Establishing Your Signatory Institution
BEFORE YOU BEGIN
- You’ll need a completed Enrollment Form and an executed Authorization Agreement.
- Your Signatory Institution Primary Contact, Research Staff, and Principal Investigators (PIs) have access to IRBManager.
SIGNATORY INSTITUTION PRIMARY CONTACT OR DESIGNEE COMPLETES THE WORKSHEET
The Annual Signatory Institution Worksheet is completed in IRBManager and can be completed by either the Signatory Institution Primary Contact or a designated member of the Signatory Institution’s research staff.
The Annual Signatory Institution Worksheet provides the local context information necessary for the CIRB to evaluate local processes and comply with regulations regarding privacy and confidentiality and pregnant women as participants. The information will include descriptions of:
- State and local laws
- Oversight of research conducted at your institution. For more information, go to Oversight Q&A.
- Recruitment area and vulnerable populations
- Minor changes to your boilerplate language. For more information, go to Boilerplate Q&A.
SIGNATORY INSTITUTION PRIMARY CONTACT OR DESIGNEE SUBMITS WORKSHEET
The Signatory Institution Primary Contact or designee submits the Worksheet to the CIRB once it has been completed. For more information, go to Completing the Annual Signatory Institution Worksheet.
CIRB OPERATIONS OFFICE CONDUCTS ADMINISTRATIVE REVIEW
IRBManager routes the Worksheet to the CIRB Operations Office for administrative review. If additional information is required, an email is sent to the individual who submitted the Worksheet. Revisions to the Worksheet are completed in IRBManager (see Step 1). This process typically takes two weeks.
CIRB LOCAL CONTEXT COMMITTEE CONDUCTS REVIEW
Following administrative review, the Worksheet goes to the CIRB Local Context Subcommittee for review. If the Subcommittee requests additional information, an email is sent to the individual who submitted the Worksheet. Revisions to the Worksheet are completed in IRBManager (see Step 1). This process typically takes five days.
CIRB OPERATIONS OFFICE GENERATES APPROVAL FOR SIGNATORY INSTITUTION
Once the Local Context Subcommittee approves the Worksheet, the CIRB Operations Office generates an approval letter and sends it to:
- the person submitting the Worksheet,
- the Signatory Institution Primary Contact(s), and
- all the Signatory Institution PIs.
SIGNATORY INSTITUTION IS ESTABLISHED WITH THE CIRB
The Signatory Institution can open studies using the CIRB after the following letters are received:
- the approval letter for the Annual Signatory Institution Worksheet
- the approval letter for at least one Signatory Institution PI, and
- the requirements complete letter from the CIRB.
For more information, go to Opening a Study.