/Institutions/United-States-University/json/current/Policy-and-Procedure-Manual-local.json

/Institutions/United-States-University/json/current/Policy-and-Procedure-Manual.json

700-31-Unanticipated Problems Involving Risks to Participants or Others

Title:	Unanticipated Problems Involving Risks to Participants or Others
Owner:	IRB
Last Update/Revised:	05/01/2024

Policy: The USU IRB requires investigators to submit reports of events that may represent unanticipated problems involving risks to research participants and others, including unexpected and related adverse events. Investigators (or in the case of doctoral student, their chairs) are required to submit the report as soon as possible after learning of the event and in all cases within 5 business days.

The terms used in this policy are defined as:

Unanticipated Problems – Unanticipated problems involve risks to research participants or others and are defined as any incident, experience, or outcome that meets all the following criteria:

• unexpected (not foreseeable by the investigator or the research participant) given the research procedures and the subject population being studied;

• related or probably related to participation in the research or if the event or problem probably or definitely affects the safety, rights, and welfare of current participants; and

• suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

Unexpected Adverse Events  - An unexpected adverse event is any adverse event occurring in one or more subjects participating in a research protocol in which the nature, severity, or frequency is not consistent with either:

• the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in the protocol-related documents, such as the IRB-approved research protocol, any applicable investigator brochure, the current IRB-approved informed consent document, and other relevant sources of information, such as product labeling and package inserts; or

• the expected natural progression of any underlying disease or condition of the participant(s) experiencing the adverse event.

Related Adverse Event - It is the investigators' responsibility to make the initial and subsequent determination of a relationship between an adverse event (either internal or external) and any investigational agent(s), intervention, or research study procedure.

• An adverse event is “related to the research” if in the opinion of the investigator, it was more likely than not related to participating in the research.

Purpose: The purpose of this policy is to explain how unanticipated problems involving risks to research participants or others are handled by the IRB.

Procedures:

1. The investigator (or the chair of a doctoral student) reports problems under this policy by completing and emailing an Event Reporting Form to the IRB via a Google Form.
2. The report should be submitted as soon as possible, and in all cases within 5 business days.
3. The submission is reviewed by the IRB Chair.
4. The IRB Chair may request clarifications, corrections, or revisions to the report from the investigator if further information is needed to evaluate the event.
5. If the IRB Chair determines that the problem is not an unanticipated problem involving risks to participants or others as defined in this policy, the IRB Chair completes a report indicating the event is not considered to be an unanticipated event involving risks to participants. The investigator (and chair of a doctoral student) is notified via email and no further action is taken.
6. If the IRB Chair determines the problem might be, or is likely, an unanticipated problem involving risks to participants or others as defined by this policy, the event is referred to a member of the IRB Committee for review.
7. If the IRB member determines that the problem is not an unanticipated problem involving risks to participants or others as defined by this policy, the IRB member completes a report indicating the event is not considered to be an unanticipated event involving risks to participants. The investigator is notified via email and no further action is taken.
8. If the IRB member determines the problem might be an unanticipated problem involving risks to participants or others as defined by this policy, the event is referred to the convened IRB for review.
9. When reports are reviewed by the convened IRB, the IRB Chair ensures board members are notified, and the documents listed below are made available in the IRB Google Drive three or more working days prior to the meeting. All IRB members are expected to review the information and be prepared to discuss it at the meeting.
   • Event Reporting Form
   • the currently approved protocol
   • the currently approved consent document
   • previous reports of unanticipated events and problems involving risks to participants or others, if they exist
10. Based on the nature of the event and the expertise required to assess it, the IRB Chair or designee acts as the primary reviewer and presents their findings to the convened IRB. The convened IRB evaluates the event by considering whether the problem is an unanticipated problem involving risks to participants or others as defined by this policy. The convened IRB votes on whether the report is an unanticipated problem involving risks to participants or others. The discussion, rationale for any action, and vote are recorded in the minutes.
11. If the convened IRB determines that the problem is not an unanticipated problem involving risks to participants or others as defined by this policy, the convened IRB acknowledges the event as submitted, indicating the event is not considered to be an unanticipated event involving risks to participants. The investigator is notified via email, and no further action is taken.
12. If the convened IRB determines that the problem is an unanticipated problem involving risks to participants or others as defined by this policy, the convened IRB may consider any of the following actions but is not limited to:
    • modification of the protocol
    • modification of the information disclosed during the consent process provided by the investigator
    • providing additional information to current participants (this must be done whenever the information may relate to the participant’s willingness to continue participation)
    • providing additional information to past participants
    • requiring current participants to re-consent to participation
    • alteration of the frequency of continuing review
    • observation of the research or the consent process
    • requiring additional training of the investigator
    • obtaining additional information
    • administrative hold, suspension, or termination of the research according to 700-34:Administrative Hold, Suspension, and Termination of Research
13. If the IRB determines that the event was an unanticipated problem involving risks to participants or others, the matter is referred to the IRB staff to handle according to 700-35: Institutional Reporting Procedures.

Scope: The policy applies to events that were unanticipated and may involve risks to research participants or others.

Documents and Forms:

Event Reporting Form