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
1---2name: informed-consent-form-clinical-trial3description: Drafts an IRB-ready Informed Consent Form (ICF) for FDA-regulated clinical trials compliant with 21 CFR 50.25, 50.27, and ICH-GCP. Use when drafting or revising consent documents for Phase I–IV trials, IND studies, or other FDA-regulated protocols requiring IRB submission.4---5
6# Informed Consent Form — Clinical Trial
7
8Produces 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.
9
10## Prerequisites
11
12Collect before drafting:
13
141. **Protocol details** — title, protocol number, phase, sponsor, IND number
152. **Investigational product** — name, mechanism, dosing, route, known risk profile
163. **Study design** — randomization, arms (incl. placebo), visit schedule, duration
174. **Site info** — PI name/title, institution, IRB name and contact
185. **Risk/benefit data** — preclinical and prior clinical risk frequencies/severities
196. **Injury/compensation policy** — sponsor coverage for research-related injury; participation payments
20
21## Output Structure
22
23### 1. Header Block
24
25On every page: protocol title, protocol number, version/date, page X of Y.
26
27### 2. Study Information
28
29**Purpose**
30- Plain-language disease/condition description
31- What the study tests; trial phase; subject count (site and total)
32- Include: *"This is a research study, not standard medical treatment."*
33
34**Procedures** (chronological)
35- Screening, randomization (arm probabilities incl. placebo), visit-by-visit table:
36
37| Visit | Timing | Duration | Procedures |
38|---|---|---|---|
39| Screening | Week −2 | ~2 hrs | Labs, exam, eligibility |
40| Baseline | Day 1 | ~3 hrs | IP administration, vitals, ECG |
41| Follow-up | Wk 4, 8, 12 | ~1 hr | Labs, safety assessments |
42| End of Study | Week 16 | ~2 hrs | Final assessments, unblinding |
43
44- Flag research-only vs. standard-of-care procedures
45- Note preparation requirements (fasting, hold meds)
46
47**Risks and Discomforts**
48
49Organize by category with frequency and severity:
50
51| Category | Example | Frequency | Severity |
52|---|---|---|---|
53| Investigational product | Nausea, hepatotoxicity | Common/Rare | Mild/Serious |
54| Study procedures | Venipuncture bruising | Common | Mild |
55| Placebo exposure | Forgoing active therapy | N/A | Study-specific |
56| Reproductive | Teratogenicity | Unknown | Potentially serious |
57| Privacy/psychosocial | Time burden, incidental findings | Low | Mild |
58
59- Include unknown-risks disclosure and new-information notification statement
60- State injury care/compensation available and what is **not** covered
61
62**Potential Benefits**
63- Direct benefit: state honestly if possible, probable, or not expected; cite prior data; note not guaranteed
64- Societal benefit: knowledge advancement
65- Payments/free medication: list but clarify these are not medical benefits
66- Include: *"Not participating will not affect your access to standard medical care."*
67
68### 3. Subject Rights
69
70**Confidentiality**
71- Coded identifiers, encrypted storage, limited access
72- Authorized accessors: research team, IRB, FDA, sponsor/monitors, DSMB
73- Mandatory disclosure circumstances (reporting obligations, court order)
74- Publication: no individual identification; data retention period stated
75- **HIPAA Authorization** (if applicable): PHI use/disclosure scope; required for participation
76
77**Voluntary Participation and Withdrawal**
78- Voluntary; refusal/withdrawal does not affect care or benefits
79- Withdraw any time without penalty; contact PI at listed number
80- Pre-withdrawal data may be retained; investigator/sponsor may remove subject for safety, non-compliance, or study termination
81- New findings affecting willingness will be communicated
82
83**Contacts**
84
85| Role | Name | Phone | Hours |
86|---|---|---|---|
87| PI (questions, injuries) | [Name, MD] | [###-###-####] | 24/7 emergencies |
88| IRB (rights concerns) | [IRB Name] | [###-###-####] | M–F 9–5 |
89| After-hours emergency | [On-call] | [###-###-####] | Evenings/weekends |
90
91### 4. Consent Statement
92
93First-person acknowledgment covering: form read/explained, questions answered, voluntary participation, right to withdraw, agreement to participate in [Study Title], Protocol [Number].
94
95**Optional check-box consents** (if applicable):
96- Future biospecimen research use
97- Genetic testing
98- Long-term follow-up contact
99- HIPAA authorization
100
101### 5. Signature Block (per 21 CFR 50.27)
102
103| Signatory | Printed Name | Signature | Date |
104|---|---|---|---|
105| Research Subject | | | |
106| Legally Authorized Representative | | | |
107| Representative's relationship/authority | | N/A | N/A |
108| Impartial Witness (if subject cannot read) | | | |
109| Person Obtaining Consent (name + role) | | | |
110
111- Subject receives signed, dated copy
112- Add re-consent rows if protocol requires re-consent at defined intervals
113
114## Drafting Rules
115
116- **Reading level**: ≤ 8th grade; define technical terms on first use
117- **No exculpatory language**: No waiver of legal rights or liability release (21 CFR 50.25(a)(8))
118- **Therapeutic misconception**: Distinguish research from treatment; do not overstate direct benefit
119- **Placebo disclosure**: Explain probability and risk of forgoing active therapy
120- **Vulnerable populations**: Add protections per 21 CFR 50 Subparts C, D (pregnant women, children, prisoners, cognitively impaired)
121- **Formatting**: ≥ 12pt font, section headings, page numbers, version/date footer; typical 8–15 pages
122
123## Checklist Before Finalizing
124
125- [ ] All 21 CFR 50.25(a) basic elements present
126- [ ] All applicable 50.25(b) additional elements included
127- [ ] No exculpatory language
128- [ ] HIPAA authorization section included (if applicable)
129- [ ] Vulnerable-population protections added (if applicable)
130- [ ] Reading level verified ≤ 8th grade
131- [ ] IRB approval required before use; retain IRB-stamped version as operative document
132- [ ] **[VERIFY]**: Confirm ICH E6(R3) GCP requirements align with jurisdiction's adoption status
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