Tarleton State University

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

QI project or research? Thomas F. Byrd M.D. HRRC Chair Subcommitees 2 and 4 December 3, 2013.
Is it Research?. Is It Research? 2 Elements –The project involves a systematic investigation –The design (meaning goal, purpose, or intent) of the investigation.
Evaluation and Human Subjects Research Julie M. Aultman, Ph.D. Chair, Institutional Review Board Associate Professor, Family and Community Medicine Northeast.
IRB SUBMISSION PROCESS FOR SHB STUDIES Version 9/18/2013.
Introduction to Human Subjects Research at the University of Michigan – Dearborn. Debra Schneider IRB Administrator (313)
Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Human Subjects Research and the Marian University Institutional Review Board (IRB)
Institutional Review Board Guidance.  Independent Ethics Committee  Ethical Review Board  Research Ethics Committee 2.
 Daylene Meuschke, Ed.D Barry Gribbons, Ph.D RP Conference: April 2, 2013.
Exempt Research Mary Banks BS, BSN IRB Director CRC IRB and BUMC IRB.
IRB 101: Introduction to Human Subject Research
IRB-Investigator/ Research Coordinator Mtg. “Research with Human Tissues at Columbia” March 9, 2004 George Gasparis Columbia University Medical Center.
CUMC IRB Investigator Meeting Human Subjects Research Non-Compliance September 15, 2005.
 Federal regulations specify “engagement” at the institutional level  Cornell has a Federalwide Assurance specifying its commitment to comply with regulations.
Cooperative Research IRB Brownbag, 3/4/08. ISU Policy Cooperative research projects are those projects which involve more than one institution. The official.
CUMC IRB Investigator Meeting November 9, 2004 Research Use of Stored Data and Tissues.
IRB Basics Helen Panageas New York University School of Medicine Institutional Review Board Portion of slides courtesy of Suzanne M. Smith, University.
Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research
RESEARCH COMPLIANCE: Health Sciences Institutional Review Board.
Is this Research? Exempt? Expedited?
Federalwide Assurance Presentation for IRB Members.
How To Begin Doing Human Subjects Research Teri Bycroft Associate Director of Human Subjects Research.
Avoiding the Pitfalls of an IRB Submission Chris Ayres Chair, Institutional Review Board Social & Behavioral Science & Chair, Department of Kinesiology,
April 2011 Conducting Research at SPC Approval Process and Procedures Center of Excellence for Teaching and Learning.
RESPONSIBLE CONDUCT IN HUMAN SUBJECTS RESEARCH MARGARITA M. CARDONA DIRECTOR OF SPONSORED RESEARCH Institutional Review Board.
The Institutional Review Board: A Community College Toolkit Dr. Geri J Anderson.
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.
SUNY Oswego Human Subjects Committee Last Revised 10/28/2011.
Investigators’ Responsibilities in Conducting Human Subjects Research Dept. of Regulatory Affairs April 18, 2012.
Human Subjects Research at ASU An Overview. Overview Definitions Historical Framework Federal Guidelines Human Subjects Research at ASU.
A step-by-step guide to help you determine if your research protocol is required to be reviewed by the Lindenwood University IRB INSTITUTIONAL REVIEW BOARD.
Dustin Yocum, MA Institutional Review Board University of Illinois HUMAN SUBJECTS RESEARCH.
Institutional Review Board Issues for Classroom Research Sharon McWhorter IRB Administrator, The University of Akron (With assistance from Phil Allen,
Human Subjects Review: Policies and Procedures. Why A Human Subjects Review? It is the policy of this University that all researchers undertaking studies.
Human Subjects Research Nellie Quezada-Aragon, Director Office of Compliance Dr. Luis A. Vazquez, Chair NMSU Institutional Review Board
CUNY Human Research Protection Program (HRPP) School of Professional Studies April 18, 2013
Paul Kelly Facility Research Compliance Officer for the Ralph H. Johnson VA Medical Center.
Conducting Research at Lincoln IRB/HRPP Policies, Procedures & Good Clinical Practices B Kanna MD, MPH, FACP Associate Program Director of Internal Medicine.
Human Subjects Protection Program Office of Research Compliance Navigating through the current HSPP and IRB Presented by: Danielle Griffin, M.S. Research.
Paul Hryvniak MS, CIP Alyssa Speier, MS, CIP September 30, 2014 Student Human Research Education Session Tel:
© 2015 Marketo, Inc. Marketo Proprietary and Confidential Page 1 Investigators’ Responsibilities in Conducting Human Subjects Research Office of the Vice.
Protecting Human Subjects in Research A Primer on Understanding the Scope, Purpose, and Process of the Kaplan University IRB Prepared by the Office of.
Human Subjects Research at Mines Colorado School of Mines New Faculty Orientation November 20, 2015.
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.
Protecting Human Subjects Overview of the Issues Applications to Educational Research The IRB Process.
University Committee on Human Subjects (UCHS) Our contract with the Federal government is our “Federalwide Assurance” (FWA), and our FWA number is FWA
COCE Institutional Review Board Academic Spotlight
University of Charleston’s
University of Central Florida Office of Research & Commercialization
Introduction to IRB (Institutional Review Board)
Research with human participants at Carnegie Mellon University
SOU Institutional Review Board
shades of gray: When is IRB approval required?
University of Central Florida Office of Research & Commercialization
USC Institutional Review Boards
What Every Harvard LMA Student Investigator Should Know
SOU Institutional Review Board
Does My Project Require HRPP/IRB Review?
This takes approximately 5 minutes or less from start to finish
What Every Harvard LMA Student Investigator Should Know
What types of research are exempt and ohrp guidance on exemptions
CUNY Human Research Protection Program (HRPP)
Everything You Wanted to Know about UOPX IRB
Human Participants Research
Valdosta State University
Research with Human Subjects
Research Compliance: Protections for Research Subjects
Presentation transcript:

