“…These developments have included a growing consensus that participants with RRIs should not be left uncompensated 1. The realisation that the USA lacks a comprehensive system for managing RRIs (as reported by the US Presidential Commission for the Study of Bioethics), and the effects such deficiency may have on global research,2 3 as well as the introduction of new and controversial regulations for clinical trial-related injury and deaths in India, have created concern about the lack of a universal approach to guide regulatory bodies and ethics committees on how to deal with RRIs globally 4 5. It is within this global context that African ethical voices need to be proactive and enter into the dialogue on RRIs because, despite the increasing number of clinical trials taking place on the continent, there are no unified guidelines on compensation for RRIs.…”

“…In 1991, the Association of British Pharmaceutical Industry (ABPI) issued a recommendation that researchers provide written assurance that in the event of an RRI, they will pay compensation to patient-volunteers according to some set guidelines 8. Additionally, the ABPI guidelines advocated that ‘compensation should be paid regardless of whether the patient is able to prove that the company has been negligent …’, a clause which forms the basis of no-fault compensation, a model advocated by some as probably the most equitable compensation policy 1 2 9 10. The same guidelines also stated that ‘… neither the fact that the adverse reaction causing the injury was foreseeable or predictable, nor was the fact that the patient freely consented (whether in writing or otherwise) to participate in the trial should exclude a patient from consideration for compensation’ 8.…”

Waiving legal rights in research

“…Various commentators and several federal commissions have argued that ethical principles, such as justice and beneficence, require that subjects receive fair compensation for research injuries 19 20 27. Although many European countries have national compensation programmes, others, including the USA, do not.…”