1. Acknowledgement Special Thanks to current and former members of the IHS National IRB and Area IRB members @ www.ihs.govwww.ihs.gov Great Appreciation for the DHHS Office Human Research Protection staff www.ohrp.gov www.ohrp.gov Public Responsibility in Medicine and Research www.primr.org www.primr.org CDC: www.cdc.govwww.cdc.gov Office of Research Integrity www.ori.govwww.ori.gov AHRQ : www.ahrq.govwww.ahrq.gov NIH : www.nih.govwww.nih.gov Native American Research Centers for Health –University and tribal partnerships

2. I know there is Real Diversity among the Indians tribes Indians tribes and their communities

3. Introduction

4. Reflections from the Research Past to Define Research forward for the Navajo Nation “ One Dine’s Perspective ” August 2011 Phillip L. Smith, M.D., MPH phillip.smith@ihs.gov

5. OVERVIEW To provide brief comments on the history of Research and the Navajo Nation To provide some thought on issues related to future Research for Navajo communities Answers and Questions

6. Wars, Conquest, Health and Governance influenced Indian world First Congress established Indian Health office in Dept of War 1779 Moved to Department of Interior 1849 Indian Wars – 471 treaties signed thru 1890 ---{1868} Statehood 1912 -NM World War I Meriam Report 1928 Citizenship 1934 WW II - 1940’s Nuremberg Trials Transfer Act 1955 IHS a DHHS Agency 1987

7. Government and Research HEW established Indian Health staff - 1955 Cornell- Many Farms Project TB drug trials Trachoma drug trials NIH CRC established Thalidomide experience NIH Ethics Committee 1964 WMA- Helsinki accord Tuskegee Kennedy Hearings -1973 National Research Act – IRB IHS – Tucson R&D office PL 93-638, and 94-437 IHS becomes an DHHS agency First IHS IRB – late 1980’s First Tribal IRB - Navajo Many Vaccine studies 1980-90’s

8. Research Among American Indians –The NAVAJO “New Beginnings”, Along the paths we have traveled over a long period of time. Taking some time for tracking and accountability.

9. AI/AN Research - key events (1970-1990) (1940) (1950-1970)(1990-current) Self- Determination & participation WWIIUSPHS and the Universities control Tribal Activity in the research process

10. The Whole Being Inter-active circles – a metaphor for our thought-life process ENVIRONMENT SPIRITUAL PHYSICALMENTAL BEHAVIORAL & SOCIAL

11. INFLUENCES for Good or Bad Language - Communication Culture Experiences Resources Luck

12. Early Studies forgotten impacts

13. Who Decides what Federal Eligibility laws, rules, regulations and the AI/AN governance Interface of the Infrastructure of the Federal agencies Business vs Service mentality Impact of the Federal Funds

14. AI/AN Research - key events (1970-1990) (1940) (1950-1970)(1990-current) Self- Determination & participation WWIIUSPHS and the Universities control Tribal Activity in the research process

15. Role of Activity between: * Research * Public Health Practice * Evaluations Legal Authority Specific Intent Responsibility Benefits and Risks Experimentation Human Subjects

16. ????

17. Hepatitis A Incidence,1990-2003 AI US Hepatitis A vaccine licensed

18. Tribal Connections to Research Remembering the successes and failures Thinking of community along with the individual Knowing it is the people and not the programs that really matter Willing to accept some risk to achieve the impossible Acknowledgement of the impact of existing Bias in exploring the unknown Remembering that Science is not the highest value to which other orders of values should be subordinate Now Future Old

20. The People Environmental Health Mental Health Physical Health Spiritual Health COMMUNITY HEALTH SERVICES AUTONOMY - Lifestyle - RESEARCH

21. Research Issues Navajo Nation is still a very Vulnerable population Education Socio-economic status Health Disparities and Inequities Infrastructure

22. Research Issues Community Protections Stigmatizations Conflict of Culture and Science Genetics Body tissue management The Community as a Lab Application of New Technology Communications Understanding of Risk-Benefits

