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. 2023 Oct 1;18(10):1362-1365.
doi: 10.2215/CJN.0000000000000197. Epub 2023 May 10.

Creation of a Single Institutional Review Board for Collaborative Research in Nephrology: The APOLLO Experience

Collaborators, Affiliations

Creation of a Single Institutional Review Board for Collaborative Research in Nephrology: The APOLLO Experience

J Brian Moore et al. Clin J Am Soc Nephrol. .
No abstract available

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Conflict of interest statement

A.A. Alexander reports an advisory or leadership role for Boston Children's Hospital. B.I. Freedman reports employment with Wake Forest University School of Medicine and Health Systems Management, Inc.; consultancy for AstraZeneca Pharmaceuticals, RenalytixAI, and Xinthera; research funding from AstraZeneca Pharmaceuticals and RenalytixAI; advisory or leadership roles on Editorial Boards of American Journal of Nephrology, JASN, and Kidney International; and other interests or relationships as Chief Medical Officer of Health Systems Management, Inc., Wake Forest University Health Sciences. B.I. Freedman has rights to a US patent related to APOL1 genetic testing. M.H. Spainhour reports employment with and research funding from Atrium Health Wake Forest Baptist. All remaining authors have nothing to disclose.

Figures

Figure 1
Figure 1
The process for single IRB approval in the APOLLO Consortium. After lead site approval, study materials were distributed to participating sites to begin their HRPP review processes, starting with submission to their local IRB as required in the SMART IRB Agreement for institutions to communicate local considerations to the single IRB. Local considerations and “cede decisions” were documented in IRB Reliance Exchange. The IRB Reliance Exchange Study Manager prescreened information before single IRB submission, often resulting in changes by the local HRPP and reducing time to approval. The IRB Reliance Exchange Study Manager submitted sites to the APOLLO single IRB system in batches. Although participating sites may have different workflows for documenting reliance and local considerations, IRB Reliance Exchange milestones are consistent across all studies and sites. The standard time points used for descriptive analysis included dates when sites were contacted by the single IRB to begin their local processes, when local considerations assessment began and ended, and when submitted to and approved by the single IRB. APOLLO, APOL1 Long-term Kidney Transplantation Outcomes; HRPP, Human Research Protections Program; IRB, Institutional Review Board; IREx, IRB Reliance Exchange.

References

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