Ethical principles and best practice guidelines

Horizonte Médico (Lima) journal, a quarterly publication edited by the School of Human Medicine of Universidad de San Martín de Porres (USMP), aims at disseminating original works and professional experiences developed in biomedical and public health areas, both nationally and internationally, and promoting research in the different fields of human medicine.

In order to accomplish this objective, the journal is published within the framework of best practice guidelines on publishing ethics, meets current ethical standards for scientific research and publications, either during the review process or afterwards (World Medical Association [WMA] Declaration of Helsinki 2013, World Health Organization [WHO], Council for International Organization of Medical Sciences [CIOMS], American College of Epidemiology [ACE] Ethics Guidelines, Health Research Ethics Authority [HREA, Canada]), and follows the Committee on Publication Ethics (COPE) guidelines (www.publicationethics.org).

Each manuscript sent to Horizonte Médico (Lima) journal should comply with the following requirements:

Cover letter signed by the lead author.
Affidavit signed by all authors, acknowledging that the intellectual property is owned by the authors of the manuscript, which has not been either published or submitted for evaluation in another journal.
Document indicating the role of each of the manuscript authors and/or co-authors.
The manuscript submitted for review should be original and un
Consent form in which all copyrights are transferred to Horizonte Médico (Lima) journal once the manuscript has been accepted for publication.
Document indicating the funding sources of the research work.
Document indicating if there is any conflict of interest in the submitted manuscript.
Authors should read Horizonte Médico (Lima) journal’s ethical principles and complete the Ethical Principles Form for Authors.

ETHICAL PRINCIPLES

According to the National Research Council of the National Academies of Sciences, Engineering and Medicine, good publication practices are as follows:

Intellectual honesty in proposing, performing and reporting research findings.
Accuracy in representing authors’ contributions to research proposals and/or findings.
Fairness in scientific manuscripts review (peer review process).

1. Institutional authorization

The following requires the approval from an institutional ethics committee: 1) Research involving human subjects. 2) Research directly involving human biological materials or potentially identifiable personal data, such as biobank samples or medical records.

The following does not require the approval from an institutional ethics committee: 1) Research using public domain secondary databases, including systematic reviews, meta-analyses and bibliometric studies. 2) Interventions in public health surveillance. 3) Research on outbreaks or health emergencies. 4) Assessments of public health programs.

If you have any questions and/or disputes, they will be assessed and solved by the Horizonte Médico (Lima) journal’s Editorial Board, as set forth herein.

2. Informed consent

Researchers should have, when necessary, the informed consent signed by the research subjects. Authors should provide such document whenever required by the Horizonte Médico (Lima) journal’s Editorial Board.

The informed consent form should be signed in a free, clear, spontaneous, voluntary and conscious manner, once the physician has informed the patient the nature of the research, along with its risks and benefits.

In the event that a research subject is unable to sign the informed consent form, the researcher should obtain the informed consent from a duly authorized representative.

The researcher should provide research subjects with the following information in a language clear enough and understandable to them in order to request their consent:

Research type, objectives and methods.
Expected research duration.
Any possible benefits that may be expected from the research.
Expected risks or discomforts that could occur as a result of the research.
Confidentiality of their personal information.
Researcher responsibility in terms of providing medical care to patients.
Availability of a compensation to research subjects, their family members or dependents in the event of death or disability as a result of the research.
Right to decline participation in and to withdraw from the research at any time after it has begun.

The researcher is obliged to:

Communicate the potential research subject all the necessary information about the research, without withholding information.
Provide research subjects with the opportunity to ask questions.
Update each research subject’s informed consent if important changes occur in the research conditions or procedures.

Informed consent for research studies may be inadvisable or unnecessary in some types of epidemiological research—i.e., when only anonymous questionnaires, field observations or archival research that would not place research subjects in risk are used. It may also be unnecessary when the ethics review committee determines that it is acceptable to conduct a research without an informed consent and if actions taken by the researcher are adequate to protect research subjects’ safety and respect their private life.

3. Incentives for participation in research studies

Researchers should make all appropriate efforts to avoid offering excessive or inadequate incentives. Nevertheless, research subjects may be paid for any discomfort or time spent due to their participation in research activities; especially, they may receive a reimbursement for the expenses they may have incurred in relation to such participation. Researchers should explain the nature of the services, as well as the risks, limitations and obligations. Research subjects may also receive free medical services. All payments, reimbursements and medical services provided to research subjects should be approved by an ethics committee.

4. Deception in research

- The use of deceptive methods is not allowed since it will deliberately mislead research subjects.
- It is not acceptable to deceive research subjects since it can involve more than a minimal risk of harm to them.
- A research subject who disapproves of having been deceived should be generally offered the opportunity to refuse to allow the researcher to use information thus obtained.

5. Termination of a research

Upon completion of the study, the researcher should provide research subjects the findings and conclusions of the study, taking into account the necessary actions to avoid misunderstandings.

6. Ethical principles in scientific manuscripts

Human rights, privacy and confidentiality: When an manuscript is accepted for publication, authors should state that they protect the rights, privacy and confidentiality of personal information of research subjects according to the Declaration of Helsinki, the US Federal Policy for the Protection of Human Subjects and the European Medicines Agency (EMA) Guidelines for Good Clinical Practice (GCP).
Culture and heritage: Manuscripts approved for publication should not include images of objects that have cultural meaning or are part of the national heritage.
Clinical trial registration: In accordance with the standards of the World Health Organization and the Declaration of Helsinki, every clinical trial should be registered.
Animals in research: Experiments with animals are basically conducted in three areas: teaching, industry and research. Using animals in research is a privilege that should be carefully kept in order to ensure the relief of sickness and pain in humans (and animals); ignoring their suffering would be irresponsible and unethical.

Every researcher who uses laboratory animals in his/her work should keep in mind the following premise: respect for life, and minimization of distress, pain and suffering that animals may undergo during the conduction of the studies.

Animal research should consider the respect for the 4 Rs:

Replacement, which refers to look for, to the extent possible, alternative methods to replace the use of animals.
Reduction, which refers to try to minimize the number of animals used in research.
Refinement, which refers to set means that seek the comprehensive welfare of animals. It essentially involves the compliance with international regulations and standards regarding management, genetics and microbiology of animals used in research (defined animals), and the optimization of the environment where they are raised and housed during the experimental procedures.
Recycling, which refers to use experimental animals more than once for other purposes.

Authors should provide information about the study design, statistical analysis, experimental procedures, number of experimental animals used, steps taken in animal experiments, characteristics of animals housing, health status of animals and mating techniques. Additionally, researchers should comply with the best practices on anesthesia, analgesia and euthanasia, taking into account that laboratory animals are living beings and, therefore, sensitive to any procedure that may cause pain in humans. Professional and technical staffs who are in contact with animals also receive the respective training.

Ethical and legal approval from the institution supporting the research should be included in the work. Authors should state if the experiments were conducted according to international and national ethical standards and regulations.

Biosecurity: Group of standards aimed to achieve attitudes and behaviors to reduce the risk of getting accidental infections, and designed to protect humans, the community and the environment from the accidental contact with potentially harmful agents such as pathogens, biological and chemical agents, and radioactive elements.

Authors should indicate if the study is considered dual-use research. If this is the case, it should comply with the guidelines for Dual-Use Life Sciences Research recommended by the National Science Advisory Board for Biosecurity (NSABB) in 2004.

Reporting format: The manuscript wording should follow the last edition of APA Style.

7. Research findings report

In this section, researchers describe their findings by means of tables, charts, graphics, drawings, diagrams or maps.
Researchers should not invent information.
Researchers should not alter numerical information.
If mistakes are found, they should be publicly corrected.

8. Research integrity

Misconduct: Misconduct causes problems to research and may be classified into three categories: conceptual, empirical and normative or regulatory. Scientific misconduct includes actions or omissions related to conceiving, organizing, conducting, evaluating or requesting research projects that, deliberately or inadvertently, distort research findings, provide misleading information about personal contribution or violate other standards of researchers’ professional work.

Misconduct involves data fabrication or falsification, citation manipulation, plagiarism and self-plagiarism in designing, conducting or reviewing research, or in reporting research findings.

If the journal’s Editorial Board suspects misconduct, it will request an investigation to the institution supporting the research or set up a commission for such purposes.

