Providing Guidance and Support for all KPNW Research Compliance Activities

  Announcements

More Researcher Training Updates

Wait, again?  Now what?!  Over the past few months, you may have noticed a lot of information swirling around regarding research-related training.  Just recently, the requirements changed yet again when the NIH released a new policy on GCP training, so we have updated our materials to reflect that.  Per NIH policy, Good Clinical Practice (GCP) training is now required for all researchers involved in the conduct of Clinical Trials as defined by NIH.  This includes clinical trials of behavioral interventions.  Biomedical clinical trial staff have likely already completed GCP training and don’t need to do anything else right now, but all clinical trial staff should verify their requirements and make sure they are up to date.

If you’re feeling a little lost, you are not alone!  Research Compliance has created an Ultimate Guide to Research-Related Training to help you get caught up with the new requirements.  The document also includes FAQs.  Our goal is to get everyone in compliance by the end of 2016.

You can also find this guide and more information on the Research Compliance Training and Education website.

Next IRB meeting: December 21, 2016

Submissions for review at the December 2016 IRB meeting should be submitted through the electronic IRB system (eIRB) by the end of work on 12/1/2016.

RE: Continuing Review Submissions: It is the Principal Investigator's responsibility to submit a report for continuing review by the submission deadline.

The eIRB sends courtesy reminders to the study team when a continuing review submission is due. Reminders are sent at 90, 60, and 30 days prior to the approval expiration date. These are the only reminders the study team will receive.

Reminders are discontinued after a continuing form has been opened. If you create a continuing review in the eIRB when you receive the 90-day reminder, you will not receive additional reminders at 60 and 30 days.

eIRB UPGRADE

The upgraded eIRB system went live on June 2. All IRB submissions made after the deadline for June submissions (end of work June 1) should be made in the new eIRB system.

Existing studies in the approved, ceded, or exempt status were migrated to the new system on June 1 unless they had an open modification or continuing review. Studies with open submissions (new study, modification, continuing review, reportable event) in the old system will be migrated to the new system after IRB approval. Study staff will be able to access the study in the new system the following day.

On the first submission after migration:

  • Read the blue text at the top of the mod/CR form!
  • Update study personnel
  • Move documents from the old system
  • Check that migrated information is correct
  • Fill in missing information

If the first submission for a migrated study is a final report, you will not need to make any other updates to study information.

For more guidance: eIRB Upgrade Info Sheet

If you have any questions, please contact us.

 

Compliance Committee Meeting Schedule

  • CHR Research Compliance Committee (local/NW) meets the second Wed of the month.
  • Hawaii CHR representatives join the committee on a quarterly basis.

View 2016 RCC Charter & Membership

eIRB

Designed to enable researchers and IRB reviewers to manage all aspects of the Institutional Review Board (IRB) Administration process.

Enter the eIRB

About the eIRB

eIRB Training

Research Compliance Newsletter

Summer 2016 Newsletter Archive

For IRB Members

Find information and documentation to support the following tasks:

Study Reviews

IRB Member Orientation

About Research Compliance & IRB

The Research Subjects Protection Office (RSPO) is an administrative office for the Institutional Review Board (IRB) at Kaiser Permanente Northwest (KPNW).

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Resources & References

Find useful information about ethical principles, federal regulations, genetic research, informed consent readability and more.

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Policies & Procedures

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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