Retrospective Chart Review

Slides:

Advertisements

Similar presentations

Ann Johnson IRB Administrator, IRB Member. Objectives 1. Identify the components necessary for management and oversight of tissue repositories used for.

Advertisements

HIPAA – Privacy Rule and Research USCRF Research Educational Series March 19, 2003.

RESEARCH COMPLIANCE Agenda 1. No Destruction of local research documents after scanning 2. Training for shipping biological samples/specimens 3. Regulatory.

1 HIPAA and Research and YOU. 2 INTRODUCTION Rule #1:Don’t Panic Rule #2:Bottom Line for Researchers: HIPAA is Manageable thru Education/Awareness and.

The Research Application Process Charles Morgan, Ph.D. Clinical Investigation Department (CID) Naval Medical Center Portsmouth, VA.

UTHSC IRB Donna Hollaway, RN, CCRC 11/30/2011 Authority to Audit 45 CFR (e) An IRB shall conduct continuing review of research covered by this.

Informed Consent Waivers IRB Health Sciences & Behavioral Sciences University of Michigan /26/20091.

Health Insurance Portability Accountability Act of 1996 HIPAA for Researchers: IRB Related Issues HSC USC IRB.

Implementation of Privacy Board Reviews at PCMC Mary Thomason, Intermountain Healthcare Privacy Board Chair.

Will you be sending data/specimens that meet the criteria of “Identifiable” under HIPAA regulations? No  If data/specimens were collected under UVa protocol-

Office of Research Oversight. Working Group Report Slide 2.

Exempt Research Mary Banks BS, BSN IRB Director CRC IRB and BUMC IRB.

IRB 101: Introduction to Human Subject Research

1 HIPAA, Researchers and the IRB: Session Four Alan Homans, IRB Chair, Nancy Stalnaker, IRB Administrator Michael Caputo, Director of Information Systems.

1 HIPAA, Researchers and the IRB: Session Three Alan Homans, IRB Chair and Nancy Stalnaker, IRB Administrator.

1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.

HRPP Policies & Forms Created/Revised for AAHRPP.

Human Investigation Committee  Is it research?  If yes, does it involve human subjects?  If yes, can it be exempt?  If no, will a Request for.

THE PERFECT PROTOCOL SUBMISSION Cathleen Montano, JD, CIP IRB Manager Jan Hewett, JD, BSN HRPP Director November 20, 2013.

2012 VA IRB Administrators Meeting Stephania H. Griffin, JD, RHIA, CIPP/G VHA Privacy Officer Director, Information Access and Privacy Privacy Officer.

Credentialing for Research Staff Engaged in Human Research Projects at the Atlanta VAMC 1.

Tuesday 13 th October MIREC Documents Procedures MIREC-1 - Terms of Reference & Procedure for MIREC Review of Research Projects Involving Human.

How To Begin Doing Human Subjects Research Teri Bycroft Associate Director of Human Subjects Research.

GW OFFICE OF HUMAN RESEARCH IRB FORUM JULY 2015 NEW FORMS AND POLICIES.

1 NJ Dept. of Health Decision Tree for eIRB Submission Revised: 06/18/2015 Is this research defined as: A systematic investigation which includes research.

IRB Survival: Part 1 Karen Blackwell, MS, CIP Director, Human Research Protection Program Fall 2008.

Primary Care and Community Outreach Research VCOM Institutional Review Board Jim Mahaney, PhD Associate Dean for Biomedical Affairs, Virginia Campus Past.

1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.

Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director.

Privacy Officer Core Responsibilities for Human Research Protection Stephania H. Griffin, RHIA, CIPP/G VHA Privacy Officer.

H I P A A T R A I N I N G Self Directed Module 7 Research Disclosures For Data Custodians START Click to begin…

How to Successfully Apply to the IRB Richard Gordin, IRB Chair True Rubal, Administrator / Director For the Protection of Human Participants in Research.

Paula Peyrani, MD Division of Infectious Diseases University of Louisville The IRB Process What do I need to know? The IRB Process.

Expedited Review – Retrospective studies: A New Path Stephanie Gentilin, MA, CCRAKatherine Bright Director SCTR SUCCESS Center, eIRB Team MemberIRB, Grants.

IRB Insights UTHSC IRB Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change.

VHA Handbook What’s new. General Requirements for Informed Consent A Legally Authorized Representative may not always qualify as a ‘personal representative’

Western Oregon University INSTITUTIONAL REVIEW BOARD.

1 Role of the Privacy Officer on the IRB Stephania H. Griffin, RHIA, CIPP/G VHA Privacy Officer.

Welcome New IRB Members! Today we will discuss: Your Role in the IRB: What to Know The IRB Review Process Resources Human Research Protections.

Human Subjects Research Office of Responsible Research Practices Human Subjects Research Vanessa Hill, MSHS, CCRC Senior Quality Improvement Specialist.

HIPAA and Human Subjects Research IRB Member CE May 2014 Slideshow by Sean Horkheimer.

HRPP Policies & Forms Chapter Two Created/Revised for AAHRPP June 1, 2007.

1 NJ Dept. of Health Decision Tree for eIRB Submission Revised: 01/25/2016 Is this research defined as: A systematic investigation which includes research.

INVESTIGATOR RESPONSIBILITIES C. Karen Jeans, MSN COACH Project Analyst.

1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.

 The purpose of IRB is to ensure the rights of research subjects are protected  In accordance with the ethical standards of the U.S. Department of Health.

IRB University is a set of classes aimed at helping the research community become familiar with submission requirement and the IRB process. Classes are.

HIPAA and RESEARCH 5 th Thursday May 31, Page 2.

Clinical Research Workflow

To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.

Decision Tree for eIRB Submission Revised: 01/25/2016

How to Get an IRB Approval in the First Pass

Introduction to Clinical Trials: Documents and Processes

Decision Tree for eIRB Submission Revised: 01/12/2016

Reasons for Auditing There are many reasons for auditing. Some examples of these reasons might be: Requested by the IRB Committee Requested by an IRB.

Dining with Diabetes IRB Training 2017.

Decision Tree for eIRB Submission Revised: 01/25/2016

Process Describing the Pathway from Initial IRB Submission of a Protocol to Approval of a Study Site Agreement (SSA) and Distribution of Site Agreement.

Anca Miron, PhD IRB Chair, UW Oshkosh Kelly Schill, BS, CIP

Clinical Investigations

Institutional Review Board

RESEARCHER SUBMITS IRB APPLICATION TO HURON COMPLETE CITI TRAINING

Michael Linke, PhD, CIP Professor Department of Internal Medicine

Click conflicts of interest

FDP Data Transfer and Use Agreement (DTUA) Template and Pilot

Case Study Retrospective review of patient’s medical record with intent to document a specific situation or the experience of an individual without intent.

Making Your IRBs and Clinical Investigators HIPAA-Ready

Sleep SMART Clinical Trial Agreements / Regulatory Webinar

Michael Linke, PhD, CIP Professor Department of Internal Medicine

Research with Human Subjects

Presentation transcript:

Retrospective Chart Review Research that involves existing data, documents records or specimens. IRB determination required. Documents: Worksheet HRP-337 Documents Required for Research on Existing Records or Specimens Protocol Template HRP-503.10 Research Involving Existing Data, Documents, Records or Specimens Cost Analysis Request for waiver of consent (Item #21 on Protocol Template) HIPAA waiver HRP-502.2 Administrative Approval from Department Chair CITI training complete COI Disclosure complete Valid agreement with any third party participating in the research