(This section is adapted and reprinted from Ross et al., “Human Subjects Protections in Community-Engaged Research: A Research Ethics Framework,” this issue.)
Finding or Forming the Community Research Partner
Although it is common to hear people talk about the “African American Community,” the “South Side of Chicago community,” or the “HIV community,” these entities are not established communities with internal structure, but groups of individuals with a shared characteristic (race/ethnicity, geography or disease, respectively). Individuals belong to many such groups, some of which they belong to voluntarily, and others involuntarily, some of which they embrace, and others which are imposed upon them. A community, by contrast, is a structured group—a group with its own social structure often with identifiable leaders. Communities may be formed because of a shared characteristic, trait, experience, belief, attitude, interest, or historical event; but merit their status because they have an internal structure, identifiable leadership, and sustain themselves over time. Sometimes, academic researchers want to work with members of an unstructured group, and these groups can be empowered to have structure for the purpose of the research. The structure may come from external sources (e.g., a community-based-organization or CBO) or internally (e.g., the researcher helps the group organize and establish leadership). For the purpose of this project, we define a community to include both structured groups that exist irrespective of the research (established communities) and groups that are structured for the purpose of the research either by external or internal sources.
For some academic researcher-community partnerships, the community is easily defined and approached. For example, an academic researcher may seek to partner with a church (established community) to evaluate pilot questions about the impact of spirituality on health beliefs and health outcomes. The academic researcher may seek permission from the minister who may help identify interested parishioners or may delegate this responsibility to an extant church committee that is focused on community healthcare needs. To the extent that the project involves an established community, the legitimacy of certain spokespersons (e.g. church leaders) is clear and they are the portals to relationship building. Although the legitimacy of the leader’s agency to make decisions is established, the decision to permit a researcher to enter the church community may not be viewed positively by all congregational members. Some congregants may question why the minister’s authority as spiritual leader gives him or her authority to promote or reject a voluntary activity in healthcare research, creating tensions between the group and its individual members. A community’s decision (or the decision by the community’s leadership) may threaten the cohesiveness of the community whose sense of identify is not centered around the particular health concern. Collaboration with academic researchers, then, may cause a structured group to be vulnerable to disassociation of individuals or even splintering of the community itself.
Some groups are unstructured and it may be more difficult to identify its members or to determine who legitimately speaks for the group. For example, imagine an academic researcher interested in doing research on the healthcare needs of abused women. Often these women are isolated and do not know each other. Even if they were to be connected, they may not view themselves as a community. In fact, for many of them, a primary goal may be to escape this situation, and as such they may not want to develop relationships with women similarly situated. However, some of these women may affiliate with a few CBOs that provide needed mental health services and can direct them to safe shelters. To partner with these women, the academic researcher may partner with one or more CBOs that serve these women to give them a voice in defining the research priorities and the methodology to be used. This does not imply that the sample is representative of all abused women: different CBOs may give voice to different women to different degrees and may make priorities with greater or lesser input from a diverse sample of clientele. This is one reason why academic researchers may want to partner with multiple CBOs or to seek multiple community partners.
Members of community groups that are formed for the research engagement itself, or that are defined by their relationship to a service CBO, are more vulnerable than members of established communities because of greater agency concerns regarding who speaks for the community. To the extent that the ideal representation within a community is determined by its members, this is not achieved when members are not adequately organized to self-determine leadership, and it often is the responsibility of a third party (e.g., a CBO) or the researchers themselves to ensure that there is a leadership structure to provide agency. In such circumstances, the idea of group agency is opaque and concerns of the legitimacy of the representatives who speak for the group magnifies agency risks. Agency risks occur both when individual members experience some degree of pressure because the group’s internal or external leadership partners with the academic researcher about projects that they may not support; and when individual members experience a sense of frustration when they know that opportunities exist but that their leadership did not pursue those opportunities. It is also more likely that academic researchers impose their own agenda on unstructured groups that have not identified for themselves their own research agenda priorities.
POINTS TO CONSIDER
- Are the prospective research participants members of an identifiable group with whom the academic researchers can partner?
- Is the group structured (an established community) or is it unstructured?
- Does the group have designated leadership (structured group) or can leadership be created, either externally (via a CBO) or internally (by group self-organization)?
- Is/are the community leader(s) responsive and inclusive to the needs of the group that he/she/they represent(s)?
- Do/does the leader(s) understand the requirements of the research project and the risks and benefits for his or her specific community?
- Are the community leaders respected by the community and the academic researchers?
