SOP H106: Sanctions and Noncompliance

Noncompliance occurs when research involving human participants is conducted in a manner that disregards or violates federal regulations, the policies or procedures of the Institutional Review Board (IRB), or institutional policies governing human research. Noncompliance with respect to human research participant protection violates the University Federalwide Assurance Registration (FWA). Even in the absence of intent, an unapproved or otherwise noncompliant research activity may place a research participant at unnecessary risk.

This policy sets forth the definition and examples of noncompliance; the procedures for reporting an allegation of noncompliance to the IRB; and the procedures for the IRB’s management of such allegations, and if appropriate, of confirmed noncompliance.

The purpose of sanctions initiated by the IRB against human subjects researchers:

• The use of sanctions is intended to promote compliance with federal and state laws and regulations, and with University System of Georgia and Georgia Southern University (GS) policies.  Actions based upon non-compliance by the IRB are not intended as punishment against any individual or group of human subjects researchers.

• The IRB has final authority and responsibility for approval of activities directly related to research conducted with human subjects by GS faculty, staff, and students.
• The IRB has authority to enact operational sanctions. (i.e., restrict research approvals, sequester data and mandate training.)
• The IRB has no authority to enact administrative sanctions but may make such recommendations to the Institutional Official.  (i.e, sanction of professional status or pay.)

Allegation: An assertion in the form of a complaint, concern or inquiry made by a party which has not yet been proven or supported by evidence.

Confirmed Noncompliance: An allegation of noncompliance that has been verified as a result of an investigation and/or a for-cause audit.

Continuing Noncompliance: A repeated pattern or un-rectified instance of noncompliance by an individual investigator or research staff member either on a single protocol or multiple protocols.

Noncompliance: Failure to comply with federal regulations; the policies or procedures of the IRB; or institutional policies governing human research.

Examples of noncompliance include:

(1) conducting human participant research without IRB approval (e.g., before approval; after expiration of approval and in the absence of a continuation application submitted to the IRB; during a suspension of IRB approval; after termination of IRB approval);

(2) disregarding or otherwise violating IRB-approved informed consent procedures (e.g., failing to obtain consent/assent, using unapproved or outdated consent, assent, and information sheets, missing signatures, failing to document consent process);

(3) deviating from the protocol approved by the IRB;

(4) modifying an approved protocol without IRB consent;

(5) failing to report or late reporting unanticipated problems;

(6) failing to maintain adequate records;

(7) failing to train research team members in the proper procedures; and

(8) failing to follow recommendations by the IRB to ensure the safety of research participants.

Serious Noncompliance:

Noncompliance involving one or more of the following:

(1) bringing harm to research participants;

(2) exposing research participants to a significant risk of
substantive harm;

(3) compromising the privacy and confidentiality of research participants;

(4) causing damage to scientific integrity of the research data that has been collected;

(5) engaging in willful or knowing noncompliance;

(6) impacting ethical principles adversely.

• The IRB administrator the Office of Research Integrity (ORI) may become aware of an
  allegation of noncompliance or of circumstances indicating potential noncompliance upon the receipt of a complaint or concern from a participant, researcher, GS employee, committee member or member of the public; or from the interpretation of information received during a Continuation, Amendment, Unanticipated Problems Review; or from the findings of a random or for-cause audit, other quality control activities or review of public or social media.
• Once it has received an allegation of noncompliance, ORI will conduct an initial interview to obtain the basic conditions of the concern and if appropriate complete and adverse event reporting form.
• ORI will meet with the IRB Chair to make the following initial determinations:
  • (a) whether noncompliance is alleged; and
  • (b) whether the allegation indicates that an immediate action such as suspension by the IRB is warranted.
  • If it is determined that immediate action by the IRB is warranted (e.g., suspension), then the IRB Chair will initiate suspension proceedings.  (See Suspensions)
•  ORI and the IRB Chair will initiate an investigation of the circumstances alleged in the noncompliance report.
• Where funded, ORI will make the appropriate report to the Office of Human Subjects Protections (OHRP) and Sponsor where required.
  • ORI may elect to investigate informally by reading relevant documents and communicating
    with the affected parties.
  • If ORI and the IRB Chair determine that the allegation is not credible or is unsubstantiated, then the inquiry ends. ORI will document this finding in a written report; place the report in the study file; and notify the IRB of the finding on the agenda of the next available meeting.
  • If the inquiry yields evidence that noncompliance that is neither serious or continuing has occurred, then the IRB Chair and ORI may identify and will devise an appropriate corrective plan  or if additional expertise is required, identify a subcommittee of IRB members to identify the harm and appropriate solutions.  In all cases,  a report will be made to the full IRB at the next available meeting.
  • If it is determined that the noncompliance is serious or continuing, a forcause audit of the protocol will be conducted.  If noncompliance creates a potential risk to participants, the protocol will be immediately suspended and contact made with the researchers chair and/or dean.
    • Protocol PI may decide voluntarily to suspend or terminate some or all of the research activities that may be under current review or investigation.
  •  The IRB Chair with the support of the IRB administrator, will report the results of the forcause audit to the Protocol PI, members of the IRB and if appropriate, the Institutional Official and/or appropriate Dean and/or Chair of the Protocol PI’s Department.  The IRB committee will consider
    • Whether the audit report and any other available information sufficiently supports a
      determination of non-compliance
    • Whether the audit report and any other available information supports suspension or
      termination of research in order to protect human participants or others
    • Additional actions to protect the rights and welfare of currently enrolled participants
    • Whether procedures for withdrawal of enrolled participants account for their rights
      and welfare
    • Whether participants should be informed of the noncompliance and/or any of the
      corrective actions
    • Construct an appropriate corrective action plan.
  • ORI will follow up with the implementation of the Protocol PI’s corrective action plan and report completion back to the IRB Chair and Committee as appropriate.
  • While the IRB has the authority to take appropriate action concerning a research protocol,
    neither the IRB nor ORI has the authority to take disciplinary action against any individual
    relating to a finding of confirmed noncompliance. Instead, disciplinary action shall be the
    responsibility of the institution. The IRB administrator shall report any termination of research
    to the appropriate institutional officials,and if requested, assist in any disciplinary action process taken by the appropriate academic unit.

• The actions taken to correct noncompliance vary and depend on the nature and seriousness of the noncompliance. The IRB Chair, in consultation with the IRB Administrator, may take any combination of the
  following actions:
  • Take no action
  • Request a protocol and/or consent form modification
  • Require that all participants be re-consented
  • Require previous participants to be informed of any changes to the protocol and/or consent procedures
  • Require observation of consent procedures
  • Require more frequent review of the conduct of the research
  • Require additional training for the research team
  • Require follow-up audit(s)
  • Suspend the research
  • Terminate the research
  • Nullification of collected data
  • Refer issues to other institutional entities (e.g., Institutional Official, Dean, Legal Counsel)
  • Any other action deemed appropriate by the IRB to protect the rights and welfare of
    current or future research participants.

• Reserved