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Columbia University Human Research Protection Program

Annual Educational Conference

 

Columbia University Homepage Slideshow

 

7th Annual Institutional Review Board Educational Conference

May 7 - May 8, 2012

 

  

        Faculty

 

 

 

 

 

David Abraham, Ph.D., M.P.H.

As Deputy Director and Director of Research at Columbia University’s National Center for Disaster Preparedness, Dr. Abramson’s areas of study include disaster recovery and resiliency, the social ecology of vulnerability, risk communication targeted at high-risk or elusive communities, and survey research on preparedness attitudes and behaviors.  He is the principal investigator of the longitudinal Gulf Coast Child & Family Health Study, an examination of need and recovery among 1,000+ randomly sampled displaced and impacted families in Louisiana and Mississippi, and of a recently-funded NIH study of the impact of the Deepwater Horizon oil spill on children’s health.  Other current or recent disaster-related research activities include a study of “Elusive Communities” and how hidden populations such as undocumented immigrants hear and respond to public health emergency messaging; the American Hotspots project, which focuses on the measurement and mapping of social vulnerability and hazard; and a CDC-funded evaluation of risk messaging and community engagement, and the identification of appropriate mechanisms for two-way communication.  From 2007 – 2010, Dr. Abramson served as an Associate Editor of the AMA peer-reviewed journal, Disaster Medicine and Public Health Preparedness. 

 

Prior to entering the field of public health in 1990, Dr. Abramson worked for a decade as a national magazine journalist, having written for Rolling Stone, Esquire, Outside, and the San Francisco Examiner, among other publications.  A former paramedic, Abramson holds a doctorate in sociomedical sciences with a specialization in political science, and a masters of public health degree, both from Columbia University.

 

 

 

 

Steven Bellovin, Ph.D. 

 

 

 

Esther Daemen, BSN, CPP, CPM, PG

As a director of professional development for the ACRP, Esther is responsible for leading the professional development program. This includes setting up the strategies for the program in line with the ACRP mission, vision and organizational strategy, leading a team of training, credentialing and clinical experts on a global scale, collaborating with the global conference planning committee and the Monitor home studies, sitting on the Association Board of Trustees and providing development service to the researchers in the clinical enterprise. She is responsible for the procedures related to the analysis, design, development, delivery and evaluation of all professional development activities organized by the ACRP, in line with the clinical researcher's needs. She works closely with the professional development committee members, who support her to identify the needs and advise her what procedures to follow, the organization of development events, development needs, etc... Esther has worked as a nurse, medical representative, CRA, SrCRA/LCRA, trainer and training and development manager for pharma, CRO and device companies. Next to a bachelor degree in nursing and being a certified prevention professional, certified online trainer and designer and certified PM she holds a postgraduate degree in senior business administration and is working her way toward achieving an MBA. Some of her favorite quotes: "It is all about the patients' - ' Work smarter, not harder"

 

 

Erik Decker, M.S., CCISSP

 

 

 

 

Jean Gabeau, J.D., is the Director of Contracts at Columbia University’s Clinical Trials Office. Jean Gabeau received his undergraduate education at Boston College, where he graduated cum laude with a B.A. in Economics and Political Science. He received his J.D. from Boston College Law School and is admitted to practice law in New York State. Mr. Gabeau joined the Contracts Department of the Clinical Trials Office (CTO) in August 2005, as a project officer. He is currently the Director of Contracts where is he responsible for managing and training staff as well as designing and implementing guidelines to facilitate clinical trial agreement negotiations. He has extensive experience reviewing, drafting and negotiating clinical trial agreements, non-disclosure agreements, subcontracts and material transfer agreements. Mr. Gabeau serves as a liaison between the CTO and the Columbia University research community in regards to all research agreement matters, and also manages several special projects at the CTO, including serving as the primary contract reviewer for all clinical trial agreements with Columbia University’s Cancer Research Management Office, as well as working closely with Columbia University’s Office of General Counsel in developing new clinical trial agreement provisions.

