Informed Consent Form — Clinical Trial

Produces a plain-language ICF (≤ 8th-grade reading level) covering all 21 CFR 50.25 required elements, HIPAA authorization, and ethics-compliant framing for research subjects.

Prerequisites

Collect before drafting:

Protocol details — title, protocol number, phase, sponsor, IND number
Investigational product — name, mechanism, dosing, route, known risk profile
Study design — randomization, arms (incl. placebo), visit schedule, duration
Site info — PI name/title, institution, IRB name and contact
Risk/benefit data — preclinical and prior clinical risk frequencies/severities
Injury/compensation policy — sponsor coverage for research-related injury; participation payments

Output Structure

1. Header Block

On every page: protocol title, protocol number, version/date, page X of Y.

2. Study Information

Purpose

Plain-language disease/condition description
What the study tests; trial phase; subject count (site and total)
Include: "This is a research study, not standard medical treatment."

Procedures (chronological)

Screening, randomization (arm probabilities incl. placebo), visit-by-visit table:

| Visit | Timing | Duration | Procedures | |---|---|---|---| | Screening | Week −2 | ~2 hrs | Labs, exam, eligibility | | Baseline | Day 1 | ~3 hrs | IP administration, vitals, ECG | | Follow-up | Wk 4, 8, 12 | ~1 hr | Labs, safety assessments | | End of Study | Week 16 | ~2 hrs | Final assessments, unblinding |

Flag research-only vs. standard-of-care procedures
Note preparation requirements (fasting, hold meds)

Risks and Discomforts

Organize by category with frequency and severity:

| Category | Example | Frequency | Severity | |---|---|---|---| | Investigational product | Nausea, hepatotoxicity | Common/Rare | Mild/Serious | | Study procedures | Venipuncture bruising | Common | Mild | | Placebo exposure | Forgoing active therapy | N/A | Study-specific | | Reproductive | Teratogenicity | Unknown | Potentially serious | | Privacy/psychosocial | Time burden, incidental findings | Low | Mild |

Include unknown-risks disclosure and new-information notification statement
State injury care/compensation available and what is not covered

Potential Benefits

Direct benefit: state honestly if possible, probable, or not expected; cite prior data; note not guaranteed
Societal benefit: knowledge advancement
Payments/free medication: list but clarify these are not medical benefits
Include: "Not participating will not affect your access to standard medical care."

3. Subject Rights

Confidentiality

Coded identifiers, encrypted storage, limited access
Authorized accessors: research team, IRB, FDA, sponsor/monitors, DSMB
Mandatory disclosure circumstances (reporting obligations, court order)
Publication: no individual identification; data retention period stated
HIPAA Authorization (if applicable): PHI use/disclosure scope; required for participation

Voluntary Participation and Withdrawal

Voluntary; refusal/withdrawal does not affect care or benefits
Withdraw any time without penalty; contact PI at listed number
Pre-withdrawal data may be retained; investigator/sponsor may remove subject for safety, non-compliance, or study termination
New findings affecting willingness will be communicated

Contacts

| Role | Name | Phone | Hours | |---|---|---|---| | PI (questions, injuries) | [Name, MD] | [###-###-####] | 24/7 emergencies | | IRB (rights concerns) | [IRB Name] | [###-###-####] | M–F 9–5 | | After-hours emergency | [On-call] | [###-###-####] | Evenings/weekends |

4. Consent Statement

First-person acknowledgment covering: form read/explained, questions answered, voluntary participation, right to withdraw, agreement to participate in [Study Title], Protocol [Number].

Optional check-box consents (if applicable):

Future biospecimen research use
Genetic testing
Long-term follow-up contact
HIPAA authorization

5. Signature Block (per 21 CFR 50.27)

| Signatory | Printed Name | Signature | Date | |---|---|---|---| | Research Subject | | | | | Legally Authorized Representative | | | | | Representative's relationship/authority | | N/A | N/A | | Impartial Witness (if subject cannot read) | | | | | Person Obtaining Consent (name + role) | | | |

Subject receives signed, dated copy
Add re-consent rows if protocol requires re-consent at defined intervals

Drafting Rules

Reading level: ≤ 8th grade; define technical terms on first use
No exculpatory language: No waiver of legal rights or liability release (21 CFR 50.25(a)(8))
Therapeutic misconception: Distinguish research from treatment; do not overstate direct benefit
Placebo disclosure: Explain probability and risk of forgoing active therapy
Vulnerable populations: Add protections per 21 CFR 50 Subparts C, D (pregnant women, children, prisoners, cognitively impaired)
Formatting: ≥ 12pt font, section headings, page numbers, version/date footer; typical 8–15 pages

Checklist Before Finalizing

[ ] All 21 CFR 50.25(a) basic elements present
[ ] All applicable 50.25(b) additional elements included
[ ] No exculpatory language
[ ] HIPAA authorization section included (if applicable)
[ ] Vulnerable-population protections added (if applicable)
[ ] Reading level verified ≤ 8th grade
[ ] IRB approval required before use; retain IRB-stamped version as operative document
[ ] [VERIFY]: Confirm ICH E6(R3) GCP requirements align with jurisdiction's adoption status