Technical Writer University Of Michigan, United States
Background: It is well documented that research informed consent documents (ICDs) are unnecessarily complex and do not promote informed decisions. Many ICDs are extremely long and ask subjects to understand complex ideas, often during stressful moments.
Program
Description: The IRB at a major university undertook a comprehensive revision and restructuring of our standard informed consent template in preparation for the NIH Data Management and Sharing policy. In review of the template, it was noted that template language pertaining to storage, sharing, and future use of data and specimens were littered throughout areas of the document. These passages had been added in reaction to policy or practice changes, and their locations within the ICD had made sense at the time of their insertion. For example, the language addressing general future use and sharing language had been in response to the 2004 Havasupai Indian Trial. Genomic data sharing language had been developed to comply with NIH’s 2015 policy. For IRB reviewers, these piecemeal revisions resulted in a document that moved back and forth between information about the “main” study and information about future uses.
Program
Assessment: To address this, the IRB restructured the document to combine all storage, sharing, and future use of data and specimen language prompts within a single new section near the end of the template. A special introduction to the new section helps to explain to potential participants what these varied uses mean to their decision whether to participate in the study and the role of each use in research. In addition to assisting potential subjects, the clearer organization will help researchers to develop informed consent documents, by situating all possible future use types clearly in one section where they may choose to utilize those that apply to their research and omit those that do not. Lastly, the clear distinction between main study information and future uses will help potential participants which of their questions pertain to the “main” study and which to future uses, some of which are likely to be optional.
Limitations: This reorganization does not address complex wording, nor does it reduce the length of the template or the ICDs based on it. Many considerable barriers to true informed decision making by potential participants remain. But this restructuring represents a contribution to the ongoing effort to combat those barriers.
Discussion: The IRB intends to continue to seek and implement improvements to their consent templates. Approaches may include striving to improve the readability and understandability of template language by organizing workshops with participant focus groups or developing visual aids—such as pictographs, which research has shown to improve document comprehension significantly—to supplement future use language.
