Observational Studies

Non-Interventional Research

~18 minutes 11 Required Fields

What You'll Need to Have Ready

Study design type (cohort, case-control, cross-sectional, etc.)
Data sources (medical records, registries, existing datasets, observations)
Variables and outcomes being measured
De-identification or coding procedures for PHI/PII
Justification for waiver of consent (if applicable)
HIPAA compliance plan for protected health information
Data analysis plan and access controls

What to Expect

→ Questions about observational study design and methodology
→ Data source specifications and access permissions
→ HIPAA-compliant de-identification procedures
→ Waiver of consent justification (if using existing data)
→ Privacy safeguards for secondary data use
→ Validation of limited data set and safe harbor methods

IRB Compliance

Aligned with HIPAA Privacy Rule §164.514 for de-identification and secondary use. Covers waiver of consent criteria under 45 CFR 46.116(d) for minimal risk observational research.

HIPAA §164.514 De-identification Safe Harbor Waiver of Consent §46.116(d) Limited Data Sets Secondary Data Use

Your Data, Your Control

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Select Your Institution(s)

Select one or more institutions to align your proposal with their specific requirements. If filing with multiple IRBs, we'll combine their requirements.

Select Organization Type(s)

Academic & Research Institutions

Universities, colleges, and academic research centers

Hospital Systems & Health Networks

Medical centers, hospital systems, and healthcare organizations

Independent Research Organizations

Contract research organizations (CROs) and independent labs

Private Companies Doing Human-Subjects Research

Pharmaceutical, biotech, and tech companies conducting studies

Government & Public Agencies

Federal, state, and local government research agencies

Third-Party or Commercial IRBs

Independent review boards providing IRB services

Tip: Select "Other" options if your specific organization isn't listed. We'll use a generic template that works for most IRBs.

~18 minutes

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IRB-ready exports