Research Ethics

Research Ethics

Research Involving Human Subjects

Institutional Review Board Statement

Research involving human subjects, human material, tissues, or data must be conducted in accordance with the Declaration of Helsinki (1975, revised 2013). Prior approval from an Institutional Review Board (IRB) or equivalent ethics committee is mandatory. The article's 'Institutional Review Board Statement' must include the committee name, approval date, and project identification code.

• Example Statement: "The study was conducted according to the Declaration of Helsinki and approved by the Ethics Committee of XXX (Code: [ID]) on [Date]."

• Non-Interventional Studies: Studies using surveys or questionnaires also require ethical approval. Participants must be informed about anonymity, purpose, data use, and risks. If approval is waived, the granting committee and reason must be      stated.

Informed Consent Statement

Manuscripts must include an 'Informed Consent Statement'.

• For Participation: A statement confirming informed consent from all participants is required. Verbal consent is acceptable in specific cases, with the rationale and script provided.

• For Publication: Written consent for publishing identifiable details (images, personal data) must be obtained from participants or guardians. A blank consent form should be available upon request. Do not send signed forms.

• Privacy: Identifiable information  should be anonymized whenever possible. Editors may reject submissions that inadequately protect privacy.

• Example Statements: "Informed consent was obtained from all subjects." / "Verbal informed consent was obtained because [reason]." / "Publication consent was obtained from all identifiable participants."

Requirements for Studies on Vulnerable Groups and Organ Transplants

• Vulnerable Groups: Studies involving vulnerable populations undergo additional editorial review. Documentary evidence (e.g., blank consent forms) may be requested.

• Organ Transplants: Studies must specify the source institution of organs/tissues. Manuscripts reporting data from illegal or unethical sources are not accepted.

Clinical Trials Registration

• Registration: Clinical trials must be prospectively registered in a public registry (e.g., clinicaltrials.gov, EU Clinical Trials Register) before participant enrollment, per ICMJE guidelines. The registry name and trial number must be included in the manuscript.

• Reporting: Results of randomized clinical trials should be reported following relevant reporting guidelines such as CONSORT.

  
  

Ethical Guidelines for the Use of Animals in Research

Research must align with the '3Rs' principles: Replacement, Reduction, Refinement. Details on housing, husbandry, and pain management must be provided.

• Approval: Where required by national law, studies must have ethics committee approval. The 'Institutional Review Board Statement' must include the committee name, approval date, and project ID.

• Compliance: Manuscripts must state compliance with relevant legislation. For client-owned animals, informed client consent is required.

• Reporting: Adherence to high standards for reporting animal research is recommended. Editors may reject submissions on ethical or welfare grounds.

References

1. NSW Department of Primary Industries and Animal Research Review Panel. Three Rs.

2. UK Home Office. Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific Purposes.

3. American Association for Laboratory Animal Science. The Scientific Basis for Regulation of Animal Care and Use.

4. European Animal Research Association. EU regulations on animal research.