Institution Q & A

Some of your frequently asked questions:

 

Steps

What do I need to do at the time of continuing review?

The Signatory Institution has no IRB review responsibilities for the regulatory continuing review. The CIRB conducts the continuing review for all institutions. However, some institutions may require information to be submitted for the purposes of institutional research oversight, which is separate from the regulatory continuing review, although may include similar information. Institutional policy should not require a duplicative continuing review for studies open under the CIRB.  For more information, go to Oversight Q & A

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What do I have to do when an amendment is distributed?

The Signatory Institution has no IRB review responsibilities for an amendment review. However, some institutions may require additional information when there are changes associated with research conducted at the institution. This requirement is separate from the regulatory review of changes in research. Institutional policy should not require a duplicative amendment review for studies open under the CIRB.

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How do I access CIRB-approved study documents?

For NCI National Clinical Trials Network (NCTN), NCI Experimental Therapeutics Clinical Trials Network (ETCTN), and NCI Community Oncology Research Program (NCORP): The Principal Investigator (PI) and research team are responsible for obtaining the approved consent forms from the Clinical Trials Support Unit (CTSU) website and ensuring changes to the consent form based on an amendment are incorporated locally.  For more information, go to Finding Information Q & A. If you are a Consortia site, go to Navigating the CIRB as a Consortia Site for information on how processes vary for you. 

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Why isn't the Investigator's Brochure (IB) posted on the CIRB website?

Investigator's Brochures are not posted to the CIRB website because they include proprietary, confidential information. Acknowledgement of an IB is available under the CIRB documents tab on the CTSU website. The acknowledgement is found in a continuing review Approval Letter or in an acknowledgement of receipt of a revised IB. If you require a copy of the IB, contact the program or Network for further guidance.

Steps

How do I determine whether or not re-consent is required?

If the Study Chair or the CIRB requires study participant consent using the most recent amendment, the CIRB notes this determination in the amendment review Outcome Letter. If the Study Chair indicates re-consent is required when the amendment is distributed but the CIRB does not, then the Study Chair’s direction takes precedence. If local policy requires re-consent when the Study Chair or CIRB do not, then local policies should be followed.  

Steps

How do I notify the CIRB that a Principal Investigator (PI) is changing?

Prior to the current PI’s departure, complete the Study-Specific Worksheet in IRBManager and indicate the reason for the PI change. For more information, go to Completing the Study-Specific Worksheet.  

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How can I request a translation review by the CIRB?

Translations completed by the institution are submitted via IRBManager using the Annual Signatory Institution Worksheet for templates and documents used across studies. The Study-Specific Worksheet is used to submit translations for a specific study. The following materials are required: a certificate of accuracy, the CIRB-approved English language document, and the translated document. For verification, it is required that all three documents reference the same version or version date.  

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Does the CIRB need to review recruitment material developed for my institution?

Yes, the CIRB must approve recruitment material prior to use.  Recruitment material designed for a specific study by the PI or research team should be submitted using the Study-Specific Worksheet in IRBManager. For more information, go to Completing the Study Specific Worksheet.  

Steps

Does the CIRB review HIPAA language?

No, the CIRB does not review or approve HIPAA language. Because the CIRB is not a privacy board, the responsibility for review and approval of HIPAA language remains with the institution. HIPAA language may be included as part of an institution’s boilerplate language that is reported on the Annual Signatory Institution Worksheet. For more information, go to Completing the Annual Signatory Institution Worksheet.  

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Do I need to report adverse events occurring at my institution to the CIRB?

The CIRB does not review adverse events. If a study participant experiences an adverse event that meets the criteria of an unanticipated problem or a serious or continuing noncompliance issue, then report this event using the Unanticipated Problem and/or Noncompliance Reporting Worksheet in IRBManager. For more information, go to Completing the Unanticipated Problem and/or the Noncompliance Reporting Worksheet.

 

 

Posted: June 15, 2017