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Chapter 6 - Ethical Considerations in CBPR

Members of the Havasupai tribe “had given DNA samples to university researchers starting in 1990, in the hope that they might provide genetic clues to the tribe’s devastating rate of diabetes. But they learned that their blood samples had been used to study many other things, including mental illness and theories of the tribe’s geographical origins that contradict their traditional stories.” … “I’m not against scientific research,” said Carletta Tilousi, 39, a member of the Havasupai tribal council. “I just want it to be done right. They used our blood for all these studies, people got degrees and grants, and they never asked our permission.” 1

In the Havasupai case, biological samples were used for other purposes than those for which participant consent was given. This bioethical dilemma is one example of an ethical misstep that is pertinent to community-based research. In this scenario, the ethical dilemma occurred at both the individual as well as at the community level. Not only was the consent of individuals who originally agreed to participate in the study for specific purposes disregarded, but there were implications for the entire community as well. In this chapter, we will explore some of the ethical issues encountered in CBPR. We will address the following areas:

1. Principles that guide ethical conduct of research and how they pertain to CBPR

2. The concepts of risk and benefit in CBPR

3. Ethical considerations unique to CBPR partnerships

  PRINCIPLES OF ETHICAL CONDUCT OF RESEARCH

The Belmont Report stands as a significant guidepost for the protection of human subjects and has influenced federal regulation and the conduct of biomedical and behavioral research nationally. 2 The report, issued in 1978, set out basic ethical principles underlying acceptable conduct of research involving human subjects. These include respect for persons, beneficence, and justice. Each of these principles has wide-ranging application for research involving individual human subjects. Respect for persons requires that the research is voluntary and that informed consent must be comprehensible to the individual. It also recognizes the protection of special populations of individuals with diminished autonomy, including children, prisoners, and those with cognitive disabilities. The concept of beneficence translates to protecting individuals from harm by minimizing risks and maximizing benefits. The concept of justice requires that the benefits and burdens of research are fairly distributed and relates to the selection of subjects in a manner that is just and fair. These concepts are the underpinnings of institutional review board (IRB) regulations. IRBs are the groups that oversee ethical conduct of research in academic environments.

There are a number of limitations of these guiding principles as they relate to CBPR. First, these concepts are primarily focused on the protection of the individual as research subject and not on the protection of communities as organized entities. Second, these principles lack guidelines for the ethical behavior of partners engaged in community/academic collaboration. They also lack guidelines for assessing the risks and benefits to a community as a whole. In a recent review of 30 IRBs, Flicker and colleagues (2007) did not find adequate evidence that IRB policies and protocols applied to communities or to CBPR projects. 3 Today, as the practice of CBPR grows, we need to assess how the Belmont principles of respect, beneficence, and justice can be expanded to include communities in addition to the individuals residing within them.

In CBPR, there are several areas that deserve particular attention from an ethical standpoint.

1. Informed consent for research at the community level

2. Risks and benefits of research from a community perspective

3. Community standards of justice, including those of partnership ethics and economic distribution

  COMMUNITY INFORMED CONSENT

In human subjects research, informed consent involving any individual participant in research is required and must meet the standards set out in the Belmont Report. However, getting informed consent from an entire community is not realistic. So how does a researcher assess informed consent at the community level? How is the value of a research project communicated to the targeted community as a whole? Most importantly, how can a researcher feel confident that the research is perceived as acceptable and feasible to the community? Obtaining community consent is particularly challenging given that the individuals in the community are not homogeneous and opinions of various subgroups may differ substantially. To address these questions, CBPR researchers need to understand the values and mores of the community at large. They need to be aware of how these unstated perspectives pertain to ethical conduct in said community. Learning about the cultural perspectives, history, governance, and so forth of a community will help the researcher develop this understanding. Take, for example, the Havasupai tribe case, in which nonconsented research on DNA from blood samples suggested migration patterns that contradicted Havasupai origin myths. In addition, blood has great spiritual meaning to the Havasupai, and its return to the tribe brings ancestors home to their resting place. Thus, research using blood samples in this community raised additional ethical concerns about the care and appropriate return of samples to the tribe, none of which was considered. 1

