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Assent form in

paediatrics

Presented by

Harshad More

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The first draft of this document was presented to the American

Academy of Pediatrics (AAP) Committee in 1985

The experience, perspective, power of children to be taken mostseriously.

He worked to make medicine and medical research safer and more

friendly for children

According to him children are in process of becoming Intelligent,

Observant, Capable, and Responsible persons who deserve our

utmost respect to either consent or to refuse medical intervention

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Information exchange between the research team and the child

Enhances decision making process between the parents and the child

Granting child ability to exercise dissent.

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Respect for the dignity of the child-participant

Safeguard the best interests of the child-participant

Protect the child-participant from harm

Assure and respect the privacy of the child-participant

Protect the confidentiality of the child-participant

Note - The National Commission for Protection of HumanSubjects of Biomedical and Behavioral Research establishedage 7 as a reasonable minimum age for involving children insome kind of assent process

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The same information needs to be conveyed but may be done

orally at the childs level of developmentcd_assent.doc

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.

Infants and children unable to understand do not need a written

assent

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Age between 7 - 12.

Written in a simpler format at the second or third grade

reading level

Used in conjunction with the parent/guardian consentform

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Age between 13 - 17.

Written in language appropriate to the youngest teenager at the sixth

to eighth grade reading level.

Used in conjunction with the Parent/Guardian Consent Form.

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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-

Providing immunizations

Performing invasive diagnostic testing for a congenital cardiac defect

Beginning long-term anticonvulsant therapy to control a seizure disorder

Initiating serial casting to correct congenital clubfoot

Undertaking surgical removal of a suspicious" neck mass.

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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

Venipuncture for a diagnostic study in a nine-year old

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

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

grader

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

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

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

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In cases of adolescents and young adults, the physicians must obtain

the informed consent of the patient, in most instances

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

Diagnostic evaluation of recurrent headache

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

Proposed long term oral antibiotics administration for severe acne ina 15-year-old;

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Committee for Proprietary Medicinal Products /CPMP) (1997) Note

for guidance on clinical investigations of medicinal products inchildren (CPMP/EWP/462/95) London

American Academy of Pediatrics Task Force on Pediatric Research,Informed Consent, and Medical Ethics. Consent. Pediatrics.

1976;57: 414-416

Regulations for the Protection of Human Subjects 11 (Title 45, Part46 of the Code of Federal Regulations, Protection of HumanSubjects; also referred to as 45 CFR 46)

"Consent (Assent) for Research with Pediatric Patients" 5by MarionE. Broome, Ph.D., RN,FAAN.http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10222509&dopt=Abstract

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