 

 

 

GAsparis

George Gasparis is the Asst. Vice President and Sr. Asst. Dean for Research Ethics at Columbia University Medical Center.  He also serves as the Executive Director, Human Subjects Protection Program for both Columbia University and Columbia University Medical Center.    Prior to his arrival at Columbia University in June 2003, Mr. Gasparis was the Director for the Division of Assurances and Quality Improvement at the Office for Human Research Protections (OHRP).  Prior to his tenure at OHRP, he was the Director, Office of Human Research at The George Washington University Medical Center (GWUMC) from 1991 –1996.  In that capacity he served as the administrator for the GWU Medical Center IRB, Director of the Research Pharmacy, and also served on the behavioral IRB for the university.  Mr. Gasparis also has had extensive experience with clinical trials when he was employed at the GWU Lipid Research Clinic (LRC) from 1981-1991.  During his tenure as Data Manager at the LRC, he managed over 40 clinical trials, including NIH awards and studies for 10 different pharmaceutical companies.  Mr. Gasparis is a graduate of GWU.  He received his CIP in 2003. He was born in Northern Virginia and moved to New Jersey in August 2003.

 

 

Janet Ellen Holwell

Ms. Holwell began her career as a clinical research coordinator in academia over 30 years ago. Prior to transitioning to industry 14 years ago, she managed the clinical pharmacology unit in dermatology at NY Presbyterian Medical Center - Columbia University, overseeing all operations.  She was also an instructor in good clinical practice (GCP) and helped develop the first GCP program in an academic institution while at Columbia.  

Ms. Holwell consulted for a variety of pharmaceutical companies and currently holds the position of Clinical Quality Lead with Pfizer, Inc.  Prior to this appointment, she held positions as a clinical research associate, regional study manager, territory development specialist, trainer, and instructor of GCP.

She is an active member of the Association of Clinical Research Professionals (ACRP), having served on their board of trustees and various forums.  She previous served as co-chair of the CRA forum.  She was a founding member, past and now current president of the New York Metropolitan Chapter. 

 

 

 

 

 

Sherif Ibrahim, M.D.

 

 

 

 

Helen Kim, Pharm.D.

Helen started her career at NewYork-Presbyterian Hospital as a Clinical Pharmacy Manager in Oncology where she provided patient care and education to the healthcare team.  She was also a Reviewer for the IRB at Columbia University Medical Center.

In 2005, she joined OrthoBiotech at Johnson and Johnson as a Manager in Clinical Affairs.  She was responsible for liaising with academic and clinical investigators in the development of clinical trials and basic science research at OrthoBiotech.  She was later promoted to Senior Clinical Science Liaison at Centocor- OrthoBiotech.

Helen joined the Clinical Trials Office at Columbia University as Director of Regulatory Affairs and Clinical Development in 2009.  In this role, she has developed different programs to assist the faculty in meeting the rigors of FDA regulated research. The IND/IDE Assistance Program provides guidance and education to faculty who hold an IND or IDE meet the requirements of a sponsor with the FDA.  She also developed and oversees the Monitoring Assistance Program, the FDA Readiness Committee, and the Clinical Research Coordinator Training Program.

She holds a Doctor of Pharmacy from University of Washington and completed a residency in oncology from University of Washington and Harborview Medical Center. She is also a licensed registered pharmacist in New York.

 

 

Greg Koski, M.D., Ph.D.

 

 

 

Rafael Lantigua, M.D., attended the Universidad Autónoma de Santo Domingo.  Graduated from medical school in 1972.  Migrated to New York City to follow his mother's footsteps that had previously migrated to the United States in 1969.  Trained in Internal Medicine at Lincoln Hospital from 1973 through 1976 and from July 7, 1976 to June 1977 he served as a chief medical resident at the same institution.

 

On July 7, 1977 moved to Rochester, New York were he trained in Endocrinology at the School of Medicine of Rochester University.  In January 1980 he returned to New York City with an appointment as Assistant Professor of Medicine at the College of Physicians and Surgeons of Columbia University and Assistant Attending at the New York Presbyterian Hospital.

