Get (pdf) Informed Consent For Paediatric Clinical Trials In ...

By definition, children are unable to provide informed consent to participate in research, although they might be able to give their assent. The IRB should determine that unless parental permission can be waived adequate provisions are made for soliciting the permission of the parent(s) or legal guardian(s).

Thus, parents can provide informed consent only for themselves. Minors cannot provide informed consent unless they have been judged to be able to act as adults for that purpose (see the discussion below of emancipated and mature minors).

Legally, children are not able to give true informed consent until they turn 18. So, before taking part in a clinical trial, they are asked for their assent. Assent means that they agree to take part. They may also dissent, which means they do not agree.

Informed consent is a discussion between the health care provider and patient explaining: Information about how and where a procedure or treatment is done and how long it takes. The benefits and possible risks or side effects of the treatment/procedure.

The problem is that informed consent is not always possible. There are some contexts in which the nature of the information is such that the patient's understanding and capacity for decision making are overwhelmed, making informed consent impossible.

Children and Informed Consent Children (typically under 17) cannot provide informed consent. As such, parents must permit treatments or interventions. In this case, it not termed "informed consent" but "informed permission."

The informed consent form, which is a legal document, must include 20 ICH-required elements (section 4.8. 10 of the GCP guidance). They include the purpose, duration, risks, benefits, costs and additional expenses of the trial; a description of the trial procedures; alternative care options; and volunteers' rights.

In determining whether children are capable of assenting, the ages, maturity, and psychological state of the children involved should be taken into account.

They do not properly reflect the ethical differences between permission or assent and informed consent. Again, as the concept has developed, only those who are held competent to make autonomous decisions on their own behalf can provide informed consent. Thus, parents can provide informed consent only for themselves.

By definition, children are unable to provide informed consent to participate in research, although they might be able to give their assent. The IRB should determine that unless parental permission can be waived adequate provisions are made for soliciting the permission of the parent(s) or legal guardian(s).

The underlying principle of consent isn't particularly complicated: Patients have a right to make an informed, voluntary decision about their care. That means they need to know the nature, risks, and benefits of their options — which includes declining treatment.

No statute governs the rights of those under the age of 16 to give consent for medical treatment or research, but the Gillick case2 determined that where a young person has sufficient understanding and intelligence to understand fully what is proposed, and use and weigh this information in reaching a decision, he or ...

By definition, children are unable to provide informed consent to participate in research, although they might be able to give their assent. The IRB should determine that unless parental permission can be waived adequate provisions are made for soliciting the permission of the parent(s) or legal guardian(s).

Thus, parents can provide informed consent only for themselves. Minors cannot provide informed consent unless they have been judged to be able to act as adults for that purpose (see the discussion below of emancipated and mature minors).

Legally, children are not able to give true informed consent until they turn 18. So, before taking part in a clinical trial, they are asked for their assent. Assent means that they agree to take part. They may also dissent, which means they do not agree.

Informed consent is a discussion between the health care provider and patient explaining: Information about how and where a procedure or treatment is done and how long it takes. The benefits and possible risks or side effects of the treatment/procedure.

The problem is that informed consent is not always possible. There are some contexts in which the nature of the information is such that the patient's understanding and capacity for decision making are overwhelmed, making informed consent impossible.

Children and Informed Consent Children (typically under 17) cannot provide informed consent. As such, parents must permit treatments or interventions. In this case, it not termed "informed consent" but "informed permission."

The informed consent form, which is a legal document, must include 20 ICH-required elements (section 4.8. 10 of the GCP guidance). They include the purpose, duration, risks, benefits, costs and additional expenses of the trial; a description of the trial procedures; alternative care options; and volunteers' rights.

In determining whether children are capable of assenting, the ages, maturity, and psychological state of the children involved should be taken into account.

They do not properly reflect the ethical differences between permission or assent and informed consent. Again, as the concept has developed, only those who are held competent to make autonomous decisions on their own behalf can provide informed consent. Thus, parents can provide informed consent only for themselves.

By definition, children are unable to provide informed consent to participate in research, although they might be able to give their assent. The IRB should determine that unless parental permission can be waived adequate provisions are made for soliciting the permission of the parent(s) or legal guardian(s).

The underlying principle of consent isn't particularly complicated: Patients have a right to make an informed, voluntary decision about their care. That means they need to know the nature, risks, and benefits of their options — which includes declining treatment.

No statute governs the rights of those under the age of 16 to give consent for medical treatment or research, but the Gillick case2 determined that where a young person has sufficient understanding and intelligence to understand fully what is proposed, and use and weigh this information in reaching a decision, he or ...