# Beyond the Federal Regulations: Ethical Guidance for Modifications of Research Informed Consent from Common Law Principles

> **NIH NIH UL1** · UNIVERSITY OF VIRGINIA · 2020 · $161,500

## Abstract

ABSTRACT
Aiming to improve medical care, researchers are proposing new ways to study treatments in “real-world”
settings, like the hospital or doctor’s office. These studies, sometimes called “pragmatic trials,” often compare
treatments that patients might receive in usual care, although the care any particular patient might receive as
part of the study is determined through random assignment, like flipping a coin. For these types of studies,
sometimes the usual processes for obtaining the informed consent of the patient for research participation is
bypassed. For example, a doctor conducting the research might tell the patient about the study after the patient
was provided care and ask if the researchers could study the patient’s medical record to see how effective the
care was. Another example would be when a person entering a hospital might sign a form agreeing that some
parts of the patient’s care would be a determined by a research study but that the patient would not be asked
to consent to specific changes in their care as long as they were in the scope of this general consent form.
Proponents of these newer consent approaches for pragmatic trials emphasize the similarity between research
and clinical practice when patients receive usual care treatments, even if chosen by random selection. There is
a lot of debate among ethicists about whether these changes to the usually strict informed consent
requirements for research are appropriate. Our research team has noticed a gap in these discussions. Rarely
do they consider what a court might say if a research participant brought a lawsuit about their participation in
research without the usual methods of consent. Based on our expertise and preliminary research, we believe
that the common law, the body of law developed through decisions of courts, such as tort or contract law,
would have something important to say about these newer approaches to consent. Our study will research and
analyze legal cases to determine how common law principles and the ethics underlying them relate to informed
consent in innovative research designs like “usual care” studies (Aim 1) and develop a framework for
incorporating ethical underpinnings of common law principles to guide design and review or innovative
research and to more completely inform future policy and practice (Aim 2). Results from this research carry
great value for the CTSA network hubs as they train translational scientists seeking ways to overcome barriers
in the translation process and support innovations to discover, develop and disseminate more treatments to
more patients more quickly.

## Key facts

- **NIH application ID:** 10131424
- **Project number:** 3UL1TR003015-02S3
- **Recipient organization:** UNIVERSITY OF VIRGINIA
- **Principal Investigator:** Donald E Brown
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $161,500
- **Award type:** 3
- **Project period:** 2020-07-01 → 2021-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10131424

## Citation

> US National Institutes of Health, RePORTER application 10131424, Beyond the Federal Regulations: Ethical Guidance for Modifications of Research Informed Consent from Common Law Principles (3UL1TR003015-02S3). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10131424. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*