v
Search
Advanced Search

Information and Policy >  > 

Ethics in Scientific Process
Content List
 Ethics in Scientific Process Description Data Sharing Policy 

Ethics in Scientific Process Description

XHP demands that all research described in its publications be conducted and reported in accordance with the guidance from the Committee on Publication Ethics (COPE) and practices according to the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals from the International Committee of Medical Journal Editors (ICMJE). Authors are expected to carry out their research-related activities in accordance with the tenets of honesty, transparency, objectivity, and accountability. Editors-in-chief, Associates Editors, editorial members, reviewers and editorial staff are requested to pay attention to prevent and eliminate author misconduct. XHP reserves the right to reject any manuscript that editors believe does not uphold high ethical standards, even if authors have obtained ethical approval or if ethical approval is not required.

Ethics in Reporting Study Procedures and Findings 
All methods used in a study should be adequately described, so that readers may replicate the experiments as they were performed by the authors. The practice of withholding a key step (including but not limited to a reagent, procedure, tool, or technique) or any other piece of information related to the study for proprietary or personal reasons is absolutely unacceptable. 

Reporting of results is expected to be complete and accurate. All statistical results of an experiment and/or study project should be presented, including data that does not meet the threshold for statistical significance. The authors must not data picking, which is the practice of presenting incomplete evidence from a series of experiments. The practice of selecting data to exclude negative findings is also prohibited and constitutes scientific misconduct.

All experimental controls should be reported. In addition, the weaknesses of the study design, which may have biased the results, should be reported.

Authors must ensure that all research records, including hand/typewritten documentation, films, and electronic files, are made available upon request at any time during the review process and in perpetuity after the publication of the article describing the study. Patient-related research records should meet the standard regulations of patient privacy and confidentiality. The refusal, disregard, or inability to provide research records that have been requested is considered evidence of scientific misconduct and should prompt an investigation into the need for an article’s dismissal from review or retraction from the journal; the decision to pursue additional actions to address the misconduct should be made at the discretion of the Editors-in-Chief.

Image Manipulation 
All images accompanying a publication should be generated in accordance with general ethical standards to ensure integrity of the data presented. Image manipulation or any other form of adjustment that modifies the data is prohibited. 

Animal Subjects
Ethical conduct is expected for all procedures related to animal handling, including husbandry, care, and experimentation. For animal studies, it will be clearly stated that approval was obtained from an institutional animal care committee and that all animals received humane care in accordance with relevant institutional and national guidelines and regulations. For example, the US authors should declare the compliance with "Guide for the Care and Use of Laboratory Animals" prepared by the National Academy of Sciences and published by the National Institutes of Health. 
Example: Ethical statement for experiments involving animals

This study was carried out in accordance with the recommendations in the Guide for the Care and Use of Laboratory Animals of the National Institutes of Health. The protocol was approved by the Committee on the Ethics of Animal Experiments of the University of **** (Protocol Number: **-****). All surgery was performed under sodium pentobarbital anesthesia, and all efforts were made to minimize suffering.

Human Subjects and Informed Consent 
For a research study using human subjects, the type of study should be indicated from the following list: randomized controlled trial, cross-sectional study, cohort study, case series, or survey. In addition, the following should be stated: participating institutions; number of subjects; methods of subject selection, recruitment, enrollment, and randomization; and subject withdrawal and completion. Concerning interventions, the criteria for assignment, methods of administration, and duration should be described. 

The authors should ensure that the planning, performance, and reporting of human research are in accordance with the Helsinki Declaration as revised in 2013. All authors should seek approval to conduct research from an independent local, regional, or national review body (e.g., ethics committee, or institutional review board). 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. 

The authors should provide declarative statements that: (a) written informed consent was obtained from each patient prior to enrollment; and (b) the study protocol was approved by the appropriate institutional review committee (IRB), with the name of the committee and institution clearly stated; and (c) the study conformed to the ethical guidelines of the Helsinki Declaration (as revised in 2013). Information that may identify the human subject should be omitted or anonymized, unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. XHP journals reserve the right to ask the author to provide signed informed consent, if necessary. 
Examples: Ethical statement for experiments involving human subjects

This study was carried out in accordance with the recommendations of [name of guidelines], [name of committee]. The protocol was approved by the [name of committee]. All subjects gave written informed consent in accordance with the Declaration of Helsinki. This study is registered at [URL]. The registration identification number is [identification number]. (Prospective study)

This study was carried out in accordance with the recommendations of [name of guidelines], [name of committee]. The protocol was approved by the [name of committee]. The individual consent for this retrospective analysis was waived. (Retrospective study)

Clinical Trial Registry 
XHP journals adopt the ICMJE’s trial registration policy. Briefly, we require registration of clinical trials in a public trials registry (such as the ClinicalTrials.gov, or other Primary Registries listed here) at or before the time of first patient enrollment as a condition of consideration for publication. The ICMJE does not define the timing of first participant enrollment, but best practice dictates registration by the time of first participant consent. For all randomized controlled trials submitted for publication, the Clinical Trials Registry identifier number and platform should be provided. Observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) do not require registration. 

Consent for Publication
All case reports and research articles including individual person’s data must have obtained consent for publication. Since human patients are typically involved, case reports should first state that the study was carried out in accordance with the ethical standards of an ethics committee or institutional review board and with the Helsinki Declaration (as revised in 2013) (“Human Subjects and Informed Consent”).
The authors should always protect the confidentiality of individual information obtained in the course of research or professional interactions (e.g., between doctors and patients). Any submitted materials (photographs/videos, etc.) including personal details that may identify the participant should be omitted or anonymized, unless the information is essential for scientific purposes. Photographs need to be cropped sufficiently to prevent participants from being recognized, and the eyes must be masked to make the individual unrecognizable. It is therefore almost always necessary to obtain written informed consent for publication from people (or from their parent/guardian) who might recognize themselves or be identified by others (e.g., from case reports or photographs). It may be possible to publish individual information without explicit consent only if public interest considerations outweigh possible harms, it is impossible to obtain consent, and a reasonable individual would be unlikely to object to publication.
Example: Ethical statement for Case reports

The study was performed in accordance with the ethical standards of the institutions to which we are affiliated and with the Declaration of Helsinki (as revised in 2013). Written informed consent was obtained from the patient for publication of this case report.

