 |  |  |  |  |  |  |  |  |  |  |  |  |  |
| • | The PI should provide justification as to why the |
| research cannot be done without the PHI. | |
|
| • | The PI must provide a written assurance to the | |
| IRB that the PHI will not be re-used or | |
| disclosed except | |
|
| – | As required by law, | |
|
| – | For authorized oversight of the research, or | |
|
| – | For other research that has been reviewed | |
| and approved by the IRB with specific | |
| approval regarding access to this PHI. | |