Excluding particular information from consent forms.
Although the informed consent process is crucial to protecting human research subjects, there are cases when particular information within the consent form may present risks to those subjects. In this paper, we examine a case in which including the sponsor's name on the consent form may allow the form to serve as a surrogate for subjects' HIV status. There is no literature addressing the ethical acceptability of excluding particular information from consent forms, and there exists little regulatory guidance on this issue. We argue that excluding information from the consent form is, in fact, obligatory when that information is disclosed orally during the consent process but its presence on the form poses risks to the subjects the consent process is designed to protect. Further, we argue that the regulations ought to be amended to reflect this obligation.
Dickert
Neal
N
Department of Health Policy and Management, Phoebe R. Berman Bioethics Institute, John Hopkins University Bloomberg School of Public Health, Hampton House 348, 624 N. Broadway, Baltimore, MD 21205, USA. ndicker@jhmi.edu
Kass
Nancy
N
Paasche-Orlow
Michael
M
Taylor
Holly
H
D003142:Communication; D003219:Confidentiality / Q000941:ethics; D032962:Consent Forms / Q000941:ethics* / Q000592:standards*; D003469:Culture; D003906:Developing Countries; D030881:Disclosure / Q000592:standards*; D004282:Documentation / Q000379:methods; D028744:Ethics Committees, Research; D033161:Government Regulation; D017408:Guidelines as Topic; D006679:HIV Seropositivity; D006304:Health Status; D006805:Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000592:standards; D018907:Privacy; D012108:Research Personnel / Q000941:ethics; D035842:Research Subjects / Q000523:psychology*; D012109:Research Support as Topic; D012306:Risk; D012725:Sexual Behavior; D013240:Stereotyping; D014481:United States