| IRB Structure |
|
| Ethical Principles |
6000-100 |
| IRB Membership and Structure |
6000-101 |
| IRB Authority and Jurisdiction |
6000-102 |
|
|
| Types Of IRB Review |
|
| Compassionate/Treatment Use of An Investigational Drug or Device |
6000-200 |
| Emergency Use of Investigational Drugs and Devices |
6000-201 |
| Exempt Review |
6000-202 |
| Expedited Review |
6000-203 |
| Hud (Humanitarian Use Of An Investigational Device) |
6000-204 |
|
|
| IRB processes |
|
| Advertising, Recruiting and Media Contact for Research Subjects |
6000-300 |
| Amendment Review Process |
6000-301 |
| Clinical Trials Compensation |
6000-302 |
| Continuing Review Process |
6000-303 |
| Informed Consent Process |
0330-1002 |
| New Protocol Submission |
6000-305
|
Reporting Serious Adverse Events
|
0330-1000
|
Protocol Deviations/ Violations
|
0330-1001
|
Study Closure
|
6000-308 |
| Vulnerable Population |
|
| Children in Research Including Unmarried Pregnant Minors, Unmarried Minor Mothers, Married Minors, and Emancipated Minors |
6000-400 |
| Elderly, Terminally Ill, Minorities and Cognitively, Impaired Persons in Research |
6000-401 |
| Pregnant Women, Fetus in Research |
6000-402 |
| Research Involving Prisoners |
6000-403 |
| Research On Decedents |
6000-404 |
| |
|
| Forms |
|
| Adverse Event Forms |
|
| Amendments & Change Requests |
|
| Continuing Review |
|
| Education |
|
| HIPAA |
|
| Humanitarian Use Device |
|
| Informed Consent |
|
| New Submissions |
|