Speaker Bios

 

SPEAKERS

Sarah Archibald, Ph.D.
Research Integrity Officer
University of Maryland, Baltimore

Sarah has a PhD in Public Policy from the University of Maryland, Baltimore County (UMBC), a Master’s degree in Sociology from George Mason University and a Master’s degree in Regulatory Science from the University of Maryland, Baltimore (UMB). She also holds a graduate certificate in Research Ethics from UMB and a Bachelor’s degree in Sociology from SUNY College at Buffalo. In addition, Sarah is a Certified Compliance and Ethics Professional (CCEP). She has five years’ experience in research administration and 11 years of experience in research compliance. She is currently the Research Integrity Officer for UMB. She also serves as the Program Director of the Research Administration Certificate Program. She teaches graduate level courses in legal, ethical and regulatory issues and has taught undergraduate criminology related sociology courses at UMBC.

Tracy Arwood, M.S.
Assistant Vice President for Research Office of Research Compliance/Safety, Division of Research
Clemson University

Ms. Tracy Arwood is the Assistant Vice President for Research at Clemson University. In this role, she manages the operations of the following federally mandated oversight committees: IRB (Human Subjects), IBC (Biosafety/rDNA) and IACUC (Animal). As the University's Research Integrity Officer, Ms. Arwood also oversees the handling of research misconduct allegations and the Responsible Conduct of Research (RCR) training program. Her responsibilities also include oversight of Research Safety (Lab Safety, Chemical Safety, Biosafety, Radiological Safety and Hazardous Waste Management).
Previously, Ms. Arwood was the Director of Regulatory Compliance at Mississippi State University (MSU). While at MSU, she also served as the prisoner representative on the MSU IRB based on her experience as an Ombudsman within the Virginia Department of Corrections.
Ms. Arwood is a regular presenter at Public Responsibility in Medicine and Research's (PRIMR) and National Council of University Research Administrators’ (NCURA) annual conferences and is also co-author of various Collaborative Institutional Training Initiative (CITI) social and behavioral science modules. Ms. Arwood holds a BS and a MS in Criminal Justice from Radford University in Virginia, and is a certified paralegal.

John Banja, Ph.D.
Center for Ethics
Emory University

John Banja is a Professor in the Department of Rehabilitation Medicine and a medical ethicist at the Center for Ethics at Emory University. He also directs the Section on Ethics for the Georgia Clinical and Translational Science Institute at Emory. Dr. Banja received a doctorate degree in philosophy from Fordham University in New York and has taught and lectured on topics in medical ethics throughout the United States. He has authored or coauthored over 200 publications and has delivered over 800 invited presentations at regional, national, and international conferences. He currently serves as the Editor of the American Journal of Bioethics-Neuroscience, the leading scholarly journal in the field of neuroethics. Dr. Banja has conducted research or educational projects with numerous federal and private organizations including the NIH, the American College of Surgeons, The Agency for Health Care Research and Quality, The National Institute for Disability and Rehabilitation Research, the American Society for Healthcare Risk Management, and the Georgia Hospital Association. He is a former board member of the Commission for Case Manager Certification as well as the American Society of Cataract and Refractive Surgery. His research interests include topics in patient safety, neuroethics, artificial intelligence and ethical dilemmas occurring in clinical and translational research. His most recent book, Patient Safety Ethics, was published by Johns Hopkins University Press in 2019.

Rebecca Beerman, Ph.D.
Scientific Integrity Associate, Advancing Scientific Integrity, Services and Training (ASIST), Duke Office of Scientific Integrity
Duke University

Rebecca Beerman received her Ph.D. in Cell and Molecular Biology at the University of Pennsylvania in 2010, where she used fruit flies as a model system to study the activity and regulation of the fragile X mental retardation protein (the absence of which causes fragile X syndrome). In 2011 Rebecca came to Duke University as a Postdoctoral Associate in the department of Molecular Genetics and Microbiology, where she studied calcium signaling in immune cells using the zebrafish-Mycobacteria marinum host-pathogen model system. Throughout her training, she also developed an interest in the process of scientific research and how to transfer and communicate that acquired experiential knowledge to others, through mentorship, protocols, and data management.
In 2017, she completed her postdoctoral research and joined the newly established research support program – ASIST, Advancing Scientific Integrity, Services, and Training, within the Duke Office of Scientific Integrity, as a Scientific Integrity Associate. The ASIST program focuses on providing consultation and support for research teams on responsible conduct of research and how to communicate and apply those best practices within research teams. Some of the ASIST projects in which Rebecca is primarily engaged include: providing support to researchers on best practices in data management and when applicable, introducing them to the LabArchives electronic research notebook; working with the Duke community to provide support for the iThenticate plagiarism detection software; developing training modules and workshops on components of research quality and reproducibility; and managing a custom training tracking system for Duke’s research faculty and staff responsible conduct of research education program (Simon et. al. Accountability in Research June 2, 2019).

Julia Behnfeldt, Ph.D.
Associate Director/Research Integrity Officer
The Ohio State University

Julia Behnfeldt earned her BA from Capital University in Biology and her PhD from The Ohio State University in Biomedical Sciences, with an emphasis in Cancer Biology. Following graduation, she was awarded an U.S. Presidential Management Fellowship (PMF). As a PMF Fellow, she worked at the Office of Research Integrity in Washington, DC, where she conducted assessments of alleged research misconduct and oversight reviews of institutional investigations. In her current role as Research Integrity Officer and Associate Director for the OSU Office of Research Compliance, she supports the university’s mission by managing research misconduct inquiries and investigations to ensure compliance with U.S. regulations and university policies.

