Susan Kornetsky, MPH - Chair
Susan Z. Kornetsky, MPH, is the senior director of clinical research compliance at Boston Children's Hospital. For the past 33 years, her responsibilities have included: Directing an IRB administrative office, educating principal investigators regarding IRB regulations, assisting investigators with protocol development, assuring institutional compliance with all federal and state regulations pertaining to human research, establishing appropriate policies and procedures, and overseeing a quality improvement program for human research protections. In May of 2010, she completed a medical ethics fellowship at Harvard Medical School. She is the current Chair of PRIM&R's Board of Directors. Ms. Kornetsky is a past appointed member of the SACHRP Subcommittee on Children, and currently serves on the SACHRP Subpart A Subcommittee. She is a past board member and site visitor for AAHRPP, as well as a former member of the IOM's Committee on Clinical Research Involving Children. She served as a consultant for federal agencies and currently serves on the Scientific and Research Advisory Committee for the Massachusetts Down Syndrome Congress. She lectures at many national meetings, in addition to PRIM&R's conferences and educational programs. She is faculty for educational programs run internationally through Harvard Medical School Office of Global education and is a faculty member for a Fogarty international grant.
Christine Grady, MSN, PhD - Vice ChairDr. Grady is serving in her personal capacity.Christine Grady is chief of the Department of Bioethics at the National Institutes of Health Clinical Center. Her research focuses on the ethics of clinical research, especially subject recruitment, incentives, vulnerability, informed consent, and international research ethics. She is currently a member of the Presidential Commission for the Study of Bioethical Issues; and also a senior research fellow at the Kennedy Institute of Ethics and an elected fellow at the Hastings Center and the American Academy of Nursing.Dr. Grady has authored more than 75 papers, authored or edited several books, and has lectured widely on ethical issues in clinical research and clinical care, HIV disease, and nursing. She is an attending on the Bioethics Consultation service, an IRB and DSMB member, and a member of several editorial boards. She holds a BS in nursing and biology from Georgetown University, a MSN in community health nursing from Boston College, and a PhD in philosophy from Georgetown University. In addition to being PRIM&R's vice chair, Christine serves as a member of the Public Policy Committee.
Heather H. Pierce, JD, MPH - SecretaryHeather Pierce is senior director for science policy and regulatory counsel in scientific affairs at the Association of American Medical Colleges (AAMC). Ms. Pierce serves as AAMC's leader on issues related to conflicts of interest, human subjects protection, regulatory compliance, and interactions between industry, government, and academia in biomedical research. Prior to joining AAMC, Heather was an attorney in the health care group of the law firm of Ropes & Gray LLP in New York. Her practice focused on regulatory compliance issues including research with human subjects, medical information privacy and security, and fraud and abuse counseling. She worked with a wide range of clients including academic medical centers, hospitals, universities, and pharmaceutical and device manufacturers. She earned her juris doctor at New York University and her master's degree in public health at Boston University. Prior to becoming a lawyer, Heather worked in development and public education for an academic medical center and as a freelance writer. In addition to being PRIM&R's Board Secretary, she also serves as chair of the Governance Committee.
Christian E. Newcomer, VMD, MS, DACLAM - TreasurerChristian E. Newcomer, VMD, MS, DACLAM is the executive director emeritus of AAALAC International and has participated in AAALAC's review activities for the past 27 years. He is a 1977 graduate of the School of Veterinary Medicine at the University of Pennsylvania. Following a year in a large animal internship at Pennsylvania State University, he entered post-doctoral training in laboratory animal medicine at the University of Michigan (1978-1981) and subsequently became board certified as a Diplomate in American College of Laboratory Animal Medicine in 1982. Prior to his appointment at AAALAC International he held academic and leadership positions in laboratory animal medicine at the Massachusetts Institute of Technology (1981-1987), Tufts-New England Medical Center (1987-1994), University of North Carolina at Chapel Hill (1994-2001), the Veterinary Resources Program at the NIH (2001-2003), and Johns Hopkins University (2003-2008). He is a past president of ACLAM (1996) and of AALAS (2008), and a past vice president of the AAALAC International Council on Accreditation (1996-8). He was a member 2012 IACUC Conference Planning Committee and co-chaired the 2013, 2014, and 2015 IACUC Conference Planning Committees. He has frequently participated as a member of the IACUC Conference Faculty since 1989.
