Create an Informed Consent Form

You are a senior MEAL specialist with expertise in research ethics and participant protection. Your task is to create a complete Informed Consent Form template for a data collection activity. **Context:** - Activity name: a descriptive title for this activity - Organization: the organization conducting this activity - Target respondents: adult participants in the data collection - Data collection method: the method used to collect the data - Topics covered: the main topics addressed - Sensitive topics (if any): any topics that may be sensitive for respondents - Vulnerable groups (if any): any vulnerable groups among respondents - Languages needed: the languages the form should be provided in - Data storage: how the data will be stored and protected - Data retention period: a defined retention period consistent with donor and legal requirements - Applicable regulations: relevant data protection regulations **Deliverables:** Create four consent form versions: **Version 1: Standard Adult Consent Form** Structure with these clearly labeled sections: **a. Header** - Organization name and logo placeholder - Study/activity title - Form version number and date - Unique form ID field **b. Introduction** - Greeting and interviewer introduction (first person, conversational) - Organization description (1-2 sentences) - Purpose of the data collection in plain language (no jargon, 6th-grade reading level) **c. What We Are Asking You to Do** Questions/activities involved, duration, recording if applicable, who else may be interviewed, whether follow-up visits are planned. **d. Voluntary Participation** Completely voluntary; right to refuse any question or stop at any time; no penalty or loss of services; include explicit statement: "Your decision will not affect any assistance you receive from the organization." **e. Risks and Benefits** Realistic risks (time, emotional discomfort), mitigation measures (skip options, referral to support services), direct benefits (compensation if any), indirect benefits (improving program quality). **f. Confidentiality** - How data will be kept confidential - Who will have access to identifiable data (specify roles, not just "the team") - How data will be stored and protected (encryption, passwords, locked cabinets) - How long data will be retained and when it will be destroyed - Limits to confidentiality (mandatory reporting of child abuse or imminent harm) - Whether data may be shared with donors or partners (in anonymized/aggregated form only) **g. Contact Information:** Name/contact for study questions, separate contact for complaints (independent of study team), and local referral service contacts (psychosocial support, protection, legal aid). **h. Consent Statement and Signature Block:** Summary statement beginning "I have been informed about..."; checkboxes for participation, recording (if applicable), and data sharing consent; participant signature or thumbprint with date; witness and interviewer signatures. **Version 2: Verbal Consent Script** Adapt Version 1 as a read-aloud script with interviewer instructions in {brackets}, simplified language, pause points for questions, and a witness attestation section. **Version 3: Parental/Guardian Consent (for studies involving minors)** Adapt Version 1 for parents/guardians: add description of what the child will be asked, whether the parent may be present, right to withdraw the child, and a note that the child will also give their own assent. **Version 4: Minor Assent Form (ages 12-17)** One-page maximum. Simple age-appropriate language. Confirm that parent has agreed but the child still decides. Reassure that refusal has no consequences. Include a contact for support if they feel upset. **Formatting:** Use headers and bullets; 12-point minimum font; avoid legal jargon; note cultural adaptation needs. Align with UNEG Ethical Guidelines, GDPR Article 7 consent requirements (where applicable), Sphere Protection Principle 1, and IASC Guidelines on Mental Health and Psychosocial Support.