Generate informed consent language for a procedure or study
advancedClaude OpusLegalContractshealthcareinformed-consentirbcomplianceresearch
Use case
Use this prompt when you need a starting draft of informed consent language for a clinical procedure, behavioral health treatment, or research study. Informed consent has a specific structure shaped by case law and the Common Rule (for research). Generic AI-generated consent text often misses required elements. This prompt produces a draft that organizes content for legal and IRB review and reads at the level patients can actually understand.
The prompt
You are a clinical and regulatory writer drafting informed consent language for{{procedure_or_study_name}}. The output is a draft for review by qualified medical, legal, and IRB or regulatory counsel before use. Inputs: - Type of consent:{{consent_type}}(clinical procedure, treatment, or research study) - Procedure or study name:{{procedure_or_study_name}}- Sponsor or provider organization:{{provider_or_sponsor}}- Description of the procedure or study activities (what will happen, where, when, by whom):{{description}}- Purpose:{{purpose}}- Reasonably foreseeable risks and discomforts:{{risks}}- Reasonably expected benefits:{{benefits}}- Alternatives to the procedure or study:{{alternatives}}- Confidentiality and data handling:{{confidentiality}}- For research: compensation, costs, contact info for the IRB and PI; statement that participation is voluntary:{{research_specific}}- Reading level target:{{reading_level}}(recommend 8th grade) Produce the consent draft with these sections, each labeled clearly: ## Title Plain-language title that names the procedure or study. ## Purpose Two to three sentences in plain language explaining why the procedure or study is being done. ## What will happen A numbered list of steps the patient or participant will go through. Include duration, location, who will perform each step, and any required follow-up. ## Risks and discomforts A bulleted list of reasonably foreseeable risks. Group by likelihood (common, less common, rare) where the source data supports it. Use plain-language equivalents of clinical terms. Include physical, psychological, and privacy risks where applicable. ## Possible benefits A bulleted list of reasonably expected benefits. Be honest about benefits that may not occur. For research, include the specific statement that participation may not directly benefit the participant. ## Alternatives A bulleted list of alternatives, including the option of no treatment or non-participation. ## Your rights - Right to ask questions before, during, and after - Right to refuse or withdraw at any time without penalty or loss of care - For research: voluntary participation; no impact on relationship with the provider; ability to withdraw without consequences - Right to a copy of the signed consent ## Confidentiality and data Explain how information will be collected, stored, used, and shared. Identify any required disclosures (e.g., to regulators, to law enforcement under specific conditions). Identify limits on confidentiality. ## Costs and compensation (for research) Costs to the participant, payment for participation if any, and what happens if the participant is injured. ## Questions and contacts Phone numbers and emails for the provider or PI, the institution's research office or IRB if applicable, and the patient relations or ombudsperson. ## Signatures Patient or participant name, signature, date. Witness signature where required. Person obtaining consent name, signature, and date. Constraints: - Plain language at the specified reading level - Use 'you' throughout - Translate clinical and statistical terms - Avoid 'fine print' density; use white space and lists - Do not promise outcomes - Do not draft language that waives the patient's or participant's rights
Variables
{{{{consent_type}}}}Replace with your {{consent type}}{{{{procedure_or_study_name}}}}Replace with your {{procedure or study name}}{{{{provider_or_sponsor}}}}Replace with your {{provider or sponsor}}{{{{description}}}}Replace with your {{description}}{{{{purpose}}}}Replace with your {{purpose}}{{{{risks}}}}Replace with your {{risks}}{{{{benefits}}}}Replace with your {{benefits}}{{{{alternatives}}}}Replace with your {{alternatives}}{{{{confidentiality}}}}Replace with your {{confidentiality}}{{{{research_specific}}}}Replace with your {{research specific}}{{{{reading_level}}}}Replace with your {{reading level}}
Example
Input
consent_type: research study (interventional, minimal risk) procedure_or_study_name: Behavioral Sleep Coaching Program for Adults with Insomnia (BeSC-1) provider_or_sponsor: Mountainside Health Research Institute, sponsored by an internal grant description: | - 8-week digital sleep coaching program with weekly 30-minute video sessions with a licensed sleep coach - Participants wear a study-provided sleep tracker each night for 12 weeks - Three online questionnaires: at start, week 8, and week 12 - One in-person visit at week 12 to return tracker and conduct exit interview (45 minutes) purpose: To evaluate whether a structured digital coaching program improves sleep quality compared with usual care for adults with chronic insomnia. risks: | - Common: temporary frustration with sleep tracking; mild discomfort wearing wrist tracker - Less common: increased awareness of sleep difficulty during the program - Rare: skin irritation from the tracker band - Privacy: study data collected and stored by the research team; risk of unauthorized data access despite safeguards benefits: | - Possible improvement in sleep quality (not guaranteed) - Greater understanding of personal sleep patterns - Information from the study may help others with insomnia in the future alternatives: | - Continue current sleep care with your regular provider without joining the study - Seek standalone behavioral therapy for insomnia (CBT-I) outside the study - Discuss medication options with your provider confidentiality: | - Study data stored on encrypted servers with access limited to research team - Identifiable information separated from study data; replaced with a code - Aggregate results may be published in scientific journals; you will not be identified - Required disclosures: serious adverse events to the IRB; legally compelled disclosures (e.g., subpoena) research_specific: | - Compensation: $40 gift card at week 8, $40 gift card at week 12 (total up to $80) - No costs to participate beyond your time - Sleep tracker is provided at no cost; you keep it after the study - PI: Dr. Lillian Ortiz, PhD; IRB: Mountainside Health IRB; 24/7 PI contact line for adverse events - Participation voluntary; you may withdraw at any time without affecting your care or relationship with the institution reading_level: 8th grade
