Skip to main content
SBER21/AER21 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Pre-Reg Required
Pre-Reg Required
New for 2020
New for 2020
CSP Icon
CSP Icon
Livestreaming Session Icon
Livestreaming Session Icon
On-Demand Session
On-Demand Session
CIP Accredited
CIP Accredited
Additional Fee
Additional Fee
Poster Icons
Record Session Icon
Record Session Icon
Pre-Reg Required
Pre-Reg Required
New for 2020
New for 2020
Part I/II
Part I/II
CSP Icon
CSP Icon
Livestreaming Session Icon
Livestreaming Session Icon
Prerecorded Session Icon
Prerecorded Session Icon
CIP Accredited
CIP Accredited
Pillars Icon
Pillars Icon

2021 AER Conference

Flexibility and Innovation in HRPP Processes Track

HRPP Leadership and Institutional Officials Track

IRB Operations Advanced Track

A03 - Beyond Reliance Agreements: Local Considerations, Risk Mitigation, and Compliance

Wednesday, November 17, 2021
11:45 AM - 12:45 PM ET
Location: Livestreamed
Livestreaming Session Icon CSP Icon New for 2020 CIP Accredited
Collaborative research among different legal entities, such as when faculty from one legal entity hold a dual appointment and cross over to another legal entity to engage in research there brings some challenges when it comes to streamlining IRB review and ensuring regulatory compliance. Issues stretch from permission to engage in research in another legal entity to data flows/HIPAA issues, sovereign immunity, local ancillary reviews and sign offs, consent forms, ceding review to an entity beyond affiliated institutions, and more. The session will explore the following concepts through the use of lecture and case studies.

Learning Objectives:

  • Identify regulatory requirements for research involving personnel from one institution who perform research activities at another legal entity where they are also credentialed
  • Discuss the content and format of agreements used to cover research activities and streamline regulatory oversight
  • Use case studies to explore issues that arise in collaborative research across affiliated institutions, such as when an affiliate does not have a local IRB office, chart review studies, ceding IRB review to an entity beyond the affiliated institutions, etc.