CERI Institutional Review Board

Federalwide Assurance

• CERI Federalwide Assurance [as required by 45 CFR 46]

• On-Line Tutorial for IRB Members

Schedule:

January 16th, 2007 3pm (Training)

January 29th, 2007 3pm

Regulations and Guidance:

• DHHS Human Subjects Regulations (45 CFR 46)

• Informed Consent Checklist (via OHRP Web Site)

• Ethical Principles and Guidelines for the Protection of Human Subjects (the Belmont Report)

• The Declaration of Helsinki

• Additional OHRP guidance on numerous topics

Researchers:

• On-Line Tutorial for CERI Investigators [Submit completion certificate to the IRB Coordinator]

• Petition for Approval of Research Involving Human Subjects [use for initial approval]

• Continuing review petition [complete yearly to maintain approval]