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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 PIF (Patient Information FolderSubject Information Sheet (SIS, Dutch: PIF - proefpersoneninformatieformulier) and the Informed Consent Form (ICICF).
Step 1
Determine whether your study is subject to the Medical Research Involving Human Subjects Act (WMO) or not. The Central Committee on Research Involving Human Subjects (CCMO) executes the WMO and the Embryo’s Act. Research that falls under the WMO or the Embryo’s Act must undergo a review by an accredited Medical Research Ethics Committees (MREC) or the CCMO. Research is not allowed to start without a positive decision of this committee.
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TBD: perhaps we don’t need this step? Since this guidance isn’t about “how to get your study approved”?
Step 2 - Study is subject to WMO
Study is not subject to WMO
Step 1
Subject Information Sheet
The CCMO has published a standardised Patient Information Form (PIF), which includes informed consent questions. (?) amodel SIS and strongly recommends its usage. Chapter 10, “What will be done with your data and body material?“ contains several questions relevant for FAIR data. (or maybe just one??)
Can we use your data and body material for other research?
Here, it is of the utmost importance that the researcher clearly explains for which purposes collected data/materials may be reused. This may be broader than the original purpose of the study, but not too broad. For example, “cancer research” may be acceptable but “any research” is not. If stored data/material is used for a different purpose, participants must give permission again or usage is not permitted.
We send your data to countries outside the European Union
If I read correctly, you only give permission for this study. So my interpretation is that for other research you are never allowed to send the data outside the European Union. Is that correct?
(same goes for e.g. the coincidental findings)
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?
ICF
CCMO’s SIS also contains an Informed Consent Form, “Appendix [X]: Informed consent form – subject”. Of particular interest for FAIR data is the table with Yes/No questions:
<if applicable> I give consent to store my data to use for other research, as stated in the information sheet.
<if applicable> I give consent to have my (remaining) body material stored for use in other research, as stated in the information sheet. The body material is stored for this purpose for another [xx] years.
<if applicable> I give consent to ask me after this study if I want to participate in a follow-up study.
Q:
If the current study does not require linkage to external registries, can (and should?) you ask permission for this for future research, e.g. “In future research we would like to be able to link your data to external registries, such as PALGA, CBS and IKNL”
I don’t see any mention of sharing data/materials with commercial parties. Does that mean that you can share it or not?
Ik geef toestemming voor het zo nodig contact opnemen met de Basisregistratie persoonsgegevens om geen fouten te maken bij het benaderen van de juiste personen.
Ik geef toestemming voor koppeling met andere Nederlandse registratiesystemen voor het opvragen van gegevens.
Ik geef wel/geen (doorhalen wat niet van toepassing is) toestemming voor onderzoek met mijn gegevens en materiaal door instellingen in het buitenland ook als het privacybeschermingsniveau minder is dan in Nederland.
Ik geef wel/geen (doorhalen wat niet van toepassing is) voor onderzoek met mijn gegevens en materiaal door commerciële partijen.
Ik geef wel/geen (doorhalen wat niet van toepassing is) toestemming om in de toekomst benaderd te worden voor eventueel vervolg onderzoek.
Ik geef toestemming om gegevens op te vragen bij bestaande Nederlandse registratiesystemen om meer inzicht te krijgen in het verloop van bepaalde aandoeningen. Deze registratiesystemen staan vermeld in deze informatiebrief
If you intend to collect cause of death data via CBS (Statistics Netherlands) in the future, please include the following sentence with yes/no option in the consent form: '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)'.
Please note: The cause of death data must be intended for scientific research in the field of public health and the study must be carried out by a university, university hospital, planning bureau or other institution, as referred to in Art. 41 of the Statistics Netherlands Act.
Voor koppelen met de CBS doodsoorzakenstatistiek staat in de comments nog dit:
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De meest up-to-date formulering vind je hier op de CBS-website.
Step 3 - Study is not subject to WMO
Gebruik https://elsi.health-ri.nl/gedragscode/opzet-en-voorbereiding/anticiperen-op-vervolgactiviteiten
[ELSI Servicedesk]
Hoi Sander,
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