Research ethics review checklist generator for any study design

# Research Ethics Review Checklist **Study Type:** Mixed-methods study with online survey and semi-structured interviews **Population:** Transgender and gender-diverse (TGD) adolescents ages 13-17 and their parents/guardians **Data Collection:** Online survey (Qualtrics) + video interviews (Zoom) + optional digital diary entries --- ## 1. Complete Ethics Review Checklist ### A. Protocol Fundamentals - [ ] Clear research question with scientific merit justification - [ ] Literature review demonstrating gap this study fills - [ ] Study design appropriate for the research question - [ ] Sample size justified (power analysis for survey; saturation rationale for interviews) - [ ] Timeline realistic for the proposed scope - [ ] Researcher qualifications documented (gender-affirming care training, adolescent research experience) ### B. Vulnerable Population Protections (CRITICAL — This Will Be Scrutinized) - [ ] **Justification for including minors:** Why this research cannot be done with adults only. You must demonstrate that the knowledge sought is directly relevant to adolescents and cannot be obtained from adult retrospective reports. - [ ] **Assent AND consent:** Adolescent assent form (age-appropriate language, reading level ≤ Grade 6) AND parent/guardian consent form - [ ] **Mature minor considerations:** Protocol for adolescents who can consent independently under local law (varies by jurisdiction — check your state/province) - [ ] **Disclosure risk assessment:** TGD identity may not be known to parents. Your recruitment strategy must not inadvertently out participants. - [ ] **Mandatory reporting protocol:** Clear procedure for what happens if a participant discloses abuse, self-harm, or suicidal ideation during an interview - [ ] **Distress protocol:** Step-by-step procedure if a participant becomes distressed during data collection, including crisis resources specific to TGD youth (e.g., Trans Lifeline, Trevor Project) ### C. Recruitment & Sampling - [ ] Recruitment materials reviewed for inclusive, non-pathologizing language - [ ] No recruitment through clinical settings that would imply TGD identity is a medical condition (unless studying clinical experiences specifically) - [ ] Social media recruitment plan addresses platform-specific risks (minors on Instagram, Reddit moderation) - [ ] Snowball sampling protocol does not require participants to identify other TGD youth - [ ] Compensation plan is appropriate and not coercive ($15-25 gift card for survey, $40-50 for interviews is typical) - [ ] Compensation provided regardless of completion (participants can withdraw and keep compensation) ### D. Data Collection Procedures - [ ] Survey questions reviewed by TGD community advisory board - [ ] Deadname/legal name is never collected unless legally required - [ ] Chosen name and pronouns are collected first and used throughout - [ ] Gender identity questions use inclusive, non-binary options (not just M/F) - [ ] Interview guide reviewed for trauma-informed language - [ ] Video interviews: participants can choose camera-off option - [ ] Digital diary: clear guidance on what not to share (identifying information about third parties) --- ## 2. Potential Ethical Concerns the Board Will Flag ### Concern 1: Parental Consent Requirement May Exclude At-Risk Youth **The problem:** The most vulnerable TGD adolescents — those with unsupportive families — are excluded if parental consent is required. This creates a systematic bias toward studying only youth with accepting parents. **Mitigation options:** - Apply for a waiver of parental consent under 45 CFR 46.408(c) — argue that the research involves no more than minimal risk and that requiring parental consent would make the research impracticable for the most at-risk subgroup - Alternatively, design a parallel study arm for ages 18+ that captures retrospective adolescent experiences - Document this limitation explicitly in your protocol and publications - **Be prepared to argue this point.** Many boards will push back. Have precedents ready (cite Clark et al., 2021 — "Ethical considerations in research with LGBTQ+ youth"). ### Concern 2: Confidentiality Breach Could Cause Real Harm **The problem:** If a participant's TGD identity is disclosed to unsupportive family, the consequences could include emotional abuse, conversion therapy, or being kicked out of the home. **Mitigation:** - Use participant-chosen pseudonyms from the first contact - Collect minimal identifying information (no address, no school name) - All communications go through participant's preferred private channel (not family email) - Certificates of Confidentiality (if in the US — these provide legal protection against compelled disclosure) - Data stored on encrypted, access-controlled servers with no identifying information linked to responses - Interview recordings transcribed and destroyed within 30 days ### Concern 3: Mandatory Reporting Obligations **The problem:** If a 14-year-old discloses suicidal ideation during an interview, you are legally required to report. But reporting may involve contacting unsupportive parents, which could worsen the situation. **Mitigation:** - Develop a tiered response protocol with your institution's counseling center - **Tier 1 (passive ideation, no plan):** Provide crisis resources, document, follow up within 48 hours, no mandatory report - **Tier 2 (active ideation with plan):** Engage crisis protocol — contact Trevor Project or