Human Research Protection Program Policy and Procedure Manual - Section 10

10 Reporting to Regulatory Agencies and Institutional Officials
10.1 Procedures


10 Reporting to Regulatory Agencies and Institutional Officials
10.1 Procedures

  1. IRB staff will initiate these procedures as soon as the IRB takes any of the following actions:
    • determines that an event may be considered an unanticipated problem involving risks to participants or other
    • determines that non-compliance was serious or continuing
    • suspends or terminates approval of research
  2. The Director or designee is responsible for preparing reports or letters which include the following information:
    • the nature of the event (unanticipated problem involving risks to participants or others, serious or continuing non-compliance, suspension or termination of approval of research);
    • name of the institution conducting the research;
    • title of the research project and/or grant proposal in which the problem occurred;
    • name of the principal investigator on the protocol;
    • number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
    • a detailed description of the problem including the findings of the organization and the reasons for the IRB’s decision;
    • actions the institution is taking or plans to take to address the problem (e.g., revise the protocol, suspend participant enrollment, terminate the research, revise the informed consent document, inform enrolled participants, increase monitoring of participants, etc.); and
    • plans, if any, to send a follow-up or final report by the earlier of
      (1.) a specific date; or
      (2.) when an investigation has been completed or a corrective action plan has been implemented
  3. The IRB Chair and the IO review the letter and modify the letter/report as needed
  4. The IO, or designee, is the signatory for all correspondence from the facility.
  5. The Director or designee sends a copy of the report to:
    • The IRB by including the letter in the next agenda packet as an information itemThe following federal agencies:
    • The IO
    • The following federal agencies:
      • OHRP, if the study is subject to DHHS regulations or subject to a DHHS federalwide assurance
      • FDA, if the study is subject to FDA regulations.
      • If the study is conducted or funded by any Federal Agency other than DHHS that is subject to “The Common Rule”, the report is sent to OHRP or the head of the agency as required by the agency
      • Reporting to a regulatory agency is not required if the event occurred at a site that was not subject to the direct oversight of the organization, and the agency has been notified of the event by the investigator, sponsor, another organization, or other mechanisms.
    • Principal investigator
    • Sponsor, if the study is sponsored
    • Chairman or supervisor of the principal investigator
    • The Information Security Officer of an organization if the event involved violations of information security requirements of that organization
    • Office of Insurance and Risk, if appropriate
    • Others as deemed appropriate by the IO


The Director ensures that all steps of this policy are completed within 10 working days of the initiating action, whenever possible. For more serious actions, the Director will expedite reporting. 

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