Informed consent is intended to provide patients, clinical trial participants, and others undergoing medical procedures with the information they need to make a decision about whether to undergo a specific procedure or participate in research. The process of informed consent can sometimes be very legal in nature leading to lack of clarity and misunderstanding. This webinar will explain the informed consent process, why patients should pay attention to it, and why rare disease advocates may want to get involved in the process.
Rare disease organizations play a critical role in connecting patients with researchers and the informed consent document is critically important. It outlines who will have access to research data that results from a study. Understanding the informed consent process and how to engage will help patients receive the greatest benefit.
Megan’s 15-year-old daughter, Shannon has Phelan-McDermid Syndrome (PMS), an ultra rare condition. This diagnosis includes autism, intellectual disabilities, epilepsy, ADHD, lymphedema, and other medical conditions.
For the past 5 years Megan has volunteered for the PMS Foundation’s Research Support Committee. She is the Principal Investigator for the Phelan-McDermid Syndrome Data Network (PMS_DN, PCORnet) and the Phelan-McDermid Syndrome International Registry (PMSIR). She directed the biosample collection at the 2012 PMSF Family Conference, creating a biorepository of over 30 DNA and fibroblast samples.
Megan is passionate about the importance of the patient’s voice in: research, drug development, clinical trial design, development of related legislation, and quality of life decisions. She advocates for data sharing, collaborating with other advocacy groups, sharing resources, a genetics-first approach and streamlining IRB practices and policies.
Megan and her family live in Arlington, VA.
John Wilbanks is the Chief Commons Officer at Sage Bionetworks. Previously, Wilbanks worked as a legislative aide to Congressman Fortney “Pete” Stark, served as the first assistant director at Harvard’s Berkman Center for Internet & Society, founded and led to acquisition the bioinformatics company Incellico, Inc., and was executive director of the Science Commons project at Creative Commons. In February 2013, in response to a We the People petition that was spearheaded by Wilbanks and signed by 65,000 people, the U.S. government announced a plan to open up taxpayer-funded research data and make it available for free. Wilbanks holds a B.A. in philosophy from Tulane University and also studied modern letters at the Sorbonne.
Kristi Clark has 21 years of experience in the biopharma (McGhan Medical and Depotech) and CRO industry (8 years at Quintiles and 6 years at Synteract). Kristi green-fielded an office in Eastern Europe for Synteract where she spent two years building the office infrastructure and client base. As part of the executive team at Synteract, Kristi played an integral part in global business strategy and acquisitions. Recently, Kristi opened Verum’s (Eastern European CRO) first US office and is responsible for operations, business development and strategy. Her global leadership and project and clinical management experience has spanned the full scope of studies, from start-up to project closeout, and has included expertise in several therapeutic areas including pediatric oncology, pediatric chronic pain, oncology, cardiovascular, CNS, biomarkers, infectious disease, gastroenterology, and ophthalmology. Kristi holds an MBA in Healthcare Administration from National University and a Bachelor of Science in Biopsychology from the University of California at Santa Barbara.
Daniel Levine, Founder & Principal, Levine Media Group
Daniel Levine is an award-winning business journalist who has reported on the life sciences, economic development, and business policy issues throughout his 25-year career. Since 2011, he has served as the lead editor and writer of Burrill Media’s acclaimed annual book on the biotech industry and hosts The Burrill Report’s weekly podcast. His work has appeared in The New York Times, The Industry Standard, TheStreet.com, and other national publications.