Diversity, Equity, and Inclusion
2020 Advancing Ethical Research Conference
Forms and Dues
Board of Directors
Natalie L. Mays is the Chair of PRIM&R's Board of Directors having served as a member of the board since 2016. In addition, she is the Director of the New York University Grossman School of Medicine's Division of IACUC and IBC Administration. After receiving a Bachelor of Arts degree in microbiology from Miami University in Oxford, OH, Natalie worked at multiple Northeast Ohio academic research institutions including Case Western Reserve University and Cleveland Clinic. While at these institutions, Natalie worked in various roles including research assistant, research technologist, administrative manager, and training/compliance coordinator. Along the way, Natalie obtained AALAS certification at the LATG level and graduated from AALAS’ Institute for Laboratory Animal Management. Prior to joining the team at the NYU Grossman School of Medicine, Natalie was the IACUC Director at Columbia University/Columbia University Medical Center where she obtained a PRIM&R CPIA certification. Natalie's professional activities included membership on multiple IACUCs and IBCs, charter membership on PRIM&R's Diversity Advisory Group and Animal Care and Use Advisory Group and Co-Chair of annual PRIM&R IACUC conferences from 2016-2018. Recently, she was appointed as a member of a newly created committee overseen by NYU Langone Health’s Workplace Culture and Inclusion Department. This committee will create an affinity group for Black employees and their allies designed to increase cultural awareness throughout the institutional network and influence recruitment of underrepresented individuals.
Dr. Suzanne Rivera is the President of Macalester College in Saint Paul, Minnesota. She also is a Professor of Public Affairs, and her scholarly work focuses on research ethics and science policy. Previously, she served as Vice President for Research and Technology Management at Case Western Reserve University in Cleveland, Ohio, where she also was a faculty member in the Department of Bioethics at the CWRU School of Medicine. Dr. Rivera served on the US Department of Health and Human Services Secretary's Advisory Committee on Human Research Protections (SACHRP) and the Environmental Protection Agency's Human Studies Review Board (HSRB). In addition to writing numerous journal articles and book chapters, Rivera co-edited the book Specimen Science, published by MIT press in 2017. She has served as Principal Investigator or Co-PI on grants from the NIH, the NSF, the DHHS Office of Research Integrity, and the Cleveland Foundation. Dr. Rivera received a Bachelor of Arts degree in American Civilization from Brown University, a Master's degree in social welfare from the University of California-Berkeley, and a doctoral degree in public policy from the University of Texas.
Martha F. Jones, MA, CIP, is executive director of the Human Research Protection Office (HRPO) at Washington University in St. Louis (WUSTL). Nationally, Ms. Jones is a member of the PRIM&R Board, the Council on Governmental Relations (COGR) Research and Regulatory Reform Subcommittee, the SMART IRB Harmonization Steering Committee, and co-leads the National Comprehensive Cancer Centers (NCCN) IRB Directors group. She is Vice Chair of the Association for the Accreditation of Human Research Protection Programs (AAAHRP) Council, and a site visit team leader. In 2017, Ms. Jones received the AAHRPP Distinguished Team Leader Award. At WUSTL, Ms. Jones serves as a member of the IRB, the Data Policy Committee, the CTSA Clinical Trials Task Force, the EPIC implementation team, the OnCore Steering Committee, and the Research Administration IT Governance Group. Ms. Jones co-developed the IRB data management system, "myIRB," which is currently used at The University of Iowa and WUSTL, and continues to lead the WUSTL IT development team. She has a background in clinical research ethics, epidemiology, biostatistics, speech pathology, audiology, public health, and the coordination of multicenter research studies.
Owen Garrick, MD, MBA, is president and chief operating officer of Bridge Clinical Research. At Bridge Clinical, Dr. Garrick has overall responsibility for the Clinical Trials, Health Services Research, and Healthcare Communications business units. Bridge Clinical is a global private equity-backed contract research and health communications firm focused on drug development, scientific advancement, and patient engagement. It is active in multiple therapeutic areas including anti-infectives, autoimmune, cardiovascular disease, endocrinology, and oncology. Since 2009, therapies that it has helped develop have generated more than $6 billion in revenues. In addition to profit and loss responsibility for the business units, Dr. Garrick has oversight of all financial, administrative, and legal aspects of the company, and serves on the Board of Directors as corporate secretary. He has led Bridge Clinical's expansion into multiple therapeutic areas, launched the public relations arm, and represents Bridge Clinical at the US Food and Drug Administration. Previous to assuming this position in 2009, Dr. Garrick was chief financial officer for its predecessor company.
