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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 used in the recommendation** and in many EU countries. 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.

NOTE:

  • 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.

The templates for minors are designed on the basis of the ETHICAL CONSIDERATIONS FOR CLINICAL TRIALS ON MEDICINAL PRODUCTS CONDUCTED WITH THE PAEDIATRIC POPULATION, **Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use. A link to this document can be found on a page; Regulations and Guidelines. The basic trial information should follow the recommended list of items to be covered in the information sheet (ANNEX 3: Information for Informed Consent).

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 used in the recommendation** and in many EU countries. 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.

NOTE:

  • 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.

The templates for minors are designed on the basis of the ETHICAL CONSIDERATIONS FOR CLINICAL TRIALS ON MEDICINAL PRODUCTS CONDUCTED WITH THE PAEDIATRIC POPULATION, **Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use. A link to this document can be found on a page; Regulations and Guidelines. The basic trial information should follow the recommended list of items to be covered in the information sheet (ANNEX 3: Information for Informed Consent).

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)