Terminology |
|
|
Medical condition |
|
|
Capacity |
|
|
Risk |
|
|
Standard of care |
|
|
Intervention |
|
|
Surrogate decision maker |
Timing prevents surrogate consent Must indicate therapeutic window for intervention Outline plan to contact SDM
|
|
Pre-clinical trial data |
| |
Advance Directives | |
|
Prospective consent |
|
|
Public Disclosure |
| |
Community Consultation |
|
|
Misc. Requirements |
Public disclosure prior to and after trial Provide IRB details at each continuing review Show requirements for informing participants and SDM Keeping related records for 3 years Allowance of refusal from any family member
| |