Managing Principal Investigator (PI) Proxy

The Principal Investigator may assign proxy permissions so that system activities only available to PIs can be completed by another member of the study team. The PI Proxy must be a member of the approved study team with current human subjects training certification.

The purpose of assigning a system-based proxy is to assist with the management of follow-on submissions (Modification/Updates and Continuing Reviews). PI Proxy permissions do not imply that the named proxy has PI responsibilities; only the Principal Investigator and Faculty Sponsor (if there is one) hold Principal Investigator responsibilities.

Important! A PI Proxy can only be assigned by the PI on an approved, non-ceded study. Any initial study application that has not yet been approved will need to be granted IRB approval before a proxy can be assigned. Any study for which the review has been ceded to an External IRB, assigning a PI Proxy is not permitted.

Once a PI Proxy has been assigned, the Proxy:
> Can submit follow-on submissions and study materials on behalf of the PI.
> Will receive all system notifications pertaining to the study.
> Cannot assign additional proxies; the PI is the only person who is able to designate a PI Proxy.

TIPFaculty Sponsors listed on any student project will not receive system notifications by default. Faculty Sponsors may be added as a PI Proxy so that they will receive system notifications about the study.

 

To assign a PI Proxy:

1. Log in to irb.harvard.edu

2. Navigate to an approved study (see Accessing a Submission for more instructions)

3. On the main study workspace (marked in the center as “Submission type: Initial Study”), under Next Steps, click Assign PI Proxy.
Image of Assign PI Proxy activity
4. A pop up will appear where you can select the individual(s) you would like to designate as PI Proxy. The list will show only approved study team members. If an individual you wish to assign as PI Proxy is not listed, they first must be added to the study via a Modification.

5. Check any/all of the individuals you wish to make PI Proxy, review the PI assurance statement

6. Click OK

7. All updates to PI Proxy will be recorded on the main study workspace, capturing the name, date, and time that the PI completed the activity, serving as record of the PI assurance of compliance.  To review the PI assurance that appears on the activity form, click on the activity name in the History.
Image of how completed proxy activity appears on the study history

To remove a PI Proxy:

1. Log in to irb.harvard.edu

2. Navigate to an approved study (see Accessing a Submission for more instructions).

3. On the main study workspace (marked in the center as “Submission type: Initial Study”), under Next Steps, click Assign PI Proxy.
Image of Assign PI Proxy activity
4. A pop up will appear where you can deselect the individual(s) you would like to remove PI Proxy permissions from.

5. Uncheck any/all of the individuals you wish to remove PI Proxy permissions from, review the PI assurance statement

6. Click OK

7. All updates to PI Proxy will be recorded on the main study workspace, capturing the name, date, and time that the PI completed the activity, serving as record of the PI assurance of compliance.  To review the PI assurance that appears on the activity form, click on the activity name in the History.
Image of how completed proxy activity appears on the study history

Important! Any PI Proxy that is removed from the study via a Modification to study team members will be automatically removed as PI Proxy.