Board of Directors Biographies

Natalie L. Mays, BA, LATG, CPIA - Chair

Natalie L. Mays is the director of the office of the IACUC and IBC at New York University Langone Health (NYULH). In this position, she is responsible for the administrative management of the IACUC and IBC. Prior to joining the team at NYULH, Ms. Mays was the IACUC director at Columbia University and Columbia University Medical Center. She has served on IACUCs since early 1988 in various capacities, including in the role of regulatory compliance and training coordinator. Ms. Mays received her bachelor's degree in microbiology from Miami University in Oxford, OH, is a graduate of AALAS' Institute for Laboratory Animal Management program, and obtained LATG certification from AALAS and CPIA certification from PRIM&R. She has been active in AALAS at the local and national levels, serving on various committees. Natalie has been involved with PRIM&R'S IACUC Conference in various roles since 2006 as an attendee, speaker, planning committee member, and co-chair of the IACUC Conferences in 2016-2018. She is a member of the Governance Committee and chair of the Certification Committee. She has served on the PRIM&R Board since 2016.

Suzanne Rivera, PhD, MSW - Vice Chair

Suzanne Rivera is the vice president for research and technology management at Case Western Reserve University in Cleveland, Ohio. She also is a faculty member in the Department of Bioethics at the CWRU School of Medicine and serves as the institutional official for human research protections. Her scholarly interests include research ethics, health disparities, and science policy. Dr. Rivera has 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). Lately, her research focus has been on the ethical and policy implications of biospecimen collection, biobanking, and use of specimens in research. In addition to writing numerous journal articles and book chapters, Rivera co-edited the book Specimen Science, which was published by MIT Press in 2017. 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. She joined the PRIM&R Board in 2018, and is the Chair of the Nominations and Elections Committee and a member of the Public Policy Committee.

Martha Jones, MA, CIP - Secretary

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 - Treasurer

Owen Garrick, MD, MBA, is President and CEO 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 the Wharton School of Business. He holds an AB in Psychology from Princeton University. He is Secretary of the board of the American Psychiatric Association Foundation and serves on the boards of the New York Blood Center and Mentoring in Medicine & Science. 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.

He served as member of the Department of Health and Human Services Advisory Council on Human Research Protections (SACHRP) from 2012 - 2016. He has co-authored industry advisory documents around biospecimen data security and patient engagement in research.

Albert J. "A.J." Allen, MD, PhD

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 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 on the the Membership and Public Policy committees, as well as the AER Core Conference Planning Committee.

Elizabeth A. Buchanan, PhD

Elizabeth Buchanan, PhD, is endowed chair in ethics and director of the Center for Applied Ethics at the University of Wisconsin-Stout. During 2015-2017, she served as director of research administration, where she was responsible for overseeing IRB, IACUC, research misconduct, and grants and contracts.

Dr. Buchanan's research focuses on the intersection of research regulations and internet research. She has written and presented widely for over 15 years to many IRBs throughout the country, and research ethics boards internationally, including Ireland, India, Finland, Canada, and Serbia, among others. In addition, she's presented to the Secretary's Advisory Committee to the Office for Human Research Protections (SACHRP) on multiple occasions, and was a primary contributor to the SACHRP Recommendations on Internet Research. She has also been a keynote speaker for a number of Office for Human Research Protections Research Community Forums. She is active in PRIM&R, serving on the speaker roster since 2008 and serving on the Conference Planning Committee since 2012. She was the Conference co-chair of PRIM&R's 2015 and 2017 Social, Behavioral, and Educational Research (SBER) Conferences, and as of 2016, joined PRIM&R's Board of Directors. Also, Dr. Buchanan has been a member of the American Association for the Advancement of Science Committee on Scientific Freedom and Responsibility since 2012.

In addition to her work on internet research, Dr. Buchanan is currently PI on her fourth National Science Foundation grant. In her recent study, she is looking at the ethical implications of service learning programs, and specifically, Engineers without Borders. Recent publications include a briefing on algorithmic harms in Data-Intensive Research in Education: Current Work and Next Steps, an article in Lecture Notes in Computer Science, titled "The New Normal: Revisiting Internet Research Ethics," an entry in the Stanford Encyclopedia of Philosophy titled "Internet Research Ethics", and a chapter on research ethics in the volume Research, Evaluation and Audit (Facet Publishing). Dr. Buchanan is the editor of one of the first anthologies of Internet research ethics (Readings in Virtual Research Ethics, 2004), and is author and/or co-author to numerous papers on research ethics and methods. She is also primary co-author to the Association of Internet Researchers Ethics Guidelines for Internet Research. She holds BA degrees from Rutgers University, and her MA and PhD from the University of Wisconsin-Milwaukee. Dr. Buchanan currently serves as Education Committee chair, member of the Governance Committee, and ombudswoman.

