Community-Based Review of Research Across Diverse Community Contexts: Key Characteristics, Critical Issues, and Future Directions

Abstract

A growing number of community-based organizations and community–academic partnerships are implementing processes to determine whether and how health research is conducted in their communities. These community-based research review processes (CRPs) can provide individual and community-level ethics protections, enhance the cultural relevance of study designs and competence of researchers, build community and academic research capacity, and shape research agendas that benefit diverse communities.

To better understand how they are organized and function, representatives of 9 CRPs from across the United States convened in 2012 for a working meeting.

In this article, we articulated and analyzed the models presented, offered guidance to communities that seek to establish a CRP, and made recommendations for future research, practice, and policy.

A growing number of community-based organizations and community–academic partnerships are implementing processes to determine whether and how health research is conducted in their communities.^1–12 These community-based research review processes (CRPs) can provide individual- and community-level ethics protections, enhance the cultural relevance of study designs and competence of researchers, build community and academic research capacity, and help to set research agendas that benefit diverse communities. In 2009, with funding from the Greenwall Foundation, Community-Campus Partnerships for Health (CCPH) completed the first national study of CRPs in the United States.^2,13

The study identified 109 CRPs that mainly function through community–academic partnerships, community-based organizations, community health centers, and tribes, with 30 more in development. These CRPs were primarily formed to ensure that the involved communities are engaged in and directly benefit from research and are protected from its harms. Some are federally recognized institutional review boards (IRBs) that approve, monitor, and review research involving human participants. Others are advisory bodies. They all routinely examine issues that institution-based IRBs typically do not, such as community risks and benefits of the research and cultural appropriateness of the study design.^2,13

To better understand how CRPs are organized and function, CCPH, The Bronx Health Link, and the Albert Einstein College of Medicine convened representatives of 3 community IRBs, 5 community-based research review committees, and 1 university-based community research review committee in the United States for a working meeting in 2012 (see the box on page 1295). The meeting goals were to celebrate successes, identify promising practices, address challenges, and plan collaborations. The 9 participating CRPs were purposefully invited to reflect diversity in terms of geography, community served, organizational structure, and experience. Meeting proceedings described the CRPs in attendance and highlighted the emerging themes.¹ In this article, we articulated and analyzed their diverse models, offered guidance to communities that seek to establish or strengthen a CRP, and outlined an agenda for future research, practice, funding, and policy.

Community-Based Research Review Processes Discussed in This Article

Name and Location	Acronym	Year Established	Review Structure
Bronx Community Research Review Board, Bronx, NY	BxCRRB	2010	Research review and advisory board
Center for Community Health Education Research and Service, Inc., Boston, MA	CCHERS	2004	Research review committee
Community Ethical Review Board, WE ACT for Environmental Justice, Inc., Harlem, NY	CERB	In development	Emerging research review committee
Community Research Advisory Board, University of Pittsburgh, Pittsburgh, PA	CRAB	2001	University-based research review committee
Galveston Island Community Research Advisory Committee, Galveston Island, TX	GICRAC	2005	Grassroots research advisory committee
Hispanic Health Council, Hartford, CT	HHC	2000	IRB
North Carolina American Indian Health Board, Winston-Salem, NC	NCAIHB	2009	State-wide research review committee
Papa Ola Lokahi, Honolulu, HI	POL-IRB	1999	IRB
Special Service for Groups, Los Angeles CA	SSG	2004	IRB

Note. IRB = institutional review board.

KEY CHARACTERISTICS OF CRPS

Each CRP possesses unique and shared characteristics (Table 1). In this section, we identified themes that cut across the CRPs and discussed their similarities and differences. CRPs were referred to by the acronyms defined in the box on page 1295.

