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Short description
Obtaining patients’ informed consent for collecting their data for scientific purposes is usually required [De novo]. Furthermore, patient consent may be necessary for archiving and sharing [uu_consent] and linkage with e.g. external registries. Furthermore, consent information is necessary for the data to be machine-actionable, as without such data a computer cannot know whether it is allowed to use the data [FAIR].
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What does the EU General Data Protection Regulation state about consent?
“Consent should be given by a clear affirmative act establishing a freely given, specific, informed and unambiguous indication of the data subject's agreement to the processing of personal data relating to him or her, such as by a written statement, including by electronic means, or an oral statement. This could include ticking a box when visiting an internet website, choosing technical settings for information society services or another statement or conduct which clearly indicates in this context the data subject's acceptance of the proposed processing of his or her personal data. Silence, pre-ticked boxes or inactivity should not therefore constitute consent. Consent should cover all processing activities carried out for the same purpose or purposes. When the processing has multiple purposes, consent should be given for all of them. If the data subject's consent is to be given following a request by electronic means, the request must be clear, concise and not unnecessarily disruptive to the use of the service for which it is provided.”
And, regarding broad consent for scientific research: “It is often not possible to fully identify the purpose of personal data processing for scientific research purposes at the time of data collection. Therefore, data subjects should be allowed to give their consent to certain areas of scientific research when in keeping with recognized ethical standards for scientific research. Data subjects should have the opportunity to give their consent only to certain areas of research or parts of research projects to the extent allowed by the intended purpose.”
When and with what procedure should patients give consent for the use of their data or biomaterial for scientific research?
This is described at ‘Toestemmings- en bezwaarprocedures’ at the ELSI Servicedesk.
What if it is impossible to ask for consent?
In some exceptional cases, you are legally allowed to perform scientific research without a consent. More information about this can be found at ‘Toestemmings- en bezwaarprocedures’ at the ELSI Servicedesk. Always minimise the data and specifically describe the arguments for not asking for consent and make sure that your institute or its Data Protection Officer has accepted your arguments, before you start your research.
Do I need informed consent to use anonymous data?
Informed consent is not mandatory if your data is truly anonymous. However, you should carefully consider whether your data indeed is anonymous: it may be possible to trace ‘anonymous’ data to an individual person by combining the data with other data sources. You should always be aware of this possibility when sharing your data with third parties. It is advisable to let an independent party (for instance a Data Access Committee or Board) objectively assess your proposed data sharing.
What does my institute need to do to inform patients?
Your institute needs to actively inform patients that they may be asked to participate in scientific research. Also, they should be informed that in some exceptional cases, it can legally be allowed to perform scientific research without a consent. Patients are offered the right to refuse to such use. Your institute needs to install a procedure to ensure that such refusals are followed through, i.e., if people have refused sharing their data for scientific research, these data should not be used in research.
What about genetic data?
The EU General Data Protection Regulation states that ‘Genetic data should be defined as personal data relating to the inherited or acquired genetic characteristics of a natural person which result from the analysis of a biological sample from the natural person in question, in particular chromosomal, deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) analysis, or from the analysis of another element enabling equivalent information to be obtained.’
Most genetic studies will involve restricted access to individual level genotype and phenotype due to privacy concerns that are associated with this type of data.
The ELSI Servicedesk answers the question to what extent the data from whole genome sequencing are regarded as (directly) identifying. Also it advises on whether an informed consent form should state that genetic data is being processed.
Who can help me at my UMC?
Use the Toolbox to find support on informed consent at your UMC.
Further reading
For more information on incidental findings, please take a look at the BBMRI publication: Handreiking voor het constateren van, omgaan met en informeren over nevenbevindingen voor biobanken in BBMRI-NL.
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