Informed Consent Form Template for Research with Human Participants - EC CIS

Sep 1, 2026

Informed consent form template to support researchers designing consent documents for studies involving human participants, provided by Ethics Committee CIS based on a BMS EC template. The template outlines required participant information and study transparency: research purpose, session procedures and timing, benefits and risks, withdrawal process, and details on personal data collection, processing, access rights, confidentiality, anonymisation, controlled sharing, archiving, and dissemination. It also specifies GDPR-consent expectations (affirmative, granular) and includes guidance on data retention and key contact and complaint channels.

LanguageEnglish

CategoryForms

FormatDOCX

Pages4

Reading Time2 min

AccessFree to download

Template purpose and adaptation

Required participant information

Study procedures, benefits, and risks

Withdrawal and data rights

Data safeguarding, archiving, and dissemination

GDPR consent requirements

Template structure and placeholders

Consent form template for research with human participants Authors: Ethics Committee CIS (based on template by BMS EC) Last edited: 19-01-2022 -------------------------------------------------------------------------------------------------------------------- Note that this is a template to assist researchers in the design of their consent forms. It is important to adapt this template to the outline and requirements of your particular study, using the notes and suggestions provided. The consent form should be accompanied by an information letter that describes adequately and comprehensibly for the participants: Purpose of the research What will happen during the session, how long it will take, what will be asked of the participant, etc Benefits and risks of participating (e.g. mention that your research project has been reviewed by the Ethics Committee Information and Computer Science) Procedures for withdrawal from the study Whether any personal information about the participant will be collected, processed and how and for what purpose; the right of the participant to request access to and rectification or erasure of personal data Usage of the data during research, safeguarding personal information, maintaining confidentiality and de-identifying (anonymising) data, controlled access to data, especially in relation to data archiving and reuse, ways of dissemination, data archiving and possible publishing Retention period for the research data, or if that is not possible, criteria used to determine that period Contact details of the researcher (or his/her representative), contact details of the Ethics Committee Computer and Information Science to file a complaint, and if applicable another institution than UT, or a funding source. Under General Data Protection Regulation (GDPR), consent needs to be: affirmative granular, seeking consent for different forms of data and for different use purposes more information on the appropriate use of personal data in scientific research according to the GDPR can be found HYPERLINK "https://www.utwente.nl/.uc/f3eda9ef2010222e8db0078d23f031a77411fe019972a00/Appropriate%20use%20of%20personal%20data%20in%20scientific%20research%20-%20V1.pdf" here In this template: square brackets indicate where specific information is to be inserted black text forms the standard content of a consent form red text is notes to help the researcher finalise the form, not to be included in the consent form. grey text indicates extra optional questions Consent Form for [name of study]YOU WILL BE GIVEN A COPY OF THIS INFORMED CONSENT FORM

FAQs

What information must the consent form include for participants?

It should cover the research purpose, what will happen during the session (including duration and what participants will be asked), benefits and risks, withdrawal procedures, and how personal information will be collected, processed, and used.

How does the template address participant rights for personal data?

It requires describing participants’ rights to access, rectify, or erase personal data, and explaining safeguarding measures like confidentiality, de-identification (anonymising), and controlled access, including archiving and reuse.

What are the GDPR consent requirements stated in the template?

Consent must be affirmative and granular, seeking consent for different data forms and different use purposes. The template also points to guidance on appropriate use of personal data in scientific research under GDPR.

Sep 1, 2026

Upload by Bill Black