Clinical and Research Data Warehouse (CRDW)

Institutional Review Board workflow

View text version below with acronyms expanded.

• Code of Federal Regulations
• Human Research Protection Program Toolkit
• Non-Human Research Self-Certification Tool

Institutional Review Board (IRB) workflow text version:

Researcher develops concept:

• 1. Does the proposed project appear to meet the definition of “research” in accordance with 45 CFR 46, 102 (I) (Code of Federal Regulations)
  • If yes, proceed to process step 1a
  • If no, proceed to process step 2
    • a. Investigator writes protocol using appropriate IRB template; completes eIRB application for research study noting use of CRDW; once complete proceed to process step 1b
    • b. PI (principal investigator) completes CRDW data request form; uploads one of the following: 1: PDF of HRPP (Human Research Protection Program) self-certification 2. Rutgers elRB Non-Human Subjects Determination 3. Rutgers elRB approval
• 2. Official Rutgers IRB Non-Human Subject Research Determination letter required (i.e. for publication purposes)?
  • If yes, proceed to process step 2a
  • If no, proceed to process step 2b
    • a. PI completes Rutgers eIRB request for Non-Human Subjects Determination; once complete proceed to process step 1b
    • b. PI uses Ruttgers HRPP tool to verify whether proposed project meets the definition of Non-Human Subjects Research. Retains a copy of self-certification; once complete proceed to process step 3
• 3. HRPP Tool confirms Non-Human Subjects Research
  • If yes, proceed to process step 1b
  • If no, proceed to process step 1a