SYSTEM OUTAGE: Lurie Children’s continues to respond to a cybersecurity matter. During this time, Stanley Manne Children’s Research Institute continues to conduct research, including recruiting and accepting research participants, collecting data, conducting research procedures, and maintaining research operations. Questions about participation in research, or research in general, may be sent to researchcompliance@luriechildrens.org.

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Resources  and Regulations

The Office of Research Integrity and Compliance has collected the following links as a resource for investigators and participants.  

Office of Human Research Protections (OHRP): 

  • 45 CFR 46​ – Regulations that govern all federally funded human research 
  • 45 CFR 164​ – The HIPAA Privacy Rule as applicable for research 

Food & Drug Administration (FDA) regulations:  

  • ​21 CFR 50​ – Protection of Human Subjects and Informed Consent 
  • 21 CFR 56 – IRBs
  • 21 CFR 312 – Investigational new drugs (IND) and biologics 
  • 21 CFR 812​ – Investigational new devices (IDE) 

  • The Belmont Report – This document describes the fundamental ethical principles - respect for persons, justice, and beneficence – of which form the foundation for the U.S. Federal Regulations 
  • The Declaration of Helsinki​ ​– This international consensus statement describes additional ethical principles to guide research with human participants.