Noncompliance

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 Distinguishing Regulatory Noncompliance from Scientific Misconduct
 Definitions
 Policy Statement
 Operating Procedures for Resolving Allegations of Regulatory Noncompliance

Distinguishing Regulatory Noncompliance from Scientific Misconduct

When an allegation of inappropriate conduct of research or scholarship is made, it is the responsibility of the Institutional Official or designee(s) to determine whether to pursue the matter as an incident of regulatory noncompliance and/or scientific misconduct.

Through the process of investigating and attempting to resolve an incident originally regarded as regulatory noncompliance, new information may be revealed that suggests re-classification as possible scientific misconduct.

Examples of regulatory noncompliance and scientific misconduct are provided below. In the event a clear determination cannot be made, the Institutional Official will be consulted.

Regulatory Noncompliance*

  • Failure to obtain/maintain approval for research
  • Failure to obtain informed consent when required
  • Failure to file adverse event reports
  • Performing an unapproved procedure
  • Performing research at an unapproved site
  • Failure to file protocol modifications
  • Failure to adhere to an approved protocol.
  • Any other failure to adhere to regulations, policies, procedures, or special conditions related to research

*Note: Noncompliance is typically due to poor procedural control. Any of the above items, if done willfully or maliciously, shall be considered scientific misconduct and reported to the Provost and Associate Dean for Research.

Scientific Misconduct

  • Plagiarism, such as misrepresentation of authorship and/or misappropriation of data
  • Fabrication and/or falsification of data
  • Other material deviations from accepted scientific practices such as obstruction of another’s research, deliberate violations of confidentiality, and willful deception or omission

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Definitions

Scientific Misconduct means fabrication, falsification, plagiarism, or other practices that materially deviate from those that are commonly accepted within the academic community for proposing, performing, or reviewing research, or reporting research results. Misconduct does not include honest error or honest differences in interpretations or judgments of data. Allegations of scientific misconduct should be reported to the Provost and Associate Dean for Research for conduct of an inquiry in accordance with our scientific misconduct policy. UT Southwestern Medical Center’s scientific misconduct policy (available on MyUTSW, the campus intranet) is consistent with that of the Office of Research Integrity and 42CFR Parts 50 and 93.

Regulatory Noncompliance is all other research-related violations that are not scientific misconduct.

UT Southwestern personnel, for the purposes of this policy, are students, staff, faculty (including part-time, emeritus, and volunteer faculty), or any other UTSW agents who conduct research requiring University oversight.

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Policy Statement

In order to demonstrate appropriate oversight of research activities and to comply with federal and state statutes, regulations, policies, and guidelines, the Institutional Review Board (IRB) will investigate all allegations of regulatory noncompliance. The IRB will strive to achieve informal resolution of noncompliance issues with the cooperation of the Investigator, when appropriate.

When an allegation of noncompliance cannot be resolved informally, the IRB has the authority to impose sanctions and to recommend additional sanctions to the Institutional Official. The IRB may temporarily halt, suspend approval, or terminate a research protocol at any time during the review process.

Operating Procedures for Resolving Allegations of Regulatory Noncompliance

Step 1 – Administrative Audit (“For Cause”)
The purpose of an Administrative Audit is to determine whether the allegation of regulatory noncompliance can be substantiated and whether it requires further review. An Administrative Audit is initiated when an allegation is received from a complainant, when deemed by the Institutional Official or an IRB Chair that a review is necessary, or when informal or formal routine (not-for-cause) post-approval monitoring activities reveal potential regulatory noncompliance.

Administrative Audits are conducted by the IRB staff in consultation with the IRB Chairs. An Administrative Audit may include review of files, literature, and documents from the Investigator and others, which could serve to validate or dismiss the allegation. When an Administrative Audit reveals information that appears to substantiate an allegation of noncompliance with policies or regulations, an IRB Chair is consulted for further action. All efforts will be made to resolve the matter informally.

Possible outcomes of an Administrative Audit are:

  • Dismiss the allegation
  • Achieve compliance with the cooperation of the Investigator (and report to the appropriate regulatory oversight committee and/or federal agency when required)
  • Recommend further review by the IRB
  • Recommend reclassification as possible scientific misconduct

The results of an Administrative Audit will be communicated by the IRB staff in writing to the Investigator (with a copy to the chair of the IRB) within 30 days of the commencement of the audit. This communication will either: notify the Investigator that the audit did not reveal any noncompliance, confirm that compliance was achieved, inform the Investigator that further IRB review was recommended, or apprise the Investigator that the incident may be investigated as a matter of scientific misconduct. In cases where the IRB finds that further review is necessary, or when the allegation is reclassified as potential scientific misconduct, the Investigator’s Department Chair and the Institutional Official will be copied on this communication.

In cases where the result of an Administrative Audit suggests that an Investigator has demonstrated an apparent pattern of disregard for research regulations, policies, or procedures, further IRB review may be recommended even when the specific finding of noncompliance is resolved informally.

Step 2 – IRB Review
A formal IRB Review is initiated after a completed Administrative Audit suggests that: 

  • An incident of noncompliance appears to have occurred and when informal resolution was not achieved.
  • Informal resolution is achieved, but it has been determined that the Investigator has engaged in a pattern of disregard for research regulations, policies, or procedures. 

IRB Reviews may be conducted by full boards or by subcommittees charged by an IRB Chair. Whenever possible, the result of an IRB Review will be informal resolution. Such reviews may include: review of files, literature, and other documents; requests for additional information from and/or interviews with the Investigator, complainant or others, and review of other documents which could serve to validate or dismiss the allegation.

Possible outcomes of an IRB Review are:

  • Dismiss the allegation
  • Achieve compliance with the cooperation of the Investigator (and report to the appropriate federal agency when required)
  • Impose sanctions to achieve compliance (and report to the appropriate federal agency when required)
  • Recommend reclassification as possible scientific misconduct

The results of an IRB Review will be communicated by the IRB Chair in writing to the Investigator (with a copy to the appropriate protocol file) within 60 days of commencement of the review. This communication will either: notify the Investigator that the allegation was dismissed, confirm that compliance was achieved, inform the Investigator of recommended sanctions, or apprise the Investigator that the incident may be investigated as a matter of scientific misconduct. If sanctions are recommended or if a report to an external agency (such as OHRP or FDA) is required, a copy of the results of the review will also be sent to the Institutional Official and the Investigator’s Department Chair. There also may be specific requirements to inform other IRBs, cooperative groups, sponsors, or law enforcement agencies.

Step 3 – Sanctions for Regulatory Noncompliance
Whenever possible, IRB staff will assist Investigators with resolving noncompliance issues informally. In cases where cooperation does not occur or when it is determined that subjects and/or the institution have been placed at risk, sanctions may be imposed by the IRB.

Possible IRB sanctions include, but are not limited to:

  • Requiring more frequent review of an Investigator’s research activities
  • Requiring addition of a Faculty Sponsor to an Investigator’s protocol(s)
  • Suspending research activities until compliance is achieved
  • Terminating committee approval for research activities

The IRB may also recommend additional sanctions to the Institutional Official.

Possible sanction recommendations include:

  • Research privilege probation
  • Suspension of research privileges
  • Termination of research privileges
  • Embargo of publications

Questions about this Noncompliance Policy may be directed to the IRB Office by emailing irb@utsouthwestern.edu.

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