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The National Catholic Bioethics Center
© 2019 by The National Catholic Bioethics Center
NCBQ EDITORAL AND PUBLISHING POLICIES
The National Catholic Bioethics Quarterly follows the editorial policies recommended by the International Committee of Medical Journal Editors (ICMJE). The NCBQ has adopted the wording found in the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals with some minor adjustments:
The editor in chief of the NCBQ has full authority over the entire editorial content of the journal and the timing of publication of that content. The National Catholic Bioethics Center (NCBC) does not interfere in the evaluation, selection, scheduling, or editing of individual articles either directly or by creating an environment that strongly influences decisions. Editorial decisions are based on the quality of the work and its importance to the NCBQ’s readers, not on the commercial implications for the journal.
The editor in chief has the final say in decisions about which advertisements or sponsored content, including supplements, the journal will and will not carry, and he or she has final say in use of the journal brand and in overall policy regarding commercial use of journal content. The NCBQ has established an independent editorial advisory board to help the editor establish and maintain editorial policy.
The editorial staff members of the NCBQ defend the confidentiality of authors and peer-reviewers (names and reviewer comments) in accordance with ICMJE policy (see Recommendations, section II C.2.a).
Manuscripts submitted to the NCBQ are privileged communications that are authors’ private, confidential property, and authors may be harmed by premature disclosure of any or all of a manuscript’s details.
The editorial staff members therefore will not share information about manuscripts, including whether they have been received and are under review, their content and status in the review process, criticism by reviewers, and their ultimate fate, to anyone other than the authors and reviewers. Requests from third parties to use manuscripts and reviews for legal proceedings will be politely refused, and the editor in chief will do his or her best not to provide such confidential material should it be subpoenaed.
Reviewers should keep manuscripts, associated material, and the information they contain strictly confidential. Reviewers and editorial staff members must not publicly discuss the authors’ work, and reviewers must not appropriate authors’ ideas before the manuscript is published. Reviewers must not retain the manuscript for their personal use and should destroy paper copies of manuscripts and delete electronic copies after submitting their reviews.
When a manuscript is published, the NCBQ will keep copies of the original submission, reviews, revisions, and correspondence to help answer future questions about the work should they arise.
The editors will not publish or publicize peer reviewers’ comments without permission of the reviewer and author. The identity of a reviewer will not be revealed to the author or anyone else without the reviewers’ expressed written permission.
Confidentiality may have to be breached if dishonesty or fraud is alleged, but editors will notify authors or reviewers if they intend to do so.
(See the chart of NCBC peer review here.)
The NCBQ policy on peer review can be viewed here.
Conflicts of Interest
The NCBQ policy on conflicts of interest can be viewed here.
Protection of Research Participants
The NCBQ policy on protecting research participants can be viewed here.
Clinical trials must be registered in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication. The NCBQ uses the date trial registration materials were first submitted to a registry as the date of registration.
A clinical trial is defined as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. The NCBQ does not define the timing of first participant enrollment, but best practice dictates registration by the time of first participant consent.
The NCBQ accepts publicly accessible registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP) or in ClinicalTrials.gov, which is a data provider to the WHO ICTRP. The NCBQ endorses these registries because they meet several criteria. They are accessible to the public at no charge, open to all prospective registrants, managed by a not-for-profit organization, have a mechanism to ensure the validity of the registration data, and are electronically searchable. An acceptable registry must include the minimum 21 item trial registration dataset such as the International Clinical Trials Registry Platform at the time of registration and before enrollment of the first participant. The NCBQ considers inadequate trial registrations missing any of the 21 data fields, those that have fields that contain uninformative information, or registrations that are not made publicly accessible such as phase I trials submitted to the EU-CTR and trials of devices for which the information is placed in a “lock box.” In order to comply with NCBQ policy, investigators registering trials of devices at ClinicalTrials.gov must “opt out” of the lock box by electing public posting prior to device approval. Although not a required item, the NCBQ encourages authors to include a statement that indicates that the results have not yet been published in a peer-reviewed journal, and to update the registration with the full journal citation when the results are published.
The purpose of clinical trial registration is to prevent selective publication and selective reporting of research outcomes, to prevent unnecessary duplication of research effort, to help patients and the public know what trials are planned or ongoing into which they might want to enroll, and to help give ethics review boards considering approval of new studies a view of similar work and data relevant to the research they are considering. Retrospective registration, for example at the time of manuscript submission, meets none of these purposes. Those purposes apply also to research with alternative designs, for example observational studies. For that reason, the NCBQ encourages registration of research with non-trial designs, but because the exposure or intervention in non-trial research is not dictated by the researchers, the NCBQ does not require it.
Secondary data analyses of primary (parent) clinical trials should not be registered as separate clinical trials, but instead should reference the trial registration number of the primary trial.