- Is there a CBO that provides services to the group for whom the research agenda is consistent with its mission?
- Is/are the leaders/CBO willing to learn/acquire knowledge that will be beneficial to the group that it/they represent(s)?
Finding an Academic Researcher Partner
Usually an academic researcher approaches a community with a research proposal, although sometimes communities have research ideas and need to find appropriate academic partners. Before agreeing to partner with a particular academic researcher, the community must be satisfied along three dimensions: (1) that the researcher is capable of performing the research; (2) that the research is expected to benefit the community or that it is useful to the community in ways that justify its participation; and (3) that the community can trust the researcher to pursue the particular research project in a manner respectful of the community. In addition, the community needs to assess the researcher’s willingness to use the research findings to effect change, aware of the constraints that academic responsibilities may place on the researcher and his or her ability to pursue advocacy or long-term involvement. Assessing, and when possible, seeking assurances from the researcher’s institution about its commitment to the community, may help the community decide whether a longitudinal partnership is likely to be successful.
POINTS TO CONSIDER
- Does the academic researcher have the skills, experience, and resources necessary for the specific research project?
- Does the academic researcher seem willing to collaborate and respect the agency of the community?
- Is the researcher committed to long-term relationships with community partners?
- Is the researcher willing to pursue the advocacy and policy issues that emanate from the research? If not, can others help in these roles?
- Does the academic researcher have some degree of institutional commitment for promoting successful academic-community partnerships?
Agenda Setting and Developing a Joint Work Plan
Practitioners of CBPR emphasize that CBPR is not a methodology but an orientation to research. Traditionally, this orientation has been focused on social justice, and CBPR is often described as a more participatory and action-oriented approach (Minkler & Wallerstein, 2008
). Whereas traditional clinical research focuses on distributive justice concerns regarding the distribution of risks and benefits, CBPR focuses on both distributive and non-distributive concerns of justice. Non-distributive concerns of justice (often referred to as social justice concerns) focus on health care disparities, the needs of vulnerable populations, and the need to address such issues as stigma, lack of respect, and lack of institutions and social practices that support capacities for self-determination—for both individuals and groups (Powers & Faden, 2006
). The first step in addressing social justice concerns is choosing a research agenda that addresses a significant health issue for the community that is both a partner and participant in the proposed research. By collectively engaging in agenda setting, the community’s priorities are incorporated into the research strategy. A community advisory board (CAB), if properly constituted to be inclusive and responsive to the community (Montanaro, 2009
), can be helpful at this stage. Data show that despite demographic differences between members of a CAB and members of the community, CABs can effectively represent the community’s needs (Conway, Hu, & Harrington, 1997
POINTS TO CONSIDER
- Has there been adequate dialog to ensure that the health priorities of the partnership reflect the community’s needs?
- Does the academic researcher have the skills and interest to address the research needs of the community?
- Is funding available for this type of research?
- If funding is not available for a particular research priority, are the academic researcher and community willing to pursue other projects and attempt to procure funds for addressing this top priority at a later stage?
Research Design and Implementation
In the design of CBPR research, both the community and academic research partners are expected to have input into research design and implementation. The academic researchers often bring expertise in research methodology and data analysis, key components for scientific integrity. The community partners often bring additional expertise: knowledge of community needs, beliefs and interests, and practical knowledge regarding the community’s social structure.
When approached by an academic researcher about a particular funding opportunity, community partners may reject particular projects because they are not congruent with community priorities, or because they fear that the data that may be obtained may be unflattering and expose vulnerabilities of the community or threaten the social structures or agency of the community. In such a case, the researcher and community may simply part ways. However, when the academic researchers have a relationship with the community, both parties may seek to negotiate and modify the proposal or pursue variation(s) of the original project that may be more acceptable to the community (Minkler & Wallerstein, 2008
Input from both the academic and community research partners is appropriate at all stages and about all components of the research project. Questions asked by either partner may offer insights not previously considered or anticipated. Within each stage of research the expertise of each party can complement that of the other, e.g., in decisions about sampling, the academic researcher might provide expertise in determining appropriate sample size for scientific soundness and power while the community partner might provide expertise regarding how the appropriate sample size might be obtained. There may be situations where one party requests training in the areas of research in which they lack expertise in order to be a more effective research partner for the current project as well as for future projects.
An effective partnership requires transparency about the research goals and methods. This requires a delineation of the research hypotheses; the foreseeable risks and benefits of participation from both the individual and community perspectives; the potential impact on the community from participation as well as from the findings that may emerge; how data will be analyzed and disseminated; and what will happen to the data and to the partnership once this particular research project has concluded. Conflicts of interest or perceived conflicts of interest should be disclosed and discussions undertaken about how they should be managed.
