...
Subject Information Sheet (ELSI Servicedesk)
<if applicable> If we collaborate with countries outside the European Union
In this study, we send encoded data [and biological material] to countries outside the EU because [explain the reason here]. It is [also] possible that the data will be shared outside the EU for other scientific research.
We only share your data [and biological materials] with researchers outside the EU if they handle your data [and biological materials] as securely as required for researchers within the EU. We also make written agreements with them regarding this.
Informed Consent Form
I do/do not (cross out what does not apply) consent to research using my data and material by institutions abroad, even if the level of privacy protection is lower than in the Netherlands.
...
Subject Information Sheet (Amsterdam UMC)
We send your data to countries outside the European Economic Area (EEA)
In this study, we also send your coded data and bodily material to countries outside the European Economic Area. These countries do not have the same privacy regulations as those within the EU. However, we strive to protect your privacy as much as possible through proper contracts. On the consent form, we will ask for your separate consent to send your coded data and/or bodily material. If you decide not to provide this consent, you [cannot/can still] participate in the study.
Informed Consent Form
I do/do not (cross out what does not apply) consent to the transfer of my data/bodily material within the scope of this study to countries outside the EEA where the European guidelines for the protection of personal data do not apply. The data/bodily material must then be transferred in coded form and without my name.
Related:
I do/do not (cross out what does not apply) consent to the transfer of my data/bodily material within the scope of this study to [countries within the EEA]/where the European guidelines for the protection of personal data apply. The data/bodily material must then be transferred in coded form and without my name.
...
Subject Information Sheet (Amsterdam UMC)
Consent for sharing data and bodily material with commercial parties
In this study, we share your data with [name of company or companies]. If you do not want us to share your data with commercial parties, you can indicate this on the consent form.
Informed Consent Form
I do/do not (cross out what does not apply) consent to the sharing of my data/bodily material with commercial companies mentioned in the letter.
...
Subject Information Sheet (Amsterdam UMC)
May we request data about you from CBS?
Statistics Netherlands (CBS) is the official authority in the Netherlands that records causes of death. If you were to pass away during the study, we ask for your consent to request information about the cause of your death from CBS. We will only request this information if it is relevant to this study.
Informed Consent Form
I do/do not (cross out what does not apply) consent to the request for my data from CBS.
Susanne: If I die during the course of the study, I give consent to request my official cause of death data from the CBS (Statistics Netherlands) [yes/no]
...
3.4 Generic database linkage
Amsterdam UMC
Subject Information Sheet
No template text available. Maybe something like (+/- AOCR):
Linking with existing Dutch registration systems.
To gain more insight into the development and progression of your condition, we require additional data. This data will be obtained by requesting information from existing Dutch health-related registration systems, such as [name of database]. Any linking with Dutch health-related registration systems will only take place after consultation with the {(voorbeeld was “Biobank Toetsings Commissie”)}.
Informed Consent Form
I do/do not (cross out what does not apply) consent to [the linking of/requesting] my data from [name of database].
...
Subject Information Sheet (Amsterdam UMC)
We retain your data for [xx] years [at the hospital/general practice/research centre]. It will also be retained for [xx] years at [name of institution/company].
Step 4 - Special cases
4.1 Cohort studies
...