# Achieving Ethically Appropriate and Effective Local Context Review by Single IRBs

> **NIH NIH UL1** · JOHNS HOPKINS UNIVERSITY · 2022 · $163,750

## Abstract

PROJECT SUMMARY/ABSTRACT
Recent changes to National Institutions of Health (NIH) policy mandate the use of a single
institutional review board (sIRB) for most federally funded multi-site studies. This policy change,
it was argued, could increase research efficiency while enhancing protections for research
participants. Although several studies have examined the impact of sIRBs on efficiency, critical
questions remain regarding their impact on ethical protections for research participants.
A key challenge for maintaining ethical protections of research participants in sIRB review is
whether and how sIRBs can collect and incorporate knowledge of the local context. Concerns
about local context that may affect the ethical conduct of research include knowledge about
investigators, research settings, the resources and capacity to conduct a trial, and issues
related to the vulnerabilities or concerns of local patient populations targeted for recruitment.
NIH policies on sIRBs instruct participating sites to communicate “relevant information” to the
sIRB regarding local context. However, there is no shared agreement as to the goals and
content of local context review, or how this review should be tailored to particular study types or
settings to best meet the twin goals of promoting efficiency while maintaining protections. As a
result, there is considerable variation in how sites consider local context, raising concerns as to
whether important issues are being missed, or, alternatively, whether some sites’ current
processes introduce unnecessary barriers to the initiation of socially valuable research.
The proposed bioethics research project will synthesize normative analysis, policy review, and
empirical data from key stakeholders to develop guidance regarding the goals, content, and
scope of local context review. In Aim 1, we will develop a conceptual model of the goals of local
context review, its content, and the criteria by which to assess its relevance or appropriateness
to specific study contexts. This model will inform our Aim 2 work, in which we will use a modified
Delphi process to develop expert-informed guidance about what local context review should
entail, and how it should be tailored to specific studies. The contribution of this research will be
significant because it will lay the essential groundwork for efficient and ethical conduct of sIRB
review. In doing so this will help advance the NIH’s broader commitment to enhance the quality
and efficiency of clinical research.

## Key facts

- **NIH application ID:** 10594273
- **Project number:** 3UL1TR003098-04S1
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Daniel Ernest Ford
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $163,750
- **Award type:** 3
- **Project period:** 2019-05-31 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10594273

## Citation

> US National Institutes of Health, RePORTER application 10594273, Achieving Ethically Appropriate and Effective Local Context Review by Single IRBs (3UL1TR003098-04S1). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10594273. Licensed CC0.

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