Research involving human participants

1) Statement of human rights

When reporting studies that involve human participants, authors should include a statement that the studies have been approved by the appropriate institutional and/or national research ethics committee and have been performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

If doubt exists whether the research was conducted in accordance with the 1964 Helsinki Declaration or comparable standards, the authors must explain the reasons for their approach, and demonstrate that the independent ethics committee or institutional review board explicitly approved the doubtful aspects of the study.

The following statements should be included in the text before the References section:

Ethical approval: “All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.”

For retrospective studies, please add the following sentence:

“For this type of study formal consent is not required.”

2) Statement on the welfare of animals

The welfare of animals used for research must be respected. When reporting experiments on animals, authors should indicate whether the international, national, and/or institutional guidelines for the care and use of animals have been followed, and that the studies have been approved by a research ethics committee at the institution or practice at which the studies were conducted (where such a committee exists).

For studies with animals, the following statement should be included in the text before the References section:

Ethical approval: “All applicable international, national, and/or institutional guidelines for the care and use of animals were followed.”

If applicable (where such a committee exists): “All procedures performed in studies involving animals were in accordance with the ethical standards of the institution or practice at which the studies were conducted.”

If articles do not contain studies with human participants or animals by any of the authors, please select one of the following statements:

“This article does not contain any studies with human participants performed by any of the authors.”

“This article does not contain any studies with animals performed by any of the authors.”

“This article does not contain any studies with human participants or animals performed by any of the authors.”