Research Compliance Newsletter Archive

Summer 2020

  • Gina Exception update and information
  • ClinicalTrials.gov Enforcement Update
  • Resource Roundup
  • Policy updates
  • Mark Mac's Media Corner

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Spring 2020

Single IRB or sIRB, website update, data commitments faqs, policy updates, IRB tips and new information, and Mark Mac's media corner.

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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.

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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.

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Summer 2019

New guidance for health system collaborators, O&A with Nangel Lindberg, policy updates, and IRB announcements.

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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.

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FALL/WINTER 2018

Closing a study before January 4th, 2019, naming documents in the eIRB, external site contacts, and IRB announcements.

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Summer 2018

Timeline for Revised Common Rule, writing a protocol, policy updates, and IRB announcements.

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Spring 2018

Reminders about business associate agreements, new sensitive-data section in eIRB, policy updates and IRB announcements.

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WInter 2018

NIH Single IRB Mandate, Emailing for Recruitment Purposes, Policy Updates, IRB Tips and New Information

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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

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SPRING 2017

Sharing Qualitative Data, Policy Updates, IRB Tips and New Information

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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.

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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.

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Summer 2016

Financial Conflict of Interest (FCOI), Tool for Mobile Health Apps, Continuing Review Summary, Announcements, IRB Tips, Research Compliance Policy Updates

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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

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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

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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

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WINTER 2015

New Consent and Authorization Templates, to Cede or Not, Annual Compliance Training Changes, IRB Tips

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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

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Aug 2014

Does My Project Require IRB Review; Informed Consent and Non-English-Speaking Subjects; Revise and Reconsent" Not Always

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SUMMER 2014

CHR Gets Aboard the Omnibus and Evaluation of Survey Vendors

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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

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WINTER 2013/14

Tips for Preparing a Submission, Research Proposal vs. Research Protocol, IRB Submission Deadlines for 2014, Data Security

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Fall 2013

Research Compliance Organizational Structure, HIPAA Omnibus Final Rule, PHI Can Be Sent Outside the U.S., and More

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Spring 2013

IRB Reliance (Ceding) Requests, Study Materials with Graphics, Genetic Research, and More

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Winter 2012/13

eIRB Updates, Training, RSPO Website Tips, New Standard Statements for Consent Forms

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Summer 2012

Guidelines on Health IT and Social Media, Updated Continuing Review Form, and More

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