Instructions for Drafting an Informed Consent
Informing participants is a crucial part of ethically responsible research involving people. We have created sample documents to help researchers convey the correct and relevant information, in a suitable fashion.
There are a number of different templates available for you to use, depending on the type of research and whether you are processing personal data. All consent forms ask participants to consent for participation in your study (in line with the declaration of Helsinki), and when applicable, ask for consent for the processing of personal data. For anonymous research a simple information letter and consent form is available. For non-anonymous research it depends on the legal basis you have chosen for processing personal data.
Download information letters and consent form templates
When filling out these templates, there are several key elements that need to be included or that you need to pay extra attention to.
- Include only relevant information for participants.
- Ensure information is digitally accessible.
- Provide information in manageable portions.
- Set clear assessment criteria.
With the introduction of GDPR in 2018, the requirements for providing information on personal data processing have increased. Participants must receive clear, understandable information about the research to give informed consent, and what their personal data will be used for.
Structure of Informed Consent
An informed consent consists of two parts: an information letter (informed) and a consent form (consent). The information letter should be kept separate from the consent form.
The information letter should include the following elements:
- General Information:
- Full title of the research.
- Date of the final version of the information letter.
- Ethical Aspects:Describe what the participant can expect during the research (purpose, methodology, duration, effort, etc.):
- The goal of the research, including the specific questions it aims to answer, and mention if it involves publication (e.g., in a scientific journal, report) or if it is a student project (e.g., thesis, only published internally).
- If applicable, state that it is a longitudinal study with multiple measurement points.
- Explain how the research will be conducted (e.g., using questionnaires, experimental methods, observations, video or audio recordings).
- Describe what is expected from the participant (type of tasks, time investment, invasiveness). Mention if the participant might encounter invasive questions that could evoke unpleasant memories.
- Specify what will happen and avoid mentioning what will not be done.
- Detail the compensation the participant will receive, specifying the type (cash, digital or physical voucher, gift), and whether the compensation is proportional or contingent on completing the study.
- Outline the potential direct and indirect benefits and disadvantages of the research for the participant.
- Emphasize the voluntary nature of participation, the right to withdraw at any time without consequences, and that data collected up to the point of withdrawal will still be used for the research.
- Data Processing and Privacy Aspects:
- Explain whether and why contact details are processed (e.g., for follow-up contact, sending invitations, home visits, payment of participant compensation) and how these details are obtained if using an external organization’s database.
- Note that for recruiting participants, contact must be made through the researcher’s institutional email address or a non-personal mailbox (which can be requested via Techsupport). Avoid using personal email accounts like Gmail. For scheduling appointments, digital calendars may be used. Refer to suitable tools on the UU Tools website.
- State whether special personal data is collected, and ensure separate consent is obtained for each type of special data. Explain why this data is necessary to answer the research question. Collect only the personal data necessary for answering the research question, adhering to the principle of “data minimization” under GDPR.
- Indicate that for payment of participant compensation, additional personal data will be collected by the F&C department, which maintains its own administration and retention periods. This data includes:
- Participant number or record number.
- Name and address (for sending gifts).
- Name, address, and IBAN (for bank transfers).
- Email address (for digital vouchers), which must be securely delivered to fsw.fenc.kas@uu.nl with a password sent via SURFfilesender.
- Signature list with the participant’s full name and signature for receiving cash or vouchers.
- Assure participants that data will be treated confidentially, primarily accessible only to directly involved researchers, and stored as anonymously as possible. Specify if the data will be pseudonymized, how long this will be maintained, and for what purpose.
- Mention that anonymized data might be included in public databases (e.g., DANS, OSF, ODISSEI) or used for future research, and provide participants with the option to opt out.
- If applicable, state that personal data may be shared with external organizations or through online tools or applications (e.g., for surveys).
- Ensure personal and research data are separated where necessary.
- Explain that personal data is stored separately from raw research data. This can be described in general terms without delving into formal legal details.
- Retention Periods:
- Specify retention periods for different categories of data:
- At least 10 years for raw data.
- 20 years for medical data.
- Personal data traceable to individuals only as long as necessary for the intended purpose.
- Personal data for compensation payments for 7 years.
- Indicate that anonymized data may be used for follow-up or future research with a different purpose and may be included in an open access database (e.g., DANS).
- Specify retention periods for different categories of data:
- Participants’ Privacy Rights:
- The right to access their data.
- The right to request the deletion of personal data (though this may not be possible in all situations).
- The right to withdraw consent for personal data processing. Analyses made up to that point will still be used for the research.
- Refer to the UU’s general privacy statement: Privacy Statement for Research Participants.
- Participants can exercise their privacy rights by contacting the researchers or via privacy@uu.nl or privacy-fsw@uu.nl.
- Contact Information:
- Contact details of the research team members (names, email addresses, phone numbers, and roles).
- Contact details of an independent contact person for questions and comments about the research (a colleague from another research group).
- Contact details for official complaints: klachtenfunctionaris-fetcsocwet@uu.nl.
- Contact details of the Data Protection Officer: Functionaris voor Gegevensbescherming or via privacy@uu.nl.
The consent form should include the following elements:
- Title of the research and the date of the document version.
- A statement that the participant has been fully informed about the purpose of the research and the handling of their data.
- Explicit consent for:
- Participation in the research.
- Processing of personal data (including special categories).
- Possible transfer of data to external organizations or countries outside the EU.
- Name and signature of the participant (without additional personal data like birth date, respondent number, student number, or email address).
- Optional consent for sharing data for future research or open access.
For online or digital data collection, alternative methods for obtaining consent are acceptable:
- For non-invasive research: Create an online page with the information letter, informed consent, and a method for participants to digitally accept the terms (e.g., by checking a box on the page). Tools like Qualtrics or LimeSurvey are recommended. MS Teams can also be used as a research tool: Office & Adobe & Teams | Tech Support Social and Behavioural Sciences.
- For invasive research: Record an audio file of a researcher reading the information letter and informed consent to the participant, who then gives verbal consent. Ensurethe participant understands the research, voluntary participation, right to withdraw, and data handling.
Consent forms are considered personal data and must be securely stored (e.g., in a designated faculty server folder). Only digitized versions should be kept (as PDF-A documents), with original paper versions destroyed afterward. Consent forms should not be sent via email (scanned), but through secure methods like SURFfilesender.
Different rules apply for obtaining consent based on age:
- For children under 12: Consent is generally required from both parents unless this is impractical, in which case one parent’s signature is sufficient.
- For children aged 12 to 18: Consent is required from the minor and, in principle, both parents unless this is impractical, in which case one parent’s signature is sufficient.
- For individuals over 18: Only the individual’s consent is required.
For non-invasive research, the current guideline is to allow 16- and 17-year-olds to provide consent independently, in line with GDPR, which sets 16 as the minimum age for privacy-related consent. If the participant is legally or mentally incapacitated, consent must be obtained from an authorized representative (guardian, curator).
For special personal data (e.g., ethnicity, religion, health, union membership), always use active or explicit consent. Seek advice from a privacy officer for such cases.
Read more about writing informed consent forms on the Research Data Management Support website.