23. RPMS Integrates Multiple Clinical Systems Laboratory Appointment System Patient Registration Dental Emergency Room PCC Patient Database Elder Care Public Health Nursing Pharmacy Behavioral Health System Women’s Health PCC Data Entry RCIS Immunization Radiology Case Management CHR Surgery

24. Research issues Participation other than just as volunteer research subjects Tribes and AI/AN communities being involved in the identifying and organizing the research questions. Sharing data; Owning the data Self-Identifying community health issues to research Community participation in data access, analysis, evaluation and dissemination Use of Tribal Epidemiology Centers and Native American Research Centers for Health

25. From Helicopter Research NARCH To TRIBALLY CONTROLLED RESEARCH! IHS NIH Student & Faculty T&D CBPR Partnerships Tribal/Universities

27. Research Issues Research in Emergency management situations in Navajo communities. Technical assistance and guidance and training on emergency environment research not yet established Critical need for learning of National Emergency policies on research management under new laws Management and operation with Agency capabilities at existing facilities and community settings

28. Research issues Providing accurate and timely clinical data on the health of American Indians and Alaska Natives. Tribal Specific health data Accountability for Data and Health research Needs Working Relations with State and Local Governments and Private Organization as well as Congress on research activities in Navajo communities

29. The Environment To build on the lessons learned To be responsive to the new world environment we now face. To increase accountability via documented performance To increase interest in addressing health disparities research between Navajo and the U.S. population

31. Research issues Supporting the delivery of quality health care by maximizing research resources. Resources for research Increasing Funding From Other Organization to Support AI/AN Health research activities Federal State governments, private foundations and corporations Health Care Facilities participation

32. Research issues Expand and maintain an adequate AI/AN Research workforce Recruitment, Retention and Development of AI/AN researchers critically needed Increasing Technical Capacity for tribal participation Research still a mystery to most AI/AN communities

33. Research issues Community Directed Research into Navajo Health issues Technical Assistance for research grants applications and management Community Based Participatory Research rather than Community Placed Participatory Research Networking required to address lack of infrastructure

34. Research issues Improving the safety and quality of THE RESEARCH. Integration of Best Practices into the Provision of research Assuring culturally competent research Implementation of quality systems in health care research Agree on Quality clinical indicators used for research outcome assessments Ensure Consumer Access to Health Research Information Ensure Provider Access to Healthcare Research Knowledge and Expertise

35. Research issues Quality health research information access for decision making for patients, providers, and communities Building the capacity of the telecommunications network Concerns about the security of information and information systems used in research Ensuring patient privacy Utilize accurate data to improve health care delivery Facilitating the sharing of information

36. Research Issues Expanding coalitions and partnerships to build Indian health research networks. Assuring the development of partnership-coalition research agenda and plans at multiple levels, including national, State, private sector, Area & local levels. Demonstrating the importance of partnerships & coalitions for research program expansion Through the Indian health system, forming workgroups to actively pursue useful partners & coalitions

37. The formal process Inter-active circles of influences and activity Clinic Environment Code of Federal Regulations / Laws Tribal Laws and Research Codes Research Stakeholders The People

38. Research Issues Developing new structures within the Navajo health network to increase collaboration and innovation in research to improve & advocate for the health care of the AI/AN population. Need processes to recognize innovative programs Need plans to consistently and systematically evaluate programs, systems and processes of the research activity ongoing in Indian Communities

39. Looking toward the Future There is Critical need for continuing the dialog and creating real activity in research by all of the stakeholders !!

40. Applications Remember the Past, especially experiences, guidelines, policies, & required Follow-up Evaluate the value, benefits and risk to individuals and to the community/Navajo Nation Think critically of the wants along with the need Know it is the people and not the protocol or process that make the difference Acknowledge that Science is not the highest value to which we should always yield Seek for Harmony in the Total life process Mind Spirit Body

41. Our goal: less of this…

42. … And more of this!

43. Questions? !

44. …. Closing thought Our Lives Begin to end the day, We become silent about things that Matter. - Martin Luther King, Jr.