TABLE 1—

Selected Characteristics of Community-Based Research Review Processes

Review Entity	Purpose of Host Organization	Rationale for Research Review Process	Research Reviewed
BxCRRB	Seeks to improve the health of Bronx residents through community education and outreach, health promotion information, community-based research, policy work, and community review of academic research and advocacy	Responds to (1) large amount of clinical research conducted in the Bronx, (2) barriers to research participation, and (3) the growing body of literature that indicates individual and community risks are not always the same; provides forum for mutual learning and relationship building between academic and community stakeholders	Research conducted in or with Bronx communities that involves investigators at the Albert Einstein College of Medicine
CCHERS	Promotes (1) the development of “academic community health centers” that integrate education, research, and service to influence and change health professions education; improve health care delivery and (2) health systems change to eliminate racial and ethnic health disparities	Offers alternative to community–academic research partnerships that require review by multiple IRBs; increases involvement in research by CCHERS and its partner community health centers; responds to increased community interest and activity and research	Research the organization, or 1 of its community health center partners, is directly involved in
CERB	Builds healthy communities through environmental justice by assuring that people of color and those who are low-income participate meaningfully in creating sound and fair environmental health and protection policies and practices	Provides a mechanism independent of institutional IRBs to address ethical issues related to community-based research	To be determined
CRAB	Aims to understand and reduce health disparities in underserved populations, particularly in western Pennsylvania, by engaging the community in efforts to reduce the major causes of excess mortality among disadvantaged populations	Responds to community members who want more input on research and to investigators who want help with research design and participant recruitment; facilitates community–academic research partnerships	Research conducted by investigators from the University of Pittsburgh and other local universities
GICRAC	Serves as gatekeeper for the health and well-being of African Americans in Galveston County, TX, by advocating for, participating in, and endorsing health research and related services; participates in research selection, research design, research implementation, and research dissemination	Assesses research conducted within the African American community and responds to community members who seek a voice in how research is conducted	Research focused on African Americans in the county that involves investigators at the University of Texas Medical Branch at Galveston
HHC	Seeks to improve the health and social well-being of Latinos and other diverse communities through community-based research, evidence-based direct services, training, and policy advocacy	Ensures protection of the rights and welfare of research participants, compliance with federal human participant regulations, and significant community input on research design	Research the organization leads or participates in; on a case-by-case basis, research conducted by local community organizations that do not have access to an IRB is reviewed
NCAIHB	Supports research, education, and advocacy to reduce health disparities among American Indians in North Carolina	Serve as liaison between researchers and tribes/urban Indian groups. Provides support for tribes with existing IRB or health committees as needed	Research conducted with tribes in North Carolina
POL-IRB	Seeks to better the health conditions of Native Hawaiians and their ‘ohana (families) by advocating for, initiating, and maintaining culturally strategic actions that improve health and empower	Supports the development of Native Hawaiian investigators; educates (1) Native Hawaiian communities on their role as partners and advisors to investigators and (2) investigators who plan on conducting research in Native Hawaiian communities; reviews study protocols of direct interest to Native Hawaiians	Research involving Native Hawaiians conducted by 5 Native Hawaiian Healthcare Systems, ‘Imi Hale-Community Cancer Network, the University of Hawaii Department of Native Hawaiian Health, RMATRIX Research Group, Chaminade University, Queen Medical Center (in partnership with ‘Imi Hale), and the Hawaii Youth Drug Coalition
SSG	Provides community-based solutions to the social and economic issues facing those most in need and most vulnerable in research such as mental health consumers, individuals who are homeless, and ex-offenders	Capitalizes on SSG’s vast experience with community-based participatory research to address racial and ethnic health disparities; responds to (1) concerns that university IRBs had minimal community representation and minimal ability to evaluate community-level considerations and (2) encouragement by academic partners to create an IRB	Studies that SSG programs and partners are directly involved in

Note. BxCRRB =  Bronx Community Research Review Board; CCHERS =  Center for Community Health Education Research and Service; CERB = Community Ethical Review Board (WE ACT for Environmental Justice, Inc.); HHC = Hispanic Health Council; CRAB = Community Research Advisory Board; GICRAC =  Galveston Island Community Research Advisory Committee; IRB = institutional review board; NCAIHB =  North Carolina American Indian Health Board; POL = Papa Ola Lokahi; SSG = Special Service for Groups.

