Table 3.
CEnR investigator/expert reports documenting challenges and recommendations for engaging with IRBs
| Study reference | CEnR | Challenges/barriers | Lessons learned(implemented) | Recommendations (suggested, not yet implemented) |
|---|---|---|---|---|
| CEnR Investigator/Expert Report | ||||
| Fullerton et al., 2015 [21] | A paper-based self-administered anonymous survey was distributed at the end of a plenary session to capture the Centers of Population Health and Health Disparities researchers' experiences with institutional oversight of CEnR and CBPR over the course of the researcher’s career | 1. The consent forms required by the IRB were burdensome, too long, technical, or too complex, a concern which may or may not reflect the community-oriented nature of study protocols 2. Difficulties with the IRB not recognizing an ethical concern specific to the community 3. The IRB raising concerns about community involvement 4. IRB requiring substantial changes to the protocol that affected community involvement 5. Limited awareness of majority regulatory mechanisms: only 31.7% heard of Institutional Review Board Authorization Agreements (IAAs) with 17.8% having used them in the CEnR/CBPR context. Only a quarter heard of Individual Investigator Agreements (IIAs), with 11.9% aware of IIAs used in the CEnR/CBPR context |
1. Submitting research proposals to a dedicated IRB panel for CBPR (e.g. American Indian nations often have their own IRBs) 2. Most researchers sought out Federal Wide Assurance (FWA) for community partners. An FWA is a statement of principles governing an institution’s approach to the protection of human subjects to permit the extension of human subjects oversight to community partners who are not otherwise affiliated with an academic research institution) 3. Having an IAAs, for CBPR/CEnR research allows entities that have an FWA to use an IRB at another assured institution for the review of their research. This reduces the burden of establishing an independent IRB and helps streamline the review of collaborative research conducted by multiple assured institutions, as would be the case in an academic-community partnership 4. Having an IIA for CBPR/CEnR research allows community collaborators not otherwise affiliated with an assured institution to conduct research under the supervision of a principal investigator from an assured institution |
1. Academic institutions with researchers who frequently employ CEnR and/or CBPR approaches in their work should take steps to ensure that their IRBs bring to investigators’ attention all potentially relevant regulatory mechanisms, including those like the IIA which might allow investigators to collaborate with non-assured community partners and partner entities 2. Researchers and academic institutions need to improve capacity-building assistance for research among community partners, which should also extend to research oversight. This should not wait until the IRB application has been submitted, but perhaps should start before funding is secured 3. IRBs require a check-off on initial submission forms as to whether there are community partners without an IRB of their own and providing IRB training that covers these mechanisms 4. IRB training and prompts on submission forms, that are tailored to investigators partnering with community organizations are probably the best way to ensure broader awareness of CBPR and CEnR research |
| Paskett et al., 2008 [36] | To describe the recruitment experiences of projects that actively recruited minority and underserved populations as part of the Centers for Population Health and Health Disparities (CPHHD) initiative and to provide examples of strategies employed to aid in recruiting underserved populations to research studies. The study describes multiple sites engaged in CBPR and recruitment issues | 1. Length of time to obtain IRB approval led to delays in beginning recruitment 2. IRBs are overburdened and restricted the number of amendments that can be submitted at a time 3. Need for different additional certificates of confidentiality or consent 4. Difficulties in coordinating IRB approval at multiple institutions5. Issues with using non-university affiliated clinics and clinic staff for recruitment6. Need for HIPAA-related requirements e.g. private spaces for interviewing and privacy guidelines |
1. Protocol changes to respond to recruitment difficulties offering extra assurances of confidentiality | Not Available |
| Shore et al., 2007 [42] | To examine the experiences of CBPR researchers with the IRB process and to generate recommendations for research teams and IRB reviewers regarding ethical and effective reviews of CBPR projects | 1. Completion of the IRB process can be time-consuming 2. A sense of disconnect occurs when researchers feel that the IRB inadequately understands their research 3. Inappropriate IRB feedback attributable to a lack of expertise in a given substantive area, as well as a rigid review process can potentially create situations that increase the risk to study participants |
Not Available | 1. A more diverse committee is needed to appropriately anticipate potential risks and benefits of CBPR projects 2. Forming a community-based IRB comprised of community members as well as members of the non-profit community and academia 3. Address assumptions that negatively impact non-traditional research approaches 4. IRB reviewers would benefit from having a basic understanding of CBPR 5. Strategies to facilitate mutual education included training, developing guidelines, serving on the IRB, and inviting IRB reviewers to CBPR events. Guidelines should not be handed down by the IRB, but rather developed by the CBPR field and/or through a collaborative effort between IRBs and CBPR teams 6. After receiving IRB approval, there is a continued need to communicate with the IRB particularly when a project needs to be modified. Work with the IRB up-front to create a system that allows for quicker turnaround time for approval or have the IRB assign a lead contact person to each research