The NCBQ expects authors to ensure that they have met the requirements of their funding and regulatory agencies regarding aggregate clinical trial results reporting in clinical trial registries. It is the authors’, and not the journal editors’, responsibility to explain any discrepancies between results reported in registries and journal publications. The NCBQ will not consider as prior publication the posting of trial results in any registry that meets the above criteria if results are limited to a brief (500 word) structured abstract or tables (to include trial participants enrolled, baseline characteristics, primary and secondary outcomes, and adverse events).
The trial registration number will be printed at the end of the abstract. Whenever a registration number is available, authors should list this number the first time they use a trial acronym to refer either to the trial they are reporting or to other trials that they mention in the manuscript.
The editors will consider whether the circumstances involved in a failure to appropriately register a clinical trial were likely to have been intended to or resulted in biased reporting. Because of the importance of prospective trial registration, if an exception to this policy is made, trials must be registered and the authors should indicate in the publication when registration was completed and why it was delayed. Such exceptions should be rare, and that authors failing to prospectively register a trial risk its inadmissibility to the NCBQ.
- As of 1 July 2019, manuscripts submitted to the NCBQ that report the results of clinical trials must contain a data sharing statement as described below.
- Clinical trials that begin enrolling participants on or after 1 January 2019 must include a data sharing plan in the trial’s registration. The NCBQ follows the ICMJE’s policy regarding trial registration, which is is explained at www.icmje.org/recommendations/browse/ publishing-and-editorial-issues/clinical-trial-registration.html. If the data sharing plan changes after registration, this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.
Data sharing statements must indicate the following: whether individual de-identified participant data (including data dictionaries) will be shared (“undecided” is not an acceptable answer); what data in particular will be shared; whether additional, related documents will be available (e.g., study protocol, statistical analysis plan, etc.); when the data will become available and for how long; by what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism).
Authors of secondary analyses using shared data must attest that their use was in accordance with the terms (if any) agreed to upon their receipt. They must also reference the source of the data using its unique, persistent identifier to provide appropriate credit to those who generated it and allow searching for the studies it has supported. Authors of secondary analyses must explain completely how theirs differ from previous analyses. In addition, those who generate and then share clinical trial data sets deserve substantial credit for their efforts. Those using data collected by others should seek collaboration with those who collected the data. As collaboration will not always be possible, practical, or desired, the efforts of those who generated the data must be recognized.
Reporting guidelines have been developed for different study designs; examples include CONSORT for randomized trials, STROBE for observational studies, PRISMA for systematic reviews and meta-analyses, and STARD for studies of diagnostic accuracy. Journals are encouraged to ask authors to follow these guidelines because they help authors describe the study in enough detail for it to be evaluated by editors, reviewers, readers, and other researchers evaluating the medical literature. Authors of review manuscripts are encouraged to describe the methods used for locating, selecting, extracting, and synthesizing data; this is mandatory for systematic reviews. Good sources for reporting guidelines are the EQUATOR Network and the NLM’s Research Reporting Guidelines and Initiatives.
Timeliness of Publication Process
The editorial staff members will do all they can to ensure timely processing of manuscripts with the resources available to them, and any planned delays should be negotiated with the authors. If the NCBQ has no intention of proceeding with a manuscript, the author will be notified as soon as possible to allow him or her to submit to a different journal. A summary of the NCBQ publication process can be viewed here.
Misconduct, Expression of Concern, and Retraction
Misconduct includes but is not necessarily limited to data fabrication; data falsification, including deceptive manipulation of images; purposeful failure to disclose conflicts of interest; and plagiarism.
When misconduct is alleged, or concerns are otherwise raised about the conduct or integrity of work described in submitted or published papers, the editor in chief will initiate appropriate procedures. If the investigation proves misconduct, a retraction of the article may be published. There may be circumstances in which no misconduct is proven, but an exchange of letters to the editor could be published to highlight matters of debate to readers.
Expressions of concern and retractions will be prominently labelled online and in-print. Online retractions will be linked with the original article in both directions, and the retracted article will be clearly labelled as retracted in all its forms. Retracted articles should remain in the public domain and be clearly labelled as retracted. The integrity of research may also be compromised by inappropriate methodology that could lead to retraction.
Defining the Role of Authors
Authorship is based on the following four criteria: (1) substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; (2) drafting the work or revising it critically for important intellectual content; (3) final approval of the version to be published; and (4) agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Those who do not meet all four criteria are considered contributors and may be acknowledged for writing assistance, technical editing, language editing, and proofreading. Because acknowledgment may imply endorsement, the corresponding author must obtain written permission to be acknowledged from all acknowledged individuals.
Authors should provide direct references to original research sources whenever possible. References should not be used by authors, editors, or peer reviewers to promote self-interests. Although references to review articles can be an efficient way to guide readers to a body of literature, review articles do not always reflect original work accurately. On the other hand, extensive lists of references to original work on a topic can use excessive space. Fewer references to key original papers often serve as well as more exhaustive lists, particularly since references can now be added to the electronic version of published papers, and since electronic literature searching allows readers to retrieve published literature efficiently.
