Clinical research has the potential to help us expand our knowledge of human diseases, to prevent and treat illnesses and to promote health and improve patient care. St James’s Hospital works together with its academic partner, Trinity College Dublin, to deliver high-quality research studies to our patients.
Doctors, scientists and other healthcare professionals such as physiotherapists and dieticians, participate in research with the aim of improving patient care. Some research studies are led by the hospital, others are led by Trinity College Dublin and others have commercial sponsors.
Clinical research is important to us in St James’s Hospital because it aims to improve the quality and efficiency of our health services, and enhance the quality of life of patients. It helps us to find new and better ways to detect, prevent, diagnose, and treat disease. Clinical research would not be possible without the participation of our patients. We hope this page will help you to understand what research is all about. Ask your doctor for more information about research studies that you may be able to take part in.
Clinical research would not be possible without the participation of our patients and the public. There are a number of ways you can get touch if you are interested in participating in a research study:
a) You may be approached by your doctor to check if you are interested in participating in a specific clinical research study. This selection process (or pre-screening) is based on certain inclusion criteria, such as disease status, medical history etc. If you decide not to take part, it won’t affect your future medical care.
b) You can ask your doctor or nurse for more information about research studies you may be able to take part in, or if there is a suitable research study or clinical trial for you.
c) Researchers may advertise throughout the hospital, using posters or information leaflets. If you would like to volunteer for one of these studies, you can get in touch directly with the researcher using the contact details provided.
d) You can view a list of recruiting cancer trials currently taking place in St James’s Hospital on the Cancer Clinical Trials Unit website.
e) You can contact the R&I Office at firstname.lastname@example.org or call on (01) 415 1978 / (01) 410 3904.
Before you decide whether or not you wish to take part in a research study, you should read the information provided by the study team carefully and, if you wish, discuss it with your family, friends or GP (doctor). Take time to ask questions – don’t feel rushed and don’t feel under pressure to make a quick decision.
You should clearly understand the risks and benefits of taking part in this study so that you can make a decision that is right for you. This process is known as ‘Informed Consent’.
All clinical research studies are reviewed by an Ethics Committee. The committee will give an opinion about whether the research is ethical. This helps to safeguard the dignity, rights, safety and well-being of research participants. Clinical research studies are also reviewed by the hospital before they are given permission to begin.
Any clinical trial using medicines, medical devices or other health products in Ireland must also have approval from the Health Products Regulatory Authority (HPRA). This is to ensure all health products are as safe as possible.
This involves looking at patient healthcare records in order to find out whether a person may be suitable to take part in a research study. Only personal data that is necessary to decide if you are a suitable candidate will be accessed. This is carried out by hospital employees or other hospital researchers who have been given authorisation by the Research and Innovation Office. You do not need to give consent for pre-screening; however, if you might be suitable to participate in a research study, the research team or your doctor will contact you to ask if you would like to receive more information and to take part. Pre-screening helps to ensure that only patients who are likely to meet the study requirements are approached about the research study.
You will always be asked to give your consent before entering into a research study – with the exception of retrospective chart review research which is explained below. You will be given an information leaflet about the study which will explain what the study involves and how your information will be used. You will be provided with the time to read the leaflet and have your questions answered before you are asked to sign a consent form.
Your participation is always voluntary and you can stop taking part in the research study at any time. It will not affect your current or future medical care in any way if you decide not to take part in the research.
In very limited circumstances, obtaining consent will not be possible and the public interest of doing the research will outweigh the need for explicit consent.
In these cases a researcher can apply to the Health Research Consent Declaration Committee (HRCDC). The HRCDC can give a declaration to allow the research to take place without explicit consent.
See the HRCDC website for further information: https://hrcdc.ie/
This is when healthcare professionals or healthcare students, for example doctors or nurses, look back at existing healthcare records with the aim of learning more about a disease or condition. This type of research is permissible when it is low risk and does not involve any intervention, but it is extremely important, as it may inform and improve future patient care. Consent is not required for this type of research. Research results are only shared in aggregated and anonymised form through reporting, publications and at conferences. Your personal information will be protected and will not be identifiable in the final results.
A biobank is a collection of biological samples and healthcare data donated by people for health research. Biological samples may include tissue, blood or other specimens. Healthcare data includes information in your medical records about your condition, for example medical history, blood tests and scan results.
Health research can take many years and large numbers of people are required to donate their samples and healthcare data to get the best results. Biobanks can speed up research by having samples and healthcare data ready to use when researchers need them.
Samples may be used immediately or stored securely with restricted access in the biobank for future research. When a sample is first collected, the name of the patient and medical record number is recorded, so that the healthcare team can link the samples to the patient. Your sample will not be labelled with any information that can identify you. Instead, it will be given a unique biobank number or code.
The decision to take part in a biobank is completely voluntary. Samples are only taken with your informed consent and a decision not to join the biobank will not impact on your care or treatment in any way. If you change your mind, you can withdraw at any time
For more information, please see Biobank Network
St James’s Hospital and Trinity College Dublin are committed to ensuring the privacy and confidentiality of your personal information.
All researchers conducting clinical research will sign a confidentiality agreement before accessing any personal information, and only information relevant to the study is released to researchers. All clinical research is carried out in compliance with General Data Protection Regulations (GDPR), part of EU-wide law to protect your data privacy. The research must also be approved by the Research Ethics Committee and the hospital. Researchers will complete a Data Protection Impact Assessment (DPIA) form before the research begins – this will help to identify and reduce any data-related risks.
There are many types of clinical research studies happening in St James’s Hospital, examples are: