New Information Reporting Guidance

Version date: January 16, 2018

Reportable events fall into three main categories: unanticipated problems, noncompliance, and new information. This documents explains what the IRB considers to constitute "new information" and when a new information report must be submitted to the IRB for review. The IRB assesses these reports to determine whether any additional actions are needed and whether the information stems from a potential unanticipated problem.

NOTE: The information provided below does NOT alter or supersede the reporting requirements for unanticipated problems or noncompliance. See the Reporting Timeframes document for details on additional reporting requirements.

The following are examples of the types of information that should be submitted as a New Information report:

  1. Notifying the IRB of new risk information and a related forthcoming change of protocol

    Study teams frequently receive information from a sponsor or coordinating center involving new risk information that should be reported promptly to subjects. This information often involves notifying the study team that a change to the protocol and/or consent documents is forthcoming. This type of information is often received in the form of an action letter, revised Comprehensive Adverse Events and Potential Risks list (CAEPR), or sometimes an updated Investigator's Drug Brochure (IDB) or Package Insert. This new risk information is frequently available well before the revised study documents are issued. In such cases, study teams still need to take prompt action to inform subjects of the new risks.

    If the revised study documents will not be available to the study team within 14 business days of receipt of the new risk information, a new information report must be submitted to the IRB to describe the new information and outline any action that will occur before the change of protocol is reviewed and approved by the IRB. This new information report allows the IRB to review new risk information in a timely manner and determine whether any action is needed in cases when a change of protocol may not be able to be submitted for weeks after the new information has been issued by the sponsor or coordinating center.

    The following information should be included in the new information report:

    • A description of any change to the enrollment status of the study based on this new risk information. If no change is being made to the enrollment status, explain why no change to enrollment status is needed.
    • A description regarding how subjects will be informed of the new risk information (e.g., orally) and how the study team will document the communication of the new information. If the study team does not think that the new information should be communicated to all or some subjects, explain the basis for this determination. Note that federal regulations require institutions to ensure communication to subjects of any “significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation."
    • Confirmation that when the study team receives the revised documents, a change of protocol will be submitted to the IRB within 60 days of their receipt by the study team.

    If the study team has been informed that they will receive revised study documents within 14 business days of receiving the new risk information, the study team does not need to submit a new information report. The study team should instead submit the change of protocol (with the action letter/revised CAEPR/updated IDB or Package Insert) within 60 business days of receipt of the new risk information. In the submission comment box, the study team should include the information (points 1, 2 and 3 above) that would have been included in the new information report. NOTE: If the new risk information addressed in the change of protocol may constitute an unanticipated problem, this must be reported to the IRB within 14 business days.

    NOTE: Although the study team has 60 business days to submit the Change of Protocol, they are still required to orally inform study subjects of new risk information in a timely manner. If a study team wishes to send a letter to study subjects informing them of this new information, study teams should submit a New Information report to the IRB including both the letter for subjects and the "new information" document (e.g., action letter, revised IDB or Package Insert). The revised study documents can then be submitted separately as a Change of Protocol. If the study team is not sure whether the revised study documents will be received within 14 days of receipt of the new risk information, a new information report should be submitted as described above.
  2. Information that has the potential to affect the IRB’s assessment of whether the study continues to meet the criteria for IRB approval, or that requires additional action on the part of the study team.

    Examples include:

    • New risks discovered on a different study using the same drug, that are potentially relevant to the current study (e.g., due to similar subject population or dose).
    • A change in study status that was not previously specified in the protocol AND that appears to impact subject safety and/or the ability of the study to meet its original aims (e.g., halt to enrollment due to equipment malfunction or drug supply issues). NOTE: This does not include meeting enrollment goals earlier than planned or a temporary suspension due to a planned interim analysis.
    • Data Monitoring Committee (DMC) or Data Safety Monitoring Board (DSMB) reports containing information that has the potential to affect subject safety. NOTE: DSMC/DSMB reports that do not contain information that has the potential to impact subject safety or do not recommend changes to study procedures or documents should be submitted at the time of continuing review.
    • DMC or DSMB reports that recommend study alterations (e.g., early termination, additional or different procedures).
  3. Any FDA audit report, regardless whether any findings were made.
  4. Temporary leave of PI (see Personnel Change Guidance)
  5. Any correspondence directed at subjects that was not previously approved by the IRB and will not otherwise result in changes to other study documents, such as the protocol or consent from.

    Examples include:

    • Study results letters
    • Unblinding information
  6. Request to disclose an incidental finding (aka adventitious findings) when the IRB has not approved such disclosure.

    NOTE: In most cases, study teams should not disclose adventitious findings until the IRB has reviewed and approved the request. The IRB typically does not allow the release of laboratory analyses to subjects unless they are performed by a CLIA-approved entity.

    The following information should be included in the new information report:

    • Description of the incidental finding (e.g., abnormal result of laboratory test or MRI), when it was discovered and who discovered it
    • Rationale for disclosing the incidental finding (i.e., why will the subject may benefit from knowing this information)
    • Process for informing the subject of the incidental finding (i.e., who is going to disclose the finding, how, and who should the subject contact regarding questions)
      • Statement clarifying whether this is expected to occur again or if this is an isolated incident (if not an isolated incident, a change of protocol is required)

Keywords:CAEPR, IDB, new information, reportable events   Doc ID:26915
Owner:Carol P.Group:Health Sciences IRBs
Created:2012-10-18 10:13 CSTUpdated:2018-01-17 12:02 CST
Sites:Health Sciences IRBs
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