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Title: Redefining Research Ethics Review: Case Studies of Five Community-Led Models

Abstract: This report presents the results of the National Collaborative Study of Community-Based Processes for Research Ethics Review. Our team of community and academic partners conducted case studies of five community-based processes for research ethics review: Special Service for Groups Institutional Review Board (IRB), Los Angeles, CA; Papa Ola Lokahi IRB, Honolulu, HI; Guam Communications Network Research Project Review Process, Long Beach, CA; Galveston Island Community Research Advisory Committee, Galveston, TX; and Center for Community Health Education Research and Service's Community-Based Research Committee, Boston, MA. Our main audience for this report is community-based organizations interested in developing or strengthening a research review process and others vested in community-engaged research. By packaging the case studies together with an overview of the study and a cross-case analysis, we aim to provide a rich set of review process examples, promising practices, and key considerations that can inform the work of community-based research review processes.

Type of Product: PDF document

Year Created: 2014

Date Published: 4/6/2015

Author Information

Corresponding Author
Nancy Shore
University of New England
716 Stevens Ave
Portland, ME 04103
United States
p: 617 281 4094

Authors (listed in order of authorship):
Nancy Shore
University of New England

Alice Park
Community-Campus Partnerships for Health

Paige Castro
Community-Campus Partnerships for Health

Eric Wat
Special Service for Groups

Lola Sablan-Santos
Guam Communications Network

Mei-Ling Isaacs
Papa Ola Lokahi

Elmer Freeman
Center for Community Health Education Research and

John Cooks
Galveston Island Community Research Advisory Commi

Elaine Drew
Community-Campus Partnerships for Health

Sarena D Seifer
Community-Campus Partnerships for Health

Product Description and Application Narrative Submitted by Corresponding Author

What general topics does your product address?

Public Health, Social & Behavioral Sciences, Research Ethics; Community-Engaged Research

What specific topics does your product address?

Community coalition , Community development, Community engagement, Health services research, Research ethics, Community-engaged research, Community-based participatory research

Does your product focus on a specific population(s)?

Asian, Black or African-American, Immigrant, Latino/Hispanic, Native Hawaiian or other Pacific Islander, Refugee, Seniors, Prisoners

What methodological approaches were used in the development of your product, or are discussed in your product?

Case study , Community-based participatory research , Focus group , Policy analysis, Qualitative research, Content Analysis, Interview, Participant observation

What resource type(s) best describe(s) your product?

Case study

Application Narrative

1. Please provide a 1600 character abstract describing your product, its intended use and the audiences for which it would be appropriate.*

This report presents the results of the National Collaborative Study of Community-Based Processes for Research Ethics Review. Our team of community and academic partners conducted case studies of five community-based processes for research ethics review: Special Service for Groups Institutional Review Board (IRB), Los Angeles, CA; Papa Ola Lokahi IRB, Honolulu, HI; Guam Communications Network Research Project Review Process, Long Beach, CA; Galveston Island Community Research Advisory Committee, Galveston, TX; and Center for Community Health Education Research and Service's Community-Based Research Committee, Boston, MA. Our main audience for this report is community-based organizations interested in developing or strengthening a research review process and others vested in community-engaged research. By packaging the case studies together with an overview of the study and a cross-case analysis, we aim to provide a rich set of review process examples, promising practices, and key considerations that can inform the work of community-based research review processes.

2. What are the goals of the product?

The goals of the report are to:
-Present case studies of five diverse community-based research ethics review processes
-Demonstrate how community-led models of research ethics review ensure protections for both individuals and communities
-Provide firsthand insight into the ethical issues faced by diverse communities engaged in research
-Make recommendations for community groups, institution-based IRBs, policymakers and funding agencies.

3. Who are the intended audiences or expected users of the product?

Our main audience for this report is community-based organizations (CBO) interested in developing or strengthening a research review process and others vested in community-engaged research.

4. Please provide any special instructions for successful use of the product, if necessary. If your product has been previously published, please provide the appropriate citation below.

The report is self-published by Community-Campus Partnerships for Health (CCPH). The citation is: Shore N, Park A, Castro P, Wat E, Sablan-Santos L, Isaacs ML, Freeman E, Cooks JM, Drew E, Seifer SD. Redefining Research Ethics Review: Case Studies of Five Community-Led Models. Seattle, WA: Community-Campus Partnerships for Health, 2014.

5. Please describe how your product or the project that resulted in the product builds on a relevant field, discipline or prior work. You may cite the literature and provide a bibliography in the next question if appropriate.

