THE THREE I’s (IACUC, IBC & IRB): RESEARCH INTEGRITY & BIOSECURITY CONFERENCE
PROMOTING RESEARCH, INTEGRITY AND COMPLIANCE BY PROVIDING TRAINING IN THE ETHICAL AND RESPONSIBLE CONDUCT OF RESEARCH
NEERA V GOPEE, DVM, PhD is the Director, Division of Policy and Education in the Office of Laboratory Animal Welfare (OLAW) at the National Institutes of Health (NIH) in Bethesda Maryland. Dr. Gopee earned her veterinary degree at the University of the West Indies and holds a doctoral degree in Toxicology from the University of Georgia. Prior to her appointment at OLAW, she served as a Veterinary Medical Officer at the National Center for Toxicological Research, US Food and Drug Administration in Jefferson, AR. Dr. Gopee is board certified in toxicology and laboratory animal medicine.
DANIEL NELSON, is Director of the Human Research Protocol Office for the National Health and Environmental Effects Research Lab (NHEERL), U.S. Environmental Protection Agency (EPA). He is also Adjunct Professor of Social Medicine and Pediatrics, and Faculty Associate in the Center for Bioethics at the University of North Carolina-Chapel Hill. Trained in medical physiology, Nelson previously held faculty appointments at the Mayo Clinic, the University of Rochester and UNC-Chapel Hill, where he directed the Institutional Review Boards for 16 years. A national leader in the field of human research protections, Nelson has served as past-president of the Applied Research Ethics National Association (ARENA); charter member of the Council for Accreditation and Site Visitor, Association for the Accreditation of Human Research Protection Programs (AAHRPP); charter member of the Council for Certification of IRB Professionals (CCIP); and consultant to the federal Office for Human Research Protections (OHRP). From 2004-2014, he chaired a subcommittee of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which advises DHHS on the regulations that govern this area. In 2013 Nelson was honored by Public Responsibility in Medicine and Research (PRIMR) with the ARENA Legacy Award, for leadership and contributions to the field of research ethics.
TED MYATT, ScD, RBP, Associate Vice President at the University of Rhode Island, has extensive experience in the fields of biosafety, environmental health and safety (EH&S), research compliance, epidemiology, building mechanical systems, and exposure assessment. Ted oversees all aspects of research compliance, including human subject research (i.e., Institutional Review Board), animal welfare (i.e., Institutional Animal Care and Use Committee), biosafety (i.e., Institutional Biosafety Committee), laboratory and chemical safety committee, export control compliance, conflict of interest, research misconduct, and responsible conduct of research (RCR) training. He has also served as the Director of the Partners HealthCare Institutional Biosafety Committee and the Biological Safety Officer at Brigham and Women’s Hospital. He received a Bachelor’s of Science in microbiology at the University of Illinois, a Master’s of Environmental Management at Duke University, and a Doctorate of Science at the Harvard School of Public Health.
DANIEL EISENMAN, PhD, RBP, SM (NRCM), CBSP, Director of Biosafety Services, Advarra, has a PhD in molecular biology and immunology and is a Certified Biological Safety Professional, American Biological Safety Association. Dan has over a decade of experience in biosafety program management and is an experienced educator and presenter in the fields of biological safety, genetic engineering, immunology, and infectious diseases. He is also a Specialist Microbiologist in Biological Safety, National Registry of Certified Microbiologists, American Society for Microbiology. He previously ran the IBC program at UNC-Chapel Hill.
ANGELA C BIRNBAUM, serves as the Director of Biosafety at Tulane University, and oversees a large university-wide biosafety program research including recombinant DNA, clinical trials, and research with high risk pathogens. She has years of experience working in academic institutions, including New York Medical College, Massachusetts Institute of Technology, and Harvard University as well as contract research organizations. Angela has a proven track record of biosafety and biosecurity program implementation, team building and integration, and a strong capacity to build and rebuild sustainable biosafety programs for complex research programs. She also has a strong history of productive interactions with local, state, and federal regulatory agencies. Angela is a Registered Biosafety Professional, Certified Hazardous Material Manager, Certified Biosafety Professional, and a Specialist Microbiologist in the National Registry of Certified Microbiologists. She brings 18 years of experience implementing compliance services to BSL1/ ABSL1, BSL2/ ABSL2, BSL3/ABSL3, and BSL3/ABSL3-enhanced containment facilities for animal models including mouse, rat, rabbit, pig and non-human primates.
