When planning a clinical trial, researchers must follow certain principles. The first principle is that the study must be ethical. This means it must be planned and carried out according to national and international guidelines.
The second principle is that the research must be scientifically sound so that it produces accurate results which answer the research question. These results must be reliable so they can be used in future.
Thirdly, as far as possible, any foreseeable risks must be no greater than the risks of the present treatment. The risks must be worthwhile for each person, including the risk of having no treatment.
The main concern will be that the trial is suitable and safe for patients, like you, to enter. Trials need a team effort to make sure they are successful. If you decide to take part, you are an essential member of this team. You must be given all the information you want, you must understand what will happen and you must freely agree to take part.
Points which your doctor or the researcher should discuss with you include:
- What type of trial this is, why it is being done and how it has been planned
- An explanation of how the research affects you, for example how long the trial will last, any extra tests or hospital visits
- The meaning of the words and phrases that are used
- The benefits, risks and any other available treatments
- The safeguards which exist to protect you
- Who you should contact if you have any concerns or problems
- How to find out the results of the research, if you want to do so.
Researchers, usually doctors, nurses and other specialists will have detailed discussions about the design of a trial. As a result of these, they will produce a protocol. This is a plan of the trial giving the reason for doing the research. It includes the background to the technique, treatment or problem and all the information currently available. Also included are details of how the study will be carried out and how the results will be analysed.
The protocol is put forward for independent scientific review. This is a review of the method to be used and how the results are to be obtained, including the checks to be carried out and the strength of the statistics. The protocol is then passed on to a Research Ethics Committee.
Research Ethics Committee
The Department of Health requires every unit within the NHS to have access to a Research Ethics Committee (REC) from which it must seek advice about all research protocols. The REC is there to provide an effective safeguard for patients and to judge the wisdom and relevance of each project. The REC is made up of doctors, scientists, nurses and non-medical people.
If a trial is thought to be inappropriate or unethical, approval won't be given and the research won't go ahead. The REC can ask for changes to the trial. Once a trial has been approved, the researcher must ask permission before it's changed in any way. Unexpected or serious events must also be reported to the REC. At the end of the trial the Committee will require a summary of results, including any problems such as difficulty recruiting patients to the study. The REC may also ask for copies of published articles based on the results of the trial.
The REC requires the researcher in charge of the trial to explain the project to you and to obtain your consent before including you in the study.