Tarleton State University Human Subjects Institutional Review Board Sally Lewis-Human Subjects IRB Chair Tarleton State University

All Human subjects research must have IRB approval prior to beginning the research project.

Human Subjects Research Review and Approval The Institutional Review Board (IRB) reviews research involving human subjects. The IRB may deem projects as Exempt, may approve projects as Expedited or require Full Board review before approval.

Human Subjects Research Scope Any activity that involves research with human subjects that is conducted by System member personnel in the course of their employment by the System member, or uses System member facilities or resources.

Human Subjects Research Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45CFR46.102).

Human Subjects Research Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains Data through intervention or interaction with the individual, or Identifiable private information. (45CFR46.102)

Human Subjects Research Examples of activities that may be human subject research: Surveys and Interviews Taking blood from living individuals for research The use of specimens or data from a repository or database Program evaluation, program assessment or demonstration project conducted for research Pilot studies, preliminary studies, or other preliminary research with human subjects Classroom research Observing or recording private behavior Obtaining private identifiable information that has been collected about or provided by individuals

Human Subjects Regulations US Department of Health & Human Services Office of Human Subjects Research Protections (OHRP) 45 CFR part 46 TAMUS Regulations Tarleton State University Compliance

IRB Sponsored Projects Office of Sponsored Projects Office of Research Compliance IRB IACUC IBC Office of Faculty Research Proposal development and submission Office of Student Research and Creative Activities Student research support

Office of Sponsored Projects Office of Research Compliance Office of Faculty Research Office of Student Research and Creative Activities Mekka Steinruck Compliance Coordinator (until 3/30/2016) Dr. Roger Wittie Executive Director

INSTITUTIONAL REVIEW BOARD MEMBERS  COMMITTEE FOR HUMAN SUBJECTS Dr. Sally Lewis  - Chair Dr. Barry Lambert, Institutional Official and Chief Research Officer [ex officio] Dr. Jordon Barkley, COE Representative Dr. Gerald Burch, COBA Representative Dr. Elaine Evans, COST Representative Dr. Chris Gearhart, COLFA Representative Dr. Mike Haynes, IE Representative Dr. Charlie Howard, Prisoner Advocate Dr. Curtis Langley, COA Representative Ms. JoAnne Phillips, Community Representative Dr. Roger Wittie, Ex-Officio

Institutional Review Board for the Use of Human Subjects

IRB 2014: TAMUS Internal Audit Tarleton State University does not have adequate processes and controls in place to ensure compliance with laws and policies governing human subject research. A review of existing human subject protection processes identified multiple conditions and instances of noncompliance with A&M System requirements. Although TSU's IRB was established in 2001 to oversee human subject research, the university does not have a functioning Human Subject Protection Program (HSPP) in place and established procedures are not adequately documented and do not meet federal and A&M System requirements. Without a fully functioning HSPP, the university is not in compliance with federal regulations related to federally funded research involving human subjects which could lead to penalties, loss of research funding, and reputational damage to the university. The university has recently put forth significant effort to create and implement procedures to improve their HSPP and IRB processes and bring them in compliance with A&M System regulations and federal laws.

IRB Process PI Determines if research is HS research? Determines if research is eligible for exempt or expedited review. Completes proposal form and submits to IRB (Mekka Steinruck) IRB Completes Clerical Review (CITI;COI; completeness; Cooperating Facilities) Assigns review to IRB Member(s) Provides weekly update to Reviewers Completes Administrative Documentation of Review Provides PI with recommendations

IRB Process PI Completes recommendations and resubmits entire proposal to Mekka Steinruck IRB Reviewer documents recommendations were included in re-submission Reviewer makes recommendation to IRB Chair for approval Chair approves proposal Completes research Maintains required documents and statistics Files Continuing Review or Amendment form if required

IRB Process PI Completion/termination document Stores documents relating to research for compliance audit IRB Monitors compliance

Human Subjects Decision Charts Is your research human subjects research? In what category of research does your project belong? Exempt Expedited Full Board Review

Training for PI’s and Researchers CITI

Proposal Form