Pavlov University

 Research involving humans

All research studies on humans (individuals, samples or data) must have been performed in accordance with the principles stated in the Declaration of Helsinki. Prior to starting the study, ethical approval must have been obtained for all protocols from the local Institutional Review Board (IRB) or other appropriate ethics committee to confirm the study meets national and international guidelines for research on humans. A statement to confirm this must be included within the manuscript, which must provide details of the name of the ethics committee and reference/permit numbers where available.

Ethics approval for all studies must be obtained before the research is conducted. Authors must be prepared to provide further information to the journal editorial office upon request.

For non-interventional studies (e.g. surveys), where a study has been granted an adopted by Ethics Committee, this should be stated within the manuscript. The name of the Ethics Committee should also be included. A non-discriminatory language should be used when describing different groups by race, ethnicity, age, disease, disability, religion, gender, etc.

Where the research involves an intervention (e.g. a clinical trial), participants must provide informed written consent to be part of the study. A statement to confirm this must be included within the manuscript. Authors must be prepared to provide signed and dated copies to the journal editorial team if requested.

Ethics approval is not necessary for a review article since this will have been obtained by the original authors.

Clinical trials

Clinical trial protocols should be also registered in a publicly accessible registry prior to participant recruitment. The public registry must be open to all prospective registrants and managed by a not-for-profit organization. A list of eligible registries can be found at the WHO International Clinical Trials Registry Platform (ICTRP). Trials can also be registered at Clinical Trials.gov or the EU Clinical Trials Register. The trial registration number and registration date must be included in the manuscript. As a rule, clinical trials should be registered prospectively – i.e. before participant recruitment. Details on prospective and retrospective registration are available from the AllTrials campaign, National Institutes of Health, and the ICMJE.

Case reports

Given the specificity of details provided in a case report or case series, authors are required to obtain consent from patients (or their guardians) for the publication of the cases. This must be done even if the authors have removed direct identifiers and authors are advised to adhere to CARE guidelines in order to ensure all key details about the case are reported. Authors may use this Patient Consent Form which should be filled, signed, and saved. Authors should be ready to provide it for the Journal editorial office on request. A statement confirming the consent must be included within the manuscript.

The journals edited by Pavlov University Publishing House consider clinical case reports. By comparison, a case series is considered a group of case reports involving patients with similar diagnoses or who received similar therapies.

A clinical dataset is a list of well-defined variables collected during ongoing patient care or as part of a clinical trial program. It includes electronic health records, administrative data, patient registries, and clinical trial data.

Organ or tissue transplants

Pavlov University Publishing House endorses the ethics guidelines described by the World Health Organisation (WHO), the World Medical Association (WMA) and the Declaration of Istanbul. Specifically, all studies involving transplantation of donated human organs should be conducted with ethical approval from an appropriate committee, and all sources of donor tissue must be provided in the submitted manuscript. Authors must be able to verify that donated organs were obtained with full informed consent from the donor or their responsible relatives if the donor is deceased. Consent must have been given with free will donorship. Authors must include a statement within the manuscript to specify the source of transplanted organs and must confirm the statement of informed consent. This applies for all studies which concern organ or tissue transplantation.

Human embryos and human stem cells

Authors of research reporting the use of human embryos, human embryonic stem cells, especially, clinical applications, must include appropriate statement within the manuscript to confirm that all experiments were performed in accordance with all safety considerations, ethical guidelines and applicable regulations. Authors must be ready to provide full informed consent, and to include a statement of the Ethics Committee which approved the study, including the referencet numbers where available, and a statement to confirm informed consent was obtained.

Pavlov University Publishing House endorses the principles on ethical stem cell research outlined in the ISSCR Guidelines for Stem Cell Research and Clinical Translation.

Consent from children, adolescents and vulnerable or incapacitated study participants

Written informed consent must be obtained from the parent or guardian of any participants who are not able to provide full informed consent themselves. Age of legal adulthood is determined by the country in which study participants are based (typically between 16-18 years old). A statement to confirm informed consent has been obtained must be included within the manuscript.

Retrospective studies

Researchers must confirm they have obtained ethical approval to conduct the study, as well as permission from the dataset owner to use this information. Where permission to use information from a database/repository is not required (e.g. where it is publicly available and unrestricted re-use is permitted via an open licence), a statement to explain this must be included within the manuscript. Data acquired must be kept anonymised unless otherwise advised by the owners of the content in the database. Where participants details are not required to be anonymised, authors must be able to provide evidence that written informed consent, including consent to publish, was obtained from participants, with appropriate statement in the manuscript.

Participant/patient privacy and informed consent

    Pavlov University Publishing House endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) which emphasizes that patients and study participants have a right to privacy that should not be infringed without informed consent. Informed consent must be voluntarily obtained from the participant who should be informed of the study including any of the benefits and risks involved.

For all studies involving human participants informed written consent to take part in the research must have been obtained prior to the commencement of the study, and a statement to confirm this must be included in the manuscript.

For patients or study participants who are not adults or are considered to be vulnerable or unable to provide informed consent, this must then be obtained from their legal guardians, or next of kin if the participant is deceased.

Consent to publish identifiable information

     For some manuscripts including information which could potentially identify the patient (e.g., individual’s name, address, date of birth, phone and e-mail addresses, medical records or patient ID, etc), its authors (or their workplace institution) must be ready to confirm that they have obtained written informed consent to publish the details from the affected individual (or their parents/guardians). Authors may provide this or similar Consent to Publish Form, which should be completed, signed, and saved securely. Consent to Publish is a Pavlov University Publishing House requirement and cannot be exempted by an ethics committee. Authors must be prepared to provide copies of signed consent forms to the journal editorial office if requested.

 Research involving animals

    Experiments involving vertebrates or regulated invertebrates, field studies and other non-experimental research on animals must have been carried out in accordance with institutional, national or international guidelines, and with approval of an appropriate ethics committee where available.

Where applicable, a statement of ethics approval, or animal licenses should be included within the manuscript. Where a study has been granted an exemption from requiring ethical approval, this should be stated along with the name of the ethics committee which provided the exemption, and the reasons for the exemption.

For non-human primate studies, it must be demonstrated the work meets the standards set out in the NC3Rs primate’s guidelines and follows best practice procedures. For experimental studies involving client-owned animals, authors must also document informed consent from the client or owner and adherence to best practices of veterinary care.

Pavlov University Publishing House endorses the principles on ethical animal research outlined in the ethical guidelines by the International Council for Laboratory Animal Science (ICLAS).