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 concerned about any ethical aspects of a trial you are considering or are currently taking part in you should first talk to your neurologist or the doctor responsible for the trial.
The ethics committees that review clinical trials in the NHS are part of the Health Research Authority's National Research Ethics Service.