Committee Reference
Complete reference for every ethics committee the Navigator can route you to. Each definition includes mission, applicable research, required documents, regulatory references, and typical timeframe.
IRB - FDA Regulated
| Field | Detail |
|---|---|
| Type | IRB |
| Jurisdiction | FDA |
| Mission | Protect rights, safety, and welfare of human subjects in FDA-regulated research |
| Timeframe | 4-6 weeks; expedited 2-3 weeks |
Applicable for: clinical trials of investigational drugs; medical device studies; biological product research; clinical investigations requiring FDA approval.
Required documents: research protocol; informed consent; investigator brochure; recruitment materials; data safety monitoring plan; FDA Form 1572; CVs; financial disclosure; IND/IDE number.
References: 21 CFR Part 50; 21 CFR Part 56; ICH-GCP E6(R2); Declaration of Helsinki; 45 CFR Part 46.
IEC - EMA/EU Regulated
| Field | Detail |
|---|---|
| Type | IEC |
| Jurisdiction | EMA |
| Mission | Protect rights, safety, dignity and well-being of participants under EU Clinical Trials Regulation |
| Timeframe | Up to 45 days (Part II assessment); varies by member state |
Applicable for: clinical trials in EU member states; multinational European research; studies requiring EMA approval; ATMPs.
Required documents: clinical trial protocol; investigator's brochure; informed consent and patient information sheet; recruitment materials; risk-benefit analysis; insurance/indemnity; EudraCT/CTIS number; lay synopsis; SAP; data management plan.
References: EU CTR No 536/2014; ICH-GCP E6(R2); Declaration of Helsinki; EU Charter of Fundamental Rights; GDPR.
Submission: Via Clinical Trials Information System (CTIS) for trials starting after January 2025.
IACUC
| Field | Detail |
|---|---|
| Type | IACUC |
| Jurisdiction | FDA, International |
| Mission | Ensure humane care and use of animals in research (3Rs: Replacement, Reduction, Refinement) |
| Timeframe | 3-6 weeks |
Applicable for: live vertebrate animal research; preclinical studies; animal behavioural research; toxicology; teaching protocols; animal breeding for research.
Required documents: animal use protocol; justification for species; pain/distress minimisation; veterinary care plan; euthanasia methods; personnel training; 3Rs alternatives search; sample size justification; endpoint criteria; housing requirements.
References: Animal Welfare Act; PHS Policy; Guide for Care and Use (8th Ed.); AAALAC; EU Directive 2010/63/EU.
Scientific Research Ethics Committee
| Field | Detail |
|---|---|
| Type | Scientific_Ethics |
| Jurisdiction | International |
| Mission | Review research with NO direct patient/human subject contact |
| Timeframe | 2-4 weeks; often expedited |
Applicable for: retrospective chart review; database/registry research; secondary analysis; archival research with de-identified data; medical record reviews; imaging/lab data analysis; published literature research; quality-improvement projects.
Required documents: research protocol; data management/security plan; privacy measures; data source description; data use agreements; HIPAA waiver (US); confidentiality procedures; statement of no patient contact; consent waiver justification.
References: 45 CFR 46; HIPAA Privacy Rule; GDPR; Declaration of Helsinki.
Non-Interventional Clinical Research Ethics Committee
| Field | Detail |
|---|---|
| Type | IRB |
| Jurisdiction | International |
| Mission | Review research with direct patient contact but NO therapeutic/medical intervention |
| Timeframe | 3-5 weeks standard; 2-3 weeks expedited |
Applicable for: observational cohorts with patient contact; prospective case-control studies; cross-sectional studies with interviews; patient surveys; prospective data collection; natural history studies; epidemiological studies; quality-of-life assessments; biomarker studies using routine samples.
Required documents: research protocol; informed consent; data collection instruments; recruitment materials; privacy/confidentiality plan; data management plan; statement of no intervention; CVs; observational-only declaration.
