By: Kelly O’Keefe, Research Ethics Senior Technical Advisor, PSI; Jennifer Wheeler, Deputy Director for Research, PSI; and Kristen Little, Senior Technical Advisor, Strategic Research, PSI
Since the start of the global Coronavirus Pandemic, organizations, universities, research institutes, and others conducting public health research have faced ethical dilemmas regarding the interruption of research that requires in-person data collection. With the opening of economies, borders, and changes in local transmission, we are now at a moment when institutions and ethics boards are discussing when and how to resume in-person research.
PSI’s Senior Technical Advisor for the Research Ethics Board responds to many of the questions received by the board. She also discusses these challenges within an informal INGO working group of ethics board advisors. In July of 2020, PSI established an appeals mechanism to resume in-person research. Below, find some of the questions Kelly received regarding the return to in-person data collection. This is part two of a recurring series of “Ask Kelly.”
I am the program manager for a malaria project. Our country has recently lifted travel restrictions and our malaria program has been allowed to return to normal operations under a government designation of being essential services. Before lockdown we had planned on implementing a research study. I’ve reached out to the research team and they insist that we are unable to conduct research without an additional ethics board approval because the study requires us to collect data in person. This research is critical and very important to the malaria community. Does the risk of exposing people to COVID-19 outweigh the benefit of these research results?
Signed –All Eagerly Awaiting Responses
Dear All EARs,
After putting a pause on some research earlier during the year, many ethics boards have started reviewing protocols and determining if it is appropriate to return to in person data collection. Some boards are asking researchers to submit an application to resume in-person research to make sure that the risks of collecting data are justified and that they are being minimized through protection measures for both participants and data collectors. These processes are in place because, while your program activities might be considered essential, participation in research may not be. Research participants in this case are not receiving a direct benefit from participation. While the malaria community may benefit from conducting the research and the community at-large may benefit from research findings, the individuals that are taking on the risk do not and, therefore, we must take extra steps to justify research implementation and mitigate risks.
Our programs have restarted in my country, and to inform our service delivery we will be speaking to men in urban, densely populated areas for this study. If we take precautions like masks, my data collection would be less risky for the participants than other parts of their daily lives. Can we just move forward?
Reluctant risk assessor
It may be true that your research would pose minimal additional risks to participants compared to those that they face in daily life during COVID-19. The review process has been designed to ensure that all potential risks—to both participants and our own data collection staff—have been identified and mitigated to the extent possible. Additional research risks can be subtle—sure you can use masks during the interview, but will participants have to take public transportation to get to the study site? Will everyone touch the same spoons or pot during the coffee break? Are data collectors traveling from one area to another for the study, potentially taking COVID-19 with them? These risks may be mitigated through careful study design, and understanding the local context is important. This is especially true when economic hardships caused by COVID-19 may induce participants to take on more risk than they ordinarily would for the promise of an incentive. Finally, we should be leaders as a public health organization and take all possible care to ensure that risks are appropriately mitigated—and benefits are maximized—before we restart any in-person data collection during the pandemic.
You can learn more about our process or ask questions by contacting kokeefe@Psi.org.
To see the first “Ask Kelly” piece, The Design Ethics of Youth-Centered Innovation, click here.