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Federalwide Assurance

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What is Federalwide Assurance?

Under the Department of Health and Human Services (DHHS) human subjects protection regulations (at 45 C.F.R. 46.103), every institution engaged in human subjects research must obtain an Assurance Of Compliance approved by the Office for Human Research Protections (OHRP). This Assurance of Compliance is called a Federalwide Assurance (FWA). MultiCare Health System's FWA number is FWA00003267.

The "awardee" is responsible for ensuring that all collaborating institutions engaged in the research hold an OHRP approved Assurance prior to their initiation of the research. This may mean that if you ask the MHS IRB to be the IRB of record for your study you may need a FWA of your own. Please send a message to the IRB office at IRB@MultiCare.org for more information.

Non-Compliance

Each study must be reviewed by the MHS IRB yearly or the study will be suspended. 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 assure his/her study receives continuing review. Any suspension will be reported to the MHS Professional Activities Committee, 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). Suspension means that 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 convene and 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, continuing non-compliance with IRB or regulatory requirements.

Audit

The MHS IRB has the right to audit investigator records to assure research is being conducted as approved. Investigators will be notified by mail 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.