Diversity, Equity, and Inclusion
2020 Advancing Ethical Research Conference
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Board of Directors
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.
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, is a Past-President of the American College of Laboratory Animal Medicine and participates as an ad-hoc specialist with AAALAC. She has served on the PRIM&R Board of Directors since 2017 and currently is a member of the Public Policy Committee and Executive Committee.
Martha F. Jones, MA, CIP, is Vice President of Human Research Affairs at Mass General Brigham. Ms. Jones is a member of the PRIM&R Board where she serves as Secretary and a member of the Executive Committee. Ms. Jones is the Chair of the Council on Accreditation of the Association for the Accreditation of Human Research Protection Programs (AAAHRP) and serves as a site visit team leader for the organization. In 2017, Ms. Jones received the AAHRPP Distinguished Team Leader Award. Ms. Jones co-leads the National Comprehensive Cancer Centers (NCCN) IRB Directors group and is also a member of the SMART IRB Harmonization Steering Committee. Ms. Jones is a member of the Mass General Hospital Chelsea Community Research Advisory Board. Ms. Jones previously worked at Washington University in St. Louis and The University of Iowa in research and administration roles. She has a background in clinical research ethics, epidemiology, biostatistics, speech pathology, audiology, public health, and the coordination of multicenter research studies. Ms. Jones co-developed a research application and data management system currently used at two large academic research institutions.
Jori Leszczynski, DVM, DACLAM is currently the Assistant Vice Chancellor for Animal Resources, Director of the Office of Laboratory Animal Resources and University Veterinarian at the University of Colorado Denver | Anschutz Medical Campus, 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 the American College of Laboratory Animal Medicine (ACLAM, Board of Directors). Her roles with PRIM&R have included service on the IACUC Conference Planning Committee 2013 – 2020, 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. She currently serves in the role of Treasurer on the Executive Committee and Chairs the Finance Committee.
Natalie L. Mays is the Immediate Past 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 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. Natalie was also Co-Chair of PRIM&R’s Annual IACUC conferences from 2016-2018. In 2020, Natalie was appointed to NYU Langone Health’s Black Employee Resource Group, a committee dedicated to establishing an inclusive environment where Black employees at NYU Langone Health can be empowered to succeed through mentorship, a community of support, recruitment and retention and professional development.
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, Ph.D., is Director of the Office of Research Support Services and Staff Senior Research Scientist at the Marshfield Clinic Research Institute in Marshfield, Wisconsin. Dr. Buchanan earned a Doctor of Philosophy (Ethics and Information Transfer) in 1999 and a Master of Library and Information Science in 1996 at the University of Wisconsin-Milwaukee. She was Associate Professor in the UWM School of Information Studies from 1999- 2011, and Endowed Chair in Ethics and Director of the Office of Research and Sponsored Programs at the University of Wisconsin-Stout from 2011-2020.
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 has been PI or Co-PI on five National Science Foundation awards, and frequently serves as a panel reviewer.
In addition to her scholarly activity, 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 free health clinic for the Chippewa Falls, Wisconsin, where she also volunteers. 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.
Brenda Curtis, PhD, MsPH, is a Tenure Track Investigator at the National Institute on Drug Abuse (NIDA) Intramural Research Program and Chief of the Technology and Translational Research Unit. Dr. Curtis is also Chair of the NIH Stigma Scientific Interest Group and has conducted empirical studies examining the role of stigmatizing language in the treatment of substance use disorders. Brenda works to pair evidenced-based research with novel methods and emerging technologies to address the societal need for empirically validated drug use interventions. Through clinical research, she works to intersect addiction treatment, technology, and long-term recovery. Using natural-language processing, digital phenotyping, and big data methodologies, she focusses on enhancing precision assessment of substance use and behavioral predictors using intensive longitudinal data and integrating passive sensor data from smartphones and wearable devices. Dr. Curtis employs multiple methodologies to facilitate the flow of scientific discovery to practical application allowing her to not only reach under-served populations, but to design health monitoring and behavioral change interventions that are user-centered, inclusive, and evidence-based.
Brenda earned both a bachelor’s degree in biology and a master’s degree in public health from the University of Illinois and subsequently obtained her doctorate in communication from the University of Pennsylvania, where she most recently held the appointment of Assistant Professor of Psychology in Psychiatry, Addictions at the Perelman School of Medicine. Dr. Curtis also completed a fellowship at the Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute.
Owen Garrick, MD, MBA, is president and chief executive 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. Dr. Garrick also served on the boards of the $6BN Bay Area Division of Sutter Health, Quorum Review IRB where he chaired the Compensation Committee, and the New York Blood Center. He was 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 serves as Ombudsperson.
Mary L. Gray is Senior Principal Researcher at Microsoft Research and Faculty Associate at Harvard University’s Berkman Klein Center for Internet and Society. She maintains a faculty position in the Luddy School of Informatics, Computing, and Engineering with affiliations in Anthropology and Gender Studies at Indiana University. Mary, an anthropologist and media scholar by training, focuses on how people’s everyday uses of technologies transform labor, identity, and human rights. Mary earned her PhD in Communication from the University of California at San Diego in 2004, under the direction of Susan Leigh Star. In 2020, Mary was named a MacArthur Fellow for her contributions to anthropology and the study of technology, digital economies, and society.
