Empowering our Research Community to Transform Health through Partnership and a Culture of Ethics

 CHR Compliance Quiet Week

When – November 1st – 5th

What to expect

• Email – Email will be checked twice a day; usually in the morning and afternoon
• Meetings – We will be blocking out our calendars for this week. If you encounter an emergent situation (reportable new information impacting subject safety; impending funding deadline) email CHR_ResCompTeam@kpchr.org and we will be in touch to schedule a touch base via Teams.
• Deadlines – The deadline for full board projects will remain November 1st for the November IRB meeting. Continuing review deadlines for minimal risk studies (expedited/exempt) remain unchanged (4-6 weeks prior to expiration).

Here’s what you can do to help prepare for our Quiet Week:

1) Familiarize yourself with our website so you know where to look for guidance on using IRBNet.

2) If you have a minimal risk project expiring November 1-5, make sure you get that continuing review package in no later than October 25 and email CHR_ResCompTeam@kpchr.org with the project # and expiration date.

3) Get any modifications or data commitments that can’t wait till after November 5th into IRBNet and/or the Data Commitments Tracking System and alert us of any time sensitive projects via email.

4) Contact us early if you anticipate this being a hardship for any reason so we can work together to make sure you have the support you need.

 

COVID-19 Information

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.

 New! Waiver Form

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:

• In IRBNet under "Forms and Templates"
• On the Forms and Templates page of our website under "Protocol and Supplemental IRB Forms"

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.

USE: Tools for GCP Compliance in Social-Behavioral Research

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 Committee

The KPNW Research Compliance Committee (RCC) typically meets the second Monday of the month.

View 2021 RCC Charter & Membership