Office of Research & Sponsored Programs

IRB Manual Noncompliance

Noncompliance

Non-compliance with IRB guidelines is a violation of UNI’s Federal Wide Assurance (FWA00002159) and federal regulations for the protection of human participants.  Any incident of serious or continuing non-compliance with IRB guidelines must be reported to the IRB Administrator or the Chair of the IRB immediately.  Incidents of non-compliance must be reported both to ensure the protection of the rights of human participants and to uphold UNI’s Assurance to the federal government. 

Definitions

Non-compliance is defined as significant failure by an investigator to abide by Federal, State, or University regulations governing the protection of human participants in research, including the requirements or determinations of the IRB.

Serious Noncompliance. 

Serious non-compliance is defined as an action that potentially places participants at more than minimal risk and involves deliberate disregard for the regulations or the determinations of the IRB.  Examples may include, but are not limited to:

  • beginning or continuing more than minimal risk research without IRB approval;
  • serious misuse or non-use of approved consent forms;
  • failure to secure IRB approval before introducing changes in an on-going protocol, when those changes potentially constitute more than minimal risk to the participants;
  • not reporting Adverse Events or Unanticipated Problems consistent with UNI policy (see Reporting Problems)

Continuing Noncompliance. In the event that an investigator engages in multiple occurrences of any level of noncompliance (serious or otherwise) and the IRB believes that the noncompliance involves deliberate disregard for IRB regulations, that will constitute Continuing noncompliance. 

Federal regulations require that instances of serious or continuing noncompliance be reported to the Office of Human Research Protections (OHRP).  Sponsors, administrators, and others may also be notified.  Noncompliance involving no or minimal risk to participants or first occurrences that are believed to be the result of ignorance or misinterpretation of the IRB regulations will not result in a report to OHRP, although other sanctions or requirements for education may be applied.  Examples include: 

  • not submitting Continuing Review/Project Closure form as a final report on the study;
  • failure to secure IRB approval before beginning research or introducing protocol changes, when those changes constitute minimal or no risk to the participants.

OHRP does not require reporting on Exempt projects, but the IRB may choose to do so, depending on the circumstances. 

Procedures for Monitoring and Addressing Noncompliance

All faculty, staff, students, and administrators are responsible for supporting the ethical conduct of research involving human participants at UNI.  This includes reporting possible noncompliance promptly to the IRB Chair or IRB Administrator so that it can be addressed, and educational and other corrective actions taken, if needed.  In addition, IRB members and staff monitor the research that goes on at UNI, including the day to day conduct of research as well as the reporting and dissemination of results.  If a question arises as to whether a particular project was reviewed by the IRB or whether particular procedures were approved, the IRB Administrator informally inquires about it, as necessary, and reports any unresolved questions to the Chair.  A letter or email describing the IRB’s concern is then prepared by the IRB Chair and/or IRB Administrator offering the investigator an opportunity to respond via email, in writing, at an informal conference, or at an IRB meeting, and specifying a time period within which the response must be provided.  If the investigator offers a timely and satisfactory explanation for the concern, the process will be terminated and the researcher will be notified in writing.  If the investigator offers an explanation that fails to satisfy the complaint, or if the investigator fails to respond within the specified time period, the IRB Chair, in consultation with the IRB Administrator, will make a determination of whether the action appears to have involved deliberate disregard or lack of knowledge/awareness and whether the noncompliance is Serious and/or Continuing.  Consideration will be given to the length of time the individual has been engaged in research, the extent and nature of previous involvement with the IRB, and any previous communications with the IRB.  If a consensus determination cannot be reached, the matter will be discussed and voted on by the full IRB.  All instances of noncompliance will be kept confidential, except when reporting within the University, OHRP, and/or sponsors is necessary. 

Possible Actions by the IRB

Federal regulations (45 CFR 46.113) provide the IRB with the authority to suspend or terminate approval of research that is not being conducted in accordance with IRB requirements.  Depending upon the nature and seriousness of the non-compliance activity, the IRB may take the following actions: 

  1. Require a response from the investigator with a plan for corrective actions
  2. Require the investigator to complete additional human participants protection training
  3. Initiate audits of the active protocols
  4. Require that research participants previously enrolled in the study be contacted and provided with additional information and/or re-consented
  5. Suspend or terminate the study
  6. Freeze sponsored research grant account
  7. Determine that data collected during non-compliance cannot be used for publication
  8. Require that data collected during non-compliance be destroyed
  9. Require that a statement be included with all publications or research reports indicating that the research was not approved by the IRB
  10. Report to the sponsor, university officials, and governmental agencies, (e.g., NIH, OHRP)
  11. Disqualify the investigator from conducting research involving human participants at the university.

As noted above, the IRB is required by Federal Regulations to report incidents of Serious or Continuing noncompliance to the Office of Human Research Protections (OHRP), and in some cases, to the research sponsor.   Initial reports to OHRP will be made as soon as possible, and at least within 4 weeks of the IRB making a determination as to the nature of the concern.  

In the case of serious or continuing non-compliance, the IRB and the University will address the question of the investigator's qualifications to conduct human participant research. The IRB will also take remedial action, as necessary, regarding the welfare of the participants and the research data gathered in non-compliance. Further, the IRB may refer instances of Serious or Continuing non-compliance to the Department Chair, Dean, and Provost who may decide whether to impose disciplinary sanctions.  Non-compliance may also be referred to the UNI Research Integrity Officer if it involves potential violations of the institutional policy on research misconduct.  The distinction between remedial action taken by the IRB and disciplinary action taken by an administrator is: Remedial action is action that the IRB takes or may require on behalf of present or future human participants in research.  Disciplinary action, in this context, is a penalty imposed by administrators on an investigator for non-compliance with human subjects or related research regulations.

 

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