An Approach to Reviewing Local Context for Exception from Informed Consent Trials Using a Single IRB

Abstract

In the context of emergency research, researchers can ask the institutional review board (IRB) to waive the regulatory requirement that individuals provide informed consent when enrolling in research studies. A requirement of the waiver of informed consent is that the reviewing IRB must review and approve a community consultation and public disclosure plan. It is critical that an IRB serving as the single IRB (sIRB) for multisite research be thoroughly versed in the local context concerns for each participating site to determine whether the site's community is being adequately consulted about the research in which individuals will be enrolled under an exception to the informed consent requirement. We designed an sIRB review model for evaluating site‐specific community consultation plans that included a local evaluation and feedback step, and we piloted the model with a four‐site, pediatric exception from informed consent (EFIC) clinical trial. We identified three key roles for the model: the sIRB, the investigators, and the representative of the institution's human research protection program (HRPP). We successfully collected the information and local input needed to evaluate each site's community consultation plan and applied the information to a thorough IRB review, despite the geographic distance between the study site and the sIRB.

Institutional Review Boards' Assessment of Local Context: A Mixed Methods Study

“…13 Standardizing what information is collected may help promote efficiency. 14 Regarding EFIC research specifically, these data suggest the perceived importance of capitalizing on both local and central bodies to appropriately contextualize a site's community-consultation and public disclosure efforts and results. How best to achieve this in a manner that is both effective and efficient warrants further discussion.…”

“…In many ways, having someone specifically focused on community engagement may allow for concentration of expertise in this domain that the local IRB generally may not have. Johnson et al 15 presented a model for EFIC sIRB review that accounts for the roles of the sIRB, the investigators, and the local IRB. Their model provides a process to bridge local input from the study site and the sIRB.…”

Pediatric specific challenges of the single institutional review board mandate

“…For studies in which informed consent is difficult to obtain (e.g., lifesaving interventions in an emergency setting), decisions to allow exemptions of informed consent present a further ethical dilemma and determinations can vary between IRBs [ 12 ]. Here, knowledge of the local context is of paramount importance to inform participant risk and benefit but also community consultation and public disclosure [ 13 ]. Thus, there are many reasons in pediatric research for institutional and single IRBs to disagree on the acceptability of proposed research.…”