2018 AER Conference: Preconference Programs
William Grizzle, MD, PhD
PhD Director, Tissue Collection and Banking Facility Senior Scientist, UAB Comprehensive Cancer Center; Comprehensive Center for Healthy Aging; Metabolic Bone Disease Research Center; Cystic Fibrosis Center, University of Alabama at Birmingham
The collection, storage, distribution, and use of biospecimens from human individuals and the subsequent sharing of biospecimens and data is absolutely essential for scientific discoveries to advance precision medicine. Research subject consent for use of their biospecimens is a critically important component. However, biobanking in an era of precision medicine raises significant challenges for IRBs, institutions, investigators regulators and policy makers, research repository managers, and funding agencies and sponsors. For example, biobanking for future research uses of biospecimens can be challenging depending upon the specificity or broadness of the consent, as well as data sharing restrictions. New regulatory requirements apply to the use of human biospecimens in research, including the new tool of “regulatory” broad consent which carries with it a host of logistical and substantive issues. Other challenges include the need to establish sound governance and oversight mechanisms for biobanks generally and to ensure oversight of data sharing and data limitations as well as complex issues such as ownership of biospecimens and data, return of research results, and other ethical issues. During this workshop, speakers and participants will examine these contemporary challenges, focusing on practical strategies for addressing them. This course will be an interactive, advanced educational workshop that will seek to integrate speaker and participant experiences and concerns. Program attendees should come with a thorough understanding of biospecimen banking issues and IRB regulatory criteria, as fundamentals are not included in this course. Please note that this preconference program may include similar content provided in past programs with updates to reflect changes in applicable regulations and emerging issues and approaches.