Take part in a trial

It depends on the trial. Some trials (usually Phase 2 or 3 trials) use only people with certain diseases or conditions, or whose family members have certain diseases or conditions. Other trials can use people who are healthy.

Not everyone who wants to be in a trial can be in one. To be in a trial, you need to meet certain conditions. Often, you need to have the disease or problem being studied. Other conditions usually have to do with the health of your heart, liver, kidneys, or other organs. To see if you meet the conditions needed for the research, you might need to answer questions or undergo a medical examination or tests like blood tests.

If you are a patient at NUH, you will usually be asked by the doctors or nurses treating you if you would be willing to take part in current research happening in our hospitals.  You are free to say yes or no, and your treatment and care will not be affected by what you decide.

People can benefit from taking part in clinical research trials in different ways:

• Help to advance scientific and clinical knowledge about our health and wellbeing
• the chance to test a new treatment at an early stage
• work with research experts in your disease
• have your progress regularly monitored
• help people who will have your disease in the future, by supporting the development of new and more effective treatments, therapies or medicines
• learn about your health and about clinical research in general

Before deciding whether taking part in a clinical research trial is right for you, you should consider all of the information available to you from the research teams. They will explain how the trial will work, any risks or side-effects that you may experience and also the benefits of the treatments being tested. They will also explain any downsides to taking part, for example that the new treatment they are testing could be less effective than the treatment you are already receiving.

Please be aware that:

• You might not get the new treatment – our research will compare a new treatment with the "usual" treatment for a disease. Other studies compare a new treatment with a "placebo". A placebo is a treatment that looks the same as medicine and is given the same way, but doesn't have any medicine in it. A placebo is used only if doctors aren't sure that the usual treatment helps or if there isn't any good treatment for that disease or condition.
   
• In studies that compare two treatments, half of the people get the new treatment, and the other half get the usual treatment or placebo. Neither you nor your researchers can choose which treatment you get. Also, in many cases, you won't know which treatment you got until the trial is over.

If you decide to take part in a trial, you will need to give your written consent.

The most important step to taking part in clinical research, is your permission (consent).

Make sure you're happy with the trial and have been given all of the information you need before you give your consent (permission). This may mean taking some time to think about it and to talk it over with family or friends.

If you decide to take part, you'll be asked to sign a document to say you're agreeing to take part in the trial and have understood what it involves. This is called giving your informed consent. 

Giving consent for others

For people under the age of 18, a parent or guardian has to give informed consent.

As a relative we may ask you to give consent on behalf of the patient if they are not well enough to make a decision. In this case we ask you to think about what the patient would prefer. You will be asked to sign a relative’s consent form if you decide to go ahead.

In an emergency

In an emergency a decision may be needed urgently because of your medical condition. If the doctor thinks you may benefit from being in the trial, they can include you using something called a waiver of consent. This means that temporarily, the doctor makes the decision about you. Before this is done every effort will be made to contact your relatives. 

Using your data

Protecting your information

Our research is only possible because patients, families, carers and the public take part.

Using data collected from you, or about you or about whole populations of people with similar diseases or characteristics as you is an essential part of our research. We understand that sharing your data with us is an important decision.

So we make sure that at every stage of our research, we protect your privacy, confidentiality and dignity. 

Our researchers are specially trained, qualified and authorised to work with your data. We handle and store data in the most secure ways possible. We will only use your data for clincal research.

We will only use your personal data with the proper approvals, regulations and safeguards in place. In order to use your data we will work in one of the following ways:

• Ask you to agree (consent) to take part in a research trial and explain to you how your data will be used
• Ask the independent Confidentiality Advisory Group (CAG) for approval of our research where it ius not possible to ask for indivuals to give their agreement (consent) 
• Anonymise the data (to make sure that an individual cannot be identified) to enable us to do research on a bigger scale, with information from thousands of people

More information about using your data in research

The video above summarises how the NHS uses data to save lives and improve treatment and care; we are grateful to the Understanding Patient Data initiative for these resources.

You will find more information and resources on the Understanding Patient Data website.

Our commitment to you

At NUH we make the following commitments about the data we keep about you and the way that we protect it. We will:

• Keep the right information to provide services and fulfil our legal responsibilities to you
• Keep your records safe, secure and accurate
• Only keep your information for as long as necessary
• Collect, store and use the information you provide to the data protection standards and the laws that govern data protection
• Comply with the NUH Privacy Policy and the General Data Protection Regulation (GDPR), which requires that the way we manage your personal data is fair, lawful and transparent.

Excellence in data analytics

We are working with our partners in the University of Nottingham to develop the skills and capabilities to analyse extremely large amounts of data for research.

We are also working nationally as part of information collaborations and new developments in research data to improve healthcare across the country.  

Our experts check all trials – before and during them – to make sure that they are safe. Our research is also accredited by the relevant national regulatory or sponsoring organisation to ensure that we consistently meet all of the standards required to carry out clinical research in the UK. If there are signs that the treatment in a trial could be unsafe, the research team or the regulators will stop the trial. 

During the trial, you will need to follow all of the instructions about visits, tests, and treatments. This may be over a period of days, weeks or months. If you experience any problems, issues or side-effects, you should contact your research doctor or nurse.

You may decide to stop taking part in a trial if your condition is getting worse or if you feel the treatment isn't helping you. You can also choose to leave at any point without giving a reason and without it affecting the care you receive.