Table 4.

Summary of challenges and recommendations for CEnR researchers engaging with IRBs

Challenges	Strategies to mitigate challenges	Importance of recommendations	ACE Domain and opportunities for improving IRB practice
Community partners not being recognized as equal research partners [17,22] Issues with using nonuniversity affiliated clinics and clinic staff for recruitment No standardized process in place for community partners to as serve research partners with academic institutions IRB concerns around human subject violations for community organizations that are not under an affiliated IRB	– The IRB allowed community/student investigators to participate in certain aspects of the study if they completed training from the institution’s Clinical and Translational Science Institute (CTSI) on human subject research and CBPR in addition to the Human Subjects Research (HSR) training required- Disseminating human subjects research training that is accessible for all community investigators, including student investigators, will be an important way to satisfy IRB concerns – Clarifying the relationship and duties and roles of research partners helps the research review and approval process- Make sure academic IRBs know community partners – Provide clear guidance and tools for navigating IRB issues unique to academic-community collaboratives – Train community partners in human subject research to demonstrate to the IRB that community partners are experienced in scientific and human subject protection protocols- 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	– Leverages the opportunity for academic researchers to have direct access to contextualized local data otherwise not captured by traditional forms of biomedical research- Enhances the interpretation of research findings through an understanding of the local context provided by community partner involvement	Strengthened Partnerships and Alliances: qualities of the IRB that will foster and strengthen alliances with community partners include shared power between IRBs and community members during the review processes, where community partners can be involved in codesigning and developing the research partnership’s shared vision, goals, and responsibilities. In turn this, level of involvement and commitment by community partners can help build trust and promote sustained relations in which community partners are regarded as equalpartners.
Cultural competence, the language of consent forms, and literacy level of partners [16,18] Difficulty in obtaining consent from immigrant and vulnerable populations Consent form language and content are often too complex and difficult to understand Use of written consent versus verbal consent	– IRB provides a waiver of written/signed informed consent, wherein documentation of verbal consent obtained through an interpreter is sufficient – Supervision of non-native speakers by a bilingual adult leader helped to provide verbal consent- Human studies certified interpretation was available for non-English speakers – Having a review board that is sensitive to cultural concerns and therefore will allow necessary flexibility to the research project, especially for projects that have a CBPR component which often needs to have sufficient leeway for the project to follow its natural evolutionary course – Conducting studies involving refugee communities may necessitate educating IRBs on cultural nuances that may fall outside the boundaries of Western values of individual autonomy, self-determination, and freedom inherent to the concept of informed consent	– Allows for the participation of vulnerable populations who often are inaccessible or understudied e.g. undocumented individuals, sex workers, unhoused individuals, etc.	Expanded Knowledge: co-creation of new insights ideas and resources and tools can facilitate bi-directional learning between academic institutions and communities engaged in research, which in turn can improve IRBs' cultural competencies and understanding cultural nuances related to engaging specific populations in community research
IRBs apply formulaic approaches to CEnR [14,23] IRBs are formulaic in their approach to the review process The review process is often designed around biomedical and behavioral research	– Training IRB’s to understand CEnR principles – Strategies such as working with IRB offices to develop processes supportive of CEnR and training tools for community investigators can remove many barriers – Community advisory boards allow for greater community member involvement – Implement and invite IRB and human subject administration staff to CEnR workshops to improve their overall understanding of the principles of CEnR and to establish regular communication between researchers and IRBs – Including a CEnR expert or ethicist in the IRB review of CEnR studies – Having an institutional faculty member with CEnR knowledge and experience to be part of the IRB group – Encourage IRBs to increase their understanding of CEnR strengthen their community composition, and explicitly include community-level ethical considerations, in their policies, processes, and application forms	– Streamline the IRB review process by reducing delays and increasing the flexibility of the IRB review process, and IRB members will understand the intricacies associated with CEnR – Community advisory board members make up members of the community whose insights can help to inform and modify research approval methods to better fit the CEnR framework	Expanded Knowledge: co-creation of new insights ideas, resources, and tools focused on community engagement and community partnerships can facilitate bi-directional learning between academic institutions and communities engaged with CEnR
Extensive time duration for IRB preparation and approval has the potential to stifle the relationship with community partners. [15,24] Working with multiple IRBs (local, tribal, and national IRBs in addition to academic IRBs) Hurdles around local and tribal policies to obtain IRB approval	– Identifying key stakeholders with influence in the community who can provide support for the research study – It is critical for academic researchers to involve their community partners with the IRB as early in the research process as possible – Implement a process to allow community partners access to the electronic IRB application and acknowledgment as a coprincipal investigator, as well as instructional guidelines, templates, and algorithms to enhance the IRB navigation process	– Reduce delays in the review process – Maintain community engagement in research	Improved Health and Health Care Programs and Policies: designing community-aligned solutions that are sustainable and actionable, can help maintain community-engaged partnerships in the research process.

ACE, assessing community engagement; CEnR, community-engaged research; CTSI, Clinical and Translational Science Institute; HSR, human subjects research; IRB, Institutional review board.