SSStudyParticipantsVulnerablePopulation object

Yes
Special provisions apply

• Art 20 & 21 of Ministerial Order No 806
• Part 3, section 9 and Part 5, section 17&19 of the Committee Act
• Further details on „Trials with children and young people under the age of 18“ are provided in in section 4.4 of the 'Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics'.

Yes
Special provisions apply

• Art 22 of Ministerial Order No 806
• Part 3, section 3-5 of the Committee Act
• Further details are provided in in section 4.4 of the 'Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics'.

Yes
Special provisions apply

Proxy consent from the „trial guardian“ must be obtained prior to the trial commencement if the trial subject is unable to give his/her informed consent and it is impossible to obtain an „ ordinary“ surrogate consent from the guardian, the custodial parent, the next of kin and the general practitioner alternativly the medical officer of health.

With limitations

According to section 2(12) of the Committee Act, the „trial guardian“ is a unit consisting of two doctors who may give proxy consent on behalf of the trial subject in acute situations; they are appointed for all the trial subjects in a clinical trial or ad hoc for individual trial subject

This is normally applicable to trials involving individuals in acute settings who are temporarily incapacitated, e.g. unconscious.

• Section 2(12) & 12 of the Committee Act
• Further details are provided in Section 4.6.2 of the Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics.

No national legal framework available

There are no common provisions mentioned in Danish law regarding the inclusion of pregnant or lactating women.

Yes

(1) Ministerial Order No 806
(2) Committee Act
(3) Further details on the inclusion of vulnerable population in a clinical trials are provided in Section 4.6.2 of the Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics.