STATUS: IN DEVELOPMENT
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].
A general informed consent form may be available, but a local Institutional Ethical Review Board may demand changes after reviewing. It is crucial that essential data sharing aspects are explicitly handled in the informed consent form [De Novo]. The consent information should be made available as metadata.
[uu_consent] https://www.uu.nl/en/research/research-data-management/guides/informed-consent-for-data-sharing
Why is this step important
A properly designed informed consent is crucial for data reuse. Without it, archiving, sharing, etc may not be possible.
How to
[Sander]
In my opinion the main question is: what is the specific information that should be in your IC to accomodate for FAIR data and its further usage. So it’s probably about data sharing for further research as well as potential data linkage?
So step-wise I would think maybe something like:
Check your institute for an IC template
Check whether it allows for “whatever it is we need for making this data FAIR and its sharing”
I know there are factors which depend on the study, like e.g. linkage with PALGA, IKNL, etc.
Does this depend on FAIR Objectives? Does “I want to publish the study in the HRI Catalogue” require something different in an IC than “I want to use your data for federated querying?”
The first doesn’t require anything special in the IC I think? Only when the owner actually share your data does the IC become relevant.
Is “sharing” by sending someone the data and “sharing via federated querying” different?
If federated querying is anonymous by default, since the data never leaves a center, does IC about sharing the data still matter?
Add these lines
Get the IC approved
FAIRopoly
The development of this ICF benefited from previous experience with ICF submissions by 4 ERN Registries (ERKReg, EuRRECa, ENROL, VASCA) and from the utilization of “machine-readable” consent-related Ontologies (Data Use Ontology and Informed Consent Ontology). Several iterative expert reviews (including patient organizations and ERN representatives) were conducted to finalize the ICF.
Some potential sources:
ELSI Servicedesk? Unfortunately in Dutch.
Templates for ICs?
https://the-turing-way.netlify.app/ethical-research/ethical-research
[HANDS] - chapter privacy and autonomy
Consent
Consent aims at informing potential study subjects of all aspects of participation, including the procedures for data handling, data access and anonymity. An informed person can freely decide to participate or not. If someone does participate, he or she understands and accepts the risks and burdens involved in participation.
The Central Committee on Research Involving Human Subjects (CCMO) has produced guidelines for obtaining informed consent and has adapted the nationally mandatory proefpersonen-informatieformulier in light of the GDPR (for WMO research). In addition, the NFU working group ‘Privacy, ethiek & recht in gezondheidsonderzoek’ is currently developing a UMC format for broad consent, which may be applicable to certain non-WMO research. Advice on how to inform donors and patients about the use of their biomaterials and/or data in scientific research can be found at the ELSI servicedesk.
The ethical committee at your UMC can help you design your informed consent procedure. Regarding data management, the informed consent should include the person's wishes about:
the use and reuse of patient data for research in the current and future projects;
notification about the research results, including incidental research findings (special concern is required for results that cannot be interpreted now, but may be interpretable in the near future);
which data he/she can access, if applicable;
the possibility to withdraw certain aspects of informed consent and the consequences;
data use by commercial parties.
Consent should be documented along with the collected data, so subsequent users of the data are aware of the conditions agreed to by study subjects.
In general, it is very difficult to re-contact patients or study subjects to extend or change the consent. So, we advise you to obtain informed consent for storing clinical and personal data for the purpose of both healthcare and future scientific research, each with a separate specific informed consent (also see: care and research environment). In addition, patients should always be able to retract their consent.
Frequently Asked Questions
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.
The How to section should:
be split into easy to follow steps;
Step 1
Step 2
etc.
help the reader to complete the step;
aspire to be readable for everyone, but, depending on the topic, may require specialised knowledge;
be a general, widely applicable approach;
if possible / applicable, add (links to) the solution necessary for onboarding in the Health-RI National Catalogue;
aim to be practical and simple, while keeping in mind: if I would come to this page looking for a solution to this problem, would this How-to actually help me solve this problem;
contain references to solutions such as those provided by FAIR Cookbook, RMDkit, Turing way and FAIR Sharing;
contain custom recipes/best-practices written by/together with experts from the field if necessary.
Expertise requirements for this step
This section could describe the expertise required. Perhaps the Build Your Team step could then be an aggregation of all the “Expertise requirements for this step” steps that someone needs to fulfil his/her FAIRification goals.
Practical examples from the community
Examples of how this step is applied in a project (link to demonstrator projects).
Training
Add links to training resources relevant for this step. Since the training aspect is still under development, currently many steps have “Relevant training will be added in the future if available.”
Suggestions
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