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									                                                             Number: 23.00
                                                             Effective Date: 03/2011
                                                             Author: Michelle Cook
 Human Research Ethics                                       Approved:
 CaroMont Health IRB                                         Authorized:

23.00 Review of Instances of Non-Compliance for Determination of Serious or
Continuing Non-Compliance and Reporting

All members of the CaroMont Health community involved in Human Subject Research are expected to comply
with the highest standards of ethical and professional conduct in accordance with federal and state
regulations and institutional and IRB policies governing the conduct of Human Subject Research.

The CaroMont Health IRB is responsible for continuing oversight of research protocols under its jurisdiction
to ensure that they are being carried out in accordance with the requirements of the approved research
protocol; all determinations of the IRB; all applicable federal and other governmental regulations; and all
applicable IRB and Institutional policies.

The IRB may receive allegations or reports of Non-Compliance from a variety of sources such as individual
complaints, compliance reviews or audits, investigator self-reports, and reports from Sponsors or
governmental entities.

The CaroMont Health IRB will review all instances of non-compliance in order to determine whether or not
they constitute Serious or Continuing Non-Compliance as defined in this section.


Non-Compliance: Failure to comply with any of the regulations and policies in these SOPs and failure to
follow the determinations of the IRB. Non-compliance may be minor or sporadic or it may be serious and/or

Continuing Non-Compliance: A pattern of Non-Compliance which in the judgment of the IRB Chair or
convened IRB suggests likelihood those instances of Non-Compliance will continue unless intervention
occurs. Continuing Non-Compliance also includes failure to respond to a request to resolve an episode of

Serious Non-Compliance: Failure to follow any of the regulations and policies described in these SOPs of
failure to follow the determination of the IRB and which, in the judgment of either the IRB Chair or the
convened IRB, increases risks to participants, decreases potential benefits, or compromises the integrity of
the Human Research Protections Program. Research being conducted without prior IRB approval is
considered Serious Non-Compliance.


Information regarding noncompliance, subject complaints and other concerns.
Information regarding noncompliance in human subject studies may come to the attention of the IRB through
several pathways. These include information contained in new applications, continuing reviews, adverse
event reports, and reports from collaborators, employees, or subjects.

23.00 Instances of Non-Compliance                                                                1 of 3
IRB investigations of noncompliance, subject complaints and other concerns: The Chair of the IRB
reviews allegations of noncompliance or subject complaints. The Chair makes a determination as to whether
the alleged practices appear to:
    1.   cause injury or any other unanticipated problems involving risks to subjects or others, or
    2.   constitute serious or continuing noncompliance with the approved protocol, IRB determinations or
         federal regulations.

In such cases, the Chair shall suspend the study procedures pending a timely investigation, and shall
immediately notify the principal investigator, the Director of the Office of Human Research Ethics (OHRE) and
the Institutional Official. When appropriate, others may also be notified, including the CaroMont Health Office
of Research Administration, the Office of Corporate Compliance, the Office of the General Counsel, or others
with a role in the given situation. Investigations by the IRB focus on the protection of study subjects. In cases
that involve allegations of scientific misconduct, the Chair shall contact the Office of Research Administration
for further action. Inquiries or investigations into scientific misconduct do not preclude IRB review and

The following are recommended procedures for resolving alleged noncompliance:

                When made aware of a potential problem, the Director of OHRE compiles file information
                 and presents concerns to the IRB Chair.
                The Chair determines whether to pursue the matter with the PI via telephone call, e-mail,
                 paper memo, or in person. The purpose of such contact is fact-finding, i.e., to determine
                 whether a problem exists and if so, its magnitude and significance relative to the rights and
                 welfare of human subjects.
                When the initial inquiry does not result in resolution of the matter, a meeting with the PI
                 may be scheduled.
                The IRB Chair will determine whether the noncompliance requires additional review at a
                 convened IRB meeting. All serious or continuing noncompliance will be reviewed by the
                 convened IRB.
                For allegations that are referred to the convened IRB, all members will receive the
                 application and consent form, where relevant, and materials describing the allegation of
                 noncompliance and any investigation to date.
                The IRB has the authority to suspend or terminate IRB approval of protocols that are found
                 to pose unanticipated or heightened risk or are out of compliance with institutional policies
                 and procedures, state laws, and/or federal regulations.
                Other actions taken by the IRB may include but are not limited to
                         modification of the research protocol;
                         modification of the information disclosed during the consent process;
                         additional information provided to past participants;
                         notification of current participants, which is required when such information might
                          relate to participants’ willingness to continue to take part in the research;
                         requirement that current participants re-consent to participation;
                         modification of the continuing review schedule;
                         monitoring of the research;
                         monitoring of the consent;

23.00 Instances of Non-Compliance                                                                  2 of 3
                         obtaining more information pending a final decision;
                         referral to other organizational entities (e.g., Office of General Counsel, Office of
                          Research Administration, Institutional Official);
                         compliance audits;
                         requirements for additional training for investigators and/or research staff;
                         letters of reprimand, and
                         restrictions on serving as an investigator on human subject protocols.

                Determinations from the convened IRB meeting are documented in the minutes.
                In cases where the IRB determines that the allegations, complaints or concerns are
                 unwarranted or resolved, relevant parties should be notified.
                If the IRB takes action regarding the noncompliance, the IRB sends written notification of
                 these actions to the PI, the Institutional Official and relevant others. To the extent that any
                 action includes suspension or termination in cases of externally funded programs, the
                 Institutional Official will communicate with the relevant sponsors.
                If the allegations of noncompliance come from a subject complaint, the complaint should be
                 acknowledged and the subject informed of the steps taken, as appropriate. Depending on
                 the circumstances, this correspondence will come from the IRB, the PI or other designated
                The Institutional Official is responsible for all required reporting of noncompliance and the
                 resulting IRB actions to the appropriate federal agencies. This reporting would generally be
                 coordinated through the CaroMont Health Office of Human Research Ethics.

Applicable Regulations:
45 CFR § 46.103(a); .103(b)(5); & .113.
21 CFR § 56.108(a); .108(b); & .113.

23.00 Instances of Non-Compliance                                                                     3 of 3

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