Radioactive Materials Licensure and Clinical Review Boards for IVB
Mr. Michael Bohan B.Sc.
I am making a presentation today on how to get your intravascular brachytherapy protocol up and running, and today we're going to be talking about the things that need to be addressed to get your radioactive materials license and your clinical review boards set to get an IVB program up and running.
Full transcript available at :
[00:00:00] Radioactive Materials Licensure and Clinical Review Boards for IVB
[00:00:24] Regulatory Agencies
[00:01:48] Regulatory Agencies (Cont)
[00:03:09] 45CFR46 - Protection of Human Subjects
[00:04:07] Purpose of the IRB
[00:05:32] Institutional Review Boards
[00:07:14] IRBs - Continued
[00:07:54] Criteria for IRB Approval of Research
[00:10:47] Criteria for IRB Approval of Research (continued)
[00:11:38] Informed consent
[00:12:10] Informed consent - For research involving more that...
[00:12:57] Informed consent - A statement that participation is voluntary...
[00:13:18] IRB Application Process
[00:13:46] IRB Application Contents
[00:16:02] IRB Application (Cont.)
[00:17:50] IRB Application (Cont.) - Copy of Proposed Informed Consent Form
[00:20:32] Protocols Involving Radioisotopes
[00:22:13] Radiation Safety Approval
[00:24:02] NRC and Agreement States
[00:24:34] NRC License Types
[00:25:33] NRC Broad Scope License
[00:27:50] NRC License Types (cont.)
[00:30:39] NRC Specific Scope License
[00:31:09] Licensing Authority
[00:31:52] Licensing Authority (cont.)
[00:34:14] Licensing Authority (cont.) - Sealed sources must be tested for encapsulation before listed as a...
[00:35:31] Licensing Authority (cont.) - IVB sources must be listed...
[00:36:09] Licensing Authority (cont.) - Usually the Radiation Safety Officer...
[00:38:19] Applying for RSC Approval
[00:38:48] Applying for RSC Approval (cont.)
[00:39:46] Additional References