705. Assessment of Complaints and Problems in Research

Updated August 31, 2026

Assessment and Disposition of Complaints

The Research Integrity & Security office may receive complaints, concerns, allegations of misconduct, or comments (complaints) from current or past research participants, interested family members, members of the community, or others by telephone or through the Contact Research Integrity & Security form available from the Human Research homepage of the Research Integrity & Security website. Phone calls involving complaints are forwarded to the RCO; they also receive an email notification each time a Contact Research Integrity & Security form is submitted.

The RCO, or their designee if they are unavailable, will conduct an initial assessment of a complaint within one business day of receipt. If applicable, they will respond to the complainant’s questions or may request more information. Upon completion of the initial assessment of the complaint the RCO will make a written determination whether the complaint has merit and warrants further inquiry, or the complaint is without merit and no further action is warranted. If further inquiry is warranted, the RCO will investigate the matter as outlined in the Research Compliance Officer Assessment section below.

When a complaint is made against the HRPP Manager or staff, it will be referred to the Research Integrity & Security Director, rather than to the HRPP Manager. The Director will complete the initial assessment and, if warranted, refer the complaint to the Research Compliance Officer for further inquiry.

Confidentiality is of paramount importance when assessing or investigating complaints. Communication must be limited only to those who need to know. Documentation must be protected in a manner that is not accessible to those not involved in the assessment, investigation, or reporting of the complaint.

Research Compliance Officer Assessment

The Research Compliance Officer (RCO) will assess all complaints referred to them and, when warranted, coordinate investigations and reporting. In the absence of the RCO, the Research Integrity & Security Director will determine who will assess the complaint. Within five working days of receipt of a complaint (or within 48 hours of receipt if the complaint that indicates participants may be at imminent risk of harm), the RCO or other assigned investigator will:

  • assess the information provided;
  • provide a written summary of the assessment to the Research Integrity & Security Director and IRB Chair; and
  • recommend dismissal of the problem, immediate determination of minor noncompliance, evaluation for serious or continuing noncompliance or unanticipated problem involving risks to participants or others, or referral to another University or affiliate entity.

Assessment for Immediate Risk of Harm

For problem reports that indicate risk of harm to participants or others may be a consideration, those involved in the initial or subsequent assessments may determine that immediate corrective actions are needed to protect the participants or others and will make the necessary recommendations to mitigate such risks.

Further Investigation Warranted

Upon review of the RCO’s assessment report, Director and IRB Chair may conclude that further investigation by the RCO is warranted before making a final recommendation. During an investigation, the RCO may:

  • Review research records including IRB correspondence, IRB applications and forms, recruitment and consent documents, and study data
  • Review the sponsor protocol; investigator brochures; and drug/device labels, packaging, or inserts
  • Review grant documents and records, including accounts
  • Interview study personnel, responsible officials, support staff, and research participants

Further Investigation Warranted: Notification of PI

Prior to initiating an investigation, the RCO or other investigator will notify the PI in writing of the impending investigation and request their full cooperation by answering questions, providing access to research records, and identifying research team members (as applicable) who may have a role in the complaint. The requirement for confidentiality will be stressed, as will the University’s policy against retaliation of any kind against complainants or those involved in an investigation.

Recommended Actions

The assessment, with or without further investigation, will result in one of the following actions.

Dismissal of the Problem as an Unjustified Claim of Noncompliance

When the RCO or HRPP Manager determines a complaint is without merit, the matter will be dismissed without further inquiry. The decision will be noted in the protocol file. Where appropriate, the PI will be notified in writing.

Dismissal of the Problem as Not Meeting the Criteria for an Unanticipated Problem Involving Risks to Participants or Others

Those involved in the assessment may determine that a problem did not involve noncompliance or meet the criteria for an unanticipated problem involving risks to participants or others (henceforth known as Unanticipated Problem). In this case, the matter will be dismissed and the PI will be informed of the dismissal.

The three criteria for an event or situation to constitute an Unanticipated Problem are:

  1. The problem or event was unexpected;
  2. The problem or event was related or possibly related to the research, or use of an investigational drug or device;
  3. The problem or event may involve greater risks to participants or others than was previously known or recognized.

Determination of Minor Noncompliance

If the initial assessment or investigation indicates the situation involves minor noncompliance, the matter may be resolved by the HRPP Manager or IRB Chair. See noncompliance policy for details.

Determination of Potential Serious or Continuing Noncompliance

If the investigation suggests that the incident may constitute serious or continuing noncompliance, the RCO, with confirmation from the IRB Chair or an appointed IRB sub-committee, will refer the matter for review by a fully convened IRB. The RCO will notify the PI and the Responsible Official of pending IRB review. See noncompliance policy for information about IRB review and assessment.

Determination of Potential Unanticipated Problem

If the investigation suggests that the situation or event may meet the three criteria for an unanticipated problem involving risks to participants or others, the RCO, with confirmation from the IRB Chair or an appointed IRB sub-committee, will refer the matter for review by a fully convened IRB at the next scheduled meeting. The RCO will notify the PI and the Responsible Official of pending IRB review. See unanticipated problem policy for information about assessment of the criteria and IRB review of Unanticipated Problems.

Referral of the Situation to More Appropriate Authority

If it is determined that the matter should be handled by another University unit or department, the Director will facilitate immediate referral to the other entity. For example, the initial assessment or further investigation indicates that the allegation or complaint may violate other University policies, such as academic misconduct or financial mismanagement. The PI will be notified of the referral. If the situation involves potential violations of both IRB policies and other institutional policies, the Director will facilitate concurrent reviews by the RCO and other relevant units.