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Updated June 10, 2024

The University IRB follows federal regulations and guidance for reporting unanticipated problems involving risks to participants or others (Unanticipated Problems), serious or continuing noncompliance, and suspensions or terminations of IRB approval according to the University’s Federalwide Assurance (FWA).

Under its FWA, the University applies the Department of Health and Human Services (DHHS) federal regulations for the protection of human participants to research that is conducted or supported by a federal agency, and equivalent protections for participants in all other research.

Research involving investigational drugs or devices, or biological products is subject to Food and Drug Administration (FDA) regulations and requirements.

Distribution of Event Reports

For Human Research Conducted or Supported by a Federal Agency

For research that is conducted or supported by a federal agency, within seven business days of the IRB’s determinations of serious or continuing noncompliance, Unanticipated Problems, or suspensions or terminations of IRB approval, event reports will be distributed to the following:

• Principal investigator,
• Responsible Official (e.g., chair, dean or director) for the research, and
• Institutional Official (i.e., the Vice President for Research and Innovation).

Within 30 days of its decision, the IRB will notify:

• University Sponsored Projects for sponsored research,
• DHHS Office for Human Research Protections (OHRP) for research that is covered by DHHS regulations according to the University’s FWA (When research is not covered by DHHS regulations, reports of unanticipated problems involving risks to participants or others are not to be reported to OHRP),
• FDA for research that is regulated by the FDA (When research is not covered by FDA regulations, reports of unanticipated problems involving risks to participants or others are not to be reported to FDA),
• Other federal agencies or organizations involved in the research (e.g., DoD, EPA, VA),
• Sponsor or funding agency, and
• IRB Administrator for other institutions engaged in the research.

Equivalent Protections for Reportable Events

For research that is neither conducted nor supported by a federal agency, the University applies the following equivalent protections to problems that may arise during the conduct or after completion of a research study:

• Investigators must notify the IRB of situations or events that may constitute noncompliance; participant complaints; and problems, external reports, or findings that may alter research risks.
• Problem reports are assessed for possible serious or continuing noncompliance, unanticipated problems involving risks to participants or others (Unanticipated Problem), or suspension or termination of IRB approval.
• Problem reports involving possible noncompliance or an Unanticipated Problem, or that may require suspension or termination of IRB approval are reviewed by the convened IRB.
• IRB determinations of serious or continuing noncompliance, Unanticipated Problems, and suspensions or terminations of IRB approval are reported to organizational officials at the University and may be reported to external entities as determined by the IRB or Research Integrity & Security Director.

(See other IRB policies for information about reporting problems to the IRB, administrative assessment of problem reports, and IRB review and determinations of noncompliance, Unanticipated Problems, and suspension or termination of IRB approval.)

Event Report Preparation

Following review at a convened IRB meeting, the Research Integrity & Security Research Compliance Officer drafts an event report summarizing the circumstances of the situation or event and the IRB’s determinations. The report is sent to the Research Integrity & Security Director for approval before it is distributed to the relevant entities.

Event Report Content

The report contains the following information:

• description of the situation or event;
• IRB determination;
• reasons for the IRB’s determination;
• actions taken by the University, IRB, and principal investigator; and
• plans for continued investigation or action (as applicable).

For research that is covered by DHHS regulations according to the University’s FWA, the following information should be included in incident reports submitted to DHHS OHRP:

For unanticipated problems involving risks to participants or others:

• 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; and
• 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.).

For serious or continuing noncompliance:

• Name of the institution conducting the research;
• Title of the research project and/or grant proposal in which the noncompliance occurred, or, for IRB or institutional noncompliance, the IRB or institution involved;
• Name of the principal investigator on the protocol, if applicable;
• 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 noncompliance; and
• Actions the institution is taking or plans to take to address the noncompliance (e.g., educate the investigator, educate all research staff, educate the IRB or institutional official, develop or revise IRB written procedures, suspend the protocol, suspend the investigator, conduct random audits of the investigator or all investigators, etc.).

For suspension or termination of IRB approval:

• Name of the institution conducting the research;
• Title of the research project and/or grant proposal that was suspended or terminated;
• Name of the principal investigator on the protocol;
• Number of the research project assigned by the IRB that was suspended or terminated and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
• A detailed description of the reason for the suspension or termination; and
• The actions the institution is taking or plans to take to address the suspension or termination (e.g., investigate alleged noncompliance, educate the investigator, educate all research staff, require monitoring of the investigator or the research project, etc.).

AAHRPP Notification

The following events will be reported to AAHRPP as soon as possible (preferably within 48 hours) after the University or any researcher becomes aware of:

1. Any negative actions by a government oversight office, including, but not limited to, OHRP Determination Letters, FDA Warning Letters, FDA 483 Inspection Reports with official action indicated, FDA Restrictions placed on IRBs or Investigators, and corresponding compliance actions taken under non-US authorities related to human research protections.
2. Any litigation, arbitration, or settlements initiated related to human research protections.
3. Any press coverage (including but not limited to radio, TV, newspaper, online publications) of a negative nature regarding the University’s HRPP.