title: Protection of health research participants in the United States: a review of two cases.
abstract: Two research-related deaths and controversies in the United States during recent years have raised public concern over the safety of research participants. This paper explores the reasons why, in two studies, there was a failure of ethical oversight. The issues exposed by these failures have international relevance as they could possibly occur anywhere where human health research is carried out. Five factors that contributed to these failures are highlighted: 1. failure to support and resource research ethics committees; 2. failure of the research oversight process to adequately assess the risks and benefits of research, while giving undue emphasis to informed consent; 3. conflicts of interest arising from financial relationships and research ethics committee membership; 4. lack of consistent oversight of privately funded research; and 5. incompetent or intentional failure to adhere by ethical guidelines. There is considerable headway to be made in the United States, as in other countries, in the fostering and maintenance of robust systems of human research oversight.
authors.affiliation: 59 Sefton St, Wadestown, Wellington, New Zealand. alison.douglass@paradise.net.nz
authors.forename: Alison
authors.initials: A
authors.lastname: Douglass
authors.forename: Peter
authors.initials: P
authors.lastname: Crampton
mesh_terms: D000046:Academic Medical Centers; D001249:Asthma / Q000188:drug therapy; D017321:Clinical Trials, Phase I as Topic / Q000009:adverse effects; D016265:Conflict of Interest / Q000191:economics; D032962:Consent Forms; D030881:Disclosure / Q000331:legislation & jurisprudence; D026724:Ethical Review / Q000592:standards*; D028744:Ethics Committees, Research / Q000191:economics / Q000592:standards; D015316:Genetic Therapy / Q000009:adverse effects; D033161:Government Regulation; D019983:Guideline Adherence; D006805:Human Experimentation / Q000592:standards; D006801:Humans; D007258:Informed Consent; D010344:Patient Advocacy; D017149:Private Sector; D035842:Research Subjects; D012109:Research Support as Topic; D018570:Risk Assessment; D014481:United States; D018172:United States Office of Research Integrity