National Death Index: Monitoring the Slippery Slope Lou Saadi, Ph.D. Kansas NAPHSIS Annual Meeting, 2007 Salt Lake City, Utah.

Slides:



Advertisements
Similar presentations
The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects.
Advertisements

Is it Research?. Is It Research? 2 Elements –The project involves a systematic investigation –The design (meaning goal, purpose, or intent) of the investigation.
Records and Information Management: An Overview. What are Records? Records - Any recorded information regardless of physical form/characteristics or storage.
1 The HIPAA Privacy Rule and Research This presentation will probably involve audience discussion, which will create action items. Use PowerPoint to keep.
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.
BOARD OF DIRECTORS REPORT 2010 – 2011 CYCLE. CONTENTS PART ONE: MAJOR ACHIEVEMENTS PART TWO: MAJOR CHALLENGES PART THREE: HIGHLIGHTS OF THE BOARD PLAN.
Fundamentals of IRB Review. Regulatory Role of the IRB Authority to approve, require modifications in (to secure approval), or disapprove all research.
IRB Determinations 1. AAHRPP Site Visit Results Site visitors observed a real commitment to human subject protections Investigator and research staff.
Welcome Welcome and thank you for agreeing to become an External Examiner for Goldsmiths, University of London. Our External Examiners play an important.
Birth and Death Data Release and Re-release Laws, Regulations, Policies and Procedures: State Survey Results 8 June, 2004 NAPHSIS – Portland, OR Mark Flotow,
International Civil Aviation Organization Regional Cooperation in the Southern African Development Community (SADC) Cliff Elbl CTA/Project Coordinator.
Recently Issued OHRP Documents: Guidance on Subject Withdrawal and Draft Revised FWA Secretary’s Advisory Committee on Human Research Protections October.
CUMC IRB Investigator Meeting November 9, 2004 Research Use of Stored Data and Tissues.
OFFICE OF INSURANCE REGULATION CURRENT STATE OF DISCOUNT MEDICAL PLAN ORGANIZATIONS (DMPOs) IN FLORIDA FLORIDA OFFICE OF INSURANCE REGULATION.
An Introduction to the Hennepin County Hennepin County GIS Technical Advisory Group (eGTAG) 10/20/2009.
Telemedicine Credentialing and Privileging October 16, 2014.
Evaluation. Practical Evaluation Michael Quinn Patton.
Brookhaven Science Associates U.S. Department of Energy 1 Brookhaven National Laboratory Protocol Compliance Monitoring Darcy Mallon May 7, 2009.
NATIONAL DEATH INDEX U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Center for Health Statistics.
© 2014 Public Health Institute PROPOSAL WRITING.
Network security policy: best practices
Health Insurance Portability and Accountability Act (HIPAA)
Is this Research? Exempt? Expedited?
What Will My Records Retention Schedule Look Like ?
Pharmacy and Therapeutics Committee
By Garland Land NAPHSIS Executive Director. Performance Measures Committee Dorothy Harshbarger, Alabama Dorothy Harshbarger, Alabama Barry Nangle, Utah.
 You can participate if :  You have cancer, including breast, ovarian, and other cancers, or  Your family members have cancer including breast, ovarian,
Presentation on Managing for Development Results in Zambia By A. Musunga Director M&E MOFNP - Zambia.
Copyright © 2014 by The University of Kansas Using the Evaluation System to Answer Key Questions About Your Initiative.
ORO Reviews: Frequent Findings Related to IRBs Bob Brooks Associate Director Research Compliance Education and Policy VHA Office of Research Oversight.
Resources, Recruitment, Qualifications, Complaints….Oh My! UC DAVIS OFFICE OF RESEARCH May 22, 2014 Miles McFann, CIP Outreach, Training and Education.
Future Use of Stored Samples & Data and the NIH Policy on GWAS and dbGaP NIAID/DAIDS Dione Washington, M.S. -- ProPEP Sudha Srinivasan, Ph.D.-- TRP Tanisha.
National Program of Cancer Registries
Continuity of Change: Where We Have Come From, Where We Are Going New Orleans, LA June 5 th – June 9 th, 2011 Model Law Revision Overview Alvin T. Onaka,
RESPONSIBLE CONDUCT IN HUMAN SUBJECTS RESEARCH MARGARITA M. CARDONA DIRECTOR OF SPONSORED RESEARCH Institutional Review Board.
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…
JJ Jamieson MIC Chair JGC update September 2014 Salt Lake City.
Department of Health and Human Services Office of the Assistant Secretary for Health (ASH) Advisory Committee on Blood Safety and Availability (ACBSA)
Building Clinical Infrastructure and Expert Support Michael Steinberg, MD, FACR ULAAC Disparity Project Centinela/Freeman Health System.
Who’s Keeping Score? Changes in the Vital Records and Statistics Infrastructure in the Computer Age Daniel J. Friedman The NAPHSIS/NCHS Collaboration—
UC DAVIS OFFICE OF RESEARCH Overview of Good Clinical Practices (GCP) Investigator and Study Team Responsibilities Miles McFann IRB Administration Training.
Centers for Disease Control and Prevention National Center for Health Statistics Melonie Heron, Ph.D. & Robert N. Anderson, Ph.D. Mortality Statistics.
Strengthening Partnerships: Shaping the Future Portland, OR June 6 th – 10 th, 2004 MISSION: Crafting an Integrated, Streamlined & Efficient Customer Service.
Office of Research & Development (ORD) Local Accountability of Research 2009 Baltimore, Maryland January 13-14, 2009 “Meeting the Current Challenges of.
Knowing What ¢ount$: Connecting Performance to the Budget
NAPHSIS Annual Meeting 2014Slide 1 NAPHSIS ANNUAL MEETING | Seattle | June 8-11, 2014 VITAL RECORDS: A CULTURE OF QUALITY Changes to Identity Information.
An Investigative Journalist Wants to Know: “What’s Really Killing America?” Lou Saadi, Ph.D. Kansas Innovations NAPHSIS Annual Meeting, 2009 Baltimore,
Innovative Contracting Opportunities?” Lou Saadi, Ph.D. Kansas Innovations NAPHSIS Annual Meeting, 2009 Baltimore, Maryland.
Copyright © 2014 by The University of Kansas Using the Evaluation System to Answer Key Questions About Your Initiative.
HIPAA and Human Subjects Research IRB Member CE May 2014 Slideshow by Sean Horkheimer.
Investigational Devices and Humanitarian Use Devices June 2007.
1 Drug Safety Oversight Board: Recent Activities FDA Science Board Advisory Committee Meeting March 31 st, 2006 Douglas C. Throckmorton, MD Deputy Director.
National Workshop on ANSN Capacity Building IT modules OAP, Thailand 25 th – 27 th June 2013 KUNJEER Sameer B Exercise on online nomination process & suggestions.
Society for Pediatric Research: Perspective on Maintenance of Certification February 2016.
Human Research Protection Program 101 March 20, 2007 Cincinnati, OH.
Research Ethics Office of Research Compliance. Responsible Conduct of Research (RCR) Covers 9 content areas –Animal Subjects (IACUC) –Human Subjects (IRB)
THE INSTITUTIONAL REVIEW BOARD. WHAT IS AN IRB? An IRB is committee set up by an institution to review, approve, and regulate research conducted under.
Shared Services and Third Party Assurance: Panel May 19, 2016.
Title of Presentation A Roundtable Discussion: Pay Equity Issues
Conditional IRB Approval
Managing Patient Contact Studies at a Central Registry
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)
University of Central Florida Office of Research & Commercialization
University of Central Florida Office of Research & Commercialization
Introduction to OSHA (Part 1)
Consent Training Module
SCHS and Health Statistics
In Argentina Ana Palmero Legal and Research Ethics Advisor
Performance Achievement a quick reference guide to
Clearinghouse Access Agreements
Presentation transcript:

