Romanian Society of Pharmaceutical Sciences
 

Publication Ethics

Publication Ethics: Conflict of Interest, Human and Animal Rights, and Informed Consent

Farmacia Journal follows strict ethical guidelines to prevent plagiarism, redundant publication, and other forms of misconduct. All contributors to a manuscript must meet criteria for authorship, and non-author contributors should be acknowledged appropriately.

Conflict of Interest

Authors must disclose any financial or personal relationships that might influence the outcomes or interpretation of their research. This includes but is not limited to employment, consultancies, stock ownership, honoraria, paid expert testimony, and patent applications or registrations. The role of any funding sponsors in study design, data collection, analysis, interpretation, and manuscript preparation should be clearly stated. If the funding sponsors had no involvement, this must be explicitly mentioned. Conflicts of interest must be disclosed during the submission process and included in a separate section in the manuscript before the references. If no conflicts of interest exist, authors should state, “The authors declare no conflicts of interest.”

Example of disclosure: “Conflicts of Interest: Author A has received research grants from Company A. Author B owns stocks in Company X. Author C has served as a consultant for Company Y.”

Farmacia Journal does not publish research funded by the tobacco industry. Research funded by other industries, such as pharmaceuticals or food, must transparently disclose the funder’s role in the study.

Research Involving Human Subjects

Research involving human subjects, materials, or data must comply with the ethical standards of the Declaration of Helsinki (1975, revised 2013). Authors must obtain approval from an appropriate ethics committee before conducting their research and include a statement in the manuscript providing the project identification code, date of approval, and the name of the ethics committee.

Example of ethical statement: “The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Ethics Committee of [Institution] (protocol code and date). Informed consent was obtained from all subjects involved in the study.”

For non-interventional studies, participants must be informed about the study’s purpose, data usage, and any potential risks, and must provide informed consent. If ethical approval is not required, authors should provide an exemption statement from the ethics committee or cite the relevant local or national legislation.

Informed Consent

The purpose of this Informed Consent Policy is to outline the responsibilities of authors submitting to Farmacia Journal regarding obtaining informed consent, particularly in research involving human participants, identifiable personal data, or potentially sensitive information. This policy ensures that Farmacia Journal adheres to ethical standards protecting research participants’ rights and dignity.

This policy applies to all submissions to Farmacia Journal involving human participants, identifiable personal data, and sensitive information. This includes but is not limited to clinical studies, surveys, and other forms of research that involve human subjects.

  1. Obtaining Informed Consent:
    • Authors must obtain informed consent from all participants involved in the study. This consent should cover participation in the research and the potential publication of identifiable data.
    • Consent must be freely given, specific, informed, and unambiguous, indicating the participant’s clear approval of their involvement in the study.
    • Participants should be informed about the purpose of the research, the procedures involved, their right to withdraw at any time without penalty, and the measures taken to ensure privacy and confidentiality.
  2. Documentation of Informed Consent:
    • Authors should retain copies of the informed consent documentation and, while maintaining confidentiality, provide evidence of consent to the journal upon request.
    • Documentation practices can vary depending on the research context, but must always comply with applicable laws and regulations.
  3. Special Considerations:
    • When research involves minors, individuals unable to give informed consent, or vulnerable groups, authors must obtain consent from a legal guardian or a responsible family member, in accordance with ethical and legal requirements.
    • Consent must also include approval from an ethics committee or review board, which should review the consent procedure.
  4. Anonymity and Confidentiality:
    • Unless explicitly agreed upon by the participant under conditions of informed consent, identifying information should be omitted from the study and publication.
    • If identification of participants is necessary for the scientific validity of the research, authors must demonstrate convincingly how they have obtained explicit consent for this and how participant confidentiality is safeguarded.
  5. Use of Images or Identifiable Data:
    • If images or identifiable data are essential to the article, authors must ensure that consent forms explicitly cover the use of this material in publications.
    • Images should not be manipulated in a way that could mislead or misrepresent the clinical condition of the patient.
  6. Ethical Review:
    • All studies involving human participants must have approval from an official ethics committee that should oversee the study’s ethical aspects, including the process of obtaining informed consent.
    • Authors must provide details of this approval within the manuscript, including the name of the ethics committee and the committee’s approval code.

Compliance and Enforcement

  • Compliance with this informed consent policy is mandatory for all submissions to Farmacia Journal where applicable.
  • Submissions found not to comply with these guidelines may be rejected without review.
  • Authors may be asked to provide proof of the informed consent process, and failure to provide this documentation may result in the rejection of the manuscript.