local TGD-affirming crisis service, assess immediate safety, report per legal requirements - **Tier 3 (imminent danger):** Call 911/crisis services immediately - Train all research staff on this protocol before any data collection - Consult with a TGD-affirming clinical psychologist who can serve as on-call resource during interview periods ### Concern 4: Researcher Positionality and Power Dynamics **The problem:** Adult researchers interviewing minors about sensitive identity topics creates inherent power imbalance. **Mitigation:** - Include TGD young adults (18-24) as research assistants or co-researchers - Establish a youth advisory board that reviews interview questions, recruitment materials, and preliminary findings - Use member checking — share preliminary themes with participants for validation - Train interviewers in trauma-informed, strengths-based interviewing techniques --- ## 3. Informed Consent/Assent Template Sections ### Adolescent Assent Form (Must Include): 1. **What this study is about** — in plain language, reading level ≤ Grade 6 2. **What you will be asked to do** — specific activities and time commitments 3. **You can say no** — explicit statement that participation is voluntary and they can stop at any time without consequence 4. **What we will do to protect your privacy** — specific measures in concrete terms ("We will not tell your parents what you said in the interview") 5. **Limits to privacy** — "If you tell us you are being hurt or you want to hurt yourself, we have to tell someone who can help. We will talk to you about this first if we can." 6. **Who to contact** — with TGD-affirming crisis resources (not just the generic campus counseling number) 7. **Compensation** — what they receive and when 8. **Questions?** — a way to ask questions before, during, and after ### Parent/Guardian Consent Form (Must Include): 1. Standard consent elements (purpose, procedures, risks, benefits, confidentiality, voluntary participation) 2. **Critical:** Clearly state that the content of adolescent interviews is confidential and will not be shared with parents. This must be unambiguous. 3. Note that the study focuses on "adolescent experiences and well-being" — the consent form should not require parents to acknowledge their child's TGD identity if the child has not disclosed it --- ## 4. Data Management & Privacy - All data stored on institutional encrypted servers (AES-256) - Qualtrics configured with anonymized responses, IP address collection disabled - Zoom recordings stored temporarily in researcher-controlled cloud (not institutional Zoom cloud), transcribed within 14 days, recordings deleted within 30 days - All transcripts de-identified: names, schools, locations, and identifying details replaced with codes - Key file (linking participant codes to contact information) stored separately from data, on a different encrypted drive, accessible only to PI - Data retention: de-identified data retained for 7 years per institutional policy; identifiable data destroyed 1 year after publication - Data sharing: only fully de-identified, aggregated data may be shared; no individual transcripts shared outside the research team --- ## 5. Risk-Benefit Analysis ### Risks | Risk | Likelihood | Severity | Mitigation | |------|-----------|----------|-----------| | Emotional distress during interviews | Moderate | Low-Moderate | Distress protocol, trained interviewers, crisis resources | | Confidentiality breach (identity disclosure) | Low | High | Encryption, pseudonyms, minimal PII, Certificate of Confidentiality | | Coercion (perceived pressure from parent to participate) | Low | Moderate | Private assent conversation without parent present | | Re-traumatization from discussing negative experiences | Low-Moderate | Moderate | Trauma-informed interview approach, participant controls topics | ### Benefits - **Direct:** Participants report feeling validated and heard (documented in prior TGD research). Access to curated resource list. - **Indirect:** Improved understanding of TGD adolescent well-being informs clinical practice, school policies, and family support programs. - **Societal:** Addresses critical evidence gap in a population with disproportionately high mental health burden. ### Board Assessment: The benefits justify the risks, provided all mitigations are implemented. The study addresses a significant health disparity, and the knowledge cannot be obtained without including this population. --- ## 6. Common Rejection Reasons & How to Avoid Them 1. **"Insufficient justification for including minors."** → Include a paragraph explicitly stating why adult retrospective data is insufficient and cite methodological literature on recall bias. 2. **"Consent process does not adequately address the outing risk."** → Detail your recruitment pipeline step-by-step, showing exactly how you will contact participants without disclosing their identity. 3. **"Mandatory reporting protocol is vague."** → Provide the specific tiered protocol with decision points, not just "we will follow institutional policy." 4. **"No community engagement."** → Boards reviewing TGD research increasingly expect community-based participatory elements. At minimum, describe your youth advisory board and any TGD community organization partnerships. 5. **"Data management plan lacks specificity."** → Name the encryption standard, the server location, the access control mechanism, and the destruction timeline. Vague statements like "data will be kept secure" are insufficient.