project, who would be familiar with the project and therefore better positioned to respond more quickly to the researcher 7. CBPR field could generate guidelines to assist IRB reviewers 8. Inform the IRB by writing the project meets the exemption or minimal risk review criteria. This strategy does not imply misrepresenting the project’s intent but rather speaks to design considerations 9. Simplify the proposal and write to your audience (i.e. the IRB). This may entail excluding references to the partnership agreements and instead focusing on the anticipated IRB concerns. If the IRB is unfamiliar with CBPR, mentioning partnership issues may cause confusion 10. Provide as much information up-front as possible, particularly for projects within an emergent design. Even if the specifics of the design cannot be mapped out, the research team should at least try to outline the general domains of the types of questions that the project will examine. |
| Shore et al., 2011 [19] | To systematically describe community-based processes for ethics review of research in the United States | 1. Recruitment and support of engaged reviewers 2. Coordination with external entities, and infrastructure to support the review process 3. Time required to co-ordinate one’s review process with other entities, such as different community groups or other ethics review processes 4. Time required of volunteer reviewers to prepare for and attend the review meetings 5. Staff time is required to coordinate the process, which often is an added responsibility to their already busy schedule 6. Time required to discuss and review protocols, especially when competing agendas or diverse perspectives exist among reviewers 7. Differences in underlying priorities or values e.g. conflict with other IRBs that do not address group harm 8. Reviewers are more familiar with traditional forms of research and often do not understand community involvement |
Not Available | 1. IRBs would need to increase their understanding of CEnR, strengthen their community composition, and explicitly include community-level ethical considerations, in their policies, processes, and application forms 2. A system involving community-based and institution-based research ethics review may be the ideal process for CEnR review |
| Shore et al., 2011 [20] | To discuss a systematic study in the United States of the community-based review process (CRP) through an online survey of community groups and community-institutional partnerships involved in conducting human subjects research and/or advising on its conduct. Survey report of community-based review processes and their relationships with institution-based research ethics boards | 1. A significant amount of time and effort is required for preparing an IRB submission and there are also time delays in working through requirements that conflict with community needs and timeframes 2. Communication problems3. IRBs often lack understanding of CEnR4. Difficulty in resolving conflicts with multiple research ethics boards especially conflicts between IRB and community-based review processes |
1. Strengthening communication and coordination between community-based review processes and IRBs may lead to improved understanding of each other’s roles and contexts, stronger working relationships, and ultimately more efficient and thorough reviews of CEnR | 1. If the CRP is a community review ethics board (C-REB) and there is an academic partner involved in the study, the study could be reviewed by both the C-REB and the Institutional Review Ethics Board (I-REB) simultaneously or sequentially 2. If the CRP is not a C-REB and there is no academic partner involved in the study, the need for an I-REB review will depend on the specifics of the study 3. A system involving community-based and institution-based research ethics review may be the ideal to strive for, despite the inevitable challenges and complexities involved 4. There is potential for a more thorough and effective ethics review of CEnR if community groups/partnerships with research ethics review processes and IRBs routinely communicated |
| Silverstein et al., 2008 [25] | To describe the range of IRB requirements for, and approaches to community-based research (CBR). Describing and ultimately reducing this variability may also be important to providing consistent benefits to all communities participating in CBPR | 1. Majority of IRBs reported that they would serve as a Federal Wide Assurance (FWA) designated review board, and a substantial proportion indicated that they would charge a fee for doing so. Institutional liability was the most common reason for an unwillingness to serve as a designated IRB. 2. High variability in approaches to obtaining IRB review for community organizations engaged in CBR; high level of variability in determining who takes responsibility for IRB review for, non-assured community researchers (i.e. researchers not covered under an FWA) may also have implications for the conduct of health disparities research |
Not Available | 1. Policies and best practice guidelines for how IRBs consider research involving unaffiliated organizations should come not only from individual institutions but also from regulatory agencies with enough credibility to encourage consistency across institutions 2. Efforts to encourage more uniform practices must not only consider the protection of human subjects, but also address institutions’ perceptions of liability, investigators’ responsibility for oversight, and how relationships between academic and community organizations are codified 3. Within institutions, offices that handle grants and contracts should coordinate their policies with those of administration and the IRB in deciding what types of research an institution can support, and what additional funds if any, need to be added to investigators’ budgets to ensure appropriate IRB review |
