| name | informed-consent-form |
| title | Informed Consent Form |
| description | Drafts regulatory-compliant informed consent forms for healthcare procedures, clinical trials, research participation, or professional services. Incorporates HIPAA, FDA, IRB/Common Rule, and ICH-GCP requirements as applicable. Use when drafting surgical consent, research participant agreements, clinical trial consent, or treatment authorization forms. |
| author | CaseMark |
| author_url | https://github.com/CaseMark/skills/tree/main/skills/legal/informed-consent-form |
| license | Apache-2.0 |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | us |
| practice | healthcare |
| language | en |
Informed Consent Form
Drafts a defensible informed consent form satisfying disclosure obligations and documenting voluntary, knowing authorization.
Quick Start
Gather before drafting:
- Jurisdiction — which consent standard applies (professional, reasonable person, or subjective)
- Regulatory framework — HIPAA, FDA, IRB/Common Rule, ICH-GCP, state rules
- Procedure details — protocol, personnel, timeline, devices, medications
- Participant population — capacity issues, language needs, literacy level
- Institutional requirements — templates, mandatory language, formatting
Core Sections
1. Procedure Description
| Element | Include |
|---|
| Process overview | Prep, intervention, follow-up in plain language; define terms parenthetically |
| Timeline | Frequency, duration, total commitment |
| Personnel | Qualifications of those performing/supervising |
| Materials | Equipment, medications, devices with lay explanations |
| Participant burden | Physical demands, time, lifestyle changes, emotional impact |
2. Risk Disclosure and Benefits
Risk frequency tiers — use consistently:
| Tier | Frequency | Label |
|---|
| Common | >10% | "commonly" / "frequently" |
| Occasional | 1–10% | "occasionally" / "sometimes" |
| Rare | <1% | "rarely" |
| Isolated | Case reports only | "in isolated cases" |
For each material risk: nature of harm, severity, temporary vs. permanent, mitigation.
Benefits: realistic expectations only, no guarantees. State if experimental. Include statistical context when available.
3. Alternatives and Right to Refuse