Responsibility of Authors

  • Authors are responsible for ensuring that all requirements of informed consent are met in their research.
  • It is the authors’ duty to protect the privacy rights of participants and to ensure that personal data is handled with care and respect.

Clinical Trials Registration

  • Farmacia Journal follows ICMJE guidelines, requiring registration of clinical trials in a public registry before the first patient enrollment. Observational studies do not require registration. Authors are encouraged to pre-register clinical trials and cite the registration in the Methods section. Approval from review bodies is not equivalent to trial registration, and lack of registration may lead to rejection.

 

Research Involving Animals

Research involving animals must comply with ethical standards and regulations, including the principles of the 3Rs: Replacement, Reduction, and Refinement. Authors must provide details on animal housing, husbandry, and pain management. Ethical approval must be obtained from an appropriate committee, and the manuscript should include the project identification code, date of approval, and the name of the ethics committee.

Example of ethical statement: “The animal study protocol was approved by the Institutional Animal Care and Use Committee of [Institution] (protocol code and date).”

If ethical approval is not required, authors must provide an exemption statement and explain why approval was not needed. Research must be conducted according to national and institutional regulations, and ethical concerns will be evaluated by reviewers and editors if no ethics committee is available.

Research Involving Cell Lines

For research involving cell lines, the origin of the cell lines must be stated, including references to published sources or details of the institution where the cell lines were obtained. If de novo cell lines were used, authors must provide details of ethics committee approval and informed consent if the lines are of human origin.

Example of ethical statement: “The HCT116 cell line was obtained from [Source]. The MLH1+ cell line was provided by [Company].”

Research Involving Plants

Experimental research on plants must comply with institutional, national, or international guidelines, such as the Convention on Biological Diversity. For rare or non-model plants, voucher specimens should be deposited in accessible herbariums or museums. Details of the plant material, including population sampled, site of collection, and parts used, must be provided.

Example of ethical statement: “Torenia fournieri plants were used in this study. The CrW and CrV cultivars were provided by Dr. [Name, Institution, Country].”

 

Research ethics 

Authors are expected to adhere strictly to these guidelines to maintain the highest level of academic honesty and transparency.

Ethical Guidelines for Authors

  1. Presentation of Research Findings:
    • Authors must present their research findings accurately and provide an objective discussion of their significance.
    • Data should be represented truthfully without manipulation. Any limitations or uncertainties should be disclosed clearly.
  2. Authorship and Contributions:
    • Authorship should include all individuals who have made significant contributions to the research and exclude those who have not.
    • Contributions of each author should be clearly described. Typically, to qualify for authorship, contributors must have been involved in at least one of the following: conceptualization and design of the study, data collection and analysis, or drafting and critically revising the article.
    • Acknowledgements should be used to recognize contributions from individuals who assisted the research but do not meet authorship criteria.
  3. Conflict of Interest:
    • At the time of submission, authors must disclose any circumstances that could be perceived as potential conflicts of interest.
    • This includes any financial, personal, or professional relationships that might influence the research results or interpretation.
  4. Data Transparency and Reproducibility:
    • Authors must present their methods and data clearly and in detail to allow for replication of results by other researchers.
    • Raw data should be made accessible unless restricted by privacy or confidentiality concerns. When data cannot be publicly shared, authors must provide a valid reason and make it available upon reasonable request.
  5. Originality and Prior Publication:
    • Submissions must represent original research and not be published previously in any form.
    • Manuscripts under consideration by Farmacia Journal must not be submitted simultaneously to other publications.
    • Authors must ensure that translations and previously published work are cited appropriately and permission for publication has been obtained.
  6. Permissions for Use of Copyrighted Material:
    • Authors are responsible for obtaining permission to reuse previously published content from the respective copyright holders. This includes text, images, and tables.
  7. Error Correction:
    • Authors must promptly inform the journal of any significant errors or inaccuracies found in their published work. The journal will facilitate the correction or retraction of the paper if necessary.

Enforcement and Compliance

  • Compliance with these guidelines is mandatory. Manuscripts failing to meet these standards may be rejected without review.
  • The editorial board of Farmacia Journal reserves the right to investigate allegations of misconduct and to take appropriate actions, including the retraction of articles if necessary.

Monitoring and Updates

  • Farmacia Journal’s editorial board regularly reviews and updates the research ethics policy to adapt to new ethical standards and practices in scientific publishing.
  • Authors are encouraged to review the policy periodically to ensure compliance with the latest guidelines.

By adhering to these ethical guidelines, authors contribute to the integrity and credibility of scientific discourse and uphold the standards of Farmacia Journal and the broader academic community. Our commitment to ethical practices in publishing ensures that the journal remains a trusted repository of high-quality scientific research.