Taking part in research - information for patients & the public
There are many opportunities for our patients and members of the public to participate and get involved with research at Lewisham and Greenwich NHS Trust .
As a patient, you may be asked to participate in a research project. Depending on the research this may involve simply filling in a questionnaire; it might involve having an extra blood test taken, or it could involve trying out a medicine that doctors believe will work as well or better than the medicine that you would normally receive.
Information about the research and what it would involve would be clearly explained to you before you make a decision about whether or not you would like to take part.
It is really important to remember that you do not have to take part in any research if you do not want to, and if you decide not to take part in a research project that you have been invited to participate in, your normal clinical care will not be affected in any way.
Research Governance sets standards to ensure that the safety, dignity, rights and welfare of research participants are protected. It also ensures that research carried out is of a high quality and is not wasteful of NHS resources. To ensure that this is the case, all research that happens within the NHS must be approved by the National Research Ethics Committee and the Health Research Authority, and must be assessed, arranged and confirmed by the Trusts Research and Development Department.
If you are interested in participating in research and you are under the care of a consultant for a particular health condition, speak to your consultant about which research projects are running at the Trust that may be suitable for you.
For further information if you are interested in participating in clinical trials, you may find this link useful: UK Clinical Trials Gateway
Protecting your privacy and how your information is used
All NHS organisations (including Health & Social Care in Northern Ireland) are expected to participate and support health and care research. The Health Research Authority and government departments in Northern Ireland, Scotland and Wales set standards for NHS organisations to make sure they protect your privacy and comply with the law when they are involved in research. You can find out all the information you need by visiting the NHS Health Research Authority website.
What is a Clinical Trial?
A Clinical Trial is a research study that involves testing or studying a drug or medical device to see if it is a safe and effective treatment for people. There are strict rules that control how clinical trials are conducted to ensure the safety of those who participate.
Experimental drug trials are categorised into four phases:
- Phase I, Researchers test a new medicine or treatment for the first time on a small number of people who may be volunteers.
- Phase II, Researchers test the new medicine or treatment on a larger group of people who are ill. This is to get a better idea of its effects in the short term
- Phase III, Researchers test the medicine or treatment on larger groups of people, including patients, and confirm effectiveness, monitor side effects and compare it to other commonly used treatments or a placebo.
- Phase IV clinical trials are conducted after the medicine or treatment has been approved for public use ie received a marketing licence. These studies continue to test the medicine or treatment to collect further information about its effects.
Is taking part in research safe?
There are risks involved in participating in research as there are in standard medical care and everyday life. However, when a study is designed every effort is made to minimise the risk to patients. This is has to be checked by the National Research Ethics Committee.
The specific risk associated to a research study are described in detail on the study Patient Information Sheet which you will be asked to read before signing the study consent form.
Can I withdraw from a study?
Partaking in research is voluntary, you can withdraw at any time. This will not affect your standard care.
Will I be paid?
Payment will depend on the study. The research team for the study should be able to provide you with details.
Who will see my personal information?
If you take part in a study other members of staff, not only your doctor will need to have access to your medical records. Everyone who has access to your records must follow the hospitals confidentiality guidelines.
Sometimes the study is conducted at many hospitals and we may need to share some information relating to how the study is progressing. If we did need to send some information to other hospitals to protect your confidentiality your personal details would not be included.
How much of my time does research involve?
Your time and involvement depends on the study and what is being investigated. The research team should be able to provide you with details.