Good Publications Practice
Categories Scientific Communication

Communicating Company-Sponsored Medical Research: Following Good Publications Practice

Introduction

The Good Publication Practice guidelines aim to bring transparency and authenticity to the data that is published in company-sponsored medical research. The guidelines provide the roadmap for ethical publication and to incorporate all the data which is required for evolving further research. The guidelines manage the publications that occur in scientific peer-reviewed journals as well as the presentation of posters in conferences and seminars.

Good Publication Practice Guidelines

The Good Publication Practice Guidelines provide recommendations about the publications of research studies that are sponsored by the pharmaceutical, biotechnological, and diagnostic companies. These guidelines are important, keeping in mind the very fact that such publications need to have a high standard of ethics and transparency. Many such publications show a path for future research. Any data fabrication or hiding of data may affect further research and harm the overall healthcare system. Following are some of the important aspects incorporated in Good Publication Practice Guidelines.

Completeness: The research paper should contain all the data related to the study. The publication should contain both positive and negative findings. The study should also be published regardless of whether the drug under the study is investigational, is approved or licensed, or withdrawn from the market.

Regulatory laws: The sponsors and researchers should follow all the relevant regulatory laws in the geographical area where the study is conducted. The study should also follow the guidelines of the food and drug administration department, such as USFDA in the USA, UKMHRA in the United Kingdom, and CDSCO in India.

Ethical guidelines: Maintaining ethical standards are essential while conducting a research study. The study should follow ethical guidelines at all times during the study. The author and sponsor should avoid duplicate publication i.e., publishing in more than one peer-reviewed journal.

Collaboration: A collaboration should be present between all the authors and contributors. The research study should reflect the collaborative efforts of all the people involved in the study. These may include statisticians, clinicians, professional medical writers, and researchers.

Roles and responsibilities: The sponsors should fix the roles and responsibilities of each contributor through a written agreement. The sponsor should define the role before the process of research writing starts. The agreement should include resolving any differences in data interpretation through scientific discussion.

Access: Data is important while writing the research paper. The sponsor should ensure that the author has access to complete and correct data. The agreement between the author and sponsor should disclose the publication process and role of the sponsor in reviewing the publication. Inform the author in advance about the assistance during the publication process. The sponsor or the research organization may remove confidential data related to the patient if required.

Responsibility and accountability: The authors should take responsibility and are accountable for the accuracy and presentation of data. The authors should be the sole authority to provide final approval for publication. The agreement between authors and sponsors should uphold the rights of authors in publishing accurate data without any hindrance from the sponsors.

Name of the contributors: The publication should contain the name of each author who contributes to the publication of the research paper. It is important to mention the level of contribution of each contributor, such as medical writer or statistician, to avoid any ambiguity.

Sponsor details: The publication clearly mentions the sponsor detail. The publication and presentation should also contain the role of the sponsor in funding, analysis, and execution of the research.

Conflict of interest: Disclosing the conflict of interest in the publication increases its authenticity. The authors and the contributors should clearly state if there is any conflict of interest. The publication should also mention the name of an individual or organization who has any vested interest in the findings of the research.

Trial registration: The registration of the trial with the appropriate authority adds value to the research study. It signifies that all the regulatory laws and ethics are followed while conducting the study. Some reputed journals do not publish the original research articles without trial registration.

Plagiarism: The authors should avoid any plagiarism. They should ensure that the publication is their original work. However, if there is any need to incorporate the copied material, the author should take due permission and properly acknowledge the original writer.

Hiring a professional medical writer: Professional medical writers are experts in writing the manuscript. The medical writers assist the authors in writing the medical manuscript completely, accurately, and on time. They are of great help in cases where the authors have limited knowledge about the presentation of data and other publication requirements.

Conclusion

The Good Publications Guidelines pose various requirements for both the authors and the sponsors. These requirements include complete and accurate data presentation, trial registration, responsibility and accountability of authors, acknowledgement of authors, and details of sponsors.

