Vulnerable Populations

Full Board Review - Enhanced Protections

~20 minutes 11 Required Fields

What You'll Need to Have Ready

Research study title, objectives, and PI information
Vulnerable population category (children, prisoners, cognitively impaired, etc.)
Justification for including vulnerable participants
Interview protocol, questions, and recording plans
Guardian/LAR consent procedures (if applicable)
Enhanced risk mitigation strategies and safety monitoring plan
Data protection measures for sensitive information

What to Expect

→ Detailed questions about vulnerable population protections
→ Justification for why this population must be included
→ Guardian/legally authorized representative (LAR) consent details
→ Risk mitigation and participant safety protocols
→ Enhanced data security for sensitive information
→ Additional IRB documentation requirements for full board review

IRB Compliance

Comprehensive compliance with Subparts B, C, and D of 45 CFR 46. Includes enhanced safeguards for children (§46.404-407), prisoners (§46.305), and other vulnerable populations.

Subpart B: Children Subpart C: Prisoners LAR/Guardian Consent Enhanced Risk Mitigation Full Board Review

Your Data, Your Control

You can enable Local Mode to keep all your proposal data in your browser only. Your work auto-saves as you go, and you can export it at any time. Learn more

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.

~20 minutes

Auto-saves your progress

IRB-ready exports