As we gear up for the implementation of the revised Common Rule, slated for January 2018, we’re still thinking about ways to make the informed consent process more meaningful for and understandable to potential subjects.
The revised rule includes a requirement that the informed consent “begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject…in understanding the reasons why or why not they may want to participate.” While specifics of how that requirement is to be met are still forthcoming, the IRB is already working on ways to make consent materials more understandable to subjects.
For example, we know that industry-sponsored studies don’t often allow much flexibility in specific consent language. However, if your study involves a long and complicated consent form, is there another way to present information that could be used to supplement the form? We know of one PI who created a stand-alone brochure with lots of pictures and bulleted lists to cover his study’s highlights, while still having a more complicated consent form that covered all the required elements of consent.
We have also made available a plain language consent template that can be adapted to supplement longer consent materials, or as a consent form in a study where you’re drafting your own consent from scratch.
And we’ve also noticed that the IRB has been more aggressive in writing contingencies regarding consent processes and forms even for experienced investigators who are hoping to use the same types of materials they’ve used in the past. So keep that in mind when creating new submissions. The IRB will likely look kindly on anything you can do to make consent materials more understandable to potential subjects.