Shortform Consent

graph TD
    A["🔍 Study Requires Informed Consent"] --> B{"Is full written consent
impractical or inappropriate?"}
    
    B -->|NO| C["📋 Use Standard
Full Written ICF"]
    C --> D["Participant reads &
signs full form"]
    D --> E["✓ Standard Process
Complete"]
    
    B -->|YES| F{"What is the reason?"}
    
    F -->|Language Barrier| G["🌍 Participant does not
speak/read English fluently"]
    F -->|Low Literacy| H["📚 Complex form +
Low literacy population"]
    F -->|Form Complexity| I["📖 Lengthy/Complex study
requires lengthy form"]
    F -->|Time-Sensitive
Emergency| J["🚨 Emergency scenario
requires immediate enrollment"]
    
    G --> K["✓ Short Form
Consent Approved"]
    H --> K
    I --> K
    J --> K
    
    K --> L["📑 IRB Approves TWO Documents"]
    L --> M["1️⃣ LONG FORM
Complete ICF with all elements"]
    L --> N["2️⃣ SHORT FORM
One-page summary"]
    
    M --> O["Researcher Prepares
for Consent Visit"]
    N --> O
    
    O --> P["👥 Consent Process Begins"]
    
    P --> Q["Step 1: INDEPENDENT WITNESS
Arrives at consent meeting"]
    Q --> R["Step 2: RESEARCHER READS ALOUD
Presents LONG FORM to participant
in participant's language/literacy level"]
    
    R --> S["Step 3: QUESTIONS & CLARIFICATION
Participant asks questions
Researcher explains"]
    
    S --> T{"Participant
understands &
agrees?"}
    
    T -->|NO| U["Participant declines
to participate"]
    U --> V["✓ Process Complete
Respect for autonomy"]
    
    T -->|YES| W["Step 4: SIGNING
Participant signs SHORT FORM ONLY
not the long form"]
    
    W --> X["Step 5: SIGNATURES
Researcher signs
Witness signs
Date documented"]
    
    X --> Y["Step 6: DISTRIBUTION
Participant receives:
• Copy of SHORT FORM
• Copy of LONG FORM"]
    
    Y --> Z["✅ Short Form Consent
Process Complete"]
    
    Z --> AA["Study Can Proceed"]
    V --> AA
    E --> AA
    
    style A fill:#e1f5ff
    style C fill:#c8e6c9
    style E fill:#81c784
    style K fill:#fff9c4
    style M fill:#ffe082
    style N fill:#ffe082
    style P fill:#f8bbd0
    style Q fill:#f8bbd0
    style R fill:#f8bbd0
    style S fill:#f8bbd0
    style W fill:#f8bbd0
    style X fill:#f8bbd0
    style Y fill:#f8bbd0
    style Z fill:#81c784
    style AA fill:#4caf50
    style U fill:#ffccbc
    style V fill:#ffccbc
    style B fill:#bbdefb
    style F fill:#bbdefb
    style T fill:#bbdefb