Bioethics Research Infrastructure Initiative

Background:  The recruitment and retention of racial and ethnic minorities into clinical trials is a leading challenge confronting clinical researchers, and undoubtedly contributes to the persistence of health disparities. Religious, spiritual, and cultural beliefs are among the barriers to increased participation. These beliefs and obstacles are further intensified by the legacy of the most infamous biomedical research study - the Tuskegee Syphillis Study - which hovers like a dark cloud over many racial and ethnic minority populations. It is perhaps the greatest dissuading factor to enroll in clinical research for many members of those communities.  Although, practical influences such as awareness of opportunities to participate in a clinical trial can be contributory, the sense of mistrust can be very pervasive and entrenched.

With President Bill Clinton’s apology to the nation in 1997 for the Tuskegee tragedy, came the creation of the Tuskegee National Bioethics Center. It is the nation’s first bioethics center devoted to engaging the sciences, humanities, law and religious faiths in the exploration of the core moral issues which underlie research and medical treatment of African Americans and other underserved people. In October 2003, the National Institutes of Health through the NCMHD and the NCRR, invested $14.4 million to complete the Bioethics Center.

Given the current underrepresentation of African Americans, Hispanics, Native Americans, and Asian Americans, Native Hawaiians, and Pacific Islanders, it is clear that the goal of maximizing the diversity of participants in clinical trials has yet to be fully realized.  While these populations account for about one-third of all Americans, less than one-tenth of U.S. clinical trial participants come from these groups.  Without clinical study participants of all races and ethnicities, promising new health interventions cannot be fully evaluated for safety and effectiveness.

Project Description: The Bioethics Research Infrastructure Initiative would establish nationally-recognized bioethics centers dedicated to fostering greater participation of racial and ethnic minority populations in clinical trials.  Academic and other private, non-profit entities with a history of research and training engagement with health disparity communities provide the perfect platform for such an initiative.  Specific aims include, but are not limited to, the development and implementation of a comprehensive effort designed to enhance recruitment and retention by:

• Utilizing non-traditional methods to reach racial and ethnic minority populations to rebuild their trust in the health care system;
• Improving health literacy, cultural competency and linguistic proficiency as a core component of navigation of the health care system;
• Conducting bioethics training and rotations on-site at the nationally-recognized bioethics center, and
• Fostering collaboration with the other institutions, organizations, or groups including the NIH through the Bioethics Department at the Clinical Center.

How to Apply:
Please refer to RFA-OD-09-004 for application and submission information at
http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-09-004.html

Contact:
Dr. Nathaniel Stinson
Phone: 301-402-1366
E-mail: stinsonn@mail.nih.gov