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• Biomedical Informatics Core
• Center for Biomedical Statistics
• Clinical Research Center Network
• Development of Novel Clinical and Translational Methodologies
  • Drug and Device Development Advisory Committee
  • Educational Programs
  • Community Outreach Programs
• Evaluation Research Core
• Regulatory Support and Bioethics
• Translational Technologies and Resources Core
• ITHS Resource Fees

Community Outreach Programs

The Development of Novel Clinical and Translational Methodologies (DNCTM) Core proposes to reduce barriers to translational research by developing and supporting programs that catalyze the transition of preclinical research into viable investigational products ready for human testing. To this end, the DNCTM will assemble a collaborative network of experts and external resources that collectively support and enable the implementation of effective preclinical programs. This collaborative environment will have two primary aims:

1. to extend the ITHS collaboratory into the larger research community enabling greater bidirectional access to expertise and resources for drug and device development
2. to create and support consulting programs that facilitate development and commercialization of translational research

Web Resources

The following web sites provide information about research ethics and regulations. Links are also provided to other organizations with which researchers at Children's collaborate.

Office for Human Research Protections (OHRP)

• OHRP Home Page
• Federal Regulations for Research with Human Subjects
  Department of Health and Human Services, 45 CFR, Part 46 Including Subpart D, Additional DHHS Protections for Children Involved as Subjects in Research IRB Guidebook for Protecting Human Research Subjects
• The Belmont Report
• The Nuremberg Code
• The World Medical Association Declaration of Helsinki
  

US Food and Drug Administration (FDA)

• FDA Home Page
• FDA Regulations, 21 CFR, Part 50
  Protection of Human Subjects
• FDA Regulations, 21 CFR Part 56
  Institutional Review Boards
• Guidance for IRBs and Clinical Investigators FDA Information Sheets
• International Conference on Harmonisation – ICH Guidelines (PDF)
• FDA CBER – What's New
  

Policies, Commissions and Task Forces

• National Bioethics Advisory Commission (NBAC)
• Case Studies of Existing Human Tissue Repositories
  

Other Regulatory Information

• FOI Services

Contact:

Kim Folger Bruce, Ph.D.
Director of Research Partnerships Institute of Translational Health Sciences
Children's Hospital and Regional Medical Center
Metropolitan Park West, Mailstop MPW 5-4 1100
Olive Way, Suite 500 Seattle, WA 98101
Phone: 206-884-7533    FAX: 206-987-7505
Email: kim.bruce@seattlechildrens.org

Director:

Lynn M. Rose
Research Associate Professor, Pediatrics
Director, Clinical Operations, Cystic Fibrosis TDN Coordinating Center
Box 359300, MPW 5-4
Phone: 206 987-7540
FAX: 206 987-7505
lynn.rose@seattlechildrens.org