Before you take part in a cancer trial you must give your written consent to do so. This is done by signing a consent form.
You will be given a Patient Information Leaflet, which explains the details of the trial such as the drugs you’ll be given, how long you’ll be on the trial and how many times you’ll need to visit the hospital so that your progress can be monitored. It will also outline the potential risks so you are fully informed of all aspects of the trial.
You’ll be able to discuss all details and any concerns you may have with the trial’s Doctor and Research Nurse before you sign the consent form to make sure all your questions have been answered and you are happy to participate.
Every reasonable precaution will be taken to ensure your safety during the trial.
Nothing you are told when you consent to take part in a trial alters your legal rights to recover damages should you suffer an injury as a result of participating in a trial.
Participation in studies is covered by an approved insurance policy in the name of the company leading the study. This could be an international research organisation or a pharmaceutical company. For studies led by Cancer Trials Ireland, this is covered by the State Claims Agency.
The study sponsor will comply with applicable guidelines (such as the Irish Pharmaceutical Healthcare Association (IPHA) Clinical Trial Compensation Guidelines for studies involving medicinal products) and with Irish law if you become ill or injured as a result of participation in a study. The amount of any compensation paid may, however, be reduced if you have not complied with the instructions issued for this study.
In addition, the medical practitioners involved in this study have current medical malpractice insurance coverage in public hospitals under the Clinical Indemnity Scheme managed by the State Claims Agency and in private hospitals by liability insurance covering research.
Key points in relation to consent
- A clinical trial involving a study drug or drug combination has to be approved by the Health Products Regulatory Authority (HPRA). The HPRA is Ireland’s state body responsible for regulating medicines, medical devices and other health products. The HPRA decides if a 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 must be approved by a national Ethics Committee and/or the Ethics Committee of the hospital in which it is taking place. These independent committees are usually made up of doctors, nurses, medical staff, lawyers and members of the public.
- Specialist cancer doctors from Cancer Trials Ireland also review trials before they are approved.
- Numerous precautions are taken to ensure your well-being during a trial. Patient safety on clinical trials is continuously monitored and subject to legally binding reporting requirements. Pharmacovigilance or drug safety in trials involves monitoring events that may occur to patients on trials.
- 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 may withdraw from a study at any time if you wish to do so.
Patient safety on clinical trials is continuously monitored and subject to legally binding reporting requirements.
Pharmacovigilance, or drug safety in trials, involves monitoring events that may occur to patients on trials.
All adverse events experienced by a trial patient are recorded on the clinical trial report forms. All events are documented whether they are considered related or not to the study drug. Some of these events are considered serious adverse events (SAEs) if they meet certain criteria, most typically hospitalisation. All serious adverse events are reported by the hospital staff within 24 hours to the sponsor of the trial such as Cancer Trials Ireland.
Our pharmacovigilance team assess all events and report them (if required) to competent authorities (e.g. the Health Products Regulatory Authority), the concerned national ethics committee (the ethics committee that approved the trial) and all doctors participating in the trial. The serious adverse events that are considered possibly related to the study drug and unexpected for the study drug (suspected unexpected serious adverse reactions (SUSARs)) are reported by Cancer Trials Ireland within defined time limits (7 or 15 days)). These SUSARs are entered in a European database (Eudravigilance) and subject to consideration and review by the national competent authorities and European Medicines Agency.
Pharmacovigilance is conducted in adherence to national and EU regulations such as the clinical trial directive 2001/20/EC and associated guidance on adverse event/reactions (‘CT-3’). Pharmacovigilance staff ensure the most up to date regulations are adhered to by attending Irish and European pharmacovigilance information days and by receiving alerts from the HRPA and other organisations. Cancer Trials Ireland’s pharmacovigilance staff ensure compliance with these regulations by following Standard Operating Procedures. Pharmacovigilance compliance is monitored continuously by HPRA.
If you require further information, please contact the pharmacovigilance department at firstname.lastname@example.org.