History, Rationale, and Goals

All 9 CRPs were established by organizations that focus on minorities and the medically underserved. Several key factors prompted their development, including bad research experiences, a growing number of researchers wanting to conduct studies in their communities, and researcher requests for community members to serve as study advisors. CRPs are viewed as effective mechanisms for increasing input or control over what research occurs and how. They are also seen as a means of addressing perceived shortcomings of institution-based IRBs by offering an additional level of review through a community-oriented lens. Protecting the community and building community capacity to shape and conduct research are core objectives of all 9 CRPs, as is educating academic researchers to increase their understanding and ability to engage diverse communities respectfully and ethically. Beyond conducting research ethics review, the goals of CRPs include advocating for the community, building relationships between community and universities, and serving as a mechanism for filing grievances and complaints about unethical research.

What Research Is Reviewed and How

All 9 CRPs serve communities that are geographically bound. They comprise individuals with shared backgrounds or experiences and recipients of offered services. Only studies conducted with the direct participation of their host organizations or involving the communities they serve are reviewed. The research reviewed typically focuses on health concerns relevant to the involved community. Some CRPs (CRAB, BxCRRB, POL-IRB) have opened or plan to open their review process to investigators from academic institutions other than the ones that sponsor them or with which they partner.

All 9 CRPs engage researchers in a consultative process of research review. Three require researchers to attend the review meetings at which their studies are discussed (SSG, CRAB, GICRAC), and 1 asks researchers to present the study to reviewers before they undertake the review (BxCRRB). CRAB and BxCRRB prohibit or discourage the use of PowerPoint (Microsoft, Redmond, WA) presentations and instead ask researchers to present studies in a more informal manner. These consultative practices allow reviewers to engage in a dialogue with researchers on how to enhance the relevance and sensitivity of their proposed studies, as well as consider strategies for disseminating findings in a meaningful manner. POL-IRB encourages researchers to work with its IRB administrator before submitting a protocol. This consultative approach promotes mutual understanding and respect; reduces stress and anxiety, especially for new researchers; and encourages a stronger relationship between POL-IRB and the involved institution. Although it can be time-consuming for the researchers as well as the reviewers and administrators, this approach ultimately helps to ensure that the proposed research critically addresses community-oriented concerns.

Review Considerations

CRPs strive to ensure that both individual- and community-level risks and benefits of research are thoroughly considered. The specific criteria used to assess a study proposal vary by CRP. All 9 use criteria or questions that reflect traditional IRB criteria, such as examining informed consent procedures and assessing individual risks and benefits. However, they expand these criteria to include community-level or cultural considerations.¹⁴ CRP reviews, for example, typically consider questions of the cultural appropriateness of informed consent procedures and participant recruitment strategies, risks and benefits to communities involved in or affected by the research, community engagement in research design and implementation, research team qualifications to conduct community-engaged research, and dissemination of research findings in community-friendly formats and venues.

CRPs assess what consultation has occurred within the community, examine how community support has been obtained, and may look for evidence of community consent. For example, SSG and CRAB, although acknowledging that their members do not represent “the community,” provide a space and protocol for academic researchers to engage the community and obtain support. SSG requires academic researchers to demonstrate how they have engaged the community in developing the research questions and may ask them to bring their community partners to the IRB meeting when their studies are being discussed. POL-IRB requires researchers to show whether and how the Native Hawaiian community is involved with the planning and execution of the study and requires a final report to the community to be included in all study protocols. Conducting research with American Indian communities is 1 example where community consent is typically required (NCAIHB). In these instances, because of the sovereignty of tribes, researchers must first secure tribal consent before an institution-based IRB will approve their study.

Reviewer Considerations

All 9 CRPs have diverse memberships that emphasize community members as reviewers (i.e., community residents, tribal representatives, community agency staff). Criteria used to identify reviewers include

1. experience with community-based participatory research (CBPR),

2. place of residence,

3. demonstrated commitment to the community,

4. experience working to reduce health disparities, and

5. reflecting cultural and ethnic diversity of the involved community.

