Faculty
IRB 101sm
Leonard Glantz, JD, is professor of health law at the Boston University (BU) School of Public Health, professor of sociomedical sciences and community medicine at the BU Medical School, and professor of law at the BU Law School. Professor Glantz is the author of numerous books, articles, reports, and appellate briefs on medico-legal issues. He has spent much of his career examining issues related to the protection of human subjects. He is the author and/or editor of two books: Informed Consent to Human Experimentation with George Annas and Barbara Katz (1977) and Children as Research Subjects: Science, Ethics and Law, co-edited with Michael Grodin (1994). He has been an IRB member for over 25 years. His current research interests include reproductive rights, rights of the terminally ill, the regulation of research with human subjects, children's rights, the constitutional limits of public health regulation, and the legal aspects of AIDS. Professor Glantz is currently the chair of PRIM&R’s Board of Directors.
Susan Kornetsky, MPH, CIP, is the director of clinical research compliance at Children’s Hospital in Boston, MA. For the past 23 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 subjects research, establishing appropriate policies and procedures, and overseeing a quality improvement program for human research protections.
Ms. Kornetsky is a past member of the Secretary’s Advisory Committee of Human Research Protection (SACHRP) and serves as the co-chair for the pediatric committee of SACHRP. She is a past member of the National Human Protection Advisory Committee, and past president for the Applied Research Ethics National Association (ARENA), PRIM&R’s former membership division. She is a past Board member of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and is a current site visitor. She also served on the Council for Certification of IRB Professionals (CCIP), an initiative of PRIM&R. She was a member of the Institute of Medicine’s Committee on Clinical Research Involving Children.
Ms. Kornetsky is faculty for PRIM&R’s At Your Doorstep programs, an educational effort established by PRIM&R to bring IRB training to individual institutions. She lectures at many national meetings and has served as a consultant on an Office for Human Research Protections (OHRP) site visit team. Ms. Kornetsky has been a PRIM&R Board member since 2001, previously serving as
vice chair.
IRB Administrator 101
Elizabeth Bankert, MA, is the assistant provost at Dartmouth College. Prior to accepting this position in January 2006, Ms. Bankert was the director of the IRB at Dartmouth College - Dartmouth Hitchcock Medical Center for over 10 years. As the designee for the institutional official, she works closely with the IRB office and also oversees other areas of research specifically related to compliance issues.
Ms. Bankert is a past president of the Applied Research Ethics National Association (ARENA), PRIM&R’s former membership division, and a member of the faculty for PRIM&R’s At Your Doorstep programs. Ms. Bankert has made numerous presentations at institutions throughout the country as an invited speaker on topics ranging from adverse event reporting to research involving incompetent patients. She is also the co-editor of the book entitled IRB: Management and Function, which was first published in October 2002. This book is a compilation of the works of over 80 authors providing expertise on many topics in the realm of research with human subjects. The second edition of the book was released in December 2005.
Via the National Institutes of Health (NIH) Enhancement Grant and through collaboration with Robert (Skip) Nelson, MD, at Children's Hospital of Philadelphia, Ms. Bankert initiated the development of the web-based tool IRBNet. The primary mission of IRBNet is to create an effective and efficient means of education and communication between sponsors, IRBs, and researchers with the goal of enhancing and streamlining the processes involved with research involving human subjects. IRBNet can be found at www.irbnet.org.
Susan Kornetsky, MPH, CIP, is the director of clinical research compliance at Children’s Hospital in Boston, MA. For the past 23 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 subjects research, establishing appropriate policies and procedures, and overseeing a quality improvement program for human research protections.
Ms. Kornetsky is a past member of the Secretary’s Advisory Committee of Human Research Protection (SACHRP) and serves as the co-chair for the pediatric committee of SACHRP. She is a past member of the National Human Protection Advisory Committee, and past president of ARENA. She is a past Board member of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and is a current site visitor. She also served on the Council for Certification of IRB Professionals (CCIP), an initiative of PRIM&R. She was a member of the Institute of Medicine’s Committee on Clinical Research Involving Children.
Ms. Kornetsky is faculty for PRIM&R’s At Your Doorstep programs, an educational effort established by PRIM&R to bring IRB training to individual institutions. She lectures at many national meetings and has served as a consultant on an Office for Human Research Protection (OHRP) site visit team. Ms. Kornetsky has been a PRIM&R Board member since 2001, previously serving as
vice chair.
