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V The first draft of this document was presented to the American
Academy of Pediatrics (AAP) Committee in 1985

V ³The experience, perspective, power of children´ to be taken most

seriously.

V He worked to make medicine and medical research safer and more

friendly for children

V According to him children are in process of becoming ³ Intelligent,

Observant, Capable, and Responsible persons´ who deserve our
utmost respect to either consent or to refuse medical intervention
V Information exchange between the research team and the child

V Enhances decision making process between the parents and the child

V Granting child ability to exercise dissent.

V Respect for the dignity of the child-participant

V Safeguard the best interests of the child-participant

V Protect the child-participant from harm

V Assure and respect the privacy of the child-participant

V Protect the confidentiality of the child-participant

V J
 - The National Commission for Protection of Human

Subjects of Biomedical and Behavioral Research established
 as a reasonable minimum age for involving children in
some kind of assent process
V The same information needs to be conveyed but may be done
orally at the child¶s level of development
cd_assent.doc
V The oral explanation of the study to the child should be attested
by the parent on the Parent Consent Form when a written
assent is not possible.

V Infants and children unable to understand do not need a written

assent
V Age between  -  

V ^ritten in a simpler format at the second or third grade

reading level

V Used in conjunction with the parent/guardian consent

form
V Age between 
 

V ^ritten in language appropriate to the youngest teenager at the sixth

to eighth grade reading level.

V Used in conjunction with the Parent/Guardian Consent Form.

V In cases of involving the following kinds of medical care for infants and
young children, the physicians must obtain the informed permission of the
parents before-

V Providing immunizations

V Performing invasive diagnostic testing for a congenital cardiac defect

V Beginning long-term anticonvulsant therapy to control a seizure disorder

V Initiating serial casting to correct congenital ³clubfoot´

V Undertaking surgical removal of a ³suspicious" neck mass.

V In cases of older school-age children, the physicians must obtain the
assent of the patient as well as the informed permission of the parents

V Venipuncture for a diagnostic study in a nine-year old

V Diagnostic testing for recurrent abdominal pain in a 10-year-old

V Psychotropic medication to control an attention-deficit disorder in a third

grader

V An orthopedic device to manage scoliosis in an 11-year-old

V An ³alarm´ system to treat nocturnal enuresis in an eight-year-old

V Surgical repair of a malformed ear in a 12-year-old.

V In cases of adolescents and young adults, the physicians must obtain
the informed consent of the patient, in most instances

V Performance of a pelvic examination in a 16-year-old

V Diagnostic evaluation of recurrent headache

V A request for oral contraceptives for fertility control in a 17-year-old

V Proposed long term oral antibiotics administration for severe acne in

a 15-year-old;
V Committee for Proprietary Medicinal Products /CPMP) (1997) Note
for guidance on clinical investigations of medicinal products in
children ë



‰ondon

V American Academy of Pediatrics Task Force on Pediatric Research,

Informed Consent, and Medical Ethics. Consent. Pediatrics.
1976;57: 414-416

V Regulations for the Protection of Human Subjects 11 (Title 45, Part

46 of the Code of Federal Regulations, Protection of Human
Subjects; also referred to as 45 CFR 46)

V "Consent (Assent) for Research with Pediatric Patients" 5 by Marion

E. Broome, Ph.D., RN,
FAAN.http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retri
eve&db=PubMed&list_uids=10222509&dopt=Abstract