What Is Ethics Committee / IRB Approval and How Should You Report It?

What is an ethics committee / IRB?

An ethics committee (or institutional review board) is an independent body that evaluates whether research complies with participant rights, patient safety, data privacy, and scientific ethical standards.

Common terms in the literature include:

Terminology varies by country, but the core reporting requirement is the same: which committee approved the study, on what date, and with what approval number?

Which studies require ethics approval?

Requirements depend on study type, data sensitivity, and local regulations. Most journals expect ethics statements for:

Important: stating “ethics approval was not required” is not enough on its own—you must explain why.

Do retrospective studies need ethics approval?

Retrospective studies use previously recorded patient data, but because that data relates to identifiable health information, many institutions and journals still require ethics review. The committee may approve the study and grant a waiver of informed consent.

This retrospective study was approved by the Institutional Review Board of [Institution Name] (approval number: XXX, date: DD/MM/YYYY). The requirement for informed consent was waived due to the retrospective nature of the study and the use of anonymized data.

How to report informed consent

Ethics approval and patient consent are not the same. A study may be ethics-approved yet still require separate written consent from participants.

Your manuscript should clarify:

• Was written informed consent obtained?
• Was consent waived?
• For clinical photos or identifiable images, was publication consent obtained?
• Were retrospective data anonymized?

Example consent sentences

Prospective: Written informed consent was obtained from all participants before enrollment.

Retrospective: The requirement for informed consent was waived by the ethics committee because of the retrospective design and anonymized data analysis.

Case report: Written informed consent was obtained from the patient for publication of this case report and accompanying images.

Where to report ethics information

Ethics details usually appear in the Methods section under headings such as Ethics Approval, Ethical Considerations, Ethics Statement, or Institutional Review Board Approval. Some journals also require a separate Declarations section at the end.

Essential information to include

Click to enlarge

Example ethics statements

Prospective clinical study

This study was approved by the Ethics Committee of [Institution Name] (approval number: XXX; date: DD/MM/YYYY). Written informed consent was obtained from all participants before inclusion in the study. The study was conducted in accordance with the principles of the Declaration of Helsinki.

Retrospective study

This retrospective study was approved by the Institutional Review Board of [Institution Name] (approval number: XXX; date: DD/MM/YYYY). The requirement for informed consent was waived due to the retrospective nature of the study and the use of anonymized patient data.

Anonymized data study

The study used anonymized data and was approved by the Ethics Committee of [Institution Name] (approval number: XXX; date: DD/MM/YYYY). No identifiable patient information was included in the analysis.

When ethics approval is not required

Ethics approval was not required for this study because it did not involve human participants, human tissue, identifiable personal data, or animal subjects.

Use this wording carefully—journals and institutions may require different phrasing.

Systematic review / meta-analysis

Ethics approval was not required because this study was based exclusively on previously published data and did not involve new data collection from human participants.

Case report

Written informed consent was obtained from the patient for publication of this case report and any accompanying images.

Common mistakes

• Not naming the ethics committee
• Omitting the approval number or date
• Writing “ethics approval was obtained” without details
• Assuming retrospective studies need no ethics review
• Not stating whether consent was obtained or waived
• Using patient images without mentioning publication consent
• Not explaining anonymization or data privacy
• Confusing ethics approval with clinical trial registration

Ethics approval is not the same as trial registration

RCTs and some prospective clinical studies may require trial registration in addition to ethics approval (ClinicalTrials.gov, ISRCTN, EU Clinical Trials Register, or local registries).

Ethics approval confirms ethical review. Trial registration confirms prospective public registration. They do not replace each other.

Pre-submission checklist

• Is the ethics committee name included?
• Is the institution name clear?
• Is the approval number stated?
• Is the approval date included?
• Is consent status explained?
• For retrospective studies, is consent waiver stated if applicable?
• Is patient data anonymization mentioned?
• For identifiable images, was publication consent obtained?
• Is Declaration of Helsinki compliance stated when needed?
• Have you checked the journal's ethics statement format?

In short

Ethics reporting is not a minor technical detail—it directly affects credibility, participant protection, and publishability.

A strong ethics statement is short, clear, verifiable, and matched to your study design—committee name, approval number, date, and consent status included.

For the broader Methods narrative, see our research methods section guide — and for pre-submission checks, our peer review checklist.