 

He has moved-up to the rank of the University to become Professor of Clinical Medicine and since 1994 he is the Associate Director of the Division of General Medicine at the Department of Medicine, and the Medical director of Associate in Internal Medicine at the New York Presbyterian Hospital. He is a member of the Admission Committee of Columbia University Medical School and member of the Internal Medicine Residency Committee. Since 1995, he has represented Columbia University at the American Medical Association (AMA) Section on Medical School, in 2010 he was elected member of the Executive Committee. On August of 2011, Dr. Lantigua was appointed Dean’s Advisor for Community Health at Columbia University Medical Center.

 

He has been actively involved in research on issues that affect the quality of life in minority population. He has served as co-investigator in a New York State Department of Health Program to promote awareness and education of cardio-vascular disease in the minority community. He also served as the principal investigator in the National Institute of Aging Study of issues of quality of life affecting the minority elderly. From 1998 -2008 he served as a Director of the Columbia Center for Active Life of Minority Elders, a Resource Center for Minority Aging Research sponsored by the National Institute of Aging and Co-Investigator in a study of the Genetics of Alzheimer’s Disease in Latino Families. Since 1999 Dr. Lantigua has served as Deputy Director of the Taub Institute for Research on Alzheimer’s disease and the Aging Brain, Columbia University. He has published more than 80 medical articles in peer- reviewed journals. A frequent speaker on health topics affecting minorities, he has been the co-chair of two major symposiums dealing with Hispanics' health in New York City.

Dr. Lantigua is co-founder, and past Chairperson of the Board of Alianza Dominicana, Inc., the largest  community based organization serving the Dominican Community in the United States. He is Co-founder and former Chairperson of the Board of the Northern Manhattan Coalition for Immigrants Rights.  He has served in multiple Boards of non-for profit organizations, such as the Puerto Rican Legal Defense Fund, Puerto Rican/Hispanic Institute for the Elderly, the Latino Commission on AIDS, and National Hispanic Leadership Agenda.

 

  He is an active member of the following non- for profit boards: The ARC Fort Washington Senior Center, the Dorothy Blumberg Community Fund, and Isabella Nursing Home. On numerous occasions he has served in the Board of Directors of the Dominican Medical Society and was the president of the Society in 1996.  From 1988 to 1997 he served as a member of the New York State Board of Professional Medical Conduct.

 

He also served as a member of the Board of the Hispanic PAC U.S.A. and he is a member of the Board of Directors and the treasurer of the Hispanic Education and Legal Fund. From 1998 to 2002 Dr. Lantigua was a member of the Board of Directors of the Northern Manhattan Empowerment Zone. On 2005, Dr. Lantigua was appointed to prestigious post of member of the Board of Scientific Counselors of the National Institute on Aging (NIA), a branch of the National Institute of Health (NIH).  He has also served as a member of the Greater New York Hospital Association advisory task force on Diversity in Health Care Leadership. Since 2006, he is Co-Director of the Community Engagement Resource Core of the Irving Institute for Clinical and Translational Research at Columbia University. In 2009, Dr. Lantigua was honored by the Legal Aid Society for his “pro bono” work in front of Federal Court, testifying as a health expert, in favor of Latinos Immigrants facing deportation.

 

He has been distinguished as a Grand Marshall of the Dominican Parade in 1983, and has been given an honorary professor degree from the Universidad Autonoma de Santo Domingo its Alma Mater and from the Universidad Technologica de Santiago, Dominican Republic. In 1998 he was conferred a Doctor Honoris Causa degree in Social Medicine by Spanish University of America., the same year, he received the “ Arnold Gold Award” in Humanism at Columbia University Medical School and in 2010 the Ewig Clinical Scholar Award (Department of Medicine, Columbia University) in recognition of outstanding quality in teaching. Dr. Lantigua has received the Key of the City of Miami and he has received commendations from the Bronx, Queens and Manhattan Borough Presidents, the Office of the Mayor of Newark, New Jersey. Also for the City Council of New York, the New York City State Senate, the U.S. Congress and from the New York City Comptroller, among others.

