Objective

Give readers a better understanding of why we include ethical approval statements in research articles, and how to construct them.

What is an ethical approval statement?

Ethical approval statements describe where ethical approval for a study was obtained. This is especially important for studies with human or animal subjects, or where private, protected, or culturally significant research locations were used. 

When to include an ethical approval statement

Though ethical approval is a cornerstone of transparent research practices, there are still frequent instances of researchers failing to disclose their approval status. In order to promote transparency and trust in science, researchers should include an ethical statement any time their study is reviewed by and conducted with the approval of an institutional review board (IRB)/research ethics committee (REC). 

How Ripeta thinks about ethical approval statements  

At Ripeta, we use natural language processing and machine learning to automatically search for, identify and extract quality indicators of trust from submitted manuscripts. Ripeta uses ethical approval statements as a measure of Trust in Professionalism because the statements indicate whether or not the author went through the appropriate safeguards and approvals for study participation before beginning their research. 

How to write an ethical approval statement

Where does the ethical approval statement go?

Most often, an ethical approval will have its own separate Ethical Approval Statement section. If not, it is often located in the first paragraph of Methods in a format such as ‘ethical approval was obtained from…committee…(in accordance with…).’ 

What is in an ethical approval statement?

Guidelines for ethical approval statements may differ based on the journal, so always check the author guidelines before submitting. With that said, an ethical approval statement will usually include:

Whether or not the study included human or animal subjects

Obviously not all research includes human or animal subjects. In all cases, the ethical approval status of the work should be stated in the ethical approval statement.   

This research did not contain any studies involving animal or human participants, nor did it take place on any private or protected areas. No specific permissions were required for corresponding locations.

The committee which approved the study

If approval was granted by an IRB/REC, cite the specific committee.

This study was conducted at The Royal London Hospital, London, UK between June 2012 and November 2014. The study was approved by the North Wales Research Ethics Committee (Reference 10/WNo3/25).

The compliance documents 

What policies, declarations, acts, etc. did the researchers follow to ensure they acted with agreed upon ethical procedure?

All animal research protocols were approved by the Texas Biomedical Research Institute (TBRI) or University of Texas Medical Branch (UTMB) Institutional Animal Care and Use Committee (IACUC) in compliance with the Animal Welfare Act, Public Health Service Policy on humane care and use of laboratory animals and other federal statutes and regulations relating to animals and experiments involving animals.

Persistent identifier: reference or approval number.

Include the registration ID/reference number if applicable. 

Research ethics approval was obtained by the Regional Ethical Review Board of Stockholm, (reference number: 2011/34) and the Ethics Committee Bern, Switzerland (reference number: 2018–00479).

Example ethical approval statement

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