134 lines
5.4 KiB
Markdown
134 lines
5.4 KiB
Markdown
# IRB & Human Subjects Research Quality Management System
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A comprehensive QMS template designed for Institutional Review Boards, research ethics committees, and human subjects protection programs.
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## 📋 Designed For
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- **Institutional Review Boards** - IRB offices and committees
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- **Human Research Protection Programs** - HRPP offices
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- **Academic Medical Centers** - Research compliance offices
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- **Independent IRBs** - Commercial ethics review organizations
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- **Research Institutions** - Universities and research centers
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- **Clinical Trial Sites** - Investigator-initiated study oversight
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- **Federal Agencies** - OHRP, FDA, and regulatory bodies
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## 📋 Regulatory Framework
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This template supports compliance with:
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- **Common Rule (45 CFR 46)** - Federal Policy for the Protection of Human Subjects
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- **FDA 21 CFR 50** - Protection of Human Subjects
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- **FDA 21 CFR 56** - Institutional Review Boards
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- **HIPAA** - Privacy Rule for research
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- **ICH-GCP E6(R2)** - Good Clinical Practice
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- **OHRP Guidance** - Office for Human Research Protections requirements
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- **AAHRPP** - Association for the Accreditation of Human Research Protection Programs
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- **Belmont Report** - Ethical Principles for Human Subjects Research
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- **Declaration of Helsinki** - International ethical guidelines
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- **State Research Regulations** - State-specific requirements
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## Repository Structure
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```
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├── SOPs/
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│ ├── Protocol-Review/ # Initial review, continuing review, amendments
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│ ├── Informed-Consent/ # Consent requirements, waivers, documentation
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│ ├── Compliance/ # Audits, monitoring, non-compliance
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│ ├── Vulnerable-Populations/# Children, prisoners, pregnant women, cognitively impaired
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│ ├── Administration/ # Committee management, record retention
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│ └── General/ # Document control, training, CAPA
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├── Forms/
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│ ├── Submission-Forms/ # New protocol, amendment, continuing review forms
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│ ├── Consent-Templates/ # ICF templates, assent forms, waivers
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│ ├── Review-Checklists/ # Reviewer worksheets, determination letters
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│ ├── Audit-Forms/ # For-cause and routine audit checklists
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│ ├── Reporting-Forms/ # Adverse events, deviations, non-compliance
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│ └── Training/ # IRB member and researcher training
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├── Policies/ # HRPP policies
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├── Work-Instructions/ # Step-by-step procedures
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└── Templates/ # Document templates
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```
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## Document Numbering Convention
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- **POL-XXX**: Policies
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- **SOP-PR-XXX**: Protocol Review SOPs
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- **SOP-IC-XXX**: Informed Consent SOPs
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- **SOP-CMP-XXX**: Compliance SOPs
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- **SOP-VP-XXX**: Vulnerable Populations SOPs
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- **SOP-ADM-XXX**: Administration SOPs
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- **WI-XXX**: Work Instructions
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- **FRM-XXX**: Forms and Records
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## 🤖 AI-Powered Assistance
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This repository includes **AtomicAI**, your IRB QMS assistant. Mention `@atomicai` in any issue or pull request to:
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- Draft protocol review procedures and checklists
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- Create informed consent templates
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- Generate compliance and audit procedures
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- Develop vulnerable population protections
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- Create IRB member training materials
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- Review documents for OHRP/FDA compliance
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### Example Prompts
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- "@atomicai create an SOP for expedited review criteria and procedures"
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- "@atomicai draft an informed consent template per Common Rule requirements"
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- "@atomicai write a continuing review procedure for greater-than-minimal-risk studies"
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- "@atomicai create an audit checklist for research site monitoring"
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- "@atomicai develop a non-compliance investigation procedure"
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- "@atomicai create a children's assent form template"
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## Getting Started
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1. **Establish Governance** - Define IRB composition and authority
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2. **Customize Review Procedures** - Adapt for your institution's research portfolio
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3. **Develop Consent Templates** - Create standard ICF language
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4. **Implement Training Program** - IRB member and researcher education
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5. **Set Up Audit Program** - Routine and for-cause audit procedures
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## Key Documents to Create First
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1. **Initial Protocol Review SOP** - Full board and expedited procedures
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2. **Informed Consent Requirements** - Consent elements and documentation
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3. **Continuing Review SOP** - Annual review procedures
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4. **Amendment Review SOP** - Modification review process
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5. **Adverse Event Reporting SOP** - Unanticipated problem procedures
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6. **Non-Compliance Investigation SOP** - Response to violations
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7. **Vulnerable Population Policy** - Additional protections
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## Special Considerations for Human Subjects Research
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### Review Procedures
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- Criteria for approval (45 CFR 46.111)
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- Expedited review categories
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- Exempt determinations
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- Risk/benefit assessment
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- Informed consent review
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### Informed Consent
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- Required elements of consent
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- Documentation requirements
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- Waiver criteria and approvals
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- Short form consent procedures
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- Electronic consent considerations
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### Vulnerable Populations
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- Children (permission and assent)
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- Prisoners (additional safeguards)
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- Pregnant women and fetuses
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- Cognitively impaired individuals
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- Economically disadvantaged populations
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### Compliance Monitoring
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- Routine protocol audits
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- For-cause investigations
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- Continuing non-compliance procedures
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- Corrective action plans
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- Reporting to OHRP/FDA
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---
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*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*
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