Camille NebekerGraduate & Research Affairs

San Diego State University

Research Conference on Research IntegrityNiagara Falls, NYMay 15-17, 2009

Karen Coleman, Ph.D, Program Evaluation

Jennifer Terpstra, MPH, Graduate Research Assistant, doctoral student

Gayle Simon, MPH, Resource Specialist

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

Integral part of public health promotion in underserved communities. Involved in:

◦Participant identification

◦Subject recruitment

◦Informed Consent

◦Data collection

Advantages to research effectiveness

increased recruitment

participation

retention

“…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.”

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.

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.

Research Integrity

Participant Protections

◦ Informed Consent

◦ Voluntary Participation

◦ Confidentiality

CHW Protection

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

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

Participant Expectations

◦ Complexity of research protocol

◦ Conflict of commitment

Research Protocol

◦ Provide assistance if believed needed

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

Training for CHW

◦ Project TRES

Ethical practices with human subjects

Intended to complement project specific training

◦ Basic Research Concepts

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

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

Consent process must reflect community and culture◦ Family involvement◦ Interactions slower to develop◦ More time to consider involvement

Consent document ◦ Flexibility◦ Language and terms

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

Project TRESProject TRES ( (TTraining in raining in RResearch esearch EEthics and thics and SStandards) was funded by tandards) was funded by the National Institutes of Health (NHLBI).the National Institutes of Health (NHLBI).

Project TRESProject TRES is the result of the significant contributions of the following is the result of the significant contributions of the following individuals (in alphabetical order): individuals (in alphabetical order):

Karen Coleman,Karen Coleman, Program Evaluator Program Evaluator John Elder, John Elder, Co-investigatorCo-investigator Michael Kalichman, Michael Kalichman, Consulting Co-investigator, UCSD Consulting Co-investigator, UCSD Lori J. McNicholas, Lori J. McNicholas, Curriculum Development Curriculum Development Camille Nebeker, Camille Nebeker, Principal InvestigatorPrincipal Investigator Gayle Simon, Gayle Simon, Human Research Ethics Specialist Human Research Ethics Specialist Greg Talavera, Greg Talavera, Co-investigator Co-investigator Ana Talavera, Ana Talavera, Project ManagerProject Manager Students Assistants: Students Assistants: Carmen Violich, Gabriel Crosswaithe, Paulina Carmen Violich, Gabriel Crosswaithe, Paulina

Martinez, Izzybeth RodriguezMartinez, Izzybeth Rodriguez

Thank you.