700-33-Non-Compliance and Research Misconduct

Title:	Non-Compliance and Research Misconduct
Owner:	IRB
Last Update/Revised:	05/01/2024

Policy: It is the policy of the USU IRB to address both allegations and confirmed reports of any noncompliance in accordance with 45 CFR Part 46 and 21 CFR Part 50, the policies, requirements, and determinations of the IRB. This policy applies to the research investigative team, the IRB members and alternates, and IRB staff. Members of the USU community must report apparent non-compliance to the IRB. The determination that non-compliance is serious or continuing rests with the IRB.

The terms used in this policy are defined as follows:

Non-Compliance - Failure to abide by the policies, requirements, and determination of the IRB, or federal rules and regulations.

Serious Non-Compliance - An act or omission to act that resulted in significant harm (physical, psychological, safety, or privacy) or significantly increased the possibility of harm to the rights and welfare of research participants.

Continuing Non-Compliance - A pattern of repeated actions or omissions to act that suggests a future likelihood of recurrence and that indicate a deficiency in the ability or willingness to comply with federal regulations or the policy, requirements, and determinations of the IRB governing human subject research.

Allegation - An assertion made by a party that must be proved or supported with evidence.

Confirmed Report - Alleged non–compliance or research misconduct which in the judgment of the IRB Chair is factual.

Research Misconduct - Any fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or reporting research results. Instances meeting the definition of research misconduct will be reported to the Provost by the IRB Chair. Attempts to unduly influence an IRB member or IRB staff is not considered research misconduct under federal or USU policy. However, this is considered a violation of USU IRB policy. IRB members or staff members who believe that they have been subject to undue influence must report this to the Provost or IRB Chair. The IRB Chair will report all allegations of undue influence to the Provost, who will coordinate the inquiry, investigation and hearing phases as needed.

Purpose: The purpose of this policy is to describe how allegations of non-compliance and research misconduct are handled.

Procedures:

Procedures for Addressing Allegations of Non-Compliance or Research Misconduct
1. The IRB Chair conducts a pre-inquiry review for preliminary informal checking of the facts to determine if there is a reasonable basis for the allegation and if the evidence can support or prove the allegation.
  1. If the IRB Chair determines the allegation not to be a credible confirmed report of non-compliance or research misconduct by definition, the inquiry stops and no further action is taken.
  2. If the IRB Chair determines the allegation to be a credible, confirmed report of non-compliance or research misconduct by definition, the inquiry proceeds as outlined in this policy. At this point, the allegation is considered a confirmed report by definition.
Procedures for Addressing Confirmed Reports of Non-Compliance or Research Misconduct
1. If the IRB Chair determines that the confirmed report of non-compliance is neither serious nor continuing non-compliance, as defined by this policy, the IRB Chair considers, but is not limited to, the following actions:
  1. Acknowledgement of the problems, requiring no sanctions but with instructions regarding the necessity to establish procedures and policies to avoid further infractions
  2. Require additional education and training applicable to human research participant protections of the investigator and/or staff
  3. Request a corrective action plan from the investigator
  4. Approve the submitted corrective action plan
  5. No further action
2. If the IRB Chair determines that the confirmed report of non-compliance might represent either serious or continuing non-compliance, as defined by this policy, the confirmed report of non-compliance is sent to the Provost.
  1. If the IRB Chair and Provost determine the confirmed report of noncompliance does not represent serious or continuing non-compliance nor represent serious or continuing non-compliance as defined in this policy, then see item 2.a. above.
  2. If the IRB Chair and Provost determine that the confirmed report of non-compliance represents serious non-compliance and/or continuing non-compliance, as defined by this policy, or determines confirmation of research misconduct, the IRB Chair refers the confirmed report to the convened IRB. When issues of non-compliance or research misconduct are reviewed by the convened IRB, the documents listed below are prepared, if they apply, and made available to all members of the convened IRB for review three working days prior to the meeting, via the IRB Google Drive. All IRB members are expected to review the information and be prepared to discuss it at the meeting.
    - The current IRB Review Form
    - The Informed Consent Document
    - The confirmed report of non-compliance
    - The investigative report, including a list of witnesses and documents reviewed
    - Previous reports of non-compliance or research misconduct and the past record of the investigator and his/her team
    - The evaluation of the confirmed report of non-compliance or research misconduct by the IRB Chair
    - All additional pertinent documents or portions thereof (e.g., primary data)
  3. The IRB Chair assigns a primary reviewer based on scientific expertise to perform an in-depth review of the documents. The primary reviewer will present their findings. The primary reviewer and the IRB Chair will lead the discussion during the convened IRB meeting. The convened IRB votes on whether the confirmed report of non-compliance represents serious non-compliance and/or continuing non-compliance as defined by this policy or confirms research misconduct. The discussion, rationale for any action, and vote are recorded in the minutes.
    1. If the convened IRB determines that the confirmed report of non-compliance is neither serious non-compliance nor continuing non-compliance, or research misconduct did not occur, as defined by this policy, the IRB considers but is not limited to the actions:
    - Acknowledgement of the problems, requiring no sanctions but with instructions regarding the necessity to establish procedures and policies to avoid further infractions
    - Require additional education and training applicable to human research participant protections of the investigator and/or staff
    - Request a corrective action plan from the investigator
    - Approve the submitted corrective action plan
    - No further action
    2. If the convened IRB determines the confirmed report of non-compliance represents serious non-compliance and/or continuing non-compliance, or research misconduct did occur, as defined by this policy, the IRB considers but is not limited to the following actions:
  - Verification that participant selection is appropriate
  - Observation of the research and the informed consent process by an IRB administrator
  - Modifications of the protocol
  - Request an increase in monitoring of the research activity via an independent data safety monitor or board
  - Safety intervention as necessary such as visits to the activity site and continuing evaluation of the site by an IRB staff member
  - Request audit and progress reports from the sponsor monitor
  - Request a directed audit of targeted areas of concern by an IRB staff member
  - Request a status report after each participant receives intervention from the investigator
  - Modify the frequency of the continuing review cycle
  - Request additional investigator and staff education focused on human research protections from appropriate available sources (e.g., OHRP conferences, NIH tutorial, human research protections seminars)
  - Notify current subjects, if the information about the non-compliance might affect their willingness to continue participation
  - Provide additional information to past participants
  - Suspend IRB approval of the respective study pending a written plan for the correction and /or prevention of the non-compliance
  - Remove the investigator of the research study
  - Suspend or terminate some or all of the research study and possibly other studies being conducted by the investigator as well (See 700-34: Administrative Hold, Suspension, and Termination of Research and 700-35: Institutional Reporting Procedures)
  - If the investigator is an employee, recommend to the Human Resource Department suspension or termination
  - If the investigator is a student, recommend to the Dean or designee suspension or termination

Scope: The policy applies to allegations of non-compliance or research misconduct.

Documents and Forms:

None