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GCP: A Question & Answer Reference Guide
the IRB. It is also the IRB's responsibility to review how subjects will be screened for an individual study. Thus,
if certain information is going to be collected for screening purposes, the IRB should review the information that
will be collected as well as the method of collection to ensure that each is consistent with FDA's informed consent
regulations. Thus, while the form may not need IRB approval (unless they require it), the information collected and
the method by which it will be collected should be reviewed and approved by the IRB."
8.60 Q. Clearly, 21 CFR 56.109(b), which states in part that "An IRB shall require that information given
to subjects as part of informed consent is in accordance with 50.25," requires the IRB to review the
informed consent form. Today, however, we are beginning to see some clinical programs featuring the
use, on a pilot basis, of "interactive multimedia presentations" to supplement the informed consent form
and process. These interactive presentations have, according to one study, involved the use of tablet PCs
and software and interactive video presentations and interactive question and answer sessions to help
potential trial subjects understand their disease and the clinical trial. If such presentations are used as
part of or to supplement the informed consent process, must the IRB first review and approve the entire
presentation and everything that the patient will see as part of it? Or can the IRB focus on just the
informed consent form itself?
A. Since such multimedia presentations would be considered part of, or could at least significantly affect, the
informed consent process, the IRB must review and approve the presentations before they are used. In an informal
communication on this subject, the FDA stated that, based on 21 CFR 56.109(b), "all information presented to
subjects as part of the consent process, including that contained in interactive multimedia presentations, would
need to be reviewed and approved by the IRB. While these interactive presentations may enhance the consent
process, without IRB review of the information conveyed, the presentations may instead cause confusion or convey
misinformation. The consent process needs to be seen as being broader than the consent form; it includes other
tools used by the researcher to help the subject understand the research."
8.61 Q. For the purposes of assessing informed consent forms, how much is known about the reading level
acceptable to most IRBs, and how IRBs assess informed consent forms for readability?
A. In June 2010, Kris Walters Herring, MSM, Ph.D., then an Assistant Professor and Director of Clinical Research
for the University of North Carolina-Wilmington and an IRB member, revealed the results of a small, informal
study to determine "what reading level both independent and affiliated IRBs in the United States require for the
approval of biopharmaceutical clinical research trial informed consent forms." While it is commonly assumed
that a sixth or eighth grade reading level is necessary for IRB approval, Walters noted that this had not been
"systematically examined."
The survey of 22 affiliated IRBs and 12 independent IRBs found that all IRBs agreed that the acceptable level
consent form reading level is the sixth to eighth grade reading level. The results also showed that 16 affiliated and
four independent IRBs had a written policy with a specific reading level defined, while five affiliated and four
independent IRBs did not have a written policy. Interestingly, about half of the surveyed IRBs used IRB member
evaluation of the reading level only, while the other half used a combination of readability software and IRB
member evaluation. Fourteen of the affiliated and five independent IRBs use a sixth to eight grade reading level
for their consent templates, while five affiliated IRBs and one independent IRB use templates at the ninth to tenth
grade reading level.
8.62 Q. Under 21 CFR 56.109, an IRB must "require that information given to subjects as part of the informed
consent is in accordance with" 21 CFR 50.25, which specifies the elements of informed consent. Although
there is no mention of the IRB's requirement that it ensure 21 CFR 50.20, which establishes that "the
information that is given to the subject or the representative [during the informed consent process] shall
be in language understandable to the subject or the representative," is it the FDA's view that the primary
responsibility for enforcing this provision falls on the IRB-for example, under 56.109(a), which states
that the IRB shall review and have authority to approve, require modifications in (to secure approval), or
disapprove all research activities covered by federal regulations?

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