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Community Engagement in Clinical ResearchAn Introduction

David O. Warner, M.D.

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Why are we talking about “community engagement?”

Traditional research approaches

~98% of Americans receive their health care outside of academic medical centers

The challenge of “translational research”

• How to reach Billy in Sleepy Eye, MN?

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The Translational Research Continuum

Basic BiomedicalDiscovery

Clinical Efficacy

ClinicalEffectivenessClinical Practice

T1

What works under controlled conditions?

(Up to phase III trials)

How can we change practice?(Dissemination and

Implementation Research)

What is the effect on population health?

(Outcomes research)T2

T3

T4

“Bench” “Bedside”

CommunityPractices

CommunityPractices

What works in real world settings?

(e.g., Comparative Effectiveness

Research)

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The Translational Research Continuum

Basic BiomedicalDiscovery

Clinical Efficacy

ClinicalEffectiveness

T1

What works under controlled conditions?

(Up to phase III trials)

What works in real world settings?

(e.g., Comparative Effectiveness

Research)

How can we change practice?(Dissemination and

Implementation Research)

What is the effect on population health?

(Outcomes research)

“Bench” “Bedside”

“T2”

Clinical Practice

CommunityPractices

CommunityPractices

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“Community engagement” as a key component of translational research

How to reach Billy? • Include him in the research

process

The NIH response• Roadmap, CTSA, etc.

Issues arise…• The ethics of conducting

research in communities - e.g., who benefits?

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What is a “Community?”

A group of people linked by social ties who share common perspectives or interests, and may also share a geographic location (MacQueen et al)

Examples of communities• Olmsted County residents• Somali immigrants• Primary care physicians in Southeastern Minnesota• And many others….

Communities are not homogeneous and seldom speak with a single voice

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What is “Community Engagement”?

…community engagement is a process of inclusive participation that supports mutual respect of values, strategies, and actions for authentic partnership of people affiliated with or self-identified by geographic proximity, special interest, or similar situations to address issues affecting the well-being of the community of focus.

NIH Council of Public Representatives, October 2008

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Unpacking Community Engagement…

A broad framework that includes the full spectrum of approaches that involve the community in the research process

• Includes research ranging from that which incorporates only a few elements of community engagement with minimal collaboration to research in which community organizations and researchers are equal partners throughout the process

Builds on community strengths

Emphasis on partnerships and collaboration

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Traditional Research Approach

Researcher writes article, obtains academic rewards, thanks community (sometimes)

Researcher or funding source identifies problem

Researcher writes protocol, selects community to be studied, obtains funding

Researcher recruits subjects from the community

Researcher collects and analyzes data

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Community-engaged Research Approaches

Problem identified of interest and relevance to the community

Protocol tailored to specific community of interest, funding obtained and shared as appropriate

Community members are participants in research, not just subjects

Data analyzed and collected with community input as appropriate

Results disseminated to both the academic world and the community

Studies that recruit subjects in community settings are not necessarily community-engaged

CO

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UN

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Identifying research topic• Community members or researcher may

make the initial approach• Example – chronic pain in Native Americans

• Researcher and community may work together to refine

Plan developed and funding secured

• Researcher contributes scientific expertise

• Community also contributes;• Ideas on logistics and recruitment• Advice on tailoring for community context

• Community receives research funds as appropriate

Examples of community-engaged research approaches

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Study conduct• Community members involved as appropriate

• e.g., hire study staff• Promote study within the community• Advice on study problems

Data analysis and reporting• Involvement of community as appropriate

Dissemination of results to the community and to the academic world

• Community determines appropriate/relevant methods for their members

Examples of community-engaged research approaches

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Community-based Participatory Research (CBPR)

One end of the community-engaged research spectrum

Equitable partnership between researcher and community in all research phases

Community identifies the problem to be addressed

Aims at achieving meaningful changes that will directly improve community health

Requires major investments of time and energy in building the relationships necessary for successful partnerships

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Data is shared, researchers and community decide its use and dissemination

Researchers own the data; may involve community in decisions about how it will be used & disseminated

Researchers own data, control use & dissemination

Researcher & community share control equally

Researchers control research, community representatives may help make minor decisions

Researchers control process, resources & data interpretation

Researchers & community work together to help build community capacity

Researchers gain skills & knowledge, some awareness of helping community develop skills

Researchers gain skills & knowledge

Community organizations are partners with researchers

Community organizations may help recruit participants & serve on Advisory Board

Community organizations may be asked to assist

People as participants & collaborators

People as participants People as subjects

Research WITH community as full partner

Researcher brings his/her interests to the community to determine if the community is interested

Research IN or ON the community

Community identifies problem or works with researcher to identify problem

Researcher defines problem, community may contribute

Researcher defines problem

Community-based

Participatory Research

Research with the

community

Community-engaged ResearchTraditional Research Approach

Research WITH community as partner

From MA MacDonald, Duke University

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Challenges of community-engaged research approaches

Requires considerable investment of time and energy to build relationships

• And any relationship has high and low points….

Community priorities may not reflect your research priorities

Community may have little capacity/experience with research, and follow a different timeline

Funding mechanisms/study sections may be unfamiliar with these approaches

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Benefits of community-engaged research approaches

Can improve reliability and validity of study tools and procedures

Helps recruitment and study flow

Results more likely to be relevant

May improve external validity

Expanded opportunities for funding• NIH expanding RFAs• Foundation funding

Relationships have their own rewards

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Successful Community-engaged Researchers…

View community partners as knowledgeableand important contributors to research

Acknowledge that they and community members bring their own beliefs to research

Think that the beliefs and values of community members should be recognized

Value relationships with the community as one of the benefits of research

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