Medical data are all data gathered for your examination and treatment. We keep them in your electronic patient file.
Body materialBody material can be blood, urine or tissue. Tissue is the bodily substance that is removed by a doctor or nurse during a puncture or biopsy (using a needle) or during an operation. This can be healthy tissue, but also unhealthy, like a tumor.
Scientific research using body material and medical data
Our researchers can use body material and medical data in different ways. They can, for example, look at differences in body material from different patients. In this way, they can research whether or not (and if so, in what way) an abnormality in the blood plays a role in the causation or course of certain diseases. The researcher often uses information from the medical file in this process.
A researcher can discover something important concerning your health during his or her scientific research. When this happens, we speak of ‘chance findings’ or ‘unexpected findings’. The chance for this to occur is very small and when is does, the researcher does not know you are the one concerned, because the body material is coded. This means that your body material and/or medical data have some code on them – but not your name. If something important concerning your health is discovered by chance, a special committee will decide whether it is important for you to know about it or not. If it is, your doctor will trace you as a patient based on the code on your material, and he or she will inform you and your general practitioner about the findings.
Rules and legislationAt Radboudumc, we keep to the rules established by doctors, researchers and patient associations. These are based on legislation. The most important rules are:
- The research has to be useful, by means of contributing to medical science.
- The research must be evaluated by an ethical review committee.
- The research has to be designed in a way that minimizes the chance of finding ‘unexpected findings’.
- The patient’s privacy must be safeguarded as much as possible.
Your privacyOur researchers use coded body materials and coded medical data. This means that your body material and/or medical data have some code on them – but not your name. Only your own doctor can find out that the material is yours, using the code. In case it is important for the research that the researcher is aware of your personal details, your doctor will ask your permission for this beforehand.
Underage or legally incapableAre you the parent/guardian of a child younger than 16 years? Or are you the legal guardian of someone who is not capable of making his or her own decisions (someone legally incapable)? This can be someone who, for example, has a severe mental disability or someone who is in coma. If so, you can object to the usage of medical data and body material.
Children from 12 to 16 years can raise objections themselves too.
Besides, the law protects minors and incapacitated people. It is regulated by law that data and materials from these people may be used only when it is impossible to conduct research using the data/materials from legally capable patients.