Brain devices: Navigating collaborations between industry, government, and researchers

by Paul J. Ford, PhD



Dr. Ford is Director of the NeuroEthics Program at the Cleveland Clinic. He is an active clinical ethicist, and teaches ethics to medical students, residents, and fellows. His publications have appeared in Science, The Hastings Center Report, Neurology, Neuromodulation, and Journal of Medical Ethics. He is also a board member for AJOB Neuroscience.



This spring (June 3-4, 2015) the National Institutes of Health (NIH) as part of the BRAIN Initiative convened an eclectic group of individuals in hopes of encouraging more investigator initiated studies of currently approved neuromodulation and neuro recording devices for new indications (agenda, session videos, and program goals available here). The participants, both on the program and in the audience, specifically included industry, researchers, universities, and governmental agencies. I was delighted to participate in the workshop and was impressed by the number of sincerely interested parties across the spectrum of roles. Within these conversations it was apparent that there existed many shared values and goals as well as complex challenges for protecting particular interests. It beautifully highlighted the complexities of interactions among varied stakeholders.





Among the group there was a broad interest in performing due diligence in discharging their various duties to their constituents. At its heart, the meeting was a good faith effort to realize a desire to see innovations develop to the point of helping clinical populations, i.e. real people who suffer. This aspect of the BRAIN initiative recognizes the current significant logistical barriers to exploring new uses of existing devices within a research context. Too often the current system in the United States with respect to devices encourages off-label use with retrospective review data, rather than small prospective trials. There are numerous disincentives within the system, some of which are bureaucratic and legalistic in nature (see Kelly et al. discussion.) In developing new ways for investigators to create partnerships with industry, the June meeting announced opportunities that would allow easier access to letters for “right of reference” (a specific type of permission needed from intellectual property owners to allow use of previously submitted safety and engineering data. Kelly et al. discusses this further) as well as standardized intellectual property agreements as part of a streamline for some types of NIH funded research. In addition, the dialogue between industry, researchers, universities, regulators, and funders creates an opportunity to standardize approaches to some of the most difficult ethics challenges in brain implant research, such as long-term access to implant upgrades.



Much of the June meeting itself was dedicated to understanding the mechanisms for collaboration, addressing the challenges of negotiating intellectual property, as well as the need for further aggregation of data across research studies. However, the organizers also dedicated a session specifically to ethics, in which I participated as a panelist. The session included a brief presentation by Joseph Fins, MD followed by panel comments by Christine Grady, MSN, PhD, Scott Kim, MD, PhD, Helen Mayberg, MD, and me. A diverse set of practical ethical issues were addressed relating to both research ethics in general and specific ethical issues in neuromodulation. Scott Kim particularly highlighted the opportunity for neuroethics research that could be undertaken in parallel to the other science conducted during further neurological device studies. This model of integrating ethical investigation in tandem with the initial clinical research provides an opportunity to fully appreciate the research participants’ perspective.



A second session of particular interest to the neuroethics community was a presentation by a Public-Private enterprise, Medical Device Innovation Consortium (MDIC) developed in collaboration with the FDA. This organization “aims to advance regulatory science in the medical device industry.” In particular it has various industry, non-profit, and governmental members. This past spring, they released a report on a framework for use in demonstrating to the FDA whether a risk benefit balance is appropriate from a patient perspective (draft release May 2015). The FDA released a companion draft guideline regarding how patient preferences could be used in the approval process. These draft guidance documents provide an opportunity to include neuroethics research into clinical trials of neurological devices. Scott Kim’s comment regarding the need for rigorous methods to be applied in undertaking the type of ethics research nicely resonates with the intention of the MDIC document to provide guidance of methods.



The initiatives and conversations that occurred during this June 2015 meeting is well worth paying attention to for their long reaching implications on how neurological device research is approached and the ethics opportunities that are available.



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Ford, P.J (2015). Brain devices: Navigating collaborations between industry, government, and researchers. The Neuroethics Blog. Retrieved on , from http://www.theneuroethicsblog.com/2015/09/brain-devices-navigating-collaborations.html