# Enabling ethical participation in innovative neuroscience on mental illness and addiction: towards a new screening tool enhancing informed consent for transformative research on the human brain

> **NIH NIH R01** · STANFORD UNIVERSITY · 2020 · $454,017

## Abstract

Great discoveries in neuroscience hold promise for reducing the burden of many of the most disabling
conditions that threaten human health on a global scale, including mental illnesses and addictions.
Increasingly, exceptionally innovative science inspires hope that these devastating brain-based disorders may
be prevented, treated, and even cured but, as the BRAIN 2025 Scientific Vision notes, a suite of novel ethical
challenges confronts those engaged in innovative neuroscience. These concerns include the deepest
questions about what defines humanity and personhood, what forms of novel inquiry may exceed ethically
acceptable limits in society, and how to perform ethically sound studies with volunteers who may be vulnerable
to exploitation in the research situation. Such issues are particularly salient in mental illness and addiction
research because these conditions affect cognition, emotion, motivation, behavior, and self-governance of
potential participants. Importantly, some of these ethical issues are amenable to empirical study, which can
yield valuable insights and evidence-informed practices that strengthen and enable ethically sound human
brain investigation. The overarching goal of this proposal is thus to accelerate neuroscience toward lessening
the burden of mental illness and addiction through hypothesis-driven empirical ethics inquiry in three parts.
First, we determine the distinct ethical issues and problems encountered in innovative neuroscience related to
mental illness and addiction through semi-structured interviews with neuroscientists, neuroethicists, and
institutional review board members. Informed by our past work and grounded in a rigorous conceptual model,
we examine factors both negative and positive that influence research decisionmaking by people with mental
illness and addiction in the context of innovative neuroscience research, and compare their decisionmaking
with that of individuals with diabetes and healthy controls. Finally, we develop a new, low-burden screening
tool to tailor and enhance the safeguard of informed consent in brain research, providing investigators with a
practical, actionable, and protocol-adaptable method for strengthening positive-valence factors and ameliorate
negative-valence factors affecting participant decisionmaking. Maximizing our established record of expertise
in empirical ethics investigations and neuroethics, this sequence of projects leverages access to the
exceptional neuroscience research conducted at Stanford University, including work by BRAIN initiative
investigators; provides extensive, systematically collected data on influences on decisionmaking about
innovative neuroscience research participation by individuals with mental or physical illness and healthy
controls; and develops a new evidence-informed tool for use as a best practice in safeguarding human
volunteers in cutting-edge neuroscience.

## Key facts

- **NIH application ID:** 9993927
- **Project number:** 5R01MH114856-04
- **Recipient organization:** STANFORD UNIVERSITY
- **Principal Investigator:** LAURA W ROBERTS
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $454,017
- **Award type:** 5
- **Project period:** 2017-09-15 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9993927

## Citation

> US National Institutes of Health, RePORTER application 9993927, Enabling ethical participation in innovative neuroscience on mental illness and addiction: towards a new screening tool enhancing informed consent for transformative research on the human brain (5R01MH114856-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9993927. Licensed CC0.

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