IBC Basics
Kathryn L. Harris, PhD, RBP, is the senior outreach and education specialist (contractor) for the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA). The NIH OBA promotes science, safety, and ethics in biotechnology through advancement of knowledge, enhancement of public understanding, and development of sound public policies. Dr. Harris joined the NIH OBA in 2004. One of her current roles within the organization is to develop national and regional programs of stakeholder relations, education, and outreach strategies relevant to the oversight of recombinant DNA research. In addition, she advises on biosafety issues. Prior to joining the NIH OBA, Dr. Harris was the biological safety officer at Northwestern University. Dr. Harris is a registered biosafety professional and a member of the American Biological Safety Association (ABSA). She was a founding member and the first president of the Midwest Area Biosafety Network (MABioN).
Allan C. Shipp, MHA, is the director of outreach for the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA)and is responsible for establishing improved lines of communication with investigators, sponsors, and institutional biosafety committees (IBCs). He planned the first NIH conference on policy issues concerning IBCs, organized the first national professional development conference for staff and members of IBCs, spoke at workshops and meetings on NIH’s oversight of human gene transfer research, organized focus groups for public consultation on the design of a database on human gene transfer research, initiated electronic communications tools to disseminate information about the NIH OBA, and served as a key point of liaison between senior NIH staff and the extramural community. Mr. Shipp also works on a range of policy issues, including the oversight and regulation of clinical research and various forms of biotechnology. Before coming to the NIH OBA, Mr. Shipp was assistant vice president for Biomedical and Health Sciences Research at the Association of American Medical Colleges (AAMC), where he worked on an array of policy issues including biotechnology, scientific integrity, research training, and human subjects research. Mr. Shipp was also principal investigator on a project with the Howard Hughes Medical Institute to evaluate the career outcomes of pre-doctoral and post-doctoral fellows. Mr. Shipp is a former member of PRIM&R’s Board of Directors.
Essentials of IACUC Administration
Molly Greene is at Michigan State University, advising the IACUC and other members of the animal care program team. She assisted with the successful effort to achieve campus-wide Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation in 2006. Ms. Greene has been consulting on IACUC issues and providing IACUC training since 1992. She was coordinator of the IACUC at the University of Texas Health Science Center at San Antonio from 1986-2003.
In addition to co-developing and co-presenting PRIM&R’s Essentials of IACUC Administration course, she is a member of the Council of Certified Professional IACUC Administrators (CPIA). Ms. Greene serves as an ad hoc specialist for AAALAC and the board of the Michigan Society for Medical Research (MISMR), and is a past member of the governing bodies of Applied Research Ethics National Association (ARENA), Scientist Center for Animal Welfare (SCAW), and Americans for Medical Progress (AMP). She received Distinguished Service Awards from ARENA and the Texas Society for Biomedical Research. In addition, Ms. Greene was chair of the 1999 American Association for Laboratory Animal Science (AALAS) ad hoc subcommittee that developed IACUC 101. She was also a member of the 1998 NIH Study on Regulatory Burden Planning Workgroup and the Animal Care and Use Workgroup.
Marky Pitts served as director of the Animal Subjects Program, University of California San Diego (UCSD) from 1984-2004, and as director of Animal Research Outreach in UCSD’s Public Information Office. She was also a member of the NIH Study on Regulatory Burden Planning Workgroup and the Animal Care and Use Workgroup in 1998. Ms. Pitts has presented on various animal research-related issues at conferences for PRIM&R, the Scientist Center for Animal Welfare (SCAW), the American Association for Laboratory Animal Science (AALAS), the Council for the Advancement and Support of Education, the Society for Neuroscience, the Society of Research Administrators (SRA), the National Council of University Research Administrators (NCURA), and UCSD. She has also published articles in Lab Animal. From 1995-2005, Ms. Pitts served on the VA San Diego Healthcare System IACUC.
Ms. Pitts has been an active member of PRIM&R through her participation as co-developer and co-presenter of the Essentials for IACUC Administration program, by serving as the organization’s liaison on the AAALAC Board of Trustees, by co-chairing PRIM&R’s IACUC conference planning committees, through her work as a co-founder of IACUC 101, by chairing the editorial committee for the ARENA/OLAW IACUC Guidebook, 2nd edition, and through her tenures as first a vice president (1991), and then president (1992) of ARENA. Ms. Pitts has served on the PRIM&R Board of Directors since 1998. In addition, she serves as a consultant to universities, organizations, and companies on IACUC issues, as an AAALAC International ad hoc consultant/specialist, and as a NIH site visitor.