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Protocol Deviations and Study Noncompliance

What is a Protocol Deviation?

A protocol deviation is any departure from the study procedures as specified in the IRB-approved protocol. For example, a protocol deviation may involve using an unapproved version of a consent form or recruitment flier, or it may involve implementing some other change to the study protocol without first receiving IRB approval.

In some rare instances, deviations from the protocol may be necessary to eliminate an apparent immediate hazard to a participant. However, all other changes to the protocol must be submitted to and approved by the IRB prior to implementation.

What is Study Noncompliance?

is defined as the failure to follow federal, state, or local regulations governing human subject research, institutional policies related to human subject research, or the requirements or determinations of the IRB. Noncompliance may be either serious, or continuing, or both serious and continuing. Noncompliance that is not serious or continuing is considered to be general noncompliance by the IRB.

Examples of noncompliance include beginning a research project without first receiving IRB approval, enrolling more participants than the IRB has approved, or not submitting a continuing review on time.

 is defined as noncompliance that, in the judgment of the convened IRB, creates an increase in risks to subjects, adversely affects the rights, welfare, or safety of subjects, or adversely affects the scientific integrity of the study. Willful violation of policies and/or federal regulations may also constitute serious noncompliance.

 is defined as a pattern of noncompliance that, in the judgment of the convened IRB, suggests a likelihood that instances of noncompliance will continue unless the IRB or institution intervenes.

When Should I Report a Deviation or Noncompliance?

Investigators and their study staff are required to report instances of possible noncompliance to the IRB within 7 working days of discovery using the Reportable New Information form in iMedRIS.

Additionally, anyone may report concerns of possible noncompliance to the HRPP or IRB verbally, by email, or other means. In such cases, the reporting party is responsible for making these reports in good faith, maintaining confidentiality and, unless reporting anonymously, cooperating with any subsequent fact-finding in relation to the report.

If an individual, whether investigator, study staff or other, is uncertain whether there is cause to report noncompliance, he or she may contact the HRPP Director or IRB Chair directly to discuss the situation informally.