- What is research?
- What is a research study?
- What is an RCT?
- What will happen if I take part? – Informed consent
- Will my contribution be of value to the future of medicine?
- Will my information be kept confidential?
- How do I get involved?
What is research?
Research tests hypotheses; answers research questions and develops our understanding and knowledge. Research is conducted across a huge variety of disciplines including; developing the technology of our mobile phones, testing the aerodynamics of a car, GM food etc. However clinical research is subtly different.
What is a research study?
The World Health Organisation defines clinical research as: "Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes." (www.who.int/topics/clinical_trials/en/)
Clinical research is not just restricted to drugs and medication, but can include a wide variety of interventions including surgical and radiological procedures, devices (such as pacemakers), behavioural treatments and therapies as well as preventive care.
Clinical research will involve the process of peer review and approval from an independent ethics committee before it can commence. Participants who take part in the research will be fully informed about the research and the risks and benefits associated with taking part, prior to giving fully informed consent.
There was a study that compared patients looked after in research studies and patients who did not after receiving hospital treatment; that showed those who took part in research had a significantly better quality of life and outcome compared to those who don’t. This phenomenon is known as the Hawthorne Effect. Read the full article here.
What is an RCT?
The RCT is often considered to be the 'gold standard' in research. The main features are:
- Patients are randomly allocated into different treatment groups.
- One treatment group acts as a control against which the treatment can be compared.
- No-one has any influence over the treatment allocations
- Often the treatments may be 'blinded', which means that neither the clinician nor patients will know which treatment they are receiving.
- A Placebo, or dummy tablet, may be used.
What will happen if I take part? – Informed consent
Usually if you are eligible to participate in a trial you will be approached by a member of the research team who will provide you with an information sheet about the study. This information sheet has been designed to tell you everything you need to know about that particular study but we understand that you will still have questions and we will be ready to answer them when you come in for your first visit.
The most important thing to know about participating in a Research trial is that ALL research is voluntary and that you can decline to participate or withdraw at any time without giving a reason or your standard clinical care being affected.
When you come for your first visit you will sit down with the doctor and researcher running the study and discuss your participation and if you are happy to take part, you will sign a consent form to confirm your participation. You will receive copies of these, and a copy will also be filed in your medical records.
Your patient information sheet will provide detailed information as to what to expect at each study visit, i.e. whether you will require a blood test so that you can come to each visit prepared and knowing what to expect.
Will my contribution be of value to the future of medicine?
Clinical trials are the most reliable way of testing new treatments or interventions. Potential new treatments might not always be better, and could even be worse than the existing ones. Only by rigorous testing is it possible to ascertain which ones are the safest and most effective which in turn allows continuous improvement in the quality of the care patients receive.
Even taking part in observational research contributes to the future of medicine as these databases allow large amounts of information to be analysed and new research questions to be raised. Whatever research you may be involved in, it is highly valued by us and we couldn’t be more grateful for your contribution.
Will my information be kept confidential?
If you agree to take part in a clinical trial, any information that is collected about you will be kept confidential. This information will be stored safely and used only for the purpose of the trial. You will be assigned a study number and it is this number that is linked to the trial database. Your name will not be disclosed outside the Hospital Clinic for the purpose of the trial.
We will often ask you for permission to let us contact your GP to let them know that you are taking part in a study. Once the trial has finished the results are usually published and often presented at conferences. Your name or any information that can identify you will not be used in any reports about the trial.
How do I get involved?
More people than ever before are taking part in research studies. Each year our trust enrols around 1,800 new people into research. New and better treatments and services become available because people take part in our research.
Members of the public can also get involved in advising us about what research should be funded and helping to design research studies. We run a monthly R&D Committee meeting and are very fortunate to have the involvement of 2 lay members of the committee, providing a non-clinical and non-scientific outlook towards the study in order to provide research in the most patient-friendly way.
- Look out for Research Posters around the hospital as well as our quarterly newsletter “Research Bytes”.
- Become a volunteer – click here to see what Rachel Craig has to say about being a Research Volunteer.