FDA’s Proposed Language for Informed Consent Documents

Have you reviewed the FDA’s proposed language for future informed consent documents (ICDs)?

“The Food and Drug Administration (FDA or agency) is issuing a proposed rule that, if finalized, would amend the informed consent regulations to require that the informed consent documents and processes for applicable drug, biologic, and device clinical investigations include a statement that clinical trial information for such clinical investigations has been or will be submitted to the National Institutes of Health/National Library of Medicine (NIH/NLM) for inclusion in the clinical trial registry databank.” (Federal Register/Vol. 74, No. 248. The complete entry of the proposed rule can be accessed at: http://www.krellclinical.com/resources.html.)

Basically, the FDA wants ICDs to include a statement that the study and some study information (not personal identifying) will be listed on the ClinicalTrials.gov website. Not a bad idea. If potential study participants can get information at that website to help them decide whether they should volunteer or not, then adding some text to an ICD to inform them seems good to me.

The problem is the proposed FDA language:

[Proposed FDA Language:] “Information, that does not include personally identifiable information, concerning this clinical trial has been or will be submitted, at the appropriate and required time, to the government-operated clinical trial registry data bank, which contains registration, results, and other information about registered clinical trials. This data bank can be accessed by you and the general public at www.ClinicalTrials.gov. Federal law requires clinical trial information for certain clinical trials to be submitted to the data bank.” [Look for the highlighted text on the last page of the PDF at: http://www.krellclinical.com/resources.html.]

A readability test of the proposed language using Microsoft Word Spelling and Grammar Check shows that the proposed new language is written far above a 12^th grade U.S. reading level. In fact, it’s written at 18.4 Flesch-Kincaid Reading Grade level. This is equivalent to the reading level of someone who is a college graduate and has 2.4 years of post-graduate education.

The following table shows the readability scores for the proposed FDA text:

As experienced, plain-language writers of informed consent documents and as professionals in the clinical research industry who are concerned with informing clinical study participants in clear, simple, unambiguous text, we wrote a response to the FDA proposal. In our response, we proposed alternative language, which is written at a 6.6 grade reading level. To read our full response to the FDA and our alternative text, go to: http://www.krellclinical.com/resources.html.

Let us know what you think of our alternative text.