MARCY BROWN, BS, MA, CMAR, CPIA, is an Animal Welfare, IACUC, and Regulatory Specialist with experience in both academic and industry settings. Marcy is a Certified Professional IACUC Administrator (CPIA) and Certified Manager of Animal Resources (CMAR). She serves on the board of directors of the California Biomedical Research Association (CBRA) and served three terms as an AAALAC, International ad hoc Specialist. Marcy has devoted significant time to presenting and co-facilitating presentations, workshops, and panels at PRIM&R’s Annual IACUC meetings and CBRA’s annual educational workshops, as well as faculty for American Association for Laboratory Animal Science (AALAS) and Massachusetts Society for Medical Research (MSMR) meetings. Marcy has a biology background, holds a Master of Arts degree from the University of California, Berkeley and is a certified Lean Six Sigma Black Belt. She is the 2016 recipient of the PRIM&R ARENA Legacy Award, which recognizes PRIM&R members who significantly promote the ethical conduct of research through mentoring, teaching, and leadership.
DEB FROLICHER, BS, CPIA, Director, IACUC Office, The Scripps Research Institute earned her Bachelor of Science degree in Agriculture/Animal Science and Nutrition at The Ohio State University, Columbus, OH and after graduation began working in biomedical research as a laboratory technician. In her 15 plus years in biomedical research she has worked with various animal models and a variety of species, including snakes, lizards, rodents, ducks, dogs, pigs, goats, cattle, and a colony of diabetic monkeys. She began her IACUC administrative career in the mid 90’s. Deb’s experience in the laboratory enables her to effectively interface with investigators and research staff to integrate IACUC review and oversight into their research programs. Currently, she is the director of the IACUC office at The Scripps Research Institute in La Jolla, CA. Deb earned CPIA certification in 2008 and served on the CPIA Council from 2010 through 2016, the last two years as Council Chair. She is a member of PRIM&R, SCAW, AALAS, and LAWTE.
ELIZABETH BUCHANAN, PhD, is Endowed Chair in Ethics and Director of the Center for Applied Ethics at the University of Wisconsin-Stout. She serves as Leadership Director and Vice-Chair of the UW Stout’s Institutional Review Board. She has presented her National Science Foundation-funded research on IRBs and Internet research to the Secretary’s Advisory Committee to the Office for Human Research Protections in 2010, 2012, 2013, and 2014, and was a primary contributor to the SACHRP Recommendations on Internet Research. She has also presented at the Office for Human Research Protections Community Research Forums, and has done professional development work with many IRBs throughout the US. She has been on the Faculty of the Public Responsibility in Medicine and Research roster since 2008. As of 2012, she is a member of the PRIM&R Conference Planning Committee, and Co-Chair of PRIM&R’s SBER 2015 conference. Elizabeth is a member of the American Association for the Advancement of Science Committee on Scientific Freedom and Responsibility. Her most recent research was funded by the National Science Foundation, and examined computer science pedagogy and ethics in graduate computer and information science education. Recent publications include an article in Lecture Notes in Computer Science, entitled “The New Normal: Revisiting Internet Research Ethics,” an entry in the Stanford Encyclopedia of Philosophy entitled 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 Master’s and PhD from the University of Wisconsin-Milwaukee.
ROBERT KLITZMAN, MD, is a professor of psychiatry at the College of Physicians and Surgeons and the Joseph Mailman School of Public Health, and the Academic Director of the Master of Science in Bioethics program at Columbia University. He cofounded and for five years co-directed the Columbia University Center for Bioethics, and directed the Ethics and Policy Core of the HIV Center for 10 years. He has published over 120 scientific journal articles, eight books, and numerous chapters on critical issues in bioethics including genetics, neuroethics, HIV prevention, research ethics, and doctor-patient relationships. His books include When Doctors Become Patients, A Year-Long Night: Tales of a Medical Internship, In a House of Dreams and Glass: Becoming a Psychiatrist, Being Positive: The Lives of Men and Women With HIV, The Trembling Mountain: A Personal Account of Kuru, Cannibals and Mad Cow Disease, Mortal Secrets: Truth and Lies in the Age of AIDS (with Ronald Bayer), Am I My Genes? Confronting Fate and Other Genetic Journeys, and The Ethics Police?: The Struggle to Make Human Research Safe.
