Clinical trial protocol
A protocol gives the reasons for doing the research and is carefully designed to safeguard the health of the participants. It should include the following information:
- The background to the trial and why it should be done
- Details as to how the study will be carried out, including numbers of patients needed and which patients can be included
- Details of the procedure or treatments to be given
- What tests the patients will have and when
- Details about how, when and what information will be collected
- How the results will be assessed.
Rules for clinical trials
When planning a clinical trial, researchers must follow certain rules:
- The protocol is put forward for independent scientific review by people who are suitably qualified to assess it. For example, they will want to check that it is likely to produce accurate results which help to answer a research question. These results must be reliable so they can be used in the future.
- The research must be ethical. The protocol is then passed on to a Research Ethics Committee.
- As far as possible, any foreseeable risks must be no greater than the risks of the present treatment or illness.
What is the Research Ethics Committee?
Clinical trials are carefully regulated by Research Ethics Committees. To meet legal requirements, every researcher planning a clinical trial must 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. No clinical trial can be undertaken without the approval of the REC.
A REC is made up of doctors, scientists, nurses and non-medical people, such as lawyers and members of the public.
If a trial is thought to be inappropriate or unethical, approval won’t be given and the research will not be allowed to go ahead. The REC can also ask for changes to the trial. Once a trial has been approved, the researcher must then ask permission before any changes are introduced.
The REC is there to look after the safety and well being of patients within a study. The research team will report unexpected side effects of the treatment or medication to the REC.
At the end of the trial the REC will require a summary of results, including any problems such as difficulty recruiting patients to the study. The REC may also ask to review any articles based on the results of the trial before they are published.
The REC requires the researcher in charge of the trial or their representative to explain the project to you and to obtain your consent before including you in the study