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.*