NIH Research Festival
The challenges of informed consent documents, including the length of the document, readability, and comprehension is a recognized theme addressed in a substantial body of literature and conferences related to human subject protections. Acknowledging that requirements based on regulations and incorporation of legal language are not negotiable, and in preparation for the enforcement of the Notice of Proposed Rulemaking issued in 2015 to employ a more meaningful informed consent, the NIAID IRB Office and Protocol Development Program deliberated on creative and applicable methods of information disclosure. Meaningful consent requires that a patient be given sufficient understandable information to make a valid choice. Discussions resulted in adding a visual style of learning to a primarily linguistic informed consent process. A pictorial glossary was created with graphics that enhance communication of both common procedures, such as phlebotomy, and complex interventions, such as randomization, conducted as part of research protocols within NIAID. Graphics can be modified to be culturally and age appropriate. The glossary and any associated changes are reviewed by the IRB prior to use. The graphics can also be uploaded to laptops, iPADs and iphones for the paper adverse participant. Appreciating a trend toward a complete electronic consent document, future approaches will include other visual media, such as videos.
Scientific Focus Area: Research Support Services
This page was last updated on Friday, March 26, 2021