You are a senior MEAL specialist with expertise in research ethics and evaluation governance. Your task is to create a complete Ethics Review / IRB Submission Package for "evaluation or study name" (from the material, if given).
Context:
- Study/evaluation name: "name" (from the material, if given)
- Type: "type" (from the material, if given)
- Commissioning organization: "organization" (from the material, if given)
- Target population: "population" (from the material, if given)
- Sample size: "sample" (from the material, if given)
- Data collection methods: "methods" (from the material, if given)
- Sensitive topics: "topics" (from the material, if given)
- Vulnerable populations involved: "populations" (from the material, if given)
- IRB or ethics committee: "committee" (from the material, if given)
Deliverables:
1. Protocol Summary (2-3 pages)
- Study title, principal investigator, institutional affiliation
- Background and rationale
- Research/evaluation questions (numbered list)
- Study design and methodology overview
- Target population and sampling strategy
- Data collection procedures summary
- Timeline
- Funding source
2. Ethical Risk Assessment Conduct a systematic risk assessment:
| Risk Category | Specific Risk | Likelihood (High/Med/Low) | Severity (High/Med/Low) | Affected Group | Mitigation Measure |
|---|
Categories must include:
- Physical risks: Safety during data collection, travel to interview sites
- Psychological risks: Distress from sensitive questions (GBV, trauma), retraumatization
- Social risks: Stigma, breach of confidentiality affecting relationships or safety
- Economic risks: Opportunity cost of participation, raised expectations
- Legal risks: Mandatory reporting obligations, data subpoena risk
- Digital risks: Data breach, unauthorized access, device theft
Include at least 10 specific risks with detailed mitigation measures.
3. Informed Consent Materials Draft three consent documents, each with provisions for verbal consent where literacy is a barrier:
- Adult Consent Form: study purpose (plain language, 6th-grade reading level), what participation involves, voluntary nature and withdrawal rights, risks and benefits, confidentiality and its limits (mandatory reporting), data storage and retention, contact information for questions and complaints, signature/thumbprint block with witness
- Parental/Guardian Consent Form: all adult form elements adapted for parents, plus explanation of what their child will be asked and the right to withdraw the child
- Minor Assent Form (ages 12-17): simplified age-appropriate language, clear statement that they can refuse even if their parent consented, information on what to do if they feel upset
4. Data Protection and Confidentiality Plan
- Data classification (personally identifiable, sensitive, aggregate)
- Anonymization and pseudonymization procedures
- Encryption standards for data at rest and in transit
- Access controls (who can access identifiable data, approval process)
- Data storage locations (physical and digital)
- Data retention schedule and destruction protocol
- Cross-border data transfer considerations (if applicable)
- Compliance with applicable regulations (GDPR if EU-funded, national data protection law)
5. Safeguarding and Referral Protocol
- Disclosure protocol: what to do if a participant discloses abuse, violence, or immediate risk
- Referral pathway: list of local services (psychosocial support, legal aid, health services, child protection)
- Mandatory reporting obligations and how they interact with confidentiality commitments
- Enumerator training on recognizing distress and appropriate response
- Debriefing protocol for enumerators exposed to distressing content
6. Community Engagement and Feedback Describe community leader orientation, the consultation process (distinct from individual consent), how participants can access results, and the complaints mechanism.
7. Researcher Qualifications and Training Specify PI qualifications and ethics certifications, enumerator training plan (minimum 1 day covering ethics, consent, and safeguarding), and ongoing supervision approach.
Align with UNEG Ethical Guidelines for Evaluation, the Belmont Report principles (respect for persons, beneficence, justice), and the Declaration of Helsinki.
Where the material is silent, write "Not in the material" rather than guessing.
Source material: Attached, or pasted below. Base everything above on it and do not invent details that are not in it.