Faculty Meeting January 26, 2009 Awareness of services for restricted data access IRB focus Some “new” rules A few IRB process tips Guides to common forms.

Slides:

Advertisements

Similar presentations

Human Investigation Committee  Is It Research?  Is It Human Subjects Research?  Is It Human Subjects Research that requires IRB review?

Advertisements

University Data Classification Table* Level 5Level 4 Information that would cause severe harm to individuals or the University if disclosed. Level 5 information.

How to Request Technical Assistance Sera Morgan Department of Health and Human Services Health Resources and Services Administration HIV/AIDS Bureau Division.

Is it Research?. Is It Research? 2 Elements –The project involves a systematic investigation –The design (meaning goal, purpose, or intent) of the investigation.

IRB SUBMISSION PROCESS FOR SHB STUDIES Version 9/18/2013.

Towards Unified Data Security Requirements for Human Research Susan Bouregy, Ph.D., CIP Chief HIPAA Privacy Officer Vice Chair, Human Subjects Committee.

THE UW HEALTH SCIENCES IRB S OVERVIEW PRACTICAL REGULATORY ISSUES IN HUMAN SUBJECTS RESEARCH.

Dr. R. Kirk JonasMs. Carolyn Strong, CIM,CRA Chair, Institutional Review Board Research Compliance Coordinator University of Richmond James Madison University.

Just-in-Time JIT features and UMass approaches. JIT purpose In an effort to focus the NIH review on the science and to save the applicant time and effort,

Data Collection An overview of how data are collected and used in Washington state.

ROLES & RESPONSIBILITIES PRIVACY ACT (PA) SYSTEMS OF RECORDS MANAGERS.

Institutional Review Board And how it affects you.

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

Human Subjects Research Institutional Review Board (IRB) Training.

1 Release 2.0 System Enhancements MAIS Connection Conference November 19, 2008.

What will be Covered? Why the Census is important. How it will affect you. The Census is confidential. How it will work in the Residence Halls and Greek.

NHPRC ELECTRONIC RECORDS RESEARCH FELLOWSHIP SYMPOSIUM Nov. 19, 2004 Rebecca Schulte University of Kansas Project Title: Testing Boundaries—An Exploration.

What Needs HSC Review? Staying compliant with Federal research regulations.

1 JPL Interdivisional Authorizations What is an Interdivisional Authorization? Authorization for Caltech to incur expenses for providing a service to JPL.

(In)Consistency of Economic Data across Federal Statistical Agencies: What Information Professionals Can Do September 29, 2014 Katherine R. Smith, Executive.

Informed Consent and HIPAA Tim Noe Coordinating Center.

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

Health and Wellness for all Arizonans Bureau of EMS and Trauma System Secure, Encrypted, On-Line EMS Services System 2015 Training Programs System Instruction.

Program Integrity. The Cost of Fraud, Waste, and Abuse Between July 2012 and January 2013, the North Carolina Division of Medical Assistance collected.

Federalwide Assurance Presentation for IRB Members.

Cornell Evaluation Network The Use of Human Participants in Research Office of Research Integrity and Assurance ~ May 14, 2007.

Electronic Records Management: What Management Needs to Know May 2009.

NIH Data Sharing Policy University of Nebraska Medical Center.

 Understanding the IRB Process University of Tennessee Health Science Center Institutional Review Board.

State Agency Updates. your “claim” to: DDOE’s amendment act: Styrofoam ban beginning January 1, 2016 Vendors that offer alternative.

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

IACUC Institutional Animal Care and Use Committee.

Tips on Routing and Contracts: An Intro for the Campus Research Coordinator Michelle Artmeier Director of Award Services Ron.

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.

Data Management Lesley A. Brown Director of Proposal Development.

Privacy and Confidentiality. Definitions n Privacy - having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally,

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

The Linguistics Department Institutional Review Board Committee Silvina Montrul, chair Fred Davidson Irene Koshik Ryan Shosted September 22, 2008.

“Surviving an Audit” Al Willie, Office of Internal Audit

THE IRB Ingrid Binswanger RWJ Clinical Scholars Program.

1. Ten Principles of Fair Trading Practice 3 General Principles 1.Consumer Interests and sustainability 2.Freedom of Contract.

Institutional Review Board Protecting Human Research Subjects.

IRBMED IRBMED Seminar Series: Quick Tips Privacy and Confidentiality.

Western Oregon University INSTITUTIONAL REVIEW BOARD.

Brown Bag Series on Research Faculty Protection of Human Subjects in Research February 10, 2012 Gerberding Hall 142, University of Washington.

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.

Eve Powell-Griner National Center for Health Statistics Centers for Disease Control and Prevention National Center for Health Statistics Microdata Release.

Institutional Review Board “IRB Snapshot”. IRB Team Annabelle Casas—Institutional Coordinator for Research Review (extension 7939) Irene Holguin—Grants.

Conducting Research at Lincoln IRB/HRPP Policies, Procedures & Good Clinical Practices B Kanna MD, MPH, FACP Associate Program Director of Internal Medicine.

Clerical Training Adding/Changing Staff Assignments in Campus Independent School District Highway 10 Elk River, MN

Human Subjects Update E. Wethington, Chair, UCHS.

KASSIE M. OBELLEIRO FUNDING OPPORTUNITIES PROGRAM COORDINATOR Using E-media to Find Funding Opportunities April 25, 2012.

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.

 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.

 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.

OHH NOOOO!!!! WHERE IS MY $MONEY$!? CORe Processing – Now and Future.

Tips for Efficient Air Conditioning Maintenance

New Work-Study Student Information

Tips for a Successful IRB Submission

Grants and Contracts Accounting

Research with human participants at Carnegie Mellon University

Reportable Events & Other IRB Updates February 2017

New Faculty Orientation

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.

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

New NIH Human Subjects & Clinical Trials Information

George Alter ICPSR Institute for Social Research

What are the Major Changes to the IRB under the Final Common Rule?

Changes to the Common Rule and Single IRB (sIRB)

Presentation transcript:

Faculty Meeting January 26, 2009 Awareness of services for restricted data access IRB focus Some “new” rules A few IRB process tips Guides to common forms

Support for IRBs and Restricted Data at PSC Staff Lisa Neidert Rhonda Moats Ricardo Rodriguiz Mark Sandstrom IRBs Restricted Data Application Secure Data Environment Contracts/Affidavits Record maintenance Compliance/Reporting

Awareness Public Use Data definition at UM New Exemption (#7) Students on projects Common mistake in Scheduled Continuing Review How to remedy Project site visits How to report

PSC website

Public Use Data at UM ICPSR Roper Selected Federal Agencies Census Bureau NCES NCHS Pre-approved

Additional public use data on UM campus Pre-approved (by request) HRS National Election Studies PSID* Survey of Consumers* Demographic and Health Surveys* International Census files from IPUMS-i* * At the request of PSC

Exemption 7 New classification No more than minimal risk Single dataset Not federally funded or using federal training grants Contract No NIH certificate of confidentiality No other contractual restrictions

Scheduled Continuing Review Confusing choices on form Correct choice Renewal – activity limited to analysis of identifiable data Wrong choice Renewal – activity limited to analysis of de-identified data If “wrong choice is made, the project will be classified as ‘exempt’ which is usually inappropriate Unless it has been classified under Exemption 7

Solutions Guides Filing a Scheduled Continuing Review (SCR) Filing an Adverse Event/ORIO Add Neidert and Moats to IRB as “staff” We can fill out/look over forms PI still has to review and “submit”