Prior to joining Bridge Clinical, Dr. Garrick was director of strategy and business development at McKesson Corporation which delivers pharmaceuticals, medical supplies, and health care information technologies. Some of his key accomplishments included the $450M acquisition of D&K Healthcare which involved due diligence, negotiations, and FTC clearances. He also led the launch of McKesson's Generic Drugs Telesales Business Unit, the development and launch of McKesson's Drug Adherence Business, and the expansion of the pharmaceutical packaging business.
Before joining McKesson, Dr. Garrick was global head of M&A negotiations at Novartis Pharmaceuticals. In this position he oversaw small and medium sized company acquisitions, equity/license right deals, mature product divestments, and venture investments in biotechnology companies. While at Novartis, he pioneered the contingent payment deal structure with the $465 million acquisition of Idenix Pharmaceuticals which launched Novartis' Anti-Infectives business unit. This structure has become an industry standard tool in life sciences deals.
Dr. Garrick's experience also includes positions at Goldman Sachs as an investment advisor working with private healthcare companies as they sought to grow, raise capital, and perform initial public offerings, and Merck & Company, where he authored the first commercial analysis of Human Papillomma Virus vaccine (Gardasil) which has had peak sales of $1.6 billion.
Dr. Garrick earned his MD from Yale School of Medicine and his MBA from Wharton School of Business. He holds an AB in Psychology from Princeton University and continues to be an active alumnus currently serving on the Executive Committee of the Alumni Council, which represents the 80,000 member alumni body. Dr. Garrick also serves on the boards of the $6BN Bay Area Division of Sutter Health, Quorum Review IRB where he chairs the Compensation Committee, and the New York Blood Center where he serves on the M&A Committee. He is also vice chair of the Board of Regents of Samuel Merritt University. Previously, he served on the board of the American Medical Association Foundation where he was Board president and Context Matters Inc., a venture backed health economics company where he was co-founder. These entities have shown double digit annual growth during his involvement. He was confirmed as a member of the Department of Health and Human Services Advisory Council on Human Research Protections in 2012. He has co-authored industry advisory documents around biospecimen data security and patient engagement in research. Dr. Garrick resides in Oakland, California with his wife and their three sons. He joined the PRIM&R Board in 2017 and is a member of the Finance Committee, the Audit Sub-committee, and the Diversity Advisory Group.
Albert J. "A.J." Allen, MD, PhD, is currently a senior medical fellow in the Medicines Development Unit at Eli Lilly and Company, where he is the medical lead for pediatric drug development efforts across all therapeutic areas.
A native of Iowa, Dr. Allen received an SB in chemistry and an MS in biochemistry from the University of Chicago in 1980, followed by an MD and PhD in pharmacology from the University of Iowa in 1988. From 1988 to 1995 he completed residencies in psychiatry and child psychiatry at Iowa, and a research fellowship in child psychiatry at the National Institute of Mental Health (NIMH). In 1995, he joined the faculty of the Institute for Juvenile Research, Division of Child Psychiatry at the University of Illinois at Chicago (UIC). Dr. Allen was introduced to research ethics through his research at NIMH and his membership on one of UIC's IRBs. He received an additional "crash course" when OHRP suspended UIC's FWA in the late 1990s due to lack of adequate support from the university.
In 2000, he joined the global development organization at Lilly to work on Strattera (atomoxetine HCl, an ADHD medication). He was the global medical director/senior medical director for Strattera from early 2004 until early 2011; during much of this time his responsibilities also included global development efforts for a number of additional neuroscience products and indications. Since 2011, Dr. Allen has been the medical lead for Lilly's pediatric drug development efforts, as well as having a number of other duties. From 2011 to 2013 he was the chair of Lilly's Bioethics Advisory Committee. He continues as a member. From 2011 to 2015 he was a member of SACHRP and SACHRP's Subcommittee on Harmonization (SoH), and he continues to be a member of SoH. A.J. is also a member of the ethics committee of the American Academy of child and Adolescent Psychiatry.