FARIBA HOUMAN, PhD, CIP, is the Research Compliance Officer at Boston Children’s Hospital. Previously, Fariba directed the Human Research Protections Program at Massachusetts Eye and Ear, and served as Associate Director of the Human Subjects Administration office at the Harvard T. H. Chan School of Public Health where she began her administrative career as Project Manager in the Department of Immunology and Infectious Diseases. Fariba received her Ph.D. in microbiology and molecular biology from Tufts Sackler School of Graduate Biomedical Sciences. Fariba did her postdoctoral work in yeast genetics as a Jane Coffin Childs fellow at The Harvard Biological Laboratories, and then conducted drug discovery research at Cubist Pharmaceuticals and Microbia Inc., two Boston-area biotechnology companies. Fariba was a 2015-2016 Fellow at the Center for Bioethics at Harvard Medical School.
JULIE SIMPSON, PhD, is the Director of Research Integrity Services (RIS) at the University of New Hampshire (UNH) and an Affiliate Assistant Professor of College Teaching and of Education. Her office administers UNH’s human subjects protections, humane care and use of animals, and responsible conduct of research and scholarly activity (RCR) programs, as well as UNH’s financial conflict of interest in research (FCOIR) and HIPAA programs. She is a member of UNH’s IRB, IACUC, RCR Committee and UNH’s Radiation Safety Committee. She has participated in research misconduct inquiries and investigations at UNH, and at a sister institution. She co-developed and co-teaches UNH’s GRAD 930: Ethics in Research and Scholarship, a cross-disciplinary graduate seminar. She was the UNH project director for an ORI grant to develop web-based RCR training materials, and administered UNH’s ORI/Council of Graduate School’s RCR grant. She has presented workshops on research integrity issues nationally, and regularly presents in UNH classes on a variety of research integrity topics.
MARLEY J THRASHER, DUKE UNIVERSITY has spent the last 17 years of her career moving into higher levels of responsibility in the learning and development (L&D) field. She has unique experience leading global training programs for public (NIH), private (AIG), not-for- profit (PRIM&R) and academic (NC State) organizations and is keenly adept at applying adult learning theory relevant to different learning cultures worldwide. Since 2009, Marley has focused on L&D for the research environment, working across multiple groups to create, facilitate and direct training for researchers, research staff, federal employees and other research professionals.
CHRIS MANGELLI is the Director, Office of Research Integrity (ORI) at Ball State University (BSU), in Muncie, IN. The BSU ORI is an integrated research and regulatory affairs office overseeing many areas, including the IRB, IACUC, IBC, RCR, Export/Deemed Export Control, COI/COC, and lab safety. Chris has a Juris Doctor (JD) degree from the University Of Maine School of Law and has three Masters degrees. In addition, Chris serves as the Chairperson for BSU’s Laboratory Safety and Security Committee and is BSU’s Chief HIPAA Privacy Officer.
CECE BROTCHIE-FINE, BS, MA, CPIA is now in her second decade of work in the pre-clinical research field, CeCe Brotchie-Fine has held diverse roles from husbandry through administration. She began her research journey working in the nutrition laboratory of the Smithsonian’s National Zoological Park assisting with research on the metabolism of the Mojave Desert Tortoise (Gopherus agassizii). She first became involved with IACUCs during a position with a start-up biotech company. Her current role is Associate Director, Global Animal Welfare Compliance Due Diligence at Novartis Institutes for BioMedical Research in Cambridge, MA, where she is also the IACUC Chair. She has received a B.S. in Animal Science from the University of Massachusetts and M.A. in Psychology from Lesley University, and is currently enrolled in the M.S. in Bioethics program at Columbia University. CeCe is also a Certified Professional IACUC Administrator. For 7 years, she was the course facilitator for MSMR’s On-Line Training Program for IACUC Members, and enjoys mentoring those new to the field.
