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Research involving Data and Biospecimens Track
2019 AER Conference
11/12/2019 5:50 PM
Marylana Saadeh Helou, Esq.
Attorney, Verrill LLP
R. Peter Iafrate, PharmD
IRB-01 Chair; Assistant Director, Research Programs and Services, University of Florida
IRB Chairman, University of Florida
Marianna J. Bledsoe, MA
Chair, Science Policy Advisory Committee, International Society for Biological and Environmental Repositories
Chair, International Society for Biological and Environmental Repositories Science Policy Committee,
This session explores the legal and practical challenges that institutions face when implementing an institution-wide research database or specimen repository. From the approach to consent, the banking protocol submitted to the IRB, the use of steering or access committees with associated policies and procedures, as well as the agreements and processes necessary for sharing the resource for downstream research purposes, there are a number of important points institutions need to consider when developing institutional resources to ensure they are done in a compliant and ethical manner. This session will offer an overview of applicable regulatory requirements, as well as practical suggestions for how institutions can effectively operationalize these resources. During this session, speakers and attendees will: