I. Consent to sharing de-identified data for care purposes.
II. Consent for the inclusion of de-identified data in ERN registries.
III. Consent to be contacted in the context of research initiatives
• Consent to treatment remains the responsibility of the institution where the patient is receiving care.
• The patient may consent to one or more of the three types of data sharing. Each type has its own consent box. A patient may consent to one type of sharing and withhold consent to others.
Freely given - the patient must understand that they can withhold consent and that their care provider will still provide care to the best of their ability.
Informed - the patient must understand what an ERN is and why sharing data in an ERN could be beneficial. Any risks that might exist to such data sharing should also be made clear.
Explicit and Unambiguous - for this reason each type of data sharing foreseen within ERNs has its own consent box on the form.
• Specific - the consent must be related to a specific type of data sharing; this is why the ERN-SCF must list all ERNs which may be consulted. The healthcare professional charged with presenting the ERN-SCF must fill in the names of the ERNs and must also sign the ERN-SCF.
The form states that data shared in the ERNs will be de-identified.
Patients must understand that this means that immediately identifying markers such as name, full date of birth, address and national ID number will be removed before records are shared.
Because the medical data shared will make it possible to re-identify the data, the patient’s consent is needed to share the de-identified data.
The ERN–SCF requests consent to add data to a Registry or Database.
The patient should understand that such databases are secure, as well as their value in building knowledge about each condition.
The patient must understand that they can withhold consent to including data in a Registry or Database.
The ERN–SCF asks if the patient consents to being contacted for research initiatives.
The patient must understand that consent must be given to a specific research initiative, rather than general research in their condition. Accordingly they are consenting to being contacted to provide specific consent if an ERN Member believes they could be suitable for a given research initiative.
The ERN-SCF states that ERNs have a legal responsibility to ensure that data are secure. This means that a patient has right to remedy if a data breach occurs, which the patient can address to the hospital or clinic where care is provided.
Patients have a right to access data held about them and to know which data are shared in an ERN.
Patients have a right to copies of their data in a portable, readable and shareable format. The healthcare professional charged with presenting the ERN-SCF must be aware of where to refer a patient if they ask for such access or data portability. This will vary in each healthcare provision institution.
Patients have a right to withdraw consent given previously at any time and to obtain the erasure of their personal and health data. However, data erasure might not occur in ERNs when such erasure would render impossible or seriously impair scientific research.