Consent Declarations and Forms

Below you will find the committee system's pre-printed consent declarations. If you need a consent declaration that you can edit or copy from, we have included a link under each consent declaration. However, be aware that it might be more challenging to get approval for consent declarations that do not follow the standards of the scientific ethics committees. You can also find the relevant requirements if you choose not to use the standard form.

NB: Remember that the duty to provide information under GDPR Article 13 applies to the parent who gives the power of attorney. If you are a private data controller, you should also be aware of the requirements of Section 11, Paragraph 2 of the Data Protection Act, which sets out specific legal requirements for the processing of personal identification numbers. If consent is used as the basis for processing a personal identification number, the relevant parent must be informed that the consent can always be withdrawn, according to Article 7 of the General Data Protection Regulation.

Consent Declarations for Competent Individuals

S1: Consent Declaration for Competent Individuals

WITHOUT a research biobank

WITHOUT a section to opt-out of receiving new health information

Download the standard version of S1

Download the editable version of S1

S2: Consent Declaration for Competent Individuals

WITHOUT a research biobank

WITH a section to opt-out of receiving new health information

Download the standard version of S2

Download the editable version of S2

S3: Samtykkeerklæring til habile personer

WITH a research biobank

WITHOUT a section to opt-out of receiving new health information

Download the standard version of S3

Download the editable version of S3

S4: Samtykkeerklæring til habile personer

WITH a research biobank

WITH a section to opt-out of receiving new health information

Download the standard version of S4

Download the editable version of S4

Consent Declarations and Forms for Parents

S5: Consent Declarations for Parents

S6: Consent Declarations for Parents

Pre-printed Parental Authority Form

In certain cases, a parental authority form may be relevant.

Download the pre-printed parental authority form

Consent Declarations for Adults Without Legal Capacity, Persons Under Guardianship, and Trial Guardians

S7: Consent Declaration for Adults Without Legal Capacity and Persons Under Guardianship

WITHOUT the establishment of a research biobank.

Download the standard version of S7

Download the editable version of S7

S8: Consent Declaration for Adults Without Legal Capacity and Persons Under Guardianship

WITH the establishment of a research biobank.

Download the standard version of S7

Download the editable version of S7

S9: Consent Declaration for Trial Guardian in Medicinal Trials

Consent Declaration for Registry Research Projects with Informed Consent

S10: Consent Declaration for Registry Research Projects with Informed Consent

WITHOUT a section for opting out of receiving new health information.

Download the standard version of S10

Download the editable version of S10

S11: Consent Declaration for Registry Research Projects with Informed Consent

WITH a section for opting out of receiving new health information.

Download the standard version of S11

Download the editable version of S11

 

Other Consent Declarations

S12: Samtykkeerklæring fra pårørende til forskning på afdøde

S14: Joint Consent Declaration for the Establishment of a Research Biobank

S15: Joint Consent Declaration Where a Research Biobank is Not Established

If the Standard is Not Used

If the standard form is not used, the following requirements apply.

The date and version number must be included on the document, and every time changes are made.

Provide options for inserting the following:

  • Original title of the trial
  • Identification of the project, e.g., reference to the committee's case number
  • Dating of the declaration
  • That there is an option to sign for:
    • Participation in a health science research project
    • Remember two sections if both parents have parental authority in projects with children
    • Having received written and oral information
    • Opting out of being contacted about significant health findings
    • Wishing to know the project's results or consequences for the trial participant
  • If biological material is taken for a research biobank:
    • Consent to take and store biological material in connection with the trial (a research biobank)
    • The person providing information must sign to confirm that written information has been given to the trial participant and that oral information has been provided.
Last updated 01-02-2024