title: Biomedical subjectivities and reproductive assumptions in the CAMELIA clinical trial in Cambodia.
abstract: The inclusion of women in clinical trials has raised a variety of ethical and practical issues in their implementation. In the recent CAMELIA clinical trial in Cambodia, the inclusion criteria included a negative pregnancy test and signature of the consent form confirming commitment to double contraceptive use as patients were given drugs contra-indicated in case of pregnancy. But despite precautions and the requirement stated in the informed consent form, 19 out of 236 enrolled women became pregnant during the trial. The current paper describes the frictions and subjectivities that emerge as new medical technologies travel to resource-poor settings--and more specifically, how trial researchers, health workers, and research subjects involved in the CAMELIA trial negotiate the injunction to avoid pregnancy while using a teratogenic drug.
authors.affiliation: a Institut de Recherche pour le Développement, International Research Unit UMI 233 TransVIHMI Translational Research applied to HIV and infectious diseases , 911, avenue Agropolis, Montpellier , BP 64501 F-3439 France.
authors.forename: Pascale Hancart
authors.initials: PH
authors.lastname: Petitet
mesh_terms: D060432:Anthropology, Medical; D002160:Cambodia; D002986:Clinical Trials as Topic / Q000941:ethics / Q000706:statistics & numerical data; D017280:Condoms; D003268:Contraception Behavior / Q000523:psychology / Q000706:statistics & numerical data; D005260:Female; D015658:HIV Infections / Q000188:drug therapy; D006801:Humans; D007258:Informed Consent; D011247:Pregnancy; D035842:Research Subjects / Q000523:psychology / Q000706:statistics & numerical data; D013723:Teratogens
chemical_list: D013723:Teratogens
keywords: Cambodia; HIV; anthropology; clinical trials; identities and subjectivities; reproduction