Transcript Minority Inclusion in Research: Lessons Learned and

Engaging Communities of
Color in Aging Research
Giselle Corbie-Smith, MD
University of North Carolina –Chapel Hill
Program on Health Disparities
Sheps Center for Health Services Research
NC Translational and Clinical Science Institute
Overview
• How did we get to mandated inclusion?
• Are older minorities underrepresented in
research?
• Influences on participation of older
minorities
• Role of community engagement
How Did We Arrive at Mandated
Inclusion?
• Public reports of ethical misconduct raised
concerns about vulnerability in research
–
–
–
–
Nuremberg Trials
Willowbrook Study
Jewish Chronic Disease Hospital
US Public Health Study at Tuskegee
• Belmont Report reinforced the need to protect
groups considered vulnerable by physical,
mental or social and economic circumstances
How Did We Arrive at Mandated
Inclusion?
• Little public pressure to enter clinical research
due to perception of high risk and low benefit
• HIV/AIDS became a pivotal event in research
participation
– Research seen as offering best and least costly
hope to victims
– AIDS victims campaigned to gain admission to
clinical studies
• Shift in clinical research being considered a
risky burden to a prized benefit from which no
one should excluded
Why Worry About Minority
Inclusion in Clinical Research
• 1993 NIH Revitalization Act
– Participation of racial and ethnic minorities in
clinical trials is critical for understanding and
eliminating racial and ethnic health disparities
• to better understand disparities in health
• to improve the generalizability of research findings
– Clinical research drives advances in medical care
– “You gotta be in it to win it”
Minority Enrollment for NIH Extramural
Phase III Research Protocols
(Reported in FY 2003)
60
Percentage
50
Unknown
Male
Female
40
30
# of protocols = 5153
n = 9,378,140
20
10
0
Amer.
Indian/
Alaskan
Native
Asian
Black
Hawaiian/
Pacific
Islander
White
More than
one race
Unknown/
Other
Dept. of Health and Human Services, (2004). Comprehensive Report:
Tracking of Human Subjects Research Reported in FY 2002 and FY 2003.
Enrollment of nonwhites in heart failure
randomized controlled trials
Heiat A, Gross CP, Krumholz HM. Arch Intern Med. 2002; 162(15):1684.
North Carolina Enrollment in NCI Treatment
Trials, 2003-2005
450
400
Number enrolled on Trial
350
300
250
Black
200
White
Other/Unk
150
100
50
0
0-21 21-30 31-40 41-50 51-55 56-60 61-65 66-70 71-75 76-80 81+
Age Group
Barriers to Accrual
•
Barriers to awareness
– Lack of education about trials
– Lack of dissemination of study
opportunities to
patients/providers
– Lack of knowledge about the
origins of cancer
•
Barriers to opportunity
•
Barriers to acceptance
– Perceived harms of clinical trial
participation
– Mistrust of research,
researchers, and the medical
system
– Fear
– Family considerations
– Cost
– Functional status
– Study’s duration and visit
structure
– Time commitment
– Lack of or inadequate health
insurance
– Lack of transportation
– Provider attitudes
Ford, Howerton, Bolen, et al. AHRQ Evidence Report. 2005
Promoters of accrual
• Promoters of awareness
– Education programs for community physicians
– Adequate knowledge about study
– Workshop on trials
• Promoters of opportunity
– Culturally relevant education about trials
– Providing transportation
• Promoters of acceptance
– Altruism
– Perceived benefits of trial participation
– Incentives
Ford, Howerton, Bolen, et al. AHRQ Evidence Report. 2005
Distrust and African Americans
• Thought to stem from the history of racial
discrimination and exploitation
– US Public Health Service Syphilis Study at
Tuskegee
– Experiences extending back to slavery
– Medical and surgical experimentation on slaves
– Robbery of Black graves for cadavers in medical
education
– Current fear of hospitalization
African Americans and Distrust
• Distrust exists among both Blacks and Whites
• African Americans more likely to believe
– doctors would ask them to participate in harmful research or
expose them to unnecessary risks
– doctors would not explain research or would treat them as part of
an experiment without their consent
• African Americans had 5 times odds of having highest distrust
scores
• Differences persisted after controlling for markers of
socioeconomic status
