Ethics

      

 

Human studies

Documented review and approval from a formally constituted review board (Institutional Review Board or Ethics committee) is required for all studies involving people, medical records, and human tissues. For those investigators who do not have access to formal ethics review committees, the principles outlined in the Declaration of Helsinki should be followed. If the study is judged exempt from review, a statement from the committee is required. Written informed consent must have been obtained from human study participants, or their next of kin if under 16 years of age. If not possible, an institutional review board must decide if this is ethically acceptable. We require that these review board approvals are documented by the authors and described in the manuscript itself.

Animal studies

Any manuscript involving animals in research must confirm that ethical and legal approval was obtained prior to the commencement of the study. The name of the body giving the approval must be provided upon manuscript submission.  Written confirmation must also be given that all experiments were performed following relevant institutional and national guidelines and regulations.

Patient identity

If a patient can be identified, even if their name or a photo is not used, a signed letter must be provided from the patient (or their family), confirming that informed consent to publish has been given. A case series involving more than three patients requires Institutional Review Board or ethical committee approval. The above requirements must be described in the manuscript. Any identifying information that are not essential to the manuscript should be omitted.  If any doubt exists about identification of subjects the Publisher at Dove Medical Press shall be the final arbiter. 

Ethics FAQ for authors 

Q: Do I need ethics approval for retrospective patient data?
A: Yes. Approval from a formally constituted review board (Institutional Review Board or Ethics committee) is required for all studies involving people, medical records, and human samples.

Q: Do I need patient consent for the use of retrospective data?
A: Informed consent by participants should always be sought. If not possible, an institutional review board must decide if this is ethically acceptable. A statement should be included in the materials and methods section of your paper, regarding the IRB decision.  

Q: Do I need ethics approval for using samples or cell lines sourced from commercial/accredited providers?
A: No. However approval from a formally constituted review board (Institutional Review Board or Ethics committee) is required for all studies involving cell lines or human samples which have not been commercially sourced. 

Q: If ethics approval was not required, what statement should I include in my paper?
A: For those investigators who do not have access to formal ethics review committees, the principles outlined in the Declaration of Helsinki should be followed. If the study is judged exempt, a statement from the ethics committee is required. A statement should be included in the Materials and methods section of your paper, regarding the decision.

Q: Do I need ethics approval for studies involving live animals? 
A: Yes. You must specify in the materials and methods section of your paper, the ethical review committee approval, and the international, national, and/or institutional guidelines followed regarding the animals welfare.

Q: Do I need ethical approval when reporting on veterinary clinical cases?
A: No. For studies using client-owned animals, a high standard (best practice) of veterinary care and involves informed client consent statement should be included in the Materials and methods section. 

Q: Do I need ethics approval for a review paper?
A: No. This will have been obtained by the original authors. 

Q: Do I need Ethical Committee approval when submitting a Meta-analysis or Systematic Review?
A: No

Updated 31 August 2017