ELIZABETH J MCEVOY, Esq., BARRETT & SINGAL, is a partner in the firm’s Litigation practice. Her practice focuses on healthcare litigation, corporate and commercial civil
litigation, white-collar criminal defense, scientific research misconduct cases, and professional licensing matters. Elizabeth’s civil practice focuses on complex business disputes, and specifically, those disputes arising in Massachusetts’ growing healthcare industry. She represents individuals, LLCs, PLLCs, and other entities in navigating a host of business disputes, including partnership disputes, corporate buy-outs, and related claims for breach of contract and violations of the Massachusetts Wage Act. Elizabeth’s criminal work focuses on white-collar criminal defense and government investigations. She represents individuals under government scrutiny for possible conspiracy and substantive mail/wire fraud charges as well as individuals and entities charged with violations of a variety of federal fraud statutes. Elizabeth also spends a significant portion of her practice representing individuals and institutions involved in research misconduct matters. She represents individual scientists accused of fabricating and/or falsifying data from the pre-inquiry stage through the inquiry, investigation, and administrative disciplinary stages as well as before the Office of Research Integrity (ORI). She also counsels institutions at all stages of the institutional investigation of reported research misconduct.
KATHRYN A. HOLTHAUS, MS, MA, DIRECTOR OF RESEARCH SUBJECTS PROTECTION AND LABORATORY SAFETY COMPLIANCE, RESEARCH ADMINISTRATION AND COMPLIANCE, BRIGHAM AND WOMEN’S HOSPITAL Kathryn’s focus is on maintaining compliance and safety in animal and human subjects research programs through proactive initiatives, such as education and training for researchers and creation of institutional policy and guidance to close gaps in existing processes. Kathryn obtained her MS in ‘Animals and Public Policy’ at Tufts University Cummings School of Veterinary Medicine in 2008, her MA in ‘Developmental Psychology and Education’ and her BS in Biology, both from Boston College. She was Co-director of the Undergraduate Teaching Laboratories at Boston College where she designed curriculum for and oversaw laboratories in molecular biology, genetics, and general biology. In the past, she has also utilized both zebrafish and murine models in cancer and matrix biology research programs at Beth Israel Deaconess Medical Center.
MICHELLE FEIGE, MSW, LCSW-C is the Executive Vice President of the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). As a member of AAHRPP’s senior management team, Ms. Feige assists the President and CEO of AAHRPP by providing strategic and substantive contributions to all aspects of AAHRPP’s operations. Prior to joining AAHRPP, Ms. Feige served as the Acting Director and Senior Public Health Advisor in the Division of Education and Development at the Office for Human Research Protections (OHRP) from 2007-2015, where she provided the research community with guidance and education regarding the DHHS regulations. From 1999-2007, Ms. Feige worked at the National Institute of Mental Health as a founding member of a novel program designed to protect research subjects with severe psychiatric illnesses. Ms. Feige also spent several years as a study coordinator at Georgetown University Hospital. Ms. Feige has spoken extensively, both nationally and internationally, on issues related to human research protections and AAHRPP accreditation, and has chaired and served on numerous committees. Ms. Feige has served as PRIM&R faculty member since 2007, participated in PRIM&R’s Workshop/Didactic Subcommittee (WDSC) since 2014, and WDSC Co-Chair in 2018 and 2019. Ms. Feige received her MSW from the University of Michigan and her BA from the University of Wisconsin.
MS. SUMMERS has been AAHRPP’s President and CEO since October 2013. She provides strategic and substantive leadership and oversight on all aspects of AAHRPP’s operations and is looking forward to leading AAHRPP well into the 21st century as the indispensable global organization for the accreditation of human research protection programs. Prior to AAHRPP, Ms. Summers was the Director of the Division of Education and Development at the US Department of Health and Human Services’ Office for Human Research Protections (OHRP), a position she held from 2008-2013. Ms. Summers first began working for OHRP’s predecessor organization (the Office for Protection Research Risks [OPRR]), in 1998, first in the Division of Compliance Oversight and then in the Division of Education. Prior to joining OPRR/OHRP, Ms. Summers practiced law pertaining to food, drugs, and other medical products (Buc & Beardsley). Included in her practice was the provision of guidance and counseling on Federal and State law, regulations, and ethical issues related to the conduct of biomedical research. Prior to that, Ms. Summers spent five years in the Office of the Commissioner at FDA, as Special Assistant to the Deputy Commissioner for External Affairs, and later as an original staff member of FDA’s Office of Women’s Health. Ms. Summers has spoken extensively and published several articles and book chapters on biomedical and behavioral research and human research protections. She has also practiced the law of tax-exempt organizations (with, respectively, Baker and Hostetler, and, Steptoe and Johnson), and has spoken and written on that topic as well. Ms. Summers began her career at the Association of American Universities, representing research universities. She earned her J.D. from the George Washington University National Law Center and her B.A. from the University of Michigan. She is a member of the Bar of the District of Columbia and of the Commonwealth of Pennsylvania.