Michelle Benson, Ph.D.
Assistant Director for Research Integrity and Compliance
Columbia University

Michelle Benson is the Assistant Director for Research Integrity and Compliance. Her work focuses on promoting research and data integrity through various workshops and trainings, research group consultations and development of resources to aid in the conduct of research. She also works on matters concerning conflict-of-interest and research misconduct. Dr. Benson has a Ph.D. in Materials Chemistry from the University of Wisconsin-Madison. Her dissertation focused on heterogenous catalysis by developing new surface functionalization techniques on nanoscale metal oxides. In addition to her research at UW-Madison, Dr. Benson also worked with the Wisconsin Alumni Research Foundation on projects involving outreach, technology transfer, and research collaboration. Before coming to Columbia in January 2014, Dr. Benson was an adjunct professor teaching undergraduate chemistry to science majors and nursing students.

Heather Boldt, M.A.
Teaching Faculty, English Language Support Program
Emory University

Heather Boldt is faculty in the English Language Support Program at Emory University where she teaches writing courses to international graduate students and postdoctoral fellows. She is an instructor, author, and editor with over 20 years’ experience in the US and abroad and is recognized by the US Department of State as an English Language Specialist.

Mackenzie Bristow, Ph.D.
Director, English Language Support Program and Global Engagement
Emory University

Mackenzie Bristow is the director and faculty member of the English Language Support Program at Emory University. She has been involved in international education and language support for over 15 years in both industry and academic contexts. Mackenzie’s dissertation work focuses on what factors contribute to supportive and successful language programs.

Gretchen Brodnicki, J.D.
Dean for Faculty and Research Integrity
Harvard University

Gretchen Brodnicki, JD, became Dean for Faculty and Research Integrity in July 2008. She is responsible for overseeing a coordinated approach to research policy setting, implementation, and compliance, including responsibility for the Office for Academic and Research Integrity on issues of conflict of interest, research misconduct, student misconduct, and authorship disputes.
As Dean she works closely with other senior colleagues at HMS and the Harvard affiliated institutions. She serves as liaison with the Harvard University Office of General Counsel on research related issues as well as other matters; ensures compliance with regulatory requirements; serves as an ad hoc member of the University’s ESCRO Committee; and provides advice and consultation to the Dean of the Faculty of Medicine, faculty and senior administrators in areas of faculty and research integrity.
Prior to coming to Harvard Medical School, Ms. Brodnicki was Director of Research Compliance for Partners HealthCare System, Inc., which includes four Harvard Medical School teaching hospitals -- Brigham and Women’s Hospital, Massachusetts General Hospital, McLean Hospital, and Spaulding Rehabilitation Hospital. Before joining Partners, she served as the Director of Research Compliance for Beth Israel Deaconess Medical Center.
Before her work with the hospitals, she was engaged in the private practice of law in the areas of civil litigation and health care. She represented clients in intellectual property disputes as well as in corporate, regulatory, and transactional matters with an emphasis on fraud prevention, practice integration, and risk management.
Ms. Brodnicki received a BS in Business Administration from Gannon University in Erie, Pennsylvania, and her JD in 1996 from Suffolk University Law School in Boston, Massachusetts.

Joanne Cono, M.D., Sc.M.
Chief Science & Medical Advisor & Research Integrity Officer, Office of Science,
Centers for Disease Control and Prevention

Joanne Cono, MD, ScM, is the Chief Science and Medical Advisor in the Centers for Disease Control and Prevention Office of Science and is CDC’s Research Integrity Officer. Dr. Cono has held many scientific leadership positions across the agency including in the Office of Infectious Diseases, the Office for Terrorism Preparedness and Emergency Response, Clinical Communications, and the National Immunization Program. A medical epidemiologist and board-certified pediatrician, Dr. Cono earned her medical degree from the State University of New York at Buffalo and completed her residency training at Children's Hospital of Pittsburgh. She completed a Community Pediatrics and Child Advocacy fellowship at the Albert Einstein College of Medicine and a genetic epidemiology fellowship at CDC. She has a Master of Science degree in Vaccine Science and International Health from Johns Hopkins University School of Hygiene and Public Health, and advanced training in facilitation, negotiation, global diplomacy, and public engagement. She has completed numerous international assignments and practiced pediatrics in the NYC homeless shelter system and at Children's Healthcare of Atlanta. As a visiting faculty member at the University of Tartu in Estonia, she taught pediatrics and epidemiology.

Philip DeShong, Ph.D.
Department of Chemistry & Biochemistry
University of Maryland
College Park, MD

Dr. Philip DeShong is a Professor of Chemistry and Biochemistry at the University of Maryland. His research interests are in synthetic organic and organometallic chemistry, medicinal chemistry, and the application of functionalized nanomaterials for use as vaccines and targeted drug delivery. In addition to his academic appointment, Dr. DeShong serves as the Chair of the Conflict of Interest and Institutional Conflict of Interest Committees. Dr. DeShong is a Fellow of the American Association for the Advancement of Science and the New York Academy of Sciences. He was also a Judge for the Westinghouse and Intel Science Talent Institute. Dr. DeShong is also a founder and President of SD Nanosciences
Dr. DeShong, in conjunction with Robert Dooling, has presented courses and workshops on Responsible Conduct of Research that have been taught in the United States and Ireland.

Sara Frizzell, M.S., C.C.R.P., E.Co.P. (EAR/ITAR)
Director, Research Compliance Services
University of Nebraska-Lincoln (UNL)

Sara Frizzell joined UNL in 2014 and serves as the Director for Research Compliance Services. She develops, promotes and oversees the responsible conduct of research training program and assists the UNL RIO in dealing with allegations of research misconduct. In addition, she is responsible for compliance with human subjects research (IRB), conflicts of interest in research, export controls, and the Scientific Research Oversight Committee (SROC) for research involving human embryonic stem cells (hESC) and human fetal tissue (hFT). Sara holds a Master of Science in Health Care Ethics from Creighton University in Omaha, Nebraska, and is a Certified Clinical Research Professional (CCRP) and Export Compliance Professional (ECoP) in both EAR and ITAR. Sara previously worked in the Research Compliance Office at Creighton.

