acknowledgement special thanks to current and former members of the ihs national irb and area irb...
TRANSCRIPT
Acknowledgement Special Thanks to current and former members of the IHS National
IRB and Area IRB members @ www.ihs.gov Great Appreciation for the DHHS Office Human Research Protection staff
www.ohrp.gov Public Responsibility in Medicine and Research
www.primr.org CDC: www.cdc.gov Office of Research Integrity www.ori.gov AHRQ : www.ahrq.gov NIH : www.nih.gov Native American Research Centers for Health –University and
tribal partnerships
I know there is Real Diversityamong the
Indians tribesand their
communities
Introduction
Reflections from the Research Past to Define Research forward for the
Navajo Nation
“One Dine’s Perspective”August 2011
Phillip L. Smith, M.D., [email protected]
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
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
Government and Research
HEW established Indian Health staff - 1955
Cornell- Many Farms Project TB drug trials Trachoma drug trialsNIH 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
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.
AI/AN Research - key events
(1970-1990)
(1940)(1950-1970) (1990-current)
Self-Determination
& participation
WWII USPHS and the
Universities
control
Tribal Activity in the research
process
The Whole Being Inter-active circles – a metaphor for our thought-life process
INFLUENCES for Good or Bad
Language - Communication
Culture
Experiences
Resources
Luck
Early Studies forgotten impacts
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
AI/AN Research - key events
(1970-1990)
(1940)(1950-1970) (1990-current)
Self-Determination
& participation
WWII USPHS and the
Universities
control
Tribal Activity in the research
process
Role of Activity between:* Research* Public Health Practice* Evaluations
Legal Authority Specific Intent Responsibility Benefits and Risks Experimentation Human Subjects
????
Hepatitis A Incidence,1990-2003
0
20
40
60
80
100
120
1990 1992 1994 1996 1998 2000 2002
Year
Cas
es/1
00,0
00 AI
US
Hepatitis Avaccine licensed
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
The People
EnvironmentalHealth
MentalHealth
PhysicalHealth
SpiritualHealth
COMMUNITY
HEALTHSERVICES
AUTONOMY- Lifestyle -
RESEARCH
Research Issues
Navajo Nation is still a very Vulnerable population
Education Socio-economic status Health Disparities and Inequities Infrastructure
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
RPMS Integrates Multiple Clinical Systems
Laboratory
AppointmentSystem
PatientRegistration
Dental
EmergencyRoom
PCCPatient
Database
Elder Care
Public Health Nursing
Pharmacy
Behavioral Health System
Women’sHealth
PCC Data Entry
RCIS
Immunization
Radiology
Case Management
CHR
Surgery
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
From Helicopter Research
NARCH
To TRIBALLY CONTROLLED RESEARCH!
IHS
NIH
Student & Faculty T&D
CBPR
Partnerships
Tribal/Universi
ties
Native American Research Centers for Health By State
ANTHC
CRIHB
GLITC
ITCA
MWTLC
NNDOH
NP
NPAIHB
OKCAITHB
SIHB
USET
Not covered by a TEC
= IHS HQE & ABQ
= NARCH
MA
RI
CT
ME
NJ
DEMD
WA
OR
CA
NV
ID
MT
WY
UTCO
AZ
TX
OK
ND
KS
NE
SD
AR
MO
IA
MN
GA
TN
MS AL
LA
MI
OHINIL
WI
FL
PA
VA
NY
WV
NC
KY
SC
AK
NHVT
HI
NM
ANTHCNARCH
CRIHBNARCH
ITCANARCH
NPAIHBNARCH
AberdeenBlack Hills
NARCH
Navajo NARCH
GLITCNARCH
ONARCHCherokeeChickasaw
= NARCH
Native American Research Centers for Health By State
MA
RI
CT
ME
NJ
DEMD
WA
OR
CA
NV
ID
MT
WY
UTCO
AZ
TX
OK
ND
KS
NE
SD
AR
MO
IA
MN
GA
TN
MS AL
LA
MI
OHINIL
WI
FL
PA
VA
NY
NC
KY
SC
AK
NHVT
HI
NM
ANTHC & SCF NARCH
USETNARCH
WMATNARCH
NPAIHBNARCH
AberdeenNARCH
MT-WY NARCH
GLITC & Fond Du LacNARCH
ONARCH
IHC-CANARCH
AAIHB
NARCH
NCAI NARCH
Ogdala NARCH
wv
Black HillsNARCH
WICNARCH
ITCA NARCH
CHICKASAW NARCH
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
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
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
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
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
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
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
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
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
The formal process Inter-active circles of influences and activity
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
Looking toward the Future
There is Critical need for continuing the dialog and creating real activity in research by all of the stakeholders !!
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
Our goal: less of this…
… And more of this!
Questions?
!
…. Closing thought
Our Lives Begin to end the day,
We become silent about things that Matter.
- Martin Luther King, Jr.