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 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).
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 Public Policy Committee.
A. Cornelius Baker
A. Cornelius Baker is the deputy coordinator for Affected Populations and Civil Society Leadership at the US Department of State's Office of the US Global AIDS Coordinator. Mr. Baker serves on the boards of PRIM&R, the Black AIDS Institute, Broadway Cares/Equity Fights AIDS, and Us Helping Us, and serves on the executive committee of the Forum for Collaborative Research on AIDS. In 2009, he was appointed to the President's Advisory Council on HIV/AIDS. Previously, he served as the senior policy advisor for the National Black Gay Men's Advocacy Coalition, a technical advisor at the Center on AIDS and Community Health at FHI 360, the executive director of Whitman-Walker Clinic, and executive director of the National Association of People with AIDS. Mr. Baker also worked as a confidential assistant to the assistant secretary for health at the US DHHS in the National AIDS Program Office. He has received the Courage Award at the Washington AIDS Walk for his outstanding leadership in living with the HIV disease, the National Lesbian and Gay Health Association's Diego Lopez Award for leadership in HIV advocacy, the American Foundation for AIDS Research Award of Courage for Community Building, and the National Association of People with AIDS' Braveheart Award. He was honored by Planned Parenthood of Metropolitan Washington in 2004 for his support of women's health and community leadership. He received his undergraduate degree at Eisenhower College/Rochester Institute of Technology. Mr. Baker also serves on the Governance Committee.
Barbara E. Bierer, MDBarbara Bierer, MD, is professor of medicine at Harvard Medical School. Dr. Bierer, a graduate of Harvard Medical School, is an internist and hematologist/oncologist with a research interest in immunology. She has been in her current position, as institutional official, since 2003. In 2006, Dr. Bierer established, and is director of, the Center for Faculty Development and Diversity at BWH. In addition, Dr. Bierer is the co-chair of the Partners HealthCare Committee on Conflict of Interest and the program director of the Regulatory Domain of the Harvard Catalyst, the Harvard Clinical and Translational Science Award. She has authored or co-authored over 150 publications and is on the editorial boards of a number of journals including Current Protocols of Immunology. In addition to her academic responsibilities, Dr. Bierer was elected to, and was president of, the Board of Directors of AAHRPP, was on the Board of Directors of the Federation of American Societies for Experimental Biology, was on the Association of American Medical Colleges and the Association of American Universities Advisory Committee on Financial Conflicts of Interest in Clinical Research, and formerly served as chair of SACHRP. Currently, she serves on the National Academies of Science's Committee on Science, Technology, and the Law. Dr. Bierer serves as a member of the Public Policy Committee.
David A. Borasky, Jr., MPH, CIPDavid A. Borasky, Jr., MPH, CIP is the vice president for quality management at the Copernicus Group IRB (CGIRB). In this role, he serves as the principal regulatory officer and provides leadership in the development, implementation, and administration of CGIRB corporate quality and compliance systems. Previously, Mr. Borasky worked as the interim director in the Office of Human Research Ethics at the University of North Carolina at Chapel Hill. He has over 17 years of experience managing institutional review boards, as well as facilitating training activities on basic research ethics and IRB operations and function for research staff and their collaborators worldwide. He is a co-author of the award-winning Research Ethics Training Curriculum and the Research Ethics Training Curriculum for Community Representatives, which together have been used to train individuals in over 70 countries. He is a contributing author of Institutional Review Board: Management and Function. In addition, David has provided hands-on assistance to IRBs throughout North America, Africa, and Asia, specializing in capacity building activities for IRBs in low-resource settings. He has served as a consultant for the Office of Human Research Protections, the US Department of Energy, the World Health Organization and numerous other institutions. David is proud to be a member of the Board of Directors for PRIM&R. He frequently lectures on the challenges of the review of research in developing country settings, and has published articles on research ethics training and international. Mr. Borasky also serves on the Public Policy Committee.
