Human Participants, Animal Welfare, and Ethical Approval Policy

The Journal of AI and Integrative Medicine (JAIIM) is committed to ensuring that all published research involving human participants, animals, biological materials, or identifiable personal data is conducted in accordance with internationally recognized ethical principles.

Authors are responsible for ensuring that their research complies with applicable institutional, national, and international ethical standards before submitting their manuscripts to the journal.

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1. Purpose

This policy aims to:

  • Protect the rights, dignity, safety, and welfare of research participants.

  • Promote ethical conduct in biomedical and healthcare research.

  • Ensure compliance with international ethical standards.

  • Support responsible reporting of research involving humans and animals.

  • Maintain public confidence in published scientific research.

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2. Scope

This policy applies to manuscripts involving:

  • Human participants.

  • Clinical research.

  • Observational studies.

  • Clinical trials.

  • Animal research.

  • Human tissues and biological specimens.

  • Medical records.

  • Patient data.

  • Artificial Intelligence studies using human data.

  • Public health and epidemiological research.

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3. Ethical Approval

Research involving human participants or animals must receive approval from an appropriate ethics committee or institutional review board (IRB) before the study begins.

Authors should include in the manuscript:

  • Name of the approving ethics committee or IRB.

  • Approval number or reference number (where applicable).

  • Date of approval, if required by institutional policy.

If ethical approval was not required, authors should clearly explain the reason within the manuscript.

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4. Research Involving Human Participants

Research involving human participants must be conducted in accordance with internationally accepted ethical principles, including the principles of the Declaration of Helsinki and applicable national regulations.

Authors should ensure that:

  • Participant rights are respected.

  • Risks are minimized.

  • Benefits outweigh potential risks.

  • Participant privacy is protected.

  • Confidentiality is maintained.

  • Ethical approval has been obtained before recruitment.

The journal reserves the right to request supporting documentation relating to ethical approval.

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5. Informed Consent

Authors must obtain informed consent from participants before their inclusion in research, where applicable.

Participants should receive adequate information regarding:

  • The purpose of the research.

  • Study procedures.

  • Potential risks and benefits.

  • Voluntary participation.

  • The right to withdraw without penalty.

  • Protection of personal information.

For minors or individuals lacking legal capacity, consent must be obtained from a parent, legal guardian, or other legally authorized representative in accordance with applicable laws and regulations.

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6. Privacy and Confidentiality

Authors must protect the privacy and confidentiality of research participants.

Manuscripts should not contain identifying information unless:

  • It is scientifically necessary.

  • Explicit written consent has been obtained.

  • Publication complies with applicable legal and ethical requirements.

Personal identifiers should be removed or anonymized whenever possible.

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7. Clinical Trials

Clinical trials submitted to JAIIM should be registered in a publicly accessible clinical trial registry before the enrollment of the first participant, where required by applicable regulations or international guidelines.

Authors should provide:

  • Registry name.

  • Registration number.

  • Registration date.

Clinical trial registration information should be included in the manuscript.

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8. Research Involving Animals

Research involving animals must comply with institutional, national, and international regulations governing animal welfare and ethical treatment.

Authors should ensure that:

  • Animal use is scientifically justified.

  • Animal suffering is minimized.

  • Appropriate anesthesia and analgesia are used where necessary.

  • Humane endpoints are established.

  • Ethical approval has been obtained before commencing the study.

The journal encourages adherence to recognized reporting guidelines for animal research, such as the ARRIVE Guidelines.

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9. Human Biological Materials

Research involving human tissues, blood samples, genetic material, or other biological specimens should comply with applicable ethical and legal requirements.

Authors should confirm that:

  • Appropriate ethical approval was obtained.

  • Necessary consent was provided by participants or legally authorized representatives.

  • Samples were collected and used in accordance with institutional and national regulations.

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10. Vulnerable Populations

Additional safeguards should be implemented when research involves vulnerable populations, including but not limited to:

  • Children.

  • Older adults with impaired decision-making capacity.

  • Individuals with cognitive impairment.

  • Pregnant women.

  • Prisoners.

  • Economically or socially disadvantaged groups.

Authors should clearly describe the additional ethical protections implemented for these participants.

