Annex IV Mandatory minimum requirements for the consent form to be provided by healthcare providers authorised to access CPMSF1

United Kingdom

1. 1Division 1
2. 2The consent form shall request the patient's explicit consent for sharing her/his personal data with one or more ERNs, with the sole purpose to improve her/his access to diagnosis and treatment and the provision of high-quality healthcare. To that end, it shall explain that:
3. 3The consent form may also request the patient's additional consent to her/his data being entered in registries or other databases for rare and low prevalence complex diseases, which serve scientific research, clinical or policy purposes. If consent is requested for this purpose, the consent form shall describe the concept and purpose of rare disease registries or databases and explain that:
4. 4The consent form may also request the patient's additional consent to being contacted by a Network Member who believes the patient could be suitable for a scientific research initiative, a specific scientific research project or parts of a scientific research project. If consent is requested for this purpose, the consent form shall explain that giving at this stage the consent to be contacted for scientific research purposes does not mean giving the consent for the patient's data to be used for a specific scientific research initiative, neither does it mean that the patient will in any event be contacted in connection with, or that the patient will be part of, a specific scientific research project and that:
5. 5The consent form shall explain the rights of the patient as regards her/his respective consent(s) to share personal data and in particular provide the information that the patient:
6. 6Division 6
7. 7Division 7
8. 8The consent form shall record separately the individual consent for each of the three different forms of data sharing in a specific, explicit and unambiguous way: