Research involving Data and Biospecimens Track
2019 AER Conference
11/12/2019 5:50 PM
E12 - Operationalizing Research Databases and Biobanks at Your Institution
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,
Speaker(s)
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:
Learning Objectives:
- Review regulatory requirements and best practices for research databases and biobanks
- Discuss various approaches to informed consent for participation in databases and biobanks, including how the revised Common Rule has impacted those options and how honest brokers can be used to facilitate secondary research
- Outline practical steps institutions can take when initiating, operating and terminating/transferring institutional research databases and biobanks to maximize the value of the resource and minimize risk, including issues related to financial sustainability