The partners should be clear about what is and what is not negotiable. Some decisions may be out of the hands of both parties (e.g., a legal requirement for reporting suspected abuse; or a funder’s requirement to publish all data, even if unflattering). However, when flexibility is feasible, negotiation should occur and must be respectful of both parties.
Two issues that should be negotiated prior to data collection are who will control the data during and after the study and how intellectual property (IP) rights will be determined. The academic researchers or the community may want to maintain primary control of data for future use. To the extent that future use is anticipated, consent for such usage from the individual participants should be sought during the consent process. Decisions regarding who has the authority to permit access to the data, what types of future uses are permissible, and what type of oversight such secondary data analyses require should be delineated in an MOU and should be shared with individual participants during the consent process. In some cases, the funders (e.g., the National Institutes of Health [NIH]) require broad accessibility of third-parties to the data, but in other cases, access can be restricted. In both circumstances, who will have the authority to participate in decisions about access and future uses should be clarified before the data are collected.
IP rights include both questions of authorship and ownership of discovery; they should be addressed prospectively. With respect to authorship, many journals limit the number of authors on a manuscript, and some journals have specific requirements about the type and degree of input required to justify authorship. The order of authorship may be very important for the academic researchers and this should be clarified upfront although roles may change as work progresses, necessitating a re-evaluation of the agreement. Patentability of discovery has economic implications and may be even more contentious. Decisions must be made about whether to apply for a patent, who will have access to tests or treatments that are developed, and who will share in the proceeds that IP may generate. Two case studies are informative: In Greenberg vs. Miami Children’s Hospital et al.
(Merz et al., 2002
), parents of children afflicted with Canavan disease gave samples and resources to Dr. Reuben Matalon to develop prenatal and carrier testing for Canavan disease on the assumption that such tests would be made accessible and affordable to the public. Unbeknownst to the Canavan families and organizations, Matalon and his employer, Miami Children’s Hospital, obtained a patent for the Canavan disease gene, and began to charge royalties and to limit the availability of testing. Although most of the judicial charges against Matalon and Miami Children’s Hospital were dismissed (except the claim of unjust enrichment) (Merz et al., 2002
), Sharon Terry has endeavored to prevent such an outcome for individuals with Pseudoxanthomatous Elasticum (PXE) (Terry et al., 2007
). Terry helped found the PXE international advocacy group, and she has taken a proactive role in defining and funding the research. She is even named in the patent issued for the discovery of the PXE-related gene (U.S. Patent No. 7,364,904, 2008
) and therefore can ensure that the patent is not used against the community that provided the samples and money for the research.
POINTS TO CONSIDER
- Have the possible results of the research been anticipated and discussed?
- Do conflicts of interest (COI) exist? Is there a COI management plan that is acceptable to all?
- What components of the research are modifiable, and have the interests of both parties been explored?
- What components of the research are non-negotiable and are these constraints acceptable to both parties?
- Will the data be usable for future research projects? Has an agreement been reached about who has access to, and control of, data after the research is completed?
- Has an agreement been reached about authorship?
- Has an agreement been reached about intellectual property?
Applying for Funding
Funding is critical for the success of research. In CBPR, funding may be necessary to support both the academic researcher and the community members as they seek to develop a potential collaborative research relationship prior to the design of the study. Funders may need to be educated about the need for resources prior to developing a research protocol in CBPR.
How funds and resources are distributed and managed between the academic partner and the community requires negotiation. NIH policy now permits more than one principal investigator, which can facilitate resource sharing by collaborative research partners. Other funders should be encouraged to permit this practice as well. However, academic centers often have personnel who are specifically trained at grant award accounting which involves very specific reporting requirements. To the extent that community partners want to have monies and resources distributed directly to them, they need to ensure that they have the expertise to manage grant funds, lest they put the project and the academic research partner at risk. One solution is to include funding for a community-based grant manager into the grant proposal. However, the additional costs may make the grant less competitively viable, and concerns that the community grant management position is not sustainable may make it difficult to hire a person with the necessary expertise.
POINTS TO CONSIDER
- Who is eligible to apply for funding as principal investigator(s)?
- Who will apply for funding as principal investigator(s)?
- Does the funder have an appreciation for the degree of collaboration intended by the research partners?
- If each partner will manage part of the funds, does each partner possess adequate expertise in managing grant funds and the resources and expertise necessary to fulfill reporting requirements?