The NIH BRAIN Initiative has been ongoing since 2013. The Initiative “is aimed at revolutionizing our understanding of the human brain” through the “development and application of innovative technologies” to deepen our understandings of how the brain and neural circuits interact in health and disease (The BRAIN Initiative, NIH, 2021).
Data sharing is essential to promote equity and maximize the impact of the significant public investment in the BRAIN Initiative. Data sharing plans are now required for BRAIN funding, but there is an urgent need to develop specific policies and practices that are empirically informed and address ethical challenges and concerns related to sharing human data from BRAIN research. Our own experience and research with investigators conducting BRAIN Initiative studies of closed loop or adaptive deep brain stimulation, for instance, suggests that the practice of sharing data is inconsistent and incomplete, despite broad agreement that it is important. Some ethical challenges relate to privacy, consent, the interoperability of data types and sharing platforms, and competing commercial and processional interests.
The specific objectives of BRAINshare: Sharing Data in BRAIN Initiative Studies are to engage key stakeholders in a deliberative process to identify challenges and concerns specific to sharing human data from the BRAIN Initiative and to generate empirically informed policy and practice options to facilitate responsible sharing of this data.
- In Aim 1, we will use informational interviews and document analysis to identify BRAIN Initiative-specific data-sharing challenges, as well as relevant policy and practice considerations.
- In Aim 2, we will use semi-structured interviews and surveys to evaluate BRAIN Initiative research participants’ attitudes, preferences, and concerns about data sharing and brain privacy.
- In Aim 3, we will employ a modified policy Delphi process with diverse stakeholders to prioritize challenges and generate and evaluate policy and practice options that address high-priority challenges.
The long-term goals of this research program are to develop, test, and disseminate strategies to improve data sharing in biomedical research associated with human neuroscience. The overall objective of this project is to apply our combined expertise in neuroscience, neuroethics, social science, law, and science policy to identify challenges and concerns and generate empirically informed policy and practice options that facilitate responsible data sharing within the NIH BRAIN Initiative.
Supported by: R01MH126937, Grant funding from BRAIN Initiative - National Institute of Mental Health of the National Institutes of Health
Project Personnel
- Amy McGuire, J.D., Ph.D., Co-Principal Investigator
- Sameer Sheth, M.D., Ph.D., Co-Principal Investigator
- Christi Guerrini, J.D., M.P.H., Co-Investigator
- Gabriel Lázaro-Muñoz, J.D., Ph.D., M.B.E., Co-Investigator (Harvard Medical School, Center for Bioethics)
- Mary Anderlik Majumder, J.D., Ph.D., Co-Investigator
- Robert Cook-Deegan, M.D., Co-Investigator (Arizona State University, School for the Future of Innovation in Society)
- Vaso Rahimzadeh, Ph.D.
- Mary Anderlik Majumder, J.D., Ph.D.
Presentations
Sharing Data: Speedbumps on the Translation Trail. ELSIcon2022: Innovating for a Just and Equitable Future. Cook-Deegan R, Maxson Jones K, Rahimzadeh V, Spector-Bagdady K (2022).
The Montreal Neurological Institute: A case study in “open” neuroscience. The BRAIN Initiative Meeting. Skvarkova Z, Maxson Jones K, Robinson J, McGuire A, Sheth S, Cook-Deegan R (2022).
Paving the Way to a More Interconnected Community of BRAINs. The BRAIN Initiative Meeting. Iyer S, Maxson Jones K, Robinson J, Cook-Deegan R, Guerrini C, Lázaro-Muñoz G, Majumder M, Sheth S, McGuire A (2022).
BRAINshare: Sharing Data in BRAIN Initiative Studies. The BRAIN Initiative Meeting. Maxson Jones K, Robinson J, Cook-Deegan R, Guerrini C, Lázaro-Muñoz G, Majumder M, Sheth S, McGuire A (2022).
Data Sharing Challenges in Academic-Industry Collaborations in the BRAIN Initiative. The BRAIN Initiative Meeting. Noor I, Maxson Jones K, Robinson J, Cook-Deegan R, Guerrini C, Lázaro-Muñoz G, Majumder M, Sheth S, McGuire A (2022).
Publications
Rahimzadeh V, Jones KM, Majumder MA, et al. Benefits of sharing neurophysiology data from the BRAIN Initiative Research Opportunities in Humans Consortium [published online ahead of print, 2023 Nov 3]. Neuron. 2023;S0896-6273(23)00717-1. doi:10.1016/j.neuron.2023.09.029
Supplement: A Case Study on Autism in Data Sharing Practices
Project Description
This one-year supplement project aims to conduct a case study on ethical data sharing challenges in autism research and how to address data sharing practices that lack diversity, equity, and inclusion considerations. Data will be collected through a literature review and in-depth interviews with diverse stakeholders to explore challenges and potential solutions to address such ethical and policy challenges in data sharing. This case study will serve as an additional research input that informs the ongoing Delphi process in the BRAINshare Project’s Aim 3 and shapes the Project’s broader policy recommendations.
Supported by: R01MH126937-03S1, National Institute of Mental Health, NIH, Research Supplement to Promote Diversity in Health-Related Research Program
Project team: Zuzana Skvarkova (Arizona State University), Robert Cook-Deegan (Arizona State University, co-mentor) and Amy McGuire (co-mentor)
