The sudden outbreak of Covid-19, a disease caused by a new coronavirus, is proving to the world every day the important role research plays in the response to global health emergencies. Rapid research has made it possible to sequence the genome of the new pathogen and to at least initially map its transmission and patterns of illness and death.
One lingering issue regarding research done in response to global health emergencies is lapses in ethics when conducting this kind of work. Local researchers and institutions in countries beset by public health emergencies have felt that their voices were not heard when decisions regarding research in their own communities were being made. Trials for novel vaccines and therapeutics have excluded pregnant or lactating women and children with no clear and scientifically sound justification. Front-line workers and researchers have reported being treated differently and feeling disadvantaged compared to expatriates occupying the same roles.
Conducting research while paying attention to ethics during a global health emergency can be especially challenging due to time and resource constraints, instability, and major health and social needs.
To provide an ethical framework for research during fraught times, the Nuffield Council on Bioethics recently released the report “Research in global health emergencies: ethical issues,” which we co-authored with several colleagues. It intends to serve as a resource for funders, governments, research institutions, and researchers, among others.
The report offers what we’ve called an “ethical compass” to guide different actors in ensuring research is conducted ethically during global health emergencies. It draws attention to three moral values — equal respect, fairness, and helping reduce suffering — that should inspire and guide approaches to this kind of research.
Equal respect calls for meaningful engagement of people participating in research, including consulting them in the design and conduct of research. Truthfully engaging communities at all times during research preparation, conduct, and follow-up has been identified as a key factor toward ensuring ethical best practices and better research outcomes. Equal respect means listening to and respecting the views and perspectives of all involved — from recruiting research participants to publishing and sharing results.
Fairness should be checked throughout the research endeavor: when defining exclusion criteria based in science, and not allowing participants to be excluded from research with no unjustified exclusions; when establishing equitable relationships between research participants, researchers and institutions; and when establishing research priorities that are just and fair for all involved.
The value of helping reduce suffering frames the overall purpose of carrying out research and should be balanced across its implementation. Keeping reduced suffering at the forefront also means being responsive and recognizing that communities are likely to have basic and immediate needs other than participating in research that should be addressed where possible.
Recommendations made in our report recognize that ethics comprise not only the people directly involved in research but also the funders, ethical review boards, and regulatory agencies, among others:
- Funders should make community engagement activities a criterion for funding. Fair collaborations and networks should be developed and endorsed to enable rapid and ethical sharing of key data about the emergency.
- Research ethics committees should require that local voices be heard in the development of research protocols and expect research designs to be adapted in ways that are sensitive to local traditions.
- Research institutions should ensure the work of all the people involved in research is fairly acknowledged.
There are many success stories grounded in ethics to look to and build upon. During the Zika outbreak in Brazil, for example, the Zika and Related Diseases Specialists Network (Renezika) was created. This network, a collaboration between Brazil’s Ministério da Saúde and the World Health Organization, the European Commission, and the U.S. Centers for Disease Control and Prevention and the National Institutes of Health, provided invaluable information that supported the development of disease surveillance and management protocols during the outbreak. As the emergency subsided, it also advanced joint epidemiological studies and research and development efforts.
During the recent responses to Ebola in the Democratic Republic of the Congo, novel study designs were tested; new therapeutic options proved successful; and survivors’ voices were brought into decision-making during the post-Ebola recovery phase. These initiatives need to be celebrated and fostered as we anticipate the next emergency.
Conducting ethical research relies on preparedness that includes building or improving on both health and ethical ecosystems. Some or most emergencies can be predicted, and what needs to be in place for appropriate response and research can be thought of well in advance, leading to better research and better health outcomes altogether.
Beatriz da Costa Thomé is a physician in the Department of Preventive Medicine at the Federal University of São Paulo, Brazil. Heidi Larson is a professor of anthropology, risk, and decision science in the Department of Infectious Disease Epidemiology at the London School of Hygiene & Tropical Medicine and director of The Vaccine Confidence Project. Both are members of the Nuffield Council on Bioethics’ working group on global health emergencies.