• Still need to explore the contributions of interpersonal and
societal trust
• Demonstrating our trustworthiness one important step in
improving minority participation
Corbie-Smith et al, Archives of Internal Medicine, Nov 2002
Social and Health Priorities of Older
African Americans and
Latinos
• Focus group with older Latinos and African
Americans, and survey of community-based
organizations serving older African Americans or
Latinos
– Affordable housing, enough money to meet their needs,
adequate transportation, and safer neighborhoods were
urgent priorities for older Latinos and African Americans and
superseded their health concerns
– Distrust of researchers, lack of information, caregiver
obligations, fear of experimentation, and lack of benefits
were identified as barriers to research participation
• Willing to participate if fully informed, perceive
tangible benefits and congruence between the
objectives of researchers and participants
Nápoles-Springer et al. Research on Aging 2000; 22; 668
Consumer Centered Models in Mental
Health Research in Older Minorities
•
Consult with community opinion leaders, gatekeepers, and
representative consumers when designing their research
– focus groups and advisory boards made up of members from the target
community
– improves research groups’ ability to understand community-specific
recruitment/retention
– collaboratively develop methods for overcoming
•
Include staff members who are ethnically similar to, have experience
working with, or are members of the target population
– may also be more sensitive to participants’ reactionsand can provide
feedback
•
•
Method of anticipating respondent burden to minimize attrition
Provide feedback to the target community
Arean, The Gerontologist, 2003
Success in longitudinal studies of
aging
• Use of a culturally grounded approach to recruitment and
retention
• Assign the same interviewers to communicate with and
interview study participants for each wave of data collection.
• Ensure that all interviewers are knowledgeable of cultural values
and norms, possible family dynamics, and social issues within
the African American community.
• Provide a mechanism by way of the toll-free number for all study
participants to contact the project staff at their convenience.
• Allow flexibility in scheduling and/or rescheduling interviews at
the participant’s convenience.
Dilworth-Anderson and Williams, J Aging Health 2004; 16; 137S
Surface Structure vs. Deep Structure
Recruitment Strategies
Surface Structure
Deep Structure
• PSAs on minority radio
stations
• Radio interview with a credible
host in the target market,
coupled with traditional PSAs
• PSAs on television
• Station viewed by the target
market, particular hours, and
use of cable channels
• Advertisements in
minority newspapers
• Include a story written about
the study and investigators in
credible print media, coupled
with ads
Resnicow et al, Ethn Dis. 1999 Winter;9(1):10-21
Suggestions for Effective
Recruitment and Retention
• “Stop by when you don’t want something”
• Community involvement in research
infrastructure
• Use appropriate channels of communication
• Demonstrate an appreciation for barriers
• Offer an incentive that is meaningful to
participants
• Provide feedback and disseminate findings
• “Ask” people to participate
What Happens When You Ask?
• Widely claimed that minority groups are less
willing than non-Hispanic whites to participate
in health research
• Examined 20 health research studies
• Small differences by race/ethnicity in
willingness to participate
– non-intervention studies: African Americans had
slightly lower consent rates; Clinical and surgical
interventions: slightly higher consent rates than
non-Hispanic whites
Wendler et al. PLoS Med.2006
Role of Community Involvement
“If you're targeting minority groups, you have a lot of community issues
that you've got to work through…buy in from churches, local, opinion
leaders… I think you've got a lot more foot work to do and discussions
to occur so that the community is fully aware of what the project is
about because misperceptions can really destroy a study. Even if the
study is done, everything is perfect, the IRB completely agrees and it's
been reviewed. The study can be destroyed by misperception.”
Investigator, stroke clinical trials in minority communities
Why Involve Communities?
