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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.
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).
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.
Alexander 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 at the Gould School of Law where he teaches public health law and torts; is Professor of Medicine and Law at the Keck School of Medicine, where he teaches health policy and bioethics; 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 was PRIM&R's Board Chair from 2013 to 2015, has served as a member of the AER Conference Planning Committees since 2012, is chair of the Nominations and Elections Committee, and is a member of the Finance Committee and the Public Policy Committee. Professor Capron has been on the PRIM&R Board since 2008.
Barbara E. Bierer, MD, a hematologist-oncologist, is a professor of medicine at Harvard Medical School and the Brigham and Women's Hospital (BWH). Dr. Bierer co-founded and now leads the Multi-Regional Clinical Trials Center of BWH and Harvard, a collaborative effort to improve standards for the planning and conduct of international clinical trials with a particular focus in emerging economies. In this capacity, she works with regulators around the world, major pharmaceutical companies, biotech, clinical research organizations, academia and patients/patient advocates to harmonize policies for and approaches to clinical trial regulation. She is co-founder of Vivli, a global data sharing platform for participant-level trial data. In addition, she is the director of the Regulatory Foundations, Ethics, and the Law program at the Harvard Catalyst, the Harvard Clinical and Translational Science Award, working across the academic spectrum to enable the clinical trial enterprise from study planning through recruitment to data acquisition and dissemination. From 2003 to 2014, Dr. Bierer served as senior vice-president, research, at the Brigham and Women's Hospital (BWH). During her tenure, Dr. Bierer founded and served as executive sponsor of the Brigham Research Institute and the Brigham Innovation Hub (iHub), a focus for entrepreneurship and innovation in healthcare. She established the Center for Faculty Development and Diversity. Dr. Bierer has been involved in policy development relating to the oversight of human research protection programs for years. She served on, and was then president of, the Board of Directors of the Association for Accreditation of Human Research Protection Programs (AAHRPP) from the time of its inception until it was well established. She served as chair of the HHS Secretary's Advisory Committee on Human Research Protections until October 2012. In addition to serving on the Board of Directors of PRIM&R, she serves on the Board of Management Sciences for Health (MSH), an international organization working in partnership globally to strengthen health care, local capability, and access. She chairs the Board of Trustees of the Edward P. Evans Foundation, a foundation supporting biomedical research and is on the board of directors of Clinithink, a company that transforms unstructured clinical text into computable data for clinical trials and population health management. She has authored or co-authored approximately 200 publications. Dr. Bierer received a BS from Yale University and an MD from Harvard Medical School. Dr. Bierer has been a member of the PRIM&R Board since 2014 and is currently co-chair of the Public Policy Committee and a member of the Finance Committee.
Bruce Gordon is vice-chancellor for regulatory affairs, professor of pediatrics, and chief of the division 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 the author of numerous original papers, chapters, review articles, and abstracts regarding human subjects protections and research ethics. Dr. Gordon is the chair of the Governance Committee and a member of the Nominations and Elections Committees. He has served on the PRIM&R Board since 2015.
Christian 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 of PRIM&R's 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. In addition to serving as treasurer, Dr. Newcomer is chair of the Finance Committee. He has been a member of PRIM&R's Board since 2013.
Executive Committee: Member
Finance Committee: Treasurer
Audit Sub-committee: Chair
Dr. 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 served as a member of the Presidential Commission for the Study of Bioethical Issues from 2010-2017. She is an elected fellow of the Hastings Center and the American Academy of Nursing; and elected member of the National Academy of Medicine. Dr. Grady has authored more than 150 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 nurse 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 Board vice chair, Dr. Grady serves as a member of the Public Policy Committee. She has been a member of PRIM&R's Board since 2013.
David Strauss is the Director of Research Operations and Compliance at the New York State Psychiatric Institute (NYSPI), and the 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 the Secretary's Advisory Committee on Human Research Protections (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. In addition to serving as PRIM&R's secretary, Dr. Strauss is co-chair of the Public Policy Committee. He has served on PRIM&R's Board since 2014.
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.
If you would like to contact PRIM&R's ombuds, please email firstname.lastname@example.org.
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.
Heather Pierce is senior director for science policy and regulatory counsel at the Association of American Medical Colleges (AAMC). She serves as AAMC's leader for scientific regulatory issues including human subject protections, clinical research, conflicts of interest, research data sharing, evidence-based regulation, and collaborations between industry, government, and academia in biomedical research. She provides subject matter expertise to the AAMC's Forum on Conflict of Interest in Academe and for Convey, the AAMC's global financial interest disclosure system. Ms. Pierce regularly speaks at national forums on issues related to the protection of human subjects, regulatory burden, research ethics, biospecimens, scientific misconduct, legislation and policymaking related to research, and research compliance. She has served on committees and task forces convened by organizations including the National Academies of Sciences, Engineering, and Medicine, The Pew Charitable Trusts, and the National Dialogue on Healthcare Innovation. Prior to joining AAMC, Ms. Pierce was an attorney in the Health Care Group of the law firm of Ropes & Gray LLP in New York. Her regulatory practice focused on medical research and clinical care. She received her law degree from New York University and her MPH in Health Law from Boston University. Ms. Pierce is a regular contributor to PRIM&R in-person programs and webinars and has served as secretary of the PRIM&R Board as well as on the Governance and Public Policy Committees. Ms. Pierce joined the PRIM&R Board in 2014 and currently serves as the Board chair.