Community engagement is increasingly recognized by research funding agencies, researchers and community groups as an integral component of clinical and translational research, health disparities research and patient-centered outcomes research (1-10). Community-engaged research (CEnR) represents a shift from viewing individual community members as research subjects to engaging community members and the organizations that represent or serve them as research partners (3-5, 8-10). Institutional IRBs, designed to protect the rights and welfare of individual study participants, are less equipped to protect the rights and welfare of communities involved in research (11-17). Specifically, the Belmont principles that guide IRBs do not cover the wide range of ethical issues that arise in CEnR, and thus institutional IRBs may not provide a thorough ethical analysis(12-13). For example, missing in the Belmont Report are critical CEnR considerations such as will the community be actively engaged in the research efforts and will the research result in benefits to the community? Further, studies of community-engaged researchers’ experiences with institutional IRB review reveal significant concerns about their consideration of partnership processes and community impacts (15-17). They find, for example, that institutional IRBs focus on how a study contributes to the scientific knowledge base or to society at large but do not usually consider what the benefits may be, if any, for the involved community.

With substantial federal investments being made in CEnR, more community groups are being approached by researchers who want to conduct research in their communities, and more community groups are initiating their own research (18). To ensure the ethics and integrity of the research in which they and their communities are engaged, a growing number of community groups and Tribes have developed their own community-based research ethics review process (CRP) that operate independently or in conjunction with institutional IRBs (19-30). In 2008 CCPH surveyed 109 CRPs and found that the primary substantive focus of research reviewed for these CRPs included health disparities and diabetes. Almost 90% of these CRPs reviewed CBPR proposals (31).

To more fully understand the operations and impact of CRPs, we conducted in-depth case studies of 5 CRPs and analyzed the cases for cross-cutting themes.

6. Please provide a bibliography for work cited above or in other parts of this application. Provide full references, in the order sited in the text (i.e. according to number order). .

1. Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences, Board on Health Sciences Policy, Institute of Medicine. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: National Academies Press; 2013.

2. Selby JV. The Patient-Centered Outcomes Research Institute: A 2013 agenda for "Research Done Differently." Popul Health Manag 2013;16(2):69-70.

3. Ahmed SM, Palermo AG. Community engagement in research: Frameworks for education and peer review. Am J Public Health 2010; 100(8): 1380-7.

4. Wallerstein N, Duran B. Community-based participatory research contributions to intervention research: The intersection of science and practice to improve health equity. Am J Public Health 2010;100(S1), S40-S46.

5. Minkler M. Linking science and policy through community-based participatory research to study and address health disparities. Am J Public Health 2010;100(S1), S81-S87.

6. Strategic Plan for Leading the Nation to Eliminate Suffering and Death due to Cancer. National Cancer Institute; 2010 [cited June 10, 2014]. Available from http://www.cancer.gov.

7. Schulz AJ, Krieger J, Galea S. Addressing social determinants of health: Community-based participatory approaches to research and practice. Health Educ & Behav 2002;29(3): 287-95.

8. O’Fallon LR, Dearry A. Community-based participatory research as a tool to advance environmental health sciences. Environ Health Persp 2002;110(2): 155-159.

9. NIH Council of Public Representatives Role of the Public in Research Workgroup. Definition of Public Participation and Community Engagement in Research. Bethesda, MD: National Institutes of Health; 2009 [cited June 10, 2014]. Available from http://www.nih.gov/about/copr/reports/index.htm.

10. Israel BA, Schulz AJ, Parker EA, Becker AB. Review of community-based research: Assessing partnership approaches to improve public health. Annu Rev Publ Health 1999;19:173-202.

11. Shore N, Wong K, Seifer SD, Grignon J, Gamble VN. Advancing the ethics of community-based participatory research. J Empir Res Hum Res Ethics 2008;3(2), 1-4.

12. Shore N. Re-conceptualizing the Belmont Report: A community-based participatory research perspective. J Community Pract 2006;14(4): 5-26.

13. Ross LR, Loup A, Nelson RM, Botkin JR, Kost R, Smith GR, Gehlert S. Human subjects protections in community-engaged research: A research ethics framework. J Empir Res Hum Res Ethics 2010;5(1): 5-18.

14. Flicker S, Travers R, Guta A, McDonald S, Meagher A. Ethical dilemmas in community-based participatory research: Recommendations for institutional review boards. J Urban Health 2007;84(4): 478-493.

