# Human Subject Core

> **NIH NIH P20** · UNIVERSITY OF NORTH DAKOTA · 2022 · $283,808

## Abstract

HUMAN SUBJECTS CORE PROJECT ABSTRACT
The Human Subjects Core (HSC) is a resource to serve the human subjects research aims of investigators
participating in the Indigenous Trauma & Resilience Research Center and more broadly at UND. The HSC will
promote a professional environment that will facilitate the progress of Individual Project Leaders (PLs) to
pursue R01 and similar funding mechanisms for human subjects research. The HSC will also assist in
expanding human subjects research capacity at UND. The HSC Director has years of experience in research
administration, including human subjects studies, and he will coordinate HSC activities with the PD/PI.
Objectives
 1. Assist COBRE project investigators with human subjects research.
 2. Build human subjects research capacity at the University of North Dakota (UND).
 3. Promote effective and appropriate tribal engagement regarding human subjects research.
Methods: Two staff positions will be hired to ensure successful HSC outcomes, including a Research
Coordinator and a Recruitment Coordinator. Services provided by the HSC include: Study Design Technical
Assistance (TA); Institutional Review Board (IRB) & Informed Consent TA; and subject recruitment and
scheduling. The HSC will assess the feasibility of developing a Biosample Database with Indigenous
communities in collaboration with the Community Engagement & Outreach Core (CEOC). We will develop
Adverse Event Reporting processes and policies in collaboration with the UND Institutional Review Board, and
we will establish and administer a Data Safety Monitoring Board for Dr. Redvers' project and for future clinical
trials. In addition, cultural safety training for engaging tribal populations and tribal IRBs will be provided to UND
researchers in collaboration with the CEOC. We will also engage in Meta Scholarship and will publish
manuscripts regarding best and promising practices for engaging American Indians into human subjects
research. These activities will be evaluated to ensure we achieve HSC objectives and outcomes. Sustainability
and growth of the HSC will be enhanced through collaboration with other UND IDeA Programs, including the
Epigenetics COBRE, as well as other non-IDeA research programs. HSC services will be available to other
UND researchers, thus providing access to additional funding sources to ensure sustainability of the HSC.

## Key facts

- **NIH application ID:** 10360441
- **Project number:** 5P20GM139759-02
- **Recipient organization:** UNIVERSITY OF NORTH DAKOTA
- **Principal Investigator:** Barry Ira Milavetz
- **Activity code:** P20 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $283,808
- **Award type:** 5
- **Project period:** 2021-03-01 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10360441

## Citation

> US National Institutes of Health, RePORTER application 10360441, Human Subject Core (5P20GM139759-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10360441. Licensed CC0.

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