By Brenda Heaton, PhD, MPH, and Madeleine Kangsen Scammell, DSc
Community-Based Participatory Research (CBPR) is a tool for community empowerment. The increasing interest in CBPR among university researchers establishing community-university partnerships creates the potential for new opportunities as well as ethical challenges. The purpose of this article is to highlight the important role of research ethics in facilitating academic- community partnerships that seek to empower community organizations and the regulatory requirements for organizations engaged in CBPR. If not clearly understood or appreciated, institution-specific policies that guide the conduct of BUMC researchers engaging in CBPR may have the effect of obstructing those same partnerships.
The term CBPR is most often used in the field of public health in the context of community-based research endeavors and partnerships between grassroots community-based organizations and academic institutions. Most people describe CBPR by its principles, which include participation of those affected by the results of research ideally at every step of the process (i.e., defining the problem, designing the study, collecting the data and analyzing results); the equitable distribution of power among partners (financial, oversight and decision-making); and a solution-oriented outcome that results in long-term community empowerment.i, ii, iii In such partnerships, value is placed on the experience and knowledge of the poor and working classes, creating new parity with the specialized training of society's most fully franchised members. CBPR validates by inclusion the experience of people not professionally trained in research.
An often under-appreciated component of CBPR is the need for review by the Institutional Review Board (IRB). Ensuring compliance with federal regulations related to the protection of human subjects can get complicated, especially when Boston University Medical Center (BUMC) investigators partner with non-BUMC researchers, as is often the case with CBPR. While the protection of human subjects is the responsibility of all organizations who are engaged in human subjects research, the coordination of research protection activities and the responsibility for IRB review typically falls to the academic institution. Under the guidance of the U.S. Office of Human Research Protections (OHRP), institutions or organizations with their own IRBs can assume responsibility for conducting IRB review of the research and allow organizations without their own IRBs (like most community-based organizations) to rely on the academic site’s IRB for IRB review. This is essentially a three step process:
The Federalwide Assurance (FWA)
When any institution or organization proposes to engage in human research that is supported by federal funding (including subcontracted funds), an OHRP-approved assurance of compliance with federal standards of human subject protection is required by the Federal Government. This assurance, called a Federalwide Assurance (FWA), is a written commitment that an institution will comply with the OHRP human subjects regulations. Without an active and approved FWA, funding by the Federal Government cannot be granted to an institution.
BUMC has an FWA that covers research projects involving the engagement of BUMC employees or agents in human subjects research. When a project involves engagement of employees or agents from another institution, then that organization must have its own FWA. Under their own FWAs, each organization accepts responsibility for the human subjects protection oversight of the individuals engaged on behalf of their institutions. If an organization or institution fails to meet its responsibilities or commitments under their FWA, then OHRP can revoke their FWA (which would result in the institution’s inability to receive further research funding).
How does a community partner obtain an FWA?While there are significant responsibilities that come with obtaining an FWA, the actual FWA application process is relatively simple. There are eight basic steps in the application. Complete instructions and application materials can be found online. As part of the FWA process, the applicant organization must agree that all qualifying research in which they are engaged will have IRB review and approval. The organization must name at least one registered IRB which will be conducting IRB review on its behalf. In instances where the organization does not have its own IRB(s), such as most community-based organizations, they must list an IRB who has agreed to enter into a reliance agreement with them. This could be an independent (commercial) IRB or it could be an IRB at a partnering academic institution.
Institutional Authorization Agreement (IAA)
Once a partnering organization has obtained an FWA, the Institutional Officials (IOs) from both institutions must sign the “reliance agreement” called an Institutional IRB Authorization Agreement (IAA). For research where BUMC partners with an organization that does not have its own IRB, the IAA states that the BUMC IRB is willing to serve as the “IRB of record” for review of the research and allows the organization to rely on BUMC’s IRB review. This agreement satisfies the organization’s FWA responsibility for ensuring IRB review of their part in the research. The agreement delineates the responsibilities of each organization and states that the BUMC IRB will review all the research activities, including those performed by the partnering organization.BUMC researchers conducting CBPR can complete an IAA request as part of their IRB submission. When the IRB office receives the request, the IRB staff will process it and obtain the necessary IO signatures on the IAA. The IAA does not go into effect until the IRB protocol is approved, both IOs have signed the IAA, and a signed copy is attached to the INSPIR protocol.
Sometimes academic researchers conducting CBPR will partner with individuals from the community who are not affiliated with a formally established community organization because these people have special expertise (e.g., community knowledge that improves subject recruitment/retention). While these individuals may not be affiliated with an “assured” organization, if they are engaged in the human subjects research, then the regulations require that their research activities be reviewed and approved by an IRB. In some instances, these individuals may be determined to be engaged in the research on behalf of BUMC. A formal employment contract or formal volunteer agreement will usually be required so that these researchers will be “covered” under BUMC’s FWA and IRB review.
There are a number of unique challenges involved with conducting research in the community setting. These are amplified when the research involves “non-traditional” researchers who may have limited background, education and/or experience conducting research.