15. Deeds B, Castillo M, Beason Z, Cunningham SD, Ellen J, Peralta L. Adolescent Trials Network for HIV/AIDS Interventions. An HIV prevention protocol reviewed at 15 national sites: Do ethics committees protect communities?. J Empir Res Hum Res Ethics 2008;3(2): 77-86.

16. Brydon-Miller M, Greenwood D. A re-examination of the relationship between action research and human subjects review processes. Act Res 2006;4(1), 117-128.

17. Malone RE, Yerger VB, McGruder C, Froelicher E. “It’s like Tuskegee in reverse”: A case study of ethical tensions in institutional review board review of community-based participatory research. Am J Public Health 2006;96(11): 1914-1919.

18. Seifer SD, Greene-Moton E. Realizing the promise of community-based participatory research: Community partners get organized! Prog Community Health Partnersh 2007;1(4): 291-294.

19. Grignon J, Wong K, Seifer SD. Ensuring Community-Level Research Protections. Seattle, WA: Community-Campus Partnerships for Health 2008 [cited June 10, 2014]. Available from http://ccph.info.

20. Community IRBs and Research Review Boards: Shaping the Future of Community-Engaged Research. Albert Einstein College of Medicine, The Bronx Health Link and Community-Campus Partnerships for Health 2012 [cited June 10, 2014]. Available from http://ccph.info.

21. Casado J. Ethical engagement of communities, institutions, and providers in research: Lessons from the community. Prog Community Health Partnersh 2013;7(3): 353-355.

22. Martin del Campo F, Casado J, Spencer P, Strelnick H. The development of the Bronx community research review board: A pilot feasibility project for a model of community consultation. Prog Community Health Partnersh 2013; 7(3):341-52.

23. Kelley A, Belcourt-Dittloff A, Belcourt C, Belcourt G. Research ethics and indigenous communities. Am J Public Health 2013;103(12): 2146-2152.

24. Morton DJ, Proudfit J, Calac D, Portillo M, Lofton-Fitzsimmons G, Molina T, Flores R, Lawson-Risso B, Majel-McCauley R. Creating research capacity through a tribally based institutional review board. Am J Public Health 2013;103(12): 2160-2164.

25. Quinn S, Kass N, Thomas S. Building trust for engagement of minorities in human subjects research: Is the glass half full, half empty or the wrong size? Am J Public Health 2013;103(12): 2119-2121.

26. Ford AF, Reddick K, Browne MC, Robins A, Thomas SB, Crouse Quinn S. Beyond the cathedral: Building trust to engage the African American community in health promotion and disease prevention. Health Promot Pract 2009;10: 485-489.

27. Blumenthal DS. A community coalition board creates a set of values for community-based research. Prev Chronic Dis 2006;3(1): A16.

28. Watkins BX, Shepard PM, Corbin-Mark CD. Completing the circle: A model for effective community review of environmental health research. Am J Public Health 2009;99(S3): S567-S577.

29. Brugge D, Missaghian M. Protecting the Navajo people through tribal regulation of research. Sci Eng Ethics 2006;12(3): 491-507.

30. Oneha MF, Beckham S. Re-examining community based research protocols. Pac Health Dialog 2004;2(11): 1-5.

31. Shore N, Brazauskas R, Drew E, Wong K, Moy L, Corage Baden A, Cyr K, Ulevicus J, Seifer SD. Understanding community-based processes for research ethics review: A national study. Am J Public Health 2011; 101(Suppl1): S359-S364.

7. Please describe the project or body of work from which the submitted product developed. Describe the ways that community and academic/institutional expertise contributed to the project. Pay particular attention to demonstrating the quality or rigor of the work:

  • For research-related work, describe (if relevant) study aims, design, sample, measurement instruments, and analysis and interpretation. Discuss how you verified the accuracy of your data.
  • For education-related work, describe (if relevant) any needs assessment conducted, learning objectives, educational strategies incorporated, and evaluation of learning.
  • For other types of work, discuss how the project was developed and reasons for the methodological choices made.

The National Collaborative Study team is comprised of Principal Investigators from Community-Campus Partnerships for Health (CCPH) and the University of New England (UNE), co-investigators from each of 5 community-based organization partners, two staff based at CCPH, and a consultant faculty member. The recruitment process entailed inviting CRP representatives that expressed an interest in partnering with CCPH to examine how they determine whether and how research occurs within their communities. Interested CRP representatives joined a conference call to discuss the proposed study. CRPs were then selected based on their interest in the study as well as diversity in their geography, racial/ethnic makeup of communities served, research areas of focus, and type of review process.