How to avoid Duplicate Publication
Categories Scientific Communication

Medical Journal Articles: How to avoid Duplicate Publication and Simultaneous Submission?

For an honest and scholarly scientific research, you must follow the ethics of research and good publication practices. All the reputed journals expect the authors to know and comply with the ethics in publication.

Here, in this post, we discuss the two common and unethical publishing practices – duplicate publication and simultaneous submission, and how to avoid them with your manuscript.

1) Duplicate Publication

What is it?

When you publish a new paper similar to a published paper by another author or yours without acknowledging the source and without getting the permission of the original author, it is called a duplicate publication. Even if you change the title or the abstract, the data and the results remain the same.

Why is duplicate publication a problem?

Duplicate publication is unethical because:

  1. It violates the copyright for the paper.
  2. Researchers who study the subject may count the same set of results twice, and thus distort the empirical evidence. Since empirical studies form the base of many health policies, it becomes a serious problem.
  3. Republication of your own work without attribution surmounts to “self-plagiarism”.
  4. It leads to the wastage of editorial and review resources.
  5. Republication of the same work unjustly takes up the limited journal space and denies other authors’ right to publish their work.

What do journals say about the issue? 

The editorial committees of the academic journals instruct the authors do not submit the papers or variations of papers already published elsewhere. They design stringent policies and ask the authors to send copies of older, related articles along with their submitted paper.

However, republication is allowed in some cases:

  • A follow-up on a published preliminary report (e.g., an abstract, poster, or conference presentation)
  • A paper with a list of the guidelines prepared by professional societies or governmental agencies
  • A paper that re-analyses or re-interprets the findings of the study for a different audience
  • A translation of the original paper
  • e-prints of the paper in repositories

Despite these exceptions, authors must adhere to the following guidelines:

  • Get permission from the copyright holders.
  • Get approval from the editor of the journal in which the paper was first published and the editor of the journal in which they will republish it.
  • Acknowledge the source of your republication by providing its full citation.

Dos and don’ts to avoid duplicate publication

  • Do not replicate content from any of your other published papers.
  • Do not offer preliminary reports about the published papers to any company without the permission of the journal.
  • When quoting data from your published work, include only a few sentences, and place the text in quotation marks and cite the source.
  • If you write more than one manuscript by using a single dataset, ensure:
    • Each manuscript addresses separate and important questions
    • You cross-reference the manuscripts
    • Inform the journal editors about this in a cover letter
  • While submitting your paper to the journal editor, provide copies of your published and related papers for complete transparency.

2) Simultaneous Submission

What is it?

The practice of submitting the same manuscript to two or more journals at the same time without informing the respective scientific journal editors is known as simultaneous or multiple or dual submission.

Why is simultaneous submission a problem?

The journals consider simultaneous submission as unethical because:

  1. If more than one journal publishes the paper, it can lead to a copyright dispute.
  2. Since two publication houses will carry out the same task, it is a waste of academic and scientific resources.

However, simultaneous submission is acceptable in following cases:

  • When the editors of the two or more journals agree to publish the paper simultaneously or jointly in the larger interest of the society.
  • When scientific conferences allow the authors to simultaneously submit their papers to other meetings with overlapping submission periods.

Dos and don’ts for the authors 

  • Do not submit the same manuscript to more than one journal.
  • If you wish to submit a paper that is “under consideration” at one journal to another journal:
    • Get a written consent from your co-authors.
    • Inform the first journal editor asking about the paper withdrawal.
    • Do not submit unless you get a formal notification from the first journal editor regarding the paper withdrawal.
    • Submit this notification to the second journal along with your paper.
  • If you have written two related papers and wish to submit them to two different journals:
    • Disclose the details of each paper to both the journals.
    • Inform both the editors that you have a similar paper under review at another journal (even if they are in different languages).
    • Enclose the copies of both the papers along with your submission.

