Rct Ethics Registration

Ethics and transparency are prerequisites, not afterthoughts.

checklist = {
    "Pre-Study (Before Participant Contact)": [
        "[ ] IRB protocol drafted",
        "[ ] Informed consent forms prepared",
        "[ ] Data security plan documented",
        "[ ] IRB approval obtained",
        "[ ] Trial registered (AEA/ClinicalTrials.gov)",
        "[ ] Pre-analysis plan filed",
        "[ ] Research team trained on ethics",
    ],
    "During Study": [
        "[ ] Informed consent obtained for all participants",
        "[ ] Adverse events monitored and reported",
        "[ ] Data encrypted and securely stored",
        "[ ] IRB amendments submitted for protocol changes",
        "[ ] Annual IRB renewal obtained",
        "[ ] Trial registry updated with progress",
    ],
    "Post-Study": [
        "[ ] Final IRB report submitted",
        "[ ] Trial registry updated with results",
        "[ ] Data de-identified before sharing",
        "[ ] Results shared with community",
        "[ ] Consent forms archived per retention policy",
        "[ ] PII destroyed per protocol timeline",
    ],
}

print("ETHICS & REGISTRATION COMPLIANCE CHECKLIST")
print("=" * 60)

for phase, items in checklist.items():
    print(f"\n{phase}")
    print("-" * 40)
    for item in items:
        print(f"  {item}")

print("\nCritical deadlines:")
print("- IRB submission: 2-3 months before start")
print("- Trial registration: Before data collection")
print("- PAP filing: Before accessing outcome data")
print("- Annual renewal: Before approval expiration")

return checklist,

</code_template>

</implementation_pattern>

<examples>

<example context="informed_consent" difficulty="basic">
<description>Create informed consent form with all required elements</description>
<code>
```python
@app.cell
def informed_consent_template():
    # Informed consent template meeting federal requirements
    # Must include all 8 basic elements per 45 CFR 46.116

    consent_text = """
    INFORMED CONSENT FOR RESEARCH PARTICIPATION

    Study Title: [Title]
    Principal Investigator: [Name, contact]

    1. PURPOSE
    You are invited to participate in research studying [purpose in plain language].
    We are enrolling approximately [N] participants.

    2. PROCEDURES
    If you agree, you will:
    - [Specific procedures]
    - [Time commitment]
    - [Number of visits/contacts]

    3. RISKS
    Possible risks include:
    - [List all risks, even if minimal]
    - [Be specific and complete]
    These risks are [minimal / greater than minimal].

    4. BENEFITS
    Possible benefits to you:
    - [Direct benefits, if any]
    - [Or state clearly if no direct benefit]

    Possible benefits to others:
    - [Broader societal benefit]

    5. COMPENSATION
    You will receive [specific compensation amount and timing].
    [If no compensation, state clearly]

    6. CONFIDENTIALITY
    Your information will be kept confidential:
    - Data will be de-identified (names removed)
    - Stored on encrypted, password-protected computers
    - Only research team will access identifiable data
    - Identifiers destroyed after [time period]

    7. VOLUNTARY PARTICIPATION
    Participation is completely voluntary. You may:
    - Refuse to participate
    - Skip any questions
    - Withdraw at any time without penalty

    Your decision will not affect [services, relationships, etc.].

    8. CONTACT INFORMATION
    Questions about study: [PI contact]
    Questions about rights: [IRB contact]

    CONSENT
    [ ] I have read this form
    [ ] My questions have been answered
    [ ] I voluntarily agree to participate

    _________________________  _________
    Participant Signature      Date

    _________________________  _________
    Researcher Signature       Date
    """

    print(consent_text)

    print("\nKey requirements:")
    print("- 8th grade reading level")
    print("- All 8 basic elements included")
    print("- Voluntary nature emphasized")
    print("- Specific risks and benefits")
    print("- Contact information provided")

    return consent_text,

Timeline:

• Exempt/Expedited: 2-4 weeks
• Full board: 4-8 weeks (meets monthly typically)
• Always add 2-3 months buffer to timeline

For vulnerable populations, demonstrate why inclusion is necessary and how risks are minimized.

Minimum info: title, PIs, outcomes, sample size, timeline, hypotheses