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Participating in a Clinical Trial

Participating in a Clinical Trial

Research is a key part of health care development. It aims to find out the causes of human illness and how it can be treated or prevented. Thousands of people each year agree to take part in research studies, contributing to the testing of potential new treatments, diagnostic aids or other developments, before they are adopted across the National Health Service. Some research compares two treatments, for example, to assess which is more effective.

You may be invited to participate in research whilst under our care. In addition to the studies already mentioned, you may be asked to complete a questionnaire about your condition or even provide some additional samples of blood or tissue for use in research studies.

If you are invited to take part in a research study, the study will be explained to you by a healthcare professional suitably trained in research and you will also be given written information explaining the following:

  • What the study is
  • Why it is needed
  • What you will need to do if you decide to participate
  • The possible risks and benefits to you
  • How your identity will be protected and details kept anonymous
  • Who will have access to the information collected
  • Arrangements in place in case of any research related injury
  • Anticipated expenses (if applicable)

Before agreeing to participate in a study, ensure that you fully understand all the information provided. Ask as may questions as you need to and discuss it with friends and family before making your decision.

If you decide to go ahead, you will normally need to sign a consent form to confirm that you wish to be involved.

Remember that you are not obliged to take part in any research. If you decide that you would rather not take part, this will not affect your care. If you decide to take part but subsequently decide you no longer wish to continue, you can leave the study at any time.

The Research Governance Framework for Health and Social Care (Dept of Health, Second edition, 2005) lays out the principles of good governance to be applied to all research studies carried out within, or in collaboration with, the NHS.

The framework includes the following key sentence: “The dignity, rights, safety and well-being of participants must be the primary consideration in any research study.” (Section 2.2.1 p.7)

The Medical Research Council (MRC) has produced some short videos about clinical trials, why they’re important and the difference they’ve made to people’s lives. Click on the link to view: http://www.youtube.com/playlist?list=PLSus4fp7v7sStG5QqcZyZFLT9yGpPCxSs

The UK Clinical Trials Gateway (UKCTG) http://www.ukctg.nihr.ac.uk/home/?utm_source=E-bulletin+subscribers&utm_campaign=739522c4ac-RDS+SW+e-bulletin&utm_medium=email&utm_term=0_a2002fb42a-739522c4ac-92863797 provides easy to understand information about clinical research trials running in the UK, and gives you and others access to a large range of information about these trials.  It is designed to enable you and your clinician to locate and contact trials of interest to you.  This information is designed to inform you of ongoing trials.  If you wish to join a trial you should discuss this with your doctor or clinical team first.  The decision to approach a trial remains yours, but you may need a referral from your doctor if the trial you are seeking to join depends on receiving treatment at a particular trial site.

If You Have Concerns while on a Study

Whilst it is something we hope will not happen, if you have concerns about any aspect of research please speak to the researchers using the contact details you will have been provided with. Alternatively, you may wish to contact the hospital's Patient Advice and Liaison Service (PALS).

PALS offers support, information and assistance to patients, relatives and visitors and will:

  • Provide information about hospital services.
  • Offer advice on where to go to get health information.
  • Help with problems that you haven’t been able to sort out with staff on a ward or in a clinic.
  • If you want to make a complaint - advise you how to do so.
  • Tell you about independent organisations that can help you with a complaint.
  • Listen to your views on how we can improve our services, and pass this on to the appropriate people for action.

PALS can be contacted at:

Patient Advice & Liaison Service
Level 7
Derriford Hospital
Plymouth
L6 8DH

Email: plh-tr.PALS@nhs.net

If you are interested in particpating in a clinical trial at Derriford Hospital please e-mail plh-tr.researchppiaccount@nhs.net for more information.


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