irb-human-subjects/README.md

IRB & Human Subjects Research Quality Management System

A comprehensive QMS template designed for Institutional Review Boards, research ethics committees, and human subjects protection programs.

📋 Designed For

• Institutional Review Boards - IRB offices and committees
• Human Research Protection Programs - HRPP offices
• Academic Medical Centers - Research compliance offices
• Independent IRBs - Commercial ethics review organizations
• Research Institutions - Universities and research centers
• Clinical Trial Sites - Investigator-initiated study oversight
• Federal Agencies - OHRP, FDA, and regulatory bodies

📋 Regulatory Framework

This template supports compliance with:

• Common Rule (45 CFR 46) - Federal Policy for the Protection of Human Subjects
• FDA 21 CFR 50 - Protection of Human Subjects
• FDA 21 CFR 56 - Institutional Review Boards
• HIPAA - Privacy Rule for research
• ICH-GCP E6(R2) - Good Clinical Practice
• OHRP Guidance - Office for Human Research Protections requirements
• AAHRPP - Association for the Accreditation of Human Research Protection Programs
• Belmont Report - Ethical Principles for Human Subjects Research
• Declaration of Helsinki - International ethical guidelines
• State Research Regulations - State-specific requirements

Repository Structure

├── SOPs/
│   ├── Protocol-Review/       # Initial review, continuing review, amendments
│   ├── Informed-Consent/      # Consent requirements, waivers, documentation
│   ├── Compliance/            # Audits, monitoring, non-compliance
│   ├── Vulnerable-Populations/# Children, prisoners, pregnant women, cognitively impaired
│   ├── Administration/        # Committee management, record retention
│   └── General/               # Document control, training, CAPA
├── Forms/
│   ├── Submission-Forms/      # New protocol, amendment, continuing review forms
│   ├── Consent-Templates/     # ICF templates, assent forms, waivers
│   ├── Review-Checklists/     # Reviewer worksheets, determination letters
│   ├── Audit-Forms/           # For-cause and routine audit checklists
│   ├── Reporting-Forms/       # Adverse events, deviations, non-compliance
│   └── Training/              # IRB member and researcher training
├── Policies/                  # HRPP policies
├── Work-Instructions/         # Step-by-step procedures
└── Templates/                 # Document templates

Document Numbering Convention

• POL-XXX: Policies
• SOP-PR-XXX: Protocol Review SOPs
• SOP-IC-XXX: Informed Consent SOPs
• SOP-CMP-XXX: Compliance SOPs
• SOP-VP-XXX: Vulnerable Populations SOPs
• SOP-ADM-XXX: Administration SOPs
• WI-XXX: Work Instructions
• FRM-XXX: Forms and Records

🤖 AI-Powered Assistance

This repository includes AtomicAI, your IRB QMS assistant. Mention @atomicai in any issue or pull request to:

• Draft protocol review procedures and checklists
• Create informed consent templates
• Generate compliance and audit procedures
• Develop vulnerable population protections
• Create IRB member training materials
• Review documents for OHRP/FDA compliance

Example Prompts

• "@atomicai create an SOP for expedited review criteria and procedures"
• "@atomicai draft an informed consent template per Common Rule requirements"
• "@atomicai write a continuing review procedure for greater-than-minimal-risk studies"
• "@atomicai create an audit checklist for research site monitoring"
• "@atomicai develop a non-compliance investigation procedure"
• "@atomicai create a children's assent form template"

Getting Started

1. Establish Governance - Define IRB composition and authority
2. Customize Review Procedures - Adapt for your institution's research portfolio
3. Develop Consent Templates - Create standard ICF language
4. Implement Training Program - IRB member and researcher education
5. Set Up Audit Program - Routine and for-cause audit procedures

Key Documents to Create First

1. Initial Protocol Review SOP - Full board and expedited procedures
2. Informed Consent Requirements - Consent elements and documentation
3. Continuing Review SOP - Annual review procedures
4. Amendment Review SOP - Modification review process
5. Adverse Event Reporting SOP - Unanticipated problem procedures
6. Non-Compliance Investigation SOP - Response to violations
7. Vulnerable Population Policy - Additional protections

Special Considerations for Human Subjects Research

Review Procedures

• Criteria for approval (45 CFR 46.111)
• Expedited review categories
• Exempt determinations
• Risk/benefit assessment
• Informed consent review

Informed Consent

• Required elements of consent
• Documentation requirements
• Waiver criteria and approvals
• Short form consent procedures
• Electronic consent considerations

Vulnerable Populations

• Children (permission and assent)
• Prisoners (additional safeguards)
• Pregnant women and fetuses
• Cognitively impaired individuals
• Economically disadvantaged populations

Compliance Monitoring

• Routine protocol audits
• For-cause investigations
• Continuing non-compliance procedures
• Corrective action plans
• Reporting to OHRP/FDA

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This template is maintained by AtomicQMS. For questions, open an issue in this repository.