Excluding particular information from consent forms

Neal Dickert, Nancy Kass, Michael Paasche-Orlow, Holly Taylor

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)33-45
Number of pages13
JournalAccountability in Research
Volume12
Issue number1
DOIs
StatePublished - Dec 1 2005

Keywords

  • Confidentiality
  • Consent form
  • Ethics
  • Human subjects research
  • Informed consent
  • International research

ASJC Scopus subject areas

  • Education
  • Library and Information Sciences

Fingerprint Dive into the research topics of 'Excluding particular information from consent forms'. Together they form a unique fingerprint.

Cite this