The “Internet of Things” and Clinical Research: Privacy, Security, and Ethical Aspects

Drug Discovery & Development, Healthcare, Life Sciences, Pharmaceutical,
  • Monday, September 28, 2015

WELCOME to Chesapeake IRB’s 2015 Advancing Thought in Clinical Research series. We have collected remarkable speakers who work, teach and conduct research around the globe. Their perspectives will be apparent. You are invited to come, listen and participate in the discussion and discovery of pathways that accelerate the research process. Creating excellence is our vision. Your presence and support help define it. Please join us!

The “Internet of Things” is a vision of the future where connected devices interact directly with other devices and database data, without any help from us. Its impact is already being felt as our ability to connect just about anything and gather attendant data grows at a dramatic rate. The Internet of Things (IoT) promises the power to transform healthcare, change how we detect and diagnose conditions, help create a larger pool of patients for clinical trials, speed enrollment, improve informed consent, and foster better care over the long run. It includes the combination of sensors, actuators, distributed computing power, and wireless communication on the hardware side, and applications and big data/analytics on the software side. The IoT is a cross-disciplinary effort involving sensor networking, data management and the internet.

The basic vision of IofT is that objects present in everyday life can be equipped with sensors which can track useful information. Attached to the internet, the information can flow through the same protocol that connects our computers to the internet. These uniquely identified internet-connected objects can sense whatever they are directed to, and communicate it – enabling collection and analysis of data in an unprecedented flow and volume.

These objects simultaneously producing data in an automated way dwarf the amount of information which individuals can enter manually. Constrained by time, physical limits, inaccurate self-reporting, and transcription errors, humans simply cannot keep up. For example, sensor chips can be implanted in patients to capture vital signs and other data and wirelessly transmit it to central databases (including research databases for clinical trials). Proteus’ smart ingestible pill can now monitor whether or not a patient has taken their medication and measure adherence. Consolidated with other patient health information, big data analytical algorithms monitor patient health in real-time. This is useful in automating monitoring of patients with heart or Alzheimer’s conditions, and in assisted living, emergency response and health monitoring applications. It is revolutionary to clinical research, ethics and policy.

Enabling secure, remote real-time access to patient data is becoming increasingly critical. The IoT has become a meaningful opportunity for pharmaceutical companies to lower costs and accelerate clinical trials. It can help identify patients whose conditional are worsening or who are developing unexpected side effects, enabling earlier and more accurate detection of safety issues. Connected devices can identify patients with poor treatment adherence, ease logistics, and accelerate subject recruitment. Pharmaceutical companies and CROs have begun cutting cost and optimizing process with such connected devices and streamlined data collection tools, and leveraging collected data for concurrent use or future clinical trials.

Along with the potential advantages and benefits of the IoT, there are complexities and barriers to adoption. The data collected are so vast and often sensitive that its collection introduces new ethical considerations. The fact that this vast quantity data not only answers our questions but also organizes itself to reveal unanticipated important questions and correlations pushes the limits of current policy and requires us to examine regulation that could limit its potential. This program will provide an important overview of the impacts and issues involved in leveraging the IoT within healthcare and clinical research in particular.


Eric Meslin, PhD, Director of the Indiana University Center for Bioethics, Dean for Bioethics, Indiana University School of Medicine

Eric M. Meslin is founding Director of the Indiana University Center for Bioethics. He is also Associate Dean for Bioethics in the Indiana University School of Medicine, and is Professor of Medicine; of Medical & Molecular Genetics; of Bioethics and Law; and of Philosophy. His other leadership positions include directing the Indiana University-Moi University Academic Research Ethics Partnership, an NIH-funded bioethics training program in Eldoret, Kenya; the Bioethics and Subject Advocacy Program of the Indiana Clinical and Translational Science Institute; and co-directs the Indiana University Center for Law, Ethics and Applied Research in Health Information (CLEAR).
Born in Canada, Dr. Meslin received his B.A. from York University (Toronto), and his M.A. and Ph.D. from Georgetown University. He was director of bioethics research for the ELSI program at the National Human Genome Research Institute (1996-98), and Executive Director of the U.S. National Bioethics Advisory Commission (1998-2001) appointed by President Bill Clinton.

Dr. Meslin has more than 150 published articles and book chapters on various topics in bioethics and science and is a co-editor of the Cambridge University Press Bioethics and Law Series. He has been a member of several boards and including the Institute of Medicine’s Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs; the Ethics Subcommittee to the Director of the U.S. Centers for Disease Control and Prevention; and the Board of Directors of Genome Canada.

On May 9, 2007 he was appointed a Chevalier de L’Order Nationale du Mérite (Knight of the National Order of Merit) by the French Ambassador to the United States for contributions to French bioethics policy.

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Jennifer Covich Bordenick, Co-Chair of the Federal HIT Policy Committee’s Strategy and Innovation Workgroup, CEO of eHealth Initiative

For over 20 years, Jennifer has focused on quality and innovative technology solutions to transform healthcare. She is co-chair of the Federal HIT Policy Committee’s Strategy and Innovation Workgroup; member of the Health Level Seven International (HL7) Advisory Council (providing framework and related standards for the exchange, integration, sharing, and retrieval of eHealth information); and member of the Diabetes Collaborative Stakeholder Panel.
Ms. Covich is CEO of eHealth Initiative which provides leadership for research, education and advocacy for innovative solutions to improve healthcare through information and technology. She works closely with executives from across the spectrum of healthcare, leading a coalition of 200 influential organizations. Her focus areas include improving health and wellness through innovative solutions; interoperability; accountable care; data exchange; privacy/security issues; and tech tools for chronic care.

