acknowledgement special thanks to current and former members of the ihs national irb and area irb...

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., MPHphillip.smith@ihs.gov

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.