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Course Overview
Introduction
Course Overview
Course Overview, con't
Course Overview, con't
Learning Aids
Program Modules
1. Intro to Guidelines
Introduction to the NIH Guidelines
NIH Office of Biotechnology Activities
History of the Guidelines Development
Scope of the Guidelines
Scope of the Guidelines
Definition
Recombinant DNA Molecules
Definition
Recombinant DNA Molecules, con't
Definition
siRNA
Definition
Transgenic Animals
Example
Cre/loxP System
The NIH Guidelines are Applicable To:
Non-Compliance Consequences
Knowledge Review
2. Roles Responsibilities
Roles and Responsibilities
Roles and Responsibilities, con't
Roles and Responsibilities of:
Institutional (UNC's) Responsibilities
Institutional Biosafety Committee (IBC) Responsibilities
Environment, Health and Safety Responsibilities
Principal Investigator Responsibilities
Principal Investigator Responsibilities, con't
Principal Investigator Responsibilities, con't
Principal Investigator's Responsibilities for Human Use Protocols
Principal Investigator's Responsibilities for Human Use Protocols, con't.
NIH Responsibilities
Please Review the Following Instructions Before Proceeding to the Next Module
Knowledge Review
Choose Your Job Type
3. Experiments Covered
Experiments Covered
Experiments Covered by the NIH Guidelines
rDNA Decision Matrix
Next Step for the PI
Knowledge Review
4. Safety Issues
Risk Assessment
Principal Investigator's Risk Assessment
Principal Investigator's Risk Assessment, con't
Risk Groups
Risk Group 1
Risk Group 1, con't
Risk Group 2
Risk Group 3
Risk Group 4
Knowledge Review
5. Submission to IBC
Submission to IBC and IBC Review
Submission of rDNA Registrations to IBC
Oversight
Animal Use Experiments
IBC and IACUC Review of Animal Research Utilizing Recombinant DNA
Human Use Experiments
IBC and IRB Review of Research with Human Subjects
Procedures
Submission of rDNA Registrations to IBC
Procedures, con't.
Submission of rDNA Registrations to IBC
Knowledge Review
6. Incident Reporting
Incident Reporting
Requirements for Reporting
Incident Definition
Incident Procedures
How to Report Incidents
How to Report Incidents, con't
Additional Information in the NIH Guidelines
Appendices
Additional Information in the NIH Guidelines
Appendices, con't
Knowledge Review
Post Test
rDNA Test
Test Time
NIH Guidelines for Research Involving Recombinant DNA Molecules
Paul Berg
In 1972, Paul Berg created the first recombinant DNA molecule and won the Nobel Prize in 1980 for his work in chemistry with Walter Gilbert and Frederick Sanger.
Scope of the Guidelines
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