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

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

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

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.

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

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

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

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

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

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