Authors

Human and Animal Rights

Research Involving Humans

All clinical research must adhere to the principles outlined in the Declaration of Helsinki. Manuscripts reporting data from studies involving human participants must obtain formal review and approval from a relevant institutional review board or ethics committee.

Patient Consent

Adherence to the guidelines established by the International Committee of Medical Journal Editors (ICMJE) http://www.icmje.org/recommendations/browse/roles-and-responsibilities/protection-of-research-participants.html is advised, in alignment with the patient’s consent for research or study participation. This adherence must comply with relevant laws and regulations governing the privacy and security of personal information, including but not limited to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), other applicable U.S. federal and state confidentiality laws, the General Data Protection Regulation (GDPR) (EU) 2016/679 and related national legislation, the Personal Information Protection and Electronic Documents Act of Canada, as well as the Information Technology Act of India and its associated Privacy Rules (collectively referred to as “Data Protection and Privacy Laws”).

Additionally, the author bears the responsibility to ensure that:

• The manuscript does not include patients’ names, initials, or hospital identification numbers in any section, including figures.
• Authors are required to secure consent-to-disclose forms from all identifiable patients featured in photographs, videos, or other materials that may be published in the journal, its derivative works, or on the journal’s website. Additionally, the manuscript must be shared with the identifiable patient for review prior to submission.
• The consent-to-disclose form must specify the intended use, including publication in both print and online medical literature, with the understanding that it will be accessible to both patients and the public. It must also bear the patient’s signature, or that of a legal guardian, accompanied by a declaration that the patient or guardian was given the opportunity to review the identifying materials and the manuscript.
• When a manuscript contains an individual’s data, such as personal information or audio-visual content, consent must be secured from the individual. For minors, consent must be obtained from a parent or legal guardian.
• A formal declaration of this approval, including a consent-to-disclose statement, must be included in the copyright letter and as a distinct paragraph at the end of the article. This is particularly crucial for human studies, where it is imperative to affirm that written informed consent has been obtained from each participant or their guardian. The original consent form should be maintained by the guarantor or corresponding author. Editors may, however, request these forms via fax or email if necessary.
• Proper consent must be acquired before publication in all such instances. Please consult the COPE guidelines available at https://publicationethics.org/resources/guidelines/journals%E2%80%99-best-practices-ensuring-consent-publishing-medical-case-reports

Editors may request authors to submit evidence of formal review and approval from the relevant institutional review board or ethics committee overseeing the study. Furthermore, the editors retain the authority to reject any manuscripts that fail to meet these specified requirements, with authors being fully responsible for any false declarations or non-compliance.

Non-identifiable Images

Images that do not directly or indirectly reveal an individual’s identity—such as X-rays, ultrasound scans, pathology slides, or laparoscopic images—do not necessitate formal consent.

However, if consent has not been obtained, masking the identity through techniques like eye bars or facial blurring will not be considered acceptable.

Animal Research Guidelines

Researchers conducting studies involving animals are required to confirm adherence to the guidelines set forth in the eighth edition of the “Guide for the Care and Use of Laboratory Animals” (https://grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals_prepub.pdf. published by the National Academy of Sciences, National Academies Press, Washington, D.C.).

Additionally, all animal studies should adhere to the NC3Rs ARRIVE Guidelines. For in vivo experiments, refer to the website https://www.nc3rs.org.uk/arrive-guidelines.

Authors must explicitly mention the approval committee’s name, confirming that both legal and ethical approvals were secured prior to commencing the research on animals. Furthermore, the experiments must be conducted in strict accordance with the applicable guidelines and regulations outlined below.

• Authors based in the United States must adhere to the US National Research Council’s “Guide for the Care and Use of Laboratory Animals”.
• Compliance with the US Public Health Service’s “Policy on Humane Care and Use of Laboratory Animals” and ” Guide for the Care and Use of Laboratory Animals” is also required.
• Authors in the United Kingdom must comply with the Animals (Scientific Procedures) Act 1986 Amendment Regulations (SI 2012/3039).
• Authors from European countries outside the UK must ensure conformity with Directive 2010/63/EU.
• All research involving animals must follow the ethical standards set by the International Council for Laboratory Animal Science (ICLAS).
• Manuscripts must explicitly declare compliance with applicable guidelines, (such as the revised Animals (Scientific Procedures) Act 1986 in the UK and Directive 2010/63/EU in Europe), as well as any necessary permissions or licenses in accordance with the IUCN Policy Statement on Research Involving Species at Risk of Extinction and the Convention on the Trade in Endangered Species of Wild Fauna and Flora.

