title: Physicians' understanding of consent requirements for phase I clinical trials in cognitively impaired or highly vulnerable populations.
abstract: We investigated physicians' attitudes about entering patients who cannot give informed consent or who are of a vulnerable population into clinical trials. A survey instrument asked a nationwide sample of practicing physicians about whether ten hypothetical patients could be enrolled in a phase I clinical trials. The impact of demographic variables on the number of scenarios viewed as completely or somewhat acceptable was analyzed via student's T tests or analysis of variance (ANOVA) as applicable. All significant (p<0.01) variables were entered into a multiple logistic regression model. Eighty-four percent of respondents indicated that at least one case scenario was acceptable. A majority of those who conduct clinical trials (62%), who had training in the ethics of clinical research (78%), and who sit on institutional review boards (IRBs) (83%) approved of at least one case scenario. Physicians approved of the entry of some patients who cannot give informed consent or who are of a vulnerable population into clinical trials. More effective education on the guidelines involving clinical research should be available to practicing physicians, residents, and medical students. There should also be assurance that physicians who conduct clinical trials or who sit on IRBs have the requisite knowledge about the ethics of clinical research.
authors.affiliation: Department of Medicine, Christiana Care Health System, 501 W. 14th St., Wilmington, DE 19899, USA. nfarber@christianacare.org
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Farber
authors.forename: Brian M
authors.initials: BM
authors.lastname: Aboff
authors.forename: Maria R
authors.initials: MR
authors.lastname: DeJoseph
authors.forename: Jerry
authors.initials: J
authors.lastname: Castellano
authors.forename: Joan
authors.initials: J
authors.lastname: Weiner
authors.forename: E Gil
authors.initials: EG
authors.lastname: Boyer
mesh_terms: D001291:Attitude of Health Personnel; D017321:Clinical Trials, Phase I as Topic / Q000941:ethics*; D003068:Coercion; D003625:Data Collection; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D016743:Mental Competency; D018579:Patient Selection / Q000941:ethics; D010820:Physicians / Q000523:psychology*; D011329:Prisoners; D035842:Research Subjects; D014481:United States; D035862:Vulnerable Populations