What should medical volunteers consider before taking part in a clinical trial?
It is important for medical volunteers to learn as much about the clinical trial before deciding to take part, and discuss any questions they have concerning the study with the research staff, in order to learn about the type of care that can be expected and the various procedures involved. Below is a list of questions that could be helpful for a medical volunteer to consider before taking part in the clinical trial. Answers to these questions are usually covered in the informed consent document that is provided to medical volunteers before taking part in the study.
- What is the aim of the study?
- What is the required medical volunteer population for the study?
- What are the reasons for researchers believing that the drug under investigation will be effective? Has the drug been researched before?
- What are the tests and procedures that will be carried during the study
- What are the likely risks, side-effects and benefits for a medical volunteer taking part in the study?
- How will my usual routine be affected?
- What is the duration of the study?
- Will I be required to stay in the clinical unit overnight
- Who is the funding the clinical trial?
- Will I be compensated for my time?
- Are there any long-term commitments required for study participation?
- How can I tell if the drug under investigation is effective? Will the study results be disclosed to me?
- Who is the person responsible for my wellbeing during the course of the study?
What preparation should potential medical volunteers make before meeting with a research team to discuss clinical trial participation?
It is important for potential medical volunteers to plan ahead and prepare any questions they have for the initial meeting with the research team. It may also be beneficial for a friend or relative to come along to the screening visit to provide support and hear the responses to these questions. Every clinical trial conducted in the UK must be approved and monitored by and Independent Research Ethics Committee (IREC) to ensure it safe to conduct the research study in human volunteers (with as least possible risks) and to ensure the study objectives are ethical and in line with Good Clinical Practice (GCP) guidelines. An IREC is an independent committee of research experts, physicians, statisticians and other community representatives that assess whether the planned research study is ethical and ensure that the rights of medical volunteers are protected. All research organisations that support or conduct biomedical research involving human medical volunteers must, by UK legislation, be approved and continuously monitored by an IREC.
How is the safety of the medical volunteer protected?
The conduct of clinical trials is strictly governed by the legal and ethical guidelines for Good Clinical Practice (GCP). Furthermore, most clinical research studies are designed with built-in safeguards aim to protect the medical volunteer participants. All clinical trials are carried out in line with a stringently controlled study protocol, detailing the required tasks and procedures that are to be carried out by the clinical and research team without any deviation. During the course of the study, the team of researchers will be responsible for reporting the results to the study sponsor, various medical journals and government agencies. However, the medical volunteers' data will not be disclosed in these reports at any time and will remain strictly confidential.