Posted on March 12, 2015 at 11:46 AM
In its recently published brief, Ethics and Ebola: Public Health Planning and Response, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) considered what lessons might be drawn from U.S. engagement in the global response to the Ebola epidemic. The brief examined two areas of human subjects research ethics that have been particularly controversial in the current Ebola epidemic: clinical trial design and the use of placebos; and the collection, use, and international sharing of biospecimens for research.
Public health emergencies add ethical complexity to the conduct of clinical research and yet the Bioethics Commission recognizes the importance of such research—especially when an emergency presents the best, or only, opportunity to conduct research on potential preventive or therapeutic interventions, as is the case for Ebola. As large clinical trials are planned or already underway in western Africa to investigate experimental Ebola vaccines and therapies, the Commission considered whether it is ethically appropriate to conduct randomized placebo-controlled trials to evaluate these interventions. The Bioethics Commission considered two perspectives on this question, one against and one in support of placebo-controlled trials in the current Ebola epidemic, as well as possible middle grounds, while underscoring ethically relevant aspects of conducting clinical research in the Ebola epidemic that might help to resolve tensions between these two viewpoints, such as the role of different levels of supportive care and responsiveness to the needs of communities in which the research is conducted.
Ultimately the Bioethics Commission recommended that the full range of trial designs that protect and promote the welfare of participants and are capable of yielding credible and reliable data on the safety and effectiveness of the interventions should be considered:
Research during the Ebola epidemic should provide all participants with the best supportive care sustainably available in the community in which the research is conducted. Trial designs should be methodologically rigorous and capable of generating results that are clearly interpretable, acceptable to the host communities and, to the extent possible, minimize delays to completing the research. Properly designed placebo-controlled trials can meet these conditions, and innovative designs, such as adaptive randomization, ought to be considered as a means of addressing these research goals. Research teams should actively engage with affected communities while planning research to determine the trial design that best reflects these ethical and scientific requirements.
The Bioethics Commission also considered the ethical and practical challenges of collecting and sharing biospecimens in the context of a communicable disease outbreak like Ebola. The analysis concluded that researchers and other stakeholders should work to ensure equitable access to the benefits that result from research using shared biospecimens and emphasized the importance of ethical acquisition of samples, informed consent, and strong privacy protections.
The Bioethics Commission recommended that the United States should play a leading role in establishing best practices for sharing the benefits of research using biospecimens:
The U.S. government should ensure that Ebola virus related biospecimens are obtained ethically, including addressing the challenges of obtaining informed consent during a public health emergency and ensuring adequate privacy protections. The U.S. government should also, in collaboration with partners, facilitate access to the benefits that result from related research to the broadest group of persons possible. This can be achieved by engaging in dialogue with global partners and working collaboratively with local scientists whenever possible to develop effective strategies for ensuring equitable distribution of the benefits of research both in the United States and abroad.
A public health emergency can magnify and complicate ethical concerns associated with research, both clinical and non-clinical, and challenge research protections for vulnerable participants. In Ethics and Ebola, the Bioethics Commission navigated these dilemmas by considering practical realities and applying core ethical principles, including beneficence and justice and fairness. It emphasized the importance of broad and inclusive public engagement and democratic deliberation in advance of public health emergencies to anticipate and address the ethical, societal, legal, and practical challenges that emerge in such crises.
Ethics and Ebola: Public Health Planning and Response, and all other Bioethics Commission reports, are available at www.bioethics.gov.