The team identified 6 critical questions:
•What are the structures and functions of community review processes?
•What are the core issues assessed during their reviews of research?
•How do these considerations compare to those typically assessed by institution-based IRBs?
•What kinds of relationships exist between these community review processes and institution-based IRBs?
•What are the review processes’ benefits and impacts?
•What challenges do these review processes encounter?

Between October 2012 and May 2013, the team gathered data from key stakeholders from each CRP, including individuals who provide leadership and support for the CRP, reviewers, and research teams. Co-investigators generated a list of researchers who had utilized their CRP within the past six years. To help protect confidentiality, CCPH research staff selected researchers from the list without informing co-investigators who was actually interviewed. The substantive focus of the selected researchers varied.

Data collection included the following for each case study: 1) structured interviews with review administrators and chairs 2) focus groups with reviewers and 3) review of key documents guiding the review process. Additionally, structured interviews were conducted with researchers at four sites that utilized the CRP and an observation of a review meeting was completed for two sites. Focus groups, interviews with administrators and chairs, and meeting observations were conducted in-person during site visits. The researcher interviews were conducted by phone. All the questions asked across data collection appproaches flowed from the team's identified six critical questions. Examples of topics covered in all the approaches included CRP review considerations, benefits and impact.

For data analysis, audio recordings of each interview and focus group were transcribed and analyzed using NVivo, a qualitative analysis software. Study PIs and study staff analyzed each transcript, identifying themes and sub-themes. The PIs, study staff and study partners engaged in ongoing discussion and reflection of the themes identified across the different study materials (i.e., interview and focus group transcripts) and their meaning. Exemplifying quotes as well as unique or contradictory information were highlighted. Ongoing discussion occurred to verify and build upon data interpretation. Based on the analysis, each study partner worked with the PIs and study staff to draft their own case study report.

The study team convened for a two-day meeting in October 2013 to discuss the similarities and differences across the individual case studies, and to formulate recommendations for 1) community groups wanting to develop or strengthen their own review process, 2) institutional IRBs, 3) policy makers and 4) funders. Based upon findings from the individual case studies, the study team identified questions to guide the discussion. Examples of questions included "what are the concerns considered in community-based review processes" and "what are the benefits and impacts of community-based review processes?" Analysis of the discussion followed the same approach used in the individual case studies.

8. Please describe the process of developing the product, including the ways that community and academic/institutional expertise were integrated in the development of this product.

The study team held monthly conference calls to track project progress and direction, provide comments on findings and review draft documents. The co-investigator from each site was lead author of his or her CRP's case study and solicited feedback from reviewers, who were mostly community members. For the cross-case analysis, the team met in-person to identify cross-cutting themes, formulate recommendations and determine study products, including this submission to CES4Health. The PI from UNE had expertise in qualitative analysis and on the topic of research ethics. CCPH PI and staff had expertise on community-engaged research. The co-investigators each had expertise in operating a CRP and in identifying and addressing ethical issues that arise in community-engaged research. Our consultant additionally had expertise in qualitative research. The collective knowledge of the group contributed to the final product.

9. Please discuss the significance and impact of your product. In your response, discuss ways your product has added to existing knowledge and benefited the community; ways others may have utilized your product; and any relevant evaluation data about impact, if available. If the impact of the product is not yet known, discuss its potential significance.

When we embarked on the National Collaborative Study, we knew that CRPs existed and we were familiar with a number of them through personal experiences, published papers and presentations at meetings. Little was known, however, about their operations and their impact. By examining 5 diverse CRPs in-depth, we documented the significant difference they make in the ethical design, conduct and impact of research as well as in the research literacy, capacity and ownership in communities. We also documented how they differ from institution-based IRBs in their committee composition (i.e., with a minimum of 51% community members), engagement of researchers in the review process and in the community and cultural lens through which they review proposed research. In the case of the two community IRBs in the study, we found they go beyond the federal research ethics regulations to include significantly more community-based reviewers and to assess community and cultural level ethical issues. Along the way, we also refuted a number of misconceptions about CRPs: that they prevent research from moving forward and that they do not provide a rigorous and thorough review. We found that the vast majority of studies reviewed by CRPs are approved. CRPs are deeply invested in research that ethically engages communities and responds to community needs, concerns and assets. They take their charge seriously, including developing policies and procedures, recruiting and preparing reviewers, and encouraging ongoing professional development whenever possible. Their reviews often entail a back-and-forth process between the CRP and the research team to address concerns raised by the CRPs, ultimately resulting in a more ethically sound, feasible and rigorous study design.

