Thinking of joining a study
16 November 2013. Related: HIV positive people, Resources.
Sometimes you may be asked to consider joining a research study. Or you may already be interested in whether you can help as part of research. Ongoing medical research is essential to increasing our understanding of both HIV and treatment.
Participating in research is a very valuable and important way to help this understanding. This involves making sure that a study is right for you and that you are happy about what is involved.
Types of studies
HIV research can look at all aspects of care. including:
- Developing new and safer drugs.
- Understanding how side effects occur and how they can be treated.
- Finding the safest combinations.
- Look at different treatment strategies.
Some studies are unlikely to benefit individual health, but have the potential to help the wider community. Other studies offer a potential personal benefit or risk. All studies have to be approved by advisory panels who review the safety of the study.
Deciding whether to take part in a study
As a patient, you have the right to decide whether or not to join a study, without the decision affecting your care afterwards. This choice to join a study or to decide not to take part is important both for your individual rights but also to ensure that the study runs well.
Most HIV research in the UK does not involve any payment to participants, although sometimes you can be reimbursed for travel costs, and sometimes for childcare costs.
Any additional payment is usually only provided in studies that require intensive clinic visits or a stay in hospital as an inpatient.
Sometimes financial payments are available for very early stages of research into new drugs, where the risk of side effects or potential resistance, are not fully known.
Understanding what is involved
Before joining a research study:
- The study details should be explained clearly in your own first language.
- Written information should be available for you can take away to read at home.
- You can take time to consider your choice.
- The alternative to the care in the study should also be explained. For example, if you do not join the study, what are your current choices. What are the advantages and disadvantages of these compared to the study options.
- You can discuss the study with a research nurse, or health advisor that is not your current doctor.
- You can discuss the study with an independent treatment advisor or advocate that is not connected to your hospital. i-Base can provide information on the risks and benefits of individual studies.
- It should be explained to you that you can leave the study in the future for any reason, and that you do not need to give a reason, and that this again will not affect the quality of your medical care in the future.
Informed consent
If you decide to join a study you will be asked to sign an informed consent form. This document confirms that you understand the study and are willing to take part. It should also include additional tests and hospital visits that are part of the study.
It is important that you have time to read this document, and that you are given a copy to keep for yourself.
New information during the study
Studies should only be designed to look at important questions that we do not currently know the answers to.
If during the study another research group answers the study question convincingly, or new research changes the understanding of this aspect of treatment, the results from the latest research should be explained to you.
If the best standard of care changes while the study is being run, these changes should be explained to participants, and the option to change treatment, if appropriate, should be available.