CTTI recommends a new model for the informed consent process that places the focus back where it should be: on the participant. The consent process should be an interactive, ongoing conversation between the participant and the research investigator or staff. "Patients who really understand what they are agreeing to when they sign an informed consent document are much more likely to adhere to trial requirements and be retained for the entire timeframe of the trial," notes patient advocate, Jane Perlmutter. "Thus, not only is excellent consenting better for patients, it will also lead to more efficient and less costly trials."
At a CTTI-hosted webinar on November 19, 2015, sponsors will hear suggestions and learn about tools to help them restructure the informed consent process and document to be more participant-friendly while retaining key information. The webinar will also explore the benefits of e-consent and how appropriate and thorough research staff training can improve the overall process for everyone involved.
The need for this new direction is recognized. "The Association of Clinical Research Professionals (ACRP) supports the recommendations put forth by our partners in the Clinical Trials Transformation Initiative," says Jim Kremidas, ACRP Executive Director. "We are confident these recommendations will result in a more efficient and higher quality informed consent process conducted by clinical research professionals. A clear understanding of the risks and expectations clinical trial participants face will enhance their experience and drive better quality research."