Our Ethical Standards
Protecting the rights and wellbeing of our clinical trial participants
BioNTech honors the privacy of the participants in its clinical trials by safeguarding personal data with the appropriate security measures in accordance with the applicable data protection requirements. As with medical records, all information collected during clinical trials will be kept confidential. Information regarding a trial participant’s identity will not be transferred to BioNTech and will not be included in any reports or publications.
Trial participants will be informed in a timely manner if new information becomes available that may impact their well-being and/or their willingness to participate in the trial.
Ensuring legal and ethical standards for our clinical trials
At BioNTech, we want to improve the quality of care for people. In accordance with this mission, we ensure that all trials and clinical research activities meet or exceed international ethical and human rights principles to respect and protect the rights, well-being, safety, and dignity of all participants in our clinical trials, including those that may involve children.
All BioNTech clinical trials are conducted in accordance with the clinical trial protocol, the ethical principles that have their origin in the Declaration of Helsinki (2000), Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, International Conference on Harmonization (ICH) for Good Clinical Practice (GCP) guidelines, and applicable laws and regulations.
By complying with the above guidelines, we ensure the highest standards when designing trials, as well when conducting, performing, monitoring, auditing, recording, analyzing, and reporting information pertaining to a clinical trial. These guidelines ensure that the data and reported results are accurate and credible. Importantly, they also protect the rights, well-being, and confidentiality of the participants in the trial.
Our external partners
BioNTech works with Contract Research Organizations (CROs) which are qualified independent service providers and other contractors to support clinical trials. We regularly audit these external organizations to ensure that the high requirements are met and that theyshare our ethical standards. All external contractors are supervised by employees at BioNTech. We also maintain partnerships with other pharmaceutical companies with whom we co-develop many compounds.
External control of clinical trials
To ensure compliance with the highest ethical standards and to protect the rights, safety and well-being of trial participants, clinical trials are reviewed by independent panels known as Institutional Review Boards (IRBs) in the US and Independent Ethics Committees (IECs) in other parts of the world. IRBs/IECs also review the appropriateness of the clinical trial protocol as well as the risks and benefits to trial participants. IRBs/IECs are independent panels composed of researchers, ethicists, legal experts, community members and physicians that are not directly involved in the trial.
In addition, clinical trials are reviewed and overseen by non-independent safety review committees (SRCs) and independent data and safety monitoring boards (IDMBs). This allows us to further protect the rights, safety and well-being of the trial participants while studying the safety and effectiveness of our investigational products.
Frequently used terms in a clinical trial
Every clinical trial follows strictly defined protocols and assesses defined clinical outcomes. Learn more about the terminology here