• Investigators bring technical knowledge about topic and
expertise in research methodology
• Community members bring in depth knowledge of community
concerns, needs, values, and priorities
– Providing the framework for study questions,
– Identifying ethical concerns about the project,
– Suggesting how to modify the study to increase acceptance of the
research in the community,
– Assuring that data collection instruments are culturally appropriate,
– Promoting enrollment and retention in the study.
• Input from community members can be important for
understanding risks research poses and identifying most
acceptable methods of ameliorating them
• Enhances ability of community groups to use research results in
advocating for social change
Examining Ethical Principles
• Due to social, historical and economic contexts,
ethical principles need to be examined in
underserved communities
– Respect for persons: Informed consent may need to be
examined if participants are vulnerable in many ways and
live in communities that lack economic and political power
– Beneficence: Participants and community representatives
may have a markedly different assessment of benefits and
risks of research than researchers or IRBs
– Justice: Often focuses on equitable selection of subjects; in
communities where there may be multiple vulnerabilities
additional issues of power, responsibility, trust, context, and
history must be considered
Approaches to Community
Involvement
• Range of involvement from none to passive to active
to partner/collaborators
– Investigators consult with individuals “at the periphery of
community cultural systems”
– Investigators consult with influential community members for
endorsement and support, but not advice or guidance
– Investigators consult with influential community members for
support, advice, and guidance, usually through an advisory
board
– Investigators partner with the community to define problem,
identify potential solutions, and conduct research -community as collaborator -- negotiating goals and conduct
of study and analysis and use of findings
• Potential for manipulation especially when
involvement is limited and decision-making power of
community members is absent
“If I do all of this and it benefits
society… given the way brothers are
treated [in this country] how is it
going to help me?”
Perceptions of Research
Participation
• Doubt and distrust about research
participation
• Not sure if research participation will lead to
improved health for them or their community
• Aware of the disparities in health and access
to care
• Experiences in clinical care inform their
expectation of research participation
How Can Investigators Ensure That
Participation in Research Translates
Into Tangible Benefits for Minority
Communities?
Rethinking Benefit
• Expected outcome of participation is
benefit
• Potential direct benefits of receiving a
particular intervention in a clinical study
• Collateral benefits of study participation
such as free medical care
• Societal benefits that accrues to others
in greater society
King NMP. The Journal of Law, Medicine and Ethics 2000
“Societal Benefit” and Minority
Communities
• Disparities in health are in part determined by social
and environmental inequities
• Consider ways to affect socioeconomic factors
–
–
–
–
Build capacity among community leaders
Creating opportunities for employment and training
Building and supporting infrastructure
Provide the results of study findings
• Take cues from international efforts
– HIV/AIDS trials
– NBAC guidelines on conducting trials in resource poor
countries
– Other nations as examples: New Zealand and Maori
Corbie-Smith, et al, Archives of Internal Medicine, 2004
“Societal Benefit” and Minority
Communities
• Need a deliberate multidimensional
approach
– Opportunity to demonstrate our
trustworthiness
– Close the circle between inclusion of
minorities in clinical research and disparate
health outcomes
– So that research participation is not
another example of inequities so evident in
this country
Types of Engagement
• Investigator Initiated Community Based
Research
• Research Collaborations
– One on one
– Multiple organizations
• Community Advisory Boards
• Community Based Participatory
Research
Why CBPR?
• Complex health and social problems illsuited to “outside expert” research
• Increasing community and funder
demands for community-driven research
• Disappointing results in intervention
research
• Increasing understanding of importance of
local and cultural context
• Increasing interest in use of research to
improve best practices/best process
Source: hsc.unm.edu/som/fcm/cpr/docs/CBPR_Intro.ppt
Definition of CBPR
“CBPR
is a collaborative approach to research that
equitably involves all partners in the research process
and recognizes the unique strengths that each brings.
CBPR begins with a research topic of importance to the
community with the aim of combining knowledge and
action for social change to improve community health
and eliminate health disparities.”
