Ethical Approval
Ethical Approval
The Clinical Research Ethics Committee of the Cork Teaching Hospitals (CREC) deals with ethical approval for clinical research involving human participants, their identifiable data or tissue. This Committee is recognised by the Department of Health and Children as a nationally competent ethics committee for clinical trials under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations. The CREC manual is available from the CREC secretariat.
All student research projects for their final Year Project must be referred for ethical approval to (CREC).
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
E-mail: crec@ucc.ie