08 ethics compliance

SKILL 08: Ethics & Compliance

Ensure your research meets the highest ethical standards and reporting requirements — because integrity is non-negotiable.

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ACTIVATE: ETHICS

When you input ACTIVATE: ETHICS, the system executes a comprehensive ethics audit across five critical sections, each with specific checklist items that must be verified before submission.

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SECTION A: HUMAN SUBJECTS RESEARCH

A1. Institutional Review Board (IRB) / Ethics Committee Approval

• IRB/ethics committee approval obtained before any data collection began
• Approval number and date documented in the manuscript (typically in Methods section)
• Approval covers the specific protocol, population, and procedures used
• If the study was deemed exempt, the exemption category and rationale are documented
• For multi-site studies: each site has its own approval or a reliance agreement is in place

A2. Informed Consent

• Informed consent obtained from all participants (or their legal guardians)
• Consent process documented: written, verbal, or electronic (with justification for non-written)
• Consent forms included all required elements: purpose, procedures, risks, benefits, alternatives, confidentiality, voluntary participation, right to withdraw, contact information
• For participants who cannot consent: assent obtained where appropriate, proxy consent documented
• For retrospective studies: waiver of consent obtained from IRB, with justification
• For studies using existing datasets: original consent covers secondary use, or waiver obtained

A3. Vulnerable Populations

• Special protections implemented for vulnerable populations (children, prisoners, pregnant women, cognitively impaired individuals, economically/educationally disadvantaged persons)
• Additional safeguards documented: assent procedures for minors, capacity assessments, independent advocates
• Coercion or undue influence risk assessed and mitigated
• Compensation is reasonable and not coercive

A4. Privacy and Confidentiality

• De-identification protocol implemented and documented
• Direct identifiers removed (name, SSN, medical record number, etc.)
• Indirect identifiers assessed (combinations of age, location, diagnosis that could enable re-identification)
• Data storage security measures documented (encryption, access controls, secure servers)
• Data retention and destruction policy specified
• If images are used: specific consent for publication of identifying images obtained

A5. Risk-Benefit Assessment

• Risks to participants identified and minimized
• Risk level classified: minimal risk vs. greater than minimal risk
• Potential benefits to participants and/or society clearly articulated
• Risk-benefit ratio justified and documented
• Data safety monitoring plan in place for greater-than-minimal-risk studies

A6. International and Cultural Considerations

• Local ethical requirements met in addition to home institution requirements
• Cultural sensitivity in study design and consent process
• Community engagement where appropriate (e.g., indigenous populations)
• Language barriers addressed in consent process and study instruments
• Compliance with local data protection laws (GDPR, HIPAA, etc.)

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SECTION B: DATA INTEGRITY

B1. Data Collection Standards

• Data collection protocol documented in sufficient detail for replication
• Standardized instruments and procedures used
• Inter-rater reliability assessed for subjective measures
• Data collection forms (paper or electronic) designed to minimize errors
• Training of data collectors documented

B2. Data Management

• Data management plan in place before data collection
• Raw data preserved in original form (never modify raw data files)
• Version control system used for datasets (dates, version numbers, change logs)
• Data entry verification: double entry or automated validation checks
• Missing data tracked and documented (not silently dropped)

B3. Data Fabrication and Falsification Prevention

• Audit trail maintained for all data modifications
• Original raw data preserved alongside processed data
• Data transformations documented and reversible
• Outlier handling policy defined a priori (not post hoc)
• Image integrity verified: no unauthorized manipulation, cropping disclosed

B4. Data Sharing and Availability

• Data sharing plan compliant with funder and journal requirements
• Sensitive data handled appropriately (de-identified, restricted access where needed)
• Data deposited in appropriate repository with DOI
• Data dictionary/codebook provided
• Licensing terms specified for shared data

B5. Secondary Data Use

• Original consent covers secondary analysis, or IRB waiver obtained
• Data provenance documented (source, version, access date)
• Limitations of secondary data acknowledged (original collection purpose may differ)
• Data quality assessment performed before analysis

B6. Qualitative Data Integrity

• Audio/video recordings stored securely with appropriate consent
• Transcription accuracy verified (double-checking, member checking)
• Coding process documented with inter-coder reliability
• Participant identities protected in quotations (pseudonyms, altered details)
• Reflexivity statement included for researcher positionality

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SECTION C: STATISTICAL INTEGRITY

C1. Analysis Pre-Registration

• Analysis plan pre-registered (e.g., OSF, AsPredicted, ClinicalTrials.gov) before data analysis
• Pre-registration includes: hypotheses, variables, exclusion criteria, analysis methods, power analysis
• Any deviations from pre-registered plan documented and justified
• Distinction between confirmatory and exploratory analyses clearly stated

C2. Sample Size Justification

• A priori power analysis conducted and reported
• Effect size estimate justified (from pilot data, literature, or minimum meaningful effect)
• Power analysis parameters reported: alpha, desired power, effect size, test type
• If post-hoc power is reported, labeled as such with appropriate caveats

