Ethical approval for studies involving human participants is essential to ensure the integrity, validity, and ethical conduct of research. At Trends in Pharmaceutical Biotechnology (TPB), we are committed to upholding the highest ethical standards and promoting responsible research practices in the field of pharmaceutical biotechnology — including clinical and pre-clinical drug trials, pharmacokinetic and bioavailability studies, and vaccine or biologic development involving human subjects.

1Ethical Review Process

• All research studies involving human participants submitted to TPB must have obtained ethical approval from a recognized Institutional Review Board (IRB) or ethics committee.
• Researchers must provide documentation of ethical approval with their manuscript submission, clearly outlining the ethical considerations, procedures, and safeguards implemented to protect participants' rights and welfare.
• For clinical drug trials, authors are encouraged to report the trial's registration number (e.g., ClinicalTrials.gov or an equivalent national registry).

2Informed Consent

• Informed consent must be obtained from all human participants involved in the study.
• Consent forms should clearly explain the purpose of the study, procedures involved, potential risks and benefits, confidentiality measures, and participants' rights.
• Participants must have the opportunity to ask questions and provide voluntary consent without coercion or undue influence.

3Confidentiality and Privacy

• Researchers must uphold confidentiality and privacy by ensuring all personal information is handled securely and anonymously.
• Data collection, storage, and sharing practices must comply with relevant data protection regulations and ethical standards.

4Minimization of Risks

• Researchers are responsible for minimizing risks to human participants throughout the research process.
• Any potential risks to participants' physical, psychological, or emotional well-being — including adverse drug reactions in pharmacological studies — must be identified and appropriately mitigated and reported.

5Respect for Participant Autonomy

• Researchers must respect the autonomy and dignity of human participants by allowing them to make informed decisions about their involvement.
• Participants have the right to withdraw from the study at any time without facing consequences.

6Reporting of Ethical Considerations

• Authors must clearly report ethical considerations and procedures in their manuscript, including details of ethical approval, informed consent procedures, and measures taken to protect participants' rights.
• Any ethical issues or concerns arising during the course of the study must be addressed and reported transparently.

7Compliance with Ethical Standards

• Researchers must adhere to relevant ethical guidelines and standards, such as the Declaration of Helsinki and applicable national and international regulations, as well as Good Clinical Practice (GCP) standards where the study involves an investigational drug or biologic.
• Non-compliance with ethical standards may result in rejection of the manuscript or retraction of published articles.

Policy: All studies involving animal participants submitted to TPB must have received ethical approval from an accredited Institutional Animal Care and Use Committee (IACUC) or an equivalent regulatory body. Ethical approval ensures that the welfare and rights of animals are protected throughout the research process.

1Protocol Submission

Researchers must submit a detailed protocol outlining the purpose, methods, and expected outcomes of the study — including, for pharmacological studies, the drug or compound under investigation, dosing regimen, and route of administration — to the appropriate ethics committee.

2Animal Welfare Considerations

The protocol must include detailed information on how the welfare of animals will be safeguarded throughout the study, including housing conditions, feeding protocols, veterinary care, and measures to minimize pain and distress.

3Justification for Animal Use

Researchers must provide a clear justification for the use of animals in the study, demonstrating that the research aims cannot be achieved through alternative methods (such as in vitro or in silico pharmacological models) and that the benefits of the research outweigh any potential harm to the animals.

4Species and Numbers

Researchers must specify the species of animals to be used and justify the number required to achieve statistically significant results while minimizing the overall number of animals used.

5Training and Qualifications

Researchers and personnel involved in animal care and experimentation must have appropriate training and qualifications to ensure competent and humane treatment of animals.

6Ethical Review Process

The submitted protocol undergoes a thorough ethical review by the IACUC or equivalent regulatory body, consisting of experts in animal welfare, veterinary science, and relevant scientific disciplines.

7Approval Criteria

Ethical approval is granted based on compliance with established ethical guidelines, scientific validity, and consideration of the 3Rs principle (Replacement, Reduction, Refinement) for animal research.

8Modifications and Amendments

Researchers must obtain approval for any modifications or amendments to the approved protocol before implementing changes to the study.

9Annual Review

Ethical approval for long-term studies involving animal participants is subject to an annual review to ensure ongoing compliance with ethical standards and welfare considerations.