Research Subject Protection Program (RSPP) Institutional Review Board (IRB)

bullet For investigators & research personnel
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bullet IRB mission
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bullet Assurance of Compliance
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bullet RSPP guidance documents
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bullet IRB forms
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bullet Informed consent templates
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bullet Nursing Research
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bullet Resident research
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bullet Quality Assurance/Quality Improvement vs. Research
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bullet Conflicts of Interest in Research
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bullet Honest Broker Requests
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bullet Humanitarian Use Devices (HUD)
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bullet NCI CIRB submissions
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bullet Emergency Use of Investigational (Experimental) Articles
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bullet IRB meeting schedule & deadline for submission
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bullet Regulations & guidance governing human subject research
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bullet Research privileging
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bullet Research compliance training
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bullet Education & training in human subjects protection
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bullet Community information
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bullet Other useful links
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bullet Mailing information
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bullet RSPP staff
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bullet IRB chairs
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bullet IRB member rosters
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bullet Contact us
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bullet Return to the IRB home page

Regulations & guidance governing human subject research

The Belmont Report:  Ethical Principles and Guidelines for the Protection of Human Subjects of Research

Code of Federal Regulations (FDA) Title 21, Part 50 [21 CFR 50] -- Protection of Human Subjects

Code of Federal Regulations (FDA) Title 21, Part 56 [21 CFR 56] -- Institutional Review Boards

Code of Federal Regulations (FDA) Title 21, Part 312 [21 CFR 312] -- Investigational New Drug Application

Code of Federal Regulations (FDA) Title 21, Part 812 [21 CFR 812] -- Investigational Device Exemptions

Code of Federal Regulations (DHHS)
Title 45, Part 46 [45 CFR 46]

ICH Guideline for Good Clinical Practice

 

 



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