Safeguarding your interests
Before any trial can start recruiting patients ethical approval has to be obtained. Ethical review is one of a number of safeguards that are in place to protect individuals involved in trials. NHS Research Ethics Committees (RECs) have been established across the UK for many years with the purpose of safeguarding the rights, dignity and welfare of people participating in research carried out in the NHS and promoting ethical research.
The individuals who sit on a REC are specially trained in research ethics and often have the sort of experience which will be useful in considering the ethical aspects of a research proposal. These include: GPs, hospital doctors, statisticians, pharmacists, academics, laymen and individuals with specific ethical expertise gained through a legal, philosophical or theological background. The REC is entirely independent of the researcher and the organisation funding or carrying out the research.
The main purpose of the research ethics committee is to protect the interests of participants in a clinical trial. In particular they check whether:
- The potential benefits of a new treatment are likely to outweigh the side effects
- The information provided to help people decide whether they want to participate in a trial is clear and satisfactory
- The way in which people are asked to take part in a trial (recruited) is appropriate
- There will be compensation for people in the trial in the unlikely event that something goes wrong
- Travel expenses will be offered to people who take part
If you are considering involvement in a trial, details of the REC that has reviewed and approved the trial should appear on the patient information leaflet that you will be given explaining all about the trial.
If you are concerned about any ethical aspects of a trial you are considering entering or are currently involved in you should first talk to your neurologist or the doctor responsible for the trial. If having done this you feel that you require further reassurance you should contact the Research and Development Office of the NHS Trust.
Contact details can be obtained from the Patient and Liaison Services (PALS). To find out where your local branch is contact your hospital, clinic, GP surgery or health centre or phone NHS Direct on 0845 4647. Alternatively look on the NHS UK website.
If having contacted the Research and Development office you still have queries or concerns the National Research Ethics Service can be emailed direct at: queries@nres.nspa.nhs.uk