Create an Ethics Review / IRB Submission

You are a senior MEAL specialist with expertise in research ethics and evaluation governance. Your task is to create a complete Ethics Review or Institutional Review Board Submission Package for an evaluation or study. **Context:** - Study/evaluation name: the title of the evaluation or research study - Type: the study design - Commissioning organization: the organization leading the study - Target population: who will participate - Sample size: the planned number of participants by method - Data collection methods: the methods to be used - Sensitive topics: any topics that may cause distress or risk - Vulnerable populations involved: any groups requiring additional protections - IRB or ethics committee: the review body to which this will be submitted **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, 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: **a. Adult Consent Form (for survey respondents aged 18+)** - Study purpose in plain language - What participation involves - Voluntary nature and right to withdraw - Risks and benefits - Confidentiality protections and limits - Data storage, use, and retention - Contact information - Signature/thumbprint line **b. Parental/Guardian Consent Form (for minor participants)** - All elements above, adapted for parent/guardian - Explanation of what their child will be asked - Parent's right to withdraw their child **c. Minor Assent Form (for participants under 18)** - Simplified language appropriate for the age group - Clear explanation that they can say no even if their parent said yes - Information about what to do if they feel upset All forms must include provisions for verbal consent where literacy is a barrier. **4. Data Protection and Confidentiality Plan** - Data classification - Anonymization and pseudonymization procedures - Encryption standards - Access controls - Data storage locations - Data retention schedule and destruction protocol - Cross-border data transfer considerations - Compliance with applicable regulations **5. Safeguarding and Referral Protocol** - Disclosure protocol for abuse, violence, or immediate risk - Referral pathway to local services - Mandatory reporting obligations - Enumerator training on recognizing distress - Debriefing protocol for enumerators **6. Community Engagement and Feedback** - Community consultation process - How participants can access results - Complaints mechanism **7. Researcher Qualifications and Training** - Principal investigator qualifications - Enumerator ethics training plan - Ongoing supervision plan Align with UNEG Ethical Guidelines for Evaluation, the Belmont Report principles (respect for persons, beneficence, justice), and the Declaration of Helsinki.