Ethics Approval Exemption

In cases where a study is exempt from ethics approval, authors are required to provide a clear justification for the exemption within the ethical statement.

An example of an ethical statement is as follows:

“This research involving animal subjects received an exemption from ethics approval due to [specific reasons]. The exemption was reviewed and approved by [Full name of ethics committee], ensuring full compliance with established ethical guidelines.”

Client-Owned Animals

Animals owned by clients (including pets or livestock not intended for commercial use) must be studied in adherence to the highest standards of veterinary care. Authors are required to confirm that written consent has been obtained from the owner(s) or their legal representatives for the study’s purposes.

Example of an Ethical Statement regarding client-owned animals

“The animal study received evaluation and approval from [Full name of the ethics committee]. Written informed consent was obtained from the owners, guaranteeing ethical treatment and compliance with established guidelines.”

International Standards and the 3Rs Principle

Research involving animal subjects must conform to globally recognized standards and uphold the 3Rs principles—Replace, Reduce, and Refine.

• Replace: Substitute animals with alternative methods wherever feasible.
• Reduce: Minimize the number of animals used in experiments.
• Refine: Enhance experimental procedures to mitigate potential harm to animals.

Researchers are strongly encouraged to adhere to the ARRIVE guidelines (Animal Research: Reporting of In Vivo Experiments) when documenting studies involving live animals.

Below is an example of an ethical statement that aligns with international standards and the 3Rs Principle:

“This research complies with internationally recognized standards for animal experimentation, adhering to the 3Rs principle. The ARRIVE guidelines were utilized to ensure ethical and comprehensive reporting of experiments involving live animals.”

Euthanasia Protocols

The use of euthanasia methods such as chloral hydrate, ether, or chloroform overdose is strongly discouraged. Authors are required to provide a detailed account of all surgical, anaesthetic, or euthanasia procedures performed during the research.

If any experimental procedures deviate from established animal research standards, editors may request additional documentation, including approval forms and pertinent literature references.

Research Involving Plants

All experimental research involving plants, whether domesticated or wild, must comply with recognized international standards. The manuscript should contain a declaration affirming that field studies adhere to the relevant guidelines and/or that the required permits or licenses have been secured, in accordance with the ICN Policy Statement on Research Involving Species at Risk of Extinction and the Convention on the Trade in Endangered Species of Wild Fauna and Flora.

Hazard Study

Any potential risks related to the use of chemicals, procedures, or equipment involved in the research must be clearly outlined by the author in the manuscript. This should be done in both the materials and methods section and the declaration section. For further details, refer to The World Medical Association https://www.wma.net/what-we-do/public-health/chemicals.

The SAGER Guidelines (For Sex and Gender Equity in Research)

We are committed to advancing gender and sex equity in research by adhering to the Sex and Gender Equity in Research (SAGER) guidelines, which ensure the inclusivity and rigor of our work. All authors submitting research papers are mandated to comply with the Sex and Gender Equity in Research (SAGER) guidelines. These guidelines aim to foster the integration of sex and gender considerations in research, thereby enhancing the accuracy and relevance of our publications.

Additionally, the SAGER guidelines for reporting sex and gender information in methodology, study design, data analysis, results, and interpretation of findings are highly recommended. Authors of review articles are encouraged to address the methods used in selecting, locating, extracting, and synthesising data. Furthermore, systematic reviews must also adhere to these guidelines.

Research Conducted In Special Or Critical Situations

Precision Digital Publishers expects all contributors to uphold the principles of justice, benevolence, and autonomy in their research endeavours. We recognize that certain circumstances, such as medical emergencies or humanitarian crises, may present challenges distinct from those found in non-emergency settings. PDP recommends that research be conducted in a manner that does not harm human subjects or researchers, ensuring it maintains adequate scientific rigour within the constraints of the situation. Special care must be taken to address the challenges faced by individuals who may be victims of disasters or involved in medical emergencies, as these are vulnerable groups. Their privacy and dignity must be safeguarded at all times. Researchers should be vigilant in identifying and addressing any issues that may arise due to such circumstances. Research undertaken in emergency contexts should prioritise the well-being of survivors and aim to minimise the risk of further harm. The fundamental requirements for research in emergency situations include the preservation of life, well-being, and security, as well as the protection of subjects’ rights to privacy and confidentiality.

Unethical Conduct

Any individual may report instances of unethical conduct or misconduct to the editor or publisher, provided there is sufficient evidence. Upon receiving such a report, the editor, in collaboration with the publisher, is obligated to initiate a thorough investigation, ensure an impartial resolution, and uphold strict confidentiality throughout the process. The author must be granted the opportunity to respond to all allegations, whether minor or significant.