GICRAC requires that reviewers must have a passion and commitment to the well-being of the African American community, and BxCRRB specifies that community members may include those with graduate degrees who have extensive community ties. It should be further noted that community members make up at least 50% of most CRPs. For CRPs such as GICRAC or POL-IRB, the latter of which requires 50% of its members to be Native Hawaiians, this ensures that power is vested in the community members.¹

The number of reviewers that serve on CRPs ranges from 7 to 20, with practices regarding term lengths varying from no restrictions to 2 to 5 years. Incentives for reviewers vary. In all instances food is provided at the review meetings. In some cases reviewers receive a stipend (BxCRRB) or are reimbursed for travel costs and parking (SSG, CRAB, POL-IRB).

Ensuring that community members who serve as reviewers have a good understanding of research and research ethics is viewed by all 9 CRPs as essential. The approaches undertaken by CRPs to train their reviewers include observing review meetings and debriefing on them afterward, holding educational sessions, facilitating mentoring relationships between experienced and novice reviewers, and accessing training sponsored by universities or the Collaborative Institutional Training Initiative. Learning through dialogue is particularly valued for its ability to illustrate the complexity of issues that must be examined during a review (e.g., discussing how the CRP determines whether an offered incentive is appropriate or coercive).

Funding and Staffing

CRPs vary considerably in their funding and staffing. Some are supported by internal discretionary funding (SSG, CCHERS, HHC). One has paid staff with designated funding to oversee its operations (POL-IRB). Another has paid staff with no designated funding source and is supplemented with support from volunteers (CRAB, HHC).

Relationships With Institutional Review Boards

Of the 9 CRPs, CRAB has the most established relationship with an institution-based IRB. CRAB’s affiliated university offers training to CRAB members and refers its researchers to the CRAB when they are proposing community-engaged research. For the other CRPs, institution-based IRBs concurrently review a given proposed study when there is an academic partner involved, but there is usually no direct communication between the 2 entities. POL-IRB requires that its feedback take precedence over that of any involved institution-based IRB.

Benefits

CRPs identify a number of benefits associated with their roles. They are a means of raising researchers’ awareness of community expectations and norms, while also helping to educate community members about research. By fostering respect for diverse perspectives, they give greater voice to underrepresented communities regarding research and empower community-based organizations to be equal research partners. Ideally, through the review process, greater mutual trust is developed between researchers and community members. CRPs also help raise community members’ expectations of how research should be conducted. For example, community members refer researchers to POL-IRB if their study has not yet been reviewed.

Meaningful engagement of community members builds community capacity. GICRAC community reviewers, for example, now serve on its partnering university’s IRB and executive boards. Native Hawaiian communities involved in POL-IRB are developing their own research agendas and protocols. Community capacity building can also help to ensure that community organizations exert their power and right to say no if they are uncomfortable participating in or endorsing a proposed study.

Ultimately, CRPs provide guidance on research protections and help to ensure research benefits are maximized and harms minimized. They protect the community by ensuring the research is conducted in a culturally competent manner consistent with the community’s best practices and social norms to ensure successful outcomes and a lasting positive impact. In instances where multiple IRBs are involved in assessing a protocol, for example, HHC IRB often identifies and requires modifications that are not identified by the other involved IRBs.

Visions for the Future

All 9 CRPs are evolving as they become more experienced and established in their communities. Their visions for the future include increasing their visibility and credibility, building capacity of review members, recruiting and training new reviewers, expanding access to other community groups or academic institutions, and offering support to community groups that want to develop or strengthen a CRP. Some CRPs (CCHERS, CRAB, CERB, NCAIHB) intend to conduct a systematic analysis of community research priorities and the research funding landscape to determine their future directions.

CRITICAL ISSUES FACED BY CRPS

A number of critical issues were identified by all 9 CRPs. These fell into 3 main categories, as described below.

