Regulatory and Ethical Principles in Research Involving Children and Individuals with Developmental Disabilities

Yan, Eric G.; Münir, Kerim

doi:10.1207/s15327019eb1401_3

Cited by 44 publications

(39 citation statements)

References 48 publications

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“…For incompetent persons, this informed consent must be given by a legally authorized representative, but if they are able to agree, their decision must be taken into consideration (12). For the inclusion of children, these requirements imply specific burden: physicians and parents have to decide at which age or cognitive developmental stage children are able to agree or disagree to study participation, and information must be designed in a written or verbal way they are able to understand.…”

Section: Placebo Effects In Childrenmentioning

confidence: 99%

“…According to the Declaration, not only children but also adults are only to be exposed to placebo treatment in case other adequate treatment options are not available (12). By contrast, the World Medical Association Declaration of Helsinki favors the position that novel compounds can only be tested against the best medical therapy currently available (comparative effectiveness research), and thus calls for more "comparator trials" in which new drugs are tested for their noninferiority in comparison with other and available treatment options (15).…”

Section: Placebo Effects In Childrenmentioning

confidence: 99%

“…An apparent immediate consequence of this would be the need to conduct specific pediatric trials and to increase the number of pediatric patients in such randomized controlled trials (as compared with the number of patients in adult trials) to achieve "significance" of the data-this would create a similar ethical paradox as the one discussed above with comparative (18) and hence is not feasible in pediatric trials. As stated above, inclusion of children and adolescents as incompetent but self-determined persons (12) requires specific considerations that influence study designs. Whether adapted study designs from adult patients may affect study outcomes in children and adolescents is unknown.…”

Section: What Are the Consequences For Clinical And Experimental Studmentioning

confidence: 99%

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Placebo effects in children: a review

Weimer¹,

et al. 2013

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Of more than 155,000 PubMed citations found with the search term "placebo, " only ~9,000 (5.8%) included the terms "children" or "adolescents. " When all these papers were screened, only ~2,000 of them investigated the placebo effect per se, and of those, only ~50 (2.5%) discussed the placebo effect in children and adolescents. In this narrative review, we explore four aspects of the placebo response in children and adolescents: (i) the legal and ethical limitations and restrictions for the inclusion of children in clinical trials as well as in experimental (placebo) research that may explain the poor knowledge base; (ii) the question of whether or not the placebo effect is larger in children and adolescents as compared with adults; (iii) whether the mechanisms underlying the placebo effect are similar between children and adults; and (iv) whether mediators and moderators of the placebo effect are comparable between children and adults. We finally discuss some of the consequences from the current placebo research in adults that may affect both experimental and clinical research in children and adolescents.

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Section: Placebo Effects In Childrenmentioning

confidence: 99%

Section: Placebo Effects In Childrenmentioning

confidence: 99%

Section: What Are the Consequences For Clinical And Experimental Studmentioning

confidence: 99%

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Placebo effects in children: a review

Weimer¹,

et al. 2013

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“…The process of ethical review and approval of protocols involving children in scientific/medical research clearly has a number of issues that have been delineated within the literature 25,26,27,28,29,30,31,32,33 .…”

Section: Concerns To Consider When Rebs Review Research Proposals Invmentioning

confidence: 99%

MRI Research Proposals Involving Child Subjects: Concerns Hindering Research Ethics Boards from Approving Them and a Checklist to Help Evaluate Them

Shiloff¹,

Magwood²,

Malisza³

2011

Camb Q Healthc Ethics

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The process of research is often lengthy and can be extremely arduous. It may take many years to proceed from the initial development of an idea through to the comparison of the new modalities against a current gold-standard practice. Each step along the way involves rigorous scientific review, where protocols are scrutinized by multiple scientists not only in the specific field at hand but related fields as well. In addition to scientific review, most countries require a further review by a panel that will specifically address the ethics of the proposed research. In Canada, those panels are referred to as Research Ethics Boards (REB), with the United States counterparts known as Institutional Review Boards (IRB).

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“…The concern about vulnerability becomes particularly significant in the case of research with children and adolescents whose vulnerability might be increased because of factors like serious illness, disability, mental health issues, abuse, sexual orientation or personal and social circumstances (Bogolub and Thomas, 2005;Cocks, 2006;Cuskelly, 2005;Fontes, 2004;helgeland, 2005;hoop et al, 2008;Kennedy, 2006;Scott et al, 2006;Solyom and Moreno, 2005;Thomas and O'Kane, 1998;Thompson, 1990;Valentine et al, 2001;Yan and Munir, 2004). historically, many cases of children's research have been conducted with particularly vulnerable groups of children and concerns about their exploitation are understandable in this context (Lederer and Grodin, 1994;Lederer, 2003).…”

Section: Risk and Benefit In Research With Childrenmentioning

confidence: 99%