Choctaw Nation Institutional Review Board

1. Choctaw Nation Institutional Review Board “Protecting Our People and Heritage” An Overview Presented at: “2008 Annual Tribal Self - Governance Conference” April 29, 2008 Las Vegas, NV Presented by: David F. Wharton, MPH, RN Choctaw Nation IRB Administrator

2. A Snapshot of the Choctaw Nation • Located in Southeastern Corner of Oklahoma • Headquarters is located in Durant, Oklahoma • 3 branch government structure • Executive – (Chief and Assistant Chief) • Legislative – (12 member Tribal Council) • Judicial – (3 Judges)

3. Geographic Profile of the Choctaw Nation

4. Geographic Profile of the Choctaw Nation

5. History (continued) • The Choctaw Nation Institutional Review Board was established in 2004 by Executive Order of Chief Gregory E. Pyle • Driving forces for development • Increased external requests for research • Increased internal opportunities for research • Grants • Partnerships • Collaborations • Identified need to protect human subjects in an organized manner

6. History (continued) • Steps in the establishment of the CNIRB • Selection of Members • Diversity • Technical / Professional Aspects • Community Aspects • Leadership Involvement • Appointment of Members by Chief Pyle • Letters of Appointment

7. History (continued) • Education of CNIRB members • On-site • Initial training occurred during CNIRB orientation • Ongoing training for several months as part of the CNIRB meetings • Online • Application and Acquisition of the Federal Wide Assurance Number - August 2004 • Registration of CNIRB #1 – August 2004

8. Role of the CNIRB • Ongoing Human Subject Protection • REVIEWALL human subject research occurring within the Choctaw Nation • Not just health related research • Provide APPROVAL for projects that meet the intent set forth in the “Common Rule” • Provide FEEDBACK when a project cannot be approved for failure to show human subject protection

9. Structure of the CNIRB • Members • Total of nine (9) members • Community Representatives 2 • Health Board Representatives 2 • Leadership 1 • Specialty / Technical • Nursing 1 • Medical 1 • Behavioral Health 1 • Community Health 1

10. Structure of the CNIRB • Meetings • Every other month • Meet at the Choctaw Nation Health Care Center located in Talihina, Oklahoma

11. Who we protect • Human subjects (regardless of race or tribal affiliation) who are involved in research that occurs within the organizational boundaries of, or within the jurisdictional control of the Choctaw Nation of Oklahoma • Protecting A Nation • The CNIRB also protects the heritage of the Choctaw People

12. Who we protect • Work in conjunction with other Tribal IRBs and OKC Area Indian Health Service IRB. • Future may hold some form of an IRB agreement between IRBs when research is occurring simultaneously in several tribal locations

13. Future Steps for CNIRB • Improvement of Tribal IRB Standard Procedures • Work with Cherokee and Chickasaw Nations and IHS OKC Area on joint jurisdictional project issues • Improve knowledge of researchers on CNIRB existence and procedures

14. Thank you! • Please hold question for discussion following all presentations.