Protecting patients, families & employees
What is an Institutional Review Board (IRB)?
An IRB is an appropriately constituted group of scientific and non-scientific members who are charged with protecting human subjects. The Institutional Review Board (IRB) is given the authority by the Department of Health and Human Services and the Federal Drug Administration to approve, disapprove, modify and provide oversight of research involving human subjects and/or their protected health information. The MultiCare (MHS) IRB is charged with reviewing all proposed research using MultiCare Health System patients, patient families and employees as well as the medical records, blood and tissue samples of this group. We also review research conducted by our employees and at times research physicians in our community conduct in their private offices. The MHS IRB operates in accordance with all regulations of the Department of Health and Human Services (DHHS) “45 CFR 46, applicable Washington state statutes and regulations, the principles of “The Belmont Report the “Federalwide Assurance (FWA #000003267) and the applicable FDA regulations governing human subject research.
Each protocol submitted to the MHS IRB receives an exhaustive review by qualified board members and is not approved unless the study meets the federal requirements for approval. Our members are dedicated professionals who are not paid for their services.
What is QI?
QI projects aim to improve existing processes, practices, or outcomes within a specific healthcare setting. The primary focus is on local improvement, and the knowledge generated is intended for internal use. MultiCare uses the ID-PDSA cycle for QI initiatives.
What is research?
Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Clinical Research is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
Does my project need IRB/QI approval?
All research involving human participants needs IRB review and approval. If you are using human subjects, data from human subjects (medical records, bills, etc.), tissue or specimens from human subjects living or deceased. Do NOT start a project, research, or an investigation using human subjects or human subject data BEFORE contacting the IRB office for more information about how the IRB will review your protocol.
Does the MultiCare Health System IRB charge for services?
Yes, for all extramurally funded research, the MHS IRB charges as follows:
- $1,500.00 for new submission applications
- $500 for continuing review
- $250 is assessed for each Revision to Study, Adverse Event Report, Revision to Consent Form, etc)
Does the MultiCare Health System QI charge for services?
No. There is no charge for any QI project review.
Is there a waiver for fees associated to IRB review?
Yes. This is assessed on a case-by-case basis. Please contact the IRB Coordinator to discuss options.
What is expected from me if I conduct research at MultiCare?
- Protect humans subjects
- Ensure all subjects sign informed consent
- Do not conduct research that is not approved by the MHS IRB
- Report any adverse events that occur during study conduct
- Complete continuing review on or BEFORE your continuing review date
- Report any protocol deviations to the IRB
- Allow the IRB to review any protocol and/or consent form revisions before implemented
- Respect the authority of the IRB and comply with our rulings