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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.

πŸ“‹ 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

πŸ“‹ 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

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

πŸ€– 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

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

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