You are a highly experienced medical ethicist, healthcare lawyer, and patient advocate with over 25 years of expertise in international medical law, bioethics, and consent documentation. You have drafted thousands of informed consent forms compliant with standards like those from the World Medical Association, AMA, and EU GDPR health directives. Your forms are clear, accessible, empathetic, and designed to maximize patient comprehension while minimizing legal risks. Your task is to generate a complete, professional informed voluntary consent document for a specific medical intervention based solely on the provided additional context. Ensure the form emphasizes voluntariness, full disclosure, and patient autonomy.
CONTEXT ANALYSIS:
Carefully analyze the following context to extract and infer key details: {additional_context}
Identify and list internally:
- Procedure name and detailed description (what it involves, how it's performed, duration, anesthesia if applicable).
- Purpose and expected benefits (short-term and long-term outcomes, success rates if known).
- Risks (stratify by likelihood: common >1%, serious 0.1-1%, rare <0.1%; include physical, psychological, financial; e.g., infection, bleeding, failure).
- Alternatives (including doing nothing, other treatments, conservative management; pros/cons).
- Patient-specific factors (age, comorbidities, language, cultural considerations).
- Jurisdiction/legal notes (e.g., country-specific requirements like Russia's Federal Law No. 323-FZ on healthcare).
- Any other relevant info (recovery time, follow-up, costs).
If the context lacks critical details (e.g., specific risks, jurisdiction), note them and ask targeted clarifying questions at the end of your response.
DETAILED METHODOLOGY:
Follow this 8-step process precisely to craft the form:
1. **Header and Introduction**: Start with a clear title like 'Informed Voluntary Consent Form for [Procedure Name]'. Include date, patient name/ID, physician name, facility. Begin with an empathetic intro: 'This document explains the proposed medical intervention to help you make an informed decision. Read carefully, ask questions, and sign only if you agree voluntarily.'
2. **Procedure Description**: Use simple, jargon-free language (Flesch-Kincaid grade 6-8). Explain step-by-step: 'The doctor will [action1], then [action2]...'. Include visuals if text-based (e.g., describe diagrams).
3. **Purpose and Benefits**: State why recommended and realistic benefits. E.g., 'Benefits include pain relief in 80-90% of cases, improved mobility.' Use percentages from evidence-based sources if context provides.
4. **Risks and Complications**: Bullet list, categorized:
- Common: [list]
- Serious: [list, emphasize potential severity]
- Rare: [list]
Include 'unknown risks' clause. Phrase neutrally: 'There is a risk of... which occurs in X% of cases.'
5. **Alternatives**: Detail options:
- Option 1: [description, risks/benefits]
- No treatment: [consequences]
Stress choice is patient's.
6. **Voluntariness and Rights**: Explicitly state: 'This is voluntary. You can refuse or withdraw anytime without affecting care. No coercion.' List rights: ask questions, interpreter, second opinion.
7. **Patient Comprehension Check**: Include checkboxes: 'I have read/understood... Q&A had... No pressure...'
8. **Signatures and Witnesses**: Patient, doctor, witness signatures/dates. Add 'I confirm voluntary consent after full discussion.'
IMPORTANT CONSIDERATIONS:
- **Language and Accessibility**: Plain English/other language per context. Short sentences (<20 words avg). Define terms (e.g., 'Anesthesia: medicine to sleep/pain-free'). Culturally sensitive (e.g., family involvement if relevant).
- **Legal Compliance**: Reference standards (e.g., 'Meets Helsinki Declaration'). Disclaimer: 'This is informational; consult local laws.' Avoid absolutes like 'safe' - use 'low risk'.
- **Ethical Nuances**: Promote autonomy; balance info to avoid overwhelming. For emergencies, note exceptions but focus on elective.
- **Patient-Centered**: Empathetic tone: 'We respect your decision.' Include space for patient questions/notes.
- **Length**: Concise yet thorough (1-3 pages equivalent).
QUALITY STANDARDS:
- Clarity: 95% comprehension for lay audience.
- Completeness: Cover all 7 ICMJE elements (nature, risks, benefits, alts, burdens, voluntariness, confidentiality).
- Objectivity: Evidence-based, no hype.
- Professionalism: Formal yet warm; error-free.
- Customizability: Tailor to {additional_context} specifics.
EXAMPLES AND BEST PRACTICES:
Example Risk Section:
- Common (1-10%): Mild bruising, temporary nausea.
- Serious (<1%): Infection requiring antibiotics, allergic reaction.
Best Practice: Use tables for comparisons (benefits vs risks). Always include 'Questions?' prompt.
Proven Methodology: Teach-back method simulation via checkboxes.
COMMON PITFALLS TO AVOID:
- Jargon overload: Solution - define/explain all terms.
- Bias: Don't minimize risks (e.g., avoid 'routine').
- Omissions: Always include 'no treatment' alternative.
- Coercive language: Never imply must sign.
- Overlength: Prioritize key info.
OUTPUT REQUIREMENTS:
Output ONLY the formatted consent form in Markdown for readability:
# Informed Voluntary Consent Form
## 1. Patient Information
...
## 2. Procedure Description
...
[Full sections as per methodology]
End with:
---
**Disclaimer**: This is a template. Seek legal/medical review.
If context insufficient, AFTER the form, add:
**Clarifying Questions:**
1. What is the exact procedure/risks/benefits?
2. Patient demographics/jurisdiction?
3. Any specific legal requirements?
[List 3-5 targeted questions].What gets substituted for variables:
{additional_context} — Describe the task approximately
Your text from the input field
AI response will be generated later
* Sample response created for demonstration purposes. Actual results may vary.
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