In 2013 Dr. Allen was diagnosed with an early, stage 1 multiple myeloma for which he underwent a course of chemotherapy and an autologous stem cell transplant. Currently in remission, his experiences and perspective as a patient have influenced his views on clinical research and bioethics.
Dr. Allen considers himself primarily a child psychiatrist and pharmacologist, as well as a pediatric drug development expert, but he also has a number of professional hobbies (meaning he has limited or no formal training in them), which include bioethics, health policy, medical economics and patient advocacy.
For Dr. Allen, bioethics is critical to enabling research subjects to feel they are treated fairly, respected and protected, whatever the research setting and the funding source(s), and to instilling public trust in all research involving humans.
Joining PRIM&R's Board of Directors in 2016, Dr. Allen also serves as Co-Chair of PRIM&R’s Public Policy Committee and member of the Nominations & Elections Committee.
Elizabeth Buchanan, PhD, is Director of the Office of Research Support Services and Staff Senior Research Scientist at the Marshfield Clinic Research Institute in Marshfield Wisconsin. Dr. Buchannan earned a Doctor of Philosophy (Ethics and Information Transfer) in 1999 and a Master of Information Science in 1996 at the University of Wisconsin-Milwaukee. She was Associate Professor in the UWM School of Information Studies until 2011. Most recently, Dr. Buchanan was the Endowed Chair in Ethics and Director of the Office of Research and Sponsored Programs at the University of Wisconsin-Stout. In her role she oversaw RCR, IRB, IACUC, grants, contracts, agreements, and student research initiatives.
Dr. Buchanan’s scholarship focuses on the intersections of ethics, regulations, and research. She has written numerous articles and has presented her work on research ethics boards and Internet research, social media, and big data, across a wide range of journals and venues. Dr. Buchanan was a primary co-author to the 2012 Association of Internet Researchers Ethics Guidelines and to the 2013 Secretary’s Advisory Committee on Human Research Ethics Considerations and Recommendations Concerning Internet Research and Human Subjects Regulations. She is a frequent speaker at the PRIM&R Advancing Ethical Research conferences, and also conference co-chair (2018-2020); she’s keynoted frequently to agencies such as NIST and NIH, as well as many universities across the United States and internationally. She has been on the faculty for the Fordham University’s Research Ethics Training Institute since 2019.
Dr. Buchanan’s research has been supported by such sponsors as the National Science Foundation, Fulbright, Welcomme Trust, and many institutional and UW system awards.
She serves on the Board of Directors, Public Responsibility in Medicine and Research (PRIM&R) (2016-2021) and on the Board of Directors for the Open Door Clinic, a community resource in Chippewa Falls, Wisconsin. She previously served on the American Association for the Advancement of Science’s (AAAS) Committee on Scientific Freedom and Responsibility (2013-2017), where she contributed to the 2017 Statement on Scientific Freedom and Responsibility. She is a frequent panelist for grant reviews, and a consultant for Advarra and HRP.
Bruce Gordon is Assistant Vice-Chancellor for Regulatory Affairs, and Professor of Pediatrics in the Division of Pediatric Hematology/Oncology at the University of Nebraska Medical Center (UNMC). Dr. Gordon has been a member of the UNMC institutional review board since 1992, served as chair since 1996, and as executive chair since 2011. He has served on a variety of national committees and task forces, including the Secretary's Advisory Committee on Human Research Protections Subpart A Subcommittee, the American Society of Clinical Oncology Task Force on Oversight of Clinical Research, the NIH Regulatory Burden Advisory Group Human Research Subcommittee, the AAMC Informed Consent Working Group, and the National Institute of Environmental Health Sciences (NIEHS) Best Practices Working Group for IRB Review of Disaster and Emergency Related Public Health Research. He was the first chair of the National Cancer Institute Pediatric Central IRB.
Dr. Gordon has been a faculty member at every ARENA/PRIMR national meeting since 2002, and was the co-chair for the 2009 AER Conference. He is an active participant in PRIMR's "At Your Doorstep" educational programs, including IRB 101, 200 and 250 programs.
He was co-developer of the Investigator Responsibility pre-conference workshop at the 2008 through 2011 annual meetings. He co-developed "Collaborating for Compliance" workshop, which has been presented as a stand-alone program since 2013. He co-developed an "IRB Chairs Boot Camp" program, which was presented at the 2014 and 2016 PRIMR AER meetings. He co-developed a "Vulnerable Subjects" program which was presented at the 2016 PRIMR AER meeting, and is currently part of the "At Your Doorstep" curriculum.
