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Document templates

Trial Information and Informed Consent document templates

These documents are intended for the use of doctors and pharma industry conducting clinical trials in Finland.

In the Finnish Medical Research Act, the term CONSENT is used in the context of minors' (<15 yrs) participation. This consent is required in written form. This term CONSENT is comparable to the term ASSENT (article 29(8) of the Clinical Trials Regulation, CTR, 16April2014) It gives no legal permission for participation and it is not valid alone, because it needs an additional consent of a guardian or other legal representative.

Information:

  • There is no separate trial information template for children under 15 years of age; it is integrated.

  • The trial information given to children under 15 years of age is based on the guardian's information sheet which is discussed thoroughly with both the guardian (s) of the child and the child, taking into account his/her level of understanding.

  • There should be a possibility for both parties to ask questions concerning the study and they should receive satisfactory answers to these questions from the person giving this information.

  • After this discussion, the child signs his/her own informed consent and upon signing, it is confirmed that the child has understood the information concerning him/her and that he/she is willing to participate in the trial.

  • After this procedure, the guardian(s) can sign the informed consent and thus give legal permission for their child's participation.

  • FINPEDMED Picture Cards or other equivalent material can be used to help understanding of the trial information. See: Picture cards.

NOTE: The templates (v.2.0, 2009) for minors have NOT yet updated according to the new EU General Data Protection Regulation (GDPR, EU 2016/679, implemented on 25May2018) NOR the updated version of the ETHICAL CONSIDERATIONS FOR CLINICAL TRIALS ON MEDICINAL PRODUCTS CONDUCTED WITH THE PAEDIATRIC POPULATION (R1, 18Sept2017). These amendments will be done to the informed consent model templates during the year 2018.

When using these old versions, please amend / modify the templates accoding to the requirements mentioned above.

Version 2 of the following document templates on 28 May 2009:

  • Clinical trial informed consent for children aged 15 to 17 years *

  • Clinical trial informed consent for a guardian of a minor (age under 15) *

A minor's (ages 6 to 10) informed consent for a clinical trial

A minor's (ages 10 to 14) informed consent for a clinical trial

Clinical trial informed consent for children aged 15 to 17 years *

Clinical trial information sheet for children aged 15 to 17 years

Notification of participation in a clinical trial to the guardian of a 15 to 17-year-old child Note: Version 2 (14Jan2010)

Clinical trial informed consent for a guardian of a minor (age under 15) *

Clinical trial information sheet for a guardian of a minor ( age under 15)

 

 

 

 

 

 

 

Document templates

Trial Information and Informed Consent document templates

These documents are intended for the use of doctors and pharma industry conducting clinical trials in Finland.

In the Finnish Medical Research Act, the term CONSENT is used in the context of minors' (<15 yrs) participation. This consent is required in written form. This term CONSENT is comparable to the term ASSENT (article 29(8) of the Clinical Trials Regulation, CTR, 16April2014) It gives no legal permission for participation and it is not valid alone, because it needs an additional consent of a guardian or other legal representative.

Information:

  • There is no separate trial information template for children under 15 years of age; it is integrated.

  • The trial information given to children under 15 years of age is based on the guardian's information sheet which is discussed thoroughly with both the guardian (s) of the child and the child, taking into account his/her level of understanding.

  • There should be a possibility for both parties to ask questions concerning the study and they should receive satisfactory answers to these questions from the person giving this information.

  • After this discussion, the child signs his/her own informed consent and upon signing, it is confirmed that the child has understood the information concerning him/her and that he/she is willing to participate in the trial.

  • After this procedure, the guardian(s) can sign the informed consent and thus give legal permission for their child's participation.

  • FINPEDMED Picture Cards or other equivalent material can be used to help understanding of the trial information. See: Picture cards.

NOTE: The templates (v.2.0, 2009) for minors have NOT yet updated according to the new EU General Data Protection Regulation (GDPR, EU 2016/679, implemented on 25May2018) NOR the updated version of the ETHICAL CONSIDERATIONS FOR CLINICAL TRIALS ON MEDICINAL PRODUCTS CONDUCTED WITH THE PAEDIATRIC POPULATION (R1, 18Sept2017). These amendments will be done to the informed consent model templates during the year 2018.

When using these old versions, please amend / modify the templates accoding to the requirements mentioned above.

Version 2 of the following document templates on 28 May 2009:

A minor's (ages 6 to 10) informed consent for a clinical trial

A minor's (ages 10 to 14) informed consent for a clinical trial

Clinical trial informed consent for children aged 15 to 17 years *

Clinical trial information sheet for children aged 15 to 17 years

Notification of participation in a clinical trial to the guardian of a 15 to 17-year-old child Note: Version 2 (14Jan2010)

Clinical trial informed consent for a guardian of a minor (age under 15) *

Clinical trial information sheet for a guardian of a minor ( age under 15)