Susan Garfinkel, Ph.D.
Assistant Vice President for Research Compliance, Office of Research Compliance
The Ohio State University

Dr. Garfinkel is currently the Assistant Vice President for Research Compliance at The Ohio State University. She serves as the senior coordinator for research misconduct and assists in coordinating institution-wide research compliance policies and procedures to ensure that the university is compliant with federal and state regulations. Previously, Dr. Garfinkel served as the Director for the Division of Investigative Oversight (DIO), in the U.S. Office of Research Integrity (ORI), responsible for oversight of institutional research misconduct matters.
Dr. Garfinkel received a Ph.D. in Genetics and conducted research in the molecular biology of aging. She was the Director of Research Grants for a non-profit organization that funded research in age-related degenerative diseases and stem cell research, and worked as a Program Officer at the National Heart, Lung and Blood Institute of the National Institutes of Health. Dr. Garfinkel also served as faculty for the Advanced Science and Technology Adjudication Resource Center (ASTAR), participating in conferences to train State and Federal court judges on various scientific and technologic issues related to genetics and molecular biology.

Ann Hohmann, Ph.D.
Senior Scientist Investigator, Office of Research Integrity
U.S. Department of Health and Human Services

After 20 years as a program officer in mental health services research at the National Institute of Mental Health (NIMH), Ann A. Hohmann became a scientist-investigator in the Office of Research Integrity (ORI) in 2008. She received a Ph.D. in medical sociology, with a minor in methods and statistics, from Rutgers University in 1983. After several months working in rehabilitation medicine at the University of Alabama Birmingham, she transitioned to the Veterans Administration Medical Center in Birmingham as the Health Services Research & Development Coordinator. In 1986 she was accepted into the USPHS Epidemiology Fellows Program, earned an MPH at Harvard School of Public Health in 1987, and began work first as a fellow and then as a program officer at NIMH. While at NIMH she oversaw research programs in methods and statistics and delivery of services to culturally diverse populations. In 2007-2008, she reviewed and evaluated grant applications for compliance with 45 CFR Part 46 human subjects protections for the Office of Extramural Research at NIH. In 2008, she began work for the Division of Investigative Oversight at ORI.

David Hudson, Ph.D.
Senior Associate Vice President for Research
University of Virginia

David Hudson is Senior Associate Vice President for Research at the University of Virginia. In addition to his role as the RIO, he works with the UVA Institutional Review Boards for human subjects research, the Animal Care and Use Committee and oversees a range of other research compliance activities including conflicts of interest and unmanned aircraft systems.
He received his undergraduate degree at the University of California at Riverside, and his Ph.D. from the University of Oregon. A post doctoral fellowship followed, first at the University of Texas at Austin, and then in the Institute for Neuroscience at the University of Oregon. A position as Asst. Department Chair in the Department of Neurobiology and Physiology at Northwestern University was a step to the Assoc. Dept. Chair in Biology at the University of Virginia.

Michael J. Imperiale, Ph.D.
Arthur F. Thurnau Professor, Department of Microbiology and Immunology
Associate Vice President for Research
University of Michigan

Dr. Michael Imperiale is a Professor in the Department of Microbiology and Immunology at the University of Michigan Medical School. He joined the department in 1984 as the Arthur F. Thurnau Assistant Professor of Microbiology and Immunology and was subsequently promoted to Associate Professor in 1990 and Professor in 1996. He is currently the Arthur F. Thurnau Professor and Associate Chair of Microbiology and Immunology. Since 2017, he has also served as UM Associate Vice President for Research. In 2010 Dr. Imperiale was elected as a Fellow of the American Academy of Microbiology and in 2011 he was elected as a Fellow of the American Association for the Advancement of Science.
Before joining the University of Michigan, Dr. Imperiale carried out research training as a postdoctoral fellow at The Rockefeller University, where he first became interested in DNA tumor viruses, studying gene regulation in the human pathogen, adenovirus. He received his undergraduate and graduate training at Columbia University, receiving a B.A. in 1976, M.A. in 1978, and Ph.D. in 1981, all in biological sciences. Currently, Dr. Imperiale’s research interests focus on the study of how DNA tumor viruses interact with the host cell.
Dr. Imperiale was appointed in 2015 as the founding Editor-in-Chief of the American Society for Microbiology journal, mSphere, and is an editor of mBio. Dr. Imperiale is also involved in national and international activities relating to science policy. He currently serves on the Committee on Science, Technology, and Law at the National Academies of Science, Engineering, and Medicine.

Donna Kessler, Ph.D.
Research Integrity Officer
Duke University

Dr. Kessler has been the Research Integrity Officer (RIO) for Duke University for 11 years and oversees misconduct inquiries and investigations in response to allegations of fabrication, falsification, or plagiarism of data. She also participates in the Responsible Conduct of Research (RCR) training of graduate and medical students, postdoctoral fellows, research staff, and faculty members at Duke each year. Dr. Kessler has a Bachelor’s degree in Chemistry from the Massachusetts Institute of Technology (MIT) and a Ph.D. in Genetics from the University of Pennsylvania. She conducted research in protein structure/function, transcriptional regulation and virology, and has taught undergraduate and graduate students in the fields of Chemistry, Genetics, Molecular Virology, Research Ethics, and Women’s and Gender Studies. Dr. Kessler has been a research administrator for over 20 years, beginning with five years as a program manager in the Life Sciences Division of the Army Research Office (the basic research funding agency for the Army). From 2000 to 2008, she worked in technology transfer offices at North Carolina (NC) State University and Duke University, managing the intellectual property assets of the universities, including 3 years as the Director of Technology Transfer at NC State. From 2008 until mid-2017, she served as a Chair of the Duke Biomedical Institutional Review Board (IRB), conducting scientific and ethical review of clinical trial protocols.

Michael A. Klein, J.D.
Director for Research Compliance, Office of Research Compliance & Training
Columbia University

Mike Klein is Director for Research Compliance in Columbia University's Office of Research Compliance and Training. Prior to joining the office in 2008, he worked as an attorney in private practice, as well as with the U.S. Department of Health and Human Services and the NY State Department of Health. He holds a J.D. from Columbia Law School and an A.B. from Amherst College.

