Quorum Review IRB recently released an online resource recommending ways to shorten and simplify consent forms. Since overly long and convoluted consent forms are an ongoing headache for IRB members and researchers, we thought we’d share some of Quorum’s suggestions with you in a series of blog items. And we recognize that with industry sponsored studies, our ability to implement some of these suggestions may be limited, as the sponsors write those consent forms. But perhaps these hints will be helpful as we draft and review consent materials.
One way to simplify consent form language is to avoid including a list of all the inclusion and exclusion criteria. There is no regulatory or policy requirement to include them all, and they may be written in language that is not readily understandable to the average reader. Does the prospective subject really need them all spelled out in great and gory detail? Or will a general explanation that the study doctor will want to make sure you qualify for the study suffice:
An example:
Old Language:
To be able to enroll in the study, you must:
- Be between the ages of 18 and 75
- Have had a diagnosis of the study condition within the past 6 months
- Have a chest x-ray done (need not be repeated if you have had one in the previous 6 months)
- Be otherwise generally healthy
- Have a BMI between 18 and 26, inclusive
- Not use any tobacco products
- Not be taking any other investigational drugs
- Not have liver or kidney disease
New Language:
Before you can enroll in the study, and after you sign this form, your study doctor will perform certain tests and procedures and ask you about your health history to determine whether or not you can continue in the study. Ask your study doctor for more information about what tests and procedures will be done.
Source: How to Simplify Your Consent Form, by Quorum Review IRB.