July 22 2009

Ancillary Care for Public Health Research in Developing Countries

Author Affiliations

Author Affiliations: Department of International Health, Johns Hopkins Bloomberg School of Public Health, and Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland.

JAMA. 2009;302(4):429-431. doi:10.1001/jama.2009.1072

Belsky and Richardson1 defined ancillary care as care needed by research participants but not necessary to ensure scientific validity, prevent study-related harms, or address study-related injuries and introduced a framework for evaluating ancillary care based on 2 questions.2 Does a participant's need for care fall within the scope of the investigator's responsibility for the participant's health, as defined by aspects of health implicitly entrusted to the investigator through the participant's consent to comply with research procedures? If so, what is the strength of the participant's moral claim on the investigator to address that need? The strength of the claim is modulated by attributes of the participant-investigator relationship, such as depth of involvement, degree of participant's vulnerability, and degree of participant's dependence, together with limits on available resources.2 Dickert et al3 questioned the narrow limits of Belsky and Richardson's definition of the investigator's scope of responsibility and exposed the tensions between vulnerability, dependency, cost, and scientific objectives in assessing the strength of a potential ancillary care claim. Participants at a workshop also highlighted the need for additional ethical guidelines to address ancillary care.4 They proposed 4 “guidance points” to help researchers and sponsors act on their ancillary care obligations—identifying a positive duty, planning for ancillary care, building partnerships, and making practical provisions.4

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