SSStudyParticipantsVulnerablePopulation object
Yes
Special provisions apply
Section 2(8) Regulation 2009 for clinical trials
Art 17&18 The Health Research Act
Yes
Special provisions apply
Section 2(8) Regulation 2009 for clinical trials
Art 17&18 The Health Research Act
Yes
Special provisions apply
Conditions for the conduct of trials if the patient is unable to give consent, and where it is impossible to obtain prior consent of that person's next of kin:
a) any risk or inconvenience to the person is insignificant
b ) the person does not oppose it, and there is no reason for scientists or other personnel to believe that she/he would have opposed the plan if he had had to consent ,
c ) it is only possible to carry out research in clinical emergencies
d ) research is undoubtedly justified by the prospect of results with great preventive, diagnostic or therapeutic value.
The person or his next of kin shall as soon as possible given information about the research and consent should be obtained as soon as possible .
No
Pregnant or breastfeeding women should not be included in studies involving IMP.
Yes
Chapter 2 of Regulation 2009 for clinical trials
Chapter 4 of The Health Research Act
ADDITIONAL PAEDIATRIC INFORMATION
LEGAL AGE OF CONSENT:
18 years
MANDATORY / SUGGESTED AGE RANGES DEFINED FOR ASSENT:
Competence to give consent: The following people are entitled to consent to take part in medical and health research:
a) legally competent persons
b) minors aged 16 and over, unless otherwise follows from statutory provisions or the nature of the activity.
Specifications regarding assent: Adolescents over the age of 16 must of their own accord, consent to taking part in a research project. However, if the research entails surgical intervention or participating in a Clinical Trial, their parents/guardians must also give their consent. If the adolescent is under the age of 16, only their parents/guardians can consent to their child’s participation.
NUMBER OF REQUIRED SIGNATORIES:
Main rule: both parents sign the consent form if
they have parental responsibility for the child.
OFFICIAL LANGUAGE OF INFORMED CONSENT:
Norwegian
INFORMATION ON MATERIAL USED TO DESCRIBE THE CLINICAL TRIAL TO THE MINOR:
The children’s information sheet will need to be adapted to their age and their level of understanding, and at the same time provide information about the type of research that they are being invited to participate in.
The Children’s Act 1981 states that when a child reaches the age of seven, they must be given an opportunity to express their opinion before a decision is made concerning personal matters affecting them. They will therefore have a greater and increasing right to be heard in terms of their health, in accordance to their age and maturity.
ADDITIONAL INFORMATION (INCLUDING REFERENCE FOR TEMPLATE):
• New regulation from 2017: Minors aged 12-16 may consent to projects that cannot be completed with the parents’ consents because the project may reveal information that the parents do not want to be revealed, e.g. violence or lack of parental care.
• Reference legislation:
o Lov om medisinsk og helsefaglig forskning (helseforskningsloven) (in Norwegian)
o Forskrift om barn mellom 12 og 16 år sin rett til selv å samtykke til deltakelse i medisinsk og helsefaglig forskning (in Norwegian)
o Lov om barn og foreldre (barnelova) (in Norwegian only)
• IC template(s) / guidelines / information sources
o The Norwegian Medicines Agency -> Clinical Trials -> Regulations
o National database for Laws and Acts -> Lov om medisinsk og helsefaglig forskning (helseforskningsloven) – information available only in Norwegian.
o Guidance to Helseforsknings-loven (in Norwegian only) Additional info.
o Regional Committees for Medical and Health Research Ethic-> Templates for Participation Information and Consent
SOURCE(S):
https://legemiddelverket.no/english/clinical-trials/regulation-relating-to-clinical-trials-on-medicinal-products-for-human-use-
https://lovdata.no/dokument/NL/lov/2008-06-20-44?q=helseforskning
http://www.legemiddelverket.no/English/Sider/default.aspx
https://lovdata.no/dokument/LTI/forskrift/2017-06-28-1000
https://lovdata.no/dokument/NL/lov/1981-04-08-7
https://helseforskning.etikkom.no/frister/malforinformasjonsskriv?p_dim=34672&_ikbLanguageCode=us
https://www.regjeringen.no/globalassets/upload/hod/hra/veileder-til-helseforskningsloven.pdf
