Implementing Evidence-based Informed Consent Practices in Clinical Trials

The National Institutes of Health (NIH) has prioritized improving informed consent for cognitively impaired individuals in clinical trials. Several best practices for obtaining informed consent and communicating risk have been identified by past research such as simplifying language, testing understanding of information, and involving legally authorized representatives as needed. However, these practices are not routinely used in clinical trials. This study is aimed at increasing awareness and adoption of best practices for informed consent among principal investigators (PIs) and clinical research coordinators (CRCs) who work with older adults.

Following collection of baseline data, we conducted a 1-year longitudinal study using a 2-group randomized design. We developed a web-based toolkit with guidance on best practices for informed consent (ConsentTools.org) and pushed the toolkit to one group of PIs and CRCs using social media. The control group received an online learning module modelled on standard online ethics trainings. Both groups completed baseline and follow-up surveys assessing study outcomes (attitudes, intention to adopt, and adoption of best practices). In the final year of the project, we will systematically disseminate findings and the toolkit to key stakeholder groups. This study will have significant impact by increasing use of best practices for informed consent, facilitating the ethical and efficient conduct of clinical trials with participants with Alzheimer’s disease or other cognitive impairments, and advancing implementation science in research ethics.

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Solomon, E. D., Mozersky, J., Goodman, M., Parsons, M. V., Baldwin, K., Friedrich, A. B., Harris, J. K., & DuBois, J. M. (2023). A randomized implementation trial to increase adoption of evidence-informed consent practices. Journal of Clinical and Translational Science, 7(1). https://pubmed.ncbi.nlm.nih.gov/36721403/

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Friedrich, A. B., Solomon, E. D., Mozersky, J., & DuBois, J. M. (2023, July 17). Using evidence-informed practices to improve eConsent. SoCRA Blog. https://www.socra.org/blog/practices-improve-econsent/

Solomon, E. D. (2024, March 8). Introducing the ConsentTools Toolkit: Promoting Best Practices for Informed Consent. PRIM&R Ampersand Blog. https://blog.primr.org/introducing-the-consenttools-toolkit-promoting-best-practices-for-informed-consent/