Perspectives of IRB chairs on the informed consent process

Eugene I. Kane, Joseph J. Gallo

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Questions have been raised by researchers and ethics committees about whether human research subjects comprehend study participation when signing a research consent form. Methods: To determine existing beliefs about the informed consent review process, impediments to shorter consent, and augmented/alternative consent methods, a survey of institutional review board (IRB) chairpersons was conducted. Results: IRB chairs expressed concern with (but do not often assess) the length, complexity, and reading level of the consent form or participant comprehension. IRB chairs reported varied (but generally low) familiarity, acceptance, and use of possible solutions and alternatives. Conclusions: Best practice standards should be developed for (1) assessing consent form reading level; (2) measuring and monitoring participant comprehension; (3) alternative consent methods and enhancements; and (4) electronic signatures.

Original languageEnglish (US)
Pages (from-to)137-143
Number of pages7
JournalAJOB Empirical Bioethics
Volume8
Issue number2
DOIs
StatePublished - Apr 3 2017

Keywords

  • IRB
  • consent comprehension
  • consent reading level
  • electronic consent
  • enhanced consent
  • informed consent
  • multimedia consent
  • participant comprehension

ASJC Scopus subject areas

  • Health(social science)
  • Philosophy
  • Health Policy

Fingerprint

Dive into the research topics of 'Perspectives of IRB chairs on the informed consent process'. Together they form a unique fingerprint.

Cite this