1. Piloting IRBchoice at Vanderbilt
Rebecca Abel, MA, CIP
Central IRB Liaison
Vanderbilt Human Research Protection Program

2. VUMC HRPP Overview
4 IRB committees (3 biomedical, 1 behavioral and social sciences)
27 regulatory staff members; 23 certified (CIM, CIP, CCRP)
DISCOVR-E- Data Integrated Study Console Of the Vanderbilt Research Enterprise
Proprietary software designed in-house.
Utilizes REDCap platform for IRB application using branching logic
Allows multiple document upload and communication back and forth with study teams
Users must have Vanderbilt specific log in to access

3. Serving as the Lead IRB
National Registry for Childhood Interstitial and Diffuse Lung Diseases

4. Study Overview
This study establishes a national registry that will be conducted at sites participating in the Children’s Interstitial and Diffuse Lung Disease Research Network (chILD Research Network). The purpose of the study is to advance knowledge on the frequency, symptoms and features, treatments, and outcomes for children with these diseases. Because these disorders are rare, multicenter studies are required to assemble large enough numbers of cases for systematic study.

5. IRB Submission and Database Considerations
Lead IRB submits via DISCOVR-E and indicates IRBchoice as study type on IRB application
Relying Sites submit via Vanderbilt PI or Vanderbilt Coordinating Center Staff, whichever applies
Review Process
Study is reviewed based on regulatory criteria
When sites agree to cede review, Vanderbilt PI submits amendment with site’s consent document for review
Database Challenges
Investigators are often unsure of what study type to select, affecting branching logic of questions
Only one amendment can be submitted at time

6. Using IRBchoice to Facilitate Our Work
Benefits
Tracking reliance relationships and status of reliance
Documenting reliance plan regarding providing documentation, reviewing HIPAA, reporting and auditing
Disseminating IRB approvals to Relying Sites
Central, transparent documentation for all IRBs in study
Repository of contacts with different IRBs to facilitate communication
Ongoing Challenges with Reliance

7. Serving as the Relying IRB
Evaluation of N-acetylcysteine Dosing for Acetaminophen Overdose in Obesity

8. Study Overview
This study compares two dosing regimens of N-acetylcysteine (NAC) in an obese population across multiple institutions, as the current practice varies
Chart review with a waiver of consent and authorization

9. IRB Submission and Database Considerations
Process for initiating reliance
Register with study in IRBchoice
Initial Submission Requirements
PI completes application based on branching logic in DISCOVR-E
Reviewed HIPAA waiver, PI & KSP qualifications, and conducted Medicare QCT analysis
Ongoing submission requirements (CRs, amendments)
Personnel changes
Continuing review- need to know enrollment numbers
Database Challenges
Current database not set up to easily document ceded review elements

10. Using IRBchoice to Facilitate Our Work
Institutional Profile
Tracking reliance relationships and status of reliance
Documenting reliance plan regarding providing documentation, reviewing HIPAA, reporting and auditing
Standardized support for investigators (investigator instruction sheet)
Notification of IRB approvals from Lead IRB
Central, transparent documentation for all IRBs in study