We take a lot of care to ensure that our trials/studies are as safe as possible.
National and international guidelines
Clinical trials/studies must follow national and international guidelines to ensure they are properly conducted. We adhere to the Medical Research Council’s Guidelines for Good Clinical Practice in Clinical Trials, to the Department of Health’s Research Governance Framework and to the Medicines for Human Use (Clinical Trials) Regulations 2004 (for drug trials) to ensure that the safety, rights and well-being of research participants are protected.
An independent ethics committee is made up of researchers, healthcare professionals and members of the public and must approve a clinical trial/study before it begins. This committee ensures that the research being carried out is ethical and as safe as possible, as well as ensuring that the rights, safety, dignity and well-being of research participants is protected.
Data monitoring & ethics committees
A data monitoring and ethics committee is an independent committee which monitors the progress of a clinical trial. The members of the committee are independent of the clinical trial team and their aim is to ensure that the trial is safe. The committee may recommend that a trial is modified or stopped if the trial data or other information cause any concern about patient safety.
Trial/Study steering committees
A Trial/Study Steering Committee (TSC/SSC) oversees the conduct of a clinical trial/study on behalf of the trial/study sponsor and trial/study Funder to ensure that the trial/study is conducted according to national guidelines. A TSC/SSC usually has a minimum of 75% independent members, including patient/public representatives.
Participants must be given the important facts about the trial/study and give their consent before joining a trial/study. They are given an information sheet which explains the aim of the trial/study, what it involves and the risks and benefits. Participants are given a form to sign giving their informed consent, which means that they have been given, and understand the important facts about the trial/study and have decided to take part of their own free will. Participants in our trials/studies often lack mental capacity to provide informed consent because of their critical illness. In these circumstances, another person (usually the next-of-kin) may be asked to agree participation on their behalf. Informed consent procedures must comply with the Mental Capacity Act 2005 or the Medicines for Human Use (Clinical Trials) Regulations 2004 for clinical trials of medicinal products. Participants can withdraw from the trial/study at any stage.
Ensuring confidentiality of patient data is extremely important. In a trial/study all patient data are confidential and must be kept securely with only a limited number of people allowed access to it. Patient names or any other details that could identify an individual are not included in any trial/study reports. We adhere to the Data Protection Act 1998, which was passed by Parliament to control the way information is handled and to give legal rights to people who have information stored about them.