W.K. Kellogg Community Scholar’s Program
(2001)
What is and is not CBPR?
• CBPR is an orientation to research
– a collaborative approach that changes the
role of researcher and researched
• CBPR is an applied approach
– Goal is to influence change in community
health, systems, programs, or policies
• CBPR is not a method or set of
methods
Source: See hsc.unm.edu/som/fcm/cpr/docs/CBPR_Intro.ppt
Perspectives on CBPR…
extremes of a continuum
Community: Research as
imposing on or using
vs.
benefiting or involving the
community
Academia: Community
participation as largely
incompatible with rigorous
research
Community-Based Participatory Research
C. helps
identify key
issues
 Incr.
motivation
to
participate
Health
Concerns
Identified
Issues
selected
from Epid.
data
C. helps with
study design,
budget,
proposal
submission
C. gives
guidance re
recruitment
and retention
C. helps with
measures
development
and testing
C. helps guide
intervention
development
C. helps with data
interpretation and
publications
 Greater
 Enhanced


 Incr.
Enhanced
recruitment
and
retention
Increased
reliability
and validity
relevance and
likelihood for
success
potential for
translation and
dissemination
acceptability
and “buy-in”
Study
Designed
and
Funding
Sought
Participants
recruited and
retention
systems
implemented
Design:
science and
feasibility
Recruitment
and
Retention
based on
science and
“best guesses”
Budget:
research
expenses
Measurement
instruments
designed and
data collected
Intervention
designed and
implemented
Measures
adopted or
adapted from
other studies,
psychometric
testing
Intervention
designed by
researchers
based on
literature and
theory
Data
analyzed
and
interpreted
Translation
of findings
Researchers
report findings
from analysis
and publish in
peer review
journals
Traditional Research
Principles of CBPR
• Acknowledges community as a unit of
identity
• Builds on strengths and resources
within the community
• Facilitates a collaborative, equitable
partnership in all phases of research,
involving an empowering and powersharing process that attends to social
inequalities
Principles of CBPR
• Fosters co-learning and capacity
building among all partners
• Seeks balance between knowledge
generation and intervention (research
and action)
• Focuses on the local relevance of
public health problems and pays
attention to the multiple determinants
of health
Principles of CBPR
• Involves a cyclical and iterative
process
• Disseminates results to all partners
and involves them in the wider
dissemination of results
• Involves a long-term process,
relationship and commitment to
sustainability
Source: Israel, Eng, Schulz, and Parker 2005
CBPR Tools and Approaches
•
•
•
•
•
•
•
•
Focus groups
Interviews
Windshield Tours
Community Capacity Inventory
Community Asset Maps
Risk Mapping
Community Dialogues
Photovoice
Source: Minkler and Wallerstein, 2008
Project GRACE: Building and sustaining
effective CBPR partnerships to address
HIV disparities
Giselle Corbie-Smith, Principal Investigator
How Project GRACE Started
• NIH Request for Application
– National Center for Minority Health and
Health Disparities (NCMHD)
– Community-Based Participatory Research
(CBPR)
– Goal to reduce/eliminate health disparities
– 3 year needs assessment
– Pilot intervention
Planned Approach to
Partnership Development
• Stage 1: Initial mobilization
• Stage 2: Establishment of
organizational structure
• Stage 3: Capacity building for action
• Stage 4: Planning for action
Source: Florin P, Mitchell R, Stevenson J. Identifying training and technical assistance needs in community coalitions: a developmental approach. Health
Educ Res 1993;8(3):417-32.
Stage 1: Initial Mobilization—
Writing the Grant
• University of North Carolina at Chapel Hill invites
the community to the table at the outset
• Community-based organization (CBO) liaison
• Assembled a group of CBOs to provide input
• Components developed by working committees
• Presentation to the larger community
Who is at the Table?
