Advancing Ancillary Care in Developing Countries

Many studies have offered recommendations on how to improve ancillary care in clinical settings but few have examined the role this crucial care plays in public health research. Ancillary care is care needed by research participants, but not necessary to ensure scientific validity, prevent study-related harms, or address study-related injuries. Researchers at the Johns Hopkins Bloomberg School of Public Health suggest that current literature and recommendations established to help researchers and sponsors act on ancillary care obligations often fail to consider studies in which the primary unit of research interest is a group. Their commentary is published in the July 22, 2009, issue of JAMA.

“Ancillary care applies to public health research, not only clinical research,” said Adnan Hyder, MD, PhD, MPH, lead author of the paper and an associate professor with the Bloomberg School’s Department of International Health and the Johns Hopkins Berman Institute of Bioethics. “After reviewing several of the larger and most widely accepted papers on ancillary care we noticed this disconnect, as none of the literature included public health research. In this commentary we began to examine how ancillary care might play out in public health research, especially in developing countries, and found that current research is constrained by several issues.”

Dr. Hyder, along with Maria Merritt, PhD, co-author of the paper and an assistant professor in the Bloomberg School’s Department of International Health and Johns Hopkins Berman Institute of Bioethics, outlined three limitations in current ancillary care research. Current research fails to examine ancillary care in dealing with groups as the unit of interest (existing accounts of the ancillary care obligation often assume that all relevant health needs are defined with respect to individuals only); the criteria for assessing the strength of ancillary care claims (international investigators and sponsors with access to external resources might have a stronger obligation to support local health systems where they are conducting research); and defining a process for consideration of ancillary care researchers (an operational approach to identifying candidate ancillary care needs outlined in a 10-step process).

To assess the strength of participant groups’ claims on researchers and sponsors to meet those needs and fulfill specified ancillary care obligations, Dr. Hyder and Dr. Merritt recommend the following:

* Understand the goals and objectives of the research study
* Understand the range of options that might be considered as ancillary care
* Assess the research-specific and context-specific factors influencing strength of participant group’s claims to options under consideration
* Rank options in order of greater to lesser strength of claim
* Identify costs, risks, and benefits of each option under consideration over specified period
* Engage in a locally driven deliberative process among concerned stakeholders, to include elicitation of participant group’s preferences
* Define the package of ancillary care that will be offered with rationale resulting from deliberative process
* Disseminate information about package of ancillary care and rationale widely to key stakeholders
* Monitor implementation and use of ancillary care over life of research study
* Analyze generalizeable lessons from experience of systematic provision of ancillary care