Federalwide Assurance

Most studies require an annual review to maintain active status. A continuing review notice is sent to investigators several months before the study is due for continuing review; it is the responsibility of the investigator to ensure his/her study receives continuing review. If the annual review submission is not submitted, it may result in a finding of non-compliance, suspension or termination of the study.

All of these findings are reported to the MHS Quality Committee of the Executive Board and, when applicable, the Office of Human Research Protection (OHRP) and the Federal Drug Administration (if the study involves a drug under an IND application or an unapproved device). These findings mean no subjects can be enrolled and no data can be collected on enrolled subjects. At the next convened meeting of the IRB, the board will decide what actions must be taken by the investigator to reinstate his/her study. If those actions are not taken in a pre-determined amount of time, the study will be terminated and the board will report the termination to the appropriate institutional and federal officials as well as the study sponsor.

When a study is suspended, an investigator has the right to petition the IRB chairs to allow data to be collected on enrolled subjects until continuing review can be reviewed by the convened board.

Studies can also be suspended or terminated for non-compliance, unanticipated risks to subjects or others, and continuing non-compliance with IRB or regulatory requirements.

Audit

The MultiCare IRB has the right to audit investigator records to ensure research is being conducted as approved. Investigators will be notified when selected for an onsite audit. The audit will be scheduled within 30 business days of receipt of the notice. Audit findings will be presented to the board where a decision will be made for corrective actions if necessary. Audits are conducted for both cause and at random.