Community informed consent depends largely on defining and understanding the community of study and making sure that the leaders (formal and informal) support the research. In order to understand cultural considerations and assess the community’s view of a research project, a CBPR researcher relies heavily on the community advisory board (CAB). The CAB serves as an entrée into the community. Its members provide needed advice and are the link between the researcher and the larger community. Their knowledge of the culture, local actors, politics, and social networks will help the researcher navigate the community landscape and determine project feasibility. As in the case of our Everett example, an actively engaged CAB that represents the community can be an enormous resource providing insight into acceptability of research and helping to ensure that there is community buy-in for the project. They will also be instrumental in helping the researcher understand the community context for the research (political and social climate), the competing priorities in the community that could limit participation, and the appropriateness of the chosen methods for consent and recruitment from both a cultural and practical standpoint. In our Everett example, the CAB was made up of leaders from the immigrant communities’ advocacy groups. When we discussed recruitment, consent, and inclusion/exclusion criteria, the opinions of these individuals played an important role in decision making. CAB members who had access to constituents could therefore vet the project and the methods before we began and could tell us what would and would not work in their community. They translated the research tools, piloted them with immigrant groups, and led the recruitment efforts. 4 These community members were able to assess acceptability and feasibility and help researchers develop their eligibility criteria, their consent forms, and the informational materials used in recruitment. They reminded the research team of the need for low-literacy materials that were easily understood and nonthreatening. As researchers, we would not have been able to communicate our research goals to the community without the help of these leaders. In addition, these community partners were likely to take any findings from the project to future action.

To sum up, some of the critical questions to consider regarding community informed consent in CBPR include:

· Is the research project acceptable to the community of interest?

· Have you connected with leaders (informal and formal) to assess this acceptability?

· Have the criteria for inclusion been discussed with the community, and does this pose any ethical challenges?

· Are there particular cultural issues that need to be addressed?

· Is the CAB actively advising on these issues?

  RISKS AND BENEFITS FROM A COMMUNITY PERSPECTIVE

The concepts of risks and benefits from research at the individual level are easily understood; how will the research potentially benefit the participants and how will it potentially harm them? Most importantly, do the benefits outweigh the risks? In CBPR, not only will the researcher need to assess the individual risks and benefits of research, but he or she will need to understand the risks and benefits for the community as a whole. In other words, it is important to identify what the community will potentially gain or lose by participation in the research. Table 6.1 presents a framework for determining community risks/benefits compared to individual risks/benefits. This is discussed in greater detail in Ross and colleagues’ (2010) work on human subjects protection in CBPR, from which this table was adapted. 5

Table 6.1    Risk and Benefits of Research: Individual and Community Perspectives

Community Risks and Benefits of the Research Process

Whereas an individual may experience physical or psychological risk from research, a community might experience a risk to its structure from the conduct or the results of research. From a risk perspective, the process of conducting CBPR may be stressful at both the individual and the community levels. Community members may have other priorities that compete for their attention, or they may have concerns about how recruitment is progressing. Similarly, the stress of CBPR on community-based organizations involved in research may also pose a risk. If the organization underestimates the time required or defers other responsibilities in favor of research, it could lead to organizational instability. There are also a myriad of other contextual forces facing communities, and during the research process, these priorities may be in direct conflict with the research process. For example, agreed-upon research methods such as random assignment or use of control groups may become untenable due to unforeseen political issues. In the face of sudden budget cuts impacting low-income women, a project that plans to randomly assign disadvantaged women to an intervention that offers additional support (navigation and coaching) may suddenly be seen as unjust or unethical because some people are excluded from receiving these services. The contextual community factors may ultimately force a mid-research shift in design. One study by Levy and colleagues (2006) speaks to this type of shift based on community values: that is, a random assignment of participants to an asthma intervention was planned, but due to community concerns, it was not possible. As Levy notes:

Much CBPR research to date has been observational or otherwise fallen short of achieving clinical trial standards, which has potentially limited the impact of these studies on public health policy and programs. This may arise partly from the complexity of managing and sustaining equitable partnerships, as well as from resistance from community or city partners to aspects of scientific methodology that may not directly benefit the community in the short term (since a more rigorous methodology may conflict with addressing immediate needs). 6