 

 

 

 

 

 

 

Ian Lipkin, M.D., is internationally recognized as an authority on the use of molecular methods for pathogen discovery. Dr. Lipkin has over 30 years of experience in diagnostics, microbial discovery and outbreak response, has mentored and trained more than 30 students and post-doctoral fellows and leads a team of over 65 investigators, post-doctoral fellows and research and support staff at MSPH. In the 1980s, Dr. Lipkin identified AIDS-associated immunological abnormalities and inflammatory neuropathy, which he showed could be treated with plasmapheresis, and demonstrated that early life exposure to viral infections affects neurotransmitter function. He was the first to use purely molecular methods to identify infectious agents, implicated West Nile virus as the cause of the encephalitis epidemic in New York in 1999, assisted the WHO and the Peoples Republic of China during the 2003 SARS outbreak, developed MassTag PCR and Greenechip technology and pioneered the use of high throughput sequencing in pathogen discovery. He and his team have discovered or characterized more than 400 infectious agents including Borna disease virus, West Nile virus, LuJo virus, human rhinovrirus C, piscine reovirus and canine hepacivirus. Dr. Lipkin has been featured by the New York Times, the Los Angeles Times, Discover Magazine, Nature Medicine, the History Channel, National Geographic, National Public Radio, Wired, and the Huffington Post.

 

 

 

Mary Mattis, Ph.D. is the Chair of the Institutional Review Board of the New York City Department of Education, the largest school district in the United States, with 1.1 million students.  She is responsible for overseeing all research activities in the NYC DOE’s public schools and program offices involving human subjects, developing and implementing a human subjects protection program, and providing leadership and support for the DOE’s IRB.  The NYCDOE IRB reviews over 400 proposals for new research studies annually, along with numerous requests for continuations of multi-year projects.   During the past year, she also led the design and implementation of the DOE’s new, fully electronic IRB proposal submission and review system. 

She holds a Ph.D. and MA in Sociology from Washington University in St. Louis.  Before joining the NYC DOE, she was a Senior Program Officer at The Wallace Foundation, where she managed the Foundation’s commissioned research on School Leadership.  From 1988-2002, she held several executive positions at Catalyst, a nonprofit membership organization that works to expand opportunities for women and business.   At Catalyst, she authored seminal reports on workplace diversity and flexibility, was a frequent speaker at business and professional conferences, and provided advisory services to Fortune 500 and Global 500 companies, firms, business schools, and associations around the world on best practices for retaining and advancing women.  She is the author and co-author of numerous books and articles and a member of the Editorial Board for Gender in Management:  An International Journal. 

 

 

 

 

 

Joyce Moon Howard, Dr. P.H., is on the faculty of Mailman School of Public Health at Columbia University where she teaches courses in program evaluation and community based participatory research (CBPR). She has been the co-principal investigator on several studies funded by both the Centers for Disease Control and Prevention (CDC) and the National Institute of Mental Health (NIMH), which use community-based participatory partnership (CBPR) approaches to research. She chaired the panel on CBPR at the Association of Schools of Public Health Education Committee Workshop, charged with making recommendations to advance teaching in graduate programs within schools of public health. A research associate of the CDC-funded Harlem Health Promotion Center, Moon-Howard has conducted community-based research to better understand sources of excess mortality in Harlem; developed interventions to address these disparities; and become known through publications in the Journal of Urban Health and AJPH for her collaborations with local churches and faith communities. As an investigator with the NIH funded CTSA's Community Engagement Research Core (CER) at Columbia University, she served as collaborator on the design and implementation of the CER's introductory CBPR course for community providers. In addition, in collaboration with the CTSAICER, she was the PI on a study (funded by NIA) with community partners the Dominican Women's Development Center (DWDC) and the Washington Heights-Inwood Council on Aging (WHICOA) to examine predisposing, enabling and reinforcing factors within the Columbia University Medical Center that affect the conduct of Community Based Participatory Research.

 

 

 

 

Pearl O'Rourke, M.D. is the Director of Human Research Affairs at Partners HealthCare Systems in Boston and an Associate Professor of Pediatrics at Harvard Medical School.  She is responsible for the systems that support the regulatory and ethical oversight of human research and the responsible conduct of research.  She is also Chair of the Partners Healthcare System ESCRO (Embryonic Stem Cell Research Oversight) Committee.

