Perspectives of IRB chairs on the informed consent process

Questions have been raised by researchers and ethics committees about whether human research subjects comprehend study participation when signing a research consent form.

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.

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.

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.