CONSENTS & APPROVALS

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.”

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

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

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

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

Informed Consent

All individuals have individual rights that are not to be infringed. Individual participants in studies have, for example, the right to decide what happens to the (identifiable) personal data gathered, to what they have said during a study or an interview, as well as to any photograph that was taken.

Hence it is important that all participants gave their informed consent in writing prior to inclusion in the study. Identifying details (names, dates of birth, identity numbers and other information) of the participants that were studied should not be published in written descriptions, photographs, and genetic profiles unless the information is essential for scientific purposes and the participant (or parent or guardian if the participant is incapable) gave written informed consent for publication.

Complete anonymity is difficult to achieve in some cases, and informed consent should be obtained if there is any doubt. For example, masking the eye region in photographs of participants is inadequate protection of anonymity. If identifying characteristics are altered to protect anonymity, such as in genetic profiles, authors should provide assurance that alterations do not distort scientific meaning.

The following statement should be included:

“Informed consent was obtained from all individual participants included in the study.”

If identifying information about participants is available in the chapter, the following statement should be included:

“Additional informed consent was obtained from all individual participants for whom identifying information is included in this chapter.”

Patient Consents and Animal Protection

The clinical studies must be conducted according to the Declaration of Helsinki principles. All submission must comply with the guidelines of the International Committee of Medical Journal Editors (www.icmje.org) with regard to the patient’s consent for research or participation in a study. The editors can demand the documentation of the formal review and recommendation from the institutional review board or ethics committee responsible for oversight of the study.

The research studies involving the animals, the authors should indicate whether the procedures followed were in accordance with the standards set forth in the eighth edition of Guide for the Care and Use of Laboratory Animals; published by the National Academy of Sciences, The National Academies Press, Washington, D.C.).