Ethical Approval for Studies Involving Human Participants

Journal of Biomedicine and Biochemistry (JBB) is firmly committed to ensuring that all research involving human participants is conducted in accordance with internationally accepted ethical principles and applicable regulatory frameworks. Ethical approval is mandatory for any study involving human subjects, personal data, biological materials, or identifiable human information.

1. Ethical Approval Requirements

All manuscripts reporting research involving human participants must include documented approval from a recognized Institutional Review Board (IRB) or Ethics Committee (EC).
Ethical approval must comply with the following international frameworks:

- Declaration of Helsinki (WMA)
- International Council for Harmonisation (ICH-GCP)
- CIOMS International Ethical Guidelines 
Authors must upload a copy of the approval letter or certificate, clearly stating the institution, approval number, and date.

2. Informed Consent

Authors must confirm that written informed consent was obtained from all participants. Consent forms must include:

- Purpose and procedures of the study
- Risks and potential benefits
- Confidentiality and data protection measures
- Participant rights, including voluntary participation and the right to withdraw

If minors or vulnerable populations are involved, consent must be obtained from legal guardians in compliance with CMJE guidelines.

3. Confidentiality and Data Protection

Researchers must ensure confidentiality and comply with:

- General Data Protection Regulation (GDPR), where applicable
- National data protection laws
- Secure storage, de-identification, and restricted access to personal data

No identifiable information may be published unless explicit written permission is obtained.

4. Minimization of Risk

Researchers must ensure that any risks—physical, psychological, social, or privacy-related—are minimized and justified by the scientific value. Safety measures must align with:

- WMA Helsinki guidelines
- National biomedical research regulations
- Institutional risk assessment policies

5. Reporting Requirements

Manuscripts must include a dedicated Ethical Compliance Statement indicating:

- Name of IRB/EC
- Approval ID
- Informed consent procedures
- Compliance with the Declaration of Helsinki and ICMJE standards

Failure to comply may result in rejection or post-publication actions, including corrections or retractions.

 

Ethical Approval for Studies Involving Animal Participants

Journal of Biomedicine and Biochemistry (JBB) strictly adheres to globally recognized standards for the ethical treatment of animals in research. Ethical approval is mandatory for all studies involving live vertebrates or higher invertebrates.

1. Ethical Approval Requirements

All animal studies must be approved by an accredited:

- Institutional Animal Care and Use Committee (IACUC)
- Animal Ethics Committee , or
- Equivalent regulatory authority

Approval must comply with international guidelines, including:

- ARRIVE Guidelines 2.0 (Animal Research: Reporting of In Vivo Experiments)
- EU Directive 2010/63/EU on the protection of animals used for scientific purposes
- OECD Good Laboratory Practice (GLP)
- NIH Office of Laboratory Animal Welfare (OLAW)

 Documentation must include protocol numbers, approval dates, and institutional affiliations.

2. Protocol Requirements

The submitted protocol must detail:

- Purpose and scientific justification for animal use
- Species, strain, sex, age, and number of animals
- Experimental procedures
- Housing, environmental conditions, and veterinary care
- Measures to reduce suffering, stress, and pain
- Euthanasia methods (must comply with AVMA Guidelines)

3. Implementation of the 3Rs Principle

Authors must explicitly demonstrate the application of:

- Replacement — using non-animal alternatives when possible
- Reduction — using the minimum number of animals necessary
- Refinement — minimizing pain, suffering, and improving welfare

Reference: NC3Rs (UK)

4. Training and Competency

All personnel must be trained and certified in proper handling, anesthesia, surgical methods, and humane endpoints, consistent with:

- Institutional training standards
- FELASA guidelines (Europe)

5. Reporting Animal Ethics Compliance

The manuscript must include:

- IACUC/committee name
- Approval number and date
- Assurance that the study followed ARRIVE guidelines
- Welfare monitoring procedures
- Statement confirming adherence to the 3Rs

Studies lacking ethical approval or violating welfare principles may be rejected or retracted.