Human Subjects Protection Training
All persons engaged in human subjects research, including investigators and study staff from partnering community-based institutions, must complete “basic” Human Subjects Protection Training (also call “certification”). BUMC and community-based investigators can obtain training by attending general in-person training sessions at BUMC or by passing a free, NIH, on-line tutorial Protecting Human Research Participants, or by completing training through CITI. While the NIH and OHRP does not endorse or require any specific programs to fulfill the mandate for education on the protection of human subjects, these tutorials are most frequently used by institutions across the country.
These educational options, however, may not be the best way to train community-based, “non-traditional” researchers. Since NIH and OHRP have determined that “institutions are in the best position to determine what programs are appropriate for fulfilling the education requirement,”iv the BUMC IRB has approved other alternative training designed to be more relevant and meaningful to community-based researchers, especially those without high levels of academic training. These trainings must cover the same general topics as the NIH training, such as a basic introduction to research, when and why it involves human subjects, why and how to protect participants, and the basic principles of informed consent.
Protocol Specific Training
In addition to certification training, investigators and research staff must be trained in the specifics of the research protocol. Depending on the complexity of the protocol and the experience of the staff, this training may need to be substantial and include detailed introductory education about the basics of conducting research, including: how to collect data and use data collection instruments, detailed explanation of study interventions and risks, what constitutes outliers (e.g., protocol deviations, unanticipated problems), how to appropriately obtain informed consent, etc. Often protocol-specific training can be done in conjunction with certification training to save time as well as create an opportunity for the university and community partners to learn material together that is likely to be unfamiliar to both “traditional” and “non-traditional” researchers in a setting that is conducive to learning and empowerment.
In order to approve research, IRBs must ensure that, “When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.”These provisions can be complicated in CBPR because of the access community-based researchers might have to confidential research information about persons within their community. The research protocol, therefore, must address the likelihood for this situation to occur, the sensitivity of the data available to the research staff, and the measures that will be taken to minimize these risks. Training of community researchers must include education about how to deal with real life confidentiality challenges, and a discussion about the obligation of staff to not discuss the knowledge they have about particular participants outside the research. In some instances, community-based researchers will have access to research information that is subject to the HIPAA Privacy Rule. In these cases, the community-based researchers must also receive sufficient HIPAA training.
Most CBPR is conducted outside the traditional research settings of laboratories and clinics, frequently in people’s homes. When research is conducted in these settings, there can be additional risks to subjects and staff.
Reporting Abuse and Neglect
Seeing subjects in their homes could increase the risk that research staff may become privy to sensitive information about research subjects that may be wholly unrelated to the research. Researchers might come across situations where there are concerns about subjects’ or others’ safety. While Massachusetts has specific laws mandating the reporting of abuse or neglect of children, the elderly, or the disabled, in many cases, BUMC and CBPR investigators will not be “mandated reporters”. This does not mean that these concerns can be ignored by researchers. The BUMC IRB generally requires that the IRB protocol includes a safety plan for how these situations should be handled if they are identified by research staff. The confidentiality section of the informed consent must address the fact that identification of safety concerns (such as abuse and neglect) might result in the reporting of this information.
[ Editor’s note: Background Checks
In addition to the considerations outlined above, the IRB may require that community-based researchers have formal background checks. If those researchers are employees of community-based agencies, they may already have had checks because many community-based agencies perform background checks as part of their hiring process. But for community-based researchers who have not had background checks, the IRB may require some level of checks. The extent of the checks will vary depending on the specifics of the research (e.g., if the researchers will go to subjects’ homes alone, whether research involves children, elderly, etc.). If any clinical procedures will be conducted by community-based researchers (e.g., blood drawing), then the background checks will need to include verification of appropriate licensure and certifications to conduct those activities. ]
While the IRB’s role is in the protection of human subjects, the overall research plan should include a plan for the protection of the research staff. Staff should be well informed, trained and given clear instructions for how to protect their personal safety (e.g., conducting research in pairs, employing the “buddy system”, utilizing technology to facilitate prompt communication between field staff and the office). Harm to research staff in the course of conducting research could significantly impede the successful completion of research and, thereby, reduce the risk-to-benefit ratio of the study and negatively impact future CBPR in the community.
Direct supervision of community-based researchers
Conducting research in the community setting can create additional challenges when researchers are geographically dispersed and when they are conducting research outside business hours.Protocols must include a plan for how CBPR staff will be supervised while in the field. The expectation should not be that they can receive a single training session and then successfully go out into the community and conduct research. Careful monitoring will be necessary to ensure that data is being collected properly, appropriate informed consent is being obtained without coercion of subjects, unanticipated problems, protocol deviations, and subject complaints are being carefully addressed and recorded, etc.
Community-based organizations who are engaged in federally-funded research must have an FWA. If they do not have their own IRB, they can often rely on the IRB at their partnering academic institution through an authorization agreement (IAA). The community organization still retains responsibilities for the protection of the human subjects and must agree to comply with the requirements of the IRB. There are a number of unique ethical considerations related to community-based research. Addressing these issues can help to ensure that conducting CBPR will actually result in community empowerment and successful collaborative relationships. Poorly conceived arrangements can intensify a community’s distrust of universities and university researchers, and taint future research relationships.
iii Park, P. What is participatory research? A theoretical and methodological perspective. In: Park, P., Brydon-Miller M., Hall, B., and Jackson, T., (eds.) Voices of Change: Participatory Research in the United States and Canada. Toronto: Ontario Institute for Studies in Education, 1993:1.
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