IRB Regulatory Documents and University Guidelines
• University of Akron Applicant Manual (Rev. 07/31/08)
• Investigator Certification -- All individuals conducting
research involving human subjects must be certified.
Beginning fall semester 2008, all new researchers must take
and pass the core modules in the Collaborative Institutional
Training Initiative (CITI) curriculum. Researchers with a previous UA certification on file with the IRB are certified until
May 15, 2009. Their certification will expire on that date, and they will need to complete the CITI training prior to submission of any protocol after May 15, 2009.
• Letter Explaining Changes in IRB Investigator Certification Requirement
By Dr. Rosalie Hall, former IRB Chair; distributed 7/31/08
• CITI Certification Tutorial for Researchers Submitting a Protocol to the IRB • Tutorial for Students Taking the CITI Training to Satisfy Course Requirements • CITI Login and Registration Page • Informed Consent Guidelines
• Required Elements of Informed Consent • Sample Informed Consent Form
• Sample Parental Consent Form • Sample Child Assent Form • 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.
|
