705. Assessment of Complaints and Problems in Research

Updated Oct. 4, 2019

Assessment and Disposition of Complaints

The Research Integrity (RI) may receive complaints, concerns, or comments from current or past research participants, interested family members, members of the community, or others by telephone or through the Contact the Research Integrity form available from the Contact Us page of the RI website. Phone calls involving complaints are forwarded to the RI Director and she/he receives an email notification each time a Contact RI form is submitted.

The RI Director responds to complaints within one business day of receipt. She/he will answer the caller’s/respondent’s questions or may request more information from the caller/respondent. Benign matters are generally resolved quickly by the Director.

Following her/his communication with the caller/respondent, if the Director determines further action is warranted (e.g., complaint requires PI involvement or further assessment) she/he refers the complaint to the RI Research Compliance Officer (RCO) and/or the IRB Chair for additional assessment and possible investigation as described below.

Research Compliance Officer Assessment

The RI RCO assesses and when warranted coordinates reviews of all complaints and problem reports. Within five working days of receipt of a complaint/problem report (or within 48 hours of receipt if the complaint/report indicates participants may be at imminent risk of harm), the RCO or, in the absence of the RCO, the RI Director or IRB Chair, or delegate, will

  • assess the information provided;
  • provide a summary to the RI 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.

If it is determined that the matter may be more appropriately handled by another unit or department, the Director or Chair may suggest immediate referral or may give the RCO permission to investigate the matter before involving other parties.

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 consultations 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

The RCO, RI Director or IRB Chair may conclude that further investigation is warranted before making a 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

Following the assessment and agreement of the RI Director or IRB Chair that further investigation is warranted, the RCO or other experienced designee will proceed. The principal investigator (PI) will be notified in writing of the impending investigation and asked to cooperate fully by answering questions,  providing access to research records, and identifying research team members (as applicable).

Recommended Actions

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

Dismissal of the Problem as an Unjustified Claim of Noncompliance

If the RCO, RI Director, or IRB Chair or designee discern that an allegation or complaint of noncompliance 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 RI Director 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 RI Director, 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 RI Director, 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 may be more appropriately handled by another University unit or department, the Director or IRB Chair may suggest immediate referral to the other entity or may give the RCO permission to investigate the matter before involving other parties. 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.