Serious noncompliance may include any behavior, action or omission in the conduct or oversight of human research that has been determined to: affect the rights and welfare of participants and others; increase risks to participants and others; reduce potential benefits or otherwise unfavorably alter the risk/benefit ratio; compromise the integrity or validity of the research; or result from the willful or knowing misconduct on the part of the principal investigators or study staff.
Serious noncompliance substantively comprises the effectiveness of the HRPP. The following are some examples of serious noncompliance:
Conducting non-exempt research that requires direct interaction or interventions with human subjects without first obtaining IRB approval.
Enrolling subjects who fail to meet the inclusion or exclusion criteria in a protocol that involves greater than minimal risk and potentially places the participants at greater risk.
Failure to report unanticipated problems or substantive changes to the proposed protocol to the IRB.
Continuing noncompliance is a persistent failure to adhere to the laws, regulations, or policies governing human research. Continuing noncompliance may result from a lack of understanding or disregard for the regulations or institutional requirements that protect the rights and welfare of participants and others. It may compromise the scientific integrity of a study such that important conclusions can no longer be reached, and it may suggest a likelihood that noncompliance will continue without intervention. Continuing noncompliance may also include failure to respond to a request from the IRB to resolve an episode of noncompliance or a pattern of minor noncompliance.
After receiving an allegation, OSP staff will share it immediately with the IRB Chair. The IRB Chair in consultation with OSP staff will conduct an initial assessment of the allegation. If the IRB Chair and OSP staff determine that an allegation or concern is substantiated but it has to do with minor or administrative issues, the IRB Chair or the OSP staff member serving as the HRPP specialist may manage the concern through communications with the principal investigator and/or the complainant.
After an initial assessment, the IRB Chair and HRP Specialist may determine that the noncompliance is not serious or continuing and no additional action is needed, or determine further inquiry and a convening of the full IRB are necessary. If the IRB Chair