Informed Consent in Decision-Making in Pediatric Practice

Katz, Aviva L.; Macauley, Robert; Mercurio, Mark R.; Moon, Margaret; Okun, Alexander L.; Opel, Douglas J.; Statter, Mindy B.

doi:10.1542/peds.2016-1484

Cited by 111 publications

(38 citation statements)

References 25 publications

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“…Hence, parents or caregivers recognized as the appropriate ethical and legal surrogate medical decision-makers for their children and adolescents. This recognition affirms parents' familiar understanding of their children's affairs and respects family autonomy [13].…”

Section: Introductionsupporting

confidence: 58%

Egyptian patients’/guardians’ experiences and perception about clinical informed consent and its purpose: Cross sectional study

et al. 2021

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Background Informed consent (IC) is a healthcare standard emphasizing the meaning of human dignity as clarified in the Universal Declaration of Human Rights. Data about IC practices in Egypt is insufficient. This study aimed to assess the Egyptian patients’/guardians’ experiences about IC and their expectations about its practices’ purposes in general and according to the type of the healthcare facility. Methods Self-administered questionnaire was carried out for 1092 participants who had undergone or were scheduled to a procedure requiring an IC at three studied types for Egyptian health care facilities. Ten statements were ranked twice by the participants to reflect their perception of IC purpose as per what is currently practiced and what they believe should be practiced. Results IC implementation varies significantly (p<0.05) across the health care facilities in Egypt. The percentage of its implementation at the non-governmental facilities, governmental facilities, and university hospital was 85.9%, 77.8%, and 63.8 respectively. The first three ranked purposes of the current IC practices were: “Helping patient/guardian decide (64.9%)”, “Documenting patient’s/guardian’s decision (59.3%)”, and “Having shared decision (57.3%)”. The perceived purposes of IC to be practiced were: “Informing the patient/guardian (68.4%)”, “Making sure patient/guardian understand (65.3%)” and “Documenting patients/guardians decisions (65.1%)”. “Being a meaningless routine” was reported by the majority to be ranked as a low purpose for IC current and preferred practices. Conclusion The practice of IC is common within the Egyptian medical community. Participants believe that information disclosure “Making sure patients understand” has to help in IC decision making and its main purpose. However, unfortunately, this is not perceived as a current purpose of IC. There was consensus agreement that documenting the patient’s/guardian’s decision and informing the patient/guardian are perceived as both important current and preferred purposes for IC practices.

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Section: Introductionsupporting

confidence: 58%

Egyptian patients’/guardians’ experiences and perception about clinical informed consent and its purpose: Cross sectional study

et al. 2021

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“…Lema et al mention that minor parents may have the authority to consent for their children’s medical care while not being considered mature enough to consent to their own research participation autonomously [ 32 ]. A recent position paper by the American Academy of Pediatrics confirms this ambiguity: All (US) states accept medical decision-making by minor parents for their children, without necessarily acknowledging minor parents as emancipated or mature to authorise their own medical care [ 11 ]. Another perspective is yet added by the Guidelines for Conduct of Clinical Trials in Kenya, which consider minor parents directly as “emancipated minors” able to consent for themselves and being explicitly allowed to consent to CT participation of their children [ 12 ].…”

Section: Discussionmentioning

confidence: 99%

“…In the UK and the USA, professional guidelines recognise that minor parents can be responsible for medical decision-making for their children if they are considered competent. Nevertheless, these guidelines lack strict criteria or principles defining such competence in relation to minor parents and its applicability to clinical trials [ 10 , 11 ].…”

Section: Introductionmentioning

confidence: 99%

Informed consent approaches for clinical trial participation of infants with minor parents in sub-Saharan Africa: A systematic review

Pretto-Lazarova¹,

Brancati-Badarau²,

Burri³

2020

PLoS ONE

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Background Regulations are vague regarding the appropriate decision-maker and authority to consent for children of minor parents participating in clinical trials. In countries with high rates of underage mothers, such as in sub-Saharan Africa, this lack of guidance may affect the rights of potential paediatric participants already bearing increased vulnerability. It can also influence the recruitment and generalizability of the research. We provide evidence and discuss informed consent management in such cases to inform best practice. Materials and methods We searched PubMed/MEDLINE, Embase, CINAHL, and Google Scholar for articles published up to March 2019. In total, 4382 articles were screened, of which 16 met our inclusion criteria. Studies addressing informed consent in clinical trials involving children with minor parents in sub-Saharan Africa were included. We performed descriptive and qualitative framework analyses. The review was registered in PROSPERO: CRD42018074220. Results Various informed consent approaches were reported. Articles supporting individual consent by minor parents based on emancipation or “mature minor” status lacked evidence in the context of research. National laws on medical care guided consent instead. When no laws or guidance existed an interpretation of the local decision-making culture, including community engagement and collaboration with local ethics committees, defined the informed consent approach. Conclusions The review emphasises that the implementation of informed consent for children with minor parents may be variable and hampered by absent or ambiguous clinical trial regulations, as well as divergent local realities. It may further be influenced by the research area and study-specific risks. Clear guidance is required to help address these challenges proactively in clinical trial planning. We provided a set of questions to be considered in the development of an ethically acceptable informed consent approach and proposed information that should be integrated into international clinical trial guidelines.

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“…The basic prerequisites for the decision-making process are open, understandable, empathetic communication and a comprehensive exchange of information with the parents (32,82). The support provided by the care team consists of a careful, stepwise examination of all options together with the pregnant mother/parents (30,83).…”

Section: Evaluating Therapeutic Goals and Treatment Choices Together: Stepwise Sound And Sustainablementioning

confidence: 99%

Palliative Care and Grief Counseling in Peri- and Neonatology: Recommendations From the German PaluTiN Group

Garten

Globisch²,

Hude

et al. 2020

Front. Pediatr.

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Informed Consent in Decision-Making in Pediatric Practice

Cited by 111 publications

References 25 publications

Egyptian patients’/guardians’ experiences and perception about clinical informed consent and its purpose: Cross sectional study

Egyptian patients’/guardians’ experiences and perception about clinical informed consent and its purpose: Cross sectional study

Informed consent approaches for clinical trial participation of infants with minor parents in sub-Saharan Africa: A systematic review

Palliative Care and Grief Counseling in Peri- and Neonatology: Recommendations From the German PaluTiN Group

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