700. Reporting Complaints or Problems
Situations may occur during implementation of a research study, after a participant withdraws or completes her/his participation, or after study completion that warrant assessment by the Research Integrity Office (RIO) and possibly, review by the IRB. These include complaints from participants or others, unapproved changes in the conduct of a research study, serious events or problems experienced by research participants, new information that suggests research risks or benefits have changed, breaches of participant privacy or data confidentiality, and sponsor or other external reports that suggest a problem may exist.
Individuals may report complaints or concerns about a research project by contacting the RIO or a specific RIO staff member either by phone or electronically, by using the Contact the Research Integrity Office form available from the Contact Us page of the RIO website. Callers may remain anonymous and the form may be submitted anonymously (e.g., by sending a printed paper copy of the completed form to the RIO) or by omitting contact information from the online reporting form.
Researchers or others who learn of problem or situation (including a complaint from a participant or others) or who receive 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. Researchers are advised to use the problem reporting form (available in the IRBNet Researcher Libraries or from the Forms page of the RIO website).
*Researchers or others involved in exempt research are advised to contact the RIO to discuss problems that may have occurred.
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.
All complaints and reports, regardless of source, are assessed 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 as described in IRB policy for assessment of complaints and problems.
Sources of Complaints or Problems
Complaints/problems may come to the attention of the RIO or the IRB from a variety of sources, including but not limited to:
- Members of the research team
- Participants or their family members
- Members of the community
- 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
Overview of Problem Reporting Form
Protocol change encompasses accidental or unintentional changes to the IRB-approved plan for non-exempt research.
Protocol deviation or violation is any unplanned departure from study procedures or treatment plans as specified in the IRB-approved protocol; generally involves a single participant. The University categorizes deviations/violations as major or minor (or administrative) and requires different reporting procedures for each.
Major Deviations/Violations: Reporting Requirements and Examples
A deviation/violation is considered major when it may affect the safety of an individual participant or substantially alter participant risks. Major deviations/violations must be reported to the IRB within five business days of its discovery or commission. Examples of major deviations/violations include the following:
- enrolling a participant who did not meet the all inclusion/exclusion criteria;
- failing to obtain informed consent prior to initiation of study procedures;
- performing a study procedure not approved by the IRB;
- failing to perform a required lab test;
- dispensing or dosing error for study medication/drug;
- conducting a study visit outside of the required timeframe when doing so may affect participant safety;
- failing to report unanticipated problems/adverse events involving risk to participants to the IRB and sponsor (if applicable); and
- failing to follow safety monitoring plan.
Minor/Administrative Deviations/Violations: Reporting Requirements and Examples
A deviation/violation is considered minor/administrative when it does not affect the scientific soundness of the research plan, or the rights, safety, or welfare of research participants. Examples of minor/administrative deviations/violations include the following:
- implementing unapproved recruitment procedures (as long as these are not unduly influential or coercive);
- allowing an unauthorized person to obtain informed consent;
- failing to document informed consent (e.g., signatures missing, copy not provided to participant, person obtaining consent not identified in protocol as one who will obtain consent);
- using outdated or unapproved version of the consent form when the use does not affect participant safety;
- failing to provide participant with a copy of the consent form;
- missing or incomplete original signed/dated consent form in study records;
- failing to implement an approved study procedure when the omission does not affect participant safety; and
- exceeding approved enrollment numbers (as long as study resources are sufficient to protect all research participants).
Local death includes any death that occurred at the local site that was both unanticipated and related to the research. NOTE: Local deaths that are not both unanticipated and related to the research are not reported individually. Instead, these are reported in aggregate form at continuing review.
Local adverse event or problem includes any untoward medical event or problem that occurred at the local site and was both unanticipated and related to the research. NOTE: Requirements for reporting SAEs to the sponsor may differ. NOTE: Local serious adverse events/problems that are not both unanticipated and related to the research are not reported individually. Instead, these are reported in aggregate form at continuing review. Similarly, external serious adverse events, unless these may constitute noncompliance or an unanticipated problem are not reported individually but are reported in aggregate form at continuing review.
Local adverse device effect includes any unanticipated serious adverse effect on health or safety, life-threatening problem or death, or other serious problem that relates to the rights, safety, or welfare of research participants that is caused by or associated with the investigational device and that occurred at the local site. NOTE: Local serious adverse device effects that are not both unanticipated and related to the research are not reported individually. Instead, these are reported in aggregate form at continuing review.
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.
New or additional risks include 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 risks) include 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. For multi-center trials, these may be reported by the sponsor or data safety monitoring board or committee.
Changes to expected benefits include findings that indicate research benefits may be accruing with less frequency or with less affect than was initially presented to the IRB. (Decreases in the expected rates or strength of research benefits warrant reporting because IRB approval was based on a projected relationship of risks and benefits.)
Sponsor includes any sponsor notification of suspension or termination of a research activity or project. Upon receipt of such notification, researchers must immediately suspend or terminate the research as requested by the sponsor, and promptly notify the IRB of the suspension/termination and grounds for same.
FDA changes applies to any change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in the research.
Federal agency includes any report from or investigation by a federal agency when the report/investigation is related to the research.
Department of Health applies to any non-compliance identified by an audit or monitoring completed by a local or state health department.
Licensing, certification, or practice changes applies to any loss of license or certification, or hospital or practice privileges by any researcher on the study.
Privacy includes any possible or actual unauthorized disclosure of a participant's involvement in a research project or of her/his personal information.
Confidentiality includes any possible or actual unauthorized disclosure of research data, including lost or stolen research records.
Complaints includes any complaints or concerns about a research study whether from participants, members of the research team, or others.
Prisoner applies to the incarceration of a participant in a research project that is not approved to enroll prisoners.
Other problems applies to situations or outcomes that may affect research participants or others, or the conduct of the research that do not align with one of the available categories (e.g., 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 complaints from participants or others, local situations or events that involve possible noncompliance, and unexpected and related or possibly related serious adverse events or problems. PIs must inform the sponsor of complaints and 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 external (i.e., occurring at other sites) complaints from participants or others, possible noncompliance, and unexpected and related or possibly related serious adverse events.
- 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 IRB of Record (AKA: 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 the external institution, and according to applicable regulations and laws.
If the IRB of Record 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 IRB's determination to suspend or terminate a research project.