While there are community risks posed by the CBPR process, there are also a number of benefits to the community. Community members who are involved in CBPR are likely to learn new skills that contribute to increased community capacity for future problem solving. As community members gain facility with the use of data, research methodology, and systematic analysis, they are more likely to use evidence in their practice settings. In our Somerville example, community partners learned about surveillance strategies and data mapping. Since that time, not only have they continued to monitor data to assess suicide attempts and completions across the age range, but they have also used these skills to examine a host of community issues ranging from food security to youth development activities. The research process also builds new partnerships and alliances that could result in future collaborations for community good. Financial resources flow to the community during the research process, supporting community members. The research process in CBPR can also give voice to vulnerable populations as they are part of the decision-making process. The empowerment experience during CBPR as community members take on their own issues is a powerful tool in community development and organizing. Building leadership along with skills is perhaps one of the most significant outcomes of the CBPR process. In our Everett example, immigrant leaders had opportunities to express themselves, shape the agenda, and lead efforts. Their empowerment is likely to translate to future action beyond the research agenda. Building capacity and empowerment in vulnerable communities is an important outcome of CBPR.

Community Risks and Benefits of the Research Results

Research results also have potential to pose risks as well as benefits for communities and community organizations involved in CBPR. An important ethical consideration is whether the research will contribute to local benefit or potentially cause harm. Certainly, results that help to solve local problems and garner support for action will likely be seen in a positive light and be embraced by community partners. However, community “harm” is also a possibility and is often unanticipated. The results of research have the potential to stigmatize a community or group if findings are disparaging. For example, in a study by Marcelli (2009) that surveyed various populations of immigrants, it was noted that one immigrant population was more likely to be undocumented than others. 7 This immigrant group perceived this type of information as stigmatizing and more likely to make them the target of law enforcement and deportation action. While this was not the intent of the research, it was an unforeseen outcome that put an already vulnerable community at further risk. Other examples might include work on environmental issues that, while providing important evidence for health improvement, could also lead to loss of property values. Further, even neutral results could pose a risk to the community. For example, an evaluation of a community program that does not show effect could lead to loss of services to vulnerable populations and a concomitant loss of jobs for employees. Thus, it is important to discuss these ethical concerns with community partners at the beginning of a project. How will the community deal with unfavorable results? How will these be disseminated and translated to the community? How will they be utilized by both community and academic partners? How will the partnership protect the community without censoring findings?

Ethical Considerations for CBPR Partnerships

The CBPR academic/community partnership serves as the cornerstone for CBPR, and thus, it is important to understand the ethical considerations that shape and maintain these partnerships. 8 Partnership relies on power sharing in decision making, trust, respect, and economic distribution. But there are also risks and benefits inherent in being a community member of a research team. On one hand, there are the benefits of opportunities for skills acquisition and resources, while on the other hand, there are risks in that the relationship with academia may alter the community member’s relationship with her or his own community. The person may even lose the respect of the community by becoming associated with the “outside” academics. 9 In addition, when the project is over and participants are no longer employed by the researcher, are they received back into the community? During the research process, there may also be conflicts among CAB members. These can lead to breakdown of the CAB and shifts in relationships that ultimately impact the community. For example, as a result of disagreement, community groups may fracture relationships with local government authorities, leading to problems within the community beyond the scope of the research project. Similarly, problems in relationships between researcher and community partners may arise if strategies for equitable sharing of power and economic resources are not in place. Does the project really allow for full participation of community partners? Is there adherence to the principles of CBPR? Are the constructs of partnership demonstrated in the research plan, in decision making, and in budgets? Researchers and their IRBs can help assess adherence to ethical principles in CBPR. As developed by the Community Engaged Research Subcommittee of the Harvard Catalyst Regulatory Core, a set of questions like the following can be helpful. 10

· Does the proposed activity respond to the needs of this community and/or support existing infrastructure or networks?

· What is the plan for engaging with this community?

· How will the community be involved in the development and implementation of this particular project?

