Journal requirements may vary regarding whether appropriate institutional review board (IRB) approval and patient consent need to be mentioned in the article text or in a separate section—in the submission cover letter, for example. But it’s still important that the authors include this information in the actual text of the article so that readers know that such ethical standards were followed.
Reporting the institutional review board approval and patient consent for study participation and for publication of data is important. It ensures that the highest scientific and ethical standards are maintained, thereby protecting research participants during the course of medical research.
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The right to privacy, including confidentiality of health information, is protected by many international and regional laws and policies. In the field of medical communication, it is the researchers’ obligation to maintain and protect patient confidentiality.
It is therefore important to take care to remove or mask patient identifiers, such as:
- Identifying numbers from laboratory reports
- Other evaluations being reported
It is also important to ensure that a patient may not be recognized in photographs and images. In many cases patients can be easily identified in photographs even if their eyes are masked. For this reason, as stated by the International Committee of Medical Journal Editors (ICMJE), authors should inform patients if any potentially identifiable piece of information might become available with the publication. Patients should consent to the inclusion of this information before a manuscript is submitted.
Less obvious personal identifiers should also be avoided. For example, an unusual case occurring in a small community can be easily identified by readers if a detailed description is given. The details of a patient admitted to a hospital for treatment of an uncommon condition on a specific date may also make them easy to identify. Personal patient data should be limited by not reporting unnecessary details or any information that is not relevant to the specific assignment, case report, or case series.
To help protect confidentiality, a number of simple measures can be done while photographing patients:
- Ask patients to remove jewelry that may be recognizable
- Ask patients with long hair to pull their hair back and out of sight
- Avoid inclusion of birthmarks or tattoos if possible
CONSORT and STROBE
The CONSORT (CONsolidated Standards of Reporting Trials) 2010 guideline is aimed at improving the reporting of parallel-group, randomized controlled trials (RCTs). This guideline helps readers to understand the trial’s design, conduct, analysis and interpretation, and to assess the validity of the results. The CONSORT checklist includes 25 items to be applied when conducting and reporting on RCTs. CONSORT also includes a useful flow diagram that can be adapted to illustrate the passage of participants through your trial.
The STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) statement was created by an international, collaborative initiative of epidemiologists, methodologists, statisticians, researchers and journal editors involved in the conduct and dissemination of observational studies. It is aimed at improving the reporting of observational studies. The STROBE checklist has 22 items to be considered for inclusion in reports of observational studies.
PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), formerly the QUOROM Statement, is an evidence-based set of items aimed at improving the conduct and reporting of systematic reviews and meta-analyses, particularly of RCTs. PRISMA can also be used as a basis for reporting systematic reviews of other types of research, particularly evaluations of interventions and for critical appraisal of published systematic reviews.
The PRISMA checklist consists of 27 items that should be included when reporting systematic reviews and meta-analyses. PRISMA also includes a four-phase flow diagram to explain the inclusion and exclusion of studies based on study eligibility criteria. Similarly, the Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group developed the MOOSE guidelines and checklist to include everything necessary for the reporting of meta-analyses of observational studies.
The EQUATOR website is a good resource to help you find the right reporting guidelines for your study: http://www.equator-network.org/
A number or organizations have been established to ensure that ethical guidelines are developed and being followed in research and academic publishing. Being familiar with these organizations can help authors better understand these ethical expectations. These organizations also provide a variety of useful information on their websites to assist authors in publishing their studies.
The International Committee of Medical Journal Editors (ICMJE) is a small, self-funded group of medical journal editors that developed the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals, formerly known as the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, first published in 1978.
This set of recommendations is intended mainly for use by authors who wish to submit manuscripts for publication in ICMJE journals. The recommendations include a comprehensive review of the best publication practices and ethical standards to help authors produce accurate, scientifically sound, well-balanced, reproducible, and clear journal articles.
Many journals advocate the implementation of these recommendations and include them as part of their instructions for authors.
The Committee on Publication Ethics (COPE), established in 1997, is formed by over 12,000 editors of academic journals and other individuals interested in publication ethics. Most reputable journals are COPE members. All COPE members are expected to follow the Code of Conduct for Journal Editors and Publishers.
In addition to providing editors and publishers with advice on all aspects of publication ethics, COPE specializes in providing advice related to research and publication misconduct.
COPE also provides its members with a number of resources, such as the COPE Forum where they can discuss any particular cases, the Code of Conduct and Best Practice Guidelines for Journal Editors and Publishers, e-learning courses, grants and funding for research, annual seminars, and ethical audit tools.
To detect and avoid cases of intentional publication misconduct, CrossCheck was created by the publisher association CrossRef. CrossCheck provides a service allowing editors, publishers, and researchers to screen submitted content for plagiarism before publication.
iThenticate is the plagiarism detection software that serves as the tool for CrossCheck services. This tool can be used by authors, researchers, and students to ensure or demonstrate that their work is free of infringement and to make sure that all the sources of the content have been appropriately and sufficiently cited.
For institutional purposes, a license has to be bought to use CrossCheck and iThenticate. For individual use, the user must create a free account and then purchase “credits” to be able to submit a file for review. The software supports the use of several different kinds of files, including Microsoft Word, Word XML, PostScript, PDF, HTML, RTF, OpenOffice (ODT) and plain text. However, there are limits in terms of file size and number of pages: < 400 pages, < 40 MB, or 2 MB of raw text.
A related service, Turnitin, that checks for text similarity is available for universities.
GPP 2022 (Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 Update) is an update of the original GPP published in 2003 and the last revision GPP3 (in 2015). These guidelines are aimed at encouraging pharmaceutical companies to publish sponsored clinical trials responsibly and ethically.
GPP 2022 is targeted at authors and investigators participating in research funded by pharmaceutical, biotechnology, and medical device companies, and also involves professional medical writers who help produce publications for peer-reviewed medical journals and scientific meetings.
GPP 2022 gives comprehensive guidance on many key issues, including:
- defining the roles of authors, sponsors, and other contributors
- assigning lead authors and guarantors
- establishing a publication steering committee
- describing sponsor roles
- the role of professional medical writers
- reimbursement and honoraria
- specific types of articles and presentations
- publication planning and documentation
- using checklists for articles and presentations
The 2022 update expands to include discussion of:
- the role of patients in publications
- policies and procedures
- using social media, documentation, and enhanced content, including plain language summaries (PLS)
Declaration of Helsinki
The World Medical Association issued the Declaration of Helsinki in 1964 to establish international regulations for medical research involving human experimentation. The original version was subsequently amended seven times, and the current version was published in 2013.
The Declaration of Helsinki includes 37 principles that regulate all aspects of research conduct. Two of the main considerations are that all participants in trials should understand the risks, benefits, and alternatives of the experiment; and, following this, that all patients should enroll in the trial under their own free will, by giving informed consent. A third party unconnected with the trial—such as an ethics committee or institutional review board—should have approved the experimental protocol after checking its design.
The Declaration of Helsinki principle B-15 emphasizes that a research study should be submitted for consideration, comment, guidance, and approval of an ethics committee.
The Declaration of Helsinki principle B-30 mentions that the author is responsible for the completeness and accuracy of reports of their research. The guidelines also mention that studies not conducted in accordance with the Declaration of Helsinki should not be accepted for publication.