The Research Compliance Committee has developed a temporary policy to address research continuity and participant protection during COVID-19. Please review it carefully:
NWRC.RIM.099 – Research Continuity and Protection of Human Subjects During COVID-19
We understand that each study is a little different, and it can be challenging to determine how the policy applies to your specific circumstances. We have created a guidance document that addresses some FAQs:
Guidance – COVID-19 Considerations for Research Studies (Updated 3/19/2020)
If you need to submit a modification to the IRB to make temporary changes, you may use the template provided here (note that the policy outlines some circumstances that DO NOT require a modification to the IRB):
Template – Temporary Study Modification in Response to COVID-19
Please contact us at CHR_ResCompTeam@kpchr.org with any questions or concerns.
Waive your hands in the air – a new Waiver or Alteration of Consent or HIPAA Authorization form is here! You’ll notice that our protocol templates and local context supplement are missing something…a place to describe your waiver/alteration requests. We’ve consolidated and streamlined the information we collect from you into a one stop shop doc for all your waiver/alteration needs.
You can access the new form in one of two locations:
Can you tell we’re EXCITED?!!? If you have questions about the document and how to use it, get in touch with our team, we’re glad to assist.
After a six-month trial period, it's been determined that the pilot program was ultimately not saving time for RSPO or investigators. Projects that qualify for exemption should be submitted in IRBNet using the normal method. If you want to set up a pre-submission meeting to review necessary materials, just email NW-IRB@KPCHR.org.
Research Compliance convened a work group starting in 2017 to create materials for social/behavioral research that can help study teams navigate the GCP requirements. If you are on a grant or have a protocol that requires the research follow GCP, we anticipate these tools will be helpful for you. See the Quality Improvement and Monitoring page for the tools and more information!
The KPNW Research Compliance Committee (RCC) typically meets the second Monday of the month.
View 2020 RCC Charter & Membership
Forms & Templates
Designed to enable researchers and IRB reviewers to manage all aspects of the Institutional Review Board (IRB) administration process.
Spring 2020 Newsletter Archive
Find vital information about Financial Conflicts of Interest, FDA-Regulated Clinical Trials, Privacy Policies, Research Integrity, Security, and Human Research Protection.
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