Human Research Ethics Policy

1. Policy Statement

Research involving human participants must respect the dignity, rights, safety, privacy, and welfare of all individuals involved. Authors are responsible for ensuring that human research submitted to Impaxon journals has been conducted ethically and with appropriate approvals, permissions, and safeguards.

Manuscripts that involve human participants, patient data, clinical information, biological materials, interviews, surveys, questionnaires, images, or other identifiable information must include appropriate ethics and consent statements.

2. Scope

This policy applies to all research submitted to Impaxon journals that involves human participants, patients, volunteers, personal data, clinical records, human biological samples, images, interviews, surveys, behavioural observations, or any information that may identify an individual directly or indirectly.

The policy applies to prospective studies, retrospective studies, observational studies, experimental studies, clinical research, case reports, surveys, interviews, questionnaires, and secondary analyses of human-related data.

3. Ethical Approval

Research involving human participants should receive approval from an appropriate institutional review board, research ethics committee, or equivalent authority before the research is conducted.

Authors must provide the name of the approving ethics committee, approval number or reference where available, and any relevant approval date in the manuscript.

If ethical approval was not required, authors must clearly explain why approval was exempted or not applicable, and should identify the authority or policy under which the exemption was granted where possible.

4. Compliance with Ethical Standards

Human research should be conducted in accordance with applicable laws, institutional policies, national regulations, and recognised ethical principles for research involving humans.

Authors are responsible for ensuring compliance with all relevant ethical, legal, and regulatory requirements in the country or institution where the research was conducted.

5. Informed Consent

Authors must obtain informed consent from participants where required by the study design, ethics approval, applicable law, or institutional policy. Consent should be obtained before participation and should be based on clear information about the purpose, procedures, risks, benefits, confidentiality, and use of the research.

Manuscripts should include a statement confirming that informed consent was obtained, or explaining why consent was waived by an appropriate ethics committee or authority.

6. Consent for Publication

Separate consent for publication may be required when a manuscript includes identifiable personal information, clinical details, photographs, images, videos, case descriptions, or other material through which an individual could reasonably be identified.

Authors must obtain appropriate written consent for publication from the individual concerned, or from a legally authorised representative where applicable.

7. Privacy and Confidentiality

Authors must protect the privacy and confidentiality of human participants. Personal data, clinical records, interview responses, survey data, images, and other sensitive information must be handled securely and disclosed only where ethically and legally appropriate.

Identifiable information should not be included in manuscripts unless it is essential for scholarly purposes and appropriate consent has been obtained.

8. Identifiable Information and Images

Authors must take particular care when using photographs, medical images, facial images, case descriptions, videos, genetic information, or other materials that may identify individuals.

Removing names or obvious identifiers may not be sufficient if individuals remain identifiable from context, images, rare conditions, institutional details, demographic information, or combined data.

9. Vulnerable Participants

Research involving vulnerable participants requires particular ethical care. Vulnerable participants may include children, older adults, patients with serious illness, individuals with cognitive impairment, persons with limited decision-making capacity, economically or socially disadvantaged groups, or individuals in dependent relationships.

Authors must ensure that additional safeguards, appropriate consent procedures, and ethics committee approval are in place where vulnerable participants are involved.

10. Clinical Studies

Clinical studies involving patients, interventions, treatments, clinical records, diagnostic procedures, or health-related outcomes must comply with applicable ethical, legal, and regulatory requirements.

Where clinical trial registration is required by law, institutional policy, journal requirements, or recognised standards, authors must provide the trial registration name and number in the manuscript.

11. Surveys, Interviews, and Questionnaires

Research based on surveys, interviews, questionnaires, focus groups, or behavioural observations must follow appropriate ethical review, consent, privacy, and confidentiality requirements.

Authors should describe how participants were informed, how consent was obtained where required, and how responses were anonymised or protected.

12. Retrospective Studies and Secondary Data

Retrospective studies and secondary analyses involving human data must comply with applicable ethics approval, data access, privacy, consent, and confidentiality requirements.

If consent or ethics approval was waived, authors must state this clearly and identify the ethics committee, authority, policy, or legal basis for the waiver where applicable.

13. Human Biological Materials

Research involving human tissue, blood, cells, genetic material, biological samples, or other human-derived materials must be conducted with appropriate ethical approval, consent, permissions, and biosafety safeguards.

Authors must describe the source of the materials and confirm that collection, storage, transfer, and use complied with applicable ethical and legal requirements.

14. Ethics Statements in Manuscripts

Manuscripts involving human participants or human-related data must include an ethics statement. The statement should identify the ethics committee or approving authority, approval reference where available, informed consent arrangements, and any waivers or exemptions.

Where the study did not require ethical approval or consent, authors must provide a clear explanation.

15. Data Protection and Availability

Human research data must be shared only where ethically and legally permissible. Authors should avoid sharing identifiable, sensitive, or confidential information unless appropriate consent, approvals, safeguards, and legal basis are in place.

Data availability statements must be consistent with participant consent, ethics approvals, privacy obligations, and the Data Availability Policy.

16. Editorial Assessment

Editors may request ethics approval documents, consent forms, trial registration details, data access permissions, or other supporting evidence during editorial assessment or peer review.

Manuscripts may be rejected if adequate ethical approval, consent, privacy protection, or supporting documentation is not provided when required.

17. Non-Compliance

Failure to comply with human research ethics requirements may result in rejection, correction, expression of concern, retraction, or notification to institutions, funders, or other relevant bodies where appropriate.

18. Post-Publication Concerns

If concerns arise after publication regarding ethical approval, consent, privacy, confidentiality, participant protection, or human research data, Impaxon may investigate the matter and request clarification or supporting documents from the authors.

Where necessary, action may be taken in accordance with the Corrections & Retractions Policy.

19. Changes to this Policy

Impaxon may revise this policy periodically to reflect developments in human research ethics, privacy law, clinical research standards, publication ethics guidance, and international best practices.