Pandemic circumstances do not justify abandoning research ethics

Scientists can conduct research in the context of the current pandemic without abandoning ethical standards. Prominent philosopher Peter Singer and colleague Richard Yetter Chappell suggest otherwise in a recent Washington Post op-ed that demonstrates a fundamental misunderstanding of the requirements of research ethics. As calls mount for taking controversial measures such as human challenge trials, it is important to understand how those requirements support responsible and high-quality research.

Singer and Chappell place informed consent at the center of their case for relaxing ethical principles. To be sure, obtaining a potential participant’s informed consent is one of the most important ethical requirements of any study proposal before it is approved to begin. Yet, genuine informed consent is about more than simply communicating that a study may include risk. It is about ensuring that the individual has enough, and the right sort of, information about the study—including its risks—to support a well-reasoned decision about whether to participate. Providing such information is a major challenge in the case of COVID-19 research, given all that is still unknown about the virus and its mutations—What antibody levels are sufficient for protection? What therapies could mitigate its symptoms? What long-term health impacts might those therapies have? It is unlikely that we could, as Singer and Chappell recommend, “fully [inform] COVID-19 patients about the risks of taking part in an experimental treatment trial.”

Furthermore, though informed consent is a necessary condition of ethical research, it is not a sufficient one. A key tenet of research ethics is that participants should not even be asked to consent to participate in a research study until researchers have done all they can to minimize the risks as much as possible, and ensure a favorable relationship between potential benefits and potential harms. A public health crisis such as the current pandemic does not lessen those obligations.

Not only does the SARS-CoV-2 pandemic not justify our abandoning these ethical principles; it does not necessitate our doing so. Participants for treatment and prevention trials can be sought from among the many healthcare workers serving on the front lines against the infection. Their medical literacy would make their consent more informed than the average person’s. Furthermore, healthcare workers who already are at great risk of contracting the virus stand to benefit in a relatively immediate way from participation in a successful trial. In other outbreaks of infectious diseases—such as Ebola—trials involving healthcare workers have been essential in vaccine development.

In 1978 the Belmont Report articulated an ethical framework that has guided US research with human beings ever since. It requires that the risks to research participants must not exceed the research’s potential benefits both to those individuals and to society. High-risk trials of the sort Singer and Chappell advocate are not forbidden—indeed, in pandemic circumstances, even the use of human challenge trials to speed vaccine development may be ethically justifiable. But such a determination must come after careful ethical consideration—including the weighing of risks and benefits—and not before it.

Moreover, just as we consider risks of unethical research to individuals, we must consider risks of such research to society: hasty science conducted without ethical safeguards may undermine efforts to identify effective treatments for and preventatives against COVID-19. As ethicists Alex John London and Jonathan Kimmelman note in a recent Science perspective, “Against pandemic research exceptionalism,” “the challenges rigorous [oversight] methods address do not disappear in the face of urgent need.”

The current pandemic, like all public health crises, forces us to confront difficult questions about how best to find cures or treatments for a disease that is rapidly taking many lives. Although some may argue that the extreme nature of our current circumstances requires throwing out our prior ethical assumptions, we could not disagree more. Adhering to long-established and widely accepted principles of human research ethics must remain an essential component of our efforts to combat COVID-19.

Written by the PRIM&R Public Policy Committee.