Research Ethics and Informed Consent Policy
Research Ethics and Informed Consent Policy
Hellenic Neurological Society / Archives of Clinical Neurology retain the right to reject any manuscript based on unethical conduct in either human or animal studies.
For research involving human experiments, the article must include a statement that ethical approval was obtained (or a statement that ethical approval was not required and why), including the name of the ethics committee(s) or institutional review board(s), the number/ID of the approval(s), and a statement that the participants gave informed consent before taking part (or a statement that consent was not required and why). Authors should also state that the study conformed to the provisions of the Declaration of Helsinki (as revised in Edinburgh 2000).
In line with the recommendations of the World Health Organization and the Declaration of Helsinki, clinical trials should be prospectively registered before participants are enrolled. Clinical trial registration numbers should be included in all papers that report on clinical trials.
Where illustrations include recognizable individuals, living or deceased, great care must be taken to ensure that consent for publication has been given. Patient anonymity should be preserved. Photographs need to be cropped sufficiently to prevent human subjects from being recognized, and (at a minimum) the eyes and eyebrows must be masked using coarse pixilation to make the individual unrecognizable.
Informed Consent for Participation in Research Studies
Authors must comply with laws and regulations within their jurisdiction concerning the privacy and security of personal patient information. Authors of research papers must include a statement in a subsection of the Methods titled “Standard Protocol Approvals, Registrations, and Patient Consents.” Authors must state that patients or their legally authorized representative consented to participate in the study, or that an ethics board (that must be identified by name) approved the study and, if applicable, granted a waiver for consent.
Consent to Disclose for Publication of Case Reports or Case Series
Authors of case reports describing individual patients must obtain written informed consent-to-disclose from all patients and other individuals presented in the manuscript (even if there is no figure/ patient image included). Permission must be obtained from the individual or, if they are unable to provide their consent, from their legally authorized representative. Authors of case series, whose data are reported in aggregate, do not need to provide consent-to-disclose forms. However, if the case series includes case details or vignettes that may contain identifying characteristics, patient consent forms must be submitted.
Archives of Clinical Neurology journal is mindful of protecting the privacy and civil rights of children. Authors of studies that include children will require parental consent.
For non-case reports, a consent-to-disclose form must be provided to the editorial office for any figure or video of a person’s face, body, or any body part that is identifiable. An identifiable figure includes the face, body, or any portion of the face or body that could be recognizable to that person themselves or another person. This includes any anomaly (rash, scar, lesion, tattoo, birthmark, hair pattern) on the part of the body being photographed. For video recordings, recognizable voice, unusual bodily affect or gait would be recognizable and a consent-to-disclose form is required at submission. The editors reserve the final right to determine identifiability in a figure or video. Patients must be informed that consent for publication includes all media (including print and online, social media, re-use in other products, and future media). If signed forms only include use for educational and research purposes, the manuscript will be returned to the authors. Any identifying information (e.g., individual’s name, initials, hospital name, medical record number, social security number, date of birth) must be removed from all images including brain images, ultrasounds, and pathology slides. For images of faces, do not blur or black out eyes as consent-to-disclose is still required at submission.
Please note that the signing and submission of this form does not violate the the Health Insurance Portability and Accountability Act (HIPAA) related to patient privacy because this is not consent for treatment or consent to participate in clinical trials. The consent-to-disclose form is never shown to the public—it is confidentially archived.
For any experiments involving animals, the authors must indicate the nature of the ethical review permissions, relevant licences and national or institutional guidelines for the care and use of animals by which the research was conducted.
Where necessary, the Editorial Office reserves the right to request additional information in relation to experiments featured in a manuscript.