The 2004 Regulations on Medicinal Products for Human Use (Clinical Trials) provide additional safeguards for clinical research on children. This can only be done if research has already been carried out without involving children, where it is important to involve minors and when the patients involved benefit. The interests of the child must be given priority and incentives should not be offered to ensure participation. In England, Wales or Northern Ireland must obtain the informed consent of a parenting officer for a minor to be involved in clinical trials. Schools: Written Authorization Form Headteachers, parental consent is optional in such a protected environment (in practice, parental consent is generally required for children under 13) Child availability to participate Federal regulations do not set an age at which CIRBs should expect investigators to begin obtaining consent from children. On the contrary, IRBs must take into account the age, maturity and psychological state of future researchers. In the commission`s experience, most IRBs require investigators to seek the consent of children over 6 or 7 years of age. The consent judgment may apply to all children who are required to participate in a study or to each child individually. As explained later in this chapter, the procedure for notifying older youth cannot differ materially from the procedure for obtaining informed consent if this compliant notification procedure is properly structured. Thus, the investigators would provide the same information as that required for adults.

Institutions: prior agreement of local child protection services. Entry into the institution can only take place with the express agreement of the Director of the Public Service responsible for the protection of children`s rights and accompanied by a representative of that public service, the signing of a declaration that all data and information received is used without infringing on the image or privacy of the child in an institution. , and the recording and use of images of children in care or care can only be made with the prior consent of the child`s parent [128] The Committee approves the National Human Research Protections Advisory Committee (NHRPAC) (Marshall, 2001) and the Society forAdo Medicine (SAM, 1995) to say that the FDA`s restrictive policy hinders important research on adolescents. As has already been explained in this chapter, the Committee considers that the status of the FDA leaves room for appreciation where parental authorization is not possible or is contrary to the best interests of the child. In addition, as NHRPAC found, FDA rules define children by referring to state laws that apply in the territorial scheme in which research takes place, which reasonably implies that the age of consent (i.e. when parental authorization is not required) depends on that state`s law.