DR. STACY PRITT is the Assistant Vice President for Conflict of Interest and the IACUC at the University of Texas Southwestern Medical Center in Dallas. In this capacity, she oversees regulatory compliance for one of the largest research programs in the United States. Dr. Pritt holds a BS in Biology from the California State Polytechnic University at Pomona, a DVM from Washington State University, a MS in Managerial Science, and an MBA in Healthcare Management. She is a Certified Professional IACUC Administrator (CPIA), is Certified in Health Care Research Compliance (CHRC), and is a diplomate of the American College of Animal Welfare (ACAW). During her career, Dr. Pritt has held positions in both academia and industry. She has served as Associate Director for Animal Care, Training, and Operations at the Harvard Medical School and was the Director of Regulatory Compliance and Animal Welfare at Covance, Inc. Dr. Pritt is a nationally recognized authority on regulatory compliance, training, and IACUC operations. She is a recipient of numerous awards including the TurnKey Leader of the Year Award (2012), LAMA Ron Orta Memorial Award for an Outstanding Presentation (2015), LAWTE Founders’ Award (2015), and the AALAS George R. Collins Education and Training Award (2016). Her leadership positions in professional associations includes chairing three different AALAS Committees (OLC, Nominations, PDCC), serving as President for the Laboratory Animal Welfare Training Exchange (LAWTE), and serving as Vice President for the American Veterinary Medical Association (AVMA). Currently she serves on the Board of Directors for ASLAP, AMP, and ACAW. In 2020, she will become President of ACAW. She is also the author of dozens of publications on management, training, IACUC management, and animal welfare.
LISA DESANTES, BS, CIP received a Bachelor of Science degree from the University of Pittsburgh and began her career in research at the Department of Veterans Affairs, moving to the University of Pittsburgh a few years later. Lisa is currently a Research Review Specialist with the University of Pittsburgh Human Research Protections Office (HRPO), specializing in the management of greater than minimal risk studies. In her senior position in the HRPO, she has been an integral part of several process improvement task forces, including data security and modification management and has over 15 years in research compliance experience. She received her Certification for IRB Professionals in the spring of 2011.
DR. CORBIN is a law-trained social scientist with a Ph.D. in Justice Policy who recently authored Dilemma of Duties: the conflicted role of juvenile defenders. This book is based on her original research examining ethical obstacles to juvenile defense work and how juvenile defenders use social capital to navigate these obstacles. Her research has historically applied an industrial/organizational psychology lens to compliance matters among justice system professionals and includes several years as a Senior Research Consultant with The Police Foundation. Her current professional work involves training government leaders on relevant matters such as: ethics, information responsibility, civility in the workplace, harassment prevention, and effective supervision.
ROSS HICKEY, JD, CIP, CPIA, is the Assistant Provost for Research Integrity at University of Southern Maine. Ross is coordinating USM’s work in the New England Ocean Cluster (NEOCH). He is an attorney and a member of the Maine Bar. Ross has built a nationally recognized research compliance office that serves not only USM, but institutions throughout the State of Maine. Ross is contacted on a regular basis provide technical assistance to other local institutions on regulatory compliance matters.
DR. BECKY ARMSTRONG began her Research Administration and Compliance career at Purdue University overseeing human and animal subjects research administrative units, and the Institutional Biosafety Committee. For the last 15 years, as Director of Research Subject Protection at the University of California Berkeley (UCB), she has had a leadership role in ensuring that UCB maintains and continuously improves its research compliance programs and activities across human, animal, responsible conduct of research and stem cell research as well as facilitating coordination across campus with Environmental Health & Safety (biosafety, radiation and laser safety) to minimize administrative burden for faculty and ensure ethical and compliant research and teaching activities. Dr. Armstrong currently serves as a voting member of the IRB, IACUC, SCRO and IBC. UCB is a world-class research institution engaged in primarily social-behavioral human subjects research (no medical school) and a moderately sized animal care and use program with a strong field research component.