· What is the researchers’ relationship with key stakeholders in the community?

· Has community risk versus individual risk been evaluated properly?

· Are recruitment strategies culturally/linguistically appropriate?

· What role will the community partner have in recruitment?

· How accessible/approachable is the researcher to the community stakeholders?

· Does the proposed consent form use (linguistically and culturally) appropriate language?

· Are there appropriate resources devoted to this project?

· What resources are required (financial, physical, etc.)?

· Is there an understanding of the institution’s and community partners’ needs/capacity for development and implementation of planned activities?

· Who will provide these resources?

· What is the community’s role and expectation regarding the allocation of these resources?

· Are there financial resources available for translation services/interpreter services?

  DISSEMINATION

Part of the any CBPR project is dissemination of results, whether it be for publication in the scientific arena (peer-reviewed journals) or for action in the community-based context (discussion, forums, press releases). The manner in which CBPR dissemination is conducted is part of the discussion of risk and benefit to the community. Inappropriate dissemination in CBPR can have ethical implications. For example, if a community is not privy to research results or required to wait until “the paper comes out,” this does not represent an equitable power-sharing relationship. While the lack of information may simply be an error of omission, it does not meet the requirements of a CBPR partnership. Thus, in CBPR, considerations for how the results will be communicated to the community should come first. The CAB should be involved in this discussion and in dissemination decision making. It needs to consider the best way to provide the results to the community, be that as a report, forum, newspaper article, or policy brief. Returning the findings to the community is a necessity, and it is this feedback loop that differentiates CBPR from other types of research. The use of the data for action is the major benefit for a community, and thus withholding the information would connote a risk. Worst-case scenarios are when the researcher disseminates results that the community partners are unaware of. Specific ethical questions around dissemination include:

· What plans/strategies are in place to disseminate the results and elicit feedback from community stakeholders?

· Will dissemination be through multiple venues (e.g., community forums, presentations, journal articles, websites)?

· Are these venues effective and accessible to both community members/providers and researchers?

· Will there be a process to inform community stakeholders about the role of the IRB?

  WHEN THE CBPR PROJECT ENDS

There may be ethical considerations that arise when a CBPR research project ends. Given the extensive community engagement in CBPR, this issue can be extremely important for the community and for the success of future academic/community partnerships. CBPR includes a focus on local action and sustainable change. The research is not just for research purposes but also has implications for local impact. A CBPR researcher must consider in all phases of the research the salient question of what the research will leave behind at the conclusion of a CBPR project. This may include direct impact from the research project and findings as well as the next steps following its conclusion. Toward that end, the CBPR partnership will have to grapple with questions of sustainability and how to obtain additional resources to support change and the activities associated with that change. Will the researcher continue to work with the community despite the loss of economic support (research grant funding)? Are the academic/community relationships ongoing or simply project based? Once a community group is mobilized and focused on action, questions about resources and sustainability will certainly arise, and the researchers must assess their role in this agenda. These are difficult questions to answer and perhaps are best assessed at the beginning of the project when the partnership determines its mutually agreed-upon goals. The use of MOAs or contractual agreements can certainly help, but the communication about these issues throughout the project is imperative. As in any relationship, the need for clear, ongoing communication about difficult issues is something that the partnership must seek to address to avoid later confrontations and to plan for sustainability from the first day forward.

  CONCLUSION

The principles outlined in the Belmont Report of respect, beneficence, and justice are applicable not only to the individual involved in research but to communities as well. Part of being a CBPR practitioner is understanding how community risk and benefit are assessed and how it will affect your research design and dissemination. The impact of research may have long-term impact on communities that ranges far beyond the specific “side effects” of the research process. The CBPR researcher should consider the risks and benefits from the perspective of the individual and the community of interest. As IRBs assess CBPR, they too will need to consider the ethical implications of this type of work. A synopsis of these implications can be found in Table 6.2 .