When possible, the NCBQ check the accuracy of all reference citations using either an electronic bibliographic source, such as PubMed, or print copies from original sources.
Contributor’s Publishing Agreement
The author grants and assigns the entire copyright for the contribution to the NCBC for its exclusive use. The copyright consists of any and all rights of whatever kind or nature now or hereafter protected by the copyright laws of the United States and of all foreign countries, in all languages and forms of communication, and the NCBC shall be the sole proprietor thereof. The NCBC, in turn, grants to the author the right to reprint the contribution in any book of which he or she is the author or editor, subject to he or she giving proper credit in the book to the original publication of the contribution in the NCBQ. To protect the copyright in the contribution, the original copyright notice as it appears in the NCBQ should be included in the credit.
The author warrants that the contribution is original with him or her; that it contains no matter which is defamatory or is otherwise unlawful or which invades individual privacy or infringes any proprietary right or any statutory copyright; and he or she agrees to indemnify and hold the NCBC harmless against any claim to the contrary. Further, the author warrants that he or she has the right to assign the copyright to the NCBC and that no portion of the copyright to the contribution has been assigned previously. It is understood that the copyright to the contribution has not been registered with the Library of Congress, but that in the event such registration has taken place the author will promptly transfer the copyright to the NCBC.
Previous Publication and Permission
The author warrants that the contribution has not been published elsewhere in whole or in substantial part (except as may be set out in a rider and signed by the NCBC) and that no agreement to publish is outstanding. Should the contribution contain material which requires written permission for inclusion in the contribution, such permission shall be obtained at the author’s own expense from the copyright proprietor and submitted for review to the editor in chief of the NCBQ with the manuscript.
The author will be given an opportunity to read and correct the edited manuscript and/or proofs, but if he or she fails to return them to the NCBQ by the date set by the editorial staff members, production and publication may proceed without his or her corrections.
Subsidiary Rights and Compensation
It is understood that the author will receive no monetary compensation from the NCBC for the assignment of copyright and publication of the contribution in the NCBQ. However, fees received from licenses to reprint the contribution in readers, anthologies, and/or textbooks will be divided equally between the author and the press. The author will receive no monetary compensation for other licenses which may be granted for the use of his or her contribution, nor will the author receive any share of fees amounting to $50.00 or less. The author’s share of fees collected by the NCBC will be paid to him or her (in the case of joint authors, to the first named) within three months of receipt.
Open Access and Author Archiving
All articles published in the NCBQ are archived at the Philosophy Documentation Center.
Reprints and Permissions
The preprint is the submitted manuscript (in word-processing format) as it was before peer review. The post-print is the manuscript after peer review and author revisions but before production work has been done on it. The published article has the look of the journal. It has been checked for accuracy, copyedited, corrected, typeset, proofread, and given final approval by the author and editor. Page proofs are an earlier typeset version; they resemble a published article but are likely to contain errors and do not show the correct page numbers. Page proofs (like the edited manuscript) are only for the author’s use during production; they may not be posted, distributed, or used in any other way or for any other purpose.
A preprint or post-print with full acknowledgment include the NCBQ’s copyright notice and a notice stating that the article has been accepted for publication or has already been published in the NCBQ. On request, the NCBQ publications department will provide the author with (1) a preprint or post-print with full acknowledgment, (2) the published article, and (3) written permission for uses that require it.
Preprint or post-print manuscripts may be used in a class the author teaches and copies given to students, presented at a meeting or conference and copies given to other attendees, shared with colleagues for their research, included in a later publication of the author’s, included in the author’s thesis or dissertation, reused for extracts, or used as part of a derivative noncommercial work. Preprint or post-print manuscripts may be posted on preprint servers and posted for scholarly purposes on the author’s personal website or the website of his or her institution with full acknowledgement to the NCBQ. Preprint or post-print manuscripts may be deposited in subject-oriented or centralized repositories only with specific agreement between the NCBQ and the repository. Preprint or post-print manuscripts may be used for posted for commercial gain or used in a way that substitutes for services provided directly by the journal only with written permission from the NCBQ.
Published articles may be used in a class the author teaches and copies given to students, presented at a meeting or conference and copies given to other attendees, shared with colleagues for their research, included in a later publication of the author’s, included in the author’s thesis or dissertation, reused for extracts, or used as part of a derivative noncommercial work. Published articles may not be posted on reprint servers. Published articles may be deposited in subject-oriented or centralized repositories only with specific agreement between the NCBQ and the repository. Published articles may be posted for scholarly purposes on the author’s personal website or the website of his or her institution, used for posted for commercial gain, or used in a way that substitutes for services provided directly by the journal only with written permission from the NCBQ.