Table 17 Information needed about users for provisioning decisions.
Information Needed to Make Provisioning and Authorization Decisions |
|---|
Institution |
Federal-Wide Assurance Number of IRB |
Nationwide IRB Identifier |
Quality of HIPAA training verified |
Has institution agreed to abide by policies? |
Has institution been debarred? |
Investigator |
Name |
Institution(s) investigator employed at |
Title(s) |
Is IRB Human Subjects Research Training up to date? |
Is the HIPAA training up to date?*** |
Who has personally vouched for this individual's identity and need for access? |
User has agreed to abide by policies |
User has promised not to try to re-identify data |
User has promised not to share credentials |
User has promised to use the system only for the purposes of the project |
Has the individual been debarred? |
Are there findings of research misconduct associated with the individual? |
Have there been OHRP sanctions? |
If user associated with unaffiliated institution – has user completed an unaffiliated user agreement? |
If user is performing preliminary research – has there been some other institutional review or approval? |
IRB Protocol |
IRB approval number |
IRB approval dates |
Category of IRB approval (not HSR, exempt, expedited, full-review) |
PI named on IRB protocol under which user is searching |
Name and short description of project |