VICTOR CUEVAS is the Regulatory Compliance Manager at The Jackson Laboratory. Victor has been with JAX for 11 years and oversees the day-to-day activities for the Institutional Animal Care and Use Committees, the Institutional Biosafety Committee and regulatory compliance. Victor has over 22 years total experience in the research regulatory field. Victor is a Registered Laboratory Animal Technician (RLAT) with AALAS and is also a Certified Professional in IACUC Administration (CPIA) with PRIMR. He has worked in the regulatory field for over xx years and holds a Bachelor of Science degree from California State University Sacramento.
KELE PIPER, MS, CIP, CHRC is a leading expert in research compliance with over 20 years of experience. In Kele’s current role at Massachusetts General Hospital, a Harvard affiliate hospital, she serves as Director of Research Compliance. In this role, her primary responsibilities are to manage and oversee the research compliance program which includes bench, animal, and human subjects research. Current initiatives include research misconduct, controlled substances, lab safety, export control, and research billing. In recent years, she has spoken at conferences for organizations such as HCCA, PRIM&R, MSMR, MaHIMA, and the AAMC on topics such as controlled substances, international research, ClinicalTrials.gov, risk-based monitoring, and research documentation in the electronic medical record. Recruited to Boston by Beth Israel Deaconess Medical Center (BIDMC) as Director of Research Compliance, Kele lead the initiative at BIDMC to develop infrastructure and compliance with ClinicalTrials.gov. BIDMC was acknowledged as the most improved institution in the Nation. Other major initiatives included infrastructure and process improvements in the areas of controlled substances, international research, minors in research laboratories, personal protective equipment (PPE), and phlebotomy in non-clinical spaces. In her previous role with Children’s Hospital Colorado, she led an initiative to create a process to assess institutional risk as it related to research as well as review and monitor QI ultimately reducing the burden on the local IRB. Over the last 10 years, Kele has been part of a research team that works to improve screening and detection of thyroid cancer. This work has been published in several scientific journals. In addition, Kele has been published in Compliance Today and authored the Export Control chapter in HCCAs Research Compliance Handbook.
DEREK ADAMS is a partner in FTLF’s Litigation and Government Investigations practice group and focuses on False Claims Act defense. Mr. Adams represents universities, colleges, companies, individuals, non-profit and for-profit organizations, and local governments facing a variety of investigations and legal actions under the False Claims Act, and related statutes. Prior to joining FTLF, Mr. Adams served as a Trial Attorney with the Department of Justice, Civil Fraud Section, where he worked on numerous complex cases under the False Claims Act and the Financial Institutions Reform, Recovery, and Enforcement Act of 1989. In under five years, Mr. Adams recovered more than $2 billion for the taxpayers through his work. Mr. Adams speaks and writes regularly about the False Claims Act, and is often quoted by reporters as a subject matter expert on issues pertaining to the False Claims Act.
MONTANA MILLER is Bowling Green State University’s Research Compliance Officer, with 15 years of IRB experience including serving as PRIM&R faculty (including at the 2019 Advancing Ethical Research conference in Boston) teaching sessions on ethnography and Internet research ethics. As Associate Professor in BGSU’s Department of Popular Culture, Dr. Miller specializes in ethnographic research methods and ethics, with a particular interest in perceptions of risk; her courses include Youth Culture, Internet Culture, and Health, Addiction, & Culture. She is the author of “Face to Face with the Digital Folk: The Ethics of Fieldwork on Facebook,” the concluding chapter of Trevor Blank’s 2012 volume Folk Culture in the Digital Age: The Emergent Dynamics of Human Interaction. Dr. Miller holds a bachelor’s degree from Harvard University and a Masters and PhD from UCLA.