Dr. Gordon serves on the AAHRPP Council on Accreditation, and has been a faculty member at numerous AAHRPP conferences and a frequent AAHRPP site visitor. He is a founding member of the Collaborative Institutional Training Initiative (CITI) and served on the Executive Advisory Committee for the program. He is the author of two modules for the Human Subjects Research course. He co-developed a course related to research involving vulnerable subjects, and is the author of three modules for that course Dr. Gordon is the author of numerous original papers, chapters, review articles, and abstracts regarding human subjects protections and research ethics, and is the co-editor of the third edition of "IRB: Management and Function."
Dr. Gordon serves on the Governance Committee and the Nominations & Elections Committee.
Mary L. Gray, PhD is a Fellow at Harvard University’s Berkman Klein Center for Internet and Society and a Senior Researcher at Microsoft Research. She maintains a faculty position in the School of Informatics, Computing, and Engineering with affiliations in Anthropology, Gender Studies, and the Media School, at Indiana University. She trained in anthropology before earning her PhD in Communication from the University of California at San Diego in 2004, under the direction of sociologist Susan Leigh Star.
Mary’s research looks at how technology access, material conditions, and everyday uses of technologies transform people’s lives. Her most recent book, Ghost Work: How to Stop Silicon Valley from Building a New Global Underclass, co-authored with computer scientist Siddharth Suri, explores the lives of people paid to train artificial intelligence and, increasingly, serve as “humans in the loop” delivering on-demand services. Her other books include In Your Face: Stories from the Lives of Queer Youth, Queering the Countryside: New Directions in Rural Queer Studies, a Choice Academic Title for 2016, and Out in the Country: Youth, Media, and Queer Visibility in Rural America, which explored how young people in the rural United States use the Internet to craft their identities, local belonging, and connections to broader queer communities.
Mary is a leading expert in the emerging field of AI and ethics, particularly research methods at the intersections of computer and social sciences. She sits on the editorial boards of Cultural Anthropology, Television and New Media, the International Journal of Communication, and Social Media + Society. Mary has also written for and been covered by popular press venues, including the Harvard Business Review, The Chronicle of Higher Education, The New York Times, Los Angeles Times, the Guardian, Nature, The Economist, and Forbes Magazine. She served on the Executive Board of the American Anthropological Association and was the Program Chair for the Association’s 113th Annual Meeting. Mary currently sits on the Executive Board of PRIM&R and Stanford University’s “One-Hundred-Year Study on Artificial Intelligence” (AI100) Standing Committee, commissioned to reflect on the future of AI and recommend directions for its policy implications.
Dr. F. Claire Hankenson is the director within Campus Animal Resources, and the attending veterinarian at Michigan State University in East Lansing, MI. In addition, she is a professor of laboratory animal medicine in the Department of Pathobiology and Diagnostic Investigation at the College of Veterinary Medicine. Dr. Hankenson obtained her veterinary degree from Purdue University. Following veterinary school, she completed her laboratory animal medicine residency and graduate work (MS, Microbiology) at the University of Washington, Seattle. She became a Diplomate of the American College of Laboratory Animal Medicine (ACLAM) in 2002. Dr. Hankenson's current position combines administrative service, regulatory input, clinical effort, and collaborative research. Dr. Hankenson has been active on committees within AALAS since 2002, serves on the Executive Board for ACLAM, currently as Immediate Past-President, and is an ad-hoc specialist with AAALAC. She has served on the PRIM&R Board since 2017 and currently is a member of the Finance Committee and and Public Policy Committee.
Karen Hansen served as Institutional Review Office Director at Fred Hutchinson Cancer Research Center for 31 years (1988-2019). Ms. Hansen was a co-founder of the Collaborative Institutional Training Initiative (CITI) in 2000. Since 2000, she has collaboratively organized and presented training seminars and conferences for regional, national and international IRB/Research Ethics Committee (REC) members, chairs and administrators. Ms. Hansen previously served as a site visitor and member of the Association for Accreditation of Human Research Protection Programs' Council on Accreditation. She also served as a co-leader on the Planning Committee for the National Comprehensive Cancer Network's IRB Directors Forum (2009-2019). Ms. Hansen currently serves as co-chair of PRIM&R's membership committee and also serves on the governance committee. She is also a member of CITI's External Advisory Board. Ms. Hansen has served on the PRIM&R Board since 2015.
