Medical researchers' obligations to human research participants in low-income countries

This week, PLoS Medicine launches a new section, called Guidelines and Guidance. The articles in this section contain advice on the conduct and reporting of health research.

Wherever medical resources are scarce and access to medical care is limited, as in most of the developing world, medical researchers face difficult issues about providing medical care beyond the purview of their research (this type of care is called "ancillary care"). In a Guidelines and Guidance article, Henry S. Richardson (Georgetown University, Washington DC, USA) and colleagues give guidance for researchers on how to handle these "ancillary-care obligations."

The authors propose four guidance points on ancillary-care, which they call "the four Ps": Positive obligation to provide ancillary care; Planning, Partnership; and Practical steps. They also propose three questions that research ethics committees (also known as institutional review boards) should consider when assessing the ethics of a human study in a developing country setting: What ancillary-care needs, if any, are likely to be encountered? Can identified ancillary-care needs be met by the existing local health system? How strong is the responsibility of researchers and their sponsors to address the ancillary-care needs they identify in this study? Although the authors have given this guidance in their piece, they acknowledge that "many difficult issues, such as how to characterize the standard of care appropriate in providing ancillary care, remain to be addressed."

Citation: Participants in the 2006 Georgetown University Workshop on the Ancillary-Care Obligations of Medical Researchers Working in Developing Countries (2008) The ancillary-care obligations of medical researchers working in developing countries. PLoS Med 5(5): e90. doi:10.1371/journal.pmed.0050090

IN YOUR COVERAGE PLEASE LINK TO THIS URL, WHICH WILL PROVIDE ACCESS TO THE PUBLISHED PAPER: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050090

PRESS-ONLY PREVIEW OF THE ARTICLE: http://www.plos.org/press/plme-05-05-richardson.pdf

CONTACT:
Henry S. Richardson
Georgetown University
New North 215
Washington, DC 20016
United States of America
+1 202-687-7487
richardh@georgetown.edu