Unit 1 Section 1.3: Ethics and CBPR

What are the ethical issues that may affect community participation in research?

If one examines the ethical principles of public health set out by the American Public Health Association and the Association of Schools of Public Health in Box 1.1, one can see a heavy emphasis on involving the community in the design of public health interventions, policy and research. This reflects in part a communitarian tradition in public health that looks beyond the individual: “This (communitarian) theory is based on a recognition that individual liberty and indeed human existence relies heavily upon the interdependent and overlapping communities to which all of us belong (families, neighbourhoods, workplace, religious and other social groups.” (Ausubel)

Historically, however, many research designs have not adequately or appropriately involved community participants, resulting in a negative perception of research. Common problems experienced by communities in research include:

• Irrelevance to the community

• Poor methodology that in turn is a waste of resources

• Research data and findings are not given back

• Communities feel “over-researched”

• Communities feel coerced to participate in research

• Communities feel researched upon rather than partners in the process

• Communities are lied to

• Insensitivity to community concerns or issues

• Benefits to community are minimal or nonexistent

CBPR attempts to address these issues and concerns both in the design of the research and its conduct from being respectful of participants, listening, and having cultural competence. As with any research study, it cannot coerce participation: “American political culture does not recognize an obligation to participate in research; rather, we consider it to be a socially desirable activity that people may elect to participate in or not, as they choose” (Pritchard).

Given that CBPR by definition requires a significant level of community member participation with the objectives of community improvement and social change, the ethical practice of CBPR requires researchers to be vigilant about the way the partnership is developed, implemented, and sustained.  For example, an ethical CBPR practitioner would not promise communities more than s/he believes the partnership can deliver, nor would s/he exploit community members’ time and expertise for personal gain.

 

What are examples of ethical issues that arise in CBPR?

Below, we briefly review ethical issues that may arise in the conduct of CBPR.  These are just some examples of ethical issues that might arise in the design and implementation of a CBPR project as well as questions that must be considered and might come forward from an IRB reviewing the research proposal.

Community participation

In CBPR, questions around “who is the community, “who represents the community,” and “who speaks for the community” are all critically important.

• Is it legitimate or ethical for community members to come from only a few neighborhoods or social identity groups, thus benefiting some communities more than others?

• What if certain neighborhoods or communities are more outspoken, have greater community organizing skills, or are more comfortable negotiating with academic researchers than others?

• Do academic researchers have a responsibility to seek participation from all communities, or just work with the groups who are the most outspoken, or easiest, to work with?

Roles

In CBPR, because everyone’s participation is highly valued, role definitions between researchers and community members can sometimes become blurred.

• When should a researcher take responsibility and ownership of critical measurement or methodological questions?

• When might asking community members for input on design issues prove burdensome and/or threatening if it is not an area they know?

• How does “equity” in the CBPR process get translated into practice so that divisions of labor and input are not exploitative to any one partner?

Dissemination of research results

Disseminating CBPR research results also involves participation from both community members and researchers:

• How do research results get re-presented and whose voice(s) is/are heard or represented? 

• Are the findings presented in an accessible and meaningful way for community members?

• Are the findings presented in scientifically valid and rigorous means for academic audiences? 

• What if the research findings in economically disadvantaged communities reinforce negative social stereotypes?
  

• Would it do more harm to the community to report such findings?

Exercise 1.3.2 is designed to help partners to consider the various types of ethical issues which may arise during a CBPR project.

 

 

CBPR and Institutional Review Boards

Like any other research endeavor involving human subjects, CBPR protocols and designs require the review of institutional review boards (IRBs) to assure the protection of participants in the study. The role of IRBs is to assure that studies maximize benefit and minimize risk to all participants.  In most institutional-community partnerships, the participating university, community health agency, public health department or hospital partner have one or more IRBs that review the research design. 

What are the primary ethical principles that guide the ethical review process?