Jori Leszczynski, DVM, DACLAM is currently the Director of the Office of Laboratory Animal Resources and University Veterinarian at the University of Colorado Denver, as well as an Associate Professor in the Department of Pathology in the School of Medicine. Dr. Leszczynski attended The Ohio State University for her Bachelors and Veterinary degrees and performed her residency in Laboratory Animal Medicine at the University of Illinois at Chicago. She became a Diplomate of the American College of Laboratory Animal Medicine in 2004. Throughout her career, she has held several other leadership roles in animal facilities including Associate Director at the Cleveland Clinic Foundation, Director and AV at National Jewish Health, and Interim Director and AV at the University of Colorado Boulder. In all of her positions, Dr. Leszczynski has focused on program compliance, personnel management, budget, husbandry, and clinical management of the species she oversees. Dr. Leszczynski has a history of service to many professional organizations including leadership roles for the American Society of Laboratory Animal Practitioners (ASLAP, Board of Directors and Membership Committee Chair), American Association for Laboratory Animal Science (AAALAS, Institute for Laboratory Animal Management Committee, Local Arrangements Chair for 2019 Denver AALAS National Meeting, President of the Mile High Branch AALAS), as well as committees for the American College of Laboratory Animal Medicine (ACLAM). Her roles with PRIM&R have included annual service on the IACUC Conference Planning Committee since 2013, including serving as Co-Chair from 2015 to 2018. She served as a member of the Animal Care and Use Advisory Group. Dr. Leszczynski joined the Board of Directors in 2019 and is a member of the Nominations and Elections Committee and the Finance Committee.
Holly Fernandez Lynch, JD, MBE, is the John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine, University of Pennsylvania. Her scholarly work focuses primarily on the ethics and regulation of research with human subjects and related areas, including payment to research participants, research with biospecimens, the use of social media in research settings, patient-engaged research, research risks to bystanders, access to investigational therapies (including “Right to Try”), and the quality of Institutional Review Board oversight of research. She is the author of Conflicts of Conscience in Health Care: An Institutional Compromise (MIT Press 2008), as well as the co-editor of seven books, covering human subjects research regulation; FDA regulation of drugs and new technologies; health law and behavioral economics; law, religion, and health; biospecimen research; big data, health law, and bioethics; and transparency in health care (forthcoming).
Professor Fernandez Lynch is the founder and co-chair of the Consortium to Advance Effective Research Ethics Oversight (AEREO), established in 2018. She served as member of the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) from 2014-2019, and she continues to serve on a SACHRP subcommittee. She has been co-investigator on projects examining issues related to improving recruitment to clinical trials, oversight of patient-centered outcomes research, and legal and ethical issues related to football player health.
Prior to joining Penn, Professor Fernandez Lynch was Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and Teaching Faculty in the Master of Bioethics program at Harvard Medical School. She has worked as an attorney in private practice focused on pharmaceuticals regulation and as a bioethicist at the NIH’s Division of AIDS and President Obama's Commission for the Study of Bioethical Issues. She attended college at Penn, was a Levy Scholar in Law and Bioethics at Penn Law, and earned a Master of Bioethics also from Penn. Professor Fernandez Lynch joined PRIM&R's Board of Directors in 2020 and serves on the Governance Committee.
Vickie M. Mays, PhD, MSPH is a Distinguished Professor in the UCLA Departments of Psychology and Health Policy and Management. She has served as an Assistant Vice Chancellor for Research Diversity, Chair of the Academic Faculty Senate, and Chair of the Undergraduate Council served on a number of ad hoc committees at UCLA as well as system-wide for the UC. She has a long-standing interest in the treatment of human subjects and ethical issues which stemmed from her work as one of the early HIV/AIDS researchers in the 80’s. This propelled her initial appointment and eventual service as the Vice Chair on the UCLA Human Protection of Subjects IRB.
Her research is shaped by underlying themes reflecting her interests in furthering empirically based research on underserved populations, particularly ethnic minority communities and women. Dr. Mays’ research team examines mental health disorders using large-scale datasets to determine the prevalence of types of disorders that are found in the racial/ethnic group with particular attention to gender.