This study received ethical approval from the institutional review board of xxx Hospital and was performed in accordance with the Declaration of Helsinki (as revised in 2013). Written informed consent was obtained from the patient for publication of this case report and the accompanying images. A copy of the written consent is available for review by the editorial office of this journal.

This single case report of [number of cases] clinical cases was a retrospective analysis of three or fewer clinical cases and is not considered as human research according to the U.S. federal policy [and institutional review board (IRB) regulations of xxx hospital]. An IRB approval was thus deemed unnecessary. This study was performed in accordance with the Declaration of Helsinki (as revised in 2013). Written informed consent was obtained from the patient for publication of this case report and the accompanying images.

Please note that consent to participate in research or undergo treatment is not the same as consent for publication of personal information. To obtain consent for publication, authors can use the XHP consent form (download here) or use an institutional consent form. The consent form must specify that the consent materials will be freely available on the internet and that all readers worldwide will be able to view them. Authors do not need to provide a copy of the consent form to the editorial office; however, the editor may ask the authors to provide a copy for verification at any time.

Proper Credit for All Individuals or Organizations
Authors are expected to give proper credit to all individuals and organizations involved in the performance of the research described in an article published by XHP journals. Individuals who do not meet the Authorship Criteria but who aided in the research, such as patients and hospital staff, should be appropriately acknowledged in the Acknowledgments section of the manuscript. Organizations that were contracted to perform work related to the research or that acted in a non-paid collaborative manner should be appropriately acknowledged in the manuscript. All funding agencies that provided support for the research or for any of the individuals involved in the research must be appropriately acknowledged in the manuscript.  


Data Sharing Policy
It is the policy of XHP that authors of papers published in our journals make all data and related metadata underlying findings reported in their manuscripts available, either in a publicly available data repository, as supplementary information alongside the publication itself, or direct provision upon request from readers.

To support this data sharing recommendation, a Data Sharing Statement is required for all research articles submitted to XHP journals. This Statement will specify the method(s) by which any reader may access the shared data, according to the following:

(1) For provision through a data repository: While there is no required repository, the authors should carefully select one according to field-specific standards, for example: GenBank for gene sequences; ArrayExpress for microarray data, etc. The Statement will include a functional hyperlink (full, and not a shortened version, such as Bitly) that takes the reader directly to the dataset for the manuscript, along with the repository(ies) name(s) and digital object identifiers (DOIs), accession numbers or codes, or other persistent identifiers for all relevant data.
Sample wording:
The [DATA TYPE, such as technical appendix, statistical code, or dataset] used in support of the findings of this study have been deposited in the [NAME] repository ([DOI or other persistent identifier]).

(2) For provision through Supplementary Information files: The authors will state that the complete data files were submitted along with the paper and are published as corresponding Supplementary Information accessible through the electronic publication.
Sample wording:
The [DATA TYPE, such as technical appendix, statistical code, or dataset] used in support of the findings of this study are included within the supplementary information file(s) accompanying this publication in the [Journal Title].

(3) For provision upon direct request: The authors will state that the complete dataset is available upon direct request to a specified contact, which can be an individual (author or otherwise, as clearly expressed in the Statement) or professional group/agency. The precise contact information of that person or group/agency, usually an email address or URL, will be provided in the Statement.
Sample wording:
The [DATA TYPE, such as technical appendix, statistical code, or dataset] used in support of the findings of this study are available from the corresponding author at [email address or URL] upon request.

(4) For restriction of data sharing: If there is any restriction to the complete and free access to the data reported in a paper, the authors must provide a detailed and rational explanation of such.
Sample wording:
The [DATA TYPE, such as technical appendix, statistical code, or dataset] used in support of the findings of this study have not been made available because [the reason].

(5) No additional data: If all data related to the study are presented within the paper, and no additional (including raw) data exist, such will be specified in the Data Sharing Statement.
Sample wording:
The [DATA TYPE, such as technical appendix, statistical code, or dataset] used in support of the findings of this study are included within the article.

(6) For Data sharing of clinical trials: XHP journals adopt ICMJE’s data sharing statement policy, which is available at http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html#two: A. As of 1 July 2018, manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement as described below. B. Clinical trials that begin enrolling participants on or after 1 January 2019 must include a data sharing plan in the trial's registration. If the data sharing plan changes after registration, this should be reflected in the statement submitted, published with the manuscript, and updated in the registry record.
Please note: Data sharing statements for clinical trials must indicate the following:
1. Whether individual deidentified data will be shared;
2. What data will be shared;
3. Availability of related documents (study protocol, statistical analysis plan, etc.);
4. When the data will be available and for how long;
5. Criteria for obtaining the data.
If an original article reports results from a clinical trial includes involving any data that are not publicly available, the authors must provide a statement to answer the above questions. Illustrative examples of data sharing statements that would meet these requirements are provided at http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html#two.

(7) For data sharing of human involved research: For studies involving human subjects, data sharing should not compromise the privacy of the participants. It should be ensured that data are shared in accordance with the local laws as well as the participants’ consent.
Please note: If there is ethical or legal restriction to complete and free access to the data, the authors should provide the reason for the restriction in detail and provide the contact information to which requests for the data can be sent.






Back to Top