Executive Committee: Chair
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.
Martha Jones is the executive director of the Human Research Protection Office (HRPO) at Washington University in St. Louis (WUSTL). Ms. Jones is a member of 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 a Council member and site visit team leader for the Association for the Accreditation of Human Research Protection Programs (AAAHRP). She has also served on the AAHRPP IRB Reliance Working Group and Evaluation Instrument Working Group and in 2017 received the AAHRPP Distinguished Team Leader Award. At WUSTL, Ms. Jones serves as a member of the IRB, 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. Ms. Jones was previously the manager for the Clinical Trials Statistical and Data Management Center, Deputy Director of the Center for Public Health Statistics, and an IRB Chair and IRB Director at The University of Iowa. She also co-directed a course in Clinical Research Ethics. Ms. Jones joined the PRIM&R Board in 2018 and is vice chair of the Certification Council.
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. Dr. Gray's research has also been published by Critical Studies in Media Communication, Cultural Anthropology, International Journal of Communication, and Social Media + Society. Dr. Gray'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 Dr. Gray'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. Dr. Gray 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. She has served on the PRIM&R Board since 2017 and is a member of the Public Policy Committee.
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.
Owen Garrick, MD, MBA, is president and chief operating officer of Bridge Clinical Research. At Bridge Clinical, Dr. Garrick has overall responsibility for the Clinical Trials, Health Services Research, and Healthcare Communications business units. Bridge Clinical is a global private equity-backed contract research and health communications firm focused on drug development, scientific advancement, and patient engagement. It is active in multiple therapeutic areas including anti-infectives, autoimmune, cardiovascular disease, endocrinology, and oncology. Since 2009, therapies that it has helped develop have generated more than $6 billion in revenues. In addition to profit and loss responsibility for the business units, Dr. Garrick has oversight of all financial, administrative, and legal aspects of the company, and serves on the Board of Directors as corporate secretary. He has led Bridge Clinical's expansion into multiple therapeutic areas, launched the public relations arm, and represents Bridge Clinical at the US Food and Drug Administration. Previous to assuming this position in 2009, Dr. Garrick was chief financial officer for its predecessor company.
Prior to joining Bridge Clinical, Dr. Garrick was director of strategy and business development at McKesson Corporation which delivers pharmaceuticals, medical supplies, and health care information technologies. Some of his key accomplishments included the $450M acquisition of D&K Healthcare which involved due diligence, negotiations, and FTC clearances. He also led the launch of McKesson's Generic Drugs Telesales Business Unit, the development and launch of McKesson's Drug Adherence Business, and the expansion of the pharmaceutical packaging business.
Before joining McKesson, Dr. Garrick was global head of M&A negotiations at Novartis Pharmaceuticals. In this position he oversaw small and medium sized company acquisitions, equity/license right deals, mature product divestments, and venture investments in biotechnology companies. While at Novartis, he pioneered the contingent payment deal structure with the $465 million acquisition of Idenix Pharmaceuticals which launched Novartis' Anti-Infectives business unit. This structure has become an industry standard tool in life sciences deals.
Dr. Garrick's experience also includes positions at Goldman Sachs as an investment advisor working with private healthcare companies as they sought to grow, raise capital, and perform initial public offerings, and Merck & Company, where he authored the first commercial analysis of Human Papillomma Virus vaccine (Gardasil) which has had peak sales of $1.6 billion.
Dr. Garrick earned his MD from Yale School of Medicine and his MBA from Wharton School of Business. He holds an AB in Psychology from Princeton University and continues to be an active alumnus currently serving on the Executive Committee of the Alumni Council, which represents the 80,000 member alumni body. Dr. Garrick also serves on the boards of the $6BN Bay Area Division of Sutter Health, Quorum Review IRB where he chairs the Compensation Committee, and the New York Blood Center where he serves on the M&A Committee. He is also vice chair of the Board of Regents of Samuel Merritt University. Previously, he served on the board of the American Medical Association Foundation where he was Board president and Context Matters Inc., a venture backed health economics company where he was co-founder. These entities have shown double digit annual growth during his involvement. He was confirmed as a member of the Department of Health and Human Services Advisory Council on Human Research Protections in 2012. He has co-authored industry advisory documents around biospecimen data security and patient engagement in research. Dr. Garrick resides in Oakland, California with his wife and their three sons. He joined the PRIM&R Board in 2017 and is a member of the Finance Committee, the Audit Sub-committee, and the Diversity Advisory Group.
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.
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, and is 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 PRIM&R.
Ms. 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. Ms. Okun is a member of PRIM&R's Finance and Public Policy committees.
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.
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 a member of the Nominations and Elections Committee.
Walter 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 and 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 the sphere that has historically characterized pharmaceutical development. This activity has led to his active involvement in internal discussions about 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 at the University of Pennsylvania. Dr. Straus serves as a member of the Finance and Nominations and Elections committees and has been on the PRIM&R Board since 2004.
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