title: Mind the gap: An empirical study of post-trial access in HIV biomedical prevention trials.
abstract: The principle of providing post-trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post-trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, especially where government bodies, sponsors, and regulatory bodies have complex interests vested in decisions about whether or not new interventions are made available, how, and to whom. This paper provides an empirical account of post-trial access in the context of HIV prevention research. It describes both access to the successful products of research and the provision antiretroviral drugs for trial participants who acquire HIV. First, we provide evidence that, in the current system, there is considerable variation in the duration and timeliness of access. We then argue that by analysing the difficulties faced by researchers to this point, and their efforts to meet this obligation, much can be learned about how to secure post-trial access in HIV biomedical preventions trials. While researchers alone have a limited obligation, their advocacy on behalf of trial participants may be necessary to call the other parties to account.
authors.forename: Bridget
authors.initials: B
authors.lastname: Haire
authors.forename: Christopher
authors.initials: C
authors.lastname: Jordens
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D002944:Circumcision, Male; D002986:Clinical Trials as Topic / Q000941:ethics*; D016265:Conflict of Interest; D003220:Conflict, Psychological; D036262:Empirical Research; D015658:HIV Infections / Q000188:drug therapy* / Q000517:prevention & control* / Q000635:transmission; D006297:Health Services Accessibility / Q000941:ethics* / Q000592:standards / Q000639:trends; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008297:Male; D012108:Research Personnel / Q000941:ethics*; D035842:Research Subjects; D012941:Social Responsibility
chemical_list: D016915:AIDS Vaccines; D044966:Anti-Retroviral Agents
keywords: HIV/AIDS; antiretroviral therapy; distributive justice; empirical ethics; research ethics