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
Yes
Special provisions apply
A clinical investigation of MD may be allowed without prior consent if the following conditions are met:
- the nature of the research project requires that it can only be undertaken in acute emergency situations (the physical/mental condition is a necessary characteristic element of the research project) where the trial subject is unable to give his/her informed consent and it is not possible to obtain proxy consent
- it may improve the health of the person in the long term
- it may improve the condition of other patiens with the same disease and the intervention poses minimal risk and burden to the patient.
- The investigator shall as soon as possible thereafter seek to obtain informed consent or proxy consent.
This is normally applicable to trials involving individuals who are temporarily incapacitated, e.g. unconscious.
NB! This shall not apply to clinical research with medicinal products!
• Section 11 of the Committee Act
• Further details are provided in Section 4.6.1 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.
Specific requirements in regard to contraception must be considered when including fertile women in clinical trials
(see “Guidance on application for the authorisation for clinical investigation of medical devices” available on CA website in section: Medicines & medical devices / Medical devices / Clinical investigations / Application
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.
