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Resources and Regulations

Resources

The University of Arizona Human Subjects Protection Program has a variety of resources to help investigators conduct compliant human participant research. Please note that references to Co-Principal Investigators were removed from the UA HSPP website and documents, therefore going forward, all such references should be interpreted as Co-Investigator (Co-I). 

Federal Regulations on Human Research 

There are a variety of federal regulations and state laws that apply to human subjects research. In addition, the Office of Human Research Protections (OHRP) and the US Food and Drug Administration (FDA) have issued guidance documents and other materials that reflect their agency's current thinking. This page provides quick links to the most commonly accessed regulations and guidance documents.

2018 Common Rule

Food and Drug Administration

  • 21 CFR 50: Regulations for informed consent (Part 50), Financial Disclosure (Part 54), and for IRB committees (Part 56)
  • 21 CFR 56: Regulations for IRB committees (Part 56)
  • 21 CFR Subpart D: Subpart D additional safeguards for children in clinical investigations of FDA-regulated products under 21 CFR 50 and 56
  • 21 CFR 312: Drug Regulations: IND Regulations including IND format, reporting requirements, sponsor responsibilities, and investigator responsibilities
  • 21 CFR 812: Device Regulations: IDE regulations including IDE content, format, reporting requirements, sponsor responsibilities, and investigator responsibilities
  • FDA Regulations Relating to Good Clinical Practice and Clinical Trials

Other Ethics Resources

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