Conclusion

Thus, duplicate publication and simultaneous submission are a serious offence and you can spoil your research career by indulging in such practices. We recommend you to contact our professional journal publication services experts to understand and follow ethical submission practices for the welfare of the society and your career.

5 Unethical Practices to Avoid While Publishing Your Research
Categories Scientific Communication

5 Unethical Practices to Avoid While Publishing Your Research

Performing a medical research and documenting the findings in a research paper are painstaking and time-consuming process. Nevertheless, the research authors must conform to the scientific ethics at each stage of performing a research and documenting its results.

‘Ethics’, derived from the Greek word ‘ethikos’ are a set of principles for right conduct in a particular field. They carry a greater significance in the field of medical research and publication as these are directly related to the suffering humanity.

In recent times, there has been a gradual neglect towards the ethical principles guiding a scientific research paper writing, and its publication. The misconduct in behavior may be intentional or may arise due to ignorance. Whatever be the cause of misconduct, the consequence is the same. And it not only affects other authors, reviewers, and editors, but also the common man. As a research author, it’s absolutely essential to abreast yourself with these ethical principles and avoid any scientific misconduct.

Here is a list of 5 common unethical practices you must avoid while publishing your research paper:

1.Duplicate Submission

Submission of your research paper or its publication in two or more identical journals with or without acknowledgement to another is called duplicate submission/publication.

Such a practice is done by authors to increase their number of publications. But, bear in mind! It’s unethical as it wastes the time of journal reviewers, publication resources, and renders no benefit to humanity or scientific community.

You can query multiple journals for submitting your research paper, but finally submit to one only!

2.Falsification/fabrication of research data

Falsification is the manipulation of the methods used in research or its key findings to produce a desired outcome. Fabrication is the false recording or recording of a fictitious data when none exists.

Such practices are more common in pharmaceutical industry where results are fabricated to promote a particular drug in the market, ignoring its side-effects. Not only unethical and wastage of limited research resources, such fabrications have negative effects on the physician’s clinical practice and creates mistrust amongst the consumers or general population.

3.Plagiarism

Plagiarism is the practice of using other’s work or ideas in your scientific writing without giving them due credit and passing them off as one’s own in publication journals to gain recognition. Even using your own text from other publications in the current writing without due reference is considered plagiarism, more specifically called self-plagiarism.

If you think you are smart and your plagiarised content will escape the eyes of the journal editors, you are highly mistaken. Detection of plagiarism has become easier with the advent of numerous plagiarism checking tools.

Sometimes plagiarism is not intentional, but happens accidentally. However, you can avoid it by providing references of all the sources you have used for writing your scientific content.

Always cite the author appropriately whose work you use in your research paper, even if they are from your past publications.

4.Authorship Conflict

As per the International Committee of Medical Journal Editor (ICMJE) guidelines, any person who contributes to the conception, designing or acquisition of research data, analysis of data, drafting or revision of the article, and its final approval before publication is entitled for the authorship of that paper.

Following unethical practices surmount to an authorship conflict:

  • Not including the name of the person who contributes to the research in any manner.
  • Failure to obtain consent from a person whose name is cited in the manuscript.
  • Adding an extra author or removing the name of an existing author before or after publication.
  • Citing a person as an author just on the basis of seniority, family or professional relationship when none of them contributed to the research or its writing.

The conflict can be prevented by deciding the authorship in the beginning of the research. That’s the reason why journals ask the authors to submit their checklist for the criteria of authorship.

5.Conflict of interest

Conflict of interest is a situation in which the author of the research study may be influenced by personal and/or financial considerations to affect the quality or the end result of the research.

If any such conflicts of interest arise, be they personal, financial or any other, they must be disclosed with complete honesty to the editorial team.

Though our publication support services experts guidelines and principles exist to prevent any misconduct in research and publication, ideally you shouldn’t require them. Self-restraint and welfare of the fellow members of the community must be the sole driving force for conducting an honest research and publication.