C3. Multiple Comparisons

• Multiple comparison problem acknowledged when applicable
• Correction method specified and justified (Bonferroni, FDR, Holm, etc.)
• Both uncorrected and corrected results reported where informative
• Pre-registered primary outcomes distinguished from secondary/exploratory analyses

C4. Effect Size Reporting

• Effect sizes reported for all statistical tests (not just p-values)
• Appropriate effect size metric chosen: Cohen's d, η², partial η², odds ratio, r, etc.
• Confidence intervals provided for effect sizes
• Practical significance discussed alongside statistical significance

C5. Assumption Checking

• Statistical test assumptions verified (normality, homogeneity of variance, independence, etc.)
• Robustness analyses conducted when assumptions are violated
• Alternative analysis approaches reported when primary assumptions are not met
• Missing data mechanism assessed and appropriate handling method used (listwise deletion, multiple imputation, etc.)

C6. P-Hacking Prevention

• No selective reporting of significant results (file drawer problem assessed)
• All conducted analyses reported, not just those yielding significant results
• Optional stopping rules avoided or pre-registered
• Outlier exclusion criteria defined before analysis
• Variable transformation decisions made before analysis, not after examining results
• Researcher degrees of freedom minimized and documented

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SECTION D: PUBLICATION ETHICS

D1. Authorship

• Authorship criteria met for all authors (substantial contribution, drafting/approval, accountability)
• All contributors who meet authorship criteria are included as authors
• Contributors who do not meet authorship criteria are acknowledged
• Author order reflects relative contribution (field-specific conventions followed)
• Corresponding author responsibilities understood and accepted
• No ghost authorship (unlisted authors who made substantial contributions)
• No gift authorship (listed authors who did not make substantial contributions)

D2. Plagiarism and Self-Plagiarism

• Originality verified: all text is in the authors' own words or properly quoted
• Self-plagiarism avoided: previously published text not recycled without quotation and citation
• Paraphrasing is genuine, not cosmetic (changing a few words is insufficient)
• All sources properly cited
• Plagiarism detection software run on manuscript (e.g., iThenticate, Turnitin)

D3. Duplicate Publication

• Manuscript not published or under review elsewhere
• Previous publication of any portion disclosed to the editor
• Conference abstracts, preprints, and theses that contain overlapping content disclosed
• If expanding a conference paper: new content is ≥ 30% of the journal version, and the conference version is cited
• No salami slicing: findings not split across multiple papers to inflate publication count

D4. Image and Figure Integrity

• No unauthorized image manipulation (no cloning, splicing, selective enhancement)
• Brightness/contrast adjustments applied uniformly and do not obscure data
• Cropping disclosed; full uncropped images available in supplementary materials
• Composite figures clearly labeled with boundaries between panels
• Microscopy images include scale bars and acquisition parameters

D5. Peer Review Integrity

• No fabrication of suggested reviewers (e.g., email addresses that route to the authors)
• No citation manipulation (adding irrelevant citations to appease editors or reviewers)
• Confidentiality of the peer review process respected
• No retaliation against reviewers (identifying and targeting critical reviewers)

D6. Conflicts of Interest

• All financial relationships disclosed (consulting, employment, equity, patents, honoraria, grants)
• All non-financial relationships disclosed (personal, academic, political, religious)
• Funding sources and their role in the research disclosed
• Industry sponsorship fully disclosed with details of funder involvement

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SECTION E: REPORTING STANDARDS

Use the appropriate reporting checklist based on study design. These are not optional — most top journals require a completed checklist at submission.

E1. CONSORT — Randomized Controlled Trials

Key items (37-item checklist):

• Title identified as randomized trial
• Scientific background and rationale
• Specific objectives and hypotheses
• Eligibility criteria, settings, and locations
• Interventions with sufficient detail for replication
• Primary and secondary outcomes with measurement methods
• Sample size calculation with assumptions
• Randomization sequence generation, allocation concealment, implementation
• Blinding: who was blinded and how
• Statistical methods for primary and secondary outcomes
• Flow diagram (enrollment → allocation → follow-up → analysis)
• Dates of recruitment and follow-up
• Baseline demographic and clinical characteristics
• Analysis populations (intention-to-treat, per-protocol)
• Harms and adverse events

E2. STROBE — Observational Studies (Cohort, Case-Control, Cross-Sectional)

Key items (22-item checklist):

• Study design in title/abstract
• Objectives, including specific hypotheses
• Study design, setting, and dates
• Eligibility criteria, selection methods, follow-up methods
• Exposure, outcomes, confounders: definition and measurement
• Bias assessment
• Study size rationale
• Quantitative variables: categories and rationale
• Statistical methods: confounder adjustment, subgroups, interactions, missing data
• Flow of participants with reasons for exclusion
• Descriptive data: characteristics, missing data, follow-up time
• Main results: estimates, confidence intervals, significance tests
• Other analyses: sensitivity, subgroup analyses
• Key results with consideration of objectives and limitations
• Generalizability (external validity)

