Informed consent children

Consideration of the use of medications in children requires a careful discussion with the child and the child s family of the risks and benefits potentially associated with the treatment. The AACAP Practice Parameters address the issue of informed consent, and how children, parents, and clinicians might reach a consensus on the use of medications (King, 1997). Children should have the opportunity to assent to the use of medications at a developmentally appropriate level. In general, pharmacotherapy should not be used as the sole intervention for a child s disorder but should be integrated into a comprehensive treatment plan. 

Krener, K.P. and Mancina, R.A. (1994) Informed consent or informed coercion Decision-making in pediatric psychopharmacology. / Child Adolesc Psychopharmacol 4 183-200. 

For children, most ethics committees agree that provision of written informed consent by a parent or guardian is acceptable. If the childis of sufficient age, then his or her concurrence may also be sought although this is not sufficient evidence of informed consent, the refusal to provide concurrence by a child that is likely to be competent to understand the clinical trial conditions should be sufficient to exclude the child from a study. 

The need for privacy when participating in research is based upon a subject s dignity and autonomy and thus warrants respect. As a result, all information regarding a research subject must be kept confidential. The researcher has a duty not to share any information without a subject s free and informed consent. Respect for privacy is an internationally recognized ethical standard and is reflected in Canadian law as a constitutional right. However, there are some circumstances where public health and safety require protection and such privacy may be lost, e.g., child abuse, sexually transmitted diseases. The REB can play an important role in assessing the balance between the need for research versus invasion of privacy, thus protecting individuals from harm as a result of unauthorized use of personal information. 

Ethical approval for the 1998—1999 and 2000—2001 surveys was granted by the University of Tasmania Human Research Ethics Committee and for the post-intervention surveys in 2003, 2004, 2005 and 2007 by the Southern Tasmanian Health and Medical Human Research Ethics Committee and the Department of Educations Office of Educational Review. Individual informed consent was obtained from a patent/guardian of each child for all surveys. 

In the case of an emergency, and when the person with parental responsibility is not contactable prior to the inclusion of the participant in the trial, a legal representative for the minor can give informed consent. In the UK, that will be someone other than the person involved in the conduct of the trial, who by virtue of his or her relationship with that minor is suitable to act as a legal representative for the pnrposes of the trial and is available and willing to act for those pnrposes. When no such person is available, a doctor who is primarily responsible for the medical treatment provided to the child, and is not connected to the clinical trial, can act as a professional representative. It is possible, however, that it would still be unlawful if the research were not expected to benefit the child in question. 

Mason S (1997). Obtaining informed consent for neonatal randomised controlled trials - an elaborate ritual Arch Dis Child 77 F143-145. 

A relaxed, child-friendly environment is a prerequisite. Informed consent should be obtained from the child/main carer, at a minimum outlining the risks of pain, allergy and infection. In children biopsies may require sedation or general anaesthetic, but most simple procedures are well tolerated under local anaesthetic given the right conditions. Ideally a parent should be present. 

Informed consent is obtained from the parent or guardian. In Quebec (Canada), a child over age 14 has the legal right to sign for him/herself. The procedure and all potential complications must be fully explained and discussed. 

Electrophysiological data were collected at the DDDL or in the field mobile laboratory. Demographic, psychometric and medical data were obtained in an auxiliary trailer or space provided by local health agencies. Families were seen for a testing protocol that took about 4h to complete, and informed consent was obtained from the parent(s). At testing, the examiner was blind as to the child s lead exposure. A maximum of four children per day were evaluated in the mobile laboratory. 

Some research based on observation, collating information from notes and tests already performed for therapeutic purposes, may be permissible without consent because it does not involve direct contact with the child. Researchers must be careful in this matter and consult the Central Office for Research Ethics Committees (COREC) to ascertain this requirement. Non-therapeutic research can be validly consented only when the research can be reasonably said not to go against the child s interests. Even though it is not legally required, research should seek assent from school-age children and should always ensure that the child does not object. 

Parents who perceived that they have insufficient time or privacy to make a decision tend to assess the risk and benefit in a more negative light (Hoehn et al., 2005). This is partly a result of stress parents who were anxious were more likely to decline their child s participation (Tait et al., 2003). This would explain why parents are more likely to give consent in an inpatient setting than in an outpatient preoperative setting (Tait et al., 1998), where there was little time and lack of privacy to ponder the issue. Every effort should be made to provide information in an unhurried manner to alleviate anxiety. 

All mood stabilisers are teratogenic tTable 29.1. pl86), so discuss reliable contraception with all women of child-bearing age. Avoid using valproate or carbamazepine, but prescribe folate if unavoidable. Document your information-giving and consent. 

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