 

Pearl has worked as a pediatric critical care physician at the Children's Hospital, Boston and at the Children's Hospital, University of Washington, Seattle where she was the Director of the Pediatric Intensive Care Unit.  She was active in clinical research in extracorporeal membrane oxygenation (ECMO), liquid ventilation, high frequency ventilation and pediatric resuscitation.  In Seattle she served many years as a member of the IRB.  Pearl has also been involved in international medical care, serving in China and Indonesia with Project HOPE. 

 

In 1995-1996, Pearl did a Robert Wood Johnson Health Policy fellowship working for Senator Edward Kennedy.  Following this fellowship, she became the Deputy Director of the Office of Science Policy in the Office of the Director at the NIH where she worked on issues such as privacy, gene therapy (transfer) embryonic stem cells, and genetic discrimination.

 

 

 

Ron Otten, Ph.D. is the Director of the Office of Scientific Integrity (OSI). He is responsible for planning, managing, and evaluating the programs of OSI and as a senior member of the Office of the Associate Director for Science (OADS) management team. His office within OADS provides leadership for the following areas: protecting the rights and welfare of human beings who participate in research; complying with laws and principles in the care and use of laboratory animals; ensuring compliance with the Paperwork Reduction Act; protecting the privacy of individuals in records maintenance; ensuring leadership in public health ethics; and ensuring that training relevant to scientific integrity is available to the CDC community.

Dr. Otten joined CDC in 1991 as a laboratory scientist in the Division of HIV/AIDS. He has authored or co-authored numerous articles on topics such as biomedical interventions designed to prevent HIV infection and detecting variant strains of HIV. His research has been presented at both national and international conferences. Dr. Otten, along with a select team, was awarded the U.S. Department of Health and Human Services Secretary's Award for Distinguished Service in 1997. In addition, he has served on numerous committees during his career such as the Emory University Institutional Review Board (2000 – 2006) and the CDC-Atlanta Institutional Animal Care and Use Committee, for which he served as Chairperson (2006 - 2010). From a regulatory perspective, Dr. Otten's experience provides him with an in-depth understanding of extremely diverse biomedical studies and a great appreciation for the ethical aspects related to those studies.

Before coming to CDC, Dr. Otten received his Bachelor's degree in Microbiology at the University of Florida (UF). He entered graduate school in the Microbiology and Immunology department where he met and followed an esteemed UF scientist to complete his doctoral degree in Medical Microbiology at the Medical College of Ohio.

 

 

 

 

Karen Pagliaro-Meyer

 

 

Pritchard

Ivor Pritchard, Ph.D., is the Senior Advisor to the Director in the Office for Human Research Protections (OHRP) in the U.S. Department of Health and Human Services.  He came to OHRP in 2004 from the Institute for Education Sciences at the U.S. Department of Education, where he was a Senior Research Analyst. He has a Ph.D. in philosophy from Boston University.  His research interests are in research ethics and federal policy, moral and civic education research and practice, and education policy.

 

   
 

John Santelli, M.D., M.P.H. is the Harriet and Robert H Heilbrunn Professor and Chair of the Heilbrunn Department of Population and Family Health at the Mailman School of Public Health at Columbia University and a Senior Fellow at The Guttmacher Institute.

John received his MD from the Buffalo School of Medicine, his MPH degree from Johns Hopkins University, and Adolescent Medicine training at the U of Maryland Hospital.  He has worked in local and national public health including 13 years with CDC (the U.S. Centers for Disease Control and Prevention). His research has included studies on HIV/STD risk behaviors in the U.S. and Uganda, trends in teen pregnancy in the U.S., and programs to prevent STD/HIV/unintended pregnancy.  He has been a leader in insuring that adolescents are appropriately included in health research and have access to medically accurate, comprehensive sexuality education. 

John is president for the Society for Adolescent Health and Medicine (March 2012- March 2013). He has served on the editorial boards of the Journal of Adolescent Health, Perspectives on Sexual and Reproductive Health, American Journal of Sexuality Education, and AIDS Education and Prevention.

