This content was originally published on April 15, 2020. It was last updated as of Friday, May 29, 2020 at 12:40 p.m. CST.
American universities, hospitals, and other institutions currently have a wide variety of healthcare, research, education, and humanitarian projects underway all over the world, with some individual universities conducting projects in over 100 countries and individual hospitals and health systems conducting projects in several dozen countries. Pharmaceutical, device, and vaccine manufacturers are also conducting an increasing volume of research globally, and a review of clinical trial registrations on ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform shows that a significant and growing number are being conducted in countries classified by the World Bank as low- and middle-income countries (LMICs). Even without the COVID-19 pandemic, there can be a complex interplay of U.S. law; foreign law; grant term compliance; and various operational, political, and ethical considerations when conducting those projects, particularly when they involve human subjects research (HSR) in LMICs.
Many of these HSR projects have been modified or put on hold as a result of the pandemic because of participant safety, personnel or supply availability, medical resource conservation, mandatory quarantines, travel restrictions, or other considerations. Other HSR projects have not yet been put on hold due to local considerations, and still others cannot safely be put on hold. The Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), and other regulators of medical research around the world (including in India, South Africa, Kenya, Brazil, and Peru) have issued guidelines for what clinical research sponsors should consider when pausing or modifying studies, but such guidelines will not be available in many LMICs.
Restarting paused HSR projects in LMICs will present challenges unique to the LMIC environment. COVID-19 statistics in many LMICs can be unreliable or censored, and testing capacity with existing technologies will not match that of high-income countries (HICs), so it may be difficult to have situational awareness of the local outbreak. In addition, vaccines and treatments are likely to become widely available in HICs first, and some may never become widely available outside of HICs, so there may be a period of time when citizens of a particular country are at significantly higher overall risk than HIC staff working on-site alongside them.
There will also, of course, be projects that are started during the pandemic, including on COVID-19 vaccines, treatments, in vitro diagnostics, social and behavioral interventions, and epidemiology, or research on an emergency itself (e.g., research on the impact of cash transfers on women’s risk of violence during a health crisis). While much of the early phase safety work for vaccine candidates and investigational drugs is likely to be carried out in HICs and China, the bulk of this work will take place globally, and some will be conducted in LMICs exclusively. As of the middle of May, well over a thousand COVID-19 clinical trials were listed in the World Health Organization’s International Clinical Trials Registry Platform that were not also listed on ClinicalTrials.gov.
We provide here a resource for institutions conducting or participating in HSR in LMICs as they evaluate whether to modify or suspend HSR projects in LMICs and when and how to start or restart them. This content is based on the firm’s extensive on-the-ground work throughout the developing world on behalf of universities and hospitals, including on vaccine clinical trials and biological sample collection projects, as well as the firm’s work with a global organization dedicated to the development of vaccines against emerging infectious diseases, including COVID-19. Because of the complex and context-specific considerations involved in these projects, this resource is far from exhaustive, but we hope that it provides a good starting point for many of the relevant issues.
If you have any questions about conducting research or public health projects abroad during the COVID-19 pandemic, please contact the authors of this resource.