Informed Consent Policy
Informed Consent Policy
The Journal of Drug Delivery and Biotherapeutics (JDDB) upholds the highest ethical standards in research and publishing, including the protection of human participants and their rights. This policy outlines the journal's requirements regarding informed consent for all studies involving human participants.
- Requirement for Informed Consent
- All research involving human participants, including case reports, clinical trials, and observational studies, must obtain written informed consent from participants prior to inclusion in the study.
- Authors must ensure that participants:
- Are fully informed about the purpose, methods, potential benefits, and risks of the research.
- Understand their rights, including the right to withdraw from the study at any time without consequences.
- Provide explicit and voluntary consent to participate in the study.
- Documentation of Informed Consent
- Authors must provide a statement in the manuscript confirming that informed consent was obtained from all participants.
- Example statement:
"Informed consent was obtained from all individual participants included in the study." - In cases where obtaining consent was not possible, authors must justify this in the manuscript and confirm that the study received approval from an ethics committee.
- Special Considerations
- Case Reports:
For case reports or studies involving identifiable individual data (e.g., images, medical records), explicit written consent must be obtained from the individual or their legal representative. The manuscript must include a statement confirming consent.
Example statement:
"Written informed consent was obtained from the patient for publication of this case report, including any accompanying images." - Vulnerable Populations:
Research involving minors, individuals with cognitive impairments, or other vulnerable populations requires consent from legal guardians or authorized representatives in addition to assent from the participants, where applicable.
- Ethical Approval
- All studies involving human participants must have prior approval from an institutional review board (IRB), ethics committee, or equivalent body.
- Authors must include a statement in the manuscript indicating that ethical approval was obtained.
- Example statement:
"The study protocol was reviewed and approved by [Name of Ethics Committee], and all procedures were conducted in accordance with the Declaration of Helsinki."
- Anonymity and Confidentiality
- Identifiable information about participants must not be published unless explicit consent has been obtained.
- Authors must ensure that confidentiality is maintained and that all identifying details are removed from the manuscript unless they are essential to the research findings and consent has been obtained.
- Retrospective Studies
- For studies analyzing previously collected data, authors must confirm that the original data collection adhered to ethical guidelines and that informed consent was obtained at the time of collection, where applicable.
- Non-Compliance
- Manuscripts submitted to Journal of Drug Delivery and Biotherapeutics (JDDB) that fail to adhere to this policy may be rejected or subjected to further ethical review. In cases of ethical violations, the journal reserves the right to retract published articles.
