| Abstract: | Objectives. We explored the relationship of community-engaged research final approval type (tribal government, health board, or public health office (TG/HB); agency staff or advisory board; or individual or no community approval) with governance processes, productivity, and perceived outcomes.Methods. We identified 294 federally funded community-engaged research projects in 2009 from the National Institutes of Health’s Research Portfolio Online Reporting Tools, Centers for Disease Control and Prevention’s Prevention Research Centers, and Native American Research Centers for Health databases. Two hundred (68.0%) investigators completed a survey about governance processes and productivity measures; 312 partners (77.2% of 404 invited) and 138 investigators (69.0% of 200 invited) completed a survey about perceived outcomes.Results. Projects with TG/HB approval had increased likelihood of community control of resources (odds ratios [ORs] ≥ 4.80). Projects with other approvals had decreased likelihood of development or revision of institutional review board policies (ORs ≤ 0.37), having written agreements (ORs ≤ 0.17), and agreements about publishing (ORs ≤ 0.28), data use (ORs ≤ 0.17), and publishing approval (ORs ≤ 0.14).Conclusions. Community-engaged research projects with TG/HB approval had strong stewardship of project resources and agreements. Governance as stewardship protects community interests; thus, is an ethical imperative for communities, especially native communities, to adopt.Researchers working with native communities (American Indian, Alaska Native, and Native Hawaiian peoples), other racial/ethnic minority communities, or other communities facing disparities that experience similar mistrust for past research issues, health inequities (e.g., gays and lesbians or people with disabilities), or both, have advocated the use of participatory research to enhance community health.1–6 Such approaches include tribal participatory research, community-based participatory research, and participatory action research and are generally grouped as community-engaged research (CEnR). There is a continuum of engagement,7 but CEnR that involves collaborative partnership and shared leadership between community members and (academic) researchers in all phases of the research can build capacity of all partners, create research that benefits the community, and enhance translation of research findings to the community.8–13 These approaches have attraction because they can advance cocreation of the research, contribute culturally centered methods, and foster research capacity.1,2,14,15Although CEnR approaches have appeal, they still require governance to provide protection, oversight, guidance, legitimacy, and community benefit. Governance over CEnR is complex and involves numerous practices and policies.16,17 Historically, oversight responsibilities have been held by institutional review boards (IRBs) that uphold federal standards established by the Office for Human Research Protections.18,19 Use of IRBs (e.g., university IRBs or Indian Health Service IRBs) for research oversight characterizes governance as regulation as the focus is on balancing the needs of protection of individuals from harm while trying to foster scientific innovation. However, when research partners consider other functions of governance alongside legal regulation (e.g., use of tribal governments or community-based review boards), the quality of research can be strengthened and more attention paid to the benefits and harm of the research for the community.20–22In recent years, policymakers, CEnR researchers, and community organizations have advocated a broader perspective of governance, one that can be characterized as stewardship of research. Governance as stewardship enhances protection of the community, helps to foster research partnerships and appropriate access to and approval of research by community bodies, ensures benefit for the community, provides legitimacy of the research, shares responsibility for the research, provides community control, and builds research capacity in communities.20–23 For example, when native communities steward research, new patterns emerge between academic and community partners that might involve (1) community and academic partners requiring and committing to oversight by a tribal council or community board, (2) review boards or tribal governments insisting the that project demonstrate benefits to the community (not just individuals), (3) all partners committing to tribal ownership of the data, and (4) all partners working to use data and disseminate findings following tribal review.2,24–27Although nontribal communities do not have a tribal council for formal governance, they establish various governance mechanisms such as oversight by faith-based networks or leaders, health boards or public health offices, project advisory boards, or community partner boards.21,28–30 Stewardship by these governing entities may involve (1) academic partners that engage in collaboration with the community to produce the research, (2) projects that use culturally relevant research designs and instruments to enhance the quality of the research, (3) projects that hire community members on research projects to build research capacity, and (4) academic partners that encourage community engagement and participation.2–4,21,28 In both native and nonnative communities, stewardship practices lead to enhanced trust of the research process by community partners, relationships that balance community and academic institutional power, IRB processes that reflect community interests and not just biomedical interests, inclusion of cultural frameworks that fit the community, and academic members committed to community engagement.21,28,31Enhancing stewardship of research through governance has focused on several activities. First, increasingly, native and nonnative communities are asserting their roles in overseeing research by developing community IRBs and other forms of research oversight.23,32,33 Second, research review can protect community knowledge by establishing protocols for oversight and can affirm tribal or community authority to approve and guide research that will benefit the community.21,22,28–30,33,34 Third, the National Congress of American Indians35–37 asserts that tribes, as sovereign nations, have regulatory authority over research that takes place on tribal lands and with tribal citizens. Several tribes have exercised governance by establishing research codes, research review boards, and formal agreements with research institutions, and some intertribal entities have established research oversight in urban and cross-tribal regions.33,38Despite the expanded view of ethical issues within CEnR projects and an upsurge in community governance expectations from communities and some funders, there has been little research that has examined the role of governance in research specifically, as well as concerns that these processes might inhibit research. Some researchers and policy analysts suggest that tribal research review is perceived as slowing or blocking research development and dissemination.25,35 A tension related to data ownership to ensure risks and benefits are considered for communities, individual research participants, and research funders also exists.What has been lacking in these discussions to date has been research about the associations of governance with agreements, control of resources, productivity, and perceived outcomes of CEnR. Agreements are the accepted standards or protocols for the research partnership such as mission and objectives, group dynamics, and dissemination.12,39 Control of resources is whether the community, academic institution, or both hire personnel and manage project resources.12,40 Research productivity measures include garnering funding, disseminating scholarship, developing new measures centered in cultural or community perspectives, and establishing new research regulation.3,23,28,30 These measures are important as the need to generate, disseminate, and regulate new knowledge and practices are core goals of funding agencies and, to a lesser extent, communities.Perceived outcomes of CEnR focus on the contributions to health, and encompass changes in power relations, sustainability, community transformation, improved health of the community, and capacity building for individuals and agencies.12 These outcomes are important as they are health outcomes or factors that enhance public health. Ultimately, the success of a CEnR project is determined by research productivity and improvement of health outcomes.The notion of governance also has often been a source of mystery and conflict in research partnerships. We sought to foster understanding and provide context around governance as “stewardship” in research partnerships in both native and nonnative communities by focusing on the type of final approval of CEnR—the body or individual who endorsed and approved the project on behalf of the community and allowed it to continue. This approval is a key factor for legitimacy, community involvement, oversight, and guidance of the project.26,35 Furthermore, the type of approval has not been studied, whereas the general oversight of research ethics through community or tribal IRBs has garnered recent research focus.21,33,38 Examining the type of approval allows an exploration of how governance as stewardship balances needs for authority and accountability, control and capacity building, and protection and benefits. |
