Diversity, Equity, and Inclusion: Translation of Informed Consent Forms

What are the goals of this project?

Ensure clinical trial eligibility and enrollment practices are in no way restrictive to the URM patient population

Why is the CBTN request important to this project?

Dr. Kline and Dr. Waanders, alongside the working group, have developed action goals to accomplish their mission and vision to ensure that all patients can be enrolled into clinical trials despite language barriers of under-represented populations. To accomplish this, we are requesting funding for vendors to create translated regulatory documents such as informed consents to ensure the retention and participation of patients and families from all racial, ethnic, and social backgrounds.

This will help to broaden enrollment options for our patients and families from under-represented backgrounds and alleviate barriers to non-English speaking patients and families. Thus, allowing patients and families greater opportunity to participate in clinical trials that provide novel therapies and treatment strategies to patients that may not have any other standard of care options. Together, we hope to end health disparities through open access to patients and families throughout our communities and beyond.

The average consent form for a single clinical trial is between 20 to 30 pages, averaging about $400 per consent per trial, and utilizing a 14-day turnaround time. We aim to have consent forms available in at least 10 different languages that most broadly represent the communities which we serve. As we add new trials to our portfolio, interpretation needs will be ongoing and as such, this will be an ongoing funding need. We'd like to create a pool of resources available to consortia members for CBTN and PNOC clinical trial consents.