The ethical guidelines built in to most IRBs rely largely on three core ethical principles: respect for persons, beneficence and justice. These derive from different philosophical traditions and at times can come into conflict with one another in determining which principle should take priority over another.   The principle of respect for persons underlies the obligation to obtain informed consent; the principle of beneficence demands the maximizing of benefit and minimizing of risks; and the principle of justice requires the equitable distribution of the burdens and the benefits of research. A more comprehensive list of ethical principles that guide research includes:

• Respect for human dignity

• Respect for free and informed consent

• Respect for vulnerable persons

• Respect for privacy and confidentiality 

• Respect for justice and inclusiveness

• Balancing harms and benefits

• Minimizing harms

• Maximizing benefits

• Equitable distribution of the burdens and benefits of research

CBPR is deliberately intended to be a flexible and adaptive research design. As a result, this may require additional bureaucratic steps with the IRB, informing them of design changes and assuring them that they continue to follow all ethical principles.

In CBPR, research involving institutions such as schools, churches or workplaces, the issue of “voluntariness” may sometimes arise. In a situation where institutional leaders (e.g., principles, teachers, pastors, managers) and peer leaders have endorsed a CBPR study, it is important to assure that not all members of those organizations feel compelled to participate in the study and that non-participation will not result in any reprisals.

This issue is closely related to “informed consent.” In all studies, participants are required to either indicate orally with a witness or in written form by signing an informed consent form that they fully understand the study and their role, they are competent to participate and their participation is voluntary. Although it is sometimes overlooked, Pritchard and other researchers remind us that informed consent should be more than a form – it should be a process.

It is important for community partners to understand the IRB process involved in the research project.  At the end of the day, community partners want to be sure that the research is helping the community by solving community problems. The IRB is a protective mechanism that community partners can use if they understand it and are part of the process of designing the research. Once community partners are clear that the human subject issues have been addressed, they can promote the research project with greater confidence.    In the words on one community partner involved in a CBPR partnership, “If I understand the IRB, I have greater confidence in my outreach to my community and advocacy for the project.  Because of the trusting relationship developed through this process, I feel a greater degree of confidence in the intended outcomes that will result from this research.  Because we have more of an understanding and know the questions to ask, we can go out and explain it to the community and know that it’s good research because we have been engaged in ensuring that we will get the intended outcome.”

Designing a study protocol to submit for IRB review

Research protocols submitted to IRBs for review generally cover these topics:

(1) Background, purpose and objectives

(2) Research methods

(3) Population or research participants

(4) Recruitment of participants

(5) Risks and benefits

(6) Privacy and confidentiality

(7) Compensation

(8) Conflicts of interest

(9) Informed consent process

Below, we walk through the purpose of each of the topics and raise questions for consideration regarding ethics and community participation.

(1) Background, purpose and objectives: This section describes the background and setting to the project, its rationale, purpose, objectives and hypothesis for research.

Questions to consider:

• Is this research really justified?

• Who benefits? How?

• How was the community involved or consulted in defining the need?

• Who came up with the objectives and how? 

• Are there concrete action outcomes?

(2)Research methods: This section describes how the research will be done. It describes the who, what, where, when and how of the research.  It indicates what procedures will be used to collect data (e.g., surveys, interviews, focus groups), the frequency of these procedures and the number of people involved.  It indicates the period of time the research will be carried out and how long each phase will last.

Questions to consider:

• How will the community be involved? At what levels?

• What training or capacity building opportunities will you build in?

• Will the methods used be sensitive and appropriate to various communities (consider literacy issues, language barriers, cultural sensitivities, etc.)?

• How will you balance scientific rigor and accessibility? 

(3)Population targeted or research participants:  This section describes who the participants are and why they were selected. It states the proposed “sample size” (e.g., how many people will be involved) and how that size was determined.  It provides any relevant inclusion or exclusion criteria for who can be involved in the study and describes any special issues with the proposed study population, (e.g., incompetent patients or minors)

Questions to consider:

• Are you really talking to the “right” people to get your questions answered appropriately (e.g., service providers, community members, leaders, etc.)?

