MinerAlert
MinerAlert
For-cause evaluations are conducted when there are concerns about the rights and welfare of participants in a specific protocol being adequately protected. The IRB may request a for-cause evaluation to:
A for-cause evaluation may also be used, during continuing review, to determine if additional information from an independent source is required to verify the ongoing safety of a project and to assist the IRB when deciding if the project requires more than an annual review.
For-cause evaluations may be requested for any project that involves human subjects.
When a researcher is aware of a protocol deviation that meets the criteria for an unanticipated problem or incident of non-compliance, they must complete and submit a Project Status Report. It is expected that researchers and research staff promptly self-report events that may meet the criteria for an unanticipated problem or non-compliance with the IRB.
Allegations or reports of protocol deviations and incidents of non-compliance may be identified via monitoring visits or via communication by someone other than the researcher through telephone calls, letters, e-mails, or any other method of communication and may be made to the IRB office or to the University Compliance Services Hotline. The identity of individuals making a report will remain confidential unless the individual provides permission to disclose his/her identity.
Upon receipt of a report or allegation of non-compliance, or upon identifying non-compliance as part of the review process, the IRB staff will make an initial assessment to determine whether the problem may rise to the level of serious and/or continuing non-compliance. Problems that are clearly not serious and/or continuing non-compliance may be managed by IRB members who are designated to conduct expedited reviews.
Problems that may or may not constitute non-compliance should be referred to IRB leadership for further consideration.
Problems that indicate a significant risk or severity will be evaluated to determine if immediate actions are necessary to ensure the ongoing protection of research subjects. The IRB Chair may elect to immediately suspend the research at any time to protect the safety, rights, or welfare of subjects.
When the facts of the situation are unclear, IRB staff may communicate with the study team to gather additional information. Upon receipt of the researcher’s response, the allegation and response will be discussed with AVP of RCRS or IRB Chair or designated reviewer if necessary. The AVP of RCRS will then determine whether the allegation is substantiated or requires further investigation.
If the non-compliance is clearly neither serious nor continuing, and there is a corrective action plan that can be readily implemented to prevent recurrence, if applicable, then the matter may be handled as a non-compliance that is neither serious nor continuing with the report being acknowledged by the designated reviewer.
Incidents that appear to involve serious and/or continuing non-compliance with a basis in fact, or if it cannot be determined if there is a basis in fact, may be the subject of further inquiry. The inquiry will be conducted by the IRB Chair, or others, as appropriate. If deemed necessary by the IRB Chair, an ad hoc subcommittee of the IRB may be appointed and may include any or all the following: IRB Chair, IRB Vice Chair, other IRB members whose presence is deemed essential, and IRB staff. It will be determined whether anyone assigned to the ad hoc subcommittee has a conflict of interest with the investigator or the research that is the subject of the inquiry and, if a conflict exists, assign other members to replace those with the conflict.
If the investigation finds evidence that serious and/or continuing non-compliance may have occurred, the problem will be referred to the convened IRB. Applicable documents (may include the study protocol, consent form(s), initial application, description of alleged non-compliance, and results of the investigation) pertaining to the incident and the investigation will be sent to IRB members prior to the meeting. Members are expected to review all documents prior to the meeting.
At a full board meeting, the IRB will then determine if the incident of non-compliance was serious or continuing and what restrictions, conditions, or other remedial actions are necessary to resolve the non-compliance, and the procedures required to prevent future occurrences. The researcher is notified in writing of the IRB’s determination and of any required corrective actions. Notification of regulatory agencies, as applicable, will be accomplished according to Section 22. All documents relating to the investigation will be retained by the IRB Office.
Research Suspension: Suspension is when research activities are suspended due to serious concerns regarding investigator non-compliance. For example, subjects may be at increased risk due to inappropriate investigator actions. The investigator will be notified in writing of such a determination, and any other actions required. The suspension will be reported to appropriate individuals and agencies as described in Section 22.
Research Termination: Termination of research activities occurs when the issues of non-compliance cannot be resolved. The investigator will be notified in writing of such a determination and the termination will be reported to appropriate individuals and agencies as described in Section 22.
Other possible IRB actions include:
Note: If an IRB suspends or terminates a protocol, the IRB must:
When non-compliance is reported or identified, the PI will be notified of the non-compliance determination in writing. Correspondence between the IRB member reviewing the non-compliance and the PI may occur as needed to determine appropriate corrective action. The non-compliance notification from the IRB will denote any required corrective action. Incidents of non-compliance that were not found to be serious or ongoing will be in the IRB minutes.
If the incidents of non-compliance are serious or continuing, and/or the IRB determines that a protocol must be suspended or terminated, the incidents and IRB actions are reported to the IO, the applicable regulating agencies, and sponsor (if applicable) according to the requirements of the institutions Federal wide Assurance (FWA).