Allegations of irregularities: Research irregularities noticed and reported by identified people or anonymously, only if accompanied by the necessary pertinent evidence, will be investigated.
Fabrication, falsification and manipulation of images: Modern scientific manuscripts should publish findings through an ideal mixture of texts, charts, graphics and images for an easy cognitive extraction of information.

Inappropriate image manipulation creates misleading findings. Researchers should notify when they edit images. Likewise, they should comply with the following guidelines:

Specific features should not be altered.
Original unprocessed images should also be submitted when the image to be published has been modified.
Adjustments to brightness or contrast are only acceptable if they apply equally across the entire image and do not misrepresent the information originally captured.
Excessive editing to highlight the size of an image is inappropriate.
Nonlinear adjustments or deleting portions of a recording should be disclosed in a figure legend.
Plagiarism: It is the total or partial copy of an experiment, data or numerical information, images or tables. It includes using tables, data or even the conclusions of a work without giving credit to the author(s). It is the publishing of images, figures and tables without having an authorized reference.
Duplicate and redundant publication: Researchers should not publish, as original data, data that have been previously published. Authors may not submit a manuscript simultaneously to more than one journal. If the Editorial Board notices this situation, the manuscript will not be considered for publication. Moreover, already published manuscripts’ translations should not be published as original articles.
Sanctions: If an infringement is demonstrated in a publication, a retraction will be issued and Horizonte Médico (Lima) journal will deny taking into account future works of the author(s) involved.

9. Editorial standards and processes

Authorship: As a general rule, all authors should participate in, at least, two of the four phases of the project: planning, data collection, findings interpretation and manuscript preparation. All authors of a scientific manuscript should significantly contribute to the development of the research.

All authors of a manuscript should sign an authorization form, indicating their degree of participation in the study.

Authorship disputes: If the Editorial Board suspects authorship problems, it should contact the pertinent author to request further information.
Funding: Funding sources should be mentioned and listed in the Acknowledgments section. If there is no specific funding source, this should be expressly stated.
Peer review: Manuscripts are initially evaluated according to Horizonte Médico (Lima) journal’s guidelines, which aim to ensure the quality and integrity of the manuscripts submitted for publication. Then, they are assessed by two or more peer reviewers who are chosen based on their experience on the topic. Peer reviewers’ participation is always anonymous and ad honorem. Original articles, brief communications, review articles, case reports and opinion articles are assessed by peer reviewers. The editorial, history, biosketch and letter to the editor are only evaluated by the Editorial Board, unless the evaluation of an external reviewer is required.
Timing of publication: The average time of the editorial process, from the reception of the manuscript to the final decision of the Horizonte Médico (Lima) journal’s Editorial Board, varies from two to four months.
Editors and journal staff as authors: Editors and members of the Editorial Board and Advisory Committee should not be involved in any decisions about their own staff’s manuscripts submitted to Horizonte Médico (Lima)
Conflicts of interest: Editors, authors and peer reviewers should disclose any conflict of interest that might affect their ability to present or review manuscripts objectively. These include financial, personal, political or religious interests.
Libel and defamation: The Editorial Board should review manuscripts and peer review reports to identify statements that may be considered defamatory and so avoid future legal actions.
Editorial independence: Universidad de San Martín de Porres University Press is in charge of publishing Horizonte Médico (Lima) However, it does not mean that this publishing house may influence in some way on editorial decisions.
Corrections: Readers and authors should notify Horizonte Médico (Lima) journal through the letter to the editor if they find errors that could affect the interpretation of the findings presented in a manuscript. The journal should publish the corrections and, when important errors that could invalidate the work are found, it should consider publishing a retraction statement.
Retractions and expressions of concern: Retractions should be published when reported errors could affect the interpretation of data or information, if work is proven to be fraudulent, when presenting fictitious data or the study is not reproducible, or in other cases of serious ethical misconduct. Expressions of concern may be issued if editors have well-founded concerns or suspicions that readers should be made aware of.
Withdrawal of manuscripts: The removal, deletion or obscuring of an manuscript should only be authorized in the event of legal infringements, defamation or other legal limitations, as well as false or inaccurate data. In such circumstances, a withdrawal statement will be published.

