Protection of Research Participants and Animal Welfare Policy

The National Journal of Physiology, Pharmacy and Pharmacology (NJPPP) is committed to the highest standards of ethical and responsible research involving human participants, human biological materials or identifiable human data, and animals. The journal expects authors to conduct research in accordance with applicable ethical principles, national and institutional regulations, and internationally recognized standards for the protection of research participants and animal welfare.

Authors are responsible for ensuring that their research has received appropriate ethical oversight before the study begins, where such oversight is required. NJPPP may request evidence of ethical approval or other documentation when necessary to assess compliance with this policy.

1. Research Involving Human Participants

1.1 Ethical Principles

Research involving human participants must comply with internationally recognized ethical principles, including the Declaration of Helsinki, the Belmont Report, and applicable national and institutional requirements.

Authors should ensure that research respects the principles of:

• respect for persons and autonomy;

• beneficence and non-maleficence;

• justice and equitable selection of participants;

• privacy and confidentiality; and

• protection of participants from unnecessary risk or harm.

Where local regulations provide additional or more stringent requirements, authors are expected to comply with those requirements.

1.2 Ethics Committee or Institutional Review Board Approval

Research involving human participants must receive approval or appropriate review from an Institutional Review Board (IRB), Research Ethics Committee (REC), or equivalent independent ethics body before the research is initiated, where required by applicable regulations or institutional policies.

The manuscript should state:

• the name of the approving ethics committee or institution;

• the approval or reference number, where available; and

• the date of approval, where applicable.

NJPPP may request documentation of ethical approval during editorial assessment or peer review.

If a study is exempt from formal ethical review under applicable regulations, authors should provide a clear statement explaining the basis for the exemption.

1.3 Informed Consent

Authors must obtain informed consent from human participants when required by applicable ethical standards, institutional requirements, or law.

Participants should receive sufficient information about the purpose and nature of the research, procedures involved, potential risks and benefits, confidentiality arrangements, and their right to decline participation or withdraw where applicable.

Consent should be obtained through an appropriate process and documented in accordance with institutional and legal requirements.

For studies involving individuals who cannot provide informed consent themselves, appropriate consent or authorization must be obtained from a legally authorized representative, together with the participant's assent where appropriate and feasible.

1.4 Waiver or Modification of Consent

In certain types of research, including some retrospective studies, secondary analyses of existing data, or studies using publicly available or fully anonymized information, an ethics committee may determine that informed consent is not required or may grant a waiver.

Where a waiver or modification of informed consent has been granted, authors must state this in the manuscript and identify the approving ethics committee or relevant authority and approval/reference number where available.

1.5 Vulnerable Participants

Research involving potentially vulnerable individuals or groups requires additional ethical safeguards. Such groups may include children, prisoners, individuals with impaired decision-making capacity, economically or socially disadvantaged populations, and others whose ability to provide voluntary informed consent may be limited.

Researchers must ensure that participation is voluntary and that additional protections required by applicable ethical and regulatory standards are implemented.

1.6 Privacy, Confidentiality, and Data Protection

Authors must protect the privacy and confidentiality of research participants.

Personally identifiable information should not be published unless there is a scientifically justified reason and appropriate consent or other lawful basis for disclosure. Authors should anonymize or de-identify participant information whenever possible.

When case reports, clinical photographs, medical records, pedigrees, or other potentially identifiable information are published, authors must obtain appropriate consent for publication when required.

1.7 Research Involving Human Biological Materials or Identifiable Data

Studies involving human tissues, blood, genetic material, biological specimens, medical records, or identifiable health-related data must comply with applicable ethical and legal requirements.

Authors should clearly indicate the source of the materials or data and provide the relevant ethics approval or exemption statement where applicable.

2. Research Involving Animals

2.1 Ethical Treatment and Animal Welfare

NJPPP is committed to the humane treatment and responsible use of animals in research.

Animal research must comply with applicable national legislation, institutional requirements, and internationally recognized standards for animal care and welfare. Where appropriate, authors should follow established guidance such as the Guide for the Care and Use of Laboratory Animals and relevant species-specific standards.

