Draft an Informed Consent Form
Draft an informed consent form or script with information completeness, comprehension aids, voluntariness, confidentiality, and special-population accommodations.
Draft: Draft an Informed Consent Form
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Your Prompt (With Your Details)
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You are an expert in research ethics and informed consent design. Draft an informed consent form or script for a research or evaluation activity. Tailor the consent to the population, the data collection method, and any special-population considerations.
Draft Requirements:
- Information completeness. Cover purpose, procedures, risks, benefits, and contact information so a participant can weigh the decision with full knowledge.
- Comprehension aids. Pitch language at an appropriate reading level for the population and build in a comprehension check rather than assuming understanding.
- Voluntariness signals. Make the right to refuse or withdraw explicit in wording and felt in the consent process, with no pressure cues from the implementer or interviewer.
- Confidentiality specifics. Describe data handling and identification practices concretely so the participant knows what will happen to their data and identifying information.
- Special populations. Build in accommodations for children, low-literacy respondents, persons with disabilities, and other vulnerable groups rather than leaving them to the interviewer.
Output Format:
Produce:
- A complete consent script or form ready for translation, with placeholders for organizational name, contact details, and date.
- A separate assent script for minors, if applicable, written at an age-appropriate reading level.
- A short comprehension-check protocol (3-5 questions the interviewer asks before recording consent).
- Interviewer instructions covering pacing, body language, refusal handling, and withdrawal procedure during data collection.
- A 1-paragraph note on translation and pilot-test requirements before field deployment.
This prompt involves designing protections for sensitive populations or sensitive data. Do not include identifying details of real respondents in your AI inputs.
Check: Score It with the Informed Consent Design Rubric
The Review Prompt
Paste the draft at the bottom of this prompt and run it. It scores each criterion from 1 to 5 and says why.
You are an expert in research ethics and informed consent design. Score the informed consent form, script, or process I will provide using the rubric below. The document may be a standalone consent form, a verbal consent script, or a description of the consent process embedded in a protocol or inception report.
SCORING RUBRIC - Informed Consent Design Score each dimension 1-5 using these criteria:
DIMENSION 1: Information Completeness
- Score 5: All elements present. Purpose of the activity is stated in plain terms. Procedures the participant will go through are described (what will be asked, how long, where, by whom). Risks (including discomfort, time burden, social or psychological risk) are named. Benefits (to the participant, the community, the program) are described honestly, with no overpromising. Contact information for questions or concerns is provided (name, role, phone or email, and an independent oversight contact where applicable).
- Score 4: At least four of five elements present. Purpose, procedures, and risks clear; benefits or contacts partial.
- Score 3: Standard elements named but not specific to the activity. Some elements (often risks or independent contacts) missing.
- Score 2: Brief generic statement. Most elements absent or boilerplate.
- Score 1: No information about purpose, procedures, risks, benefits, or contacts.
DIMENSION 2: Comprehension Aids
- Score 5: Language is pitched at the appropriate reading level for the population (short sentences, plain words, no jargon, technical terms defined). Comprehension is verified through a teach-back step, a short comprehension check, or a structured pause for questions. Translation or interpretation is planned for non-dominant languages. The form or script is laid out for readability (headings, white space, no wall of legal text). Visual aids or examples are used where helpful (especially for low-literacy or technical concepts).
- Score 4: At least four of five elements present. Language and layout clear; verification or translation partial.
- Score 3: Language is mostly accessible but verification is not built in. Translation handled ad hoc.
- Score 2: Dense or technical language. No verification step. No translation plan.
- Score 1: Inaccessible language. No comprehension aids.
DIMENSION 3: Voluntariness Signals
- Score 5: The right to refuse is stated explicitly and early in the script. The right to withdraw at any time, including mid-interview, is named. The right to skip individual questions is named. The script includes language that neutralizes pressure (no consequences to services, employment, or program participation; the interviewer is not in a position of authority over the participant). The consent process is conducted in a setting that supports a real choice (private, unhurried, without supervisors or program staff present).
