# Healthy Volunteers as Model Organisms: Comparative Research Ethics and Policy for Phase I trials

> **NIH NIH R01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $393,321

## Abstract

PROJECT SUMMARY
The proposed project addresses the need for a novel evidence-based approach to the protection of Phase I
healthy volunteers. Phase I clinical trials test the safety of investigational drugs that eventually may be used in
affected patients. These trials have distinctive features that may undermine the validity of data gathered and
lead to ethics and policy gaps in protecting healthy volunteers. One such feature is that healthy volunteers
must stay in the clinic during the trial where they are given a prescribed diet and experience other restrictions.
Another feature of Phase I trials is they rely on repeat volunteers who do not mirror the health or sociodemo-
graphic characteristics of typical patient populations. Given these unique features of Phase I trials, we contend
that valuable insights may be gained through a comparison with non-human animal “model organism” re-
search. We will investigate this comparison and generate new ethics and policy guidance that addresses the
problems of risk, subject selection, validity, and translation that are particular to healthy volunteer trials.
To do so, this project has 3 primary aims: (1) Describe and normatively evaluate the limitations of current re-
search oversight in Phase I trials by analyzing data on healthy volunteers' perceptions of clinical trials, includ-
ing through a non-human animal research “model organism” lens; (2) Compare the ways in which Phase I re-
searchers, non-human animal researchers, bioethicists and policymakers, regulatory and research oversight
staff, and healthy volunteers conceptualize: a.) similarities and differences between healthy volunteer and non-
human animal research and b.) ethical, policy, and translational science problems particular to each arena; and
(3) Develop ethics and policy guidance for Phase I healthy volunteer research that a.) extrapolates from the
model organism framework in Specific Aims 1 and 2, b.) is attentive to the structural features of Phase I re-
search, and c.) is vetted by expert stakeholders.
This 4-year project is a proposed renewal of our current longitudinal study of 180 healthy volunteers. To ad-
dress the new aims, we will analyze the current grant's dataset to identify ethics and policy gaps and generate
empirically-grounded points of comparison between Phase I trials and animal research (Aim 1). We will also
conduct 60 interviews and 300 surveys with expert informants from Phase I healthy volunteer research, animal
studies, and bioethics and regulatory perspectives about the key ethical, policy, and translational issues at
stake (Aim 2). Finally, we will develop ethics and policy guidance to protect Phase I subjects and improve the
translational science pipeline. Four stakeholder forums across the US will provide a vetting process for our
draft guidance and initiate dissemination for our final recommendations (Aim 3). We expect the contribution of
the proposed project to be significant because it will generate ethics ...

## Key facts

- **NIH application ID:** 9928062
- **Project number:** 5R01GM099952-09
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** JILL A FISHER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $393,321
- **Award type:** 5
- **Project period:** 2012-09-05 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9928062

## Citation

> US National Institutes of Health, RePORTER application 9928062, Healthy Volunteers as Model Organisms: Comparative Research Ethics and Policy for Phase I trials (5R01GM099952-09). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9928062. Licensed CC0.

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