title: Ethical issues in tuberculosis vaccine trials.
abstract: Bacille Calmette-Guérin (BCG) vaccines are widely used, even though estimates of efficacy have ranged from zero to 80%. BCG is a relatively safe vaccine, but it can cause disseminated infection, especially in immunocompromised hosts. Thus, the development of a more reliably efficacious and safer vaccine is important to the control of tuberculosis. The testing of any new vaccine in human populations presents a number of ethical challenges that must be addressed. These include (1) the appropriateness of conducting such trials in developing countries; (2) the use of a BCG-vaccinated population as the control group; (3) the provision of tuberculin skin-test screening and preventive therapy to study participants; (4) the involvement of various "communities" in the trial(s); (5) the structure and process of ethical review; (6) establishing an effective method of obtaining informed consent; and (7) the roles and responsibilities of researchers and others in ensuring that trial results are available to the study population after the trial ends.
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. des1@cdc.gov.
authors.forename: D E
authors.initials: DE
authors.lastname: Snider
mesh_terms: D001500:BCG Vaccine; D001428:Bacterial Vaccines; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D003906:Developing Countries; D004992:Ethics, Medical; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000276:immunology*; D014374:Tuberculin Test; D014397:Tuberculosis, Pulmonary / Q000517:prevention & control*
chemical_list: D001500:BCG Vaccine; D001428:Bacterial Vaccines