- Score 4: At least four of five elements present. Refusal and withdrawal explicit; setting or pressure-neutralizing language partial.
- Score 3: Refusal stated but withdrawal or skip rights unclear. Pressure not addressed.
- Score 2: Voluntariness mentioned in passing. Withdrawal and skip rights absent.
- Score 1: No voluntariness signals.
DIMENSION 4: Confidentiality Specifics
- Score 5: Where data is stored is described (device, server, location, encryption). Who has access is named (interviewer, analyst, supervisor, donor). Whether responses are anonymous, pseudonymized, or identifiable is stated plainly. How findings will be reported (aggregated, with or without quotes, with or without identifying details) is described. How long data is kept and what happens at the end is stated.
- Score 4: At least four of five elements present. Storage, access, and identification clear; reporting or retention partial.
- Score 3: Confidentiality promised but operational details thin. Storage or access mentioned without specifics.
- Score 2: Generic confidentiality statement. No data handling specifics.
- Score 1: No confidentiality detail.
DIMENSION 5: Special Populations
- Score 5: Accommodations for children include parental or guardian consent plus child assent in age-appropriate language. Accommodations for low-literacy respondents include verbal consent, witnessed if needed, with the form read aloud. Accommodations for persons with disabilities are named (sign language, accessible format, support person). Accommodations for displaced, marginalized, or other vulnerable groups are described (trusted interpreter, safe location, gender-matched interviewer where relevant). The script names which special populations apply to this activity and how each is handled.
- Score 4: At least four of five elements present. Children and low-literacy handled; disability or vulnerable-group accommodations partial.
- Score 3: One special population addressed; others mentioned without operational detail.
- Score 2: Special populations named as a concept. No accommodations built in.
- Score 1: No consideration of special populations.
OUTPUT FORMAT: Return your assessment as a table followed by a summary:
| Dimension | Score (1-5) | Evidence | Priority Revision |
|---|---|---|---|
| Information Completeness | |||
| Comprehension Aids | |||
| Voluntariness Signals | |||
| Confidentiality Specifics | |||
| Special Populations |
Total: X/25 Band: Strong (22-25) / Adequate (17-21) / Needs Revision (11-16) / Substantial Revision (5-10) Single Most Important Revision: [One specific sentence]
For any dimension scored 1 or 2, add a brief explanation and a concrete revision example.
CONSENT DOCUMENT TO SCORE: [Paste your consent form or script here]
Fix: Revise What Scored Low
The Revise Prompt
Paste the draft and its scores at the bottom of this prompt. It revises the parts that scored below 4.
You are an expert in research ethics and informed consent design. Review the consent form or script I will provide and fix every problem that falls below the Good (4) threshold on the Informed Consent Design rubric.
WHAT TO LOOK FOR AND FIX:
Information completeness problems: Missing purpose statement. Vague procedures. Risks understated or absent. Overpromised benefits. No contact information.
Comprehension problems: Reading level too high. Jargon undefined. No verification step. No translation plan. Wall-of-text layout.
Voluntariness problems: Refusal or withdrawal rights missing or buried. Skip rights absent. Pressure cues present (mention of program benefits, presence of supervisors). Setting not conducive to a real choice.
Confidentiality problems: Storage location unstated. Access list missing. Identification practice unclear. Reporting practice unstated. Retention period missing.
Special-population problems: No child assent. No low-literacy adaptation. No disability accommodations. No accommodations for marginalized or displaced groups in the target population.
OUTPUT FORMAT: For each problem found:
- Dimension: [which dimension]
- Location: [which section of the consent document]
- Problem: [one sentence describing what is wrong]
- Revised version: [the corrected text]
Then provide the complete revised consent form or script incorporating all corrections.
CONSENT DRAFT TO REVISE: [Paste your consent draft here]