# Exploring the Ethical Dimensions of Peanut Allergy Immunotherapy Research

> **NIH NIH R21** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2022 · $194,375

## Abstract

PROJECT SUMMARY
An important area of pediatric research and development is peanut allergy immunotherapy. Researchers are
pursuing oral, sublingual, subcutaneous, and epicutaneous products that activate the immune system through
allergen exposure to desensitize individuals to peanuts. One such treatment is now FDA approved, and another
is poised to receive market approval. However, immunotherapy conveys significant risk to patients, such as high
rates of treatment-induced anaphylaxis. This project's objective is to identify empirically the on-the-ground ethical
challenges that emerge in pediatric peanut immunotherapy (PIT) clinical trials. To date, there has been little
attention to ethics within the broad domain of food allergy research and practice. Yet, PIT research involves
many features that warrant ethical consideration, including clinical trials that enroll children, some as young as
1 year old, and risk-benefit profiles that differ from many other therapeutic areas. To explore these ethical issues,
the project has 2 specific aims: (1) Document how stakeholders—investigators, caregivers, adolescents, patient
advocates, FDA officers, and pharmaceutical company representatives—define and understand acceptable risks
and benefits from peanut immunotherapy, both in terms of research protocols and the eventual products to be
used in clinical practice; and (2) Identify the ethical challenges that emerge from these stakeholders' stances on
peanut immunotherapy risks and benefits. For Aim 1, the project uses an ethnographic approach—consisting of
observational studies and 125 semi-structured interviews—that focuses on 6 leading U.S. PIT research centers,
academic food allergy conferences, patient advocacy events, and FDA hearings for PIT products. To accomplish
Aim 2, the project employs analytic methods to ground the empirical findings from Aim 1 in bioethical frameworks,
including principlism and research on vulnerable or complex populations. The proposed research is significant
because it will develop an initial framework for the ethical conduct of PIT clinical trials that attends to the myriad
interests that drive biomedical research, including the search for therapies that meaningfully improve the lives of
children and adults with peanut allergy, the need to design and conduct clinical trials to meet the regulatory
standards required by the FDA for the approval of products, and the commercial context in which investigators
and companies have financial conflicts of interest that motivate the successful development of new therapies.
This project is innovative because it explores a novel area of social science and bioethics research and because
it investigates the entire sphere of PIT research and a wide array of stakeholders. This application is directly
responsive to NIH's Notice of Interest in High Priority Research in Bioethical, Legal, and Societal Implications of
Biomedical Research (NOT-LM-17-001), focusing in particular on new and emerging...

## Key facts

- **NIH application ID:** 10308499
- **Project number:** 5R21AI156709-02
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** JILL A FISHER
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $194,375
- **Award type:** 5
- **Project period:** 2020-12-01 → 2023-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10308499

## Citation

> US National Institutes of Health, RePORTER application 10308499, Exploring the Ethical Dimensions of Peanut Allergy Immunotherapy Research (5R21AI156709-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10308499. Licensed CC0.

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