Maya R. Kobersy, J.D.
Associate General Counsel
The University of Michigan

Maya Kobersy’s primary practice areas at the University of Michigan include affirmative action and diversity, research and research misconduct, election law, privacy, University logo issues, and in- state tuition guidelines. Maya is past chair of the University of Michigan Office of the Vice President and General Counsel (“OGC”) Research Practice Group and is the OGC liaison to the University’s Institutional Review Board-Health Sciences and Behavioral Sciences. She also serves on a number of University committees and is an active member of the National Association of College and University Attorneys, where she currently serves as vice chair of the NACUANotes Editorial Board. She has presented at University, state, and national conferences on issues relating to diversity, human subjects research, election law, Title IX, the Family Educational Rights and Privacy Act, and employment compensation, among other topics.
Prior to joining OGC in 2005, Maya worked in the Education Group of Hogan & Hartson, L.L.P. (now Hogan Lovells), where she advised clients on numerous K-12, higher education, and civil rights issues. She received her B.A. from the University of Michigan and her J.D. from Harvard Law School, where she was an Executive Editor of the Harvard Law Review and a finalist and oralist in the Ames Moot Court Competition.
In recognition of her work to help ensure that Americans with limited English proficiency have meaningful access to federal and federally funded programs, Maya received the Mexican American Legal Defense and Education Fund’s Excellence in the Legal Profession Award in 2002 and the National Asian Pacific American Legal Consortium’s Distinguished Service Award in 2003.

James Kroll, Ph.D.
Director, Research Integrity and Administrative Investigations, Office of the Inspector General
National Science Foundation

Jim Kroll has been the Director of Research Integrity and Administrative Investigations for the National Science Foundation’s Office of the Inspector General since April 2001. In this role, Jim is primarily responsible for leading the investigation and resolution of all allegations that, if substantiated, would result in administrative action rather than civil or criminal prosecution. These include allegations of: research misconduct under NSF proposals and awards; certain types of employee misconduct; violations of NSF regulations, policy or directives; improprieties in program management that cannot be practicably resolved by management itself; and other issues that are not of a civil/criminal nature. Prior to working for the OIG, Jim served 21 years as a meteorological officer with the U.S. Air Force. Jim completed his undergraduate studies at Rutgers University where he received his B.S. in Meteorology in 1980. Jim later attended North Carolina State University where he received his M.S. in Atmospheric Sciences in 1985 and his Ph.D. in 1988.

Dario Kuzmanovic
Assistant Vice Chancellor, Research Integrity
University of California, Riverside

Dario Kuzmanović is a research ethicist and a member of Joint Centre for Bioethics at University of Toronto. Since 2015, he has worked at University of California Riverside in most areas related to research compliance and integrity. His professional and academic focus is on research ethics, privacy and confidentiality, as well as HIV/AIDS research. As a research ethicist, Dario has consulted for numerous private companies and international groups, including the World Health Organization. He brings vast experience of 12 months in the area of research misconduct rules and regulations.

Kiptyn R. Locke
Vice President
LabArchives, LLC

Kiptyn Locke currently serves as LabArchives Vice President for Research.
His primary focus is working directly with institutional leadership and administration to best understand their ongoing needs and then work with the LabArchives development team to evolve the product offerings to meet those needs. Kiptyn currently works directly with leadership at more than 100 academic research customer institutions throughout the US, Canada, Europe and around the world.

Patricia Mantoan, J.D.
Section Chief in the Public Health & Science Branch of the Public Health Division, Office of the General Counsel (OGC)
Department of Health and Human Services

Patricia Mantoan is a Section Chief in the Public Health & Science Branch of the Public Health Division, Office of the General Counsel (OGC), Department of Health and Human Services, with expertise in research integrity and intellectual property issues. Prior to joining the Public Health Division, she served with the General Law Division of OGC, advising on the Freedom of Information Act, Privacy Act, Federal Advisory Committee Act, and other information laws. Ms. Mantoan has been with the Office of the General Counsel since 1997. She graduated from the George Washington University Law School. Before joining the Department of Health and Human Services, she was a judicial law clerk for the Honorable Wilkes C. Robinson at the U.S. Court of Federal Claims.

Benyamin Margolis, M.D., Ph.D.
Health Scientist Administrator, Office of Research Integrity
U.S. Department of Health and Human Services

A native of Rockville, MD, Dr. Benyamin Margolis earned his BA and MPH from Emory University. Dr. Margolis earned his PhD from UNC at Chapel Hill in Health Behavior and Health Education, with a minor in Epidemiology and additional doctoral-level coursework in Anthropology. He has been a Certified Health Education Specialist since 2003, and as a member of the initial cohort, earned his CPH in 2008. Dr. Margolis started his Federal career at the Administration for Children and Families before moving to the Maternal and Child Health Bureau at HRSA. Ben was then at the Office of the Naval Inspector General for nearly 5 years. Coming full circle, Ben started at the Division of Education and Integrity, based in Rockville and not far from where he grew up, this past April.

Monika S. Markowitz, PhD, MA, MSN, RN
Director of the Office of Research Integrity and Ethics, Office of Research and Innovation
Virginia Commonwealth University

Monika Markowitz is the Director of the Office of Research Integrity and Ethics in the Office of Research and Innovation at Virginia Commonwealth University (VCU) in Richmond, Virginia. Monika directs the Research Conflict of Interests Program and chairs the Conflict of Interests Committee. She is the VCU Research Integrity Officer. Monika is a research ethics consultant and directs the Responsible Conduct of Research program at VCU. She is faculty with Public Responsibility in Medicine and Research (PRIM&R), Association for the Accreditation of Human Research Protection Programs (AAHRPP), the AAMC Forum on Conflict of Interests in Academe (FOCI-A), the ARIO, and the Virginia IRB Consortium. Monika is a former member of the FOCI-A Steering Committee. She serves as an AAHRPP accreditation site visitor and is a member of the AAHRPP Council on Accreditation. Monika serves on the ARIO Communications Committee.

