IRB Regulatory Documents and University Guidelines
• University of Akron Applicant Manual (Rev. 08/07)
• The Belmont Report -- Ethical principles and guidelines
for the protection of human subjects in research.
• The Code of Federal Regulations -- Title 45 Part 46 -- The Federal regulations under which the IRB is required to conduct review of research involving human subjects.
• Subpart A -- Common Rule.
• Subpart C -- Research Involving Prisoners.
• Subpart D -- Research Involving Children.
• Informed Consent
• Required Elements of Informed Consent • Sample Informed Consent Form
• Sample Parental Consent Form • Sample Child Assent Form • Investigator Certification Form -- Any individual conducting research on human subjects must have a signed certification form on file with the IRB before his/her application will be approved. The researcher must affirm that the regulatory materials have been read and that he/she understands and will follow all applicable guidelines for research involving human subjects.
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