Learn how you can take part in research and support our clinicians to improve care for all
Taking part in research
If you are treated at one of our hospitals, you may be invited to take part in clinical research. It is entirely up to you whether or not you wish to be involved. If you decide not to participate, you will still be treated with the best care currently available.
The length of time each study takes and what you’ll need to do varies depending on what is being investigated and on the specific tests and measurements that are needed. Some trials may involve overnight stays, or making additional visits to hospital. We’ll make these clear to you when you sign up for the trial.
If you enquire about one of our clinical research studies our research staff will give you more information on the estimated length of the study and what to expect if you agree to take part. They will also discuss eligibility and screening with you. Most studies have quite specific inclusion and exclusion criteria, and all potential participants are screened to make sure they are eligible for a study.
Patients from hospital outside our Trust can take part in our trials dependent on eligibility criteria but would need referral to a specialist team at our Trust.
Healthy volunteers can take also part in some healthcare research.
What type of clinical research studies do we carry out?
We carry out two main types of clinical research: observational studies and interventional clinical trials.
During a clinical trial, participants receive a pre-planned medical ‘intervention’ under development. This might be a particular new drug, device or medical procedure. Some clinical trials are designed to compare a new treatment to one that already exists. In other trials, a new treatment is compared to a placebo or to the results of a participant who receives no treatment at all. All trials seek to understand if the new treatment is both effective and safe.
This type of trial is thoroughly regulated in line with national and European law, to ensure patient safety, informed consent and scientific effectiveness.
Observational studies do not involve a medical ‘intervention’, but instead involve observing the behaviour of a group of participants within routine clinical practice, and recording the results. An observational study may follow a group of participants over time to assess the incidence of disease when exposed to one more risk factors. For example, the incidence of lung cancer in participants who smoke and those who don’t smoke. In some cases, additional clinical tests may be required (e.g. blood/urine samples) for participants, over and above routine clinical care.
Why do organisations conduct healthcare research?
- To look at a new treatment or technique and evaluate how effective it is in the treatment of particular disease or condition
- To identify ways of stopping or reversing the development of a particular disease or condition
- To identify ways of diagnosing a particular disease or condition
- To look at ways of improving the quality of life for people who have a particular disease or condition
- To prevent the incidence of particular diseases or conditions in specific patient populations
What are the benefits of taking part in a trial?
Research trials examine potential new treatments and techniques which, in the long-term, could help to cure or control a particular health condition. Dependent on the condition you are suffering from, the trial you take part in could help to improve your symptoms. By taking part in healthcare research you will have access to new drugs and techniques that are not yet licensed or available on prescription. You will be supported throughout your trial and have regular access to healthcare professionals and experts.
Many people participate in studies from an altruistic perspective. They understand that while the research trial they are taking part in might not make a difference to their prognosis or symptoms, it may help sufferers of a particular condition in future generations. They are happy to be able to support the advancement of healthcare and the development of new techniques and therapies.
What are the risks of taking part in a clinical trial?
The risks of taking part in clinical research are low due to the levels of expertise, regulation and quality assurance involved. However, in studying new treatments and investigations, our research teams may be aware of possible side effects, and will discuss these with you in advance. For earlier phase research, there is a possibility of unknown side-effects but again, this will be discussed with you, so you can make the decision as to whether the risk outweighs the potential benefits. It is important to bear in mind that many routine treatments and investigations have the potential for side effects, but these are rarely serious.
We will closely monitor your health during a study and ask you to tell us about any illnesses or changes in your body that you notice.
What typically happens during a clinical research trial?
During an interventional trial you may be given a particular drug, or device, or treated using a new procedure. How you respond to this intervention will be closely monitored and recorded. During the trial you will probably need to be examined, which might involve measurements such as your weight, height or blood pressure. You may need to have blood tests and scans, to see how you react to a particular intervention. If you enquire about a trial, the research team will be able to provide you with more detail on exactly what you will need to do.
How long do trials take?
The length of a particular trial or study will vary. If you enquire about a particular trial, the research team will be able to explain to you the time commitment, how long the trial will last, where it’s located, how many visits you will need to make to hospital and whether you will need to stay overnight. Some studies only involve one visit and be over in a few months, while others can continue for several years. The length of time depends upon how long it takes to identify and recruit an appropriate number of participants, how long each participant needs to spend in the study and how long is needed to follow up and analyse the resulting data.
What about confidentiality?
If you take part in a study, people other than your doctors will need access to your medical records. However, this information is usually anonymised. Everyone who will have access to your records has to follow the same confidentiality guidelines as all other hospital staff. Sometimes the research is carried out at many hospitals and we need to share the information about how the study is progressing. If we do send out information to other organisations, your personal details will be replaced by an anonymised identification number to protect your confidentiality. All confidentiality issues will be detailed in a patient information sheet accompanying each research study, which you can read and discuss before you give your consent to participate.
How do I know if I’m eligible to take part?
Every trial has specific eligibility criteria, which may include age, gender, your medical condition and treatment history. You can read about the basic inclusion criteria in our list of current research trials.
Who does the research?
This will depend on the study, but it is likely to be a combination of doctors, nurses or midwives and other healthcare professionals. Research can also involve medical students. Please feel free to ask who is carrying out the research and who is funding the study, if this may affect your decision to take part.
Who approves the study?
All studies carried out at our Trust are approved by an independent research ethics committee, following national procedures and guidelines. They examine everything that will take place in the study and how it will be done, with a particular focus on the interests of patients.
Will I be able to find out the results of the research?
The research team will be able to tell you when the project is completed and when the results will be available.
What if I have concerns about the research?
If you have any questions or concerns about the research, you should contact the research team in the first instance. If you need to take your concerns further please then speak to the patient advice and liaison service (PALS) at the hospital.
Will I have to decide straight away if I want to take part?
No. It is better to take the time to discuss the benefits and the risks with other healthcare professionals (such as your GP) or with relatives or friends before you decide. The research team will also be available to discuss the study further.
Will I be paid to take part?
Some healthcare research trials pay their participants a fee to take part. Others reimburse their participants for any expenses incurred such as travel to and from hospital. It is worth discussing the financial implications of the trial with the researcher responsible for it when you enquire about taking part.
Can I withdraw from the trial at any time?
Yes you can withdraw from a clinical research study at any time, without giving a reason, and your ongoing treatment and care will continue as normal.
My first language isn’t English – do you provide interpretation?
Yes, study documentation such as patient information sheets are often translated into a number of other languages.
Questions for you to ask the researcher or principal investigator:
- What are the aims of this particular research study/trial?
- What will happen to me during the trial? (e.g. what medical interventions will I receive or what additional tests/measurements will I be required to contribute?)
- Will I receive any reimbursement or payment for the trial? Will there be any upfront costs, e.g. parking?
- How long will the study/trial last and what is the time commitment?
- Who is the principal investigator?
- Who are you likely to see during the research study/trial?
- What happens after the study/trial?
About this page
- Last updated