9:277 aul > € Gb!) Gbely daa 2 Usb 3, A Case. Case $: Conducting Human Subject Research Abroad: Whose Standards? Relevant Professions: Biomedical Science, Translational Sefence, Medicine, Public Health Issue: Protection of Human Subjects Why this is important: Increasingly biomedical research is being conducted in developing (esource poor) countries, No mater where you live. you may have an ‘opportunity to be involved in research in other countries. ‘The cave: Aragen. a UK-based company has developed a vaccine against HIV that appears promising. Animal stdies were very stccexsful, Phase I and phase I trials demonstrated that the vaccine wis remarkably safe and it proloced significant antibody levels in essentially all of the volunteers. The sornpany now wishes 10 hegin phase Il irals in Guatemala where previous surveillance studies revealed 3 very high incidence of HIV. Such a study could be completed in two years: The Guatemalan government fas expressed infeest in having the study conducted and hegins negotiations with Aragen. The vaccine, whichis specifically directed against the stain in the Guatemalan population, will he provided free by Aragen, The ‘company will over the cost of conducting the study, which will ke cared out by the Guatemala Vaccine Insite, I adition to dhe study cost, the company’ il provide all che laboratory equipment necessary’ to conduct the studies, ten eam ters forthe Institute, andl two Vehicles to visi the sud sites. The company agrees that if the vaccine proves elective it will he given free of charge to the affected Population ofthe city at no cos to the country for five year. Tn designing the Phase Il study the sponsor Aragen proposes a randomized double blind prospective study with one group receiving the test vaccine and the w 6 Cons ‘other groap receiving a placebo. All potential paricipants will be tested for HIV prior to being enrolled inthe study. I they are HEV + they willbe referred to one of ‘he municipal hospitals ofthe Guatemala Corporation. Further, any research subject who converts to HIV + during the study’ wil be randomized—half will be seferred 10 ane af the Municipal Corporation hospitals to be tweated by the standard method in Gustemala, which does not include retroviral drugs, including AZT, of any protease inhibitors. The other half wil not be told oftheir HIV status wo measre whether the vaseine has any impact on the disease as sugested by animal mols {Wahere is any change inthe standard therapy recommended by the government any previous o Future seroconver willbe switched to this therapy, Due tothe AIDS epidemic. the Guatemalan goserament has proposed making the vaccine manda tory, however, once enrolled the subjets can withdraw at any time, The Municipal ‘Corporation will continue to provide treatment forthe patient's lifetime. Questions: When, if ever, can the cost dliference of conducting studies in developing ‘counties be ethically justified? ‘What ae the ethical standands for conducting researc? Are they the same in all ‘countries? Should a study like this meet the standards of the U.S, or Guatemala ‘or both? 23. You are the chairnan of a IRB in developing county tasked with evalting this protocol What questions. would you ask? Do you need any’ addtional Information? What would you advise and why? Case 6: Authorship and Clinical Equipoise Relevant Professions: Medicine and Biomedical Science Issues: Authorship, Placcho controlled studies, Children in research, Financial ‘confict of meres, or) ‘counties, and