# Core 09: Ethics and Regulatory Knowledge Core

> **NIH NIH U54** · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · 2022 · $100,969

## Abstract

Project Summary: Ethics and Regulatory Knowledge Core 
The overarching goal of the Ethics and Regulatory Knowledge (ERK) Core of the Louisiana Clinical and 
Translational Science Center (LA CaTS) is to create a unified systematic approach to the conduct of clinical and 
translational research across Louisiana. We will build on the successful research infrastructure established 
during the 1st and 2nd funding cycles by expanding Core services to a wider variety of researchers at more sites. 
The ERK Core proposes to achieve the following goals: 1) Advance the reliance review process among all LA 
CaTS institutions. As part of achieving this goal, the ERK Core will take the next steps in improving IRB 
processes by integrating a procedure for early determination of whether a data analysis project is appropriate 
for regulatory reliance. 2) Continue to make contacts with Regulatory/IRB offices at partner institutions to 
implement a state-wide regulatory network to include institutions not part of LA CaTS. This initiative will support 
the expansion of regulatory reliance review and will greatly enhance efforts across the state to support multi- 
institutional and multi-disciplinary projects designed to address health outcomes and disparities. 3) Further 
enhance the LA CaTS mission to facilitate initiation, conduct, and completion of trials by aligning the ERK Core 
activities as part of a Disease Focused Interest Group in close coordination with the Community Engagement 
and Outreach Core. Our Specific Aims are designed to improve the regulatory process and screen early for any 
potential ethical issues related to the research projects before they go into implementation in the community. 
Aim 1. Continue to provide regulatory support through consultations by the Core leaders and institutional liaisons 
to 1) investigators and research staff and 2) the regulatory Review Committees (IRB and IACUC) at each LA 
CaTS institution. Aim 2. Continue to incorporate ethics and regulatory resources into the training and 
professional development of investigators at all LA CaTS institutions with a focus on training new investigators 
and our Roadmap Scholars on the ethical and responsible conduct of research and research integrity. Aim 3. 
To establish and maintain a research participant advocacy board, a subgroup of the ERK Core Working Group, 
which will act as a sounding board for potential research participants by serving as a human research participant 
advocacy resource. We will accomplish these aims by: 1) further strengthening the connections among 
institutional IRB (and other regulatory) offices in order to create a network of ethics and regulatory experts and 
utilize the reliance mechanism outlined in the research strategy; 2) providing formal and informal instruction in 
scientific research integrity and the responsible conduct of research; and 3) addressing social and economic 
barriers to participation in the research effort and promotion of the...

## Key facts

- **NIH application ID:** 10513340
- **Project number:** 2U54GM104940-07
- **Recipient organization:** LSU PENNINGTON BIOMEDICAL RESEARCH CTR
- **Principal Investigator:** Leigh Lamonica
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $100,969
- **Award type:** 2
- **Project period:** 2012-08-15 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10513340

## Citation

> US National Institutes of Health, RePORTER application 10513340, Core 09: Ethics and Regulatory Knowledge Core (2U54GM104940-07). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10513340. Licensed CC0.

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