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700-35-Institutional Reporting Procedures

Title: Institutional Reporting Procedures
Owner: IRB
Last Update/Revised: 05/01/2024

Policy: It is the policy of the USU IRB to comply with all federal regulations in the conduct of research studies and to communicate certain actions to entities that may have an interest in the status of the research being conducted. The IRB will notify institutional officials as well as funding sources and regulatory agencies, as appropriate, once the IRB takes any of the following actions:

  • determines that an event represents an unanticipated problem involving risks to participants or others
  • determines that non-compliance is serious or continuing
  • suspends or terminates approval of research
  • allegations of research misconduct/non-compliance 

Purpose: The purpose of this policy is to describe institutional reporting procedures used when reporting any of the following in relation to a protocol: an unanticipated problem involving risks to participants or others, serious or continuing non-compliance, and/or the suspension or termination of approved research.

Procedures:

  1. The IRB Chair or designee prepares a letter that contains the following information:
    1.  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)
    2. Title of the research project in which the problem occurred
    3. Name of the investigator on the protocol (and chair if the investigator is a doctoral student)
    4. Number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement)
    5. A detailed description of the problem, including the findings of the organization and the reasons for the IRB decision
    6. Corrective actions and/or sanctions the institution is taking or plans to take to address the problem, including results for the Code of Conduct investigation, if applicable (e.g., revise the protocol, suspend subject enrollment, terminate the research, revise the informed consent document, inform enrolled subjects, increase monitoring of subjects, etc.)
    7. Plans, if any, to send a follow-up or final report by a specific date or when an investigation has been completed or a corrective action plan has been implemented.
  2. The IRB Chair sends a copy of the report to the following, as applicable. 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.
    1. Investigator (and chair for a doctoral student)
    2. Sponsor, if the study is sponsored
    3. The Provost
    4. Supervisor of the investigator (in the case of a doctoral candidate, the chair of the committee, Program Director, Dean, and Assistant Dean will be notified)
    5. The IRB Committee, by providing the determination letter
    6. OHRP, if the study is subject to DHHS regulations or subject to a DHHS Federal Wide Assurance
    7. Other federal agencies, when the research is overseen by those agencies, if they require reporting separate from that to OHRP
  3. The IRB Chair will ensure that all steps of this policy will be completed within 30 days of the initiating action. For events that require investigation per the Code of Conduct policy, the letter will be sent within 10 days the result of that investigation. For more serious actions, the IRB Chair will expedite reporting.

Scope: The policy applies to previously approved research.

Documents and Forms:

 None