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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 February 12, 2019

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 team at NW-IRB@kpchr.org.

Data Transfer Request (DTR)

Complete the DTR form in the Data Commitments System to explain how the data will be transferred.  Contact CHR_ComplianceApprovals@kpchr.org if you have questions.

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.)

IRBNet Questions

For questions about your IRBNet application, system access or functionality email NW-IRB@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 Coordinator/Trainer, Mark.J.McNamara@kpchr.org or the IRB Manager, Kaija.H.Maggard@kpchr.org.

IRB Review Status and Questions

Contact the RSPO team at NW-IRB@kpchr.org.

Quality Improvement Monitoring Program

Contact the Research Compliance Program Manager, Melinda.JA.Bodayla@kpchr.org.

Preparing and Creating an IRB Submission

For help with completing IRB protocols and thinking through study material design, contact the IRB team at NW-IRB@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 CHR_complianceapprovals@kpchr.org.

Reliance Agreements:

For general help with reliance (or ceding) agreements contact the IRB team at NW-IRB@kpchr.org.

For help with the NIH sIRB mandate or SMART IRB, contact the IRB Manager,  Kaija.H.Maggard@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

CHR_Compliance@kpchr.org

  CHR Website