Human and Animal Ethics Policy

Ethical Requirements for Research Involving Human Participants and Animals

The Journal of Pharmacovigilance and Drug Research (JPADR) is committed to maintaining the highest ethical standards in biomedical and health-related research involving human participants and animals. All submitted manuscripts must comply with internationally accepted ethical principles, institutional regulations, and national laws governing research ethics. Authors are responsible for ensuring that all research has been conducted ethically, responsibly, and transparently.

JPADR follows ethical guidance and recommendations issued by the World Medical Association (WMA), Committee on Publication Ethics (COPE), International Committee of Medical Journal Editors (ICMJE), and other internationally recognized ethical and regulatory authorities.

1. Ethical Approval Requirement for Human Research

All research involving human participants, human tissues, human biological materials, medical records, identifiable personal data, or clinical information must receive prior ethical approval from an appropriately constituted ethics committee before the study begins.

Authors are responsible for ensuring that ethical approval was obtained before participant recruitment and that the study complied with all institutional and national ethical regulations.

Authors must confirm that:

• The study protocol was reviewed and approved by an Institutional Review Board (IRB), Institutional Ethics Committee (IEC), or equivalent ethics authority.
• The research complied with applicable institutional, regional, and national ethical regulations.
• Ethical approval was obtained prior to commencement of the study.
• Any protocol amendments requiring ethical review received additional approval where applicable.
• The approved protocol adequately protected participant rights and welfare.

The manuscript must clearly report:

• Name of the approving ethics committee.
• Approval or reference number.
• Date of approval, where applicable.

2. Compliance with the Declaration of Helsinki

All research involving human participants must comply with the ethical principles outlined in the Declaration of Helsinki and its subsequent revisions.

The Declaration of Helsinki establishes internationally recognized ethical principles governing medical research involving human subjects and places participant welfare above scientific interests.

Authors must ensure that:

• Participant dignity, safety, rights, and welfare were protected throughout the study.
• Potential risks and anticipated benefits were carefully assessed before study initiation.
• Scientific objectives justified participant involvement.
• Research was scientifically valid and ethically sound.
• Privacy and confidentiality were maintained.
• Additional safeguards were implemented for vulnerable populations.
• Participants received adequate information regarding study procedures.
• The study complied with all applicable ethical requirements throughout its duration.

3. Informed Consent Requirement

Authors must confirm that informed consent was obtained from every participant prior to enrollment in the study. Participation in research must always be voluntary and based upon adequate understanding of the study.

Informed consent should include:

• The purpose of the research.
• Description of study procedures.
• Expected duration of participation.
• Potential risks and discomforts.
• Expected benefits.
• Alternative options where appropriate.
• Confidentiality protections.
• Voluntary participation.
• The participant's right to withdraw at any time without penalty.

Special populations

For research involving individuals unable to provide legally valid consent, appropriate authorization must be obtained from legally authorized representatives in accordance with institutional and national regulations.

This requirement applies to studies involving:

• Children and minors
• Cognitively impaired individuals
• Individuals with diminished decision-making capacity
• Other legally protected vulnerable populations

Where verbal consent was obtained instead of written consent, authors should justify the procedure and indicate that the ethics committee specifically approved this consent process.

4. Patient Privacy and Anonymity Policy

JPADR is committed to protecting patient privacy, confidentiality, and personal dignity. Authors must ensure that manuscripts do not disclose information capable of directly or indirectly identifying patients unless explicit written permission has been obtained.

Authors must ensure that:

• Patients cannot be identified directly or indirectly.
• Names, initials, hospital identification numbers, and personal identifiers are omitted.
• Clinical photographs and radiological images are appropriately anonymized.
• Confidential information is handled responsibly.
• Patient privacy is maintained throughout publication.

If identifiable information is scientifically essential, authors must obtain explicit written informed consent for publication from the patient or legally authorized representative.

Authors should avoid altering scientific observations merely to preserve anonymity if doing so compromises scientific accuracy.

5. Publication of Case Reports and Clinical Images

Case reports, clinical photographs, videos, radiographs, diagnostic images, pathology slides, and other potentially identifiable materials require additional ethical safeguards before publication.

Authors must obtain written informed consent for publication from the patient or legal guardian before submission.

Requirements include:

• Written informed consent for publication.
• Consent obtained from the patient or legally authorized representative.
• Confirmation of consent within the manuscript.
• Appropriate anonymization of all clinical material.
• Removal of unnecessary identifying information.

6. Animal Ethics Policy

Research involving experimental animals must be conducted in accordance with internationally accepted ethical principles governing the humane care and use of laboratory animals. JPADR supports responsible animal research that is scientifically justified, ethically reviewed, and designed to minimize pain, distress, and unnecessary use of animals.

Authors are responsible for ensuring that all animal studies comply with applicable institutional, national, and international regulations before commencement of the research.

Authors must confirm that:

• The study received prior approval from an Institutional Animal Ethics Committee (IAEC) or an equivalent ethics authority.
• Animal experiments complied with applicable institutional, national, and international regulations.
• Animal welfare was protected throughout the study.
• Appropriate anesthesia, analgesia, and humane endpoints were used whenever applicable.
• Personnel conducting animal procedures were appropriately trained.
• Animals were housed and cared for according to recognized welfare standards.

The manuscript must include:

• Name of the approving ethics committee.
• Approval/reference number.
• Name of the ethical guideline or regulatory framework followed.

