Informed Consent Process

Participation in the study is based on informed consent

Participation in research is always based on voluntary consent and awareness of what one intends to participate in. All persons requested to participate in the study, or their legal representatives, must obtain informed consent before participating in the study. Consent is based on information provided about the study. Consent can be given in writing in both paper and electronic form. Consent (guardian and/or child/young person) can be withdrawn at any time and even after consent, the investigation can be interrupted at any time before the end of the investigation without affecting the care that the child may need.

The consent process refers to both the consent discussion at the beginning of the study and assessing the consent during the entire study

The participant´s opinion and any potential changes that may have occurred after the previous visit, should be discussed on each upcoming visit (e.g. the need for re-consent).

• In the consent process, the discussion may only be conducted by a person with sufficient skills and knowledge of both the research and the legislation related to consent. Consent discussion should always be documented.
• The person requested to participate to trial (and his/her guardian) must be given information about the study, both orally and in writing. The guardians’ information must contain all legally required information.
• Information for children and young people must be in a format appropriate to their age and level of development and understanding, and preferably very short. It is recommended to use visual materials that facilitate understanding, such as images* or videos.
• In the consent process, those asked to participate must be given sufficient time to familiarize themselves with the material provided, as well as the opportunity to ask questions and get answers to them before deciding about participation.
• If electronic consent is used, it must include study information separately the adults´ and minors´ versions also when using the electronic consent. If participants cannot provide consent electronically, they must be given the option to do so on paper (manually).
• Any use of financial or other benefits, incentives and inducements is prohibited. Participation in the study must be free of charge, and the costs of participation must be reimbursed.
• The opinion expressed by the child must be followed, considering his or her age and level of development. The child’s opinion must be heard and his or her wish to refuse to participate in the study must be respected. No one can be pressured or forced to participate in research.

Picture Card Models*:Resources; FINPEDMED Picture Cards.

For more information, as well as templates for informed consent forms: FINPEDMED Patient information and Informed Consent guidelines and templates