Assessing the Impact of Mandatory NIH Neuroethics Requirements

Human subjects research with novel neural devices raises unique ethical issues, such as post-trial responsibilities, privacy of brain data, and atypical risks such as changes to personality. To manage the discrepancy between research practices and ethics oversight, in 2018 the NIH added a mandatory neuroethics section to a subset of neuroscience grants in addition to the standard protection of human subjects component. However, despite the unique nature of this requirement, to date there have been no systematic efforts to assess stakeholders’ experiences with and attitudes toward these mandates. This represents both a critical gap and opportunity. Without empirical research evaluating the impact of neuroethics mandates, we risk implementing ineffective requirements, lack the information needed to make useful modifications, and remain unaware of their strengths and weaknesses. Furthermore, given that there is no established pathway nor guidance for investigators to address neuroethics requirements, examining researchers’ experiences offers a valuable opportunity to understand how they devise neuroethics plans as well as barriers they might encounter when implementing them. The overall objective of this short-term R21 exploratory proposal is to assess the impact of mandatory NIH neuroethics guidelines on the ethical design and conduct of brain-related research and to identify effective strategies that investigators have utilized to address neuroethics in their research. This will be achieved through two complementary aims that involve interviewing researchers who have been funded through NIH grants requiring neuroethics sections (Aim 1) and surveying those who review neuroethics components of grant applications (Aim 2). This project directly addresses the broad area of RFA-MH-25-171 (“enhance integration of neuroethics and neuroscience”). The expected outcomes of this two-year exploratory R21 project are a set of multistakeholder perspectives on the impact of neuroethics mandates and recommendations for improving them, an identification of strategies that researchers have utilized to address neuroethics mandates, and a determination of areas of unmet needs regarding resources for addressing neuroethics requirements. Our findings will benefit funders, by providing insights into the impact of neuroethics requirements and recommendations for improving them; researchers, by providing a set of effective strategies that have been used to address neuroethics sections; neuroethicists, by determining areas of unmet need regarding neuroethics resources; and the public, by identifying pathways for enhancing the ethical conduct of neurotechnology research. This project is significant because it has the potential to impact the way that the ethics is integrated and assessed across BRAIN Initiative research and in other scientific endeavors. Project Number: 1R21MH141490-01 | Fiscal Year: 2026 | NIH Institute/Center: National Institute of Mental Health (NIMH) | Principal Investigator: ANNA WEXLER | Institution: UNIVERSITY OF PENNSYLVANIA, PHILADELPHIA, PA | Award Amount: $221,302 | Activity Code: R21 | Study Section: Special Emphasis Panel[ZMH1 ERB-E (03)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11220726