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11. Artificial Intelligence (AI) Research Using Human Data

Research involving Artificial Intelligence (AI), Machine Learning (ML), or other computational methods that utilize human-derived data must comply with applicable ethical, legal, and regulatory requirements.

Authors should clearly describe:

  • The source of the data.

  • Whether informed consent was obtained, where applicable.

  • Procedures used to protect privacy and confidentiality.

  • Methods of data anonymization or de-identification.

  • Ethical approval for the use of human data.

  • Measures implemented to minimize algorithmic bias and ensure fairness.

Authors are encouraged to discuss the limitations and potential ethical implications of AI systems used in healthcare research.

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12. Case Reports and Patient Consent

Case reports, case series, and clinical images that include identifiable patient information require written informed consent from the patient or their legally authorized representative before publication.

Authors should ensure that:

  • Patient privacy is protected.

  • Identifying information is removed unless essential for scientific purposes.

  • Written consent has been obtained prior to submission.

  • Consent documentation is retained and made available to the Editorial Office upon request.

The journal reserves the right to request evidence of patient consent during the editorial process.

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13. Biosafety and Biosecurity

Research involving infectious agents, genetically modified organisms, hazardous biological materials, or other potentially dangerous substances must comply with all applicable institutional, national, and international biosafety and biosecurity regulations.

Authors should confirm that:

  • Appropriate safety approvals were obtained.

  • Laboratory procedures complied with recognized biosafety standards.

  • Necessary precautions were implemented to protect researchers, participants, and the environment.

The Editorial Office may request additional information regarding biosafety compliance where appropriate.

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14. Ethical Misconduct

Failure to comply with ethical requirements may constitute research misconduct.

Examples include:

  • Absence of required ethical approval.

  • Failure to obtain informed consent.

  • Fabrication or falsification of ethical approval information.

  • Unauthorized use of patient data.

  • Misrepresentation of participant consent.

  • Violation of participant confidentiality.

  • Unethical treatment of research animals.

Suspected ethical misconduct will be investigated in accordance with the journal's Publication Ethics Policy and the guidance of the Committee on Publication Ethics (COPE).

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15. Editorial Assessment

Editors may request additional documentation to verify ethical compliance, including:

  • Ethics committee approval letters.

  • Institutional Review Board (IRB) approvals.

  • Patient consent forms.

  • Clinical trial registration records.

  • Animal ethics approvals.

  • Additional supporting documentation relevant to ethical review.

Failure to provide requested documentation may result in delays, rejection of the manuscript, or withdrawal from the editorial process.

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16. Post-Publication Ethical Concerns

If ethical concerns are identified after publication, JAIIM will investigate the matter in accordance with its Publication Ethics Policy.

Where appropriate, the journal may:

  • Publish a correction.

  • Publish an Expression of Concern.

  • Retract the article.

  • Notify relevant institutions, ethics committees, or funding agencies.

  • Take any other appropriate editorial action to preserve the integrity of the scholarly record.

All investigations will be conducted fairly, confidentially, and objectively.

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17. Policy Review

JAIIM periodically reviews this policy to ensure continued alignment with internationally recognized ethical standards and evolving best practices.

Updates may reflect recommendations issued by:

  • Committee on Publication Ethics (COPE)

  • International Committee of Medical Journal Editors (ICMJE)

  • World Medical Association (WMA)

  • World Association of Medical Editors (WAME)

  • Directory of Open Access Journals (DOAJ)

The latest version of this policy will be available on the journal website.

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18. Contact Information

Questions regarding ethical approval, human participants, animal welfare, patient consent, or related matters may be directed to:

Editorial Office
Journal of AI and Integrative Medicine (JAIIM)
Novadex Publications

Email: editor@novadexpub.com

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19. Commitment to Ethical Research

The Journal of AI and Integrative Medicine (JAIIM) is dedicated to promoting ethical, responsible, and transparent research involving human participants, animals, biological materials, and health-related data.

By requiring appropriate ethical approval, informed consent, respect for participant rights, and adherence to internationally accepted standards, JAIIM seeks to ensure that all published research upholds the highest principles of scientific integrity, patient welfare, and public trust.

The journal encourages authors, reviewers, editors, institutions, and readers to work collaboratively in advancing ethical biomedical research for the benefit of global healthcare and scientific progress.