Assessment of risk in research on children

Janofsky, Jeffrey S.; Starfield, Bárbara

doi:10.1016/s0022-3476(81)80865-7

Cited by 85 publications

(29 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Is the acceptance of both parents really necessary when it is unusual for both parents to be available at the same time and when the agreement of one parent is sufficient for hos pitalization and for surgery? The low accep tance rate in our study illustrates the contra diction between opinion in France regarding the need for evaluation and the refusal that one's own child take part in this evaluation [2][3][4][5], Nevertheless, clinical trials are the best way of ensuring safety in the use of drugs. The fear of immediate risk from a trial is greater than the long-term fear of using poorly evalu ated drugs.…”

Section: Discussionmentioning

confidence: 94%

Parental Opinions about Biomedical Research in Children in Tours, France

Autret

Jp²,

Barbier³

et al. 1993

Dev Pharmacol Ther

View full text Add to dashboard Cite

In order to evaluate parental awareness of the law governing clinical trials in France (Loi Huriet), a study was performed by questionnaire between February and April 1991 in a maternity unit during the days following delivery. The response rate was 59%. 59% of the parents (319/541) were informed of the existence of the law by the media (7 5 %) or their general practitioners (12%). Twenty-one percent (116/541) of the parents would accept the participation of their children in a clinical trial and 74% would refuse. The principal reasons for acceptance were: for the benefit of other children, contribution to medical progress and confidence in physicians. The reasons for refusal were: risk of side effects and unproven efficacy. Parents who would accept had more often received higher education (44%) than parents who would refuse (30%), the latter being less influenced by the explanations of physicians and less willing to accept that a physician should decide for them. Physicians should consider transmitting information directly to parents and indirectly via the media.

show abstract

Section: Discussionmentioning

confidence: 94%

Parental Opinions about Biomedical Research in Children in Tours, France

Autret

Jp²,

Barbier³

et al. 1993

Dev Pharmacol Ther

View full text Add to dashboard Cite

show abstract

“…49 Surveys of IRB members or scientists and scientific administrators regarding how they apply the risk-benefit analysis regulations can also illuminate how policies may in fact get applied. 50 Surveys of the general public on the appropriateness of certain implied tradeoffs in research protocols can also inform the debate.…”

Section: Favorable Risk-benefit Ratiomentioning

confidence: 99%

Evidence-based ethics for neurology and psychiatry research

Kim

2004

Neurotherapeutics

View full text Add to dashboard Cite

Summary: American bioethics, historically arising out of theology and philosophy, has been dominated by the method of normative analysis. Ethics as policy, however, requires in addition a solid evidence base. This paper discusses the background conditions that make neurotherapeutics research particularly challenging. Three key ethical issues are discussed within an evidence-based ethics framework: the ethical challenges arising from changes in the financial incentive structures for academic researchers and their institutions, the challenges of risk-benefit analysis for neurotherapeutics protocols testing innovative interventions, and the evolving issues surrounding impaired decision-making capacity and surrogate consent for research. For each of these issues, selected empirical data are reviewed, areas for further inquiry are noted, and the need for development of novel methods for bioethics policy research is discussed.

show abstract

“…Die Risiken für eine Punktion der Femoralvene, der Vena jugularis interna an Neugeborenen, einer Arterie an Kindern aller Altersstufen sowie eine Magenspiegelung bei Neugeborenen und Kindern bis sechs Jahren wurden von der Mehrheit der Befragten für größer als minimal angesehen. Insgesamt zeigt diese Untersuchung jedoch, dass es auch unter Fachleuten keinen allgemeinen Konsens darüber gibt, wie groß das Risiko für bestimmte Untersuchungen einzuschätzen ist 19 [18].…”

Section: Zur Situation In Den Usaunclassified

“…Eine differenzierte Auswertung ergab, dass für 73% der Befragten die Reife des Kindes, für 20% das biologische Alter das maßgebliche Kriterium war [18]. Ein Konsens besteht offensichtlich darüber, Kinder prinzipiell in Entscheidungen mit einzubeziehen, Uneinigkeit hingegen, wie und wo man die Grenze ziehen soll.…”

Section: Zur Situation In Den Usaunclassified

See 1 more Smart Citation

Forschung an Minderjährigen im internationalen Vergleich: Bilanz und Zukunftsperspektiven

Dahl

Wiesemann

2001

Ethik in der Medizin

View full text Add to dashboard Cite

Research with minors from an international perspectiveAbstract: Definition of the problem: Medical research with children, especially non-therapeutic research, requires particular consideration. In the current situation this kind of research is not clearly regulated by law in Germany. This entails practical problems in evaluating clinical studies from an ethical point of view. Arguments and conclusion: To develop a new policy framework the international ethical discussion is reviewed. The article analyzes the historical development of research with minors from an ethical perspective, the notion of minimal risk, criteria for evaluating risk and harm in research, consent and assent procedures, and the participation of parents and children in the planning of clinical studies. A list of proposals for minimal standard in ethical regulation of research with minors is developed.

show abstract

Assessment of risk in research on children

Cited by 85 publications

References 11 publications

Parental Opinions about Biomedical Research in Children in Tours, France

Parental Opinions about Biomedical Research in Children in Tours, France

Evidence-based ethics for neurology and psychiatry research

Forschung an Minderjährigen im internationalen Vergleich: Bilanz und Zukunftsperspektiven

Contact Info

Product

Resources

About