What rights and safeguards protect clinical trial participants?
When someone first hears about a clinical trial that may be relevant to them, it is natural for questions to arise. How much is already known about the treatment being studied? What happens if a side effect occurs? Who oversees the trial? And what if I later decide that I no longer want to take part?
One of the most important principles of clinical research is that protecting participants’ rights, safety, dignity and well-being must take priority over all other interests. This does not, of course, mean that a clinical trial is entirely free of risk. The purpose of research is precisely to gain new knowledge about a treatment’s effects, benefits and potential risks. For this reason, several interconnected safeguards are in place to protect participants both before a trial begins and throughout its duration.
Before the first patient takes part
A clinical trial does not begin by simply testing a new medicine or treatment on patients.
Before the trial starts, researchers prepare a detailed research plan known as the trial protocol. Among other things, it sets out the purpose of the research, who may take part, which treatments and procedures will be used, how participants’ health will be monitored and how potential safety concerns will be managed.
The trial must also undergo scientific and ethical review before it can begin. This assessment considers, among other things, whether the anticipated benefits justify the foreseeable risks to participants, whether appropriate safety measures are in place and whether the trial site is suitable for conducting the research.
In the UK, the Medicines and Healthcare products Regulatory Agency, MHRA plays an important role in this process.
The review is not limited to the research itself. Participant information materials, informed-consent forms and certain recruitment materials may also be examined.
Informed consent is more than a signature
The term informed consent is frequently used in connection with clinical trials. However, it means much more than simply signing a document.
Before deciding whether to participate in a study, a person must receive appropriate information about matters including:
- the purpose and procedures of the trial;
- the treatment being studied;
- known and potential risks;
- anticipated or possible benefits;
- other available treatment options;
- the required visits and examinations;
- and whom to contact with questions or in the event of a problem.
If the trial may involve the use of a placebo, the participant must also be informed of this.
Participants must be given sufficient time to make their decision, and the information must be clear and understandable to a non-specialist audience. They must also have the opportunity to ask questions.
Signing an informed-consent form therefore does not mean that a patient gives up the right to ask questions or make decisions. On the contrary, its purpose is to ensure that they can freely decide whether to participate on the basis of adequate information.
How is participant safety monitored during the trial?
Safety oversight does not end once a trial has been authorised. Participants’ health is monitored throughout the trial in accordance with the procedures set out in the protocol.
The exact process varies from one trial to another. It may include regular medical visits, laboratory tests, various measurements, imaging procedures or other health assessments.
It is also important for participants to inform the research team if they experience a new symptom, if their health changes, if they begin taking a new medicine or if they receive any other medical treatment.
Health-related events occurring during the trial are documented and assessed. Not every such event automatically means that the treatment being studied has caused a side effect. Researchers therefore also evaluate whether there may be a connection between the treatment and the event.
Serious or unexpected safety issues are subject to specific reporting requirements. New safety information may lead to additional precautions, changes to the trial protocol or participant information materials, or, where necessary, the temporary suspension or termination of the trial.
Can I change my mind during the trial?
Yes.
Participation in a clinical trial is voluntary, and this remains true after the trial has begun. A participant may decide at any time that they no longer wish to continue. They do not have to give a reason, and their decision must not result in any disadvantage.
Depending on the trial and the treatment involved, the trial doctor may recommend a final or follow-up visit. Participants should therefore discuss their decision to discontinue participation with the trial site.
However, withdrawing from a trial does not necessarily mean that all previously collected data will automatically be deleted. Some information already recorded may still need to be retained for research or safety reasons.
Participants are also part of the safety system
Laws, regulatory authorities, ethics committees, researchers and doctors all contribute to the safety of clinical trials, but participants are not passive members of this process.
Asking questions, reporting new symptoms, sharing changes in their health and cooperating with the research team can all contribute to safe participation.
In case you’d like to learn more about how clinical trials are conducted you might find this article interesting: From Phase I to IV: Clinical Trials Explained – British Research Panel
And of course, if you’d like to participate yourself or just keep up to date with the latest developments, you can join our community here.
Sources:
Regulation – 536/2014 – EN – EUR-Lex
Reporting safety information on clinical trials | European Medicines Agency (EMA)
Clinical trials in human medicines | European Medicines Agency (EMA)