References: 45 CFR 46; Declaration of Helsinki; ICH-GCP (observational); HIPAA; GDPR.
Clinical Research Ethics Committee (Interventional)
| Field | Detail |
|---|---|
| Type | IRB |
| Jurisdiction | FDA, EMA, International |
| Mission | Protect subjects in research involving medical interventions that could alter patient outcomes |
| Timeframe | 4-8 weeks full board review |
Applicable for: clinical drug trials; medical device studies; surgical interventions; therapeutic interventions; exercise/rehab programs; dietary interventions; gene therapy; radiation therapy; experimental diagnostics; biological sample collection beyond routine care.
Required documents: complete protocol; informed consent; investigator brochure; recruitment materials; data safety monitoring plan; adverse event procedures; risk-benefit analysis; insurance/indemnity; CVs; financial disclosure; regulatory approvals; intervention risk statement.
References: 21 CFR Part 50/56; EU CTR No 536/2014; ICH-GCP E6(R2); Declaration of Helsinki; 45 CFR Part 46.
Resolves against jurisdiction: FDA shows IRB-FDA, EMA shows IEC-EMA.
Research Ethics Board (REB) - Canadian
| Field | Detail |
|---|---|
| Type | REB |
| Jurisdiction | International |
| Mission | Protect dignity, rights, safety and well-being per the Tri-Council Policy Statement |
| Timeframe | 4-8 weeks (full board, delegated, or expedited) |
Applicable for: human participant research in Canada; clinical trials in Canadian institutions; social sciences/humanities; health research; educational research with participants.
Required documents: research protocol; informed consent; recruitment materials; risk assessment; data management plan; privacy impact assessment; researcher qualifications; funding disclosure; conflict of interest disclosure.
References: TCPS 2 (2022); ICH-GCP; Health Canada Food and Drug Regulations; PIPEDA; provincial privacy legislation.
Educational Research Ethics Committee
| Field | Detail |
|---|---|
| Type | Educational_Ethics |
| Jurisdiction | International |
| Mission | Review educational interventions, pedagogical studies, and educational assessment |
| Timeframe | 3-6 weeks; often expedited |
Applicable for: educational interventions; curriculum evaluation; teaching method comparisons; student assessment research; educational technology studies; classroom-based research.
Required documents: protocol with educational context; informed/parental consent; student assent forms; curriculum/intervention description; assessment instruments; data privacy plan; school/district approval; recruitment procedures; minimal risk justification.
References: 45 CFR 46 Subpart D; FERPA; BERA Guidelines; AERA Code of Ethics.
No Ethics Committee Required
| Field | Detail |
|---|---|
| Type | None |
| Jurisdiction | FDA, EMA, International |
| Timeframe | Institutional consultation 1-2 weeks if needed |
Applicable for: systematic reviews of published data; meta-analyses; literature reviews; theoretical research; publicly available de-identified datasets; quality-improvement without research intent; educational assessment with anonymous data; environmental research routed to environmental assessment, permits, monitoring, or standard safety oversight rather than an ethics committee.
Guidance: No submission required; consider institutional consultation for borderline cases; document that research uses only published/de-identified data; follow dataset terms of use.
Important: "None" means the module found no review trigger. Borderline cases should be confirmed with your institution.
Quick comparison
| Committee | Jurisdiction | Governs |
|---|---|---|
| IRB (FDA) | FDA | FDA-regulated human-subjects research |
| IEC (EMA) | EMA | EU/EMA clinical trials |
| IACUC | FDA, Intl | Live vertebrate animal research |
| Scientific Ethics | Intl | No-contact retrospective/secondary data |
| Non-Interventional | Intl | Patient contact, no intervention |
| Clinical Interventional | FDA, EMA, Intl | Medical interventions |
| REB | Intl | Canadian human-participant research |
| Educational Ethics | Intl | Educational interventions/assessment |
| None | All | No committee required |