JAMA
Vol. 302 No. 4, pp. 349-452, July 22/29, 2009
http://jama.ama-assn.org/current.dtl

Grand Rounds
Ancillary Care Obligations of Medical Researchers

Neal Dickert, MD, PhD; David Wendler, PhD
JAMA. 2009;302(4):424-428.

An investigator planning a study in Africa of the prevalence of pulmonary hypertension in children with severe malaria anticipates that she and her team will encounter significant unmet health needs during the course of the study. She recognizes that study procedures, particularly echocardiography, may identify and diagnose conditions that are not treatable within the local health system due to resource constraints. Aware that some of these needs may be serious, as well as difficult and costly to treat, she asks the bioethics consultation service for assistance in determining the extent to which she as an investigator has a responsibility to provide clinical care for conditions that she finds while conducting the study. This article reviews the issue of investigators’ responsibilities to meet participants’ needs for ancillary care and argues that investigators can have a responsibility to provide care for a wide range of health needs, including at times care for conditions not connected to the research question or study procedures. That responsibility, however, is significantly limited by the depth of the investigator’s relationship with participants and the resource demands of providing such care.

Commentaries
Ancillary Care for Public Health Research in Developing Countries
Adnan A. Hyder; Maria W. Merritt
JAMA. 2009;302(4):429-431.

[First 150 words per JAMA convention]
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 . . .