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 the eIRB link on the Home page of this website. New eIRB users will need to register in the system to request an eIRB account. A link for registration is found on the right side of the eIRB 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 eIRB submission.
When is the deadline for IRB submission?
You may submit at any time; however, to ensure a submission is reviewed at an IRB meeting, a new study or study modification must be submitted through the eIRB by the end of business on the first working day of the month you would like it reviewed. 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.
Continuing review submissions (progress or final reports) are due by the end of business on the first working day of the month prior to the month in which current IRB approval ends. For example, if a study's approval ends on June 15, a progress or final report is due by the end of business on the first working day in June.
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 submission for a new study 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 supporting documents section of the application.
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 submission for a new study 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 into the eIRB. You may do this in the section for supporting documents at the end of the application.
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 section for supporting documents at the end of the application.
What is a Universal Investigator?
A Universal Investigator is a TCHR (The 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 TCHR other than their own. The TCHR regions are KP Georgia, KP Hawaii, and KP Northwest.
Universal Investigator Guidelines are designed to assist a TCHR Investigator who is planning to act as a Universal Investigator in one or more of TCHR regions.
Do all new studies need to be reviewed by the full board?
No. Minimal risk studies that meet criteria for expedited review as set by the Department of Health and Human Services may be expedited. The final determination about whether a new study will be expedited will be made by the KPNW IRB.