Publication Ethics and Malpractice Statement
International Journal of Drug Regulatory Affairs (IJDRA) is a peer-reviewed journal dedicated to the publication of Research papers, Reviews, and case studies.
Ethical standards for publication exist to ensure high-quality scientific publications, public trust in scientific findings, and that people receive credit for their work and ideas.
Publication ethics and malpractice statement of IJDRA journal, adapted from and based on guidelines provided by Committee on Publication Ethics (COPE) and abides by its Code of Conduct and aims to adhere to its guidelines.
Duplicate Submission and Redundant Publication
Authorship and Acknowledgements
All manuscripts are subject to peer review and are expected to meet standards of academic excellence. If approved by the editor, submissions will be considered by peer reviewers, whose identities will remain anonymous to the authors.
Our Research Integrity team will occasionally seek advice outside standard peer review, for example, on submissions with serious ethical, security, biosecurity, or societal implications. We may consult experts and the academic editor before deciding on appropriate actions, including but not limited to recruiting reviewers with specific expertise, assessment by additional editors, and declining to further consider a submission.
Authors must not use the words, figures, or ideas of others without attribution. All sources must be cited at the point they are used, and reuse of wording must be limited and be attributed or quoted in the text.
IJDRA uses Crossref Similarity Check (iThenticate) and our own software to detect submissions that overlap with published and submitted manuscripts. Editors can see our Similarity Check page for more information on how to interpret these reports.
Manuscripts that are found to have been plagiarized from a manuscript by other authors, whether published or unpublished, will be rejected and the authors may incur sanctions. Any published articles may need to be corrected or retracted.
Duplicate Submission and Redundant Publication
IJDRA journal considers only original content, i.e. articles that have not been previously published, including in a language other than English. Articles based on content previously made public only on a preprint server, institutional repository, or in a thesis will be considered.
Manuscripts submitted to IJDRA journal must not be submitted elsewhere while under consideration and must be withdrawn before being submitted elsewhere. Authors whose articles are found to have been simultaneously submitted elsewhere may incur sanctions.
If authors have used their own previously published work, or work that is currently under review, as the basis for a submitted manuscript, they must cite the previous articles and indicate how their submitted manuscript differs from their previous work. Reuse of the authors’ own words outside the Methods should be attributed or quoted in the text. Reuse of the authors’ own figures or substantial amounts of wording may require permission from the copyright holder and the authors are responsible for obtaining this.
IJDRA journal will consider extended versions of articles published at conferences provided this is declared in the cover letter, the previous version is clearly cited and discussed, there is significant new content, and any necessary permission are obtained.
Redundant publication, the inappropriate division of study outcomes into more than one article (also known as salami slicing), may result in rejection or a request to merge submitted manuscripts, and the correction of published articles.
Authors whose submitted manuscripts are found to include citations whose primary purpose is to increase the number of citations to a given author’s work, or to articles published in a particular journal, may incur sanctions.
Editors and reviewers must not ask authors to include references merely to increase citations to their own or an associate’s work, to the journal, or to another journal they are associated with.
Fabrication and Falsification
The authors of submitted manuscripts or published articles that are found to have fabricated or falsified the results, including the manipulation of images, may incur sanctions, and published articles may be retracted.
Authorship and Acknowledgements
All listed authors must have made a significant scientific contribution to the research in the manuscript, approved its claims, and agreed to be an author. It is important to list everyone who made a significant scientific contribution. We refer to the ICMJE guidelines. Author contributions may be described at the end of the submission, optionally using roles defined by CRediT. Changes in authorship must be declared to the journal and agreed to by all authors.
- Anyone who contributed to the research or manuscript preparation, but is not an author, should be acknowledged with their permission.
- Submissions by anyone other than one of the authors will not be considered.