JANE A. MCCUTCHEON, PhD, became a member of the New York University IRB in 2000 and have been involved in issues related to human subjects since that time. I have implemented a robust research education program for the New York University Washington Square Campus on issues relating to using humans as subjects. AT NYU I have provided seminars on using humans and animals as subjects and research misconduct seminars. As a member of the FDP, am the co-chair of the human subjects research subcommittee. I instigated the “Wizard” project a smart form that allows investigators to self-determine exempt status. Phase I of the project has been completed and we are moving forward with phase II of the project.
CASSANDRA (CASSIE) MYERS, CIP, is the Director for the Office of Human Research Ethics at UNC-Chapel Hill. Myers has over 15 years’ experience in health care and IRB administration; managing Institutional Review Board’s (IRB), developing clinical guidelines, and leading process improvement efforts. Myers is a graduate of The University of Minnesota in Health Management.
MIKE MATAMOROS, CIP, is the Quality Improvement/Assurance Manager for the Office of Human Research Ethics at UNC-Chapel Hill. Matamoros has over 11 years’ experience in IRB administration, quality improvement/assurance, and systems implementation. Matamoros is a graduate of The University of Texas at San Antonio with a Master of Science in Experimental Psychology.
JOHN ROBERTS, CIP, is the Reliance/Compliance Manager for the Office of Human Research ethics at UNC-Chapel Hill. Roberts has over 19 years’ experience in IRB administration, reliance management and research administration. Roberts is a graduate of Duke University in Environmental Science and Policy.
HEATHER LARSEN, MEd, Research Specialist, Tribal Research Office, Sisseton-Wahpeton Oyate. Heather Larsen is an enrolled tribal member of the Sisseton-Wahpeton Oyate (SWO) of the Lake Traverse Reservation located in the northeast corner of South Dakota and the southeast corner of North Dakota. Ms. Larsen earned her Master of Education degree from South Dakota State University in the Counseling and Human Development program, specializing in the Administration of Student Affairs. She completed her undergraduate degrees at the University of Minnesota, Morris, with B.A. degrees in American Indian Studies and Liberal Arts for the Human Services. She also earned an Associate of Arts in General Studies while attending her own tribal college, the Sisseton Wahpeton College. She graduated high school from a Native American boarding school named the Flandreau Indian School. Since 2015, Ms. Larsen has worked as the Research Specialist in the Tribal Research Office where her primary role is to provide oversight for all research activities conducted on the Lake Traverse Reservation. In her current work, she develops and promulgates policies and procedures surrounding research protections and data management using a culturally-appropriate framework. She serves as the administrator of the SWO Local Research Review Board (Tribal IRB) where she continues to build the research infrastructure for her tribal nation.
WILLIAM “WILL” SO, PhD, is currently a Policy & Program Specialist with the Federal Bureau of Investigation’s (FBI) Weapons of Mass Destruction (WMD) Directorate, Biological Countermeasures Unit. In this capacity Will provides subject matter expertise, in the field of biological sciences, for matters dealing with FBI policy, national policy, response planning, and biosecurity. He has been in this position for the past four years, after serving one year as an Intelligence Analyst, and an additional one year prior to that as a Physical Scientist in FBI’s Laboratory Division. Will received his Ph.D. in Environmental Toxicology in 2005 and a Master of Science in Ecology from The George Washington University in 1997. Dr. So’s experience includes policy, strategic guidance, and concept-of-operations related to biological crimes for both the FBI and the United States Government. He assisted and then later served as the project lead providing training on the Joint Criminal and Epidemiological Investigations model to over 3000 local, State, and Federal law enforcement and public health investigators. In recognition, he received two Merit Awards from the WMD Directorate. Will’s current projects include bridging the gap between researchers/academics and law enforcement/security officials in matters related to biosecurity, dual-use, and pathogen security.
MICHAEL NEAFSEY, DVM, MPH, Assistant Director Of Field Operations at USDA Animal and Plant Health Inspection Service (APHIS)- Animal Care, is an accomplished veterinarian with a Masters of Public Health who exemplifies partnership, outreach and commitment. Skilled veterinarian with hands-on experience in the animal welfare, public health and safety, identification and control of zoonotic pathogens, field epidemiology, animal disease and outbreak and laboratory biologics. Dedicated public health professional with proven ability to develop comprehensive regulatory programs to increase animal and public health. Strong communicator committed to excellence.
