Institutional Review Board
The IRB is federally mandated by the Department of Health and Human Services (HHS) under Title 45 CFR 46 also known as the Common Rule, and regulated by the Office of Human Subjects Protections OHRP) within the HHS. The IRB is also regulated by the Food and Drug Administration under Title 21 of the Code of Federal Regulations when the research involves FDA-regulated products. It was established to review and approve any biomedical or behavioral research involving human participants, data or specimens that may be immediately identifiable or through coded identification. Investigators will seek and obtain legally effective informed consent from the subject or the subject's legally authorized representative prior to any involvement in a study, in the majority of cases. Approval by the Western Institutional Review Board (WIRB) must be obtained prior to any research study being started at St. Joseph Medical Center.
The Western Institutional Review Board (WIRB) is the IRB of record for St. Joseph Medical Center. It is a fully accredited, commercial institutional review board (IRB) regulated by the Office of Human Research Protections (OHRP) within the Department of Health and Human Services (HHS). It reviews and monitors to Food and Drug Administration (FDA) and HHS regulations and the International Conference on Harmonization (ICH) Good Clinical Practice, as well as applicable Maryland State and local laws and the St. Joseph Medical Center policies and ethical principles. WIRB has been providing the review and oversight of all biomedical and behavioral clinical trials conducted by medical and nursing staffs as well as full-time employees, at or through the St. Joseph Medical Center, since September 28, 2001.
Investigators may commence research involving human subjects only after the WIRB has approved the study or has determined it to be exempt from IRB approval.
The following sections of interest for investigators are linked to the WIRB web site. Click on one of the following links for information of specific interest to Investigators:
- Regulations Affecting Clinical Research, Including HIPAA
- Conflicts of Interest
- Site Staff Levels
- The Informed Consent Process
- Adverse Events, Protocol Variances, and Unanticipated Problems
- Continuing Review Activities and Reports including Study Closure and Site Visits
- Study Closure and Site Visits
WIRB considers an approved study to be open at the site until a study closure report is received. Please complete the study closure form when:
- All subjects have finished their final visits and follow-up and
- The sponsor or sponsor representative has indicated the study is closed at your site and
- If the study was conducted under a Federal wide Assurance, all data analysis at the site is completed. WIRB will close the study upon receipt of the closure report.
Applying for Human Subjects Review by Western Institutional Review Board (WIRB)
All protocols must have the following prior to submitting an application to the Western IRB:
- Approved clinical trials budget;
- Final approval of the Scientific Review Committee (SRC);
- Fully executed/signed Clinical Trials Agreement among sponsor, PI/group and St. Joseph;
- Signature of an official of the Office of Clinical Research is required on the WIRB application.
- Application form for new protocols: Complete the WIRB application form [Initial Review Submission Form & Additional Sites Page. The instructions for completing the form are on the first page of the application. Please read the instructions carefully, as well as those instructions required by SJMC/OCR.
- Investigative drug or biologic studies: FDA Form 1572 is required for drug/biologic studies. In Box 5 (IRB of record), enter: Western Institutional Review Board (WIRB), 3535 Seventh Avenue, Olympia, WA 98502-5010.
- Investigative device studies: Need an FDA letter granting an Investigational Device Exemption (IDE), if one is required for the research.
- Documentation of human subjects training: Please include a copy of your human subjects training certification with your WIRB application packet. For SJMC investigators and coordinators, WIRB is a participating organization in the Collaborative IRB Training Initiative (CITI); The NIH Office of Extramural Research also provides an online course for investigators in Protecting Human Research Participants (PHRP).
- Application packet: Complete application packet as described in the instructions of the WIRB application and send to WIRB:
Street address (FedEx, UPS or receipted mail):
3535 Seventh Avenue SW, Olympia, WA 98502-5010
Mailing address (US Mail):
P.O. Box 12029, Olympia, WA 98508-2029
- Follow up to your submission: You may contact WIRB Client Services, at 1-800-562-4789 or email firstname.lastname@example.org with any questions regarding your application and review. There is also an online tracking system to determine the status of your application.