• The “Community”
– Subcontractors
– Agency/CBO
Representation
– Grassroots
Representation
– Individual
Representation
Stage 2: Establish Organizational
Structure
Project GRACE
Consortium
Comprised of **51** organizations and **43** individuals
Steering Committee
Area L AHEC (Comm Outreach Spec)
Better Days Ahead
CEO (Youth LHA Supv)
Citizens of Edgecombe Co.
East Tarboro-Princeville CDC
Edgecombe Co. Health Dept.
Freedom Hill Community Health Center
Heritage Hospital
NAACP, Edgecombe County
Membership & By-Laws
Sub-Committee
Events Planning
Sub-Committee
Research Design
Sub-Committee
Nash Co. Health Dept.
Nash Health Care Systems
New Sources, Inc. (Parent LHA Supv)
Project Momentum, Inc. (COC)
Rocky Mount OIC (Interviewer Supv)
Sozo Ministries
Visions, Inc. (Process Consultants)
Wright Center, Inc.
UNC-Chapel Hill (Project Coordinator, PI)
Fiscal/ Budget
Sub-Committee
Nominations
Sub-Committee
Communications &
Publications Sub-Committee
The Consortium
Mission
To improve the health of minority and/or high-risk
populations by establishing collaborative
structures and processes that respond to,
empower, and facilitate communities in defining
and solving their own problems.
Includes volunteers from many fields, including:
-HIV/STI prevention and/or care services
-Edgecombe County and City Government
-Health Care Services
-Education & Educational Support for Youth
-Daycare Services
-Housing Assistance
-Legislative Representation
-Education & Educational Support for Young Adults and Adults
-Local History/Genealogy for African Americans
-Recreation
-Private Business
-Mental Health Services & Support
-Character and Life Skills Training
-Employment assistance
-Religious/Spiritual Support
Stage 3: Capacity Building for
Action
• Initial and ongoing
multicultural “isms”
training
• Process consultants
at each community
meeting
• Annual process
evaluation
• Coalition building
sessions
• Periodic retreats to
address concerns,
progress and strategic
planning
Stage 4: Planning for Action
• Identify community
needs and assets to plan
intervention
• 11 focus groups
conducted
• 37 stakeholder interviews
• Intervention mapping to
plan intervention
• Pre-test curriculum
pieces
• Pilot test intervention
Lessons Learned
• Planned approach has
resulted in effective
engagement of community
members
–
–
–
–
–
Consortium membership increased
from 15 to 57
Representation from 51+ community
agencies and 43 individuals
82% of steering committee reside or
work in the two counties
Community members chair 5 of the
6 working committees
Over 100 people attended
community forums
• Need for flexibility in bylaws, organizational
structure and processes
• Paying close attention
to organizational
structure, developing
by-laws and focusing on
process have been
crucial
Summary
• Multiple factors influence participation in
research
• Effective strategies are
– Multidimensional
– Engage target populations
– Address community concerns and expectations
NC TraCS and Community
Engagement in Translational
Research
Giselle Corbie-Smith, MD, MSc
Deputy Director, NC TraCS Institute
Director, Community Engagement Core
Director, Program on Health Disparities
Sheps Center
www.tracs.unc.edu
(866) 705-4931
Clinical and Translational
Science Awards (CTSA)
A national consortium of medical research institutions, working
together and sharing a common vision to:
• Improve the way biomedical research is conducted across the
country
• Reduce the time it takes for laboratory discoveries to become
treatments for patients
• Engage communities in clinical research efforts
• Train the next generation of clinical and translational researchers
CTSA Network 2009
To date, 46 institutions have received CTSA funding,
the total is expected to reach 60 by 2010
NC Translational and Clinical
Sciences (TraCS) Institute
• Our mission:
– transform all activities relating to clinical and translational
research
– create new programs and pathways that make it easier for
research to be performed at UNC and throughout the State of
North Carolina.