7. Ethical Standards for Animal Research

JPADR encourages authors to follow internationally recognized reporting standards and ethical principles for laboratory animal research to improve reproducibility, transparency, and animal welfare.

Authors are encouraged to follow:

• ARRIVE (Animal Research: Reporting of In Vivo Experiments) Guidelines.
• CPCSEA regulations (where applicable).
• International laboratory animal care standards.
• Institutional animal welfare policies.

Authors should demonstrate that they have:

• Used the minimum number of animals necessary to achieve scientific objectives.
• Scientifically justified the use of animals.
• Applied the principles of Replacement, Reduction, and Refinement (3Rs).
• Implemented appropriate housing and environmental enrichment.
• Clearly described animal welfare measures.
• Minimized unnecessary pain, suffering, and distress.

8. Clinical Trial Registration Requirements

All clinical trials submitted to JPADR must be prospectively registered in a publicly accessible clinical trial registry before enrollment of the first participant.

Prospective registration improves research transparency, prevents selective reporting, and promotes public trust in clinical research.

Acceptable registries include:

• ClinicalTrials.gov
• Clinical Trials Registry – India (CTRI)
• WHO International Clinical Trials Registry Platform (ICTRP) recognized registries
• Other recognized national or international trial registries

The manuscript must include:

• Trial registration number.
• Name of the registry.
• Date of registration.

9. Reporting Standards for Clinical Research

JPADR encourages authors to follow internationally recognized reporting guidelines appropriate to the study design. Compliance with reporting standards enhances transparency, reproducibility, completeness of reporting, and scientific integrity.

Recommended reporting guidelines include:

Authors are encouraged to submit completed reporting guideline checklists whenever applicable to facilitate peer review.

10. Vulnerable Populations

Research involving vulnerable populations requires additional ethical safeguards because participants may have limited ability to provide fully independent informed consent or may be at increased risk of coercion or exploitation.

Examples of vulnerable populations include:

• Children and adolescents.
• Pregnant women.
• Prisoners.
• Economically or socially disadvantaged individuals.
• Cognitively impaired participants.
• Individuals with diminished decision-making capacity.

Authors must confirm that:

• Additional ethical protections were implemented.
• Participation was entirely voluntary.
• Appropriate informed consent or legally authorized consent was obtained.
• The ethics committee specifically reviewed and approved research involving vulnerable populations.
• The anticipated benefits justified inclusion of the vulnerable population.

11. Biological Materials and Human Samples

Research involving human tissues, blood samples, genetic materials, biological specimens, or other human-derived materials must comply with applicable ethical, legal, and institutional requirements. Authors are responsible for ensuring that the collection, storage, use, and sharing of biological materials were conducted in accordance with approved ethical protocols and relevant regulatory frameworks.

Research involving biological materials must comply with:

• Institutional Ethics Committee (IEC) or Institutional Review Board (IRB) approval.
• Applicable informed consent requirements.
• Institutional policies governing biological sample collection and storage.
• Biobank regulations where applicable.
• National laws governing human biological materials and genetic research.

Authors should clearly state:

• The source of biological samples.
• The informed consent procedures used.
• Ethics approval details.
• Storage and future use approvals where applicable.
• Whether samples were anonymized or coded before analysis.

12. Ethical Misconduct and Investigations

JPADR takes all allegations of ethical misconduct seriously and investigates concerns fairly, confidentially, and in accordance with internationally accepted publication ethics principles.

Ethical concerns may be identified during editorial assessment, peer review, post-publication review, or through notifications from readers, institutions, regulatory authorities, or other stakeholders.

Examples of ethical violations include:

• Lack of appropriate ethical approval.
• Failure to obtain informed consent.
• Patient confidentiality or privacy breaches.
• Unethical animal experimentation.
• Fabricated or falsified ethics approval documents.
• Misrepresentation of ethical compliance.
• Submission of misleading ethical statements.

Depending upon the severity of the violation, editorial actions may include:

• Immediate manuscript rejection.
• Suspension of editorial processing.
• Publication of corrections or expressions of concern.
• Retraction of published articles.
• Notification of authors' institutions.
• Notification of funding agencies where appropriate.
• Reporting to regulatory or professional authorities where warranted.

13. Editorial Rights

The Editorial Office reserves the right to verify compliance with ethical requirements at any stage of the editorial and publication process.

The journal may request:

• Copies of ethics committee approval letters.
• Patient informed consent forms for publication.
• Clinical trial registration documentation.
• Animal ethics approval certificates.
• Additional information regarding ethical procedures.
• Supporting documentation related to participant recruitment or consent.

Failure to provide requested documentation within a reasonable time may result in rejection of the manuscript or suspension of editorial evaluation.

14. Commitment to Ethical Research

JPADR is committed to promoting responsible, ethical, transparent, and reproducible scientific research. The journal encourages adherence to internationally recognized ethical principles throughout the entire research, reporting, peer-review, and publication process.

Through rigorous ethical oversight, the journal seeks to protect the rights, dignity, safety, and welfare of research participants while fostering integrity, accountability, and public confidence in biomedical research.

JPADR supports research that protects:

• Human dignity.
• Participant rights and welfare.
• Patient privacy and confidentiality.
• Animal welfare.
• Research integrity.
• Scientific transparency.
• Responsible publication practices.

References

1. World Medical Association. Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.
2. Committee on Publication Ethics (COPE). COPE Core Practices and Ethical Guidelines.
3. International Committee of Medical Journal Editors (ICMJE). Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.
4. World Health Organization (WHO). International Standards for Clinical Trial Registration.