What do I need to submit for initial review of my research?
Review of new studies requires submission of a new study form found within the electronic IRB (eIRB) system. To access this system click the Enter IRBNet link on the Home page of this website. New IRBNet users will need to register in the system to request an account. A link for registration is found on the right side of the IRBNet welcome page.
All new IRB applications for studies that require informed consent should include informed consent documents written to meet plain language standards. Researchers and project managers should review Consent Writing in Plain Language prior to submitting an application for any study that requires informed consent.
Please note: For single patient and emergency use of drugs or devices, contact IRB staff for guidance prior to starting an IRBNet submission.
When is the deadline for IRB submission?
Greater than minimal risk - Submission of a complete and accurate progress or final report is due by the end of the first business day of the month prior to the month in which IRB approval expires. For example, if you want your submission to be reviewed at the June IRB meeting, you must submit by the end of business on the first working day in June.
Minimal risk - Submission of a complete and accurate progress or final report is due 4-6 weeks prior to expiration.
When will I hear about the IRB's decision?
In most cases IRB staff will provide notification to the principal investigator and primary contact for the study through the eIRB within one week after the IRB meeting.
Can I appeal to the IRB for reconsideration of an IRB decision?
Yes. A PI may appeal to the IRB for reconsideration of a decision. The PI should make this appeal within 30 days after notification of the IRB decision. For more information about the appeal process:
How does the IRB monitor my research study?
The IRB is required by federal regulations and KPNW policy to review studies at least annually. The IRB may request review more frequently if the study is high risk or if they determine that other circumstances warrant more frequent monitoring.
Research studies are also monitored through the quality improvement & monitoring program to provide assistance for investigators and study staff to ensure that their study is in compliance with federal and state regulatory requirements and KP policies.
Does my data-only study need to have IRB review?
Yes. All research must be reviewed and approved by the KPNW IRB.
What do I need to do to request that the KPNW IRB cede IRB review to another IRB, e.g., OHSU?
The Core Data Form will ask you whether an external IRB will act as IRB of record for the study (ceding request). Upload the external IRB's application form and approval letter in the Designer section of the package along with your other documentation.
If the study has already been approved, you may submit a study modification to request that the KPNW IRB to rely on another institution’s IRB review.
What do I need to do to request that the KPNW IRB accept review authority from another institution?
The Core Data Form will ask you to identify each external site that is engaged in the research in collaboration with KPNW and whether the site will rely on the KPNW IRB. If the other external site has already agreed to this reliance, upload a copy of that approval on the Designer page of IRBNet.
If the study has already been approved, you may submit a study modification to request the KPNW IRB to accept review authority from an external collaborating site. If the external site has agreed to this, upload that approval in the Designer page of IRBNet.
What is a Universal Investigator?
A Universal Investigator is a CHR (Center for Health Research) investigator in good standing (e.g., has a track record of meeting all regional compliance and IRB requirements) who can be the principal investigator in a region or regions of CHR other than their own. The CHR regions are KP Georgia, KP Hawaii, and KP Northwest.
Universal Investigator Guidelines are designed to assist a CHR Investigator who is planning to act as a Universal Investigator in one or more of CHR regions.
Do all new studies need to be reviewed by the full board?
No. Minimal risk studies that meet criteria for expedited or exempt review as set by the Department of Health and Human Services may be reviewed by administrative staff in the office. The final determination about whether a new study will require full board will be made by the KPNW IRB.