Policies and Guidance

Joint OHSU-Kaiser Studies

One of the missions of the Investigator Support and Integration Services unit is streamlining IRB processes for investigators, particularly those conducting cross-institutional research, such as OHSU-Kaiser collaborative projects.  Recent initiatives include:

• Agreement of both IRBs to accept each others’ compliance trainings
• Streamlined Principal Investigator requirements 
• Single IRB review of some minimal risk joint OHSU-Kaiser studies

Research Policies

• OHSU IRB Policies and Procedures
• KPNW IRB/Research Subjects Protection Office (RSPO)
• KPCHR Policy on Research Eithics
  For more information, contact Vance Bauer, vance.bauer@kpchr.org.
• OHSU University Research Policies
• OHSU Distinguishing Gifts from Grants, Contracts and Other Sponsored Projects 04-40-01
• OHSU Sponsored Project Budgets and Cost Coverage 04-40-020

OHSU Research Related Health System Policies

• Admitting OHSU Patients Involved in Research
• Adverse Drug Reaction Reporting, Clin 05.01
• Authorization for Use and Disclosure of Protected Health Information, Adm 04.02
• Charges for Research Support, HC-ADM-CAB-P005
• EPIC Access for External Auditors
• Innovative Procedures or Therpaies, HC-CLN-GPC-P024
• Inpatient Orders in Epic
• Drugs Dispensed to Research Subjects, HC-CLN-MPI-P010
• Investigational Gene Therapy Agents, HC-CLN-MPI-P015
• Permitted Uses & Disclosures of Protected Health Information, Adm 04.22
• Research Documentation in the Integrated Health Record, Clin 2.15
• Research Study Rate Request, Account(s) Setup, and Billing of Clinical Services, HC-ADM-CAB-P018
• Right to an Accounting of Disclosures of Health Information, Adm 04.25
• Right to Request Access to Inspect or Obtain a Copy of Protected Health Information, Adm 04.26
• Scope of Practice for Research Assistants/Associates
• Scheduling Research Patients for Outpatient Appointments in Practices on Cadence
• Use of Devices in Patients and Research Subjects, HC-ADM-CAB-P021
• Use of Research Devices and Equipment, Adm 10.04.10

Other OHSU Administrative Guidance

• Budget Development
• Guidance Regarding the International Committee of Medical Journal Editors (ICJME) Requirement for Clinical Trial Registration
• Information Security and Research Data Resource Guide
• 21 CFR11: hospital guidance
• 21 CFR11: eIRB guidance
• Industry Sponsored Clinical Trials
• Proposal Development
• OHSU Research Rates, Registration, Admission, and Charging Processes
• Research Record Retention Requirement Summary
• Scope of Practice for Research Assistants/Associates
• Training Requirements Checklist for Clinical Research Coordinators

Clinical Research Resources

OHSU Clinical Research Core Facilities and Shared Resources

Research Development and Administration (RDA)

• Conflict of Interest in Research
• Institutional Biosafety Committee (IBC)
• Institutional Review Board (IRB)
• Research Contracts and Grants (RCG)
• Sponsored Projects Administration (SPA)
• Radiation Safety

OCI CRM

Portland VA Medical Center (PVAMC) Research and Development Service

External Regulations and Guidance