Excluding Particular Information From Consent Forms
Accountability in Research 2005 January-March; 12(1): 33-45
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.
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Paasche-Orlow, Michael K.; Taylor, Holly A.; Brancati, Frederick L. (2003-02-20)BACKGROUND: Institutional review boards (IRBs) are charged with safeguarding potential research subjects with limited literacy but may have an inadvertent role in promulgating unreadable consent forms. We hypothesized ...
How to Achieve Informed Consent for Research From Spanish-Speaking Individuals With Low Literacy: A Qualitative Report Cortés, Dharma E; Drainoni, Mari-Lynn; Henault, Lori E; Paasche-Orlow, Michael K (2010)Investigators have the responsibility to ensure that prospective participants are fully informed about a research protocol prior to consenting to participate, yet many researchers face challenges when obtaining consent, ...