摘要：Community-based public health intervention research in developing countries typically takes place not in clinics but in people's homes and other living spaces. Research subjects and their communities may lack adequate nutrition, clean water, sanitation, and basic preventive and therapeutic services. Researchers often encounter unmet health needs in their interactions with individual subjects and need ethical guidelines to help them decide how to respond. To what extent do researchers have an ethical obligation to provide ancillary care—health care beyond what is necessary to ensure scientific validity and subjects' safety? We discuss a case example from Nepal and propose a simple 2-step sequence of questions to aid decision making. PEOPLE LIVING IN LOW-RE source settings around the world suffer disproportionately from preventable or treatable conditions, including respiratory infections, diarrheal diseases, malnutrition, neonatal infections, and complications of pregnancy and childbirth. To alleviate the global burden of disease, it is crucial to develop and evaluate new approaches to the delivery of health interventions in low-resource settings. To this end, community-based public health intervention (CBPHI) research is designed to assess the effectiveness of health interventions delivered in the absence of advanced clinical facilities. For example, a group of simple preventive and curative newborn care interventions, delivered to women in their homes by community health workers, reduced neonatal mortality by 34%, as compared with services normally available in rural Bangladesh. 1 In CBPHI research, by contrast with similar efforts based in facilities such as clinics, semiskilled local community health workers and data collectors typically carry out research activities in people's homes and other functional living spaces. (CBPHI research may be, but is not necessarily, community-based participatory research, in which community members collaborate actively in all phases of research, from the choice of objectives to the communication of results. 2 ) Host communities may lack adequate nutrition, clean water, sanitation, and basic preventive and therapeutic health services. CBPHI research workers therefore often encounter unmet health needs in their interactions with subjects. For instance, pregnant women invited to enroll in studies of interventions directed at neonatal health outcomes may lack access to basic antenatal care such as micronutrient supplementation. To what extent, and for what reasons, do CBPHI researchers have an ethical duty to respond to such unmet needs on the part of subjects in their studies? 3 This is a question of obligations to provide ancillary care. Ancillary care is health care that research subjects need but that is not necessary to secure scientific validity in meeting research objectives or to prevent or redress research-related harms. 4 , 5 Ethical analysis of obligations to provide ancillary care has focused mainly on clinic-based trials. 4 – 8 Here we extend this ethical analysis to CBPHI research. After briefly reviewing key elements of the current ancillary care discussion, we outline 3 attributes that frequently occur together in CBPHI research and illustrate these attributes with a case example from Nepal. We propose a simple 2-step sequence of questions to aid decision making about the provision of ancillary care, and we illustrate the practical implementation of this sequence through analysis of the case example.
