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Noncompliance, Protocol Exceptions and Deviations

Summary

Federal regulations require the reporting of serious and continuing noncompliance to the IRB, institutional officials and certain federal agencies and department heads. Because the federal regulations do not define noncompliance, institutional policy must be applied. This document describes the campus policy regarding noncompliance, how the term is defined, and requirements for IRB review.

Definition of Noncompliance

When noncompliance has occurred, federal regulations require IRBs to determine whether the incident is serious, continuing, or both. The University IRBs define serious noncompliance as non-compliance that affects the rights and welfare of participants or that may put participants at risk of harm. Continuing noncompliance is defined as multiple or repeated instances of noncompliance, particularly after written notice from the IRB that the investigator must take action to correct noncompliance. The multiple or repeated instances of noncompliance may occur on one protocol or on more than one protocol and may occur simultaneously or over a period of time.

Examples of noncompliance with federal regulations may include:

• failure to obtain informed consent or inadequate procedures for obtaining informed consent from subjects
• conducting human subjects research without IRB approved protocol or exemption
• inadequate supervision of research that involves potential risks to subjects and others
• conducting research, including enrollment of subjects, when IRB approval has expired or has been suspended or terminated
• initiating changes to the research protocol without prior IRB approval unless the change is necessary to eliminate apparent immediate hazards to the subject
• failing to adhere to the conditions of approval of a protocol as specified by a IRB
• starting research under a protocol before meeting the conditions required by an IRB and receiving an IRB notification of approval
• failing to take IRB or institutionally required human subjects protection training; enrolling more subjects than approved by an IRB
• failing to have research participants sign a new consent form when new and relevant risks are discovered or failing to provide this new information to participants
• altering an IRB-approved consent process or an IRB-approved recruitment process without prior IRB approval

Examples of serious noncompliance include:

• one or more instances of conduct defined above as noncompliance that exposes subjects or others to risks of harm that are not an inherent part of the approved research protocol
• conduct defined as noncompliance above, even though subjects or others have not been exposed to risks of harm not inherent in the approved protocol, where the IRB finds no mitigating circumstances
• misrepresentation of information related to the human subjects research protocol or performance of the research
• conducting non-exempt research without IRB approval
• making substantive changes to a previously approved protocol without IRB approval

Whether the conduct was inadvertent, careless or reckless, or intentional may be taken into consideration by the IRB in a determination of seriousness.

Minor Administrative Noncompliance

Minor administrative noncompliance is an occasional instance of noncompliance that does not affect the rights and welfare of participants or put participants at risk of harm. Examples include a single instance of failure to submit a continuing review progress report to the IRB in time to prevent the lapse of approval, or failing to sign a protocol application as required.

IRB Determinations about Noncompliance

When the IRB has determined that serious and/or continuing noncompliance has occurred, the committee also must decide what further action is required. Actions related to the protocol can include:

• Requesting the investigator make modifications to the protocol
• Requiring more frequent review of the protocol (e.g., more often that the minimal of annual review)
• Requesting the investigator modify the consent process or consent documents
• Requiring the investigator to provide additional information to current and/or past participants or re-consenting to participation
• Requiring additional training of the investigator and/or study staff
• Reconsideration of IRB approval
• Implementation of monitoring of the research
• Implementation of monitoring of the consent process
• Suspension of the research
• Termination of the research
• Refer the matter for further consideration by the Institutional Official.

If the IRB decides that a report constitutes serious and/or continuing noncompliance, it must also make recommendations regarding whether the Institutional Official will report the noncompliance to the OHRP, the VA, the FDA and any other federal department or agency that funds or supports the research in which the noncompliance occurred.

NOTE: Although the IRB can suspend the research study, only the Institutional Official has the authority to suspend an individual's privileges to conduct research.