Winter 2022 IRBs from KPNW, KPGA, KPWA and KPCO Combine to Form IRB-Hydra-Like-Creature Ceded Study Updates – What does the IRB need to see and when do they need to see it? Consent Guidance for Decisionally Impaired Adults Mark Mac’s Media Corner Open Newsletter
Summer 2021 Staffing changes at the CHR RSPO, updated waver of consent/authorization form and accompanying guidance, compensation for KP employees for research, IRB tips and new information, and Mark Mac's Media Corner Open Newsletter Spring 2021 New consent language for participants payments, developing a mobile medical app, be sensitive about the use of sensitive data, policy updates, IRB tips and new information, and Mark Mac's contest corner. Open Newsletter Winter 2021 Breaking down continuing review, consent information sheet template now available, tips on submitting an inquiry, policy updates and Mark Mac's contest corner. Open Newsletter Summer 2020 Gina Exception update and information, ClinicalTrials.gov Enforcement Update, Resource Roundup, Policy updates, Mark Mac's Media Corner Newsletter Spring 2020 Single IRB or sIRB, website update, data commitments faqs, policy updates, IRB tips and new information, and Mark Mac's media corner. Open Newsletter Winter 2020 Research compliance has moved, what happens when research participants call the compliance manager, opinions- regulation of decedent data under HIPAA, policy updates, IRB tips and new information, Mark Mac's Media Corner. Open Newsletter Fall/Winter 2019 RSPO satisfaction survey results are in, express exemption pilot says farewell, IRBNet automated reports, IRB tips and new information, and Mark Mac's media corner. Open Newsletter Summer 2019 New guidance for health system collaborators, O&A with Nangel Lindberg, policy updates, and IRB announcements. Open Newsletter Spring 2019 IRBNet is hot right now, new common rule makes some types of research uncommonly easy to get IRB approval, social/behavioral research and good clinical practice, policy updates, IRB tips, and new information. Open Newsletter FALL/WINTER 2018 Closing a study before January 4th, 2019, naming documents in the eIRB, external site contacts, and IRB announcements. Open Newsletter Summer 2018 Timeline for Revised Common Rule, writing a protocol, policy updates, and IRB announcements. Open Newsletter Spring 2018 Reminders about business associate agreements, new sensitive-data section in eIRB, policy updates and IRB announcements. Open Newsletter WInter 2018 NIH Single IRB Mandate, Emailing for Recruitment Purposes, Policy Updates, IRB Tips and New Information Open Newsletter FALL 2017 Most Published Research Findings Are False, New Common Rule: Benign Behavioral Interventions, NIH Releases Updated Policy on Certificates of Confidentiality, Policy Updates, IRB Tips and New Information Open Newsletter SPRING 2017 Sharing Qualitative Data, Policy Updates, IRB Tips and New Information Open Newsletter WINTER 2017 New Regulations and NIH Policy: ClinicalTrials.gov Registration and Results Reporting, Refresher Training for Human Subjects Protection, Quality Improvement Monitoring Program Update, IRB Tips and New Information. Open Newsletter Fall 2016 Involving Pregnant Women in Research, Researcher Training – Financial Conflicts of Interest, Human Subjects, and Good Clinical Practice, Policy Updates, IRB Tips and New Information. Open Newsletter Summer 2016 Financial Conflict of Interest (FCOI), Tool for Mobile Health Apps, Continuing Review Summary, Announcements, IRB Tips, Research Compliance Policy Updates Open Newsletter Spring 2016 Change in IRB Chair, Change in Process for 'Approval in Concept', Non-KP Collaborators and Access to KP PHI, eIRB Upgrade Update, Naming Study Documents in the Upgraded System, IRB Tips and New Information Open Newsletter Winter 2016 New Cede Request Flowcharts, When do I Submit a Final Report to Close my Study?, Why do I Need to Complete Non-Required Sections of My IRQ?, eIRB Upgrade Update, Modification Descriptions and the IRQ, IRB Tips and New Information Open Newsletter FALL 2015 Continuing Review Reminders, Genetic Exclusion Database, Certificates of Confidentiality, HIPAA Privacy Rule Authorization for Research, Hello from the New Research Compliance Manager, Quality Improvement Monitoring Program Update, IRB Tips and New Information Open Newsletter WINTER 2015 New Consent and Authorization Templates, to Cede or Not, Annual Compliance Training Changes, IRB Tips Open Newsletter FALL 2014 Surprise! We're Here for an Inspection; Quality Improvement Monitoring Visits; Breaking It Down; Project Components and IRB Exemption; eIRB Tips From the Pros Open Newsletter Aug 2014 Does My Project Require IRB Review; Informed Consent and Non-English-Speaking Subjects; Revise and Reconsent" Not Always Open Newsletter SUMMER 2014 CHR Gets Aboard the Omnibus and Evaluation of Survey Vendors Open Newsletter Spring 2014 Prepare a Study Application, IRB Study 'Approval in Concept' for Funding Agencies, Key Elements of Informed Consent and Consent Waivers, Assistance Visits for Study Teams Open Newsletter WINTER 2013/14 Tips for Preparing a Submission, Research Proposal vs. Research Protocol, IRB Submission Deadlines for 2014, Data Security Open Newsletter Fall 2013 Research Compliance Organizational Structure, HIPAA Omnibus Final Rule, PHI Can Be Sent Outside the U.S., and More Open Newsletter Spring 2013 IRB Reliance (Ceding) Requests, Study Materials with Graphics, Genetic Research, and More Open Newsletter Summer 2012 Guidelines on Health IT and Social Media, Updated Continuing Review Form, and More Open Newsletter Winter 2012/13 eIRB Updates, Training, RSPO Website Tips, New Standard Statements for Consent Forms Open Newsletter