Agency Assessment of Ethical, Legal, and Societal Implications of Neuroscience and Technology Research and Its Relationship to the Presidential BRAIN Initiative
Creators: name: Zafar, Sahar
Publisher: name: Maryland Shared Open Access Repository
Year: 2017
Subjects: Research and Development
Federal Agency Funding
BRAIN Initiative
Presidential Initiatives
Communication -- Moral and ethical aspects
Biology, Neuroscience (0317)
Ethical, Legal and Societal Implications

description: In this study, I examined the societal views for neuroscience and technology research (neuro S&amp;T), as reflected through interviews conducted with agency personnel and researchers.  Thus, the aim of the study was to address the ethical and legal questions surrounding neuro S&amp;T research by interviewing agency leaders and the scientific community, reviewing data from public surveys, and analyzing research and development funding allocations (specific to the BRAIN initiative), in order to better understand the influence of Presidential initiatives on agencies, the resulting science and technology outputs, and the effect these have on the general public.
Consequently, this study was divided into three parts, (I) agency and researcher interview, (II) review of public survey data on neuro S&amp;T, and (III) archival analysis of research and development funding specific to the BRAIN initiative for FY 2014, 2015 and 2016.  The two programs chosen from NIH were (1) Next Generation Human Imaging and (2) Next Generation Human Invasive Devices. The two programs chosen from DARPA were (1) Hand Proprioception and Touch Interfaces (HAPTIX) and (2) Electrical Prescriptions (ElectRx).
Through collection and analysis of the data in this study, our findings were able to address the central research question of this study, of how agencies that follow the Presidential BRAIN initiative address ethical, legal and societal views on neuro S&amp;T research.  Both agencies, DARPA and NIH, utilize internal and external mechanisms to control for potential risks associated with the funded research.  The external boards, such as the ELSI panel used by DARPA and the NWG panel used by NIH, have members that are experts in all fields of neuroscience, as well as outside experts that provide a worldview of society and the impacts of these technologies.  There are several different levels of oversight and internal and external review of all aspects of the research study.  These mechanisms ensure all research is conducted with the highest ethical standards and minimizes all risks associated with the research. Researchers and agency personnel incorporate the recommendations from these experts in their programs to ensure safe distribution and use by the public upon release of these technologies. 
At the beginning of this study, we chose to explore how DARPA and NIH, two agencies that are so vastly different in their mission, vision, and structure along with Federal alignment (which changes the policies and guidelines they have to adhere to for ethical and legal issues; DARPA/DoD and NIH/DHHS), choose to participate in the BRAIN initiative. Through analysis of the data (H1), we saw that choosing to participate in the BRAIN initiative aligned with DARPA’s and NIH’s structure, mission, and vision. While we deduced, the responses should be very different due to the two agencies being completely different from each other, it seems in following the BRAIN initiative funding for extramural research, specifically neuro S&amp;T research that can be translated into public use, DARPA and NIH follow a very similar path.  However, H1 was rejected, due to the responses gathered after change in the Presidential administration.  The responses showed no change in how agencies were participating or funding the BRAIN initiative.  Therefore, it was concluded that based on data gathered to date, Presidential administration does not influence an agencies participation in an initiative. 
Through analysis of the interviews by the agency personnel and researchers (H2), we were able to see how agencies and researchers, find and resolve ethical and legal issues surrounding neuro S&amp;T research, and weigh them based on the needs of the society.  They use internal and external subject matter experts, cost-benefit analysis, risk-reducing strategies, oversight of data safety monitoring boards, and IRBs to ensure work occurs with the highest ethical standards.  We saw that agencies and researchers are utilizing both internal and external aid to figure out and address all possible issues relating to neuro S&amp;T.  Public outreach programs to include open call meetings and webinars are being held by Neuroethics groups.  These outreach programs through agencies have potential to influence the outlook of the public and decrease their apprehension on the use of these technologies. 
Communication between stakeholders and timely addressing of issues (such as continual access to treatment and care, post-trial obligations, responsible conduct, etc.) through policies, can lead to an increase in the public trust in these technologies. This study made it clear that agencies and researchers are very cautious about funding neuro S&amp;T research.  They have set up several checks and balances within agencies and research institutes to ensure all funded research occurs with the highest ethical and legal standards and increases the positive societal impact of these technologies.  Since most of these devices are currently in their novice stages of development, their full impact on society will not be known until full deployment into society.  Therefore, careful consideration into policies that address and place emphasis on the “human values” will ensure a positive impact on the society, as well as implementing Presidential initiatives.