700. Reporting Problems to the IRB
Anyone learning of a problem or situation, or receiving external reports or notifications related to a non-exempt* research study must notify the IRB within five business days unless the problem may be life-threatening or fatal. In the latter case, notification is required within 48 hours of learning of the situation.
Reporting requirements extend to new information that becomes known about studies that are closed, expired or terminated when that information involves new risks to former participants. The IRB will determine if participants must be informed of the findings and may decide that other steps are warranted to protect participants or others.
Researchers are advised to use the problem reporting form (available in the IRBNet Researcher Libraries or from the Forms page of the RIO website). Others may use the form available from the Contact Us page of the RIO website. The report may be submitted anonymously (e.g., by sending a paper copy of the completed form to the RIO) or by omitting contact information from the online reporting form.
*Researchers conducting exempt research are advised to contact the RIO to discuss problems that may have occurred.
Each report or complaint is reviewed by the University's Research Integrity Office (RIO) Quality Improvement Officer (QI Officer), RIO Director, or IRB Chair or designee in a consistent, prompt, and professional manner.
Sources of Problem Reports
Information regarding noncompliance may come to the attention of the IRB from a variety of sources, including but not limited to:
- Members of the research team
- Participants or their family members
- Continuing reviews, research summaries, or progress reports from investigators
- Internal audits or reviews
- External or agency audits (e.g., FDA, VA)
- Monitoring activities by PIs or sponsors
- Adverse event, problem, or safety reports
- Members of the community
Types of Problems to Report
A variety of situations may occur during a research study or after study completion, or after participant withdrawal or completion that require reporting to the IRB. These include unapproved changes in the conduct of a research study, problems or situations that may affect participants, new information that suggests research risks or benefits have changed, participant complaints, and sponsor or other external reports that suggest a problem may exist.
The following list of types of problems is taken directly from the problem reporting form.
Protocol change encompasses accidental or unintentional changes to the IRB-approved plan for non-exempt research.
New or additional risks apply to findings that suggest participants may be at risk in ways not previously identified. For example, the research resulted in undesirable outcomes or harms that were not anticipated earlier, but that appear to be related to participation in the research. For multi-center trials, such risks may be prompted by a sponsor report.
Changes to expected harms or benefits apply to research findings that indicate that harms may be occurring more often (i.e., with greater frequency) or with more severity (i.e., increased magnitude) than was initially presented to the IRB. Decreases in the expected rates of research benefits may also warrant reporting because IRB approval was based on a projected relationship of risks and benefits. For multi-center trials, these changes may be prompted by a sponsor report.
Immediate harm applies when researchers must change the protocol to eliminate an apparent immediate hazard to a research participant and insufficient time exists to obtain prior IRB approval for the change.
Sponsor: If a sponsor suspends or terminates a research activity, researchers should immediately suspend or terminate the research as requested by the sponsor, and promptly notify the IRB of the suspension/termination and grounds for same.
Federal agency: The IRB must be notified any time an investigator is investigated by or receives a report from a federal agency when the investigation or report is related to the research.
Privacy: Researchers must inform the IRB of possible or actual unauthorized disclosure of a participant's involvement in a research project or of her/his personal information.
Confidentiality: Investigators must inform the IRB of possible or actual unauthorized disclosure of research data, including lost or stolen research records.
Complaints about a research study whether from participants, members of the research team, or others must be reported to the IRB for assessment.
Prisoner: Investigators must inform the IRB of incarceration of a participant in a research project that is not approved to enroll prisoners.
Other problems, situations or outcomes that may affect research participants or others, the conduct of the research, or the University should be reported to the IRB for assessment, including PI imposed suspension or termination of the project.
Suggested Content for Reporting Problems to the IRB
Individuals reporting problems to the IRB must provide sufficient information for the RIO to evaluate the effects of the problem, situation, unapproved changes, or external reports and to determine the appropriate review path (e.g., assessment for noncompliance or Unanticipated Problem).
Ideally, the information in the report would allow the IRB to evaluate each problem or situation. For example:
- Does the situation involve unapproved changes to or divergence from an approved research plan?
- Was the incident expected (i.e., identified in the application and consent form) or unexpected?
- Is the problem or situation related or possibly related to participation in the research?
- Does the problem or event suggest participants or others may be at greater risk of harm than was previously known or recognized?
At a minimum the report should include the following:
- study title and project number;
- name of the principal investigator;
- description of the problem, situation, or incident, including specific changes to procedures in the approved research plan if applicable;
- assessment of why the event occurred;
- evaluation of potential effects (e.g., increased participant risk, reduced research benefits, or compromised research integrity);
- description of immediate changes to the protocol that were made in response to the situation;
- description of corrective actions that were implemented or that are proposed to ensure that similar events do not occur in the future;
- relevant materials or documents including sponsor assessments or reports; and
- the name of the individual reporting the event (unless the person reporting the problem prefers to remain anonymous).
Reporting Requirements for Multi-Site Research
When a University or affiliate investigator is involved in the conduct of a multi-center study, reporting requirements vary as follows:
- For problems that occur locally (i.e., at the investigator's institution), the PI must inform the University IRB of local situations or events that involve possible noncompliance, complaints, and unexpected, serious problems; and must inform the sponsor of local problems and adverse events as described in the clinical protocol or contract.
- The investigator must inform the University IRB and sponsor of her/his decision to suspend or terminate a research project at the local site.
- If a University or affiliate investigator is the lead PI or managing investigator for a multi-center study, she/he must inform the University IRB of possible noncompliance, complaints, and unexpected, serious problems that occurred at external sites.
- If the University or affiliate investigator is not the lead PI or managing investigator, she/he is not required to inform the University IRB of noncompliance or events that occurred at external sites unless these may constitute Unanticipated Problems.
NOTE: PIs are required to report sponsor assessments or notifications, or safety reports involving external serious adverse events that may be Unanticipated Problems; and all notifications of suspension or termination of a research project.
Reporting Requirements for Research Reviewed by an External IRB
For research in which the University accepts an external IRB as the Reviewing IRB, University and affiliate PIs must report complaints, potential noncompliance, Unanticipated Problems, and suspension or termination of a research project to the Reviewing IRB as required by that institution, and according to applicable regulations and laws.
If the Reviewing IRB determines an event, situation or problem constitutes serious or continuing noncompliance, or an Unanticipated Problem, within five business days of being notified of the Reviewing IRB's decision, the PI must submit a copy of the determination notification to the University IRB.
The PI must notify the University IRB within five business days of the Reviewing IRBs determination to suspend or terminate a research project.