 

 

 

Naomi Schrag, J.D., is the Associate Vice President for Research Compliance and Training in the Office of the Executive Vice President for Research. She oversees work on issues such as research misconduct, conflict-of-interest and international research compliance, and 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.

 

 

 

 

 

Marjorie Speers, Ph.D.

Dr. Speers is the President and CEO of the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Previously, she served at the National Bioethics Advisory Commission from 1999-2001, both as project director for a report on the research oversight system and as Acting Executive Director. Dr. Speers was Deputy Associate Director for Science at the Centers for Disease Control and Prevention (CDC) from 1995-2000. As the Deputy Associate Director for Science, Dr. Speers oversaw the human subjects protection program both for domestic and international research in addition to overseeing science policy.

While at CDC, Dr. Speers held a variety of positions at CDC from 1988-1995: Director of the Division of Chronic Disease Control and Community Intervention, Chief of the Aging and Statistics Branch, and staff epidemiologist. Prior to joining CDC, she was a faculty member at the University of Texas Medical Branch. 

Her research is focused in public health, primarily on prevention and health promotion.  Dr. Speers received doctoral degrees in psychology and epidemiology from Yale University and a bachelor’s degree in psychology from Dickinson College.   

 

Latanya Sweeney, Ph.D., is the Director and founder of the Data Privacy Lab at Harvard University. The Lab, formerly at Carnegie Mellon, works with real-world stakeholders to solve today's privacy technology problems. Dr. Sweeney, a Visiting Professor and Scholar at Harvard, previously a Distinguished Career Professor of Computer Science, Technology and Policy at Carnegie Mellon University, was recently appointed to the Privacy and Security Seat of the Federal HIT Policy Committee, the group responsible for advising ONC on policy for the new national health information infrastructure. Dr. Sweeney's work involves creating technologies and related policies with provable guarantees of privacy protection while allowing society to collect and share person-specific information for many worthy purposes. She has made numerous discoveries related to identifiability and privacy technologies and she has had significant impact on American privacy policy. Her work has received awards from numerous organizations, including the American Psychiatric Association, the American Medical Informatics Association, and the Blue Cross Blue Shield Association. Dr. Sweeney's work has appeared in hundreds of news articles, numerous academic papers, and was even cited in the original publication of the HIPAA Privacy Rule and the Health Breach Regulation. Companies have licensed and continue to use her privacy technologies. Dr. Sweeney received her PhD in computer science from the Massachusetts Institute of Technology. For more, see dataprivacylab.org/people/sweeney/index.html

 

 

Bio photo

 

Hugh Tilson, M.D., M.P.H., Dr. P.H.

Hugh Tilson M.D. (Washington University, St. Louis, Missouri 1964), Dr.P.H. (Harvard School of Public Health 1972) has spent fifteen years each in public service, the multinational pharmaceutical industry, and academia. Recognized as a public health systems, pharmacoepidemiology, and outcomes researcher focusing on drug safety, he is a Lifetime National Associate of the National Academies of Science, a member of the Public Health Accreditation Board (PHAB) and the Board of Public Responsibility in Medicine and Research (PRIM&R).

Tilson chaired the national Steering Committee for the U.S. Centers for Education and Research on Therapeutics (CERTs) 1999-2009.  A founding member and lifetime (honorary) fellow of the International Society for Pharmacoepidemiology (ISPE) and of the Academy of Pharmaceutical Physicians and Investigators (APPI), Tilson has received the highest honors from each. 

 

 

Alan Wertheimer, Ph.D. is Professor Emeritus of Political Science at the University of Vermont and Senior Research Scholar, Department of Bioethics, Clinical Center, National Institutes of Health.  He is the author of Coercion (Princeton University Press, 1987), Exploitation (Princeton University Press, 1996), Consent to Sexual Relations (Cambridge University Press, 2003) and Rethinking the Ethics of Clinical Research: Widening the Lens  (Oxford University Press, 2011).   (I’ll have to search for a photo or have one taken). 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
 

                                                                            

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

           

 

 

 

 

 

 

 

 

 

 

 

 
     


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