Ivan Oransky, M.D.
Vice President, Editorial, Medscape
Distinguished Writer in Residence, New York University's Arthur Carter Journalism Institute
Co-Founder, Retraction Watch
President, Association of Health Care Journalists
Clinical Assistant Professor of Medicine, New York University School of Medicine

Ivan Oransky, MD, is co-founder of Retraction Watch, vice president of editorial at Medscape, and distinguished writer in residence at New York University's Arthur Carter Journalism Institute. He also serves as president of the Association of Health Care Journalists. Ivan previously was global editorial director of MedPage Today, executive editor of Reuters Health, and held editorial positions at Scientific American and The Scientist. A 2012 TEDMED speaker, he is the recipient of the 2015 John P. McGovern Medal for excellence in biomedical communication from the American Medical Writers Association, and in 2017 was awarded an honorary doctorate in civil laws from The University of the South (Sewanee).

Shekhar Patil, Ph.D.
Administrative Director CoREs and Shared Resources
Icahn School of Medicine, Mount Sinai University

I received my PhD in India and moved to the United States to obtain postdoctoral training and career advancement. As a postdoc at Icahn School of Medicine at Mount Sinai (ISMMS), I developed interests in and switched to research administration and began working with ISMMS’s institutional committees such as the IACUC, IBC, and the lab Safety Committee. At present, I am the Administrative Director of the Cores and Shared Resources there. In this role, I was involved with or oversaw various implementation phases of the LabArchives electronic lab notebooks at ISMMS- a rigorous vendor vetting and selection (LabArchives), a brief training or early adopter program for few selected users, institutional rollout in 2019, as well as continuous outreach and awareness within ISMMS research community. In the breakout session, I will discuss the overall ELN implementation strategy/process at Mount Sinai, the vendors we invited, why and which vendor we selected, describe our early adopter program, ELN rollout, and the continuous outreach it requires.

Kimberly A. Petrosky, J.D.
Research Integrity Analyst, Office for Research Protections
Penn State University

Kim serves as the Research Integrity Analyst at Penn State’s Office for Research Protections. In this role, she provides support to the Research Integrity Officer and Deputy Research Integrity Officer by managing assessment, inquiries, and investigations of allegations of research misconduct in accordance with federal regulations and University policy. Additionally, she is tasked with assisting in maintaining and developing University policies and procedures on research misconduct and ensuring compliance with federal and sponsor regulations and requirements.
Prior to joining the Office for Research Protections in 2015, Kim served as judicial law clerk to the Honorable Jonathan D. Grine of Centre County and practiced family law with Delafield, McGee, Jones & Kauffman, P.C. in State College, Pennsylvania. She is a 2010 graduate of Penn State Law and a 2007 graduate of Gannon University (summa cum laude) with a BA in Psychology and minors in Women’s Studies and Forensic Investigation.

Corinna Raimondo, Ph.D.
Senior Compliance Specialist
Northwestern University

Corinna Raimondo is a Senior Compliance Specialist aiding Northwestern University’s RIO. Corinna holds a BS and MS from the University of Genoa (Italy), a PhD from the Institut de Science et d’Ingenierie Supramoleculaires of the University of Strasbourg (France), and after two Postdocs in the Chemistry and Chemical Engineering Departments at Northwestern and a fellowship at the National Academy of Engineering she obtained a Master of Science in Law from the Northwestern’s Pritzker School of Law. In her daily duties Corinna is involved in every aspect of the research misconduct process but focuses on forensics, sequestration, and the technical side of the job. In her spare time Corinna is an Adjunct Professor in RCR for Northwestern’s McCormick School of Engineering and a consultant web developer for ARIO.

Alexander Runko, Ph.D.
Director, Division of Investigative Oversight, Office
U.S. Department of Health and Human Services

Dr. Alex Runko first worked at ORI as a Scientist-Investigator from 2010-2016, and returned in April 2019, where he was involved in handling and assessing allegations and reports of inquiries and investigations of research misconduct, and provided guidance to research institutions on forensic image analysis. Dr. Runko has a Ph.D. from the University of Massachusetts Memorial Medical Center, where his research focused on developmental neurogenesis. He completed his postdoctoral training analyzing neurodegenerative diseases at the NIH’s National Institute of Neurological Disorders and Stroke (NINDS), and also worked at NINDS as a Health Program Specialist in the extramural research program, where he managed portfolios of grant proposals and awards on neurological diseases. More recently at the NIH’s National Heart, Lung, and Blood Institute, Dr. Runko was the Extramural Genomic Program Administrator and Data Access Committee Chair, where he directed the management of genomic and phenotypic data submissions and the review of applications to access NIH and NHLBI databases.

Naomi Schrag, J.D.
Vice President for Research Compliance, Training, and Policy, and research Integrity Officer
Columbia University

Naomi Schrag is the Vice President for Research Compliance, Training, and Policy in Columbia University’s Office of the Executive Vice President for Research, and is the University’s Research Integrity Officer (RIO). She oversees work on issues such as research misconduct, conflict of interest, export controls and international research compliance, grants management, and develops proactive programs to promote rigor and reproducibility. She also collaborates closely with other offices across the University to develop integrated approaches to compliance and training. Before joining Columbia in January 2006, Ms. Schrag practiced law for nine years, focusing on regulatory compliance and litigation involving biomedical research, with clients including pharmaceutical companies and not-for-profit organizations. Ms. Schrag also clerked in the Court of Appeals for the Second Circuit. Ms. Schrag graduated from New York University School of Law in 1995. Before entering law school, she worked on an oral history of the Holocaust for the Museum of Jewish Heritage.