10. Copyright and intellectual property

Authors should transfer their copyright to Horizonte Médico (Lima) journal by signing a copyright transfer agreement once the manuscript is accepted for publication.

Notwithstanding the foregoing, all manuscripts accepted and published in the journal are distributed free of charge under the terms of a Creative Commons license – Attribution 4.0 International (CC BY 4.0).

11. Data socialization for verification

Researchers may share their databases with other researchers from the same field or topic who may verify the findings after the publication. Data should maintain the confidentiality of the research subjects. Authorship legal rights should always be protected.

12. Peer reviewers

Manuscripts are initially evaluated according to Horizonte Médico (Lima) journal’s guidelines, which aim to ensure the quality and integrity of the manuscripts submitted for publication. Then, they are assessed by two or more peer reviewers who are chosen based on their experience on the topic. Peer reviewers’ participation is always anonymous and ad honorem.

Original articles, brief communications, review articles, case reports and opinion articles are assessed by peer reviewers. The editorial, history, biosketch and letter to the editor are only evaluated by the Editorial Board, unless the evaluation of an external reviewer is required.

Peer reviewers’ grading may be as follows: a) The manuscript is recommended to be published with no modifications. b) The manuscript should be published after the implementation of some corrections and improvements. c) The manuscript is rejected for the moment, but it is recommended to make corrections and submit a new version. d) The manuscript is rejected with observations not subject to validation.

Based on the peer reviewers’ observations, the Editorial Board will decide if the manuscript is to be published or rejected, or if it will send recommendations to the authors.

MALPRACTICE STATEMENT

1. Anti-plagiarism policy

Plagiarism, data fabrication or manipulation are serious breaches of academic ethics and publication ethics statement set forth by the journal. Each submitted manuscript is subjected to similarity verification through the Turnitin platform (not exceeding 15% per institutional policy) to identify potential plagiarism.

Authors bear the responsibility of ensuring their data have not been plagiarized, fabricated, distorted or manipulated. Furthermore, the study should include adequate data so that other researchers can replicate the research, facilitating confirmation or refutation of the presented results. In the case of using information or data from other persons or institutions, authors should provide appropriate acknowledgements according to Author Guidelines.

2. Claims policy

Horizonte Médico (Lima) journal bases its manuscript acceptance or rejection decisions on the judgment of the Editorial Board and peer review. However, the journal acknowledges that circumstances may arise where authors or contributors wish to raise complaints or grievances about the process.

If an author wishes to request a re-evaluation of a rejected manuscript or withdraw a manuscript during the editorial process, they should send an email to horizonte_medico@usmp.pe containing the following information:

The name and affiliation of the corresponding author.
A detailed description of the complaint, grievance or reason for reevaluation/withdrawal.
Any evidence or documentation supporting the complaint or grievance.

The director, editor or a designated member of the editorial team will review the complaint or grievance and strive to resolve it in a timely manner, always upholding the principles of transparency, integrity and good practice in scholarly publishing.

The journal is committed to ensuring fairness, respect and integrity in all its editorial procedures, and will take the necessary steps to rectify any situation identified as a violation of these policies.

3. Advertising policy

Currently, the journal does not feature any third-party advertising in its published issues, whether in physical or electronic format, or on its website. However, the eventual inclusion of advertising does not grant advertisers any influence over decisions related to website contents, manuscript publication or the Editorial Board of the journal.

4. Authors’ responsibilities

Manuscripts submitted for potential publication should result from original primary or secondary research. Moreover, manuscripts should not have been previously published. Therefore, authors should ensure that no significant portion of the article has been previously published either as an article, book chapter or any other publication, or is currently considered for publication elsewhere. An exception applies to manuscripts whose authors declare the use of self-archiving (see V. ADOPTION OF OPEN SCIENCE in Author Guidelines). Additionally, authors are responsible for adhering to the following principles:

