Informed Consent in Pediatric Practice
(Diploma, 5 marks, June 2024, Paper 1, System: Informed Consent in Pediatric Practice
(Diploma, 5 marks, June 2024, Paper 1, System: Ethics & Legal, Topic: Informed Consent)
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Definition
Informed consent is the process by which a patient or guardian voluntarily confirms their willingness to undergo a particular procedure, treatment, or participate in research, after being informed of all relevant aspects.
In pediatrics, the process is more complex due to involvement of parents/legal guardians and the child’s developing autonomy.
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Components of Informed Consent
1. Disclosure:
Nature, purpose, benefits, risks, and alternatives of the procedure or study.
Use simple, age-appropriate language.
2. Understanding:
Ensure the parent/guardian (and child if appropriate) comprehends the information.
3. Voluntariness:
Consent must be given freely without coercion or undue influence.
4. Competence:
In pediatrics, parents or legal guardians provide consent.
Adolescents may be considered for assent or even consent in specific legal settings.
5. Consent/Assent Documentation:
Signed written form preferred, especially in research.
Verbal consent may be acceptable in minor procedures.
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Special Considerations in Pediatrics
Assent:
Children above 7 years should be involved in the decision-making process depending on maturity.
It is ethically desirable though not legally required in India.
Emergency Situations:
Treatment can be provided under implied consent if guardian is unavailable and delay would harm the child.
Research:
Separate consent for participation in studies is mandatory.
Institutional Ethics Committee (IEC) approval needed.
Confidentiality:
Adolescents have a right to confidentiality in sensitive matters (e.g., STIs, contraception).
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Legal and Ethical Framework
Indian law doesn’t specify a minimum age for medical consent but uses 12 years as a guide.
ICMR and IAP recommend dual consent (guardian + child assent) in research.
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Conclusion
Informed consent in pediatrics must balance ethical obligations to respect autonomy with protection of the child’s best interests. It is a dynamic, ongoing process and an essential component of ethical pediatric practice.
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📘 References:
Ghai Essential Pediatrics, 9th ed., Ch 2, Ethics in Pediatrics, p. 35–37
AIIMS Protocols, Ethics Section, 2021
IAP Ethical Guidelines for Pediatricians, IAP Journal 2022
Nelson Textbook of Pediatrics, 21st ed., Ch 3, p. 11, Topic: Informed Consent)
—
Definition
Informed consent is the process by which a patient or guardian voluntarily confirms their willingness to undergo a particular procedure, treatment, or participate in research, after being informed of all relevant aspects.
In pediatrics, the process is more complex due to involvement of parents/legal guardians and the child’s developing autonomy.
—
Components of Informed Consent
1. Disclosure:
Nature, purpose, benefits, risks, and alternatives of the procedure or study.
Use simple, age-appropriate language.
2. Understanding:
Ensure the parent/guardian (and child if appropriate) comprehends the information.
3. Voluntariness:
Consent must be given freely without coercion or undue influence.
4. Competence:
In pediatrics, parents or legal guardians provide consent.
Adolescents may be considered for assent or even consent in specific legal settings.
5. Consent/Assent Documentation:
Signed written form preferred, especially in research.
Verbal consent may be acceptable in minor procedures.
—
Special Considerations in Pediatrics
Assent:
Children above 7 years should be involved in the decision-making process depending on maturity.
It is ethically desirable though not legally required in India.
Emergency Situations:
Treatment can be provided under implied consent if guardian is unavailable and delay would harm the child.
Research:
Separate consent for participation in studies is mandatory.
Institutional Ethics Committee (IEC) approval needed.
Confidentiality:
Adolescents have a right to confidentiality in sensitive matters (e.g., STIs, contraception).
—
Legal and Ethical Framework
Indian law doesn’t specify a minimum age for medical consent but uses 12 years as a guide.
ICMR and IAP recommend dual consent (guardian + child assent) in research.
—
Conclusion
Informed consent in pediatrics must balance ethical obligations to respect autonomy with protection of the child’s best interests. It is a dynamic, ongoing process and an essential component of ethical pediatric practice.
—
📘 References:
Ghai Essential Pediatrics, 9th ed., Ch 2, Ethics in Pediatrics, p. 35–37
AIIMS Protocols, Ethics Section, 2021
IAP Ethical Guidelines for Pediatricians, IAP Journal 2022
Nelson Textbook of Pediatrics, 21st ed., Ch 3, p. 11
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Post written by: Healer
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