Todd Sherer, Ph.D., CLP, RTTP
Interim V.P. for Research Admin.
Emory University

Dr. Sherer serves as the chief administrative officer responsible for the infrastructure that supports the research mission of Emory University. He oversees the Office of Sponsored Programs, Office of Research Compliance, Office for Clinical Research, the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee Office (IACUC), Environmental Health and Safety Office, the Conflict of Interest in Research Office, and the Office of Technology Transfer, and Occupational Health. He is the designated Institutional Official for both the IRB and IACUC programs. From 2003-2018, Dr. Sherer led Emory’s Office of Technology Transfer. During that time, he transformed the program into an internationally recognized leader in academic technology transfer. He introduced the use of product pipelines to illustrate the important role that research plays in the innovation pathway and built a team of professionals focused on risk-reduction and value creation. He was able to combine industry sponsored research with technology transfer to create a one-stop shop for companies looking to partner with Emory researchers. Other accomplishments include the creation of an in-house patent group to reduce costs while aligning patenting and licensing functions, and a dedicated technology scout function to increase the disclosure of new inventions. Prior to joining Emory, Dr. Sherer held similar roles at Oregon Health & Science University, the University of Oregon, and Washington State University. He received his PhD in Pharmacology/Toxicology from Washington State University in 1991 where his research focused on gene expression during brain development. He holds a BS degree from Oregon State University.

Kelly Simmons, J.D.
Assistant RIO
University of California, San Francisco

Kelly has been the Assistant Research Integrity Officer at UCSF since July 2017. Serving as the campus subject matter expert on research misconduct and emerging issues in research integrity, Kelly works closely with UCSF’s Research Integrity Officer, the Associate Director of Ethics & Compliance, the Office of Legal Affairs, and other key campus leaders to administer the UCSF Integrity of Research Procedures and ensure compliance with federal regulations governing research integrity. Kelly joined UCSF in 2013 in a dual capacity, supporting faculty misconduct investigation committees appointed by the Vice Provost for Academic Affairs, as well as RIO-appointed committees investigating allegations of research misconduct. Kelly earned a B.A. in journalism from the University of Wisconsin, Madison, and a J.D. from the University of San Francisco, School of Law.

Stacey Springs, M.S., Ph.D.
Research Integrity Officer
Harvard University

As the Research Integrity Officer for the Faculty of Arts and Sciences and School of Engineering and Applied Sciences, Stacey handles research integrity matters and serves as course director for Responsible Conduct of Research (RCR) training and education for faculty, postdocs, students and staff.
She holds a PhD in Pharmaceutical Economics and Health Policy and completed post-doctoral training in Comparative Effectiveness Research and Evidence Synthesis at Brown University and a fellowship in Bioethics at Harvard Medical School. In her role at Harvard University, she combines her meta-research expertise and bioethics training to support institutional policies to improve the integrity, rigor, reproducibility and ethical conduct of research across the disciplines of arts, sciences, engineering and applied sciences.

Michelle Stalilonis, J.D.
Senior Compliance Specialist
Northwestern University

Michelle Stalilonis is a Senior Compliance Specialist supporting the RIO at Northwestern University. She previously worked as an associate with the law firm Cray Huber in Chicago and clerked for the Honorable Peter Flynn in the Circuit Court of Cook County, Chicago. Michelle received her J.D. from Loyola University Chicago and her B.A. from Saint Mary’s College, Notre Dame, IN.

Brandon Stell
The PubPeer Foundation

Brandon Stell is president of The PubPeer Foundation and founder of the website PubPeer.com which launched in 2012 to facilitate crowd-sourced review of published scientific research. PubPeer centralizes discussion of the scientific literature across all fields and has amassed over 70k comments to date. In 2018 The PubPeer Foundation launched Peeriodicals.com which provides a flexible platform for the creation of overlay journals and allows scientists to select the best science. The overarching goal of the two websites is to help democratize the evaluation and curation of scientific literature.

Blake A. Talbot, M.P.H.
Research Integrity Program Manager, Office for Academic and Research Integrity
Harvard Medical School

Blake Talbot is the Research Integrity Program Manager in the Office for Academic and Research Integrity at Harvard Medical School where he is responsible for providing staff support to the Standing Committee on Faculty Conduct, including handling responses to allegations of research misconduct, assisting with forensic analyses of scientific research relevant to issues of potential research misconduct, staffing and supporting ad hoc research misconduct case panels, and drafting reports. He previously worked within the Primary Care Research Institute at the University at Buffalo as a Research Associate focusing on pediatric obesity prevention, medical school education and community-based participatory research, in addition to tobacco cessation research and an evaluation of a school-based childhood obesity prevention program while at the University of Arkansas for Medical Sciences (UAMS). Blake received his Bachelor of Science degree from Arkansas State University and a Master of Public Health degree with an emphasis in Biostatistics from UAMS.

Patricia A. Valdez, Ph.D.
Extramural Research Integrity Officer
Department of Health and Human Services NIH OD/OER

Dr. Valdez serves at the NIH Extramural Research Integrity Officer in the National Institutes of Health (NIH) Office of Extramural Research (OER). Dr. Valdez received her Ph.D. in Molecular and Cell Biology from the University of California, Berkeley and carried out her postdoctoral training at Genentech. She then joined the NIH as an Intramural Staff Scientist in the NIAID Laboratory of Clinical Infectious Disease. Prior to joining OER, Dr. Valdez served as the Manager of Publication Ethics for the American Society for Biochemistry and Molecular Biology (ASBMB).

Dan Wainstock, Ph.D.
Associate Director for Research Integrity
Harvard Medical School

Dan is the Associate Director for Research Integrity at Harvard Medical School (HMS). He coordinates assessments of possible research misconduct for HMS and its affiliates, and collaborates with practicing scientists and institutional stakeholders to support the development and implementation of resources for research integrity and reproducibility at HMS. His scientific training in developmental genetics (Ph.D. Biology, M.I.T.) and nearly 15 years of editorial and publishing experience (Cell Press) in the fields of cellular and developmental biology inform his perspective on many aspects of research rigor and transparency.

