If the research project is clinical in nature, then it must be referred to the Research Ethics Committee of the Cork Teaching Hospitals (CREC).
The requirements of CREC are set out in the Committee’s manual which is freely available from the secretariat (email@example.com). In broad terms, prior approval is necessary where the research methodology involves:
- therapeutic interaction with a human participant
- a clinical trial of, inter alia, a medical device, medicinal product or clinical technique as stipulated under relevant legislation
- development of diagnostic techniques using human participants
- access to, or utilisation of, human tissue and body fluids
- access to, or utilisation of, identifiable medical data concerning individuals (such as clinical records) by parties not directly concerned in the provision of care to these individuals
- interaction with / observation of individuals in a healthcare contact or setting