UK Issues New Guidance on Pediatric Trials - Applied Clinical Trials

ADVERTISEMENT

See our 2013 Buyers Guide Digital Edition.
UK Issues New Guidance on Pediatric Trials

Source: Applied Clinical Trials

Children and young people should routinely be offered the opportunity to participate in and to benefit from medical research, according to updated guidance from the UK Royal College of Pediatrics and Child Health. 

The guidelines provide updated practical information on ethical issues in relation to research involving children, aimed at research councils. It reflects many of the changes that have taken place with regards to EU regulations over the last 14 years. The key principles include: 

  • Risk. Research should ideally carry no greater than minimal or low risk. However, research that involves greater than minimal risk may be acceptable if the interventions involve diagnostic procedures or treatments that are important for the individual child.
  • Assent or consent. In most instances, the child's assent or consent should be underpinned by parent consent. However, in the context of research, dissent should be respected, even if parent consent continues.
  • Sedation. Researchers must justify the use of sedation, and provide evidence that appropriate monitoring will be in place during the procedure, and that they possess the necessary competencies and skills to carry out the procedures, and to deal immediately with any adverse effects.
  • Rewards. The nature of any token of thanks should be in proportion with the age of the child, approved by the research ethics committee, and made clear in the parent/patient information sheets. 

“Children require protection, but this should not preclude the claim of other rights, including the right to the highest standard of healthcare, to be informed, express their views, and influence decisions made about them,” said lead author Neena Modi, MD, Professor of Neonatal Medicine at Imperial College London. “The more robust research we can conduct, the greater the likelihood of developing new treatments and procedures that will greatly improve healthcare for children and young people.”

The guidelines also emphasize the importance of involving children, young people and parents in all aspects of medical research—from prioritization to development and dissemination. Overall, they reflect current regulations and should help researchers make the right decisions about child health research in the best interest of the child, she added.

The guidance was published in an online article posted on June 9 by Archives of Disease in Childhood. To access the full article, click here.

 

ADVERTISEMENT

blog comments powered by Disqus

ADVERTISEMENT

UPCOMING CONFERENCES

8th Annual Forum on Transparency and Aggregate Spend 2014
Washington, DC
August 18-20, 2014

eSource Data in Clinical Investigations
Philadelphia, PA
August 20-21, 2014

Pharmacovigilance 2014
Philadelphia, PA
September 10-11, 2014

Collaborative Research Summit
Philadelphia, PA
October 15-16, 2014

See All Conferences >>

Survey
As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
86%
Borrow lightly from EMA's pathway program?
6%
Create entirely its own pathway program?
7%
View Results
Untitled Document
Source: Applied Clinical Trials,
Click here