Mary Walsh, Ph.D.
Chief Scientific Investigator, Office for Academic and Research Integrity
Harvard Medical School

Mary C. Walsh is Chief Scientific Investigator, Office for Academic Research and Integrity (ARI), Harvard Medical School (HMS). Mary is responsible for the forensic analysis of scientific research relevant to issues of potential academic misconduct at HMS. Her current responsibilities include the application of advanced forensic analysis techniques and tools approved by the federal Office for Research Integrity throughout the course of an academic misconduct review, conferring as needed with both scientific investigators, senior faculty, and respondents throughout the proceedings of all academic misconduct cases, and reporting out to inquiry and investigation panels at HMS on all evaluations of potential misconduct following the conclusion of forensic data analysis. Prior to joining the ARI team, Mary was Assistant Dean for Faculty Affairs and Instructor of Anesthesia at HMS.

Karen A. Wehner, Ph.D. Associate Director, Research Integrity, Office of Policy Coordination
Johns Hopkins University School of Medicine

As the Associate Director of the Division of Research Integrity at Johns Hopkins University School of Medicine, Karen is responsible for overseeing and developing RCR training for faculty, postdocs, and staff at the School of Medicine; consulting on and supporting RCR training for graduate students; and providing comprehensive support for the handling of research misconduct issues and other related matters. Prior to her current position, Karen earned her Ph.D. in Genetics at Yale University, completed postdoctoral work at Stanford University School of Medicine, and conducted biomedical research at Johns Hopkins University School of Medicine. Karen now uses her many years of experience with: biomedical research, handling research misconduct issues, and handling other research integrity matters to develop and further her institution’s RCR mission.

Kristin West, J.D.
Chief Compliance Officerr
Emory University

Kris West is the Chief Compliance Officer for Emory University. Prior to becoming Chief Compliance Officer, she worked for Emory first as Senior Associate General Counsel, and then as Associate Vice President for Research Administration & Director of the Office of Research Compliance. She is responsible for providing compliance guidance and oversight for research and non-research areas with respect to the vast range of legal requirements affecting institutions of research and higher education. Ms. West also serves as Emory University's Privacy Officer and Research Integrity Officer. As RIO she has overseen the administration of a number of cases of research misconduct.
Ms. West is an active member of the Georgia Bar. She attended the University of Maryland and Mercer University School of Law and also holds a M.S. degree in drug regulatory affairs from the University of Florida.

Karen C. Weston, M.S.
Research Integrity Program Manager
Mount Sinai Health System

Karen Weston is the Research Integrity Program Manager for the Mount Sinai Health System in New York City. She reports to the Senior Research Integrity Officer (RIO) for the Heath System, Dr. Reginald W. Miller. In her role as Program Manager, Karen assists with all aspects of research misconduct reviews for the Icahn School of Medicine at Mount Sinai, The Mount Sinai Hospital, Mount Sinai St. Luke’s, Mount Sinai West, Mount Sinai Beth Israel, and New York Eye and Ear Infirmary of Mount Sinai. Karen is also responsible for maintaining the institution’s Research Integrity website (which she helped design); assisting with policy review and revisions; and preparing guidance materials for current and future Mount Sinai RIOs.
From 2008-2018, Karen worked in the Mount Sinai Legal Department as both a paralegal and an assistant to the Research Integrity Officer. Prior to joining Mount Sinai, Karen worked as a paralegal at two NYC law firms, received an M.S. in Education (Special Education) from Hunter College in New York, and taught young children with special needs.
Karen has presented at several research integrity-related conferences, including two RIO Boot Camps.

Tracy Wilson-Holden, M.A.
Executive Director, Research Integrity, Education and Outreach, Office of Research Administration
Case Western Reserve University

Tracy Wilson-Holden has been with Case Western Reserve University’s (CWRU) Office of Research Administration since 2005. She serves as the Research Integrity Officer and is also responsible for overseeing research education and outreach to the community. She directs the human subjects training program and oversees the work of the Conflict of Interests committee. She is an adjunct instructor in the Department of Bioethics, teaching the graduate course “On Being a Professional Scientist”. Tracy is also the executive director of CWRU’s signature campus-wide celebration of research called Research ShowCASE. She holds a BA in Communication Science and Disorders and a MA in Audiology, both from the University of Pittsburgh. Prior to working in Research Administration, Tracy spent 11 years working as an intraoperative neurophysiologist in private practice and at Washington University in St. Louis.

Lela M. Young, J.D.
Associate General Counsel

Lela Young received a B.A. in history from the University of Virginia. She earned a J.D., summa cum laude, from the University of Tennessee College of Law, where she served as editor-in-chief of the Tennessee Law Review. After law school, Young served as law clerk to the Hon. Susan H. Black, United States Court of Appeals for the 11th Circuit, in Jacksonville, Florida, and then practiced employment law with the firm of Sutherland, Asbill and Brennan in Atlanta.
Young returned to Knoxville where she served the University as an adjunct professor in the 1L research and writing program at UT College of Law and joined the Office of General Counsel in 2008. Her current practice focuses on academic and employment issues, particularly faculty employment policies, academic policies and faculty-related litigation.

Jennifer Yucel, Ph.D.
Associate Vice President, Research Compliance and Research Integrity Officer
The Ohio State University

Jennifer “Jen” Yucel joined The Ohio State University in 2004 and is the Associate Vice President, Research Compliance and Director of the Office of Research Compliance. In this role, Jen oversees and facilitates research compliance activities across the university, specifically focusing on issues involving research misconduct, national security & export controls, conflicts of interest, human gene transfer, human stem cell research, and various other research compliance areas. Born and raised in Southern California, Jen received her Ph.D. in Cellular Biology from the University of California, San Diego and completed her post-doctoral work at the Ludwig Institute for Cancer Research in La Jolla, California. In her spare time, Jen and her husband Harold have a small horse farm on the outskirts of Columbus and both greatly enjoy spending time on the tractor, masquerading as farmers on the weekends.
PLANNING COMMITTEE
Dario Kuzmanovic
Speaker
Monica Markowitz
Speaker

Gabriella Neff, R.H.I.A., C.H.C., C.H.R.C., C.H.P.C.
Research Compliance Officer
Moffitt Cancer Center

Oversee and manage all compliance activities related to research and advise on a variety of research compliance matters. Review research violations, conduct investigations, and make recommendations for disciplinary action in accordance with institutional policy. Monitor the implementation of corrective action plans and/or process improvements resulting from internal or external reviews/audits. Manage and oversee all internal Compliance clinical trial audits.
Assist in managing and expanding the visibility of the Corporate Compliance Program. Develop and lead education and training to help ensure all Center members have knowledge of, and comply with, pertinent laws, rules, regulations and policies, as applicable. Assist in the interpretation of new or revised regulatory requirements and develop policies and procedures, as needed. Serve as a resource for HIPAA Privacy research related matters as needed.
Frequently interact and partner with the Internal Audit Department on reviewing and/or assessing potential or actual risks and the Office of Research Administration to provide guidance on regulatory matters in the conduct and administration of clinical trials and research.

