To ensure that the content of the study documentation is relevant and accurate, the submissions are prepared and progressed in a consistent manner, and they are subject to appropriate ethical review and approval procedures.
Policy
The Irish College of General Practitioners Ethics Committee will safeguard the rights, safety and well-being of all study/trial subjects. Special attention will be paid to studies/trials that may include vulnerable subjects. The Committee will ensure that studies and clinical trials are conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with GCP, the Clinical Trials Acts 87/90, the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004, and the Irish Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018.