Authors must ensure that animals are used only when scientifically justified and that unnecessary pain, distress, suffering, and death are avoided or minimized.

2.2 The 3Rs Principles

Authors are expected to apply the internationally recognized 3Rs principles:

• Replacement: using non-animal methods or alternative models whenever scientifically appropriate;

• Reduction: using the minimum number of animals necessary to obtain scientifically valid results; and

• Refinement: modifying procedures and husbandry practices to minimize pain, distress, and suffering and improve animal welfare.

2.3 Institutional Animal Ethics Approval

Research involving animals must receive prior approval from an Institutional Animal Care and Use Committee (IACUC), Animal Ethics Committee, or equivalent competent ethics body, where required by applicable regulations or institutional policies.

The manuscript should identify:

• the approving committee or institution;

• the approval or protocol number, where available; and

• the date of approval, where applicable.

If formal ethical approval is not required for a particular study, authors should provide a clear explanation and identify the applicable institutional or regulatory basis.

2.4 Animal Housing, Care, and Experimental Procedures

Authors must provide sufficient information to demonstrate that animals were appropriately housed, cared for, and handled throughout the study.

Where relevant, manuscripts should describe:

• animal species, strain, sex, age, and number;

• housing and husbandry conditions;

• anesthesia and analgesia;

• procedures used to minimize pain and distress;

• humane endpoints;

• euthanasia methods; and

• relevant monitoring and welfare measures.

Procedures involving significant pain or distress must be scientifically justified and conducted using appropriate measures to minimize suffering.

2.5 Humane Endpoints and Euthanasia

Authors must establish and apply appropriate humane endpoints whenever animals may experience significant pain, distress, deterioration, or other adverse effects.

Euthanasia, when necessary, must be performed using methods consistent with applicable ethical, veterinary, institutional, and regulatory standards.

2.6 Field Studies and Wildlife

Research involving wildlife, free-ranging animals, or field studies must comply with applicable animal-welfare, conservation, environmental, and permitting requirements.

Authors should report relevant permits, ethical approvals, capture or handling procedures, and measures taken to minimize disturbance, injury, or mortality.

3. Reporting Ethical Compliance

Authors must provide clear ethical statements in the manuscript where human or animal research is involved.

An appropriate statement should normally identify the relevant ethics committee or institution and approval/reference number where applicable.

Failure to provide sufficient information concerning ethical approval, informed consent, participant protection, or animal welfare may result in requests for clarification, additional documentation, rejection of the manuscript, or other appropriate editorial action.

4. Editorial Assessment of Ethical Compliance

NJPPP may assess ethical compliance during initial editorial screening, peer review, revision, or post-publication investigation.

The journal may request:

• ethics approval documentation;

• evidence of informed consent or an explanation of a consent waiver;

• animal-use or welfare documentation;

• relevant research permits;

• clarification from the authors or their institution; or

• other information necessary to assess compliance.

Ethical approval does not automatically guarantee publication. Editors may consider whether the research was conducted and reported in a manner consistent with accepted ethical standards.

Where serious ethical concerns arise, NJPPP may reject a manuscript or, in the case of published work, issue a correction, expression of concern, or retraction as appropriate.

5. Exceptions and Special Circumstances

Not every study involving human-derived information or biological material requires the same form of ethical review or individual consent. Requirements may vary according to the study design, jurisdiction, data source, degree of anonymization, and applicable regulations.

Authors are responsible for determining and complying with the ethical and legal requirements applicable to their research and should explain any exemption, waiver, or special circumstance clearly in the manuscript.

6. Commitment to Research Participant Protection and Animal Welfare

NJPPP will not knowingly publish research that involves unacceptable risks to human participants or unjustified harm or suffering to animals.

The journal is committed to protecting the integrity of the scientific record while ensuring respect for human dignity, privacy, autonomy, and welfare and promoting the humane and responsible use of animals in research.

This policy should be read together with NJPPP's Publication Ethics and Publication Malpractice Statement, Editorial Policies, Conflict of Interest Policy, Plagiarism Policy, and other applicable editorial and research-integrity policies.