Manuscript submission guidelines: Authors should submit accurate research results, providing sufficient detail and references to allow replication. Review articles should be accurate and comprehensive, while opinion articles should be clearly identified as such. Fraudulent or inaccurate statements are unacceptable.
Data access and retention: Authors may be required to provide raw data from their study and should be willing to make them publicly accessible, ensuring their availability for at least five (5) years after publication. This is provided that the confidentiality of subjects can be protected and legal rights regarding data ownership do not prevent disclosure.
Confidentiality: Authors should adhere to their institutions’ protocols for accessing data from medical records or other documents containing personal information when necessary for research purposes. They should declare their compliance with these protocols.
Privacy: Authors should protect the identity of the participants, avoiding the use of any information that could identify them, unless essential for scientific objectives and accompanied by a written informed consent from the participant or, if applicable, their parent or legal guardian. This consent should authorize publication, reproduction and dissemination of the information in the journal’s digital platform and submission to the editors.
Originality and plagiarism: Authors should submit fully original work and properly cite any material from other authors. The journal uses a plagiarism detection software, and plagiarism is strictly prohibited. In case the submitted manuscript derives from an academic research paper, thesis or other academic document, authors should provide a link to the repository publication of such academic work, if available.
Acknowledgement of sources: Authors should properly cite the work of others and indicate if the manuscript is derived from another scholarly work. They should not use privately obtained information without explicit permission from the source unless they have obtained explicit written permission from the authors of the involved work.
Permissions: Authors should obtain permissions from authors or institutions to reproduce material from other publications, as well as permissions to publish from the institution that funded the research.
Multiple, duplicate, redundant or concurrent submission or publication: Authors should ensure that their manuscript is original and not previously published in or submitted to another journal. Publication in more than one journal is acceptable only in very specific cases and under certain conditions. The Editorial Board conducts inquiries into possible scientific misconduct using plagiarism detection software, systematic search of publications or other necessary methods.
Manuscript authorship: Only individuals who have substantially contributed to the research, agree to be authors and can assume public responsibility for the content should be listed as authors. The International Committee of Medical Journal Editors (ICMJE) outlines four requirements for authorship. The CRediT taxonomy will be considered for individual author contributions to the article, i.e., conceptualization, data curation, formal analysis, funding acquisition, investigation, methodology, project administration, resources, software, supervision, validation, visualization, writing – original draft, and writing – review & editing.
Declaration of conflicts of interest: Authors should promptly disclose any potential conflict of interest that could influence the outcome or interpretation of the work, whether financial (fees, grants, stocks, paid testimonials, among others) or non-financial (personal or professional relationships, affiliations, beliefs related to the manuscript subject).
Funding: Authors should fully disclose all sources of financial support for the work, including grant numbers or other reference numbers, if applicable, whether monetary or non-monetary. In cases where no external funding is received, authors should state that the research is “self-funded.”
Human research ethics: All research involving human subjects should adhere to the ethical principles outlined by the World Medical Association and the Declaration of Helsinki. Authors should specify whether their research received approval from a research ethics committee (required for research involving human subjects), describe the procedures for ensuring participant privacy rights, and indicate the use of informed consent where applicable. Additionally, any use of images should protect the anonymity of individuals.
Animal research ethics: Research involving animals should comply with relevant guidelines and regulations and obtain approval by the appropriate ethics committee. Authors should adhere to the principles of replacement (using alternative methods to minimize animal involvement), reduction (methods for limiting the number of animals used) and refinement (methods for improving animal welfare). Manuscripts should include details on animal characteristics and handling, experimental protocols, efforts to minimize or avoid any pain or suffering, and compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals.
Ethics in research involving plants or other natural resources: Studies involving plants or any other natural resource do not require approval by an ethics committee unless sensitive natural resources are involved. Authors should indicate in the manuscript whether the plants used have been deposited in a herbarium or public collection that allows access to the deposited material, along with the information about the specimen and the identifier.
Institutional Research Ethics Committee (IREC) approval: IREC approval is a crucial component to ensure that research is conducted with the utmost respect for the study subjects and society in general.
Informed consent and assent: Authors should obtain and document informed consent from participants when necessary. For the publication of photographs or data, it is essential to ensure that they do not allow identification of the subject. Written informed consent should be obtained from the patient (or legal guardian) authorizing publication and dissemination on the journal’s digital platform. Institutional approval is required for the publication of case reports from the institution where the patient was treated.
Significant errors in published work: Authors who identify significant errors in their published work should inform the editors to correct or retract the article. If the editors discover an error, authors should correct it, retract the article or submit evidence of the correction.
Generative AI use statement: The journal requires authors to report any use of AI-assisted technologies in generating any part of the manuscript, either in the cover letter accompanying the manuscript submission or in citations and referenced sources. Moreover, authors should be prepared to provide additional information as required by the Editorial Board regarding the nature of their use. However, AI-assisted technologies should not be named as authors of articles, as they do not meet several criteria required by the ICMJE for authorship.