Elizabeth Buchanan, PhDElizabeth 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 is serving as director of research administration, where she is responsible for overseeing IRB, IACUC, research misconduct, and grants and contracts. Elizabeth's research focuses on the intersection of research regulations and internet research. She has written and presented widely for over fifteen 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 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 Community Research Forums. Elizabeth is active in Public Responsibility in Medicine and Research (PRIM&R), serving on the faculty roster since 2008 and serving on the Conference Planning Committee since 2012. She was the Conference co-chair of PRIM&R's 2015 Social, Behavioral, and Educational Research (SBER) Conference, and as of 2016, joined PRIM&R's Board of Directors. Also, Elizabeth 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, Elizabeth 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). Elizabeth 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. Elizabeth 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.
Joseph J. Byrne, PhD
Joseph J. Byrne joined Tufts University in 1969, and held various positions until retirement in 1998, including University Associate Provost for Research, Assistant Professor of Family Medicine and Community Health, and Associate Dean for Medical and Governmental Affairs at the School of Medicine. Dr. Byrne was appointed Associate Provost Emeritus and Assistant Professor Emeritus upon retirement. He also served, until retirement, as a member of the Operating Board of Tufts-New England Medical Center, a corporation providing common services to the Tufts Health Sciences Campus and the New England Medical Center, including the IRB, Lab Animal Medicine, Radiation and Biosafety services, and more. Dr. Byrne's continuing health-related activities include board membership in the Caritas Health Care System and the Biomedical Sciences Exchange Program). Dr. Byrne began his PRIM&R relationship as an original member of the Boston-based informal group in 1972, and then co-founding Director in 1974. Dr. Byrne has been a Board Director since that time. He served as Treasurer and Executive Committee Member until 2001. In 2005, Dr. Byrne received PRIM&R's Founders' Award in recognition of his long service to the organization. He currently serves as a member of the Finance Committee.
Alexander M. Capron, LLBAlexander Capron, LLB, holds the rank of university professor at the University of Southern California (USC), where he occupies the Scott H. Bice Chair in Healthcare Law, Policy and Ethics; teaches public health law, health policy, torts, and bioethics in the Gould School of Law and the Keck School of Medicine; serves as co-director of USC's Pacific Center for Health Policy and Ethics; and leads the Research Ethics Program of the Southern California Clinical and Translational Science Institute. Professor Capron previously taught at Georgetown University, the University of Pennsylvania, and Yale University. From 2002 to 2006, he served as the first director of Ethics, Trade, Human Rights, and Health Law at the WHO in Geneva, and from 1979 to 1983 he was the executive director of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Professor Capron is a founding fellow of The Hastings Center, an elected member of the Institute of Medicine and of the American Law Institute, as well as a fellow of the American Association for the Advancement of Science. He has been president of the International Association of Bioethics and of the American Society of Law, Medicine and Ethics. Professor Capron is a member of the 2012, 2013, 2014, and 2015 AER Conference Planning Committees and the Public Policy Committee.
