Ethical Statements Guidance

It is important to have clear statements regarding ethics approval and patient consent when reporting results in publications. Refer to the below guidelines for when to provide which kinds of statements.

Studies involving humans – Ethics Approval – Consent | Studies involving animals | Studies not involving humans or animals

Studies involving patients, human samples, or study participants

Examples of specific scenarios

Ethics approval for a study involving survey participants
The XXXX Ethics Review Committee at XXXX University approved our interviews (Approval: XYZ123) on Month DD, YYYY. A written consent form was furnished to respondents for review and signature before starting interviews.

Ethics approval obtained, but patient consent not required
This study received ethical approval from the XXXX IRB (Approval #XYZ123) on Month DD, YYYY. This is an IRB-approved retrospective study, all patient information was deidentified and patient consent was not required.

Our study was approved by XXXX Institution Review Board (approval no. XYZ123) on Month DD, YYYY. This is a retrospective study and does not require informed consent. Patient data will not be shared with outside parties.

Ethics approval for retrospective study
The study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of XXXX (no. XYZ123) on Month DD, YYYY, with an exemption from informed consent. No specific consent is needed for statistical analyses of aggregated deidentified data. For this study, the raw data were first extracted from HIS, and patients’ identities, including names, screening IDs, patient IDs, and mobile phone numbers, were de-identified.

Ethics approval for retrospective, multicentre study
This study was conducted in accordance with the Declaration of Helsinki. Approval was granted on Month DD, YYYY. The Institutional Review Board (IRB) at XXXX acted as the central IRB, whose review was accepted by all participating institutions’ IRBs (Ref. XYZ123). The central IRB determined that this research involved no greater than minimal risk and approved a waiver for informed consent.

Ethics approval obtained for use of human samples
This study was approved by the Ethics Committee of XXXX University (Ethics Code: XYZ123) on Month DD, YYYY. All participants provided written informed consent prior to enrolment in the study. This research was conducted ethically in accordance with the World Medical Association Declaration of Helsinki.

The ethics review committee of the XXXX University approved this study on Month DD, YYYY. Number: XYZ123. Date: Month DD, YYYY. Written informed consent for this research was obtained from the patients prior to surgery.

The experimental protocols were approved by the Institutional Review Board (IRB) of the XXX University (No. XYZ123) on Month DD, YYYY. All research activities complied with all relevant ethical regulations and were performed in accordance with relevant guidelines and regulations of each hospital. Informed consent to use histopathological samples and pathological diagnostic reports for research purposes had previously been obtained from all patients prior to the surgical procedures at both hospitals and an opportunity for refusal to participate in research was guaranteed by an opt-out manner.

Ethics approval and patient consent were waived
The Ethics Committee of the XXXX waived the need for ethics approval and the need to obtain consent for the collection, analysis and publication of the retrospectively obtained and anonymized data for this non-interventional study.

This study was approved by the Danish Data Protection Agency. According to Danish legislation, neither approval from the ethics committee nor informed consent from the study populations is required for registry linkage studies [23].

Ethics approval for case reports or case series
Ethical approval to report this case was obtained from *NAME OF ETHICS COMMITTEE OR INSTITUTIONAL REVIEW BOARD (APPROVAL NUMBER/ID)*.

Ethical approval to report this case series was obtained from *NAME OF ETHICS COMMITTEE OR INSTITUTIONAL REVIEW BOARD (APPROVAL NUMBER/ID)*.

Our institution does not require ethical approval for reporting individual cases or case series.
 

Consent

Patient consent

Informed consent for participation in a study

• Patient consent obtained
  All participants provided written or verbal informed consent prior to enrolment in the study.

General Examples

• Written informed consent
  The study was approved by the XXXX (Ethical Clearance Reference Number: XYZ123) on Month DD, YYYY. All participants provided written informed consent prior to participating.

  Written informed consent was obtained from a legally authorized representative(s) for anonymized patient information to be published in this article.

• Verbal informed consent
  Informed consent was obtained verbally before participation. The consent was audio-recorded in the presence of an independent witness.
   
• Patient consent for studies involving minors
  Written informed consent to participate in this study was provided by the participants’ legal guardian/next of kin.
   
• Patient or participant consent for use of images including faces
  Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article.

Ethics approval and patient consent were waived

The Ethics Committee of the XXXX waived the need for ethics approval and the need to obtain consent for the collection, analysis and publication of the retrospectively obtained and anonymized data for this non-interventional study.

This study was approved by the Danish Data Protection Agency. According to Danish legislation, neither approval from the ethics committee nor informed consent from the study populations is required for registry linkage studies [23].

Patient consent NOT obtained
Informed consent for patient information to be published in this article was not obtained because *REASON*.
 

Participant consent

General Examples

• Participant consent for use of images including faces or identifying information
  Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article. All participants understand these images will be published in an online, open access journal that is available to anyone with an internet connection.
   
• Participant consent for identifying information of sensitive populations in small geographic regions
  Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable data included in this article. All participants understand these images will be published in an online, open access journal that is available to anyone with an internet connection.
   
• Anonymization of participant information
  Identifying information, such as names, images, or specific locations, have been anonymized to ensure participant safety and privacy.
   
• Participant consent for identifying information in ethnographies and autoethnographies
  Identifying information, such as names and places, have been anonymized to ensure participant safety and privacy. Where this was not possible, written informed consent was obtained from the involved institutions and participants.
   

Informed consent for publication

Patient consent for a case report
Written informed consent was obtained from the patient for the publication of this case report.

Patient or participant consent for use of images including faces
Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article.

Informed consent for publication NOT obtained
Informed consent for publication was not obtained because *REASON*.

Studies involving animals

Studies not involving humans or animals

These statements can be used in situations where a study did not involve human or animal participants as well as non-research articles such as reviews.

Approval not needed because of the study type or article type

This article does not contain any studies with human or animal participants.

There are no human participants in this article and informed consent is not applicable.