Section VIII:

Review Types

WPP #: VIII-9

Title 9:

Investigations of General, Serious or Continuing Noncompliance

Effective Date:

9-21-17

Revision History:

06-20-00; 07-26-00; 09-20-01; 06-07-04; 04-30-06; 06-21-06; 01-30-08; 04-22-14; 08-08-14; 06-23-15

Policy Statement

Investigators and researchers are required to comply with all ethical standards, institutional policies, governmental regulations, and conditions placed on the conduct of research involving human subjects. Failure to adhere to these requirements may constitute noncompliance. All instances of suspected noncompliance must be reported to the Office of Research Subjects Protection (ORSP) or the IRB. Noncompliance may be managed by the ORSP. Suspected serious or continuing noncompliance will be referred to the convened IRB for review. IRB determinations of serious or continuing noncompliance will be reported within 30 days to OHRP and/or FDA as required by 46 CFR 46.103(b)(5) and 21 CFR §56.108(b)(3)].

Procedures and Guidance

  1. Definitions

    Noncompliance: Failure on the part of the PI or any member of the research team to adhere to the terms of the VCU IRB approval and/or abide by applicable laws, regulations, or VCU policies related to the conduct of research involving human subjects. Examples of noncompliance may include, but are not limited to:

    • Failure to obtain an institutional exempt determination prior to beginning exempt research;
    • Continuing research activities beyond study expiration date or during protocol suspension;
    • Enrolling more subjects in a greater than minimal risk study than approved by the IRB;
    • Implementing changes to an expedited or full review protocol without prior IRB approval, unless the change is necessary to eliminate apparent immediate hazard to subjects; or
    • Violating IRB approved informed consent procedures (e.g., failing to obtain consent/assent, using unapproved or outdated consent document(s), missing signatures, failing to document consent process as required).

    Serious Noncompliance: Noncompliance that, in the judgment of the convened IRB, increases risk to subjects; adversely affects the rights, welfare, or safety of subjects, or adversely affects the scientific integrity of the study. Examples of noncompliance may be determined to be serious if the noncompliance increases risk or adversely affects the rights, welfare, or safety of subjects. Examples of problems that may constitute serious noncompliance include, but are not limited to:

    • Failure to obtain expedited or full review IRB approval prior to initiating human research activities;
    • Failure to obtain informed consent as required by the IRB approved protocol;
    • Failure to report unanticipated problems involving risk to subjects or others;
    • Enrolling subjects who do not meet eligibility criteria unless the exception was made in concurrence with a research sponsor;
    • Protocol violation that adversely affects the integrity of the research.

    Serious noncompliance is a finding that is determined by the convened IRB Panel.

    Continuing Noncompliance: repeated noncompliance by an individual investigator either on a single protocol or across multiple protocols, or a pattern of ongoing activities that indicate a lack of understanding of human research requirements that may affect research subjects or the validity of the research. Continuing noncompliance is a finding that is determined by the convened IRB.

  2. Evaluations and Investigations of Allegations of Noncompliance

    Identification of potential noncompliance: Noncompliance may be found or alleged in a number of ways, including but not limited to: 1) evidence based on materials submitted to the IRB; 2) as an Unanticipated Problem involving risks to subjects or others; 3) during post-approval monitoring visits; or 4) may be reported by a concerned individual to the ORSP, the IRB Chair, or the VCU Helpline (1-888-242-6022; www.vcuhelpline.com). Reasonable efforts will be taken to protect the confidentiality of any persons who allege non-compliance or file reports or grievances, as well as the confidentiality of the investigator and those involved in an investigative process.

    Initial evaluation by ORSP and/or IRB Chair/designee: Identification of problems that clearly constitute non-serious or not continuing noncompliance may be managed by ORSP staff or the IRB. Problems that may or may not constitute noncompliance may require input from IRB leadership and information gathering before a determination can be made. Problems that indicate significant risk or severity will be evaluated to determine if immediate actions are necessary to ensure the ongoing protection of research subjects.

    Fact Finding: If additional information is needed to make a noncompliance determination, the ORSP may initiate fact-finding activities, which may include reviewing study documentation or corresponding with the principal investigator and research personnel to determine whether the allegation is substantiated. The IRB Chair/ IRB reviewer(s) may participate with the ORSP as needed. Possible outcomes of the fact finding may include:

    • Dismissal of an unsubstantiated allegation;
    • Determination of noncompliance with or without corrective actions required; Refer to convened IRB if the problem may involve serious and/or continuing noncompliance;
    • Referral to other appropriate university processes (e.g., misconduct investigation).

    IRB review of noncompliance associated with an unanticipated problem report and of serious and/or continuing noncompliance:

    • All members of the IRB are provided with submission documentation pertaining to the problem.
    • The IRB (or PI) may request the PI’s presence at the convened Panel meeting in order to provide clarifications.
    • The IRB should determine whether the problem constitutes serious and/or continuing noncompliance based on the definitions provided.
    • The IRB will determine whether the investigator satisfactorily resolved the noncompliance, if applicable, and whether corrective actions are needed. Possible actions imposed by the IRB in response to a determination of serious or continuing noncompliance may include, but are not limited to:
      • Research study specific corrective action
      • Education of the investigator(s) and research team
      • Modification to the protocol or other study documents
      • Require that subjects be re-contacted and provided with updated information or re-consent subjects
      • Notification of current subjects when such information may relate to subjects’ willingness to continuing participating in the research
      • Providing additional information to past subjects
      • Limit or prohibit publication of data
      • Discarding data or samples associated with the noncompliance
      • Suspension or termination of the research
      • Letter of reprimand to the investigator, which may be copied to the department chair
      • Disqualify the investigator(s) from conducting research involving human subjects at VCU
      • Require periodic monitoring or auditing
      • Enforce more frequent continuing review
    • If the noncompliance is determined to be neither ‘serious’ or ‘continuing,’ the IRB may determine that noncompliance has occurred and may require a corrective action plan.
    • All reports of noncompliance should also be considered to determine if the criteria for an unanticipated problem involving risk to subjects or others are met. See WPP VIII-7: Unanticipated Problems Involving Risk to Subject or Others.

    Documentation and Reporting of Findings: The principal investigator is notified of a noncompliance determination via a letter. Findings of serious and/or continuing noncompliance are reported to relevant regulatory agencies within 30 days of the final determination, with copies sent to the principal investigator, IRB Chair, and Institutional Official.

References

VCU IRB WPP VIII-7 Required Reporting of Unanticipated Problems Involving Risk or Harm to Subjects or Others
VCU IRB WPP VIII-8 Suspensions and Terminations of Previously Approved Research