Our report adds to existing knowledge by documenting the critically important role for CRPs in research ethics review that is not being fulfilled by institution-based IRBs. In the report, we recommend competitive federal grants be awarded to support the start-up or expansion of CRPs. The potential impact of the report might be to support CBOs in the development of a CRP, raise awareness about ethical issues among communities approached by researchers and influence the federal regulations that govern human participants research to incorporate CEnR related ethical issues. Indeed, the study team successfully applied and obtained funding from the Greenwall Foundation to draft a revised Belmont Report and federal regulations that encompass the ethical principles for CEnR and develop possible scenarios for a system of research ethics review that could effectively assess the ethics of CEnR.

10. Please describe why you chose the presentation format you did.

A written report was chosen due to its accessible and in-depth format (as opposed to journal articles) for the general public and our key audience of community-based organizations developing or operating a CRP. We chose to package the case studies collectively so the range in models of CRPs could be illustrated. Each case study is also available as its own report to faciliate use of community-specific information.

11. Please reflect on the strengths and limitations of your product. In what ways did community and academic/institutional collaborators provide feedback and how was such feedback used? Include relevant evaluation data about strengths and limitations if available.

Strengths of the report include the community participatory process in which it and the underlying project were developed. The report also provides an in-depth look at five different CRPs varying in structure, location and population served to better understand how they operate. The report's limitations include the small sample size of only 5 CRPs, hence the findings may not be generalizable to all CRPs. In particular, tribally based CRPs may operate differently due to their status as sovereign nations. In addition, we were unable to interview many researchers who submitted a proposal to the CRP and an institution-based IRB or examine the impact of the CRP review on study implementation and outcomes. The co-investigator from each site was lead author of their case study, and all study partners, which included community and academic collaborators, contributed to the cross-case analysis, which was based on an in-person focus group with the study team. Additionally, all study partners provided feedback on the product drafts and these were incorporated into the final product.

12. Please describe ways that the project resulting in the product involved collaboration that embodied principles of mutual respect, shared work and shared credit. If different, describe ways that the product itself involved collaboration that embodied principles of mutual respect, shared work and shared credit. Have all collaborators on the product been notified of and approved submission of the product to CES4Health.info? If not, why not? Please indicate whether the project resulting in the product was approved by an Institutional Review Board (IRB) and/or community-based review mechanism, if applicable, and provide the name(s) of the IRB/mechanism.

The study team was comprised of two principal investigators (one from UNE, and one from CCPH), two staff at CCPH, one co-investigator from each community-based organization partner and a consultant. The community co-investigators were involved in every aspect of the project from proposal development, implementation, analysis, writing, dissemination and determination of next steps. Decision-making throughout the study was a shared process between the PIs and co-investigators. The co-investigators contributed to the study aims, design, and respective roles and responsibilities. The study team convened in person at the beginning of the study to review and revise study aims, finalize the protocol and develop related policies and procedures, including a researcher recruitment protocol, document review protocol, recruitment scripts, introductory email/recruitment for researchers, publications policy, and analysis plan. The study team also developed, piloted and finalized study instruments, informed consent forms and the outline for the case study reports. At the beginning of Year 2, the study team re-convened to conduct a cross-case study analysis, make plans for developing and disseminating study products, and identify priorities for future collaborative research. Monthly conference calls were held with the study team to finalize and implement the case study protocol, develop manuscripts and other study products, provide a regular forum to respond to questions, address any conflict or challenges, offer support and exchange ideas, and plan for dissemination and future collaborative efforts. A web-based project site was established to facilitate sharing of study-related documents. In person site visits were conducted of each CRP. Each co-investigator was responsible for gathering key guiding documents for their CRP for the document review as well as scheduling the focus groups. Each of the co-investigators participated in an interview as administrator of their CRP, and generated a list of research proposals that had been reviewed by their CRP and an institution-based IRB. Co-investigators reviewed summaries of themes from the qualitative data analysis for their site to ensure accuracy in interpretation. Each co-investigator served as lead author for the case study of his or her CRP. The project was reviewed and approved by the Special Service for Groups and Papa Ola Lokahi IRBs. The project was reviewed and deemed exempt by the University of New England (UNE) IRB. The project's determination by the UNE IRB was accepted by Northeastern University, the IRB of record for the Center for Community Health Education Research and Service. The study team collaboratively determined to submit the product to CES4Health. All members of the study team were involved in writing portions of the product and reviewing the entire product.