2012 Webinar: Including Children In Research

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Overview

Clinical research is essential to our health and quality of life, but while many potential participants recognize the need for clinical studies, they feel uncertain about participating. This hesitation is especially evident around research involving children, and public perception of pediatric research can pose an additional challenge to the recruitment of research subjects.

This webinar addressed the following topics:

  • Research with children in the context of the Belmont Report, the American Academy of Pediatrics, and 45 CFR 46, subpart D
  • Attitudes of healthcare workers toward pediatric research and their potential to influence parental decisions
  • Differentiating between assent, consent, and permission; identifying criteria to determine children's decision-making capacity as valid; and distinguishing assent for treatment from assent for research
  • The National Institutes of Health (NIH)-supported "Children and Clinical Studies" campaign as an educational tool for parents, research teams, and institutional review boards (IRBs)
  • Ideas for practical and realistic approaches to assist investigators and IRBs when evaluating and considering children's roles in research.

Audience

This intermediate-level webinar was of interest to IRB chairs, members, and staff who review protocols on pediatric research, as well as clinical investigators and regulatory professionals involved in research with children.

Faculty

Victoria Pemberton, RNC, MS, CCRC
Victoria Pemberton is a clinical trials specialist at the National Heart, Lung, and Blood Institute’s division of cardiovascular diseases, where she manages pediatric research grants and contracts. Her portfolio includes research in pediatric congenital and acquired heart disease, pediatric cardiac arrest, and developmental origins of adult disease. Ms. Pemberton is dedicated to promoting ethical research involving children and she actively works on a number of initiatives related to the conduct of pediatric research. Her current efforts are directed at developing strategies to encourage a better understanding of research concepts and safeguards by parents and caregivers alike while emphasizing how pediatric research can positively impact health outcomes. One initiative that she developed called for innovative tools to improve pediatric research and resulted in two funded projects to develop an interactive consent form for pediatric studies and a videogame to enhance a child’s understanding of clinical research. The Children in Clinical Studies website is another initiative that Ms. Pemberton developed to educate the public about the importance of conducting research with children.

Yoram Unguru, MD, MS, MA, FASPHO
Dr. Yoram Unguru is a pediatric hematologist/oncologist at The Herman and Walter Samuelson Children's Hospital at Sinai and at The Berman Institute of Bioethics at John Hopkins University. Dr. Unguru is interested in surrogate decision-making and the role of children and providers in facilitating shared decision making.  His 2007 essay titled Pediatric Assent: Should Children Decide and Does it Really Matter? was recognized as the winning bioethics essay by the American Academy of Pediatrics. His professional interests also include research ethics, ethics education, and end-of-life decision-making. As a pediatric resident, Dr. Unguru was a founding member of the Pediatric Committee on End-of-Life at The Children’s Hospital at Sinai, which he now chairs. Dr. Unguru continues to serve as an ethics committee and IRB member and is a member of the Children’s Oncology Group, Bioethics Steering Committee, and the American Society of Clinical Oncology Ethics Committee.

Dr. Unguru earned his MD (and was the valedictorian) at the Technion (Israel Institute of Technology Bruce Rappaport Faculty of Medicine); his MA and BA degrees from the University of Maryland, Baltimore County; and his MS from the Touro College Barry Z. Levine School of Health Sciences in New York, NY (also as the valedictorian). He completed his pediatric residency at the Children's Hospital at Sinai and his pediatric hematology/oncology fellowship at Children’s National Medical Center in Washington, DC.  Dr. Unguru was a postdoctoral Greenwall Fellow in bioethics and public policy at Johns Hopkins University.  He is board certified both in pediatrics and in pediatric hematology/oncology. 

Certificates of Attendance

Certificates of Attendance were made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

CE Credit for Certified IRB Professional (CIP®) Recertification
Webinar participants holding the CIP credential who wish to apply credits from this webinar toward CIP recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.

Additional information about CIP recertification can be found here.