In addition, Dr. Mays is the Director of the UCLA Center for Bridging Research Innovation, Training and Education on Minority Health Disparities Solutions. This NIH funded center is the source of the development of a curriculum designed to train racial/ethnic minority community members in ethical research principles in order to join the research workforce. The Center has developed a Mexican Spanish version of the CITI training at a seventh-grade reading level in order to make the training available to community members wanting to become involved in the interpretation and production of research data.
Dr. Mays has received a number of awards for her research including APA’s Distinguished Contributions for Research in Public Policy, the AMFAR Lifetime Research award for her women and HIV publications and a host of others.
Gianna “Gigi” McMillan, MA, D. Bioethics, is the Program Administrator for the Bioethics Institute at Loyola Marymount University in Los Angeles, where she manages the graduate and undergraduate academic curriculum and teaches Research Ethics. In 1996 she co-founded We Can, Pediatric Brain Tumor Network, a support network for families whose children have been diagnosed with brain cancer. This Los Angeles-based group evolved into a state-wide non-profit organization, serving hundreds of families each year. We Can became a national demonstration project, offering support to patients and family members – in Spanish and in English, until it became the California chapter of the Pediatric Brain Tumor Foundation of the United States in 2016. Dr. McMillan has been an advisor to the Children’s Brain Tumor Foundation, the National Brain Tumor Society, and the Pediatric Brain Tumor Consortium. She has extensive experience as a Subject/Patient Advocate on local and national IRBs, was a member of the Subpart A Subcommittee for the Secretary’s Advisory Committee on Human Research Protection, and is a patient representative on the FDA’s Pediatric Oncology Drug Advisory Committee. Dr. McMillan was a Student Director for the American Society for Bioethics and Humanities, has been a faculty member at PRIM&R since 2004, and is the Director of Community Engagement for the academic journal, Narrative Inquiry in Bioethics. Her primary interests are consent issues in clinical research and the use of narrative as an educational tool in bioethics. Dr. McMillan joined PRIM&R's Board of Directors in 2020 and serves on the Nomination & Election Committee.
Robert Nobles, DrPH, MPH, CIP serves as the Vice President for Research Administration at Emory University. Within Emory Nobles leads the 10 research administrative and compliance departments [Business Operations, Strategic Initiatives, Clinical Research, Conflict of Interest, Environmental Health and Safety, Institutional Animal Care and Use Committee, Institutional Review Board, Research Administration Services, Research Grants and Contracts, Sponsored Programs] with more than 300 team members providing outstanding services that catalyze research excellence. Daily, Nobles and team are responsible for providing the foundation for the research growth that Emory continues to experience while pursuing discovery. As an example of scope, in fiscal year 2018, Emory received $734 million in total research funding awards. Of the overall total, $440.8 million came from federal research funding awards, led by the National Institutes of Health with $359.2 million. Emory researchers submitted 4,410 proposals to sponsors totaling $1.197 billion in 2018.
As the Vice President for Research Administration, Nobles promotes Emory's research growth through oversight and execution of a strategic direction and effective operations for research enterprise wide. Nobles works in tandem with senior leaders and faculty to ensure proactive, user-focused customer service; effective, metric-driven processes; and transparent communication, to further new and on-going research initiatives that comply with all regulatory requirements. Nobles also fosters the scholarly work of faculty, facilitate multidisciplinary initiatives, support innovative technology-transfer and commercialization programs, and strives to increase funding support from all sources, while nurturing positive external relationships.
Stephen Rosenfeld is currently the President of Freeport Research Systems, LLC.
Dr. Rosenfeld is a hematologist who earned his medical degree from Cornell. He trained in internal medicine at Dartmouth and completed his hematology fellowship at the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH). He spent 19 years at NIH, holding positions at NHLBI and the NIH Clinical Center, doing both basic and clinical research, and finally working in medical informatics and administration. He ended his time at the NIH as the Chief Information Officer of the Clinical Center. Dr. Rosenfeld moved from Bethesda, Maryland to Portland, Maine, where he was the CIO of MaineHealth, a large independent delivery network, before moving to Olympia, Washington as the CEO of the Western Institutional Review Board (WIRB). In addition to his medical degree, he holds a Master's in Business Administration from Georgetown. Dr. Rosenfeld received the honor of Distinguished Professor of Medicine from Daegu Catholic University Medical Center in Korea in 2013. In July 2013, he was appointed to the Secretary's Advisory Committee on Human Research Protections (SACHRP) and in 2016 he was appointed Chair of SACHRP. In 2019 he joined the board of the Association for Accreditation of Human Research Protection Programs (AAHRPP), and is currently the vice-chair.
