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, Submission Statuses and Actions NWRC.HRP.070, Investigator Obligations NWRC.HRP.071, Prompt Reporting Requirements NWRC.HRP.090, Collaborative IRB Reliance Arrangements NWRC.HRP.091, Employees as Research Participants NWRC.HRP.092, Research Participant Exclusion Database 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 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 Best Practices for Sending Emails Care Everywhere Guidelines for Researchers Checklist for Plain Language Consent Forms Children in Research and Informed Consent Children - IRB Determinations Data Commitments Tracking Overview Establishing IRB Reliance with KPNW IRB 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 Guide for PIs IRBNet - User Profile Instructions & Track Training Tool IRBNet - What's Different in IRBNet IRBNet - Where to Find Documents in IRBNet IRBNet - Modification Quick Guide Pregnant Women and Prisoners Decision Charts Reliance Flow Chart - KPNW Relying Reportable New Information - Examples Reportable New Information - Guidance Research-Related Training - Ultimate Guide Researcher Training Matrix Secondary Use of Data and Biospecimens Service Level Expectations Sharing Data Overview - Flowchart Surrogate Consent Top 10 Tips for Speedy IRB Review and Approval 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 IRBNet 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