Issues Related to Institutional Review Boards
One commonly encountered challenge when conducting high quality CBPR work within an academic institution is the ethical review process. An IRB, also known as an independent ethics committee, ethical review board, or research ethics board, is a committee established to ensure that human research is conducted in accordance with all federal, institutional, and ethical guidelines. As discussed by Coughlin and Ackerson in chapter 5, the purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study.
Formal review procedures for institutional human subject studies were originally developed in direct response to research abuses in the 20th century. Tangible results include the National Research Act of 1974 and the development of the Belmont Report, which outlined the primary ethical principles in human subjects review; these include “respect for persons,” “beneficence,” and “justice.”6 These ethical principles are operationalized in terms of forms and procedures that require constant updating as new research models are developed, as our understanding of the risks, potential harms, and benefits of research are improved, and as new ethical issues emerge. While the ethical issues of testing a drug in a double- blinded randomized control trial may be well understood, IRBs have been slow to adapt their policies and procedures to accommodate different methodologies and methods. This is especially true for the review of CBPR protocols.
Institutional review boards have been criticized for relying on conceptions of research that privilege biomedical, clinical, and experimental designs, therefore penalizing research that deviates from this model.7,8 Institutional review boards are often less familiar with social science and especially CBPR procedures. Descriptions of such research may not provide definitive sample sizes or sample selection procedures. They may not provide a specific guide or instrument to be used uniformly, or be able to consent each participant. When community members conduct research, they may not be ethically certified, or the IRBs may be uncomfortable with their level of training. Many social scientists, CBPR focused and otherwise, have argued that their research is not understood by IRBs and that IRBs impose unnecessary and time-consuming bureaucratic processes that do nothing to ensure the ethical well-being of research subjects. This is reflected in the institutional structures of ethical review boards. Flicker et al.7 reviewed forms and guidelines commonly used by public health IRBs in the United States and Canada to assess if and how the forms reflected common CBPR experiences. The authors found that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experiences. They are primarily focused on assessing risks to individuals and not to communities and continue to perpetuate the notion that the domain of knowledge production is the sole right of academic researchers. Researchers concluded that IRBs might be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR.7
Another concern is that IRB members often have only biomedical expertise and lack a working knowledge of CBPR; proposals are often misunderstood or held to inappropriate stipulations. While every institution may not have the capacity and internal expertise to have all research types represented on an IRB, it is important to seek that expertise. A possible solution offered by Guta et al.8 is that IRBs can solicit external expertise from researchers at other institutions in the form of a one-time consultation, similar to journals and funding agencies.
A commonly discussed challenge regarding IRB approval for CBPR research relates to the time it takes to complete IRB procedures. Institutional review boards have been accused of having a clunky, bureaucratic default mode that is excessively and unnecessarily time-consuming.9,10 As Gunsalus noted, “In too many cases, the focus is on form over ethical substance: counting what can be counted, rather than focusing instead on what counts.”10 Community-based participatory research does not necessarily follow the IRB-prescribed expectations of the provision of all materials and plans at the initiation of the project. Community- based participatory research uses iterative and emergent processes in the field to develop many of these materials, which have been met with confusion and resistance by IRBs. Institutional review boards are often more familiar with hypo- theticodeductive approaches to research.11 Flexibility is needed with respect to research designs that evolve in the field. Delays due to the need for IRB approval of a new iteration of study materials are a source of frustration. Delays are compounded when projects require multiple reviews by different IRBs, as each IRB may have a different application and requirements. In some CBPR partnerships, community representatives act as an informal IRB with ethical standards that arguably may be higher and more relevant than the university IRB’s standards.12 Time delays can pose problems for community partners who may operate under rapid timelines and not be accustomed to the lengthy administrative timelines of many academic institutions. Lengthy delays also present challenges to community partners such as low-income collaborators relying on stipends/incentives for their project-related expenses or students who need to complete assignments by the end of their academic term.
Some common CBPR data collection and dissemination methods, such as photovoice, pose novel ethical challenges to IRBs. As discussed by Coughlin and Yoo in chapter 2, photovoice is a participatory health-promotion strategy in which people use cameras to document their health and work realities, and may use these powerful images to communicate with policy makers when advocating for change in their communities.13 Similar to other data collection approaches whereby community members gather sensitive data, unique ethical implications arise. For example, when capturing images there is the potential for invasion of privacy. Further issues arise regarding representation, participation, ownership of images, and so forth While ethical protocols exist for photovoice methods, communication of these protocols to IRBs is often unprecedented and can raise concerns.
Recommendations to improve the IRB process for CBPR research include (1) recruit reviewers with CBPR and related experience, as well as community advocates, to join ethical review boards;8-12-14 (2) provide mutual education between IRB staff, researchers, and community review boards to maximize CBPR understandings and each stakeholder’s requirements to ensure ethical research;7-812-14 (3) encourage improved communication, relationship building, and mutual education between IRB staff and researchers;8,12,14 and (4) encourage IRBs to remain flexible where variances from the protocol do not constitute a material change in risk to participants and their communities.8