Engaging Community Health Workers in Research: Ethical Challenges and Practical Solutions

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Engaging Community Health Workers in Research
Ethical Challenges and Practical Solutions

• Camille Nebeker
• Graduate Research Affairs
• San Diego State University
• Research Conference on Research Integrity
• Niagara Falls, NY
• May 15-17, 2009

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Co-authors

• Karen Coleman, Ph.D, Program Evaluation
• Jennifer Terpstra, MPH, Graduate Research
  Assistant, doctoral student
• Gayle Simon, MPH, Resource Specialist

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Presentation Goals

• Describe role of community health workers (CHW)
  in health promotion research
• Address challenges and ethical concerns
  associated with this research approach
• Discuss need for changing research practices and
  policy when working with CHWs

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Community Health Workers

• Integral part of public health promotion in
  underserved communities. Involved in
• Participant identification
• Subject recruitment
• Informed Consent
• Data collection

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Community Health Workers

• Advantages to research effectiveness
• increased recruitment
• participation
• retention

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Protection of Human Subjects

• I have become increasingly aware of the
  challenges we face on our community-based studies
  that involve the Latino community and utilize
  promotoras it would be a great resource for us
  to have culturally tailored, Spanish language
  training materials that emphasize the application
  of human subjects protections to field situations
  common to the promotoras.

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Focus Groups Project Managers/Principal
Investigators

• A series of six focus groups were convened with
  PM/PIs who have involved CHWs/promotores to
  deliver research.  
• Participants described training needs specific to
  human subjects protections and challenges faced
  with training.

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Focus Groups with Promotores

• Two focus groups were held with CHWs/promotores
  experienced in community based research and
  community service projects.
• CHWs/promotores were asked to describe their
  responsibilities as research staff, their
  knowledge of research procedures and the
  challenges they faced as members of a research
  team.

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Research Challenges

• Research Integrity
• Participant Protections
• Informed Consent
• Voluntary Participation
• Confidentiality
• CHW Protection

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Research Integrity

• Role in research vs role in the community
• Pros and cons of bridging the gap
• Implementing research protocol
• Random assignment
• Belief that research benefits participant
• Need for training in basic research methods

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Participant Protections

• Informed Consent
• Lack of understanding of importance of process
• Conflict with role in service project vs.
  research project
• Voluntary Participation
• Possible perceived obligation to participate due
  to CHWs role in the community
• Pressure surrounding recruitment goals may not
  convey risks
• Confidentiality
• Knowledge of community members
• Social interactions

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CHW Protections

• Participant Expectations
• Complexity of research protocol
• Conflict of commitment
• Research Protocol
• Provide assistance if believed needed

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Discussion

• Traditional experimental design
• Inappropriate for community-based research
• Fundamental gap between research, practice and
  policy
• Alternatives to traditional models
• Adaptation for CHWs
• Must fit with relationship to community
• Community-centric approaches for interventions

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Recommendations - Training

• Training for CHW
• Project TRES
• Ethical practices with human subjects
• Intended to complement project specific training
• Basic Research Concepts

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Basic Research Concepts
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TRES Topics

• Roles/responsibilities of the research team
• Research vs. service projects
• Risks and benefits of research
• Informed consent process (identification,
  recruitment and enrollment)
• Confidentiality and privacy

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Web Training
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Roles Responsibilities

• Consider design that puts fewer demands on the
  CHW
• Randomize neighborhoods rather than individuals
• Evaluate CHWs role in recruitment and screening
• Conflicts with no-treatment controls

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Cultural Sensitivity

• Consent process must reflect community and
  culture
• Family involvement
• Interactions slower to develop
• More time to consider involvement
• Consent document
• Flexibility
• Language and terms

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Limitations

• Focus groups were conducted to inform curricular
  development not to gather information on
  challenges associated with the CHW model.
• Important issues may be overlooked since specific
  questions were not included for this purpose.
• Small sample size and limited qualitative
  analyses

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Acknowledgements

• Project TRES (Training in Research Ethics and
  Standards) was funded by the National Institutes
  of Health (NHLBI).
• Project TRES is the result of the significant
  contributions of the following individuals (in
  alphabetical order)
• Karen Coleman, Program Evaluator
• John Elder, Co-investigator
• Michael Kalichman, Consulting Co-investigator,
  UCSD
• Lori J. McNicholas, Curriculum Development
• Camille Nebeker, Principal Investigator
• Gayle Simon, Human Research Ethics Specialist
• Greg Talavera, Co-investigator
• Ana Talavera, Project Manager
• Students Assistants Carmen Violich, Gabriel
  Crosswaithe, Paulina Martinez, Izzybeth Rodriguez

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• Thank you.