title: Ethics of medical care and clinical research: a qualitative study of principal investigators in biomedical HIV prevention research.
abstract: In clinical research there is a tension between the role of a doctor, who must serve the best interests of the patient, and the role of the researcher, who must produce knowledge that may not have any immediate benefits for the research participant. This tension is exacerbated in HIV research in low and middle income countries, which frequently uncovers comorbidities other than the condition under study. Some bioethicists argue that as the goals of medicine and those of research are distinct, it is a mistake for researchers to assume therapeutic responsibilities while engaging in research. Others propose that there is a duty of care, but disagree as to how this is limited and specified. In this qualitative study, principal investigators from HIV prevention trials discuss their experience of providing medical benefits to participants within the context of conducting research into HIV biomedical prevention technologies. They describe the limitations imposed at times by funders and at times by infrastructure constraints, and canvass the importance of ancillary care provision and capacity building in trial communities. The views of the principal investigators are compatible with the perspective that there is a duty of care, limited by the nature of the research, the depth of the relationship between research and participant, and the capacity of the research site. The therapeutic orientation in HIV prevention trial appears to be indivisible from competent research practise by making concrete and appropriate benefits available to trial participants and their communities that support rather than compete with local infrastructure.
authors.affiliation: Centre for Values, Ethics and the Law in Medicine, University of Sydney, Medical Foundation Building, Parramatta Road, Camperdown, Sydney, NSW 2050, Australia. bridget.haire@sydney.edu.au
authors.forename: Bridget G
authors.initials: BG
authors.lastname: Haire
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D016265:Conflict of Interest; D003220:Conflict, Psychological; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control*; D006801:Humans; D018802:Patient-Centered Care / Q000941:ethics*; D010819:Physician's Role; D010817:Physician-Patient Relations / Q000941:ethics*; D012107:Research Design; D012108:Research Personnel / Q000941:ethics*; D035844:Researcher-Subject Relations / Q000941:ethics*; D012306:Risk