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Research Compliance Team

Melinda Bodayla
- Program Manager, Research Compliance
- Melinda.JA.Bodayla@kpchr.org
- (503) 335-6753

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.

Kaija Maggard
- Manager, IRB
- Kaija.H.Maggard@kpchr.org
- (503) 335-6699
Samuel Wasmann
- Chair, IRB
- Samuel.I.Wasmann@kp.org
- (503) 335-3945
Mark McNamara
- Coordinator/Trainer, IRB
- Mark.J.McNamara@kpchr.org
- (503) 335-6712
Alex Mitchell
- Coordinator, IRB
- Alex.D.Mitchell@kpchr.org

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 disclosure approvals	Submit a Data Transfer Request in the Data Commitments Tracking System.
Aggregate Data disclosure approvals	See the Aggregate Data Transfer Flowchart and Rules on Sharing Aggregate Data
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 N W-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 N W-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 N W-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.