...
Informed consent (IC) is the process by which a patient voluntarily agrees to a medical procedure, treatment, or participation in research after being fully informed about of the relevant details. Obtaining patients’ informed consent is usually required when collecting their Collecting data for scientific purposes typically requires participants' IC [De novoNovo]. To align with the FAIR principles, it is crucial essential that data-sharing aspects practices are explicitly handled addressed in the informed consent form [De Novo]. FurthermoreAdditionally, consent may also be necessary for, for example, archiving [uu_consent] of the data and linkage with required for activities such as data archiving and linkage to external registries.
Many different forms of IC exist. The image below highlights some variants of informed consent and how they are (generally) related.
...
To support enable machine actionability of data and metadata, it is essential that informed consent is also actionability—the ability of a dataset to be automatically accessed, processed, and used by machines without significant manual intervention—the IC must also be machine-actionable. This enables ensures that automated systems to can interpret consent terms, ensuring that allowing data can to be ethically and legally shared across systems while maintaining safeguarding participant rights [FAIR]. In this step we focus solely on the content of the SIS and ICF. For more information about making the informed consent IC machine actionable, see Step XYZ.
In this step, guidance is provided to help you create an Informed Consent Form (ICF) and Subject Information Sheet (SIS) that support are aligned with the FAIR principles. The guidance assumes you already know whether your study is subject to the WMO (Medical Research Involving Human Subjects Act) or not. If you’re uncertain learn , read more about this on the CCMO website, the ELSI Servicedesk (in Dutch) and or contact your local experts for help.
Depending on the type of study and the goals, specific rules for the allowed form of consent can exist. For example, an invasive study involving human subjects need to adhere to the rules set by the CCMO.
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.
IC is also vital for GDPR compliance, as processing personal data (especially sensitive health data) often requires explicit consent from the data subject. Furthermore, patient consent is necessary for, for example, archiving, sharing [uu_consent] and linkage with external registries.
A general informed consent form is available on the website of the CCMO, but a local Institutional Ethical Review Board may demand changes after reviewing and assesses whether the IC aligns with ethical standards, legal requirements and takes considerations into account such as age. This is important because:
It ensures that the consent form is written in a way that participants in that particular region can understand.
The local committee will assess whether the consent form adequately explains the data processing activities, the purpose of data collection, and participants' rights (e.g., the right to withdraw consent).
The committee ensures that the study adheres to local regulations regarding the use of personal and sensitive health data.
...
SdR: The step is call Obtain informed consent. Can you “obtain” IC with an opt-out model?
Why is this step important
The FAIR principles encourage making data more useful for both immediate research purposes and future secondary purposes, such as replication, validation and meta-analysis, while still protecting participants' privacy and rights. To accommodate for the FAIR data principles in the Informed Consent (IC) for health research data, the IC must include specific information that addresses both the immediate use of the data and its potential future uses in a way that aligns with GDPR requirements.
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
As explained, informed consent (IC) is an essential component for collecting and reusing data. Research that falls under the WMO must undergo a review by an accredited Medical Research Ethics Committees (MREC) or the Central Committee on Research Involving Human Subjects (CCMO). Non-WMO studies are reviewed by an MREC. Research is not allowed to start without a positive decision of the approriate reviewing committee.
If your study is subject to the WMO go to Step 1 and for a non-WMO study go to Step 2. In Step 3, some special cases are described. Note that, while this guidance aims to provide up-to-date and accurate information, you should always check with your local privacy and legal specialists!
Step 1 - Study is subject to WMO
The CCMO has published SIS models for both adults and children and strongly recommends their usage. The models are available in both English and Dutch. The MREC/CCMO reviewing committee only assesses the Dutch SIS and ICF. However, if a participant who is not adequately fluent in Dutch is asked to participate in a study, the information must be provided in a language the participant is proficient in.
Subject Information Sheet
The CCMO’s SIS has the following item relevant for FAIR:
Can we use your data and body material for other research?
Here, it is crucial that the researcher clearly explains the potential purposes for which collected data or materials may be reused. While these purposes can be broader than the original study's aim, they should not be overly vague. For instance, "cancer research" might be acceptable, but "any research" would not. If stored data/material is used for a different purpose, participants must give permission again or usage is not permitted.
Informed Consent Form
The CCMO’s SIS contains an ICF as an Appendix. The following items are relevant for FAIR:
...
I give consent to store my data to use for other research, as stated in the information sheet.
...
(Praktisch gezien lijkt her op dit moment op dat we dus met name Opt-In Consent doen hier)
Why is this step important
The FAIR principles encourage making data more useful for both immediate research purposes and future secondary purposes, such as replication, validation and meta-analysis, while still protecting participants' privacy and rights. To accommodate for the FAIR data principles in the Informed Consent (IC) for health research data, the IC must include specific information that addresses both the immediate use of the data and its potential future uses in a way that aligns with GDPR requirements.
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
As explained, informed consent (IC) is an essential component for collecting and reusing data. Research that falls under the WMO must undergo a review by an accredited Medical Research Ethics Committees (MREC) or the Central Committee on Research Involving Human Subjects (CCMO). Non-WMO studies are reviewed by an MREC. Research is not allowed to start without a positive decision of the approriate reviewing committee.
If your study is subject to the WMO go to Step 1 and for a non-WMO study go to Step 2. In Step 3, some special cases are described. Note that, while this guidance aims to provide up-to-date and accurate information, you should always check with your local privacy and legal specialists!