Having More Authority

CRPs want “more teeth” so that researchers who submit studies for review are bound by their decisions and can be held accountable for ethical practices throughout the duration of the study. Ideally, they assert, every institution-based researcher who is working with vulnerable populations would have their studies reviewed by their institution-based IRB and a CRP. These goals are hampered by a lack of power, authority, and recognition. Because CRP research review is usually not required, institution-based researchers may “shop” for other community organizations to partner with or endorse the study if one organization refuses. Some CRPs, such as CRAB, which routinely receives researcher referrals from the University of Pittsburgh’s IRB, have positioned themselves as respected and valued partners. Researchers may seek community approval for studies, however, without committing to the underlying values of CBPR. The CRAB has encountered situations in which researchers try to use its review process as a “vehicle to legitimize what [they] are doing wrong.”^1(p6)

Becoming a federally recognized IRB can increase a CRP’s legitimacy and authority and increase its ability to hold researchers accountable to research practices that engage the community and protect community members from harm. Even when a CRP is a federally recognized IRB, however, institution-based researchers may choose not to submit their proposal to it and move forward with approval from their institution-based IRB. Conflicts can also emerge between the CRP and the involved institution’s IRB when their respective reviews of a given study differ. For example, federal guidelines allow IRBs to exempt certain genetic protocols, whereas POL-IRB also considers cultural guidelines that could result in denying the same protocol. POL-IRB’s application process requires that its IRB decision trumps any concurrent IRB decision.

Signed agreements between a community partner and a researcher’s institution could specify that proposed research be reviewed and approved by a CRP. Ideally, institution-based IRBs would ensure researchers follow the approved plan. If a researcher is out of compliance and his or her institution does not adequately respond, the community would need to identify effective ways to expose and rectify the problem. An independent ombudsman position could help to ensure fair assessment of community concerns that arise out of contract violations.

Evaluating and Improving Their Work

CRPs are interested in feedback from their key stakeholder groups, including reviewers, researchers who have engaged in the process, community members involved in the research they review, and the broader community. None of the 9 CRPs has completed a comprehensive evaluation to determine their impact at both the community and academic levels. Their ability to do so is tied in part to having adequate resources in place, identified as another critical issue in the “Securing Sustainable Funding” section.

Securing Sustainable Funding

Sustainable resources are needed to support the functioning of CRPs. Recipients of federal research grants typically are universities, and as a result they receive the indirect funds that flow along with the grant, a portion of which supports the functioning of their IRBs. Community organizations are hard-pressed to find this sort of funding. Some are addressing these concerns by considering implementing fees for reviews (POL-IRB) and being included in research grant budgets (GICRAC). Other strategies include building costs into the overall operating budget of the host organization, securing a federally negotiated rate and including the costs of the process in that rate, charging researchers a fee for the review or any technical assistance they may provide, requiring reviewed projects to build a fee for the review into their budgets, and “taxing” reviewed studies a percentage of the grant funding that supports them. If funders mandated that researchers go through a community review, funds for the review could be included in grant budgets.

ESTABLISHING A RESEARCH REVIEW PROCESS

The experiences of all 9 CRPs raise several key questions that should be considered by community groups before developing a CRP.

What Are the Purposes of the Review Process?

If a purpose is to serve as a gatekeeper by determining whether research can occur within a given community, a federally recognized IRB may be the best option, as it carries the greatest weight in terms of its decision-making authority. Exceeding the minimum requirement for the number of nonscientific and nonaffiliated members can help community IRBs to ensure broad community input on a given proposed study.

If a purpose is to shape the research that occurs within the community and to build community and academic capacity to ethically engage in research, both federally recognized IRBs and community research review committees can fulfill review, consultative, and educational roles. The regulatory requirements of being an IRB could pose challenges to maintaining a clear focus on community interests and may not align with cultural practices. However, it is possible to combine both effectively, as both SSG and POL-IRB have demonstrated.

How is the Host Organization Regarded?

A host organization’s reputation and relationships are important factors that can affect the design of the CRP. When they are strong, for example, it may not be necessary to establish an IRB to exert a decision-making role. If the organization has widespread support within the community, it may encourage other organizations in the community to utilize the CRP for the research they engage in and may prevent situations in which researchers try to gain community access by shopping around to find a willing partner. Strong working relationships with research institutions and their IRBs may increase a CRP’s ability to enforce academic researchers to comply with its requirements. For example, they may be able to establish a system similar to that employed by CRAB and the University of Pittsburgh, where the university’s IRB routinely encourages researchers who propose community-based studies to have their protocols reviewed first by the CRP.

