Informed Consent, Privacy and Confidentiality Statement

Patients and Study Participants: Patients have a right to privacy that should not be violated without informed consent. Identifying information, including names, initials, or hospital numbers, should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that an identifiable patient be shown the manuscript to be published. Authors should disclose to these patients whether any potential identifiable material might be available via the Internet as well as in print after publication. Patient consent should be written and archived with the journal, the authors, or both, as dictated by local regulations or laws. The Journal requires that all authors obtain written patient consent and that this be archived by the author and available for inspection for a period of at least three years. A written statement should be included in the manuscript that attests that the authors have obtained and archived written patient consent. Nonessential identifying details should be omitted. Informed consent should be obtained if there is any doubt that anonymity can be maintained. For example, masking the eye region in photographs of patients is inadequate protection of anonymity. If identifying characteristics are altered to protect anonymity, such as in genetic pedigrees, authors should provide assurance, and editors should so note, that such alterations do not distort scientific meaning.

Manuscripts that include human subjects must include a statement that written informed consent was obtained. If materials or records derived from humans are included, the statement that approval from an Institutional Review Board (IRB) or Ethics Committee was obtained prior to initiation of the study, if it is required by the institution. When reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study. When reporting experiments on animals, authors should indicate whether the institutional and national guide for the care and use of laboratory animals was followed.

The use of laboratory animals must follow the standards established by the NIH Office of Animal Care and Use and Institute for Laboratory Animal Research as published in the Guide for the Care and Use of Laboratory Animals.

Manuscripts will be reviewed with due respect for authors’ and reviewers’ confidentiality. Our editors have been instructed to not disclose information about manuscripts (including their receipt, content, status in the reviewing process, criticism by reviewers, or ultimate fate) to anyone other than the authors and reviewers. Manuscripts sent for review are privileged communications. Therefore, reviewers and members of the editorial staff must respect the authors’ rights by not publicly discussing the authors’ work or appropriating their ideas before the manuscript is published. Reviewers may not make copies of the manuscript for their files and will not share it with others, except with the editor’s permission. Reviewers should return or destroy copies of manuscripts after submitting reviews.