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Institutional Review Board
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 purposed 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 research?
Research is defined as a systematic investigation designed to develop or contribute to general knowledge. Clinical Research is defined as: the study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or to determine its safety and efficacy. Clinical investigations are systematic studies designed to evaluate a product (drug, device, or biologic) using human subjects, in the treatment, prevention, or diagnosis of a disease or condition, as determined by the product's benefits relative to its risks.
Does my project need IRB 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, the MHS IRB charges $1,500.00 for new submission applications. There is a charge of $500 for continuing review which is required at least annually depending on the board’s recommendation. A charge of $250 is assessed for each Interim Status Report (i.e. Revision to Study, Adverse Event Report, Revision to Consent Form, etc). Payment must be received with submission.
Is there a waiver for fees associated to IRB review?
No. In the past the MHS IRB has not charged for its services. Due to the increased workload, technical assistance and support staff the MHS IRB now charges for most studies. MultiCare employees and studies supported by an institutional grant to MultiCare are not charged IRB fees. All other submissions will not be reviewed without payment of fees listed above.
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