JIM NEWMAN serves as director of strategic communications for Americans for Medical Progress, where he leads AMP’s media and communications programs and is the editor of Amplify Advocacy, a monthly newsletter focused on outreach, and AMPNews, a weekly subscription newsletter about research communications and security. Prior to joining AMP as an employee, Jim served on the organization’s Board of Directors for several years. In the past, Jim was the director of external communications for The University of Texas MD Anderson Cancer Center and the director of media relations for Oregon Health & Science University and OHSU’s Oregon National Primate Research Center. Throughout his 13+ years at OHSU, Jim managed communications to counter claims and actions by several animal rights groups including PETA, In Defense of Animals, Stop Animal Exploitation Now and the Animal Liberation Front. This work included directing proactive and reactive communications following two activist infiltrations of the Oregon National Primate Research Center, two ALF attacks, the harassment of scientists and their families at their homes and countless protests. Jim has also worked as an account supervisor at KGBTexas Communications, a highly-regarded PR and marketing firm in Texas, with offices in San Antonio and Houston.
Jim’s professional experience includes nearly a decade of work as a television news producer in the following media markets: Portland, Oregon; Nashville, Tennessee; South Bend, Indiana; and Lansing, Michigan. Jim graduated from Michigan State University with a bachelor’s degree in telecommunications. He has been a member of the National Association of Science Writers and the Public Relations Society of America.
MARY BETH KOZA is the retired Executive Director of the Department of Environment, Health & Safety for The University of North Carolina at Chapel Hill. She led an organization which has the responsibility for developing innovative EHS programs via an integrated management system. She and her team translated complex EHS regulatory requirements and builds and maintains strong credible relationships with colleagues and outside agencies. She was the Responsible Official, with oversight for 5 high containment laboratories. In 2017, the University’s Risk Management function became part of her organization where she worked on Enterprise Risk Management. She is currently active in the American Chemical Society as the Chair Elect for the NC local Section, Treasurer for the Division of Chemical Health and Safety and a member of the Committee on Science. She has 40 years’ experience in the environment, health, and safety field, and was previously the Director of EHS at Bristol-Myers Squibb Co. She holds a Bachelor of Arts/Chemistry from Kean University and an MBA in Pharmaceutical Science from Farleigh Dickinson University.
SHERRIE SETTLE has served as Director of Sponsored Programs for North Carolina State University since 2016. Her 28 years of research administration experience includes college, central office, pre-award and compliance roles with Virginia Tech, the University of North Carolina at Chapel Hill, and the North Carolina Department of Health and Human Services. Sherrie holds a BA from the University of Virginia and an MHA and MBA from the University of Pittsburgh, where she first learned that there was such a thing as research administration.
JENNIE OFSTEIN serves as the IRB Director for NC State University. She received her undergraduate degree in English Literature and Religion from Florida State University and her Master’s Degree from NC State University in Higher Education Administration. She is currently finishing up her PhD in Educational Policy and Leadership. Jennie is a social justice educator and a practical ethicist. She practices these perspectives through facilitating review and approval for research with human subjects at NC State. Her areas of expertise lie in social-behavioral research, organizational effectiveness, equity, policy, accountability, and managing gray areas of ethics and compliance.
ROBIN CYR has over twenty years of experience in research administration. In March 2020, Cyr will be the Vice Provost, Research Administration at Northeastern University. Before taking this position she was the Research Compliance Officer and Associate Vice Chancellor for Research at the University of North Carolina at Chapel Hill. Cyr has also held the dual role of Associate Vice Chancellor for Research and Director of the Office of Sponsored Research. She came to UNC in 2012 from Partner’s HealthCare system in Boston, MA, where she was director of training and policy in the Department of Research Management. Prior to being promoted into that position, she had served as their director of grants and contracts, serving Brigham and Women’s Hospital since early 2004. Cyr began working in research administration as a grant and contract officer in the Office of Sponsored Programs at Cornell University in 1997 before being promoted to associate director of the office, responsible for staff training and the negotiation of all industry sponsored agreements and material transfer agreements for the university. Before her transition into research administration, Cyr held several key positions over fifteen years in human and social services. She is a graduate of Virginia Intermont College in Bristol, VA, where she dual majored in psychology and sociology. Cyr has successfully obtained the credential of certified compliance and ethics professional (CCEP) and recently accepted an advisory board member position for the World Research Centre.