Informed Consent Forum

FDA Rewrites Informed Consent Rule

If you did not receive my email: “FDA Requires New Informed Consent Statement,” here is a summary.

In late 2009, FDA posted its draft of proposed new text that will be required for all informed consent documents for clinical trials. The industry responded to FDA with comments in January 2010. A year later, FDA posted some of those comments along with its responses.

Some industry comments were openly critical and saw no need to add more text to informed consent documents that are already too long. Others complained that it was difficult to understand what FDA was trying to communicate in the new paragraph.

My letter to FDA pointed out that NIH, NCI, and HHS are all trying to get informed consent documents written in plain language at or below 8^th grade reading level. Yet, FDA’s proposed new text was written at a post-graduate reading level, i.e., for someone beyond a bachelor’s degree.

The alternative that I offered was written at a 6th grade reading level. To its credit, FDA acknowledged that its proposed text was beyond the reading level of the average study participant (and therefore inappropriate for an informed consent document). FDA rewrote the text to a 7^th grade reading level:

“A description of this clinical trial will be available on  www.ClincalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

I was pleased to know that FDA listened and was open-minded, and to get a call from Drug Industry Daily for an interview. If you have a subscription to FDANews, you can read the article online.

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.

Do Your Numbers Add Up?

By: Robert Krell, President, Krell Clinical Communications

Since half of the adult readers in the US are reading at eighth grade or below, would it be safe to assume that the average reader of an informed consent form (ICF) might have math skills that are also at or below eighth grade? 

When it comes to informed consent, we should probably keep the math as simple as possible. Here is a typical example of the kind of numerical references that one often encounters in informed consent forms:

Between the clinic visits, you will have a telephone call from the study staff every 3 months after your last clinic visit. The first telephone visit will be at visit 9, which is 15 months after visit 3.

The first sentence is simple enough on the math side, although the sentence length is too long, which brings the reading level up to tenth grade. The second sentence is the real problem. It challenges one to figure out what the relationship is between visit 9 and visit 3. To what end? In addition, why does the reader need to know that it is 15 months between visits 9 and 3? Why not simply say:

Between the clinic visits, you will have a telephone call from the study staff every 3 months after your last clinic visit. The first telephone call will be after visit 9.

Then, end it there. How does the time between visits 9 and 3 help the potential study participant decide whether to sign up for the study? In fact, because it’s confusing, it probably gives the potential participant a reason not to sign up.

Here’s what may be happening to ICFs. Almost every bit of information from the protocol that is meant to explain something to Investigators, ends up in the ICF. It may be great information for Investigators, but that doesn’t mean potential study participants need to know it also.

Developing a good informed consent document is as much a question of what to leave out that is not necessary for the participant to know, as it is a question of what to include. However, if it is something that the participant should know and it involves numbers, just keep it simple. Even if the information is true. Yes, there are 15 months between visits 9 and 3. There may also be 15 months between visits 10 and 4, and 1 month between visits 10 and 9. Does the information help the reader? If not, leave it out. Keeping it simple will help the reader understand why the numbers are there in the first place.

I invite you to comment.