Section VIII:

Review Types

WPP #: VIII-9

Title 9:

Investigations of General, Serious or Continuing Noncompliance

Effective Date:

9-12-18

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; 9-21-17

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. Serious noncompliance and continuing noncompliance are findings that are determined by the convened IRB Panel. The VCU ORSP reports serious and continuous noncompliance determinations that occur at internal research settings under the VCU IRB’s oversight in accordance with the requirements of federal oversight agencies (i.e. OHRP, appropriate institutional officials, and other applicable departments or agencies) and following the procedures outlined in WPP VII-4.

Definitions

  1. Noncompliance

    Failure on the part of the Principal Investigator or any member of the research team to follow:

    • the terms of the VCU IRB approval (outlined in IRB initial and continuing review approval letters and in WPP X-1);
    • applicable laws, regulations; AND/OR
    • VCU policies related to the conduct of research involving human subjects

    General noncompliance is a term that refers to noncompliance that is neither serious nor continuing.

  2. Serious Noncompliance

    Noncompliance that

    • presents actual or potential increased risk to subjects;
    • adversely affects the rights, welfare, or safety of subjects; AND/OR
    • adversely affects the scientific integrity of the study.

  3. Continuing Noncompliance

    Noncompliance that

    • is repeated either on a single protocol, or across multiple protocols under an individual investigator, AND/OR
    • represents 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.

    Examples of noncompliance may include, but are not limited to: (Note that these examples could constitute serious or continuing noncompliance based on the circumstances of the event)

    • Failure to obtain an institutional exempt determination prior to beginning exempt research;
    • Continuing research activities beyond study expiration date or during protocol suspension;
    • Failure to conduct the research as described in and required by the Protocol.
    • Over-enrollment - Enrolling more subjects in a study than were 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;
    • Not following IRB approved informed consent procedures (e.g., using unapproved or outdated consent document(s), missing signatures, failing to document consent process as required).

    Examples of serious or continuing noncompliance may 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/assent/parental permission 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 deviations that adversely affect the integrity of the research.

Procedures and Guidance

  1. Evaluations and Investigations of Potential Noncompliance

    Identification of Potential Noncompliance: Noncompliance may be found or alleged in a number of ways, including but not limited to:

    • evidence based on materials submitted to the IRB;
    • as an Unanticipated Problem involving risks to subjects or others;
    • during post-approval monitoring visits; or
    • 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 evaluated and 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 they constitute an unanticipated problem and whether 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. All reports of noncompliance should also be evaluated to determine if the criteria for an unanticipated problem involving risk to subjects or others are met. See WPP VII-6.

    Outcomes of Fact Finding and Initial Evaluation: Possible outcomes of the fact finding may include:

    • Dismissal of an unsubstantiated allegation;
    • Referral to the convened IRB if the problem may involve 1) serious and/or continuing noncompliance or 2) meets the definition of being an unanticipated problem (See WPP VII-6);
    • Referral to other appropriate university processes (e.g., misconduct investigation).
    • Determination of noncompliance with or without corrective actions required
    • Examples of possible actions that may be imposed by the IRB Chair/IRB reviewer in response to a determination of noncompliance that is neither serious nor continuing could include, but are not limited to:

      • Study specific corrective action(s)
      • Education of the investigator(s) and research team
      • Modification to the protocol and/or other study documents
      • Require that subjects be re-contacted and provided with updated information or re-consented
      • Notification of current subjects when such information may relate to subjects’ willingness to continue participating in the research
      • Request post-approval monitoring of the research
  2. Convened IRB Review of Potential Noncompliance

    All events that may involve serious or continuing noncompliance will be referred to the convened IRB. All members of the IRB at the convened meeting will be provided with submission documentation pertaining to the problem (e.g. a written summary of the noncompliance, the outcome, and any steps taken to prevent recurrence). The IRB (or Principal Investigator) may request the Principal Investigator’s presence at the convened Panel meeting in order to provide clarifications. During their review, the IRB should determine whether the problem constitutes serious and/or continuing noncompliance, based on the definitions provided in this policy.

  3. Corrective Actions

    The IRB will determine whether the investigator satisfactorily resolved the noncompliance, if applicable, and whether corrective actions are needed. If the noncompliance is determined to be neither ‘serious’ nor ‘continuing,’ the IRB may determine that general noncompliance has occurred and may require a corrective action plan.

    Possible actions imposed by the convened IRB in response to a determination of serious or continuing noncompliance may include, but are not limited to:

    • Study specific corrective action(s)
    • Education of the investigator(s) and research team
    • Modification to the protocol and/or other study documents
    • Require that subjects be re-contacted and provided with updated information or re-consented
    • Notification of current subjects when such information may relate to subjects’ willingness to continue participating in the research
    • Providing additional information to past subjects
    • 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 of the research
    • Require monitoring of the consent process
    • Enforce more frequent continuing review

    Note: The IRB cannot require the destruction of the research data set as this would contradict other institutional policies regarding data retention and ownership. However, such a requirement would be within the purview of other institutional officials and offices.

  4. Documentation and Reporting of Findings

    The Principal Investigator is notified of a noncompliance determination via a written letter. Findings of serious and/or continuing noncompliance are promptly reported to relevant regulatory agencies and distributed to other individuals and organizational officials according to the procedures in WPP VII-4.

References

VCU IRB WPP VII-6 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
VCU IRB WPP VII-4 Reporting to Regulatory Agencies