Susan S. Fish, PharmD, MPHSusan Fish, PharmD, MPH, is a professor of biostatistics and epidemiology at the Boston University School of Public Health. Dr. Fish received her Doctor of Pharmacy degree from the University of Minnesota and her Masters of Public Health from Boston University. She received a bachelor's degree in pharmacy from Massachusetts College of Pharmacy and Allied Health Sciences and a bachelor's degree in chemistry and education from the University of Massachusetts. Dr. Fish is the co-director of the masters in clinical research program at Boston University School of Medicine (BUSM). She previously held positions as director of human subjects protection and associate director of the Office of Clinical Research at Boston University Medical Center (BUMC), director of the BUMC IRB, and director of research participant safety at the General Clinical Research Center at BUSM. She has also served as director of regulatory affairs at CareStat, Inc. (a contract research organization), vice chair for research in the Department of Emergency Medicine at Boston City Hospital/Boston Medical Center, and associate professor of emergency medicine at BUSM. Prior to that, she was associate director of the Massachusetts Poison Control System and an associate professor at Massachusetts College of Pharmacy and Allied Health Sciences. On the national level, Dr. Fish is an active member of many organizations, including the Society for Academic Emergency Medicine and PRIM&R, where she serves on the Board of Directors. Dr. Fish was a member of the 2012 AER Conference CCPC and was co-chair of the Poster-Abstract Sub-Committee for the 2012, 2013, 2014, and 2015 AER Conferences. She currently serves as a member of the Diversity Advisory Group and Finance, Membership, and Nominations and Elections Committees.
Owen Garrick, MD MBA is President & Chief Operating Officer of Bridge Clinical Research. At Bridge Clinical, Dr. Garrick, 47, 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 developed have generated more than $6 billion in revenues. In addition to profit & 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 & 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 size 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.
Cynthia A. Gómez, EdM, PhDCynthia A. Gómez is the founding director of Health Equity Institute at San Francisco State University where she leads efforts to enhance and integrate campus research, curricula, community service, and training programs that address health disparities and/or promote health equity in the United States. She previously served as co-director of the Center for AIDS Prevention Studies (CAPS) at the University of California at San Francisco, where she was also an associate professor in the Department of Medicine since 1991. She received her master's degree in counseling psychology from Harvard University and her PhD in Clinical Psychology from Boston University. Prior to her work with CAPS, Dr. Gómez spent 12 years working in community health settings, including five years as director of a child and family mental health center in Boston. Dr. Gómez is considered a pioneer in the areas of cultural determinants in sexual behaviors among Latinos, in the role of power dynamics in sexual risk among women, and in the development of HIV prevention interventions, including interventions for people living with HIV. Dr. Gómez is a nationally renowned speaker and an expert in the field of HIV prevention and sexual health. She has served on several national committees, including the Center for Disease Control's HIV and STD Advisory Council, National Institute on Drug Abuse's National Hispanic Science Network, and the Substance Abuse and Mental Health Services Administration's Advisory Committee on Women's Services. She is a member and past chair of the board of directors of the Guttmacher Institute. Dr. Gómez was also an appointed member to the Presidential Advisory Council on HIV/AIDS under both WJ Clinton and GW Bush administrations. Dr. Gómez is a member of the Governance and Nominations and Elections Committees.
Bruce Gordon, MDBruce Gordon is professor of pediatrics in the section of pediatric hematology/oncology and stem cell transplantation at the University of Nebraska Medical Center (UNMC). Dr. Gordon has been a member of the UNMC institutional review board (IRB) since 1992, served as chair since 1996, and as executive chair since 2011. He organized, and is first chair of, a joint pediatric IRB with the Children's Hospital and Medical Center in Omaha. 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, and as the first chair of the National Cancer Institute Pediatric Central IRB. Dr. Gordon has been a faculty member at PRIM&R's regional and national meetings, served as the co-chair for the 2009 AER Conference, and is the author of numerous original papers, review articles, and abstracts regarding human subjects protections and research ethics. Dr. Gordon is a member of the Education and Governance Committees.
