700. Reporting Complaints and Problems in Research

Updated Oct. 4, 2019

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 Research Integrity (RI) 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.

Anyone (i.e., participants, members of the community, principal investigators, research staff, employees, or IRB members) may report complaints, potential noncompliance, or concerns related to a research project by contacting RI or a specific RI staff member either by phone or email; or electronically, by using the Contact Research Integrity form available from the Contact Us page of the RI 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 RI or by omitting contact information from the online reporting form).

For non-exempt research (including Humanitarian Device Exemption), principal investigators, research or RI staff, IRB members, or other employees must notify the IRB within five business days of learning of a complaint, deviation, potential noncompliance, or problem; or within 48 hours if the problem may be life-threatening or fatal. Reporting requirements also apply to individuals who receive external reports or notifications. Researchers are advised to use the appropriate Reportable Event Form, available in the IRBNet Researcher Library. Others may contact RI or complete the Contact Research Integrity form available from the Contact Us page of the RI website.

For exempt research, researchers or others who know of a complaint or problem are advised to contact RI 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.

Regardless of source (see below), all complaints, deviations, potential noncompliance, and problems are assessed by the University’s Research Integrity (RI) Research Compliance Officer (RCO), RI Director, or IRB Chair or designee in a consistent, prompt, and professional manner as described in the IRB policy for assessment of complaints and problems in research.

Sources of Complaints, Potential Noncompliance, or Problems

Complaints/problems may come to the attention of RI 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

Suggested Content for Reporting Problems to the IRB

Individuals reporting problems to the IRB must provide sufficient information for RI 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 Forms

Investigators are advised to use the appropriate Reportable Event Form to report problems in research. For more information on reportable events, see policies for Protocol Deviations and Unanticipated Problems.

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 unanticipated problems involving risks to participants or others. 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.
  • PIs are required to report sponsor assessments or notifications, or safety reports involving external adverse events that may be unanticipated problems involving risks to participants or others; and all notifications of suspension or termination of a research project.
  • 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 unanticipated problems involving risks to participants or others. If the University or affiliate investigator is not the lead PI or managing investigator, and University of Nevada, Reno is in the position as a relying institution, she/he will promptly notify Overall PI, Site Investigator(s), and Relying Institution(s) of any findings of serious and/or continuing noncompliance. The Reviewing IRB will also notify the Overall PI, Site Investigator(s), and Relying Institution(s) of any suspension or termination of IRB approval and any remediation actions pertaining to findings of serious and/or continuing noncompliance at any other institution if such finding or actions relate to or may affect the conduct of the Research or the safety, rights, or welfare of human subjects participating in the Research at the Relying Institution(s). The Reviewing IRB shall inform the Relying Institution of any corrective actions in connection with the audit, investigation, or resolution of any matter that are required by the Reviewing IRB but shall not prevent the Relying Institution from adopting its own more stringent additional corrective actions.