In the late 1990s my doctor suggested I head over to the local academic medical center where a research project was underway to discover the genes associated with my autoimmune condition. That’s when I came face-to-face with my first consent form and the inevitable tradeoff patients make when presented with pages of gobbledygook punctuated by a signature line: either sacrifice understanding in the name of contributing to the greater good, or politely decline.
Despite the oxymoron they’ve come to represent, “informed” consents are rooted in the ethical principle of respect and supported by three pillars:
- Information – What is communicated
- Comprehension – How it is communicated
- Voluntariness – Whether it conveys a sense of choice
With the intent clearly spelled out and a list of core ingredients, why are consent forms still so hard to understand? Without comprehension, information is meaningless and cannot be used to form an opinion regarding participation. Plain language greases the skids for comprehension, making information digestible to the point that an informed decision to take part (or not) can be made.
A sense of urgency
A national $215 million dollar Precision Medicine Initiative is schedule to launch later this year. Precision medicine takes into account differences in our genes, environments, and lifestyles to help doctors understand why one treatment may work especially well for one person, but not another. Success hinges on the recruitment of a diverse pool of one million volunteers. Each will be asked to sign a consent form.
While precision medicine has the potential to reduce health disparities, or differences in health that occur along the lines of diversity (such as geographic, racial, ethnic, or socioeconomic), the field of health literacy suggests that those who may be at risk for low health literacy, and therefore most confused by the “informed” consent process, are also those who stand to benefit the most from the research.
The solution is simple: co-develop consent forms with the very people who will be asked to sign them. Research subjects are the only ones in a position to say whether the consent is understandable and informative enough to inform decisions around participation. I can think of no better way to show respect for those willing to give of themselves for the greater good.
About the author: Jennifer Pearce is the founder of Plain Language Health and leads health literacy and patient experience research efforts within Sutter Health’s Research, Development and Dissemination department. She signed the gobbledygook consent form but has dedicated her career to making consents (and other health information) easier to understand.