Section VII:

General Operations

WPP #: VII-4

Title 4:

Reporting to Regulatory Agencies

Effective Date:

06-23-15

Revision History:

04-22-14

Policy Statement

The VCU IRB will report, within 30 days of identifying a reportable event, the following to relevant regulatory and oversight agencies [in accordance with 45 CFR 46.103(a), 21CFR56.108(b), and 21 CFR 56.113] for non-exempt research, regardless of funding:

  1. unanticipated problems involving risks to subjects or others;
  2. serious and/or continuing noncompliance with the requirements or determinations of the IRB; and
  3. suspension or termination of previously approved research.

Procedures

  1. Report Preparation:

    Official written reports for official reporting to oversight agencies are to be prepared as follows:

    1. Drafted by the Director of the ORSP
    2. Reviewed for comments, as appropriate, by the IRB Chair/designee, Director of OSP, the principal investigator, and others. If the report is related to a WIRB-approved protocol, the ORSP Director coordinates the drafting and review of the report with the WIRB counterpart.
    3. Signed by the Director of the ORSP, the IO, or designee.
  2. Elements of the Report:

    The following elements must be included in the report, which should be kept concise and include only detail which directly supports the actions taken:

    1. Name of institution conducting the research;
    2. Title of research project and/or grant proposal;
    3. Name of the principal investigator on the protocol;
    4. The number assigned to the study by the IRB;
    5. The number of any applicable federal award;
    6. A description of the event or events resulting in the unanticipated problem, serious/ continuing noncompliance, and/or suspension or termination;
    7. The findings of the organization;
    8. Actions taken by the organization, including any IRB actions taken related to the matter; and
    9. Clear identification that the issue is resolved or specific plans for continued investigation or action.
  3. Distribution of the Report:

    The distribution of the written report begins with federal agencies that have oversight due to funding, conduct, or an assurance of compliance. A report is always sent to OHRP, the FDA if FDA-regulated research, and other “Common Rule Signatories” that require reporting separate from OHRP. A VCU report may not be sent to federal agencies already made aware of the event by way of the investigator, sponsor, or another organization, as determined by the ORSP Director and/or IRB Chair.

    1. The report must be drafted as soon as information is available that confirms or clarifies the issue to be reported. The timing for official distribution of the report to oversight agencies should be as soon as practicable, with the primary attention first given to taking any actions (if necessary) to ensure the ongoing protection of human research participants. For more serious incidents, the report will be filed as soon as practicable (maybe even within days). It may be necessary to telephone an agency in order to alert the agency to a very serious problem.
    2. Copies of the report are directed to:
      1. The VCU IRB Panel Chairperson
      2. The Institutional Official
      3. The Office of Sponsored Programs, as appropriate (for reporting to any sponsoring organization)
      4. The Principal Investigator and/or supervisor of the Principal Investigator

References

DHHS OHRP Guidance: Incident Reporting
FDA Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval
AAHRPP Tip Sheet: Reporting of Unanticipated Problems