E3. PRISMA — Systematic Reviews and Meta-Analyses

Key items (27-item checklist):

• Title identified as systematic review or meta-analysis
• Structured summary: background, objectives, data sources, eligibility criteria, participants/interventions, study appraisal/synthesis methods, results, limitations, conclusions
• Rationale for review
• Clearly stated research questions (PICOS: Population, Intervention, Comparison, Outcomes, Study design)
• Protocol registration information
• Eligibility criteria
• Information sources with dates of coverage
• Search strategy for at least one database
• Study selection process
• Data collection process
• Data items and definitions
• Risk of bias assessment method
• Effect measures and synthesis methods
• Additional analyses (meta-regression, sensitivity)
• PRISMA flow diagram
• Study characteristics summary
• Risk of bias within and across studies
• Results of individual studies and syntheses
• Certainty of evidence assessment (GRADE)

E4. COREQ / SRQR — Qualitative Research

COREQ key items (32-item checklist):

• Researcher characteristics and reflexivity
• Theoretical framework and methodology
• Participant selection, setting, and data collection
• Interview guide and pilot testing
• Recording and transcription methods
• Data analysis method and software
• Derivation of themes/codes
• Techniques to enhance trustworthiness (member checking, triangulation, audit trail)

E5. STARD — Diagnostic Accuracy Studies

Key items (30-item checklist):

• Index test and reference standard described
• Flow and timing: order of test administration, interval between tests
• Blinding of index test interpreters from reference standard results
• 2×2 contingency table with all four cells populated
• Sensitivity, specificity with confidence intervals
• Indeterminate results reported and handled
• Clinical context and intended use of the test

E6. CARE — Case Reports

Key items (13-item checklist):

• Patient perspective when appropriate
• Timeline of events
• Diagnostic challenges and reasoning
• Intervention details and outcomes
• Follow-up and outcomes
• Informed consent obtained

E7. ARRIVE — Animal Research

Key items (21-item checklist):

• Ethical approval statement
• Species, strain, and characteristics
• Housing and husbandry conditions
• Sample size justification
• Allocation and blinding procedures
• Outcome measures and statistical methods
• Adverse events and humane endpoints

E8. MODEL CARDS — AI/ML Model Reporting

Key items:

• Model details (architecture, training data, performance metrics)
• Intended use and users
• Factors affecting performance (demographic, environmental, temporal)
• Metrics and evaluation data
• Training data description
• Quantitative analyses (disaggregated by subgroups)
• Ethical considerations and limitations
• Caveats and recommendations

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Transparency Statement Template

The following statement should appear in all manuscripts, adapted to the specific study:

## Transparency Statement

**Data Availability:** [All data / Anonymized data / Summary data] supporting
the findings of this study are available at [repository name and DOI/URL].
[OR: Available from the corresponding author upon reasonable request, due to
(privacy/consent/legal restrictions).]

**Code Availability:** All analysis code is available at [repository URL]
under [license type]. A permanent archived version is available at [DOI].

**Pre-registration:** This study was pre-registered at [registry name]
([registration URL/DOI]). All confirmatory analyses followed the
pre-registered plan. Any deviations are documented in the manuscript.

**AI Disclosure:** [No AI tools were used in the writing or analysis of this
manuscript. / AI-assisted tools (e.g., [tool name]) were used for
[specific purpose: e.g., "grammar checking," "code generation for data
processing," "literature search"]. All AI-generated content was reviewed,
verified, and revised by the authors, who take full responsibility for the
content of this publication.]

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Ethics Audit Scoring

Category	Items	Critical Items	Status
A: Human Subjects	6	A1, A2, A4	Must be fully compliant before submission
B: Data Integrity	6	B1, B3	Must be fully compliant before submission
C: Statistical Integrity	6	C1, C3, C6	Must be fully compliant before submission
D: Publication Ethics	6	D1, D2, D3	Must be fully compliant before submission
E: Reporting Standards	8 checklists	Appropriate checklist	Must be completed at submission

Status Definitions

• Compliant: All items checked and documented
• Partially Compliant: Some items addressed; action plan needed for remaining items
• Non-Compliant: Critical items not addressed; must be resolved before submission
• Not Applicable: Item does not apply to this study type (document the reason)

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Integration Notes

This skill integrates with:

• Skill 01 (Topic Ideation): Ethical considerations should inform research questions from the start
• Skill 03 (Methodology Design): Pre-registration and power analysis begin at design stage
• Skill 05 (Discussion Architecture): Limitations should include ethical limitations
• Skill 07 (Journal Strategy): Cover letter must include compliance statements; reporting checklists required at submission
• Skill 10 (Impact Amplifier): Transparency and openness amplify impact through trust

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Last updated: 2024 | CRES v2.0