Defining a Standard of Care in Research Debated (web article)

For years, researchers have debated how to define the standard of medical care that should be provided to research subjects during a study, especially in developing countries where the best methods of medical care are not available to the population at large. The debate intensifies when wealthy countries sponsor such studies in developing countries. In an article in the May 2005 issue of Developing World Bioethics, researchers from the Johns Hopkins Bloomberg School of Public Health propose that a country’s existing health system must be taken into consideration and that an evaluation of the country’s health system should be completed before defining a standard of care for research participants.

Adnan A. Hyder, MD, MPH, PhD

“We reviewed the literature, and felt that the current discourse was quite theoretical and had not reached out towards more operational approaches to defining standard of care—this is what we start doing in this paper,” said Adnan A. Hyder, MD, MPH, PhD, coauthor of the study and an assistant professor and the Leon Robertson Faculty Development Chair in the Bloomberg School of Public Health’s Department of International Health.

Dr. Hyder and Lisa Dawson, a research associate in the Johns Hopkins Phoebe R. Berman Bioethics Institute at the time the paper was written, determined that discussions about standard of care in research should not be completed without first considering a country’s existing national health system. They explain in their article that potential researchers have a responsibility to understand the health system in the areas where they plan to conduct research. The researchers must then determine if this level of available care and treatment is typical of the type of care provided for an area or if the health system, although quite capable of providing a high level of care, is failing its patients because of inefficient delivery of services.

“Researchers should not simply use inefficiencies of the national health system to provide care as a determination of the population’s standard of care,” said Dr. Hyder. “Our analysis may be helpful to researchers and ethics committees when designing and reviewing research involving standard of care for control groups in developing-country research.”

“Defining Standard of Care in the Developing World: The Intersection of International Research Ethics and Health System Analysis” is coauthored by Adnan A. Hyder and Liza Dawson.