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Current Research Purpose: The IC should clearly explain the primary purpose for which the health data is being collected (e.g., a specific clinical study, disease research, or a longitudinal health survey).
Potential Future Use: To align with the FAIR principles, the IC should also mention the possibility that the data may be used for future research purposes, which may not yet be fully known at the time of data collection. However, the scope of future research should be described as broadly but as clearly as possible, respecting GDPR’s transparency principle.
FAIR Data Goals: The IC should include a statement that aligns with the goals of FAIR data, explaining that the data will be made findable, accessible, interoperable, and reusable by other researchers and stakeholders in the scientific community.
Data Registries or Repositories: If applicable, the IC should state that the data will be deposited into data repositories or registries that adhere to FAIR principles, allowing it to be discoverable and reusable by others.
Who Will Access the Data: Provide clarity on who will be allowed to access the data. This includes mentioning both internal and external researchers and potential data-sharing partnerships.
Controlled vs. Open Access: Explain whether the data will be made available via open access (where anyone can access the data) or via controlled access (where only approved researchers or organizations can access it).
Cross-border Data Transfers: If the data may be shared internationally, the IC must comply with GDPR’s rules on cross-border data transfers. Explain if the data will be shared with researchers outside the EU and what safeguards are in place to protect the data in international transfers.
How to
Step 1 - What type of consent can you use? Is consent even necessary?
Informed consent is the process by which a patient voluntarily agrees to a medical procedure, treatment, or participation in research after being fully informed about the relevant details. Informed consent is mandatory for all medical research involving human participants. Best known informed consent procedures are the opt-in and opt-out consent.
Opt-in. Patients actively agree to participate in a treatment or study after being informed about its details and risks.
Example: A patient signs a consent form before undergoing elective surgery, having discussed the procedure with their doctor.
Opt-out. Patients are automatically included in a program or research study unless they choose to decline.
Example: Patients are included in a healthcare system's data collection for research purposes unless they explicitly opt out.
Under GDPR, individuals must give clear and affirmative consent for their data to be used in research, i.e. opt-in consent.
When is informed consent not necessary?
Research involving animals. Here, informed consent is not applicable in the same way it is for human research. Instead, ethical approval is required to ensure the humane treatment of animals.
Deceased participants. Informed consent is generally not required for the use of data or biological specimens from deceased individuals, provided that the research adheres to ethical guidelines and legal regulations.
Anonymised data. If data is anonymised, it is no longer considered personal data under regulations like the GDPR.
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Starting a new study may require a multitude of documents. Here, we focus specifically on the FAIR components that can be included in the Subject Information Sheet (SIS, Dutch: PIF - proefpersoneninformatieformulier) and the Informed Consent Form (ICF).
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May we use your data <if applicable> [and biomaterial] for other scientific research?
<if applicable> If we collaborate with countries outside the European Union
SdR: dit hierboven is vrij zwak, aangezien het mijn vertaling is. Is het een optie om de inhoud te vertalen naar het Engels en de inhoud of bij ELSI neer te zetten of desnoods hier? Overleggen met Susanne.
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SdR: wat is het verschil tussen die standaard PIFs, waarom komt er meer dan 1 standaard PIF en wanneer moet je welke gebruiken? Hoe kunnen we onderzoekers helpen met het kiezen van de juiste?
Chapter 10
What data do we store?
<if applicable> What body material do we store?
Why do we collect, use and store your data <if applicable> and body material?
How do we protect your privacy?
Who can see your data?
For how long do we store your data and body material?
<if applicable> Can we use your data and body material for other research?
<If applicable> What happens if there are coincidental findings?
Can you take back your consent for the use of your data?
<If applicable> We send your data to countries outside the European Union
Do you want to know more about your privacy?
Where can you find more information about the study?
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