How are you protected if you take part in a clinical trial?

It is important to note that nothing your are told about when you consent to take part in a study alters your legal rights to recover damages should injury be suffered as a result of participation in this study.

Every reasonable precaution will be taken to ensure safety during the course of the trial.

Participation in this study is covered by an approved policy of insurance in the name of the study sponsor In addition, the medical practitioners involved in this study have current medical malpractice insurance coverage under the current Clinical Indemnity Scheme. The Sponsor will comply with the ABPI guidelines (The Association of the British Pharmaceutical Industry)and Irish Law (statutory and otherwise) in the unlikely event of your becoming ill or injured as a result of participation in this clinical study. The amount of any compensation paid may, however, be reduced if you have not complied with the instructions issued for the study.

• A clinical trial has to be approved by the Irish Medicines Board. This government department decides if a clinical trial can take place in Ireland. It ensures that the trial will be carried out in line with current Irish, EU and international standards for clinical research.

• A clinical trial has to be approved by the Ethics Committee of the hospital in which it is taking place. This independent committee is usually made up of doctors, nurses, medical staff, lawyers and members of the public.
• Specialist cancer doctors from the Irish Clinical Oncology Research Group (ICORG) also review proposed studies.
• Every reasonable precaution is taken to ensure your well being during a study. Every clinical trial is covered by an approved policy of insurance and all doctors involved must have current insurance cover.
• The information collected on the effects of the treatment will be shared with other doctors and researchers, but you will not be identified personally.
• You cannot be part of a clinical trial if you have not given your permission. Regulations require that patients are thoroughly informed about a study's treatments and tests before deciding whether or not to participate in the study. This is called informed consent.

• You may withdraw from a study at any time if you wish to do so.