Mary L. Gray is Senior Researcher at Microsoft Research and Fellow at Harvard University's Berkman Klein Center for Internet and Society. She maintains a faculty appointment in the School of Informatics, Computing and Engineering, the Media School, American Studies, Anthropology and Gender Studies at Indiana University. Her most recent book, Out in the Country: Youth, Media, and Queer Visibility in Rural America (NYU Press), looked at how young people in the rural United States use media to negotiate their sexual and gender identities, local belonging, and connections to broader, imagined queer communities. Mary's research has also been published by Critical Studies in Media Communication, Cultural Anthropology, International Journal of Communication, and Social Media + Society. Mary's current book project, co-authored with computer scientist Siddharth Suri, combines ethnography, interviews, survey data and large scale data analysis to understand workers' experiences of on-demand economies and their implications for the future of work. A third thread of Mary's work examines how ethics and research compliance processes produce norms of vulnerability and risk in human subjects research, particularly work at the intersections of computer and social science. Mary served on the Executive Board of the American Anthropological Association from 2008 through 2010 and was the Executive Program Chair for the Association's 113th Annual Meeting.
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, 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 (M.S., 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.
Karen M. HansenKaren 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 (www.citiprogram.org) in 2000. She also collaboratively organized and presented training seminars and conferences for institutional review board (IRB)/research ethics committee (REC) members, chairs, and administrators held in Botswana, Dominican Republic, Egypt, Malawi, South Africa, Taiwan and Uganda. From 2004 to 2006, Ms. Hansen served as a site visitor and member of the Association for Accreditation of Human Research Protection Program (AAHRPP) Council on Accreditation. She is interested in supporting and providing continued national and international training experiences and opportunities for the IRB/REC community. Ms. Hansen currently serves as a member of the PRIM&R Education Committee and the Planning Committee for the National Comprehensive Cancer Network's (www.nccn.org) IRB Directors Forum. She is currently co-chair of the Membership Committee.
Tanise L. Jackson, DVM, DACLAM, CPIATanise L. Jackson is an assistant professor at Florida A&M University (FAMU) College of Pharmacy and Pharmaceutical Sciences and the director of the Office of Animal Welfare and Research Integrity, Division of Research, in Tallahassee, FL. Dr. Jackson is responsible for direction of care and maintenance of laboratory animals at the Florida A&M University Animal Care Facility. Dr. Jackson also holds responsibility for Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International Accreditation for the Animal Care Facilities at FAMU, February 2003. She is a member of American Association for Laboratory Animal Science and she sits on the Board of Trustees of AAALAC International, representing PRIM&R and Association of Minority Health Professions Schools. Prior to joining the FAMU faculty in 1997, Dr. Jackson worked for more than 10 years as supervisory veterinary medical officer for the Food Safety and Inspection Service of the United States Department of Agriculture in its Atlanta, GA, Field Operations. Dr. Jackson's research interests include drug delivery for lung and breast cancer. She is the chair of PRIM&R's Certification Committee.
Moira A. Keane, MA, CIPMoira Keane is the former Executive Director of the University of Minnesota, Human Research Protection Program which includes the Institutional Review Board (IRB), and the Institutional Biosafety Committee (IBC). The HRPP oversees the research of all University of Minnesota campuses which encompasses review of basic science, clinical research, and social and behavioral sciences projects conducted by faculty, staff, and students. Ms. Keane is actively involved in subjects protections and served as Chair of the AAHRPP Council on Accreditation, as Vice Chair of the Council on Certified IRB Professionals (CCIP), and as a member of the Secretary's Advisory Committee on Human Subjects Protection (SACHRP) Sub Part A Sub Committee. Ms. Keane serves as the Vice Chair of the Certification Committee and a member of the Finance Committee.