Dr. Rosenfeld has been a member of PRIM&R since joining the ethical review community as CEO of WIRB. He has presented on IRB Quality and has been an active participant at PRIM&R's annual Advancing Ethical Research Conference. As a physician/researcher who has worked on both the business and review sides of the independent IRB community, he has a unique understanding of the complex ethical and procedural issues facing the larger community as it adapts to the single IRB mandate from the NIH and in the updated Common Rule. He has additional expertise in public policy and information systems, topics that are becoming increasingly important as the research community adopts the tools and methods of mobile devices, e-commerce, and big data. Dr. Rosenfeld joined PRIM&R's Board in 2018 and serves on the Finance Committee and is co-chair of the Public Policy Committee.
Megan Kasimatis Singleton, JD, MBE, CIP is Assistant Dean for Human Research Protection and Director of the Human Research Protection Program at Johns Hopkins University School of Medicine. In this role she is responsible for oversight and direction of JHM's 7 IRBs. Ms. Singleton is a licensed attorney in Pennsylvania. She earned her law degree from Temple University and her Masters in Bioethics from the University of Pennsylvania. In addition to her current role in leading the Johns Hopkins Medicine HRPP, she serves as the director of central IRB (CIRB) activities for the Johns Hopkins/Tufts Trial Innovation Center (TIC), leading the charge for innovations in operationalizing single IRB (sIRB) review. Ms. Singleton serves as a member of the SMART IRB Harmonization Steering Committee, co-chair of the PRIM&R Advancing Ethical Research Conference Workshop/Didactic Subcommittee, is an AAHRPP, Inc. site visitor and member of AAHRPP council and is a member of the Steering Committee for AEREO, a consortium designed to advance effective research ethics oversight through empirical research.
Ms. Singleton currently teaches at the graduate level at the University of Pennsylvania and Johns Hopkins University, leading courses in research ethics and clinical trial management. She has developed research ethics curriculum and practical training in IRB administration tailored for national and international audiences. Ms. Singleton serves as Co-chair of PRIM&R’s Certification Committee.
Elisa A. Hurley, PhD, is the executive director of Public Responsibility in Medicine and Research (PRIM&R). In that capacity, she has overall strategic and operational responsibility for PRIM&R's staff, programs, and organizational relationships, and leads the organization in the execution of its mission. Dr. Hurley also teaches webinars and short courses for PRIM&R; serves as a blog contributor for both PRIM&R and other research-focused organizations; spearheads PRIM&R's public policy activities; and represents PRIM&R and its mission at meetings in the United States and abroad. She is a moral philosopher by training. Prior to arriving at PRIM&R in December 2010 as its education director, she was an assistant professor of philosophy at The University of Western Ontario, where her research and teaching focused on biomedical ethics, metaethics, and moral psychology. Dr. Hurley received a BA in philosophy from Brown University in 1996, a PhD in philosophy from Georgetown University in 2006, and held a Greenwall Fellowship in Bioethics and Health Policy at the Johns Hopkins Berman Institute of Bioethics and Georgetown University's Kennedy Institute of Ethics from 2006 to 2007. She is most recently co-author of a chapter on public trust and biospecimens research in Specimen Science: Ethics and Policy Implications (MIT Press, 2017), a chapter on the past and present of human subject protections in Human Subjects Research Regulation: Perspectives on the Future (MIT Press, 2014), and a commentary in Hastings Center Special Report: The Intersection of Research Fraud and Human Subjects Research: A Regulatory Review (2014). Dr. Hurley is a member of the Consortium to Advance Effective Research Ethics Oversight (AEREO), a collaboration aiming to evaluate and improve the effectiveness of Institutional Review Boards and Human Research Protection Programs through empirical study. She is also a long-serving member of the Dana-Farber Cancer Institute IRB.
For the first twenty-five years of PRIM&R’s existence, a distinguished group of founders and long-time Board directors took a lead in charting the organization's course. The title of Distinguished Leader of PRIM&R was developed in 2014 to give special recognition to those who have provided lasting contributions to PRIM&R through long-term service on the Board of Directors.
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