B15 - Operationalizing Research Databases and Biobanks at Your Institution

Wednesday, November 17, 2021

1:45 PM – 2:45 PM ET

Location: On-Demand

This session will explore the legal and practical challenges 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.

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

Presenter(s)

Jaime O. Hernandez, JD, M.Be.

Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
Rockville, MD
R. Peter Iafrate, PharmD

University of Florida
University of Florida
Gainesville, FL
LS

Lauren Sauer, MS

University of Nebraska Medical Center