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Research Compliance Team

Research Subjects Protection Office (RSPO)

The Research Subjects Protection Office (RSPO) is the administrative office supporting the Institutional Review Board (IRB) within Research Compliance at KPNW.

Quick Guide: CHR Research Compliance & Research Subject Protection Procedures

Updated October 18, 2018

Procedure

How to Complete

Agreements for specimen and/or data sharing (DUA,  DTA, MDTA, etc.)

Send agreement via email to CHR_ComplianceApprovals@kpchr.org for review and processing. You can find agreement templates here: KFRI Contract Templates

CITI Account Questions and Training Status

Contact the IRB Coordinator, Andrea.Volz@kpchr.org.

Data Transfer Request (DTR)

Use the simplified form in Compliance Manager to explain how the data will be transferred.  Contact CHR_ComplianceApprovals@kpchr.org if you need access to a study in Compliance Manager.

De-Identified Data and Aggregate Data disclosure approvals

Submit completed De-Identified or Aggregate Data form to CHR_ComplianceApprovals@kpchr.org.  (Note that an Aggregate Data form is only required in certain circumstances – see the Aggregate Data Flowchart.)

eIRB Questions

Email eIRB@kpchr.org.

General compliance questions

Email CHR_Compliance@kpchr.org.

HIPAA Research Training for New Hires

Hiring manager provides new hire with a training PowerPoint and an attestation that the supervisor will have the employee complete.  The PowerPoint is in the new hire packet.

IRB Education and Training

Contact the IRB Manager, Kaija.H.Maggard@kpchr.org .

IRB Review Status and Questions

Contact the assigned IRB Coordinator listed at the top of the page in eIRB. You may also contact the RSPO team at CHR_ResCompTeam.kpchr.org.

Quality Improvement Monitoring Program

Contact the Quality Improvement Compliance Coordinator, Melinda.J.Allie@kpchr.org.

Preparing and Creating an IRB Submission

For help with completing IRB protocols and thinking through study material design, contact an IRB Coordinator, Andrea.Volz@kpchr.org.

Potential HIPAA violations

Email CHR_Compliance@kpchr.org immediately (same day the issue is discovered).

Preparatory to Research (PTR) Request

Submit a completed PTR form to the Manager for Research Analytics, Michael.J.Allison@kpchr.org.

RAMP reviews

Review the options in the IRQ and the Risk Assessment Tool, if applicable.  Contact the Research Compliance Manager, Andrea.M.Seykora@kpchr.org, early in the preparation of your IRB submission with any questions.

Reliance Agreements:

For general help with reliance (or ceding) agreements contact an IRB Coordinator, Andrea.Volz@kpchr.org.

For help with the NIH sIRB mandate, contact the IRB Manager, Kaija.H.Maggard@kpchr.org or IRB Coordinator, Andrea.Volz@kpchr.org.

For help with SMART IRB, contact the IRB Manager, Kaija.H.Maggard@kpchr.org or IRB Coordinator Andrea.Volz@kpchr.org.

Reports of noncompliance or suspected noncompliance

Email CHR_Compliance@kpchr.org.

Reportable New Information (RNI) Questions or Assistance

For help with reporting timelines and what needs to be reported, call or email IRB Manager, Kaija.H.Mggard@kpchr.org.

Kaiser Permanente Center for Health Research
3800 N Interstate Ave.
Portland, OR 97227

  (503) 528-3945

  compliance@kpchr.org

  CHR Website