Human & Animal Research Ethics Policy

01. Human Participant Research Standards

All investigations involving human subjects, identifiable human tissue samples, patient records, or biometric data must comply with the World Medical Association Declaration of Helsinki (ethical principles for medical research involving human subjects).

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Institutional Review Board (IRB) Approval: Authors must state explicitly in the Methods section the name of the institutional ethics committee or review board that approved the protocol, alongside the formal approval reference number. If an ethics waiver was granted, formal documentation from the ethics committee must be cited.

02. Informed Consent & Privacy Safeguards

Authors must obtain freely given, written informed consent from all adult participants prior to participation in any study or clinical trial.

Patient Anonymity: Identifying personal details (names, initials, national ID numbers, hospital admission codes) must not be published in text, figures, tables, or supplementary databases.
Facial Photographs: Medical photographs must obscure patient faces unless written informed consent specifically authorizing publication has been provided.
Minors & Incapacitated Subjects: Consent must be obtained from legal parents or guardians, accompanied by assent from the minor where feasible.

03. Animal Welfare & The 3Rs Principle

Studies involving vertebrate animals or higher invertebrates must comply with the ARRIVE guidelines (Animal Research: Reporting of In Vivo Experiments) and international animal welfare regulations.

Replacement

Authors must verify that non-animal alternatives (in vitro assays, in silico computational simulations) were unfeasible.

Reduction

Experimental designs and statistical power calculations must minimize the number of animals required.

Refinement

Procedures, housing, and veterinary care must minimize pain, distress, and discomfort throughout the study.

Ethical Oversight

State the specific Institutional Animal Care and Use Committee (IACUC) permit or government regulatory license number.

04. Clinical Trial Registration & Reporting Standards

In accordance with ICMJE recommendations, all clinical intervention trials must be prospectively registered in a public trials registry approved by the WHO (e.g., ClinicalTrials.gov, ISRCTN, or national registries).

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Reporting Guidelines: Authors must follow established reporting checklists based on study type: CONSORT for randomized trials, PRISMA for systematic reviews, STROBE for observational epidemiology, and CARE for clinical case reports.

05. Research Involving Vulnerable Populations

Investigations involving vulnerable groups (prisoners, refugees, indigenous communities, children, economically marginalized populations) require heightened scrutiny. Researchers must substantiate that the inquiry addresses specific needs of the population and that coercion-free informed consent was guaranteed.

06. Required Declarations Format in Manuscript

Authors must place the following mandatory statements before the References section:

Ethical Approval: "This study was reviewed and approved by the [Full Committee Name] (Approval No. [XYZ-1234])."

Informed Consent: "Informed consent was obtained from all individual participants included in the study."

Animal Welfare: "All institutional and national guidelines for the care and use of laboratory animals were followed."

Research Ethics: Human Participants & Animal Subjects Policy