Robert J. Levine, MDRobert J. Levine is Professor of Medicine and Lecturer in Pharmacology, Senior Fellow in the Interdisciplinary Center for Bioethics (of which he was Founding Co-Director) and Director of the Law, Policy and Ethics Core of the Center for Interdisciplinary Research on AIDS at Yale University. He is Fellow of The Hastings Center, the American College of Physicians and the American Association for the Advancement of Science; a member of the American Society for Clinical Investigation and American Society for Pharmacology and Experimental Therapeutics, past-President of the American Society of Law, Medicine & Ethics (two terms), and past-Chairman of the Connecticut Humanities Council. He was the Chair of the Institutional Review Board at Yale-New Haven Medical Center (1969 - 2000), Chief of the Section of Clinical Pharmacology at Yale, Chair of the Section on Medico-Legal Matters and R&D Administration of the American Society for Clinical Pharmacology and Therapeutics, Associate Editor of Biochemical Pharmacology and Editor of Clinical Research. Dr. Levine is the founding editor of IRB: A Review of Human Subjects Research (Editor 1979 – 2000 and currently Chair of the Editorial Board) and has served as consultant to several federal and international agencies involved in the development of policy for the protection of human subjects. He was, for example, Chair of the Council for International Organizations of Medical Sciences' Steering Committee for revision of its International Ethical Guidelines for Biomedical Research Involving Human Subjects (1993 and 2002 versions). He is the author of numerous publications including the book, Ethics and Regulation of Clinical Research. In the last 35 years, most of Dr. Levine's research, teaching and publications have been in the field of medical ethics with particular concentration on the ethics of research involving human subjects. Additionally, Dr. Levine was awarded the Outstanding Achievement Medal from the Office for Human Research Protection, US Department of Health and Human Services in 2004 for his role in the development of the Belmont Report; he received the Lifetime Award for Excellence in Human Research Protection from the Health Improvement Institute in 2004; he received PRIM&R's Lifetime Achievement Award for Excellence in Research Ethics in 2005, the Distinguished Alumni Scholar Award from The George Washington University in 2008 and the Academy of Pharmaceutical Physicians and Investigators' Special Recognition Award in 2009. Dr. Levine serves as a member of the Education Committee.
Natalie L. Mays, BA, LATG, CPIANatalie L. Mays is the director of the office of the IACUC and IBC at New York University Langone Medical Center (NYULMC). In this position, she is responsible for the administrative management of the IACUC and IBC. Prior to joining the team at NYULMC, 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, obtained a LATG 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, faculty member, planning committee member, and she will serve as co-chair of the 2016 IACUC Conference. She also serves on PRIM&R's Diversity Advisory Group and the Certification Committee.
Sally Okun, RN, BSN, MMHS
Sally Okun is the Vice President for Advocacy, Policy and Patient Safety at PatientsLikeMe, an online patient research network. She is responsible for bringing patient voice and insight to diverse advocacy and health policy discussions at the national and global level, and is the company's liaison with external organizations, government and regulatory agencies including a Research Collaboration Agreement with the FDA's Office of Surveillance and Epidemiology and co-PI for a sub-award through Scripps Translational Research Institute for the NIH All of Us Research Program's Participant Technology Center.
Sally joined PatientsLikeMe in 2008 as the manager of Health Data Integrity and Patient Safety responsible for developing the site's medical ontology and codifying the patient reported health data into standardized terminologies. She coordinated the development of the site's Drug Safety and Pharmacovigilance Platform. Since assuming the VP position in 2013 she's been actively involved in numerous external activities including serving as a member of the PCORI Patient Engagement Advisory Panel; the Advisory Committee for the Reagan-Udall Foundation's Big Data for Patients (BD4P) program and a member of the Scientific Advisory Committee for Innovation in Medical Evidence Development and Surveillance (IMEDS) program. Sally is on the Strategic Planning Task Force for the American Heart Association Institute for Precision Cardiovascular Medicine, a member of the Leadership Consortium for a Value & Science-driven Health System at the National Academy of Medicine. Sally is a frequent contributor to expert panels convened by groups such as the National Quality Forum, Agency for Health Care Research and Quality, The Commonwealth Fund, Center for Medical Technology Policy, National Patient Advocacy Foundation, the American College of Cardiology's Diabetes Collaborative Registry, the Schwartz Center for Compassionate Care and many others. In 2017 Sally joined the Board of Directors for Public Responsibility in Medicine and Research (PRIM&R).
