Cystic Fibrosis (iABC) Ethical Advisory Board
The Ethical Advisory Board (EAB) provides guidance on ethical issues related to animal experimentation, human genetic material, data collection, safety, and more within the Inhaled Antibiotics in Bronchiectasis and Cystic Fibrosis programme. The EAB sets ethical standards, advises on clinical and animal studies, and ensures compliance with regulations. Board members include experts in pulmonology, ethics, and patient representation, working to maintain ethical integrity in research processes.
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Presentation Transcript
The Inhaled Antibiotics in Bronchiectasis and Cystic Fibrosis (iABC) Ethical Advisory Board
Task The EAB will advise the Participants of the iABC programme on any ethical issues relating to animal experimentation, use of human genetic material, use of Human Samples, use of human data collection, data access and transfer, animal use, safety, as well as any other ethical considerations that may arise in the course of the Programme and as such may require information from any or all Participants during the course of the programme. The team is a guidance body for the consortium. Output of the EAB cannot override local ethical regulations requirements.
Specific tasks Set ethical standards on the conduct of the clinical and/or animal studies within the Project to prevent a conflict of interest or the appearance of an ethics conflict. Provide advice related to ethical issues, Good Clinical Practices guidelines and/or animal welfare regulations as applicable to the performance of clinical trials and/or animal experimentation. EAB members advising on a clinical trial or animal experimentation shall be independent from the trial involved. During the performance of a clinical and/or animal study, the EAB is entitled to provide advice related to ethical issues involved in such trial, to the iABC Management Board (MB) During the performance of the animal studies or studies utilising Human Samples, the EAB shall advise the iABC MB in the event that the iABC MB intends to terminate animal studies or studies utilising Human Samples Advise Participants and the iABC MB in the event a national or local medical ethical committee, animal review board or national authority intends to terminate studies utilising Human Samples or an animal trial in a specific country or at the facilities of a Participant Reporting of any violation of the ethics standard operational procedures or any scientific (clinical or laboratory) misconduct to the iABC MB
Members Scott Bell (Chair) Pulmonologist CF/non CF bronchiectasis Brisbane Australia Harry Heijerman Pulmonologist CF/non CF bronchiectasis The Hague The Netherlands Janet Allen Director of Strategic Innovation CF trust UK Background: Biotechnology and biological sciences. Suzanne van de Vathorst Ethics and Philosophy Rotterdam The Netherlands Clare Hopley Patient with non-CF bronchiectasis (London, UK) (retired with a legal background)
What have we done to date. Tobramycin Inhalation Powder/TBM100 A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection Model Patient Information and Informed Consent for Protocol No. CTBM100G2202 Pregnancy follow-up Model Informed Consent for pregnant participants for Protocol No. CTBM100G2202 Model Patient Informed Consent Form Genetic Consent Protocol No. CTBM100G2202
