Research Ethics and Ethical Approval Policy

The Journal Pharmaceutical Science and Application (JPSA) is committed to ensuring that all published research complies with internationally recognized ethical standards for research involving human participants, human biological materials, human data, and experimental animals.

JPSA follows relevant principles of the Declaration of Helsinki, the recommendations of the International Committee of Medical Journal Editors (ICMJE), and applicable institutional and national research ethics regulations.

1. Research Involving Human Participants

Original research involving human participants, identifiable human data, medical records, or human biological materials must receive approval from an appropriately constituted Research Ethics Committee or Institutional Review Board before the research begins, unless a formal exemption or waiver is granted by an authorized ethics review body.

This requirement applies to relevant clinical, observational, interventional, pharmaceutical care, and other human-related research.

Authors must provide the following information:

Full name of the approving ethics committee or institutional review board.
Ethical approval number or reference number, where applicable.
Date of ethical approval, where available.
Information regarding informed consent or an authorized waiver of consent.

The manuscript must clearly describe the ethical approval and informed consent procedures in the Methods section.

Informed Consent

Authors must ensure that informed consent is obtained from research participants when required.

For research involving children or individuals unable to provide informed consent, consent must be obtained from a legally authorized representative, with participant assent when appropriate.

Participant privacy, confidentiality, and personal data must be protected throughout the research and publication processes.

For case reports or publications containing identifiable patient information or images, appropriate informed consent for publication must be obtained.

2. Research Involving Experimental Animals

Studies involving experimental animals must obtain approval from an authorized Animal Research Ethics Committee or equivalent institutional body before the initiation of animal experiments, as required by applicable regulations.

Animal research must comply with institutional and national standards for animal care and welfare, including the principles of Replacement, Reduction, and Refinement (3Rs).

Authors should follow the ARRIVE 2.0 guidelines when reporting animal experiments.

The manuscript must identify the approving ethics committee, approval reference number, and relevant ethical standards followed.

3. Ethical Approval Exemptions

Some studies may qualify for exemption from formal ethical review, depending on the study design, data sources, and applicable institutional or national regulations.

Examples may include certain studies using publicly available, fully anonymized datasets or research that does not involve human participants, human materials requiring review, or experimental animals.

Where an ethics committee has formally determined that approval is not required, authors must report the exemption or waiver and identify the responsible body, where applicable.

Authors must not independently claim an ethics exemption when formal determination is required.

4. Ethical Approval Declaration

All original research manuscripts must include an "Ethical Approval" statement indicating whether ethical approval was obtained, waived, formally exempted, or not applicable.

Example A — Human participant research

"This study was approved by the Research Ethics Committee of [Institution Name] (Approval No. [XXXX], Date: [DD Month YYYY]). Written informed consent was obtained from all participants before their enrollment in the study."

Example B — Ethics approval or consent waived

"The requirement for ethical approval [or informed consent, as applicable] was waived by the Research Ethics Committee of [Institution Name] (Reference No. [XXXX]) because [brief justification]."

Example C — Animal experimental research

"All animal experimental procedures were approved by the Animal Research Ethics Committee of [Institution Name] (Approval No. [XXXX]). The study was conducted in accordance with applicable institutional animal welfare guidelines and the principles of the 3Rs."

Example D — Ethical approval not applicable

"Ethical approval was not applicable because this study did not involve human participants, human data or materials requiring ethical review, or experimental animals."

5. Ethical Documentation and Verification

Authors must provide accurate and verifiable information regarding research ethics approval.

JPSA reserves the right to request copies of ethics approval certificates, exemption letters, or relevant supporting documents during the editorial process.

Failure to provide adequate ethical documentation, misrepresentation of ethical approval, or serious violations of research ethics may result in manuscript rejection or appropriate post-publication action.

This policy applies to original research and other manuscript types involving ethical considerations, including relevant case reports and studies using human or animal materials.