If you are a patient attending hospitals, outpatient clinics or GP surgeries, you may at some stage be invited to participate in a research study. It is important that you are given sufficient information to make your decision whether or not to participate. An information leaflet, specific to the study will be given to you and a detailed discussion about your participation will be undertaken between you, your doctor, and in some cases a research nurse.
The following information may help you decide whether to participate in a research study or clinical trial.
Safety of Research
All research studies conducted within the Irish Healthcare Service are reviewed and approved by an ethics committee. Any risks or disadvantages associated with taking part in a research study will be disclosed fully to you. These may include, but are not limited to, side effects from drugs, discomfort associated with medical tests and procedures, and unknown risks. All drug trials will have prior approval from the Health Products Regulatory Board (the regulatory authority for medicines in Ireland).
Patient Rights
There is no obligation on you to participate in a research study when invited to do so by your doctor. If you decide not to participate, or to withdraw at any time during a research study, you may do so without having to give a reason. Your care or treatment will not be compromised.
Compensation for any injury caused by taking part in a clinical trial where a new medicine is being tested will normally be in accordance with the guidelines of the Association of the British Pharmaceutical Industry. Your doctor will be able to give you a copy of these.
Benefits
There may not be any direct or personal benefit gained by you from participating in a research study. Information obtained during the course of the study may help doctors to better understand certain conditions and may help treat patients in the future.
Expenses
In some studies travel expenses incurred by a patient may be reimbursed. This arrangement will be discussed prior to your consenting to participation in a study.
Confidentiality
Any information obtained by researchers during the course of a research study is anonymised and you will be referred to only as a study number. Medical records may be inspected by regulatory authorities, and if applicable by the company sponsoring the study, to ensure that the study is being carried out correctly. It is normal for your GP to be notified if you participate in a research study.
During the study
Some research studies take a few moments, others may involve frequent visits to a hospital or clinic over the course of a number of years. During this period you will have the contact name and number of research staff whom you may contact for further information or if you are having problems.
At the end of a study
Results obtained from a research study may be presented at medical meetings or published in medical journals. These results will contain no information as to your identity.
Genetic research
Genetic research involves looking at genes and their effect on your health. We inherit genes from our parents and these determine physical appearance such as eye and hair colour. Some genes also decide whether we will develop certain illnesses. Genes are studied to understand more clearly why some people develop some medical conditions and why a medication may work for one patient and not for another. Genetic research involves donating a tissue or blood sample. These studies are subject to the same safety and confidentiality precautions as clinical trials.
It is important that you are completely happy about participating in a research study before you give your consent. Ask any questions you may have and be happy that they have been answered adequately before you consent to the study.