# New Frameworks for Informed Consent in Genomic and Precision Medicine

> **NIH NIH G13** · WASHINGTON STATE UNIVERSITY · 2020 · $49,149

## Abstract

Project Summary/Abstract
HudsonAlpha Institute for Biotechnology
The emergence of genomic medicine has not been without unique concerns that continue to
challenge clinicians working in this arena. Genomic test results have implications for individuals other
than the person tested. Related to this, interpretation of genomic data often requires several related
individuals; and even then what can be known about the meaning of an individual's specific variants
is, and will continue to be, a function of “big data” analysis of the genomic data of many thousands (or
even millions) of individuals. As well, the rapid emergence of the field complicates the meaning of
results, as the lack of gene-disease associations are often a reflection of the nascent state of the
field, rather than the lack of such associations. These characteristics, along with myriad uncertainties
tied to variants of unknown significance or otherwise "non-actionable" or contested results, pose
direct problems for translation of results to treatment plans or interventions that are consistent with
patient values.
This project proposes a scholarly work consisting of a book-length manuscript (200 pages; 100,000
words) that fully develops, and then applies a new model of patient autonomy and informed consent
in the context of genomic medicine. Once completed, P.I./author Thomas May has been offered a
book contract by a leading publisher in academic medicine (Springer) to publish and disseminate the
manuscript in book form. It is the aim of this project to:
· Provide a conceptually sound model of patient autonomy, which can be easily understood
 and applied in novel circumstances by genomic clinicians who have no sophisticated training
 in moral philosophy.
· Provide concrete examples for the application of the model of informed consent developed to
 common challenges in genomic medicine (e.g. return of incidental findings; rights to genetic
 ignorance; testing of children; and potential screening uses of genomic technologies).
· Critique existing alternative models of autonomy and informed consent, and to situate the
 model developed here within the broader philosophical and medical ethics literature.

## Key facts

- **NIH application ID:** 9986897
- **Project number:** 5G13LM012445-03
- **Recipient organization:** WASHINGTON STATE UNIVERSITY
- **Principal Investigator:** Thomas C May
- **Activity code:** G13 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $49,149
- **Award type:** 5
- **Project period:** 2017-09-01 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9986897

## Citation

> US National Institutes of Health, RePORTER application 9986897, New Frameworks for Informed Consent in Genomic and Precision Medicine (5G13LM012445-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9986897. Licensed CC0.

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