Mary’s work includes In Your Face: Stories from the Lives of Queer Youth (1999) and Out in the Country: Youth, Media, and Queer Visibility in Rural America (2009), which looked at how young people in rural Southeast Appalachia use media to negotiate identity, local belonging, and connections to broader, imagined queer communities. The book won the American Anthropological Association’s Ruth Benedict Prize and the American Sociological Association’s Sexualities Studies Book Award in 2009. And, with Colin Johnson and Brian Gilley, Mary co-edited Queering the Countryside: New Directions in Rural Queer Studies (2016), a 2016 Choice Academic Title.
In 2019, Mary co-authored (with computer scientist Siddharth Suri), Ghost Work: How to Stop Silicon Valley from Building a New Global Underclass. The book chronicles workers’ experiences of on-demand information service jobs—from content moderation and data-labeling to telehealth—work that is essential to the global growth of artificial intelligence and platform economies more broadly. It was named a Financial Times’ Critic’s Pick and awarded the McGannon Center for Communication Research Book Prize in 2019. The book was also awarded the 2020 Communication, Information Technologies, and Media Sociology section of the American Sociological Association (CITAMS) Book Award Honorable Mention. The book has been translated into Korean and Chinese.
Mary chairs the Microsoft Research Ethics Review Program—the only federally-registered institutional review board of its kind in Tech. She is recognized as a leading expert in the emerging field of AI and ethics, particularly research 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’s research has been covered by popular press venues, including The Guardian, El Pais, The New York Times, The Los Angeles Times, Nature, The Economist, Harvard Business Review, The Chronicle of Higher Education, and Forbes Magazine. She served on the Executive Board of the American Anthropological Association and was the Association’s Section Assembly Convenor from 2006-2010 as well as the co-chair of the Association’s 113th Annual Meeting. Mary currently sits on several boards, including the California Governor’s Council of Economic Advisors, Public Responsibility in Medicine and Research (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.
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, and the quality of Institutional Review Board oversight of research. She was named a Greenwall Faculty Scholar in 2019 to examine the ethics of health care gatekeeping, with an emphasis on access to investigational therapies outside clinical trials. In the context of COVID-19, she has applied her expertise to the ethical conduct of research, drug and vaccine development and FDA oversight, and allocation of scarce investigational products during a pandemic. 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.
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. She currently serves as a board member of the American Society of Law, Medicine, and Ethics. Professor Fernandez Lynch joined PRIM&R's Board of Directors in 2020 and co-chairs the Public Policy Committee.
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.
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 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, serves on the Nomination & Election Committee, and is Co-Chair of the Membership Committee.
Robert Nobles, DrPH, MPH, CIP serves as the Vice President for Research Administration at Emory University. Within Emory Nobles leads the 12 research administrative and compliance departments [Business Operations, Strategic and Training 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, Technology Transfer, and Occupational Health] with more than 450 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 2020, Emory received $831 million in total research funding awards. Of the overall total more than $500 million came from federal research funding awards, led by the National Institutes of Health. Emory researchers submitted more than 4,500 proposals to sponsors totaling more than $1.5 billion in 2020.
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.
Helen O’Meara, provides leadership for the staff team supporting the Institutional Animal Care and Use (IACUC) and the Institutional Biosafety Committees at The Ohio State University. She is also a member of the IACUC at Ohio State. Helen previously served as the IACUC Quality Improvement Specialist. She is a Certified Professional in IACUC Administration (CPIA) and has obtained Lean Six Sigma green belt certification. Prior to her Ohio State employment, Helen worked in contract animal research laboratories directing toxicology studies and preparing health assessments for regulatory agencies. She was also the director of a statewide non-profit organization. Helen received her Masters of Science in Environmental Health Science from Case Western Reserve University in Cleveland Ohio and her Bachelor of Science in Environmental Science and Biology from Bowling Green State University in Bowling Green, Ohio. She has also been certified as a Laboratory Animal Technologist by AALAS. Helen has been involved in organizations including AALAS-Northern Ohio Branch, and Society of Toxicology – Ohio Valley Chapter and has been a board member for the Ohio Scientific, Education and Research Association (OSERA), a board member and President pro-temp for a local county health department and an officer of the Columbus area Mortar Board Alumni Society. Helen has served on the PRIM&R planning committee for the annual IACUC conference since 2017.
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 Associate 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 Chair of PRIM&R’s Certification Committee.
Elisa A. Hurley, PhD, is the executive director of Public Responsibility in Medicine and Research (PRIM&R), a position she has held since 2014. In addition to directing the strategic, programmatic, and operational activities of the organization, Elisa writes, lectures, and teaches on a range of issues in research ethics, spearheads PRIM&R’s public policy efforts, 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, a PhD in philosophy from Georgetown University, 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. She is recently the author of “Modernizing the Common Rule: Public Trust and Investigator Accountability” in the American Journal of Bioethics (2017) and is a co-editor of the 3rd edition of IRB Management and Function (Jones & Bartlett), forthcoming February 2021. Elisa is a member of the Consortium to Advance Effective Research Ethics Oversight (AEREO), a collaboration of leaders in human research protections aiming to evaluate and improve the effectiveness of Institutional Review Boards through empirical study, and was 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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