"Kids Are Not Small Adults: Ethical Considerations in Clinical Research"
Speakers:
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LUKE GELINAS, PHD | Senior IRB Chair Director, Advarra
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ROBERT NELSON, MD | Senior Director, Pediatric Drug Development, Child Health Innovation Leadership Department, Johnson & Johnson
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ANGIE PRICE, RN, MSN | Diretor, Clinical Research Network - QI, I-ACT
Learning Objective (s):
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Examine the unique history of pediatric research and the scientific necessity of conducting a clinical investigation in children.
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Explain the process for determining risk in pediatric research and assessing risk for interventions or procedures with a prospect of direct benefit.
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Compare study design issues that affect the participation of pediatric subjects.(Placebo, PK, study requirements, e.g., # of visits, procedures, etc.).
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Describe the challenges with obtaining parental permission/child assent if the protocol does not offer the prospect of direct benefit.
About the Seminar:
As a condition for receiving federal funding for health research training grants and career development awards, federal funders (including NIH, DOD, and NSF) require all participants in training grants to receive training in RCR. Visit https://ctsicn.org/RCR for more information
Visit ctsicn.org/RCR to learn more about RCR Training Requirements.
Accreditation Information:
This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of INOVA and
Children’s National Medical Center. The INOVA Office of Continuing Medical Education is accredited by the MSV to provide continuing medical education for physicians. Children's National Hospital is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.
American Nurses Credentialing Center's Commission on Accreditation
Children's National Hospital is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.
Credit Designation
The Inova Office of Continuing Medical Education designates this live educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity. Physicians may claim up to 1.0 credit in Type 1 CME on the Virginia Board of Medicine Continued Competency and Assessment Form required for renewal of an active medical license in Virginia.