Sarah Pruett, Ph.D.
Director of Research Integrity, Office of Research & Engagement
The University of Tennessee, Knoxville

Dr. Sarah Pruett is the Director of Research Integrity for the University of Tennessee where she manages the daily operations for research integrity, responsible conduct of research training, and export control. Before joining the University of Tennessee, she was a mass spectrometrist for almost 20 years primarily studying lipids and drug design. She received her PhD in chemistry from Emory University and was a faculty member at the Yerkes National Primate Research Center for 8 years prior to pursuing opportunities in private industry and research integrity.

Lauran Qualkenbush
Director, Office for Research Integrity
Northwestern University

Lauran Qualkenbush is the Director of the Office for Research Integrity and the Research Integrity Officer for Northwestern University. She is responsible for promoting the responsible conduct and appropriate administration of University research and is involved in Responsible Conduct of Research education across the University. She oversees the development of research-related training and responds to allegations of research misconduct as well as other types of research non-compliance.
Ms. Qualkenbush is a founding member and President of the Association for Research Integrity Officers (ARIO). She is a teaching RIO for the HHS ORI RIO boot camps and has served on the HHS review panel for research integrity conference grants.
Ms. Qualkenbush holds a Bachelor of Science degree in biology from Xavier University in Cincinnati, Ohio and previously worked in Northwestern’s IRB Office and as a certified clinical research coordinator.

Nancy Rhea M.S., CHRC, CCRP
Research Compliance Analyst
University of Arkansas for Medical Sciences

Nancy Rhea is a Research Compliance Analyst working in the Office of Research Compliance where she serves as support for the RIO, performs compliance audits of human subjects research, and trains research staff in the areas of research compliance and research integrity. Prior to serving in this role, she served as the Director of Conflict of Interest, and also as a compliance analyst auditing the IRB and the animal research program. Before joining the research compliance world, Nancy was a mental health therapist for 15 years. In that role, she worked with emotionally distressed adolescents and their families.

Daniel Wainstock

Speaker

Kristen West, J.D.

Speaker

Tracy Wilson-Holden

Speaker
BOARD MEMBERS

Sheila R. Garrity, J.D., M.P.H., M.B.A.
Co-Founder, Association of Research Integrity Officers
Associate Vice President for Research Integrity
George Washington University

Ms. Garrity is the Associate Vice President for Research Integrity and serves as the Research Integrity Officer for The George Washington University. She is responsible for policy development, informational sessions, and development of educational modules to assist investigators with understanding their ethical and fiduciary responsibilities with regard to their research. In her role, she oversees the operations of the Office of Laboratory and Radiation Safety; the Office of Human Research; the Animal Research Facilities; and Regulatory Affairs.
Ms. Garrity is a national leader in the fields of research integrity and the responsible conduct of research education. She joined The George Washington University after spending over 20 years at Johns Hopkins University School of Medicine where she most recently served as the Director of the Division of Research Integrity. She is a founding member and current vice president of the Association for Research Integrity Officers (ARIO). Ms. Garrity earned her MBA and MPH at Johns Hopkins where she also received a Certificate in Health and Human Rights and her JD from the University of Maryland School of Law.

Lauran Qualkenbush

Program Committee

Debra Thurley, J.D.
Executive Director of Research Compliance
The Pennsylvania State University

Debra Thurley, J.D., is the Executive Director for Research Compliance in the Office for Research Protections (“ORP”) at The Pennsylvania State University (“Penn State”) where she provides leadership and oversight to the University’s ten research compliance programs (IRB, IACUC, IBC, UIC, Individual COI, Institutional COI, faculty consulting, Stem Cell Research, Dual Use Research of Concern and Unmanned Aircraft Systems (“Drones”)) and compliance committees. Debra also serves as the Deputy Research Integrity Officer, overseeing the research misconduct process at the University along with the University’s Research Integrity Officer and Associate Vice President for Research. Debra graduated from Penn State in 1996 with dual Bachelor of Science degrees in Human Development and Family Studies and in Administration of Justice. She received her Juris Doctor, magna cum laude, in 2001 from Western New England University School of Law. Prior to joining Penn State in 2004, Debra practiced administrative and regulatory law in Connecticut and general civil and criminal law in Pennsylvania. She has presented nationally and internationally on research misconduct and conflict of interest topics. Along with being a member of the Board for ARIO, Debra is a member of the Association of American Medical College’s (AAMC) Forum on Conflict of Interest (FOCI) Academe, the National Association of College and University Attorneys (NACUA), and the Research & Regulatory Reform (RRR) Committee of COGR (Council On Governmental Relations).

Daniel Wainstock

Speaker

Diane Rosecrans Wender, J.D.
Research Integrity Officer
University of Pennsylvania

Diane has been in the University of Pennsylvania’s Research Integrity Office since 2009. That Office supports the Vice Provost for Research in administration of the University’s policies addressing research misconduct and financial conflicts of interest in research. Before joining Penn’s Research Integrity Office, Diane had a long-term career as a business and healthcare attorney in private practice. She also supervised one of Penn Law School’s transactional law clinical programs for several years. Diane is a graduate of Yale University and the University of Pennsylvania Law School.

Tracy Wilson-Holden

Speaker