Federal Regulations and Guidance

When conducting research at MultiCare the investigator has these responsibilities:

1. Protect humans 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. Contact the MHS IRB 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.

Federal Drug Administration (FDA)

Expanded Access (Single Patient IND/Compassionate Use)
Food and Drug Administration (FDA)
Protection of Human Subjects - FDA Regulations, 21 CFR, Part 50
Institutional Review Boards - FDA Regulations, 21 CFR Part 56
Guidance for IRBs and Clinical Investigators
Humanitarian Device Exemption

Office for Human Research Protections (OHRP)

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