ETHICAL CLEARANCE POLICY
ETHICAL CLEARANCE POLICY
1. Purpose and Scope
The journal requires authors to protect the rights, dignity, safety, and welfare of participants and to ensure appropriate animal welfare. Ethical requirements apply according to the nature of the work, including research, programme evaluation, and community service activities.
Authors must comply with applicable institutional and national requirements and relevant international ethical standards.
2. Research Involving Human Participants
Research involving human participants, including the use of identifiable human data or biological materials, must receive approval from an appropriate independent research ethics committee before activities requiring approval begin.
Human medical research should follow the Declaration of Helsinki and applicable ethical requirements. Material protocol amendments must receive further approval when required.
Administrative permission from a university, hospital, school, community leader, or partner organization does not replace ethics committee approval or individual informed consent.
3. Informed Consent
Authors must explain how voluntary informed consent was obtained and documented. Where participants cannot legally provide consent, permission from a legally authorized representative and participant assent must be obtained as applicable.
Participation must be free from coercion. Additional safeguards are required where dependency, vulnerability, or unequal power relationships may affect voluntary participation.
A waiver or modification of consent must be authorized by the competent ethics committee or authority and reported with its justification. Authors must not assume that retrospective research or the absence of an intervention automatically removes consent requirements.
4. Privacy and Consent for Publication
Authors must minimize identifiable information and protect confidential records.
Written consent for publication is required when photographs, narratives, or other details could identify an individual. Consent to participate in research or receive a service does not automatically constitute consent to publication.
Authors must securely retain relevant consent documentation and provide confirmation or supporting evidence through an appropriate confidential process when requested. Identifiable consent forms should not be uploaded as public supplementary material.
5. Community Service and Programme Evaluation
Community service articles must explain partner authorization, participant protection, voluntary participation, and the handling of personal information.
Ethics review is required when the activities constitute human participant research or otherwise fall within applicable review requirements. Calling an activity “community service,” “training,” or “programme evaluation” does not determine its ethical status.
Routine non-research activities may not require research ethics approval. Authors must explain the applicable basis and provide an institutional or ethics committee determination where required. Permission from community leaders does not replace individual consent when individual consent is necessary.
6. Research Involving Animals
Animal research must comply with applicable welfare requirements and obtain approval from the relevant ethics committee or regulatory authority before regulated procedures begin.
Authors must identify the approving body and relevant protocol or licence number, describe measures to minimize pain and distress, and apply the principles of Replacement, Reduction, and Refinement.
Reporting should follow ARRIVE guidelines where applicable. If formal approval is not required, authors must explain the exemption and the welfare standards followed.
7. Secondary Data, Specimens, and Exempt Work
Studies using existing records, stored specimens, public datasets, or cell lines must explain their source, authorization, ethical status, and relevant consent or access conditions.
Public availability or de-identification does not automatically establish exemption. Authors must provide the applicable basis for any exemption or determination that review is not required.
Literature reviews and computational studies using exclusively public, non-identifiable information may not require ethical clearance. The manuscript must state why approval was not applicable. Additional permissions, biosafety requirements, and data-use restrictions remain applicable where relevant.
8. Reporting and Verification
Manuscripts must include an “Ethics Approval and Consent” statement in the Methods section or another clearly identified section. As applicable, it must report:
- The full name of the reviewing committee.
- The approval or exemption reference and date.
- Consent procedures or an authorized waiver.
- Relevant animal research authorization.
- Consent for publication of identifiable material.
The journal may request approval documents, protocol details, or clarification. Required approval obtained only after the relevant activities were completed does not retrospectively replace prior review.
9. Editorial Action
Ethical approval does not guarantee acceptance. Editors may seek independent advice or contact the relevant institution when concerns arise.
Missing information may require clarification. Evidence of absent required approval, fabricated documentation, or serious ethical breaches may lead to rejection or action under the journal’s Research Misconduct and Correction and Retraction policies.
This policy takes effect on the date announced by the journal and is reviewed periodically.
Example text in manuscript
Approved Human Participant Research
Ethics Approval and Consent: This study was approved by [full committee name] on [date], approval number [number]. Informed consent was obtained from [participants/their legally authorized representatives], with assent where applicable. [Describe the actual consent procedure.]
Approved Waiver of Consent
Ethics Approval and Consent: This study was approved by [committee], reference [number], dated [date]. The committee waived the requirement for [specify the type of consent] because [approved justification].
Formal Exemption or Non-Research Determination
Ethics Approval and Consent: [Authorized body] determined that this activity [was exempt from ethics review/did not constitute human participant research], reference [number, if available], dated [date], because [reason].
Ethics Approval Not Applicable
Ethics Approval and Consent: This work involved only [describe materials or information used] and did not involve human participants, identifiable human data or specimens, or live animals. Ethics approval was not required under [applicable institutional policy or determination].
Consent for Publication
Written informed consent for publication of identifiable images or information was obtained from the individuals concerned or their legally authorized representatives.