| Brown et al., 2010 [23] | To highlight problems that arise when Belmont principles meet the IRB review process, and how those problems undermine rather than support the spirit of the Belmont Report. Using accounts with reports from other CBPR researchers, this article proposes procedures that will allow IRBs and CBPR researchers to work together in a review process that promotes their shared goal of ethical, principled, and beneficial research | 1. IRB has become too formulaic and inflexible, often the process can become costly and cause long delays 2. The IRB process was designed around biomedical and behavioral research, making the IRB review process inappropriate to the methods, challenges, and objectives of other approaches to research like CBPR 3. Layperson participation in the research process is often outside the conventional jurisdiction of institutional IRBs. This is due to their capacity to oversee and hold accountable the research work of independent organizations that were not legal entities of the university 4. The CBPR philosophy of openness and the practice of reporting back, challenges IRB assumptions about who controls the flow of data produced in human subjects research, when and whether those data should be made available to members of an affected community, and what the nature and duration of the researcher-subject relationship should be 5. IRBs frequently express concerns that disseminating uncertain data may harm human subjects 6. IRBs express concerns when community-based organizations (CBOs) serve as formal partners in a research initiative due to institutional jurisdiction. IRBs are reluctant to oversee human subjects protection compliance for partner organizations outside the university 7. IRBs may be particularly disturbed when a CBO challenges traditional academic norms by engaging in both research and advocacy, leading IRBs to attempt to influence activities that many CBOs believe should be under their own control |
1. The inclusion of community advisory boards which helps to involve community members centrally has helped some IRBs understand the need to transcend traditional models for human subjects review 2. Preparation of extensive memos to university IRBs that lay out the history and practices of CBPR, bolstered by extensive in-person dialogue and email with IRB staff 3. Demonstrate to the IRB how other researchers at prominent institutions have successfully carried out collaborative work like CBPR while observing sound ethical practices, and that other IRBs have approved such multi-partner collaborative research. 4. Demonstrate to the IRB that community partners are experienced in scientific research and well-versed in human subjects protection protocols |
1. Make sure academic IRBs know community partners 2. IRBs can keep well-informed of CBPR and other cutting-edge research approaches 3. IRBs can develop routine procedures for the review of CBPR projects 4. Provide clear guidance and tools for navigating IRB issues unique to academic-community collaboratives 5. Reassess how IRBs oversee situations in which participants desire access to and disclosure of their own study results 6. Work with community and tribal IRBs 7. Share positive models and problematic experiences with other teams, IRBs, and funding institutions 8. Research IRB members to assess their familiarity with CBPR and expertise in the field 9. Implement and invite IRB and human subjects administration staff to CBPR workshops to improve their overall understanding of the principles of CBPR10. Establish regular communication between researchers and IRBs |
| Hueston et al., 2006 [43] | To convene a panel to review issues of data integrity and participant protection in educational research, community-based participatory research, and research conducted by practice-based networks and summarize the issues and recommendations of this expert panel | 1. Communities face the challenges of whether a community review and approval process are in place and the level of importance of the community’s decision | Not Available | 1. There needs to be an ethical review of the CBPR project by both the IRB and the participating community 2. IRBs need to consider whether they have adequate knowledge of CBPR 3. IRBs need to consider whether appropriate community members are included in the process 4. IRBs need to consider how they can review an application in which the researcher proposes to develop the research focus and methodology with the community members 5. IRB oversight in cases of CBPR should include attention to the protection of the reputation of a community and the possibility of stigmatization of community members in addition to the protection of individual participants. 6. Investigators conducting CBPR should assure that all research projects are reviewed and approved by community representatives in addition to or as part of an IRB 7. For CBPR, the dissemination plan should be anticipated and reviewed, particularly for the dissemination of sensitive (i.e. potentially stigmatizing) results 8. Data from CBPR research should be made available for additional analyses only with the consent of the participating community and the original investigators |
| Malone et al., 2006 [17] | To examine the implications of the refusal of the university IRB to approve a CBPR study on cigarette sales practices in an inner-city community | 1. IRB refused to approve modification because of the legality around buying and selling single cigarettes 2. IRB did not see community research partners, as researchers but rather as subjects 3. Community research partners felt betrayed by IRB’s rejection, feeling as though the IRB chose to protect community predators over the health of the community itself |
1. Clarifying the relationship and duties and roles of research partners help the IRB process. 2. Having funders write a letter on behalf of the research will help the IRB process 3. Providing evidence-based research to back up claims also helps with IRB approval |
1. Including a CBPR expert or ethicist in the IRB review of CBPR studies |
CBPR, community based participatory research; CEnR, community-engaged research; CTSI, Clinical and Translational Science Institute; IRB, Institutional review board