Frequently Asked Questions

Here at the CRF at St. James’s Hospital we facilitate the conduct of a number of different types of research studies and clinical trials by health care professionals at the hospital.

There are a number of ways you can become involved in clinical research. If eligible you can participate in a clinical trial or research study as a patient or you may be eligible to participate in research as a healthy volunteer. Please ask your hospital doctor if there are any opportunities.

Research helps us to further understand the causes, development and effects of diseases and find better ways to prevent, diagnose and treat these diseases. The patient plays a central role in all clinical studies. People get involved in research for many different reasons. We know that some people decide to get involved because they want a chance to give something back and help influence research that might benefit others; have personal knowledge and experience which they would like research to take into account, or want to bring about improvements to health services and treatments for themselves and others.

The research activities that take place within the CRF are dependent on the individual study taking place. It is also dependent on the particular study visit as different activities may happen on different study visit days. A Patient Information Leaflet and Informed Consent Form will be provided to you prior to you taking part in any research activity. This will outline the research activities that will take place during the study. Should you require any additional information, please contact the CRF or your study doctor.

Risks will vary between studies. The Patient Information Leaflet and Informed Consent Form provided to you when you agree to take part in a study will outline all the possible risks involved. It is important to read these carefully and discuss any concerns or questions you may have with your study doctor prior to taking part in the study. You will be carefully monitored throughout the study by the clinical research team (doctors and nurses). If at any time throughout the study you have any concerns or questions, you should ask your study doctor or research nurse. Contact information for your study team will be provided to you before you take part in a study.

The benefits of taking part in research will vary between studies. In addition to taking a more active role in your own healthcare you may also be helping others by contributing to clinical research. Furthermore, you may have the opportunity to access new and innovative treatments not currently widely available.

You are free to withdraw from any research study at any time. You do not have to provide a reason for withdrawal if you do not wish to do so, but it would be helpful if you could let your doctor know why you have decided to withdraw.

Clinical trials and research studies must follow strict regulations and guidelines. Medical research must adhere to ethical standards that respect the rights, safety and well-being of participants. All studies must have Research Ethics Committee approval before commencing. Clinical Trials involving a medicinal product must also receive Regulatory approval from the Health Products Regulatory Authority prior to commencing. In addition, all research performed within the Clinical Research Facility is reviewed and approved by the CRF Operational Management. The CRF Scientific Advisory Committee may also review a study if required. A full time Quality and Regulatory Affairs Manager is employed within the CRF. They ensure study activities are consistent with those outlined in the study protocol and in compliance with current legislation and guidelines, and that participants’ rights, safety and well-being are maintained while taking part in the study.

The Clinical Research Facility considers the protection of our participants’ rights to privacy and confidentiality as critically important. We achieve this this by adhering to the St. James’s Hospital policy on Healthcare Records and Data Protection laws.

In order to maintain continuity of care we may request that your GP become aware of your involvement in a study. This is to make sure all relevant information about your care and treatment is available to them so that they can continue to manage your care appropriately. We will only inform your GP with your consent and this will be outlined in your Patient Information Leaflet.

It is important to bring your current medications and including any medications that you might have to take that day. You may want to bring a book or magazine depending on the type of study you are involved in and the anticipated length of the visit. If it is your first visit to the hospital or clinical research facility you will be asked a number of questions in order to register you to St. James’s Hospital. Please bring the following information with you as applicable: your PPS number or medical card, your address and phone number for your next of kin, your GP address and phone number, your insurance details if applicable.

The clinical research facility has procedures in place to care for you if you become unwell during your visit and can arrange transfer to St. James’s Hospital Emergency Department if necessary. All research participants to the clinical research facility have a doctor assigned for on-site medical cover and emergency out-of-hours medical cover as necessary.

If you need to cancel or change your appointment please let us know as soon as possible and we will make an alternative arrangement where possible. Contact the clinical research facility at 01 4103900.

Yes, each person attending the CRF may be accompanied by one visitor over 14 years of age.

If possible, please inform the research staff of this when you agree to take part in a research study. If you wish to contact the research staff after your appointment has been made you can contact the clinical research facility at 01 4103900. There are two wheelchair bays for patients who require a wheelchair. The first is located in the middle of the Concourse, past the shop. The other is located off Route 1 near the Porter’s desk. Please ask a member of reception staff to assist you if you require a wheelchair. We need to book Interpreter or Sign Language Assistance services in advance so it is important that you inform the clinical research facility if you require interpreter or sign language assistance before attending the clinical research facility.