Informed consent forms the basis of clinical investigations and performance studies of medical devices. It ensures that patients understand the objectives, risks and benefits.
Medical devices (e.g. hip replacements, compresses, condoms, etc.) and in vitro diagnostic (IVD) medical devices (e.g. pregnancy tests, COVID-19 self-tests, etc.) are omnipresent in our daily lives.
Before these medical devices are made available to users, they are tested and assessed. Preclinical studies (laboratory tests on biological models) ensure that devices are safe enough and offer a presumed benefit for patients. After this stage, devices enter the clinical investigation phase (if it is a medical device) or the performance study phase (if it is an IVD device). This phase aims to demonstrate and/or confirm the safety, the efficacy of the devices and their benefits for the patient. All participation in a clinical investigation (or performance studies) begins with signing an informed consent form.
What are the conditions for informed consent?
Informed consent means that a person gives voluntary consent (without coercion or pressure) to participate in a specific clinical investigation or performance study. The participant expresses their choice (i.e. acceptance or refusal) explicitly and unambiguously. No response is neither an agreement nor a refusal.
This consent is given directly by the participant or by the participant's legal representative (if the participant is a minor or unable to give consent).
Which information will I receive?
The participant must be fully and clearly informed about all aspects of the clinical investigation or performance study. The participant decides whether or not to participate after understanding the acts to be performed, the procedures involved and the potential risks.
During a preliminary interview, an investigator will provide at least the following information orally and in writing:
- the nature, objectives, benefits/disadvantages and risks involved;
- conditions relating to the conduct of the investigation or performance study, such as location and expected duration;
- possible alternatives (including follow-up measures), if the investigation or evaluation is terminated for the participant;
- information on the damage compensation system;
- the unique identification number of the study assigned and information about the availability of results.
Can I change my mind along the way?
The participant always has the option to refuse to participate or even to stop the clinical investigation or performance study at any time. They do not have to justify why they refuse or leave, and they will not be subject to any consequences (prejudice or penalty) as a result of this decision.
Advice for participants
- Take time to reflect.
- Ask for more information about the clinical investigation or device performance study process.
- Ask as many questions as you need.
- Keep a copy of all documents.
Legal basis: informed consent in the context of a clinical investigation is defined by Articles 2 and 63 of Regulation (EU) 2017/745 on medical devices.
Ethical framework: the Declaration of Helsinki.