574. IRB Review of Community Based Participatory Research

Updated November 18, 2021

Community-Based Participatory Research

Community-based participatory research is a collaborative approach to research that equitably involves all partners in the research process and recognizes the unique strengths that each may bring. The process typically (but not always) starts with a topic of importance to the community and has the aim of combining knowledge with action with the intention of instituting change to improve community well-being. The community residents participate in the full spectrum of research from concept, design, conduct, data analysis, interpretation, conclusions, and communication of results. Academic/research and community partners join to develop models and approaches to building communication, trust and capacity, with the final goal of increasing community participation in the research process. Community-based participatory research has emerged as an alternative research model which integrates education and social action to improve communities and enhance the scientific base of knowledge. It is most often associated with improving community health outcomes through transfer of evidence-based research from clinical settings to communities that can most benefit.

Community-based participatory research requires that the researcher follow the best practices for respectful and productive relationships. The following principles are in addition to those required for all human research:

  1. Be certain that the research topic addresses a community-defined need, question or problem.
  2. Recognize research as a partnership (i.e., engagement of research projects is to be led by a team of academic and community Co-Investigators as partners).
  3. Respect the community partner’s interest in the research.
  4. Be open to the guidance of community insights and experiences.
  5. Maintain a balance in decision making between the researchers and community participants.
  6. Provide continuous feedback to enhance the partnership and its outcomes.
  7. Disseminate research findings to community stakeholders and participants.
  8. Recognize partnerships can dissolve and a plan for closure should be developed.

IRB Process

When preparing an initial application, investigators should include appropriate details to allow the IRB to apply the federal criteria for approval. However, when describing the operational procedures, the descriptions should be general enough to allow flexibility. Researchers are encouraged to consider and include the following:

  • Community Involvement – A description of the aspects of the research wherein community members will be involved, as well as how they will be involved. Often, the researchers involve the community members in the research design or conceptualization, conduct or implementation of the study, and dissemination or distribution of study results. In some topics or research areas, it may be necessary to involve the community members as well in the analysis and interpretation of data, and to seek their input into how the results or findings will be distributed or shared with others. This gives the community members the opportunity to include their views about the interpretation prior to final publication.
  • Community Consultation – Researchers should work with the community members to identify any risks and potential issues (e.g., literacy, language barriers, local or cultural beliefs and attitudes) the researcher may not have considered. Risks should be considered for both individuals and the community. Appropriate measures to minimize any foreseeable risks can also be established in consultation with the community members.
  • Collaborative IRB Review – Some groups, agencies or entities (e.g., tribes, retirement communities, and school districts) may have their own ethical review process for research. If this is the case, researchers should apply to the local ethics review body for review and approval of their research. Institutional and/or investigator agreements may also be necessary.
  • Plan for Modifications – It is often necessary to make changes to the procedures or survey/data collection instruments as the research progresses or is implemented in the field. Researchers must anticipate and plan for this by including in the IRB application information that is sufficient to allow for a thorough review but general enough to allow flexibility.
  • Plan Disclosure of Research Findings – Most group harms result from inappropriate disclosure of research findings. Researchers should work with the community to inform the members about the research findings and how they plan to disclose these as well as possible implications of disclosure. This approach may reduce the possibility of harms resulting to the community as the research is published or presented.
  • Make Benefits Available to Groups – Researchers should design studies so that they will provide benefits to the communities involved. Productive partnerships between researchers and community members should be encouraged to last beyond the life of the project. This will make it more likely that research findings will be incorporated into ongoing community programs and therefore provide the greatest possible benefit to the community from research.

Institutional Review Board Considerations

Reviewers should ensure that principal investigators have submitted enough information to assess whether the study adequately meets the criteria for approval, including:

  1. Evidence of an equitable partnership between the investigator and the community partner.
  2. The Investigators have defined the relevant community or communities.
  3. The investigators have identified the appropriate community or communities for the project.
  4. The community Co-Investigator has identified the appropriate research partner for the project.
  5. Community engagement is an integral part of the research.
  6. Letters of support (from the community) are clear and well-defined.
  7. There is an appropriate division of funding (if applicable).
  8. There are adequate training opportunities for investigators and community members.
  9. The research environment is adequate.
    1. The community benefits from the presence and implementation of the research.
    2. The research is conducted in an environment that enhances the likelihood of success.
  10. The research strives for positive change in the community’s outcomes.
  11. The research fosters long-term relationships between the University and the community for the benefit of both.

To support an appropriate review of community-based participatory research projects that takes into account the above considerations, Research Integrity will offer periodic training to IRB members that covers topics related to the design, implementation, and dissemination of results of such research. The training may include presentation of pertinent information (e.g., principles of community-based participatory research, policy and checklist requirements for reviewing such research) during IRB meetings, articles covering aspects of this methodology, as well as requirements to complete relevant course modules or to attend live or recorded presentations by Research Integrity staff or subject matter experts.

In addition, Research Integrity will make an effort to include IRB members and/or consultants with expertise in community-based participatory research by identifying and recruiting local investigators and community members whose credentials reflect such knowledge and experience.