Bruce Gordon, MD

Bruce Gordon is assistant vice-chancellor for regulatory affairs and professor of pediatric hematology/oncology at the University of Nebraska Medical Center (UNMC). Dr. Gordon has been a member of the UNMC IRB 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 speaker at every ARENA/PRIM&R national meeting since 2002 and was the co-chair for the 2009 AER Conference. He is an active participant in PRIM&R'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 the workshop Putting Together the HRPP Puzzle, 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 AER meetings. He co-developed a "Vulnerable Subjects" program, A Systematic Exploration of IRB Review and Oversight of Research On, About, and Including Vulnerable Populations, which was presented at the 2016 AER Conference, and is currently part of the At Your Doorstep curriculum. 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 editor of the 3rd edition of “IRB: Management and Function”, and is the author of numerous original papers, chapters, review articles, and abstracts regarding human subjects protections and research ethics. Dr. Gordon is a member of the Governance Committee and the Nominations and Elections Committees. He has served on the PRIM&R Board since 2015.

Mary L. Gray, PhD

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.

F. Claire Hankenson, DVM, MS, DACLAM

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 Nominations and Elections Committee, Education Committee, and Public Policy Committee.

Karen M. Hansen

Karen Hansen is the director of the Institutional Review Office of the Fred Hutchinson Cancer Research Center in Seattle, WA, USA. Ms. Hansen was a co-founder of the Collaborative Institutional Training Initiative (CITI). She also collaboratively organized and presented training seminars and conferences for 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 Program Council on Accreditation. She continues to support national and international training experiences and opportunities for the IRB/REC community. Ms. Hansen currently serves as co-chair of PRIM&R's Membership Committee. She is also a member of CITI's External Advisory Board and the Planning Committee for the National Comprehensive Cancer Network's IRB Directors Forum. Ms. Hansen joined the PRIM&R Board in 2015.

Jori Leszczynski, DVM, DACLAM

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 is also currently serving 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.

Holly Fernandez Lynch, JD, MBE

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.

Gianna McMillan, MA, D. Bioethics

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.

Vickie M. Mays, PhD, MSPH

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.

Robert Nobles, DrPH, MPH, CIP

Robert Nobles serves as the interim vice chancellor for research and engagement and associate vice chancellor for research at the University of Tennessee, Knoxville where he has a faculty appointment in the Department of Public Health.

In his current role, Dr. Nobles is the chief research officer of the university and provides strategic leadership to a team of professionals responsible for research development, funding capture, strategic investments, proposal development, grant and contract negotiation and support, research communications, core facilities, research informatics, research safety, and research compliance. He prides himself on enhancing research infrastructures to support individuals in their scholarly pursuit of research answers.

In addition to his teaching and leadership roles, Dr. Nobles serves as the co-investigator on a five-year $4.9 million NIH award for the Program for Excellence and Equity in Research (PEER); has multiple awards focusing on at-risk underrepresented youth from the US Health and Human Services Administration on Children and Families, Texas Health and Human Services Commission, Department of Justice, and AETNA Foundation totaling over $6 million; and chairs the UT institutional compliance and campus safety committees.

Prior to joining UT, Dr. Nobles served as the research compliance officer and public health faculty member at both Texas A&M University and the University of Texas Health Science Center in Houston, the public health prevention specialist for the Centers for Disease Control and Prevention in Atlanta; and as a program manager for the state of Florida's Department of Public Health.

Dr. Nobles has taught in higher education since 2001 in several areas related to public health and administration, healthcare law and ethics, responsible conduct of research, public administration, anatomy and physiology, and biology.

Dr. Nobles earned his Doctor of Public Health degree at the University of Texas Health Science Center in Houston with a triple major that included health policy and management, epidemiology, and health economics; and he received his Master of Public Health specializing in epidemiology, and Bachelor of Science in molecular biology from Florida A&M University.

Dr. Nobles has been a member of PRIM&R for more than a decade; supports the mission and initiatives of PRIM&R; provides financial support to staff to become members, attend conferences, and training activities; and frequently shares information and resources to university researchers developed by PRIM&R. Dr. Nobles joined the PRIM&R Board in 2018 and serves as a member of the Governance Committee and the Diversity Advisory Group.

Stephen Rosenfeld, MD

Stephen Rosenfeld is currently the executive chairperson of the review board at Quorum Review IRB, an independent IRB located in Seattle.

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.

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 Nominations and Elections Committee.

Megan Kasimatis Singleton, JD, MBE, CIP

Megan Kasimatis Singleton, JD, MBE, CIP, is Assistant Dean for Human Research Protections and Director of the Human Research Protections Program at Johns Hopkins University School of Medicine. In this role she is responsible for oversight and direction of JHM’s seven 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. She is also heavily engaged in national efforts to streamline the implementation of sIRB review processes, serving as a member of the Federal Demonstration Partnership taskforce on sIRB review and as a member of the SMART IRB Harmonization Steering Committee. Ms. Singleton is the co-chair of PRIM&R’s Advancing Ethical Research Conference Workshop/Didactic Subcommittee, is an AAHRPP, Inc. site visitor, and is a member of the Steering Committee for AEREO, a consortium designed to advance effective research ethics oversight through empirical research.

Ms. Singleton is also an educator in research ethics and clinical research. She co-directs a course in Clinical Trials Management at the University of Pennsylvania and serves as Associate in the Bloomberg School of Public Health leading a course in Research Ethics & Integrity. She has developed international training initiatives in research ethics and IRB administration in both Botswana and Guatemala. Ms. Singleton joined PRIM&R's Board of Directors in 2020 and serves as vice chair of the Certification Committee.

Elisa A. Hurley, PhD

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.