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IRB-Regulations and Guidance

The Institutional Review Board (IRB) at Children’s helps make sure our research teams abide by best practices to meet the strictest standards of ethics, clinical practices and government guidance to protect patients participating in clinical studies.

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Medical Professional Resources

Resources are provided for researchers who want to utilize the Institutional Review Board (IRB) and reference best practices while conducting clinical studies.

Institutional Guidance

  • Non-human subjects research determination
  • Case studies
  • Device research
  • Pregnancy and contraception in research
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  • Short forms
  • Skin biopsy risk
  • Regulatory binders
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Government Regulations

  • Department of Health and Human Services (DHHS)
  • Health Insurance Portability and Accountability Act (HIPAA)
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  • Protection of human subjects (CFR Title 21 Part 50)
  • Review boards (CFR Title 21 Part 56)
  • Financial disclosure (CFR Title 21 Part 54)
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  • Conflict of interest policy

Government Guidance

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Ethical Codes

  • Nuremberg Code
  • The Belmont Report
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General Resources

  • Public Responsibility in Medicine and Research (PRIMR)
  • Human subject determination decision charts

Research Administration

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Contact Us

irb@choa.org
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