Output
## Title Consent to Participate in the Behavioral Sleep Coaching Program for Adults with Insomnia (BeSC-1) Research Study ## Purpose We are inviting you to take part in a research study at Mountainside Health Research Institute. The purpose of the study is to learn whether a structured digital sleep coaching program helps adults who have trouble sleeping (chronic insomnia) sleep better than usual care. ## What will happen If you agree to take part, you will: 1. Meet with a licensed sleep coach by video for about 30 minutes each week for 8 weeks. 2. Wear a study-provided wristband sleep tracker every night for 12 weeks. You can take it off when needed (showering, exercise) and put it back on. 3. Complete three online questionnaires: when you start, at week 8, and at week 12. Each takes about 15 minutes. 4. Visit the research office once at week 12 for a 45-minute exit interview and to return the tracker (you may keep it). Total time commitment is about 12 weeks. ## Risks and discomforts - Common: feeling frustrated by tracking your sleep; mild discomfort from wearing the wristband. - Less common: becoming more aware of sleep problems during the program, which can briefly feel worse before it feels better. - Rare: skin irritation where the wristband is worn. - Privacy: even with strong protections, there is always a small risk that someone could access study data without permission. ## Possible benefits - You may sleep better. We cannot guarantee this. - You may learn more about your own sleep patterns. - What we learn from this study may help other people with insomnia in the future. There may be no direct benefit to you. ## Alternatives You do not have to take part in this study. Other options include: - Continue your current sleep care with your regular provider without joining the study. - Get cognitive behavioral therapy for insomnia (CBT-I) outside the study, which is a recommended treatment. - Talk to your provider about medication options. Choosing not to participate will not affect your care at Mountainside Health. ## Your rights - You can ask questions before, during, and after the study. - You can refuse to take part. You can also stop at any time without giving a reason. - Stopping will not affect your medical care or your relationship with Mountainside Health. - You will receive a copy of this signed consent form. ## Confidentiality and data - Your study data is stored on encrypted servers. Only the research team has access. - Your name and other identifying information are kept separate from your study data and replaced with a code. - When we publish or present results, we will not identify you. - In some situations, we may have to share information: serious safety events must be reported to the Institutional Review Board (IRB), and we may be required to share information if a court orders us to. ## Costs and compensation - There is no cost to take part beyond your time. - You will receive a $40 gift card after the week 8 questionnaire and a $40 gift card after the week 12 visit, for a total of up to $80. - The sleep tracker is yours to keep at the end of the study. - If you are injured because of taking part in the study, contact the research team. The institution will provide reasonable medical care for study-related injuries; payment terms are explained on a separate sheet. ## Questions and contacts If you have questions about the study, contact the principal investigator: - Dr. Lillian Ortiz, PhD, BeSC-1 Study, Mountainside Health Research Institute - 24/7 study line for adverse events or urgent questions: [phone] - Email: besc1@mountainside.example If you have questions about your rights as a research participant or concerns about the study, contact: - Mountainside Health IRB: [phone] / [email] ## Signatures By signing below, I confirm that I have read this consent form, had time to ask questions, and agree to take part in the study. Participant name (printed): __________________________ Participant signature: __________________________ Date: __________ Person obtaining consent (printed): __________________________ Signature: __________________________ Date: __________
Tips for best results
- 1Match the consent type to the framework. Research consent must address Common Rule elements (45 CFR 46.116); clinical consent must address procedure-specific risks and alternatives. Mixing the two creates gaps.
- 2Plain language is a substantive requirement, not a stylistic preference. Test the draft at the target reading level before submitting to IRB or counsel.
- 3Do not draft any language that waives or appears to waive the patient's or participant's rights. The Common Rule prohibits this for research consent.
- 4Be honest about benefits. Overpromising benefits is one of the most common reasons IRBs require consent revisions.
- 5This is a draft. All informed consent documents must be reviewed by qualified medical, legal, and IRB or regulatory counsel before use with patients or participants.
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