2007 Webinar: Protocol Review in the New Era of Genetics

Overview

Protocol Review in the New Era of Genetics included cases, and other concrete examples, of many of the genetics issues that Institutional Review Boards/Human Research Protections Programs (IRBs/HRPPs) face when reviewing research protocols. Beginning with "PRIM&R's primer" on genetic and pharmacogenetic research, this webinar addressed the recent changes that have occurred in the field, including the shift in focus from single-gene disorders to complex traits. Case studies based on actual protocols allowed participants the opportunity to explore some of the most pressing issues faced by IRBs/HRPPs. Strategies for reviewing such protocols and improving the corresponding consent documents were shared.

Audience

The audience for this webinar included all those engaged in IRB/HRPP work and/or those engaged in conducting research more broadly. IRB chairs, members, administrators, and staff, as well as institutional officials, signatory officials, researchers, subject advocates, ethicists, and industry representatives will all find this webinar beneficial.

Faculty

Barbara Handelin, PhD
Barbara Handelin is a seasoned biotech business executive and board certified Medical Geneticist (Molecular and Biochemical Genetics) who has pioneered the responsible application of genetics to clinical medicine and drug development research over a 16 year career. In 1987, Dr. Handelin established what became the largest commercial DNA testing laboratory in the world at Integrated Genetics (now Genzyme Genetics). After being recruited to found a gene therapy company in the Philadelphia region, Dr. Handelin founded her own consulting practice, Handelin Associates, in the biopharmaceutical and technology transfer sector. She delivered consulting services to venture capital investors, CEOs of new technology companies, senior business development executives of biotechnology, diagnostics, genomics, pharmacogenomics and bioinformatics companies, and biomedical universities. In late 2000, Dr. Handelin founded a biosimulation company, Kenna Technologies, where she served as CEO until its acquisition by DNA Print Genomics in October 2005. Today at DNA Print Pharmaceuticals she oversees the development of new diagnostic tests for indications including genetics, pharmacogenetics, and other aspects of disease management. Dr. Handelin serves on the Board of Directors of RedPath Integrated Pathology, Inc. She previously served on the advisory boards of two biotech companies, and was a PRIM&R Board member for ten years.

Dr. Handelin has served on a variety of federal committees and advisory panels on genetic testing and pharmacogenetics, including the Secretary’s Advisory Panel on Genetics, Health and Society, and was the Principal Investigator on a DOE ELSI grant on the “The Responsibility of Oversight in Genetics Research: How to Enable Effective Human Subjects Review of Public and Privately Funded Research Programs.” Dr. Handelin took her PhD at the Oregon Health Sciences University and the Massachusetts Institute of Technology and has authored journal publications in human genetics, bioethics for industry, and genetics education.

Ingrid Holm, MD, MPH
Ingrid Holm is the Director of the Phenotype Core of the Program in Genomics at Children’s Hospital Boston and an Assistant Professor of Pediatrics at Harvard Medical School. Dr. Holm's research focuses on the genetics of bone disorders, including the role of mutations in the PHEX gene in hypophosphatemic rickets. Her studies have sought to elucidate the genetic and environmental components of disorders of bone mineralization. She is particularly interested in the contribution of environmental factors to the low bone mass seen in individuals with neuromuscular diseases, such as muscular dystrophy.

Dr. Holm is also interested in the genetics of complex traits. She has worked with researchers to develop clinical genetic research projects in diabetes, autism, congenital heart disease, and atopic dermatitis, and has her own project in the genetic contributions to congenital hip dysplasia.

Dr. Holm received her MD from the University of California, Los Angeles. She completed an internship, residency, and post-graduate fellowships in genetics and pediatric endocrinology at Children's Hospital Boston. She received an MPH degree from Harvard School of Public Health, and is board-certified in pediatric endocrinology and medical genetics. Dr. Holm is Past President of Advances in Mineral Metabolism, an organization of professionals in the field of mineral metabolism.