What Infrastructure Is Available?

The size and scope of a CRP will depend upon the infrastructure that is in place to support it and the likelihood of it being sustained. This infrastructure includes, for example, the availability of individuals to manage it and to serve as reviewers. It will be important to consider 1 or more of the sustainable funding strategies previously discussed.

RECOMMENDATIONS

The experiences of all 9 CRPs point to a number of recommendations for future research, practice, policy, and funding.

Research

Future research needs to move beyond descriptive analyses of CRPs to assess their contributions, value, and impact over time. With funding from the National Institutes of Environmental Health Sciences, CCPH collaborated with 5 CRPs to articulate their research ethics considerations, experiences, and outcomes and to compare the research ethics issues they raise with those of institution-based IRBs that review the same studies.¹⁵ Future research would also benefit from prospective studies of different models of CRPs and the varied relationships between them and institution-based IRBs.¹³

CRP Practice

Strengthening of CRPs and enhancing how research occurs may be achieved through mentorship, in which CRPs can share advice and resources on working with institution-based IRBs, such as sample policies and protocols, best practices, and lessons learned. The CRP community of practice that is being incubated by CCPH through the Community Network for Research Equity and Impact is a good start and should be expanded.¹⁶

Institutional Practice and Policy

Research institutions ideally will reflect upon how their practices and policies support or inhibit community-engaged research, including those concerning research ethics reviews.^17–20 Academic institutions can demonstrate their commitment to ensuring community-level research protections by initiating relationships with local CRPs and requiring participation by affiliated researchers seeking to conduct community-based research or recruit underrepresented study participants, as the University of Pittsburgh has done with CRAB.^12,13

In locations where an accessible CRP does not exist, research institutions should develop policies that ensure all research engaging vulnerable populations undergoes a process that provides an opportunity for community review, consultation, and input before it can be approved. The 3 community IRBs we examined, for example, demonstrate how it is possible to achieve this by going beyond the minimum expectations of federal research ethics regulations. Guidance is available on institution-based IRBs on questions to incorporate into their reviews of community-engaged research.^14,21

CRPs recognize the value of supporting community members who serve on institution-based IRBs, as they can often feel disempowered or disrespected by the review process.²² Institution-based IRBs could use similar capacity-building strategies to those used by CRPs and go beyond the minimum federal regulatory requirements for nonscientific, unaffiliated members.

Federal Funding and Policy

The Office of Human Research Protections and the National Institutes of Health should collaborate to provide competitive grant funding for initiating new and strengthening existing CRPs. Furthermore, federal research ethics policies must be informed by CRPs. The body that advises the US Department of Health and Human Services on research ethics—the Secretary’s Advisory Committee on Human Research Protections—has no community IRB representation among its members, a situation we believe should be rectified.²³

CONCLUSIONS

CRPs offer promising approaches to ensuring that research minimizes risks to participating individuals and communities and maximizes community engagement, capacity, and impact. Although the 9 CRPs examined in this article do not include every possible configuration, they nevertheless offer important insights about how these processes can be structured and function, the important contributions they can make, and the critical issues they face moving forward.

Our findings point to at least 3 possible scenarios for ensuring a thorough ethics review of community-engaged research in the future. When research does not involve an academic institution, it can be reviewed by a CRP. When research involves an academic institution, options include review by both a CRP and an institution-based IRB or review by an institution-based IRB that routinely considers community-level ethical issues in its reviews. Given the membership composition and already burdensome workload of institution-based IRBs, the latter scenario may not be realistic to implement widely.²⁴ Furthermore, the protection of communities in research may be more appropriately situated in review mechanisms that are developed and managed by communities involved in research. Fortunately, through the efforts of CCPH and others, CRPs and those in development are beginning to organize to mentor each other, replicate promising practices, and strengthen their collective voice in research practice and policy.^20,25