National Death Index: Monitoring the Slippery Slope Lou Saadi, Ph.D. Kansas NAPHSIS Annual Meeting, 2007 Salt Lake City, Utah

NAPHSIS membership represented on the NDI advisory committee  Alvin Onaka, Hawaii  Bob Hayman, Maryland  Richard Genovese, New York City  Lou Saadi, Kansas  Other members of the advisory committee include those conducting research from the private sector, public health, other government and universities.

We all Participate in NDI via contract  States provide identifiable death information to the NDI for research purposes only (no administrative, legal or other non-statistical uses).  There is a rigorous application process to obtain data from NDI and fees apply.  Many researchers wish to discover whether a person in a cohort they are studying has died only and they provide names to the NDI (Routine NDI request). Others also wish to capture the cause of death and may or may not know the name of the decedent (NDI Plus).  Requests are made to NCHS staff for screening, processing and tracking.  Advisors are sent requests and once consensus is achieved, data are provided to the requester.

Examples of Research that benefit from NDI  Costs and consequences of gastrointestinal bleeding events  Diet and survival from ovarian cancer in Illinois Women  Epidemiology, infectivity and natural history of Hepatitis C virus infection in a blood donor population  Many worthy studies that will contribute to medical knowledge. However, our job is to assure the data are being used appropriately and within the criteria established by the advisors.

Recently strengthened criteria for NDI applications  Criteria hadn’t been officially changed since There was a concern that with new technologies and more educated users, criteria needed to be re-evaluated.  Registries were allowed to keep data indefinitely and without justification for continued maintenance of NDI data.  No evidence of IRB approval for research.

Recently strengthened criteria for NDI applications  Researchers have to indicate the when they will dispose of data. All fields related to NDI will be destroyed as well as linkage fields.  Exception: Registries are allowed to maintain data indefinitely as long as they provide justification as to why the data needs to be retained. Researchers can make the case for longer retention if justified.

Issues often addressed with applications  Determining whether the use of the data fit within the guidelines of non-administrative use and focusing on research and statistics.  Assuring all involved in the project are accounted for and proper signatories are in place.  Assuring the information provided “jives” with use and dispensation of the data.

States may be asked to provide paper copies of certificates  Depending on the state’s preference, a researcher may ask a state for a copy of the certificates needed to conduct followback or other uses.  Are states seeing many of these requests or are these diminishing since NDI Plus gives most researchers cause of death?

Other issues  Do states have any issues they wish to address regarding NDI issues?  Concerns?  Thank you