- Only persons who meet these authorship criteria should be listed as authors in the manuscript as they must be able to take public responsibility for the content: (i) made significant contributions to the conception, design, execution, data acquisition, or analysis/interpretation of the study; and (ii) drafted the manuscript or revised it critically for important intellectual content; and (iii) have seen and approved the final version of the paper and agreed to its submission for publication. All persons who made substantial contributions to the work reported in the manuscript (such as technical help, writing and editing assistance, general support) but who do not meet the criteria for authorship must not be listed as an author, but should be acknowledged in the "Acknowledgements" section after their written permission to be named as been obtained.
- All submitted papers are subject to strict peer-review process by at least two international reviewers & one national reviewer that are experts in the area of the particular paper.
- The factors that are taken into account in review are relevance, soundness, significance, originality, readability and language.
- The possible decisions include acceptance, acceptance with revisions, or rejection.
- If authors are encouraged to revise and resubmit a submission, there is no guarantee that the revised submission will be accepted.
- Rejected articles will not be re-reviewed.
- The paper acceptance is constrained by such legal requirements as shall then be in force regarding libel, copyright infringement and plagiarism.
- No research can be included in more than one publication.
Conflicts of Interest
Conflicts of interest (COIs, also known as ‘competing interests’) occur when issues outside research could be reasonably perceived to affect the neutrality or objectivity of the work or its assessment. Potential conflicts of interest must be declared—whether or not they actually had an influence—to allow informed decisions. In most cases, this declaration will not stop work from being published nor will it always prevent someone from being involved in a review process.
If unsure, declare a potential interest or discuss with the editorial office. Undeclared interests may incur sanctions. Submissions with undeclared conflicts that are later revealed may be rejected. Published articles may need to be re-assessed, have a corrigendum published, or in serious cases be retracted. For more information on COIs, see the guidance from the ICMJE and WAME.
Conflicts include the following:
- Financial—funding and other payments, goods and services received or expected by the authors relating to the subject of the work or from an organization with an interest in the outcome of the work
- Affiliations—being employed by, on the advisory board for, or a member of an organization with an interest in the outcome of the work
- Intellectual property—patents or trademarks owned by someone or their organization
- Personal—friends, family, relationships, and other close personal connections
- Ideology—beliefs or activism, for example, political or religious, relevant to the work
- Academic—competitors or someone whose work is critiqued
Authors must declare all potential interests in a ‘Conflicts of interest’ section, which should explain why the interest may be a conflict. If there are none, the authors should state “The author(s) declare(s) that there are no conflicts of interest regarding the publication of this paper.” Submitting authors are responsible for coauthors declaring their interests.
Authors must declare current or recent funding (including article processing charges) and other payments, goods or services that might influence the work. All funding, whether a conflict or not, must be declared in the ‘Acknowledgments’.
The involvement of anyone other than the authors who 1) has an interest in the outcome of the work; 2) is affiliated to an organization with such an interest; or 3) was employed or paid by a funder, in the commissioning, conception, planning, design, conduct, or analysis of the work, the preparation or editing of the manuscript, or the decision to publish must be declared.
Declared conflicts of interest will be considered by the editor and reviewers and included in the published article.
Editors and Reviewers:
Editors and reviewers should decline to be involved with a submission when they
- Have a recent publication or current submission with any author
- Share or recently shared an affiliation with any author
- Collaborate or recently collaborated with any author
- Have a close personal connection to any author
- Have a financial interest in the subject of the work
- Feel unable to be objective
Reviewers must declare any remaining interests in the ‘Confidential’ section of the review form, which will be considered by the editor.
Editors and reviewers must declare if they have previously discussed the manuscript with the authors.
If IJDRA becomes aware of breaches of our publication ethics policies, whether or not the breach occurred in a journal published by IJDRA, the following sanctions may be applied across the IJDRA journal:
- Rejection of the manuscript and any other manuscripts submitted by the author(s).
- Not allowing submission for 1-3 years.
- Prohibition from acting as an editor or reviewer.
IJDRA may apply additional sanctions for severe ethical violations.
Suspected breaches of our publication ethics policies, either before or after publication, as well as concerns about research ethics, should be reported to our Research Integrity team, overseen by the Head of Research Integrity.
