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.
Research Compliance also has a sparkly new form for prep to reseach activities. The document is called "Intention to Use PHI Preparatory to Research" (yes, we like long titles over here).
Copies of this form, including directions for use, can be found found in the following areas of our website:
Under the Revised Common Rule, effective January 21, 2019, more studies qualify for exemption. Exemption means that after an initial determination by the IRB, no further review is required unless there is a significant change in the project. We are piloting a new initiative to make it quicker and easier to get an exemption. You can even do this before you submit your proposal!
Express Exemption Instructions
Express Exemption Request Form
The new process is optional. You may still choose to complete a full study submission, and the IRB will still issue an exemption determination if the study fits an applicable exempt category.
Review our Revised Common Rule page for information about new exemption categories and more.
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) meets the second Monday of the month.
View 2019 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 2019 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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