Treating Vulnerable Populations

And here the A2J Lab goes again talking about RCTs and the lessons we can learn from the medical field! This time, the topic in question is ethics.

Two prominent figures from the medical research community, Susan Ellenberg and Jason Schwartz, recently presented at HLS as part of the Health Policy and Bioethics Consortia put on by the Center for Bioethics at Harvard Medical School, the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital, and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. The panel discussion focused on conducting RCTs during public health crises, with specific emphasis on lessons learned from trials during the recent outbreaks of Ebola and Zika.

Ellenberg in particular spoke to the ethics of RCTs when testing on vulnerable populations and working within community groups, issues that we at the Lab are constantly aware of as the Lab works closely with our field partners, who range from legal aid providers to the courts to administrative agencies.

The ethics of RCTs in medicine are often a legitimate concern, particularly given the history of scientific experimentation in the U.S. (For more information on the Lab’s perspective on RCTs and ethics in law, see this prior post.) There’s a lot to be learned from the medical research community here. For example, during the Zika outbreak it became clear that the disease affects mothers and fetuses in very distinct ways. However, pregnant women were initially excluded from clinical trials because of the strong ethical protections in place for this group, considered a vulnerable population. This exclusion protected the group from potential harm during the study but also prevented the medical community from learning how vaccines could impact such a high-needs group. This question is still pending research.

Vulnerable populations also have a history of raising their voices in support of randomized evaluation. Ellenberg spoke about how, during the AIDS epidemic, activists became some of the strongest proponents of RCTs. They realized they wanted to effective treatments, not treatments that were a shot in the dark. So community partners, activists, and researchers sat down together to figure out the best way to combat AIDS.

Innovation by itself does not lead to more effective intervention. We can keep innovating, coming up with new document assembly tools, and changing procedural rules, but the act of innovating does not guarantee successful outcomes. In law, as in medicine, we should learn what works from our innovations and why, perhaps uncovering deficits within our legal system and approaches to access to justice along the way. During public health emergencies there have been huge knowledge deficits. The same can be said about the now decades-long access to justice crisis in the U.S.

Both Schwartz and Ellenberg spoke to the fact that the medical field is still struggling with RCTs; in this case, particularly the ins and outs of when and how to conduct them, especially with vulnerable populations or in times of crisis. Their efficacy is still being questioned, new working groups created, and declarations updated that underline the ethical guidelines through which this testing can take place. Imagine what law could accomplish if, as a field, we accepted, promoted, debated, and implemented rigorous research that could allow us to advance access to justice not only in the present, but also for generations in the future. There’s a lot of talk about trying to achieve 100% access to justice, but it’s hard to consistently build towards that when we aren’t leaving future generations any data or evidence-based lessons learned from the present.

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