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Policies & Guidance
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Policies & Guidance
Policies & Procedures
Human Research Protection Program
NWRC.HRP.001, Definitions
NWRC.HRP.002, Abbreviations
NWRC.HRP.003, Designations
NWRC.HRP.010, Human Research Protection Program
NWRC.HRP.020, IRB Member Review Expectations
NWRC.HRP.021, Legally Authorized Representatives, Children, and Guardians
NWRC.HRP.022, End Approval Dates
NWRC.HRP.023, IRB Records
NWRC.HRP.024, IRB Roster
NWRC.HRP.050, States and Transitions
NWRC.HRP.070, Investigator Obligations
NWRC.HRP.071, Prompt Reporting Requirements
NWRC.HRP.080, IRB Member Review Expectations HUD
NWRC.HRP.090, Collaborative IRB Reliance Arrangements
NWRC.HRP.091, Employees as Research Participants
NWRC.HRP.101, Regulatory Review
NWRC.HRP.102, Designated Reviewers
NWRC.HRP.103, Non-Committee Review Preparation
NWRC.HRP.104, Non-Committee Review Conduct
NWRC.HRP.105, Committee Review Preparation
NWRC.HRP.106, Committee Review Conduct
NWRC.HRP.107, Committee Review Monitoring
NWRC.HRP.108, Minutes
NWRC.HRP.109, Not Otherwise Approvable Research
NWRC.HRP.110, Consultation
NWRC.HRP.111, Post Review
NWRC.HRP.112, New Information
NWRC.HRP.113, Unexpected Incarceration
NWRC.HRP.114, Suspension and Termination by the Organization
NWRC.HRP.115, Response to Questions, Concerns, and Complaints
NWRC.HRP.122, Undue Influence of the HRPP
NWRC.HRP.130, IRB Formation
NWRC.HRP.131, IRB Deactivation
NWRC.HRP.132, IRB Member Addition
NWRC.HRP.133, IRB Member Removal
NWRC.HRP.140, IRB Records Retention
NWRC.HRP.141, Annual Tasks
NWRC.HRP.143, Daily Tasks
NWRC.HRP.144, Meeting Scheduling
NWRC.HRP.170, External IRB Screening
NWRC.HRP.180, Emergency and Compassionate Uses
Health Care Systems Research Network: IRB Review of Multi-Site Research
Financial Conflicts of Interest
NWRC.FCOI.01, Research Financial Conflicts of Interest
FDA-Regulated Clinical Trials
NWRC.FDA.01, Conducting FDA-Regulated Clinical Research at KPNW
SOP KPNW-400, Clinical Trial Site Operations
SOP KPNW-401, Clinical Trial Regulatory Management
SOP KPNW-402, Clinical Trial Subject Management
SOP KPNW-403, Clinical Trial Data Management
SOP KPNW-018, Investigational Drug Accountability and Management for KP Clinical Trials
Privacy
NWRC.PRIV.01, PHI Disclosure Accounting for Research
NWRC.PRIV.02, HIPAA Privacy Rule Authorization for Research
NWRC.PRIV.03, HIPAA Breach Reporting for Research
NWRC.PRIV.04, Data Privacy and Security for Research
Research Integrity & Misconduct
NWRC.RIM.01, Research Integrity and Ethics
NWRC.RIM.02, Responding to Allegations of Research Misconduct
NWRC.RIM.03, Quality Improvement Monitoring (QI-M) in IRB Approved Research
NWRC.RIM.04, Conducting Research in KPNW Medical Facilities
NWRC.RIM.05, Researcher Training
NWRC.RIM.06, Clinical Trial Registration and Reporting
NWRC.RIM.07, Action Plans for Research
Security
NWRC.SEC.01, Electronic Data Destruction Definition and Documentation for Research
NWRC.SEC.02, Physically Moving Research-Related Data
NWRC.SEC.03, Disclosing Information about New Industry-Sponsored Research Proposals and Grants to the RFTC
Guidance Library
A-Z List of Downloadable KPNW Guidance Documents
Aggregate Data Sharing - Considerations
Aggregate Data Sharing - Flowchart
Aggregate Data Sharing - Rules
Care Everywhere Guidelines for Researchers
Checklist for Plain Language Consent Forms
Children in Research and Informed Consent
Children - IRB Determinations
GCP Compliance for Social-Behavioral Research
Genetic Consent Form Language
IRBNet - Adding Removing Staff
IRBNet - FAQ
IRBNet - IRB Submission Guide
IRBNet - Naming Documents in IRBNet
IRBNet - User Guide
IRBNet - User Profile Instructions & Track Training Tool
IRBNet - What's Different in IRBNet
IRBNet - Where to Find Documents in IRBNet
Pregnant Women and Prisoners Decision Charts
Research-Related Training - Ultimate Guide
Researcher Training Matrix
Secondary Use of Data and Biospecimens
Sharing Data Overview - Flowchart
Surrogate Consent
Resources
Ethical Principles & Federal Regulations
Belmont Report
Declaration of Helsinki
Nuremburg Code
21 CFR 50, FDA —Protection of Human Subjects
21 CFR 56, FDA — Institutional Review Boards
45 CFR 46, HHS — “Common Rule”
45 CFR 164 — HIPAA Privacy Rule
Frequently Asked Questions
About the IRB
About the Review Process
Getting Started with a Study
Study Modifications
Reporting to the IRB: Continuing Review, Final Reports, and Reportable New Information
About the eIRB
Genetic Research
Oregon Genetic Privacy Law
Genetic Information Nondiscrimination Act of 2008 (GINA)
NIH Genomic Data Sharing Policy
Glad You Asked: Participants’ Opinion of Re-consent for dbGaP Data Submission
Informed Consent Readability
PRISM Readability Toolkit
PRISM Readability Toolkit Appendix B: Alternative Wording Suggestions
PRISM Website
Quick Reference Guide for Improving Readability
General Resources & References
Certificates of Confidentiality for KP Investigators and IRBs
HIPAA (Health Insurance Portability and Accountability Act)
KFRI Human Research Participant Protection Program Glossary
KPNW IRB Registration with OHRP
OHRP Decision Charts
Revised Common Rule
Effective January 21, 2019
More Information
Browse Guidance by Topic
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Financial Conflict of Interest (FCOI)
Quality Improvement and Monitoring
Related Policies (KP internal)
KP National Compliance Policies
KPNW Compliance Policies
KFRI SOPs
CHR Policies