Establishing a Principal Investigator
OVERVIEW
BEFORE YOU BEGIN
- You’ll want to be sure that your Signatory Institution has a completed Enrollment Form and an executed Authorization Agreement.
- The RUMS Update Person needs to add the PI to the CIRB’s roster using the Roster Update Maintenance System (RUMS). For more information, go to Updating Your CIRB Roster Using RUMS.
- The PI should have access to IRBManager.
STEPS
PI OR DESIGNEE COMPLETES THE ANNUAL PRINCIPAL INVESTIGATOR WORKSHEET
The Annual Principal Investigator Worksheet helps establish the local context considerations for all research conducted by the PI. This is the first step to allow a PI to open CIRB studies. The Worksheet can be completed by either the PI or a designated member of the institution’s research staff.
The Annual Principal Investigator Worksheet is completed in IRBManager.
The Annual Principal Investigator Worksheet provides details on local context considerations necessary for the CIRB to conduct a review. This information includes descriptions of:
- Resources available to the PI
- Consent form process and procedures
- Processes for consenting individuals that do not speak English or require the use of a legally authorized representative
- Safeguards for vulnerable populations
- Assurances should a woman become pregnant during the study
PI OR DESIGNEE SUBMITS WORKSHEET
The PI or designee is responsible for submitting the Worksheet to the CIRB once it has been completed and reviewed locally. For more information, go to Completing the Annual Principal Investigator Worksheet.
CIRB OPERATIONS OFFICE CONDUCTS ADMINISTRATIVE REVIEW
Once the Worksheet is submitted, it is sent to the CIRB Operations Office for administrative review. This process typically takes two weeks. If additional information is required, an email is sent to the person who submitted the Worksheet. Revisions to the Worksheet are completed in IRBManager (see Step 1).
CIRB LOCAL CONTEXT COMMITTEE CONDUCTS REVIEW
Once the administrative review is complete, the Worksheet is sent to the CIRB Local Context Subcommittee for the local context review. This process typically takes five days. If additional information is required, an email is sent to the person who submitted the Worksheet. Revisions to the Worksheet are completed in IRBManager (see Step 1).
CIRB OPERATIONS OFFICE GENERATES APPROVAL FOR PI
Once the Local Context Subcommittee approves the Worksheet, the CIRB Operations Office will generate the approval letter and send it to:
- the PI
- the person submitting the Worksheet, and
- the Signatory Institution Primary Contact(s).
PI IS ABLE TO OPEN STUDIES WITH THE CIRB
The PI will be able to start opening studies with the CIRB after the following letters arereceived:
- the approval letter for the Annual Principal Investigator Worksheet
- ad copy of the approval letter for the Annual Signatory Institution Worksheet
- and the Requirements Complete letter
For more information, go to Opening a Study.