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 8th 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 7th 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.