For instance:

   1.  The deviation has resulted in increased risk of harm.

        Examples:

a.  A research subject was enrolled but does not meet the inclusion/exclusion criteria
b.  A research subject received the wrong treatment or incorrect dose
c.  A research subject met withdrawal criteria during the study but was not withdrawn
d.  Failure to perform protocol procedures in place specifically to monitor for the occurrence of potential harms
e.  A research subject received an excluded concomitant medication during a clinical study
f.  The investigational product was stored at the wrong temperature

   2.  The deviation affects the integrity of the study data.

        Examples:

a.  Failure to perform protocol procedures in place specifically to measure primary efficacy outcomes
b.  Inadvertent loss of samples or data that relate specifically to safety or primary efficacy outcomes

   3.  The deviation has affected the rights or welfare of the subject(s).

        Examples:

a.  Initiating conduct of a research protocol prior to IRB approval
b.  Failure to obtain informed consent prior to initiation of study-related procedures
c.  Inadequate or improper informed consent procedure
d.  Storage of medical records with study records (Different levels of confidentiality/ access permissions apply. Those who have routine access to subjects' medical records may not be one of the individuals or groups listed in a research study consent document. Individuals and groups that may access both medical records and study records are limited to those described in the consent document.)
e.  Working under an expired professional license or certification
f.  Performance of tests or procedures by study staff which are beyond the staff member's professional scope or privilege status (credentials)

IRB Review of Deviations

Goodwyn IRB evaluates deviations to assess whether they represent an unanticipated problem, or serious or continuing non-compliance with human subject protection regulations, policies and procedures.

Serious non-compliance means that there is a pattern of not reporting or responding to the IRB or evidence of disregard for regulatory obligations and/or the requirements of the IRB. This is serious because the IRB cannot perform its oversight functions if it does not have access to information.

        Examples:

a.  Ongoing failure to report required information (including, but not limited to, unanticipated problems, deviations or periodic status reports) to the sponsor or IRB
b.  Failure to respond to the requirements of the IRB

Continuing non-compliance means that deviations continue to recur over time without adequate mitigation.

        Example:

c.  Repeated deviations (including repeated minor deviations)

Under the regulations, Goodwyn IRB must report any determination of serious or continuing non-compliance to the regulatory authorities [FDA (for FDA-regulated research) or DHHS (for federally funded research)].