Benefits and risks - Rights and responsibilities

Benefits and risks

The safety of participants is always paramount and there are strict codes of practice that must be observed to protect volunteers. Each trial has a pre-agreed protocol to be followed and findings are carefully monitored as the trial progresses. Individual names of participants are not normally disclosed.

As trials aim to test the effectiveness of new treatments, the obvious advantage of taking part is that you may have an opportunity to use a treatment that works better for you than your existing treatment. Also you are likely to have access to very experienced healthcare professionals and will receive close monitoring of your condition throughout the trial. You may also learn more about Parkinson’s and find out information that might be helpful to you in the future as well as meeting others in a similar situation to share experiences.

While there are potential benefits to taking part in a trial it should be remembered though that there are also some risks. Although every care will have been taken to eliminate the risk of serious or even life-threatening side effects, the fact that a treatment is still in the experimental stages means that the risk of complications is present. You won’t have any certainty when you enter the trial that your treatment will improve your condition and, in some cases, this may deteriorate in the absence of effective medication. You may also experience unwanted side effects. Participating in trials can also be time-consuming and may require hospital stays. However most trials reimburse costs incurred and some pay participants for their involvement.

Any volunteer can withdraw from a trial at any time. If you do, it is always helpful to let the care team know the reasons for withdrawing.

Did you know?

Although levodopa has been the most widely used treatment for over 30 years, it was in fact registered for the treatment of Parkinson’s without a formal trial. The first and only double-blind placebo controlled trial of levodopa started in 2001 and was published in 2004 in the New England Journal of Medicine.

What are my rights and responsibilities as a volunteer?

If you are accepted as a trial volunteer it is important to understand your rights and responsibilities before confirming your participation. Prior to enrolling one of the research team will go through the informed consent document to ensure that you clearly understand details of the trial and the potential risks and benefits. This will help you decide if the trial is right for you and will explain what the research team expect of you. It is important to note that although you will be asked to sign an informed consent document, this is not a contract and you may withdraw from the trial at any time.

Below are just some of the responsibilities you should expect to undertake when enrolling as a volunteer. You should:

read all the information you have been given and ask questions if anything is unclear
ensure that you inform study staff if your contact details change at any time
provide a full medical history before you start treatment and a list of any medications you take, including over-the-counter medications
keep a written record and report any illnesses or changes in your condition as the study progresses
follow instructions carefully and always talk to study staff if you think you need to make any adjustments
diarise any appointments you are asked to attend as these are important to the study
be honest with your feedback relating to the treatment or study
try to remain in the study until its conclusion unless there is good reason to withdraw
follow instructions regarding submission of any expenses, making sure that receipts are passed on within the requested timeframe.

What protection do volunteers have against injury or illness resulting from participation in clinical trials?

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Did you know?

In the early to mid-19th century pills were produced in a pharmacy by combining different powers using glucose syrup. The mixture was cut and pieces rolled in talcum powder to give a pearlised finish or, if the customers were rich, in silver or gold, to produce a finished pill. Mass production of sugar coated pills began in France in the mid 1800s and gelatine capsules came into use in 1875.