Claimants will be kept anonymous if requested, though claimants may also wish to use an anonymous email service such as ProtonMail or TorGuard.
IJDRA may ask the authors to provide the underlying data and images, consult editors, and contact institutions or employers to ask for an investigation or to raise concerns.
Corrections and Retractions
In some cases it might be necessary to correct the literature in order to maintain the integrity of the research literature. The COPE Retraction Guidelines describe exactly when and which option should be used.
When errors are identified in published articles, the publisher will consider what action is required and may consult the editors and the authors’ institution(s).
Errors by the authors may be corrected by a corrigendum and errors by the publisher by an erratum.
If there are errors that significantly affect the conclusions or there is evidence of misconduct, this may require retraction or an expression of concern following the COPE Retraction Guidelines.
All authors will be asked to agree to the content of the notice.
Erratum – Journal Editors should consider issuing an erratum if:
- A small portion of an otherwise reliable publication proves to be misleading (especially because of honest error) the author/contributor list is incorrect.
Retraction Note – Journal Editors should consider retracting a publication if:
- There is clear evidence that the findings are unreliable, either as a result of misconduct or honest error.
- The findings have previously been published elsewhere without proper cross-referencing, permission or justification.
- It constitutes plagiarism.
- It reports unethical research.
The text for retraction notes can be submitted/written by the author(s), Journal editor or jointly.
Expression of Concern– Journal Editors should consider issuing an expression of concern if:
- There is inconclusive evidence of research or publication misconduct by the authors.
- There is evidence that the findings are unreliable but the authors’ institution will not investigate the case.
- It is believed that an investigation into alleged misconduct related to the publication either has not been, or would not be, fair and impartial or conclusive.
- An investigation is under way but a judgment will not be available for a considerable time.
- Authors must certify that their manuscripts are their original work.
- Authors must certify that the manuscript has not previously been published elsewhere.
- Authors must certify that the manuscript is not currently being considered for publication elsewhere.
- Authors must participate in the peer review process.
- Authors are obliged to provide retractions or corrections of mistakes.
- All Authors mentioned in the paper must have significantly contributed to the research.
- Authors must state that all data in the paper are real and authentic.
- Authors must notify the Editors of any conflicts of interest.
- Authors must provide a formal written transfer of copyright for each article required to publish.
- Authors must identify all sources used in the creation of their manuscript.
- Authors must report any errors they discover in their published paper to the Editors.
- Hazards and human or animal subjects: If the work involves chemicals, procedures or equipment that has any unusual hazards inherent in their use, the authors must clearly identify these in the manuscript. If the work involves the use of animals or human participants, the authors should ensure that all procedures were performed in compliance with relevant laws and institutional guidelines and that the appropriate institutional committee(s) has approved them; the manuscript should contain a statement to this effect. Authors should also include a statement in the manuscript that informed consent was obtained for experimentation with human participants. The privacy rights of human participants must always be observed.
- Reviewers should keep all information regarding papers confidential and treat them as privileged information.
- Reviews should be conducted objectively, with no personal criticism of the author.
- Reviewers should express their views clearly with supporting arguments.
- Reviewers should identify relevant published work that has not been cited by the authors.
- Reviewers should also call to the Editor in Chief's attention any substantial similarity or overlap between the manuscript under consideration and any other published paper of which they have personal knowledge.
- Reviewers should not review manuscripts in which they have conflicts of interest resulting from competitive, collaborative, or other relationships or connections with any of the authors, companies, or institutions connected to the papers.
- Editors have complete responsibility and authority to reject/accept an article.
- Editors are responsible for the contents and overall quality of the publication.
- Editors should always consider the needs of the authors and the readers when attempting to improve the publication.
- Editors should guarantee the quality of the papers and the integrity of the academic record.
- Editors should publish errata pages or make corrections when needed.
- Editors should have a clear picture of a research's funding sources.
- Editors should base their decisions solely on the papers' importance, originality, clarity and relevance to publication's scope.
- Editors should not reverse their decisions nor overturn the ones of previous editors without serious reason.
- Editors should preserve the anonymity of reviewers.
