Faculty
IRB 101sm
Susan Kornetsky, MPH, CIP is the Director of Clinical Research Compliance at Children’s Hospital in Boston. For the past 20 years, her responsibilities include directing an IRB administrative office, educating principal investigators regarding IRB regulations, assisting investigators with protocol development, assuring institutional compliance with all federal and state regulations pertaining to human research, establishing appropriate policies and procedures and overseeing a quality improvement program for human research protections. She is a current 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). She is a current Board member of the Association for the Accreditation of Human Research Programs. She has served on the Council for Certification of IRB Professionals (CCIP), and was a member of the Institute of Medicine’s Committee on Clinical Research Involving Children. She is faculty for PRIM&R’s IRB 101, and co-developer of IRB Administration 101. Ms. Kornetsky lectures at many national meetings and has served as a consultant on an Office of Protection from Research Risks (OPRR) site visit team. Ms. Kornetsky was Vice Chair of PRIM&R’s Board of Directors from 2005-2007.
Paula Knudson, CIP is Special Advisor to the Vice President of Research at the University of Texas Health Sciences Center, Houston. She was the Executive Secretary of the Committee on the Protection of Human Subjects at the University of Texas Health Sciences Center, Houston for 26 years. Ms. Knudson has served on the Planning Committees and faculties of almost every Annual HRPP Conference that PRIM&R has hosted, and has been instrumental in organizing four successful PRIM&R conferences in Houston. Ms. Knudson was instrumental in providing commentary on the emergency waiver provision of 45 CFR 46, and has similarly been sought after by OPRR, OHRP, and the FDA when new regulations or guidances are being considered. She has many areas of interest within the human subjects protection field, among them are community consultation, HIV/AIDS, international research, payment to subjects for participation, and conflicts of interest, and special populations, including ethnic minorities. Ms. Knudson is a member of the IRB 101 faculty and is one of a small number of IRB professionals who will consistently take the time to mentor new IRBs and new IRB Administrators. She has even set up and helped nurture several IRBs in and around Houston, including one in Tijuana, Mexico.
IRB Administrator 101
Susan Kornetsky, MPH, CIP is the Director of Clinical Research Compliance at Children’s Hospital in Boston. For the past 20 years, her responsibilities include directing an IRB administrative office, educating principal investigators regarding IRB regulations, assisting investigators with protocol development, assuring institutional compliance with all federal and state regulations pertaining to human research, establishing appropriate policies and procedures and overseeing a quality improvement program for human research protections. She is a current 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). She is a current Board member of the Association for the Accreditation of Human Research Programs. She has served on the Council for Certification of IRB Professionals (CCIP), and was a member of the Institute of Medicine’s Committee on Clinical Research Involving Children. She is faculty for PRIM&R’s IRB 101, and co-developer of IRB Administration 101. Ms. Kornetsky lectures at many national meetings and has served as a consultant on an Office of Protection from Research Risks (OPRR) site visit team. Ms. Kornetsky was Vice Chair of PRIM&R’s Board of Directors from 2005-2007.
Ada Sue Selwitz, MA, is responsible for assisting the University of Kentucky in developing institutional policies pertaining to a variety of compliance issues such as protection of human subjects, scientific misconduct, humane care and use of animals, and data retention. Ms. Selwitz received her Masters Degree from the University of Kentucky College of Communications and completed her qualifying exams for doctorate in Higher Education at the University. Since 1978, she has worked at the University of Kentucky Research Foundation in a variety of roles including Director of Sponsored Program Development. Since 1999, Ms. Selwitz has been Director of the Office of Research Integrity. Ms. Selwitz has an Adjunct Associate Professor appointment in the Department of Behavioral Sciences in the College of Medicine.
Ms. Selwitz has co-authored publications and given over 100 national/state presentations. Ms. Selwitz has been involved in nine extramurally funded research projects funded by the National Institutes of Health, the Scientist Center on Animal Welfare, and the National Science Foundation. Ms. Selwitz has served a leadership role within the state and nation through her participation in several national and federally sponsored education and policy development initiatives. She served on the Department of Health and Human Services Advisory group on the Public Health Service Responsible Conduct of Research policy, the NIH Regulatory Burden Committee, and chaired the NIH Regulatory Burden Human Research Protections Subcommittee. Ms. Selwitz was co-faculty in the Investigator 101 CD-ROM, which has been distributed by the Office of Human Research Protections to all institutions with assurances. She co-founded and developed PRIM&R’s At Your Doorstep programs, which provide fundamental education on human research protections. Ms. Selwitz is a University of Kentucky Fellow and a native of Kentucky.
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 AAALAC accreditation in 2006. Ms. Greene has been consulting on IACUC issues and providing IACUC training since 1992. She was coordinator of the Institutional Animal Care and Use Committee at the University of Texas Health Science Center at San Antonio from 1986-2003.
In addition to co-developing (with Ms Pitts) 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 on 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 National Institutes of Health (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 National Institutes of Health (NIH) Study on Regulatory Burden, Animal Care and Use Workgroup in 1998. Ms. Pitts has presented on various animal research-related issues at conferences for PRIM&R, the Scientists Center for Animal Welfare (SCAW), the American Association for Laboratory Animal Science (AALAS), the Council for the Advancement and Support of Education, Society for Neuroscience, Society of Research Administrators, National Council of University Research Administrators, and UCSD. She has also published articles in Lab Animal Magazine. From 1995-2005, Ms. Pitts served on the VA San Diego Healthcare System IACUC. Currently, she is a member of the Zoological Society of San Diego’s IACUC.
Ms. Pitts has been an active member of PRIM&R through her participation, with Molly Greene, on 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 a NIH site visitor.
Questions?
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