Federal Regulations and Guidance

When conducting research at MultiCare the investigator has these responsibilities:

1. Protect human subjects
2. Ensure all subjects sign informed consent
3. Do not conduct research that is not approved by the MHS IRB or the sponsor-directed central IRB
4. Report any adverse events that occur during study conduct
5. Complete continuing review on or BEFORE your continuing review date
6. Report any protocol deviations to the IRB
7. Allow the IRB to review any protocol and/or consent form revisions before implemented
8. Respect the authority of the IRB and comply with our rulings
9. Contact the MHS IRB at 253-403-3877 with questions

If you are conducting a clinical trial, you should be well versed in Good Clinical Practices (GCP). The MultiCare IRB expects all investigators to follow the guidance set forth by the Federal Drug Administration when doing clinical research using a drug under an IND or a device not approved for general use.

• OHRP
• Federal Regulations for Research with Human Subjects – Department of Health and Human Services, 45 CFR, Part 46 Including Subpart D, Additional DHHS Protections for Children Involved as Subjects in Research IRB Guidebook for Protecting Human Research Subjects
• The Belmont Report
• The World Medical Association Declaration of Helsinki