• How will you protect vulnerable groups?

• Will the research process include or engage marginalized or disenfranchised individuals? How?

• Who speaks for the community?

• Is there a reason to exclude some people? Why?

• Are the potential research benefits and harms likely to be shared relatively equally among all participants?

(4)Recruitment: This section describes how and by whom participants will be approached and recruited.  It includes copies of any recruiting materials (e.g., letters, advertisements, flyers, telephone scripts).  It states where participants will be recruited from (e.g., hospital, clinic, school).  It provides a statement of the investigator’s relationship, if any, to the participants (e.g., physician, teacher, community public health representative).

Questions to consider:

• What is the power relationship between the investigator(s) and participants? Is there potential for coercion?

• Are the service providers and researchers different people?

• Is it clear to the population that they may still receive services even if they choose not to participate in the research?

• Who approaches people about the study and how?

• Are your recruitment strategies and materials culturally appropriate and adapted to the participants?

• How will you assure confidentiality?

(5)Risks and benefits: This section describes the anticipated risks and benefits to research participants.  It explains how these risks and benefits are balanced and what strategies are in place to minimize and manage any risks.

Questions to consider:

• What are the risks for communities? For individuals?

• Have you been fully honest about risks? How will you minimize these?

• Are there built in mechanisms for how unflattering results will be dealt with?Are your recruitment strategies and materials culturally appropriate and adapted to the participants?

• Is it clear and transparent who will benefit from this research and how?

• How do you distribute the benefits most equitably?

(6)Privacy and confidentiality:  This section provides a description of how privacy and confidentiality will be protected.  It includes a description of data maintenance, storage, release of information, access to information, use of names or codes, destruction of data at the conclusion of the research and includes information on the use of audio or videotapes.  Protecting the privacy and confidentiality of research participants is sometimes a challenge in CBPR when community members become “participant researchers” who are active in the research design, data collection and analysis. In qualitative data analysis, it is common for researchers to go back to research participants to confirm the findings and interpretations of results. This may preclude having completely anonymous research participants or may require more protections around confidentiality of participants.

Questions to consider:

• How do you maintain boundaries between multiple roles (e.g., researcher, counselor, peer)?

• What processes will you put in place to be inclusive about data analysis and yet maintain privacy of participants?

• Where will you store data? Who will have access to the data? How?Is it clear and transparent who will benefit from this research and how?

• What rules will you have for working with transcripts or surveys with identifying information?

(7)Compensation:  This section describes any reimbursements, remuneration or other compensation that will be provided to the participants, and the terms of this compensation.

Questions to consider:

• Are people being reimbursed for their time and effort? If so, how can this be done without being “coercive"?

• Have you consider other types of compensation such as travel or parking costs and childcare?

• Who is managing the budget? Which partners are getting what compensations?

• Who is being paid? Who is volunteering? How are those decisions being made?

• Have you assured that participation in the research and service delivery are not being linked?

(8)Conflicts of interest:  This section provides information relevant to actual or potential conflicts of interest (to allow the IRB to assess whether this information should be shared with participants as part of the informed consent process).

Questions to consider:

• What happens when your job depends on the results?

• What happens when you are the researcher and the

• Friend
• Peer
• Service Provider
• Doctor, nurse, social worker
• Educator
• Funding agency?

(9)Informed consent process:  This section describes the procedures that will be followed to obtain informed consent from participants. It includes a copy of the information letter(s) and consent form(s). If written informed consent is not being obtained, it explains why. Where minors are to be included as participants, a copy of the assent script to be used is provided.  If you are dealing with a population with special needs (e.g., illiterate) or with a different language base, how these differences will be addressed to assure that they are fully informed is explained.

Questions to consider:

• What does this mean for “vulnerable” populations (e.g., children, mentally ill, developmentally challenged)?

• What does it mean to inform?

• What does it mean to “consent”?

• How do you do this in a culturally sensitive manner?

• Whose permission do you need to talk to whom?