This administrative supplement proposes to integrate neuroethics analysis into the development of small and highly portable MRI devices, through the addition of three senior key personnel and the collaborative development of publications on the ethical issues and potential solutions. The emergence of highly portable MRI raises unexplored ethical and legal questions. This supplement will produce publications on two fundamental issues. At present this U01 grant has no ethicists embedded. In order to address core neuroethics issues, additional expertise is necessary.
In Aim #1 we will examine how existing approaches to the return of individual-specific research results (IRRs) and incidental (or secondary) findings (IFs) to research participants can be translated to the use of highly portable MRI. We will also consider emerging law and norms on participant access to individual-specific research data on request, an issue that has become urgent after 2014 regulatory changes empowering individuals to request their own laboratory results. This will be a first step toward formulating the necessary guidance for research with this highly mobile neuroimaging.
In Aim #2 we will examine governance of highly portable MRI as a direct-to-consumer (DTC) technology. The ethics, norms, and legal rules governing DTC biomedical analyses are in development in the United States. Highly portable MRI creates an urgent need to anticipate the DTC use cases and develop standards to address quality of analyses, informational and procedure safety issues, accurate representation of the DTC technology, interpretive challenges, and individual data privacy and management. Because highly portable MRI will expand the diversity of research participant populations, we will give special attention in both Aims to the challenge of neuroimaging interpretation when the interpretive algorithms may be derived from the brain data of research populations that are not culturally or socioeconomically diverse. To accomplish these aims, we will hold regular meetings with parent project personnel, and at the all- hands meeting of the parent grant in October 2018, we will devote meeting time to exploring the neuroethics issues and developing use cases with the full parent project research team. Then, in February 2019, we will make a presentation to the senior leadership of the parent project for interdisciplinary feedback. This continuous two-way communication with senior personnel in the parent U01 grant will help to ensure that our neuroethics analysis is based in realistic use cases and benefits from parent project feedback. It will also ensure that highly portable MRI is developed with attention to the ethical and legal issues. This supplement project will produce multiple publications mapping the core ethical and legal issues and proposing solutions.
This supplement seeks funds to integrate neuroethics senior personnel into our development of highly portable MRI, a high-impact emerging technology raising major ethical and legal issues. These senior personnel will work collaboratively to examine, in the portable MRI context: (1) returning individual-specific research results (IRRs) and incidental findings (IFs) to research participants as well as participant access to data; and (2) ethical as well as legal governance of highly portable MRI as a direct-to-consumer technology. At present the parent U01 grant has no ethicists embedded. In order to address these core ethical and legal issues, additional expertise is necessary.
| Garwood, Michael; U?urbil, Kamil (2018) RF pulse methods for use with surface coils: Frequency-modulated pulses and parallel transmission. J Magn Reson 291:84-93 |
