Trends in Pharmaceutical Biotechnology (TPB)requires authors to obtain documented informed consent from all individuals who participate in research involving human subjects or whose personal data, images, or identifiable information are included in a manuscript.

Informed consent must be given voluntarily , and only after the participant has received clear, accurate, and comprehensive information regarding:

1. The purpose, nature, and procedures of the research.
2. Potential benefits and foreseeable risks associated with participation.
3. Any available alternative treatments or options, when applicable.
4. The right to withdraw from the study at any time without penalty.
5. How personal data, images, or biological materials will be used, stored, published, or shared.

 

1. Requirements for Informed Consent

- Consent must be obtained before participation in the study.
- Consent forms must be approved by an appropriate Institutional Review Board (IRB) or Ethics Committee.
- For participants under the age of legal consent, approval must be obtained from a parent or legal guardian.

Authors must confirm in the manuscript that:

- Informed consent was obtained from all participants.
- Ethics approval was granted (when required).
- Privacy and confidentiality were protected.

2. Identifiable Information

Manuscripts that include:

- Patient images
- Case reports
- Videos
- Personal details
- Genetic information

must have explicit written consent allowing publication.If consent cannot be obtained, the material must not be submitted.

3. Anonymity and Privacy

Authors should ensure that personal identities cannot be recognized unless:

- Explicit permission has been granted, and
- The participant has understood that full anonymity cannot be guaranteed.

Removing names or facial features alone may not be sufficient if the individual could still be identified.

4. Documentation and Verification

- Authors must retain copies of consent forms and ethics approval documents.
- The journal may request these documents during peer review or post-publication assessment.
- Copies should not be submitted with the manuscript to preserve patient confidentiality.

5. Exceptions

Informed consent is not required for:

- Completely anonymized data that cannot be traced back to an individual;
- Publicly available datasets that comply with ethical standards;
- Studies that have received a documented waiver from an Ethics Committee.

Waivers must be clearly justified and reported in the manuscript.

6. Non-Compliance

Failure to comply with the journal’s informed consent policy may result in:

- Manuscript rejection.
- Retraction of published work.
- Notification of the authors’ institution or funding agency (if necessary).

 

Statement for Manuscripts

Authors must include a statement such as:

“Informed consent was obtained from all individual participants included in the study. The study protocol was approved by the Institutional Review Board of [institution name].”