Recommended Reading for Human Subject Researchers

                           

These resources offer guidelines and information that will assist researchers and IRB members in understanding the policies and principles that govern research with human subjects and the issues they affect.

Regulations and Guidance:

• Office for Human Subjects Protection (OHRP) home page
• Department of Health and Human Services Code of Federal Regulations 45 CFR 46
• Food and Drug Administration (FDA) Regulations 21 CFR 50 and 56
• Good Clinical Practice in FDA-regulated Clinical Trials
• FDA Information Sheet Guidance (for IRB, Clinical Investigators & Sponsors)

Compliance and Oversight:

• FDA Warning Letters
• OHRP Determinations Letters

Historical Documents in Human Subject Research:

• Nuremberg Code
• Declaration of Helsinki
• Belmont Report

Other On-line Resource:

• IRB Forum
• UNT Health BioSafety Office for UNT Health Human Subject Research Protocols involving biospecimens or human biological material