Why it exists
Taking part in a clinical study is always your free decision. Informed consent records that you received all the necessary information and made this decision knowingly.
What you must be told
Before you sign, the study doctor explains the following and answers your questions about:
- the aim of the study and which medicine is being studied;
- the procedures: which examinations, tests and visits to expect, and how long it all lasts;
- possible risks and inconveniences, and the benefit the study may bring;
- your responsibilities: for example, to follow the regimen and to report how you feel;
- data protection: who will see information about you and how it is stored;
- the terms of participation: what you receive and what it costs you.
The terms of insurance for participants, compensation and the contact details of the ethics committee are also stated in the document.
Questions worth asking
- What will happen at each visit, and how long does it take?
- Which side effects occur, and what should I do if they appear?
- Whom can I contact at any time, including at night?
- Can I take other medicines during the study?
- What will happen to my data and samples after the study ends?
Your rights
- You may ask any questions before and during the study.
- You may withdraw at any stage: participation is voluntary throughout the whole period of the study.
- You must be told about any new information that may affect your decision.
If anything in the document is unclear, ask for it to be explained again — that is normal and is part of the doctor’s duties.
What happens next
After you sign, a medical examination takes place: the doctor checks whether you meet the criteria of the study. More in the article “How a volunteer is selected” and in the “Questions from volunteers” section.
Questions and answers
Can I take the informed consent form home and think about it?
Yes, you have the right to read the document calmly and discuss it with your family or with the doctor. Sign the consent only when everything is clear to you.
Can I leave the study after signing?
Participation is voluntary throughout the whole study. Tell the study doctor about your decision: they will explain how to end your participation correctly.
See also
Questions and answers for volunteers
Answers to frequently asked questions from prospective volunteers: informed consent, selection criteria, how a study works, the right to withdraw, safety and data.
Learn moreHow a volunteer is selected for a clinical study
Selection begins with a talk and informed consent. Then the doctor carries out an examination and checks whether you meet the protocol criteria. The decision is made by the study doctor on the basis of those criteria.
Learn more