Informed Consent Form templates for paediatric clinical trials

The FINPEDMED Informed Consent Form and Trial Information Sheet -template models are intended for the use of health care professionals and pharma industry conducting paediatric clinical trials in Finland.

The new European Clinical Trials Regulation, CTR (2014) supported by the new EU portal and database; Clinical Trials Information System (CTIS) came into application on 31st January 2022. Due to the CTR, the Finnish national Act on Clinical Trials on Medicinal Products (983/2021) has been changed according to the CTR. This legislation came into force at the same time on 31st January 2022.

NOTE: In Finland, the term CONSENT is used in the national legal texts, instead of Assent, in the context of minors’ (<15 yrs and 15-17 yrs) Informed Consent process related to participation in a new Clinical trial. In Finland the legal age for independent consent is 15 years. When the minor has reached the age of 15 and, in view of his/her age and maturity and the type of illness and research, is capable of understanding the importance of the research procedure and the research is likely to be of direct benefit to the minor’s health, the minor is can give his/her informed consent in writing. In such cases, the guardian must be informed of this (notification to the guardians of trial participation). For lower age groups (<15 yrs), the child´s own consent is not legally valid alone for participation and it always needs an additional consent of a guardian or other legal representative (i.e. parent/-s).

About the models:

• The age grouping is according to the ne law; children below 15-years and 15-17 years , based on the legal ability to give indpendent consent.
• The ICF template for children under 15-years of age is INTEGRATED, i.e. it includes the main information and there is no need for separate trial information sheet. However, it is strongly advised and preferred to provide some additional visual information for this age group, for example by using pictures, especially about the trial time schedule.
• To use the ICF templates and Information documents, the documents need to be opened by using pdf-software (e.g. Adobe Acrobat Reader).
• FINPEDMED Picture Cards or other equivalent material can be used to help understanding of the trial information. See: Picture cards.
• Principally, 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.

The new templates for minors have been updated in 2021 according to the new EU General Data Protection Regulation (GDPR, EU 2016/679, implemented on 25th May 2018) together with the updated version of the ETHICAL CONSIDERATIONS FOR CLINICAL TRIALS ON MEDICINAL PRODUCTS CONDUCTED WITH THE PAEDIATRIC POPULATION (R1, 18th September 2017). New document have been created according to the GDPR for the 15-17 years old participants about the processing the personal data in clinical trials, and it has been updated according to the new Clinical Research Act. All these document models have been designed together with the valuable comments provided by HUS Department of Children and Adolescents Resaerch Panel (Young Person´s Advisory Group). By this way, children and adolescents can be better involved to the decision makig processes related to their own interests and enhance the understanding of trial information during the informed consent process.

The new Informed Consent and Patient Information Sheet templates 2021 (*updated on 16Dec2021):

• FPM-E-001-EN-A_Under 15 year old_Informed Consent – template for a clinical trial_2021
• FPM-E-001-EN-B_UNDER 15 YEAR OLD_INFORMED CONSENT – TEMPLATE FOR A CLINICAL TRIAL_2021
• FPM-E-001-EN-C_Under 15 year old_Additional sections for Informed Consent_2021
• FPM-E-002-EN_15-17 years old_Trial Information Sheet –Table of Contents_2021
• FPM-E-003-EN_15-17 years old_Informed Consent – template for Clinical trial_2021
• *FPM-E-004-EN_15-17 years old_Information on the Processing of Personal Data_2021
• FPM-E-005-EN_15-17 years old_Notification to Guardians of Trial Participation_2022
• FPM-E-006-EN_Under 15 year old_Informed Consent – template for a Guardian_2021

Templates for paediatric clinical trials in Finnish and Swedish can be found here.

Maternal ICF for pregnant women for clinical drug trial or medical device trial can be found here.