In cases of severe violations, the editor or publisher, after thoroughly reviewing all relevant evidence or consulting experts in the field when necessary, may inform the author as deemed appropriate.

Conclusion

• Authors and reviewers must be promptly notified in cases of any misinterpretation or mishandling of established International Standards.
• A formal warning should be issued to both the author and reviewer to prevent future instances of unethical conduct.
• An editorial addressing the reported misconduct should be published, or an official notice of the unethical behaviour should be posted on the website.
• Official correspondence regarding the misconduct should be sent to the relevant department heads, funding agencies of the implicated author, the reviewer, and abstracting and indexing agencies.
• If necessary, the retraction or withdrawal of the publication should be coordinated with the author’s or reviewer’s department head, and all pertinent higher authorities should be informed.
• The publisher may enforce a temporary restriction on the author’s ability to submit future publications to the journal.

Consent for Publication

When a manuscript includes personal data, such as identifiable information, audio-visual content, or similar materials, consent must be obtained from the individual involved. For children, this consent must be secured from a parent or legal guardian.

A formal declaration of this approval, including a consent-to-disclose statement, must be clearly indicated in the copyright letter and included as a separate paragraph at the article’s conclusion. This is particularly essential in studies involving human subjects, where obtaining written informed consent from each participant or their guardian is mandatory. The guarantor or corresponding author must retain the original consent form, and editors may request copies via fax or email when necessary.

Randomised Drug Clinical Trial Studies

Randomised drug clinical trials are health-focused or biomedical research studies, conducted in phases, involving human participants who are randomly assigned to receive or not receive a preventive, therapeutic, or diagnostic intervention according to a pre-established protocol. The primary objective of these studies is to assess the safety and effectiveness of methods used in disease diagnosis, prevention and treatment.

Authors conducting randomised controlled trials are encouraged to submit their trial protocols alongside their manuscripts. All clinical trials must be registered in a suitable public trial registry prior to enrolling the first participant. The registry must be independent of any commercial interests (e.g., www.clinicaltrials.gov)  If an editor is required to review an unregistered trial, a concise explanation for the lack of registration must be provided.

• All randomized clinical trials are required to include a flow diagram, accompanied by a completed checklist in adherence to the CONSORT guidelines (refer to the CONSORT Flow Diagram and Checklist at consort-statement.org) and the trial protocol. Additional information can be found in the comprehensive guidelines available at: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html.
• Studies evaluating diagnostic accuracy must be presented in accordance with the STARD guidelines (stard-statement.org).
• Observational studies, whether cohort, case-control, or cross-sectional, must follow the STROBE guidelines and should be submitted with their respective protocols (strobe-statement.org).
• Genetic association studies must be reported in compliance with the STREGA guidelines (equator-network.org/reporting-guidelines/strobe-strega/).
• Systematic reviews and meta-analyses are to be reported following the PRISMA guidelines (prisma-statement.org).
• For access to all relevant reporting guidelines, please visit equator-network.org.

The following key considerations must be observed when submitting clinical trial manuscripts

• Each manuscript must explicitly present a clear objective or hypothesis, the study design and methodology (including the setting, duration, participants with inclusion and exclusion criteria, or data sources, and their selection process), the key aspects of any interventions, primary outcome measures, main findings, a discussion contextualizing the results with existing literature while addressing limitations, and the conclusions. All data presented must be original.
• The trial registry name, registration identification number, and registry URL must be provided both at the end of the abstract and in the designated section of the online submission form. For controlled healthcare intervention studies, the trial registry and unique identifying number must be listed, ensuring no spaces between letters and numbers. Studies focused on other objectives, such as pharmacokinetics or toxicity (e.g., phase 1 trials), are exempt from this requirement.
• All reports on randomized trials must contain a section within the methods labelled “Randomization and Masking.”
• The manuscript must include a declaration identifying the institutional and/or licensing committee that approved the experiments, along with relevant details.
• The SI unit system and the Recommended International Non-Proprietary Name (rINN) for drugs must be used. Additionally, the dosage, route, and frequency of drug administration must be accurately detailed.
• Clinical trials sponsored by pharmaceutical companies must adhere to good publication practice guidelines: (https://www.ismpp.org/about-us).

Editors reserve the right to reject manuscripts that fail to meet these requirements. Furthermore, the author assumes full responsibility for any inaccuracies or failure to comply with these stipulations.