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:

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.