Okun received her nursing diploma from the Hospital of St. Raphael School of Nursing, her baccalaureate degree in nursing science from Southern Connecticut State University, and her Master's degree from The Heller School for Social Policy & Management at Brandeis University. She was a 2010 Fellow in Biomedical Informatics for the National Library of Medicine and a 2014 Salzburg Global Fellow in New Paradigms for Behavioral and Mental Health.
Prior to joining PatientsLikeMe Okun was an independent consultant through her firm Caretography, LLC. In addition to private practice with patients and families facing life-changing illnesses she participated in numerous multi-year clinical, research, and education projects focused on palliative care. Sally was a national facilitator for “Healing Conversations: Effective Communication in Breast Cancer Care” and served as a Senior Consultant to the hospice industry on regulatory compliance, quality and clinical excellence. She served as an expert witness for Medicare Hospice Fraud and Abuse investigations initiated by the Department of Justice and the Office of Inspector General and wrote the first clinical Corporate Compliance Agreement for hospice.
Walter L. Straus, MD, MPHWalter L. Straus is the Associate Vice President, Clinical Safety and Risk Management 2, Merck & Co, Inc. He has involvement in issues ranging from molecular epidemiology, to development of patient-reported outcome measures for use in clinical trials, through to assessment of the safety and effectiveness of marketed products. While much of his work is done in support of clinical research, his group is also involved in basic research. Additionally, since so much of the burden of vaccine preventable diseases falls on developing countries, Dr. Straus' team is also involved in epidemiologic assessment of disease in areas of the world normally outside of sphere that has historically characterized pharmaceutical development. This activity has led to his active involvement in internal discussions about proper research ethical considerations for research in developing countries. Dr. Straus is a former Epidemic Intelligence Service Officer at the Centers for Disease Control and Prevention, and has served as a consultant to the World Health Organization and other non-governmental organizations. His primary medical ethics focus is upon ensuring appropriate research protection for vaccine research in developing countries. His team is active in scientific presentations and publications. He serves as a Technical Consultant to the AHRQ Center for Education and Research on Therapeutics at the University of Alabama, and holds an adjunct appointment with the Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania. Dr. Straus serves as a member of the Finance Committee.
David Strauss, MDDavid Strauss is the Director of Research Operations and Compliance, New York State Psychiatric Institute, Columbia University Department of Psychiatry. From 2000 until 2010, Dr. Strauss chaired the NYSPI IRB and directed the Office of Humans Subjects Research. He co-chairs Columbia University's Standing Committee on the Conduct of Research, and serves as co-director of the Ethics, Public Policy, and Human Rights Core of the current HIV Center for Clinical and Behavioral Studies. Dr. Strauss is past recipient of two NIH grants on research ethics training and the enhancement of human subjects oversight for psychiatric research. He is a former member of SACHRP and completed work as co-chair of its Subcommittee on the Inclusion of Individuals with Impaired Decision-making in Research. He currently serves on a SACHRP subcommittee charged with developing recommendations to enhance Subpart A or the "Common Rule." Dr. Strauss practices psychiatry and psychopharmacology, and teaches, lectures, and consults widely on matters of human subjects protections and applied research ethics. He serves on PRIM&R's Board of Directors and is Chair of the Public Policy Committee.
Elisa A. Hurley, PhDElisa 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; and represents PRIM&R and its mission at meetings in the United States and abroad. Prior to taking on the role of executive director in April 2014, Dr. Hurley served for three years as PRIM&R's education director. She oversaw curriculum development and faculty cultivation for the organization's suite of in-person and virtual educational programs; managed PRIM&R's public policy activities; and served as a member of the senior management team. She is a moral philosopher by training. Prior to arriving at PRIM&R in December 2010, 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 Ethic from 2006 to 2007. She is most recently co-author of 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). She also currently serves as a nonaffiliated member on both an institutional review board and an institutional animal care and use committee.