Establishing Your Signatory Institution

OVERVIEW

The Annual Signatory Institution Worksheet provides the information that defines the “local context” for all research conducted under the authority of the Signatory Institution and covered by the CIRB. This is the mechanism that allows the institution to utilize the NCI CIRB as its IRB of record. This Quickguide outlines the steps for establishing the local context considerations for your Signatory Institution with the CIRB.

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.

 

Steps

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.
Steps

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.

Steps

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.

Steps

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.

Steps

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.
Steps

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.

USEFUL TIP

You can expect to receive the approval letter within four weeks of submitting the Annual Signatory Institution Worksheet. If the submission is incomplete or if there are questions raised during the Administrative or Local Context Review, the process will take longer.

 

 

Posted: June 15, 2017