Prior to joining eHI, Ms. Covich headed up the strategic marketing at OpenNetworks, Inc., focusing on security solutions for the healthcare industry. She led healthcare industry relations at MicroStrategy, Inc., focusing on data-mining solutions for the Pharmaceutical and healthcare industry. She spent four years at the National Committee for Quality Assurance as Director of Policy and Product Development, helping develop national quality standards for healthcare organizations. Jennifer began her career at the George Washington University Hospital, Medical Center and Health Plan working on quality management initiatives and healthcare administration. Ms. Covich earned a Master’s degree in Human Resource Development, completed coursework in health administration doctoral program at George Washington University in Washington DC.

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Marvin Slepian, MD, Co-Founder and Chief Scientific Officer of SynCardia Systems Inc., Founder and Director of The Arizona Center for Accelerated Biomedical Innovation

Marvin J. Slepian, M.D. is the Co-Founder and Chief Scientific Officer of SynCardia Systems Inc., the owner and manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart. He is the Founder and Director of ACABI – The Arizona Center for Accelerated Biomedical Innovation. He is a McGuire Scholar, Eller College of Management and a Professor of Medicine (Cardiology), Director of Interventional Cardiology and Director of the Tissue Engineering Lab at the University of Arizona.
Dr. Slepian has founded numerous medical device companies, including Focal (NASDAQ-traded, acquired by Genzyme), Endotex, Angiotrax and Hansen Medical, and has served as acting CEO and Board Member of several medical device startups. He is also Senior Strategic Adviser for Apurba Technologies Inc., a software development company that creates enterprise data solutions for data processing, visualization and analytics.

Dr. Slepian has conducted extensive research, development and pre-clinical investigation of novel cardiovascular therapeutic methods and devices, and is the holder of more than 25 issued and 41 filed patents. He is an expert in polymeric biomaterials and local drug delivery, and has also helped develop a new class of small, high-performance electronics that are biodegradable and capable of dissolving completely in water or bodily fluids. The applications most promising for this transient technology are medical implants, consumer electronics and environmental monitors.

He earned his A.B. in Biochemical Sciences and Science in Human Affairs from Princeton University, and his M.D. from the University of Cincinnati College of Medicine. Dr. Slepian completed his Internal Medicine training at NYU-Bellevue in New York where he was a Resident and Chief Resident in Medicine. He completed his Cardiology training at Johns Hopkins where he was a Clinical and Research Fellow. He completed a second fellowship in Interventional Cardiology at Cleveland Clinic. He has received additional post-doctoral training at MIT and Washington University.

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Megan Doerr, MS, CGC, Principal Scientist, Governance Team, Sage Bionetworks

Megan Doerr, MS, CGC, is Principal Scientist with The Sage Bionetworks Governance team. Sage Bionetworks is a non-profit bioinformatics research organization focused on promoting innovative, open and collaborative science leveraging big data to improve human health. Sage’s Governance team generated the open-source Participant-Centered Consent (PCC) toolkit for e-consent recently utilized with Apple’s new ResearchKit and works with legal, ethical, and regulatory experts to develop and implement the policies and procedures for appropriate data access and sharing on Sage’s collaborative data platforms – including managing data captured from studies conducted through mobile technology platforms.
Prior to joining Sage Bionetworks, Ms. Doerr served as clinical lead for the development and use of Cleveland Clinic’s electronic family health history gathering tool. She received her undergraduate degree from the University of Vermont and her graduate degree in genetic counseling from Case Western Reserve University.

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Ellen Kelso, Executive Director Strategic Development, Chesapeake IRB

Ellen Kelso has more than thirty-five years of experience in the Pharmaceutical industry and currently serves Chesapeake IRB as Executive Director Strategic Development. Prior to Chesapeake IRB, Ms. Kelso founded Goodwyn IRB and served for 15 years as Managing Member and Chief Executive Officer.
Ms. Kelso began her career with Eli Lilly and served the Pharmaceutical industry in clinical operations and both domestic and international regulatory affairs. Her experience includes leading project teams through development, production and approval of New Drug Applications (NDAs), managing worldwide regulatory strategies, establishing electronic publication, and document management and regulatory compliance processes. She has also successfully combined the expertise of academic and industry professionals to create best practices and leverage technology to enhance ethical review and human subject protections.

She serves on the Steering Committee of the public-private Clinical Trials Transformation Initiative to identify and promote practices that will increase the quality and efficiency of clinical trials, and the Drug Information Association Program Planning Committee. Ms. Kelso holds a BS degree in Microbiology and Molecular Biology from Indiana University and also has completed numerous professional and management training and development programs.

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Innovation is occurring at lightning speed. Because there can never be too many people working to create excellence, Chesapeake IRB is sponsoring a forum for discussion on ethical issues in research, inviting all to the table – experts and lay people. Our Advancing Thought in Clinical Research series invites your active engagement in thoughtful discussions contributing to the discovery of consistent and coherent practices.

Chesapeake IRB provides ethical review and oversight of studies involving human research subjects in the U.S. and Canada. Since 1993, we have been at the forefront of human research protection for all types of research. By leveraging the expertise of bioethicists, leading therapeutic area clinicians, experienced academic and industry researchers, and research participants with our strategic and effective use of technology, Chesapeake IRB keeps research moving forward as quickly as possible.

Chesapeake IRB fosters innovation through our capability to apply ethical principles to revolutionary and disruptive research. We work with our partners to optimize resources and accelerate clinical development. Our agility optimizes your ability to identify risks and take early strategic actions to maximize success.

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