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  • Faculty (Global Research)

    David Borasky - 2

    David A. Borasky, Jr., MPH, CIP, is the vice president for quality management at the Copernicus Group IRB (CGIRB). In this role, he serves as the principal regulatory officer and provides leadership in the development, implementation, and administration of CGIRB corporate quality and compliance systems. Previously, Mr. Borasky worked as the interim director in the Office of Human Research Ethics at the University of North Carolina at Chapel Hill. He has over 17 years of experience managing institutional review boards, as well as facilitating training activities on basic research ethics and IRB operations and function for research staff and their collaborators worldwide. He is a co-author of the award-winning Research Ethics Training Curriculum and the Research Ethics Training Curriculum for Community Representatives, which together have been used to train individuals in over 70 countries. He is a contributing author of Institutional Review Board: Management and Function. In addition, David has provided hands-on assistance to IRBs throughout North America, Africa, and Asia, specializing in capacity building activities for IRBs in low-resource settings. He has served as a consultant for the Office of Human Research Protections, the US Department of Energy, the World Health Organization and numerous other institutions. David is proud to be a member of the Board of Directors for PRIM&R. He frequently lectures on the challenges of the review of research in developing country settings, and has published articles on research ethics training and international. Mr. Borasky also serves on the Public Policy Committee.

    David Christiani

    David Christiani, MD, MPH, MS, is a professor of medicine at Harvard Medical School, Physician, Pulmonary and Critical Care Unit of Massachusetts General Hospital (MGH), and the Elkan Blout of Environmental Genetics at the Harvard T. H. Chan School of Public Health (HSPH). He is also one of the chairs of the HSPH Institutional Review Board.

    Dr. Christiani’s major research interest lies in the interaction between human genes and the environment. In the emerging field of molecular epidemiology, he studies the impact of exposure to pollutants on human health, as well as the how genetic and acquired susceptibility to these diseases along with environmental exposures can lead to acute and chronic pulmonary and cardiovascular disease. He has led environmental and genetic epidemiology studies internationally for the past 35 years.

    Working with wide network of collaborators, Dr. Christiani and his research team have been studying the health effects of exposure to dusts and chemicals, in China; arsenic exposure and bladder and skin cancer and respiratory disease in Taiwan and Bangladesh; exposure to indoor combustion products in respiratory disease; and the respiratory effects of paraquat exposure in Africa. He has conducted a landmark 35-year-long study of respiratory disease in cotton-textile workers in Shanghai, China. This study has determined the rate of loss in lung function among dust-exposed workers and described the relationship between exposure to endotoxins produced by bacteria in cotton and acute and chronic lung disease.

    Dr. Christiani has led a large molecular and genetic analysis of lung cancer, examining genetic factors that make people susceptibility to lung cancer and help predict the outcome of treatment. He also leads the Molecular Epidemiology Research Group at MGH that conducts research on environmental conditions of the lung, including acute lung injury, lung cancer, and respiratory responses to environmental toxicants. He has authored or co-authored over 600 peer-reviewed publications, with an H-index of 66. In 2012, he was appointed by President Obama to the National Cancer Advisory Board.

    Kathleen Lawry

    Kathleen “Kathy” Lawry, CIP, is a consultant for the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Ms. Lawry is a graduate of Case Western Reserve University Mandel School of Applied Social Sciences. She worked at the Cleveland Clinic as a clinical social worker and researcher. Her area of specialization was Pediatric Nephrology and Transplant. While at the Cleveland Clinic, Ms. Lawry was a founding member of the hospital’s Ethics Committee and served on the committee for many years. Ms. Lawry has extensive experience as a clinical research coordinator. She has also worked in the private sector as a clinical research monitor for numerous multicenter clinical drug and device trials. Her research interests have been focused on of the impact of chronic illness on the cognitive functioning, educational achievement, and social functioning of children and adolescents. She has written and lectured extensively on children and adolescents, chronic illness and biomedical ethics. Ms. Lawry has been an adjunct instructor at the Case Western Reserve Mandel School of Applied Social Science, editor of the Journal of Nephrology Social Work, and served on the board of many organizations involved with healthcare issues. She has worked in both research compliance as an assistant director of research administration and the IRB as the manager of the Institutional Review Board at MetroHealth Medical Center. In these positions she had oversight of the Institutional Review Board, Conflict of Interest Reporting, Human Subjects Training, and Time and Effort Reporting. In her role as a consultant for AAHRPP, Ms. Lawry has reviewed application from numerous international sites, conducted site visits, and provided best practice advice to institutions outside the US according to AAHRPP standards.

    Delia Wolf

    Delia Y. Wolf, MD, JD, MSCI, is the associate dean for regulatory affairs and research compliance at Harvard T.H. Chan School of Public Health (HSPH). She is also a faculty member in the department of health policy and management. In her role as associate dean, Dr. Wolf is responsible for establishing, implementing, and maintaining a comprehensive human research protection program (HRPP), developing and implementing policies and procedures, and ensuring faculty and institutional regulatory compliance in the areas of human research, animal research, lab safety, bio-safety and research integrity. She serves as the institutional official (IO) for all research involving humans, environmental safety compliance officer, and research integrity officer (RIO) at HSPH. She also oversees efforts in international research, including review of institution collaboration agreements and global research ethics training. Besides her medical degree from her native country, China, Dr. Wolf earned a Master of Science in Clinical Investigation, and a Juris Doctor degree from Suffolk University Law School. She is a licensed attorney in the Commonwealth of Massachusetts. She also completed a fellowship in medical ethics at Harvard Medical School, where she concentrated on ethical issues in conducting clinical research at international sites. As a former clinical researcher, IRB chair, director for a QA/QI Program at Partners Healthcare System, and director for Human Research Administration at Harvard School of Public Health for almost two decades, Dr. Wolf has extensive experience in conducting, organizing, developing, and overseeing the full spectrum of clinical research. Her research interests include legal, ethical, and practical issues in conducting and managing clinical research in different countries.