Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations

Shaddy, Robert E.; Denne, Scott C.

doi:10.1542/peds.2010-0082

Cited by 139 publications

(90 citation statements)

References 5 publications

(2 reference statements)

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“…The physician in this case should seek Anu's assent to perform the rape kit and should do so independently of the mother's views. Obtaining a minor's assent, or expressed voluntary participation, has been shown to empower minors and give them a means and sense of control, making it easier for them to cope with the treatment or procedure [6]. In obtaining Anu's assent, the care team should ensure that both the mother and Anu understand the risks, benefits, and consequences of each possible action.…”

Section: Consent and Assentmentioning

confidence: 99%

Should a Physician Comply with a Parent's Demands for a Forensic Exam on a 16-Year-Old Trauma Patient?

Bowdler

Kent²

2018

AMA Journal of Ethics

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Physicians must remain vigilant about their ethical duties to patients, especially in high-stakes situations. The question raised by this casewhether a physician should comply with a parent's demand for treatment against her underage child's wishes-is not one of life or death in which a guardian might more credibly argue her judgment should stand. Given that forcing a rape kit exam on a patient who refuses to give assent could be further traumatizing, we argue that the physician should not comply. Deciding upon a course of action in this situation will involve considering what is in the patient's best interest and what constitutes a physician's appropriate role in gathering evidence for criminal investigations.

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Section: Consent and Assentmentioning

confidence: 99%

Should a Physician Comply with a Parent's Demands for a Forensic Exam on a 16-Year-Old Trauma Patient?

Bowdler

Kent²

2018

AMA Journal of Ethics

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“…There are reasonable concerns about conducting certain types of MCM research in the context of the special protections afforded to children as human subjects, [18][19][20] related in part to their relative vulnerability and general inability to provide their own informed consent.…”

Section: Practical Concerns Related To Research On Mcms In Childrenmentioning

confidence: 99%

Medical Countermeasures for Children in Public Health Emergencies, Disasters, or Terrorism

Krug¹,

Chung²,

Fagbuyi³

et al. 2016

Pediatrics

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Signifi cant strides have been made over the past 10 to 15 years to develop medical countermeasures (MCMs) to address potential disaster hazards, including chemical, biological, radiologic, and nuclear threats. Signifi cant and effective collaboration between the pediatric health community, including the American Academy of Pediatrics, and federal partners, such as the Offi ce of the Assistant Secretary for Preparedness and Response, Centers for Disease Control and Prevention, Federal Emergency Management Agency, National Institutes of Health, Food and Drug Administration, and other federal agencies, over the past 5 years has resulted in substantial gains in addressing the needs of children related to disaster preparedness in general and MCMs in particular. Yet, major gaps still remain related to MCMs for children, a population highly vulnerable to the effects of exposure to such threats, because many vaccines and pharmaceuticals approved for use by adults as MCMs do not yet have pediatric formulations, dosing information, or safety information. As a result, the nation's stockpiles and other caches (designated supply of MCMs) where pharmacotherapeutic and other MCMs are stored are less prepared to address the needs of children compared with those of adults in the event of a disaster. This policy statement provides recommendations to close the remaining gaps for the development and use of MCMs in children during public health emergencies or disasters. The progress made by federal agencies to date to address the needs of children and the shared commitment of collaboration that characterizes the current relationship between the pediatric health community and the federal agencies responsible for MCMs should encourage all child advocates to invest the necessary energy and resources now to complete the process of remedying the remaining signifi cant gaps in preparedness.

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“…When the intellectual age cannot be approximated, the chronologic age of 7 is usually the cut-off point [31]. As shown above, new evidence suggests that the majority of children younger than 9 years of age lack the capacity necessary to meaningfully consent [8,9].…”

Section: Assentmentioning

confidence: 99%

“…While the situation in which a minor is receiving medical treatment without his or her parents being in the loop is quite conceivable, the question of allowing him/her to decide for themselves not to involve their parents in a research study is far from resolved, even if the protocol deals with adolescent health (e.g., treatment of STIs). The American Academy of Pediatrics submits that waiver of parental permission should be considered only if the risk is minimal, if the research addresses questions that can only be answered in this population, and that the treatment for the medical condition could be given to the minors based on their consent only [31]. For example, a new antibiotic treatment for gonorrhea in adolescents meets the above criteria [30].…”

Section: Consent By Mature Minorsmentioning

confidence: 99%

Informed Consent in Pediatric Research

Leibson

Koren

2014

Pediatr Drugs

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Pediatric drug research is gradually becoming more and more accepted as the norm for assessing whether a drug is safe and efficacious for infants and children. The process of informed consent and assent for these trials presents a major challenge. The aim of this review is to map historical, ethical and legal aspects relevant to the challenges of informed consent in the setting of pediatric drug research. The impact of age, level of maturity and life circumstances on the process of obtaining informed consent as well as the relations between consent and assent are discussed. There appears to be a lack of regulatory clarity in the area of pediatric clinical trials; while numerous statements have been made regarding children's rights to autonomy and their ability to care for themselves and for younger ones, the ever changing status of adolescence is still difficult to translate to informed consent. This may delay scientific and clinical advancement for children who are at the very junction of being independent and not needing parental permission. Obtaining consent and assent for pediatric clinical trials is a delicate matter, as both parent and child need to agree to participate. The appropriate transfer of information to guardians and the children, especially concerning potential risks and benefits, is at the heart of informed consent, as it serves to protect both patient and physician. As many adults lack health literacy, one must ensure that guardians receive relevant information at a level and in forms they can understand regarding the trials their children are asked to participate in. Key PointsThe appropriate transfer of information to guardians and the children, especially concerning potential risks and benefits, is at the heart of informed consent, as it serves to protect both patient and physician.There is compelling evidence that most children younger than 9 years of age lack the capacity to consent for participation in clinical trials.In some jurisdictions, institutional review boards approve the participation in drug research of healthy volunteering children during early adolescence.

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Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations

Cited by 139 publications

References 5 publications

Should a Physician Comply with a Parent's Demands for a Forensic Exam on a 16-Year-Old Trauma Patient?

Should a Physician Comply with a Parent's Demands for a Forensic Exam on a 16-Year-Old Trauma Patient?

Medical Countermeasures for Children in Public Health Emergencies, Disasters, or Terrorism

Informed Consent in Pediatric Research

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