Informed Consent

All investigators should ensure that the planning conduct and reporting of human research are in accordance with the Helsinki Declaration as revised in 2013. All authors are required to seek approval to conduct research from an independent local, regional or national review body (e.g., ethics committee, institutional review board) and/or obtain an exempt status from such a body. 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 local, regional or national review body explicitly approved the doubtful aspects of the study. Approval by a responsible review body does not preclude journal editors and reviewers from forming their own judgment whether the conduct of the research was appropriate.

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 Identifying information, including names, initials, or hospital numbers, should not be published unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication.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 and to agree to its publication. Authors should disclose to these patients that potential identifiable material will be available via the Internet or printed from the internet after publication. Patient consent should be written and archived with the authors and provided if requested by the journal. Nonessential identifying details should be omitted. Informed consent should be obtained if there is any doubt that anonymity can be maintained. 

21 CFR 50.20 General requirements for informed consent 

(US CODE: Title 5a, Ethics In Government Act Of 1978 US CODE: Title 5a, TITLE I—FINANCIAL DISCLOSURE REQUIREMENTS)

Except as provided in ß50.23, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

(Modified from ICMJE http://www.icmje.org/recommendations/browse/roles-and-responsibilities/protection-of-research-participants.html)