Step 1 - Study is subject to WMO
The CCMO has published SIS models for both adults and children and strongly recommends their usage. The models are available in both English and Dutch. The MREC/CCMO reviewing committee only assesses the Dutch SIS and ICF. However, if a participant who is not adequately fluent in Dutch is asked to participate in a study, the information must be provided in a language the participant is proficient in.
Subject Information Sheet
The CCMO’s SIS has the following item relevant for FAIR:
Can we use your data and body material for other research?
Here, it is crucial that the researcher clearly explains the potential purposes for which collected data or materials may be reused. While these purposes can be broader than the original study's aim, they should not be overly vague. For instance, "cancer research" might be acceptable, but "any research" would not. If stored data/material is used for a different purpose, participants must give permission again or usage is not permitted.
Informed Consent Form
The CCMO’s SIS contains an ICF as an Appendix. The following items are relevant for FAIR:
I give consent to store my data to use for other research, as stated in the information sheet.
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.
Participants < 16 years old (children)
The CCMO’s SIS model for children does not contain these FAIR items. Hence, to support reuse of this data, these items should be added to the SIS and ICF before subjecting the documents for review. (?????)
Next
Go to Step 3.
Step 2 - Study is not subject to WMO
First, check with your local MREC which SIS and ICF templates they accept. Verify whether these templates contain FAIR components. The ELSI Servicedesk provides standardised text that can be used in the SIS and ICF (only available in Dutch).
Subject Information Sheet
In English, the SIS needs information concerning the following topics:
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 is vrij zwak, aangezien het mijn vertalingen zijn. 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.
Add the applicable sections to your SIS to ensure it allows for FAIR usage of data and materials.
Informed Consent Form
In English, the ICF needs to include the following:
I give consent to use my data <if applicable> [and (residual (remaining?)) biomaterial] for other scientific research, as stated (explained?) in the subject information sheet.
SdR: dit is vrij zwak, aangezien het mijn vertalingen zijn. 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.
Participants < 16 years old (children)
The CCMO’s SIS model for children does not contain these FAIR items. Hence, to support reuse of this data, these items should be added to the SIS and ICF before subjecting the documents for review. (?????)
Additional FAIR consideration for your SIS and ICF
Andere relevante zinnen om toe te voegen?
...
If the MREC requires you to use a specific SIS/ICF template for children, check whether it contains FAIR components. If not, consider reusing the entries described above.
Next
Go to Step 3.
Step 3 - Additional FAIR consideration
Sharing data with parties outside of the EU
Subject Information Sheet
(Vertaalde versie van standardised text van de ELSI Servicedesk)
<if applicable> If we collaborate with countries outside the European Union
...
Next
Go to Step 3.
Step 2 - Study is not subject to WMO
First, check with your local MREC which SIS and ICF templates they accept. Verify whether these templates contain FAIR components. The ELSI Servicedesk provides standardised text that can be used in the SIS and ICF (only available in Dutch).
Subject Information Sheet
In English, the SIS needs information concerning the following topics:
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: how is the second aspect handled in WMO-studies?
SdR: dit is vrij zwak, aangezien het mijn vertalingen zijn. 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.
Add the applicable sections to your SIS to ensure it allows for FAIR usage of data and materials.
Subject Information Sheet
In English, the ICF needs to include the following:
I give consent to use my data <if applicable> [and (residual (remaining?)) biomaterial] for other scientific research, as stated (explained?) in the subject information sheet.
SdR: dit is vrij zwak, aangezien het mijn vertalingen zijn. 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.
Participants < 16 years old (children)
If the MREC requires you to use a specific SIS/ICF template for children, check whether it contains FAIR components. If not, consider reusing the entries described above.
Additional FAIR consideration for your SIS and ICF
Andere relevante zinnen om toe te voegen?
Next
Go to Step 3.
Step 3
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
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.
Sharing data with commercial parties
Subject Information Sheet
(Gebaseerd op de vorige, waarschijnlijk niet goed…………)
In this study, your data [and biological material] may be shared with commercial parties for research purposes, such as [explain the reason here]. It is also possible that the data will be shared with commercial entities for the development of new products or services.
We only share your data [and biological materials] with commercial parties if they handle your data [and biological materials] securely and in accordance with the same standards required for researchers within the EU. We will also make written agreements with them to ensure your privacy and the protection of your data.
Informed Consent Form
Ik geef wel/geen (doorhalen wat niet van toepassing is) voor onderzoek met mijn gegevens en materiaal door commerciële partijen.
Step 4 - Special cases
Cohort studies and biobanks.
...
ELSI Servicedesk? Unfortunately in Dutch.
Templates for ICs?
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.https://book.the-turing-way.org/project-design/sdpm/informed.html
[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
[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.
...
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.
IC is also vital for GDPR compliance, as processing personal data (especially sensitive health data) often requires explicit consent from the data subject. Furthermore, patient consent is necessary for, for example, archiving, sharing [uu_consent] and linkage with external registries.
A general informed consent form is available on the website of the CCMO, but a local Institutional Ethical Review Board may demand changes after reviewing and assesses whether the IC aligns with ethical standards, legal requirements and takes considerations into account such as age. This is important because:
It ensures that the consent form is written in a way that participants in that particular region can understand.
The local committee will assess whether the consent form adequately explains the data processing activities, the purpose of data collection, and participants' rights (e.g., the right to withdraw consent).
The committee ensures that the study adheres to local regulations regarding the use of personal and sensitive health data.
[uu_consent] https://www.uu.nl/en/research/research-data-management/guides/informed-consent-for-data-sharing
SdR: The step is call Obtain informed consent. Can you “obtain” IC with an opt-out model?
...
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.
...