- Editors should ensure that all research material they publish conforms to internationally accepted ethical guidelines.
- Editors should only accept a paper when reasonably certain.
- Editors should act if they suspect misconduct, whether a paper is published or unpublished, and make all reasonable attempts to persist in obtaining a resolution to the problem.
- Editors should not reject papers based on suspicions; they should have proof of misconduct.
- Editors should not allow any conflicts of interest between staff, authors, reviewers and board members.
- Maintain Relationship
To maintain the relationship with editors and parties involved in the publication and should support the editorial decisions and should work in the way to achieve the publication goal set by the editor.
- Maintain confidentiality
To maintain the confidentiality of author and his/her research work.
- Maintain the policies
To promote and encourage policies regarding journals ethics, authorship, editorial independence, conflict of interest, research funding, review system and process.
- Corrections, Retractions, Republication, and errors
To publish corrections, clarification, retractions whenever required. Publication should be done on the timely basis to achieve timeliness of publishing schedule of the journal.
Honest errors are a part of science and publishing and require publication of a correction when they are detected. So Correction, Retractions, Republication, and errors are handled as per standards prescribed by ICMJE
Copyright and Intellectual Property
It is a legal requirement for an author to sign a copyright agreement before publication.
Copyright Transfer Agreement (CTA)
Under this form of agreement, the author retains broad re-use rights in their article, but transfers copyright to the journal or publisher. Signing a CTA ensures maximum protection against copyright infringement with the publisher acting on behalf of the author.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published (Copyright Form). We therefore ask Author’s to complete and return this form, retaining a copy for records. Author’s cooperation is essential and appreciated. Any delay will result in a delay in publication.
Rights of Authors
The International Journal of Drug Regulatory affairs recognize the retention of the following:
- Patent and trademark rights and rights to any process or procedure described in the article.
- The right to photocopy or make single electronic copies of the article for their own personal use, including for their own classroom use, or for the personal use of colleagues, provided the copies are not offered for sale and are not distributed in a systematic way outside of their employing institution (e.g. via an e-mail list or public file server). Posting of an article on a secure network (not accessible to the public) within the author’s institution is permitted.
- The right, subsequent to publication, to use the article or any part thereof free of charge in a printed compilation of works of their own, such as collected writings or lecture notes.
Note: All copies, paper, electronic or other use, of the information must include an indication of the IJDRA copyright and a full citation of the journal source.
- If the article was prepared jointly with other author(s), the signing author has informed the co-author(s) of the terms of this copyright transfer and is signing on their behalf as their agent and represents that he or she is authorized to do so, then please confirm by checking the appropriate box following the signature line. The signing author shall bear the responsibility for designating the co-author(s) and must inform the IJDRA of any changes in authorship.
- If copyright is held by the employer, then the employer or an authorized representative of the employer must sign. If the author signs, it is understood that this is with the authorization of the employer and the employer’s acceptance of the terms of the transfer.
The author(s) warrant(s) that the article is the author’s original work and has not been published before. The author(s) warrant(s) that the article contains no libelous or other unlawful statements, and does not infringe on the rights of others. If excerpts from copyrighted works are included, the author(s) has (have) obtained or will obtain written permission from the copyright owners and will credit the source in the article.
The author(s) must agree that if a prior version of this work (normally a preprint) has been posted to an electronic public server, they will not update and/or replace the prior version in order to make it identical in content to the final published version.
Online Open Access Statement
The International Journal of Drug Regulatory Affairs use article open access policy by providing them to be made available the Creative Commons License (CC-BY-NC) in order to meet the terms of open access publication and ensure the widest possible dissemination.
All articles published open access will be immediately and permanently free for everyone to read, download, copy and distribute. Permitted reuse is defined by the user license CC-BY-NC.
The International Journal of Drug Regulatory Affairs operates under the Creative Commons Licence CC-BY-NC. This allows for the reproduction of articles, free of charge, for non-commercial use only and with the appropriate citation information. All authors publishing with the IJDRA accept these as the terms of publication.