Table 6.2    Application of the Belmont Principles for CBPR

Informed Consent Voluntariness	· How is the community consent to be obtained? · How are community leaders and groups involved in recruitment? · What compensation is allocated to community members or groups? · What conflicts of interest may affect community participation?
Comprehension	· Are materials culturally and linguistically appropriate? · How are community leaders and groups involved in key decisions in the design and conduct of research? · What training will be provided to community members?
Risks and Benefits	· Individual · Individual by association with the group · Community · Disruption of community cohesion by research · Risks of disseminating sensitive data to the community · Risks of results harming community
Selection of Subjects	· How is the community defined? · How are community leaders identified? · How are community leaders involved in defining inclusion and exclusion criteria? · What are the criteria for distribution of economic benefits? · How are community standards of fairness applied?

  QUESTIONS AND ACTIVITIES

Activities

Provide students with an example of a CBPR project that was conducted locally. Then have students point out potential ethical issues that this research might have raised for the individuals and the community.

A CBPR project focuses on environmental health hazards in a community of 80,000 people. The project is trying to assess the impact of an incinerator on cancer rates in the community. Based on preliminary findings, the community advisory board begins to suspect there is a link between the incinerator and higher cancer rates in one community. As the researcher, you have not drawn any conclusions yet or “crunched the data”; however, you are getting pressure from your community partners to release the data for advocacy purposes. Describe three ethical dilemmas that you might face given this situation.

Questions

1. What are the three concepts underpinning the Belmont Report? Describe each of these concepts.

2. How do these concepts apply to a community rather than an individual?

3. What are the risks of research when the community is the concern rather than an individual?

4. Are there times when an individual would be protected but a community might suffer harm? Describe an example of this.

5. What are some strategies a researcher could use to protect a community from hazardous research?

  NOTES

1 . Harmon A. Indian tribe wins fight to limit research of its DNA. New York Times. April 21, 2010.

2 . The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. Ethical Principles and Guideline for the Protection of Human Subjects of Research. Washington, DC: U.S. Department of Health, Education, and Welfare; 1978.

3 . Flicker S, Travers R, Guta A, McDonald S, Meagher A. Ethical dilemmas in community-based participatory research: recommendations for institutional review boards. Journal of Urban Health. 2007 Jul;84(4):478–93.

4 . Hacker K, Chu J, Leung C, Marra R, Pirie A, Brahimi M, English M, Beckmann J, Acevedo-Garcia D, Marlin RP. The impact of Immigration and Customs Enforcement on immigrant health: perceptions of immigrants in Everett, Massachusetts, USA. Social Science & Medicine. 2011 Aug;73(4):586–94.

5 . Ross LF, Loup A, Nelson RM, Botkin JR, Kost R, Smith GR, Gehlert S.

Human subjects protections in community-engaged research: a research ethics framework. Journal of Empirical Research on Human Research Ethics: An International Journal. 2010;5(1):5–18.

6 . Levy JI, Brugge D, Peters JL, Clougherty JE, Saddler SS. A community-based participatory research study of multifaceted in-home environmental interventions for pediatric asthmatics in public housing. Social Science & Medicine. 2006 Oct;63(8):2191–203.

7 . Marcelli E, Holmes L, Estella D, da Rocha F, Granberry P, Buxton O. (In)Visible (Im)migrants: The Health and Socioeconomic integration of Brazilians in Metropolitan Boston. San Diego, CA: Center for Behavioral and Community Health Studies, San Diego State University; 2009.

8 . Ross LF, Loup A, Nelson RM, Botkin JR, Kost R, Smith GR, Gehlert S.

Nine key functions for a human subjects protection program for community-engaged research: points to consider. Journal of Empirical Research on Human Research Ethics: An International Journal. 2010;5(1):33–48.

9 . Minkler M, Wallerstein N., eds. Comunity-Based Participatory Research for Health. San Francisco, CA: Jossey-Bass; 2003.

10 . Harvard Catalyst Community Engaged Research (CeNR) Subcommittee. Top Questions for IRB to Assess Community Engaged Research (unpublished committee notes). Boston, MA: Harvard Catalyst; 2011.

(Hacker 107-120)

Hacker, Karen. Community-Based Participatory Research. SAGE Publications, Inc, 02/2013. VitalBook file.

The citation provided is a guideline. Please check each citation for accuracy before use.