NC TraCS Community Engagement Core
focused on conducting T2 research and ensuring community
input and outreach:
•Increased acceptance of and adherence to effective medical
interventions
•Improved recruitment and retention
•Dissemination of culturally appropriate health-related
information
Community Engagement Core (CEC)
Giselle Corbie-Smith, MD, MSc - Director
CEC Purpose:
Create permanent research structures Regional TraCS campuses-local community
boards, single connection portal and core resources with stable research staff so that
population research dictated by community needs can proceed rapidly and successfully.
Guiding Principles:
Two-way Exchange Bi-directional between university and community
Participatory Approaches Co-learning , shared decision making, mutual ownership of
products and processes
Education and Training Specific capacity building for all partners – community,
investigators and health care providers
Regional TraCS Campus (RTC)
Community Research
Network
Clinical Research
Network
Community
Outreach
Specialist
Community Based
Organizations
Clinical
Coordinator
University
Researchers
Community
Practices
Local Community
Advisory Board
Healthy Carolinians
Practice Based
Research Network
Regional TraCS Campuses
57
The CEC provides consultation on
a range of services, including:
Connection Portal
• Identify potential community and university partners for collaboration
• Map service areas of research efforts
Education and Training
• Training – community and clinical audiences
• Identify potential community and university partners for collaboration
• Technical assistance at community level for pilot application process
Regional TraCS Campuses
• Local research staff
• Identification of meeting space
• Dissemination of study results
• Assistance with study implementation/data collection (i.e. interviewing, focus groups,
screening potential study participants, survey administration, etc.)
• Coordination of community meetings
• Identification of community-based organizations
• Identification of clinical practices
• Data entry
• Report summaries
NC TraCS Services
Providing the infrastructure to increase the safety,
speed, and rigor of patient-oriented research:
TraCS Research Inquiry Desk
Education
Data Management
Research Navigators
Consultation Services
Biostatistics
IND/IDE Specialists
Clinical Trials Resources
Ethics/Regulatory
Research Subject Advocates
Core Facilities
Bioinformatics
Recruitment Specialists
Dissemination
Career Development Resources
Strategic Opportunities
Grant & IRB Assistance
NC TraCS Pilot Grant Program
•
TraC$2K
TraCS offers up to $2,000 grants to assist researchers implement a proposed study, or
move a research project forward by providing rapid access to funds that will support
almost any aspect of promising and innovative research.
•
TraC$10K
TraCS offers up to $10,000 grants to support researchers with the early development of
a research idea, or to expand an existing study beyond the original scope into promising
new directions.
•
Large Pilot Program
The TraCS Large Pilot Grant serves as a stimulus for new research initiatives aimed at
obtaining sufficient preliminary data to allow new applications for extramural funding.
Each of these pilot programs will be offered multiple times within the first year of the
CTSA. For specific program guidelines and application due dates, please visit our
website www.tracs.unc.edu
60
Questions?
www.tracs.unc.edu
(866) 705-4931
Additional CBPR Resources
• CBPR Curriculum
– http://www.cbprcurriculum.info/
• CBPR Toolkits
– http://www.shepscenter.unc.edu/research_programs/aging/publicati
ons/CEAL-UNC%20Manual%20for%20CommunityBased%20Participatory%20Research-1.pdf
• Books
– Israel BA, Eng E, Schulz AJ, Parker EA. (Eds.) (2005). Methods in
Community-Based Participatory Research for Health. San
Francisco: Jossey-Bass.
– Minkler, M, Wallerstein, E. (Eds.) (2008) Community-Based
Participatory Research for Health: From Process to Outcomes.
San Francisco: Jossey- Bass.
How Can We Move the Field
Forward
• Don’t assume that others (or you) know
what you mean by race
– Explicit definitions of race
• More careful in invoking either biological
or social constructions of race
• Statement on the theory that might
explain differences in health outcomes
Proportion of Blacks Enrolled in Trials of the Southwest Oncology
Group (SWOG) as Compared with the Proportion of Blacks in the U.S.
Population of Patients with Cancer, According to the Type of Cancer
Hutchins LF, Unger JM, Crowley JJ et al. N Engl J Med 1999;341:2061-7.).