5. Editorial board’s responsibilities
The director, editor or members of the Editorial Board are entrusted with the responsibility of determining which manuscripts will be published, solely based on the quality of the work and without consideration of the authors’ personal characteristics, such as religion, race, nationality, gender, sexual orientation or political convictions. Therefore, the responsibilities to be upheld are:

Being impartial in managing submitted manuscripts for publication and respecting the authors’ intellectual independence. In cases of a negative evaluation, the Editorial Board will acknowledge the authors’ right of reply.
Maintaining confidentiality regarding received manuscripts and their content until publication.
Refraining from using data or arguments from unpublished papers for their own research until publication. Once the manuscript is published, proper citation of this data in other research is required.
Making publication decisions independent of commercial or financial considerations.
Withdrawing from the editorial decision in cases of conflicts of interest between themselves and the manuscript.

6. Reviewers’ responsibilities
Reviewers selected to evaluate and/or provide opinions on manuscripts should adhere to the following principles:

Purpose of the review: This review process plays a crucial role in editorial decision-making and may contribute to enhancing manuscripts through editor-mediated communication with authors.
Promptness: Any potential reviewer who feels unqualified to conduct a thorough review or anticipates being unable to provide a timely feedback should promptly inform the editors and decline the invitation. This allows other potential reviewers to be contacted.
Confidentiality: Maintaining confidentiality is of utmost importance. Manuscripts received for review should not be shared or discussed with third parties unless authorized by the editor-in-chief, and this should only occur in exceptional and specific circumstances. The same confidentiality applies to reviewers who decline the review invitation.
Objectivity: Reviews should be conducted objectively and constructively, providing clear arguments to help authors improve their manuscripts. Personal criticism of authors is inappropriate.
Acknowledgment of sources: Reviewers should identify and report any relevant studies not cited in the manuscript under review or any statements requiring a citation. They should also report any substantial similarity or overlap with other published or unpublished works they are aware of.
Disclosure and conflicts of interest: Reviewers should declare any conflicts of interest to the editors and decline the invitation to review if necessary. They should not use unpublished material, ideas or information from the manuscript in their own research without the explicit consent of the authors. This applies even to reviewers who decline the review invitation.

References

APA. APA Style 2016. 6^th edition.

COPE. Code of Conduction for Journal Publishers. Website viewed on October 5, 2016. Available on http://publicationethics.org/resources/code-conduct.

Ehringhaus S, Korn D. Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials. Association of American Medical Colleges. January 2006.

Miller S, Selgelid MJ. Ethical and philosophical consideration of the dual-use dilemma in the biological sciences. Sci Eng Ethics. 2007;13:523–80. doi: 10.1007/s11948-007-9043-4.

Montenegro S, Gayol M, Tarrés M. Aspectos éticos de la investigación con animales. Cátedra de Biología, Facultad de Ciencias Médicas, Universidad Nacional de Rosario. Rev. Med. Rosario. 2011; 77: 69-74.

National Science Advisory Board for Biosecurity (NSABB). Website viewed on October 5, 2016. Available on http://www.biosecurityboard.gov.

Selgelid MJ. Governance of dual-use research: an ethical dilemma. Bull World Health Organ. 2009;87(9):720-3.

United Nations. The Universal Declaration of Human Rights 2015. Website viewed on October 5, 2016. Available on http://www.un.org/en/documents/udhr/ (accessed on October 5, 2011).

Vicerrectorado de Política Científica e Investigación, Universidad de Granada. Buenas Prácticas de Investigación. Ética, 2013. Website viewed on October 5, 2016. Available on http://investigacion.ugr.es/pages/etica.

World Health Organization. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Subjects. Geneva. 2011.