Exempt Unless otherwise required by Department or Agency heads, research activities in which the only involvement of human subjects will be in one or more.

Slides:

Advertisements

Similar presentations

QI project or research? Thomas F. Byrd M.D. HRRC Chair Subcommitees 2 and 4 December 3, 2013.

Advertisements

Protecting the Privacy of Family Members in Survey and Pedigree Research Jeffrey R. Botkin, MD, MPH University of Utah.

Human Subjects Research at UCAR Overview of the Process September 9, 2014 Meg McClellan UCAR Chief Legal Officer.

Expedited Review Procedure Expedited Review Procedure Initial Review of Research.

Jeopardy Rules Game show host will divide the room into two teams When you know the answer, raise your hand and wait to be called on Your answer must.

OHRP Electronic Access Web Site:

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

Human Research Protection Program Training CHR Introductory Training: Protecting Human Research Subjects Melanie Mace, MA Education Coordinator, HRPP

 Federal regulations specify “engagement” at the institutional level  Cornell has a Federalwide Assurance specifying its commitment to comply with regulations.

8 Criteria for IRB Approval of Research 45 CFR (a)

Determinations of Research, Human Subjects Research, Exemptions, and Expedited Review Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst, Program for.

Is this Research? Exempt? Expedited?

Precursor Preference in Surfactant Synthesis of Newborns Sarah Frankel, PhD Human Studies Committee Washington University School of Medicine.

Quick Facts about Exempt Research No continuing review required IRB Reviewer makes Exempt determination 6 OHRP & 4 FDA categories(1 category overlaps)

Institutional Review Board

Dana Evans 1 1 Exempt & Expedited Human Subjects Research.

IRB Triage: What Path Do I Follow? IRB Administrators 2012 PRIDE/ Theresa M. Straut, CIP, RAC May 30, 2012.

Expedited vs Exempt by Richard R. Riker MD Vice-Chair, IRB Maine Medical Center.

What is your Acronym IQ? ASC DOC DOS FYS SACS NEH NIH OSHA IRB TGIF.

The IRB Approval Process Michael Bingham, JD Assistant Director, University of Wisconsin-Madison Education IRB

Expedited Procedures Bob Craig June Expedited problems Usually individual investigators (rather than trained coordinators) Individuals not “ active.

Risk by Richard R. Riker MD Vice-Chair, IRB Maine Medical Center.

Committee on Human Research Processes Clinical Translational Research Fellowship Program Curriculum Core.

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

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.

Stanley Estime, MSCI, CIP Senior QA/QI Specialist Lisa Gabel, CIP QA/QI Specialist IRB Determinations: What type of Review will your study receive?

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

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.

Determining the Appropriate IRB Application for Your Research August 10, 2015.

UD IRB Guidelines for Applications for: Registrations of exempt research, Expedited IRB review, Full IRB review.

Determinations of Research, Human Subjects Research, Exemptions, and Expedited Review Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for.

NAVIGATING THE IRB PROCESS University Institutional Review Board California State University, Stanislaus.

Determining the Appropriate IRB Application for Your Research June 7, 2011.

Case Studies: Puzzles in Human Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst, Program for Research Integrity Development and Education.

Regulations 201: Thorny Issues What is Research? Exempt and Expedited Reviews.

WELCOME to the TULANE UNIVERSITY HUMAN RESEARCH PROTECTION OFFICE WORKSHOP for SOCIAL/BEHAVIORAL RESEARCH (March 2, 2010) Tulane University HRPO Uptown.

 Epidemiology -- Research – or Not Research? Medical Research Summit March Tom Puglisi, PhD.

Betsy Ripley, MD, MS Professor of Medicine Division of Nephrology VCU IRB Senior Chair VCU Clinical Research Compliance Officer Associate Chair Faculty.

Joni Barnard IRB Information Session: EHE Workshop 10/13/2015.

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.

EXPEDITED PROTOCOL REVIEW AN IRB INFOSHORT APRIL 2013.

Human Specimen Repositories Requirements of 21 CFR Parts 50 & 56 PRIM & R May 5, 2004 Sally A. Hojvat, Ph.D. Director of Microbiology Devices Office of.

Levels of Review of Research and Quality Improvement Walter Kraft, MD Associate Director, Office of Human Subjects Protection Department of Pharmacology.

Human Research Protection Program 101 March 20, 2007 Cincinnati, OH.

HUMAN SUBJECTS QUIZ! TRUE OR FALSE?

Research Ethics Office of Research Compliance. Responsible Conduct of Research (RCR) Covers 9 content areas –Animal Subjects (IACUC) –Human Subjects (IRB)

0 Ethics Lecture Research. ACADEMY OF OPHTHALMOLOGY Disclosures  The speaker has no financial interest in the subject matter of this.

Created by Steve Martin, PA-C IRB Application Received Exempt Complete Yes No Mississippi College IRB Application Process Determine Review Category Expedited.

Protecting Human Subjects Overview of the Issues Applications to Educational Research The IRB Process.

FDA Drug Advisory Committee Pediatric Ethics Subcommittee Gonadotropin Releasing Hormone Agonist Test in Disorders of Puberty CHARGE TO COMMITTEE Norman.

What is exempt research? Angela Bain, IRB Administrator

Institutional Review Board

University of Central Florida Office of Research & Commercialization

University of Central Florida Office of Research & Commercialization

Introduction to the Institutional Review Board

Lana Gevorkyan Corporate Director Human Research Protection Program

IRB Educational Session - IRB Regulations and Types of Review

USC Institutional Review Boards

This takes approximately 5 minutes or less from start to finish

What types of research are exempt and ohrp guidance on exemptions

Jeffrey M. Cohen, Ph.D. Associate Dean,

Human Subject Research

Common Rule Update: Exempt categories UT IRB

IRB Educational Session - IRB Regulations on Expedited Review

Determining the Appropriate IRB Application for Your Research

What the IRB is looking for when reviewing your protocol

Human Participants Research

Valdosta State University

Current IRB at DMACC September 2018.

Presentation transcript:

Exempt Unless otherwise required by Department or Agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:  [Exemptions b(1-6)] [45 CFR (b)]  Exemption categories 1-5 are not applicable to research governed by FDA regulations (21 CFR 50.20)

Categories of Exempt Research 1. Research conducted in established educational settings, involving normal educational practices 2. Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior 3. Same as # 2, but covers elected officials 4. Research involving use of existing data 5. Research and demonstration projects by approval of agency heads

Exempt if it is “ONLY”… Research in one or more exempt categories, for example, an anonymous survey of adults. AND NOT research in any covered research category, for example, collecting private identifiable data from future records.

What are the Covered Research Categories? Identifiable private information? Vulnerable populations? Subjects vulnerable to coercion or undue influence? Treatments or procedures? Incomplete Information? These types of activities would not qualify for exemption.

What research activities are eligible for expedited review? No more than Minimal Risk. Must fit one or more of the categories on the Expedited Review Categories List [Authority: 45 CFR and 21 CFR ] Minor changes in previously approved research during the period for which the approval is authorized

Minimal risk …means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological tests. (45 CFR (i))

Expedited Categories Clinical studies of drugs and medical devices only under specific conditions Collection of blood samples Biological specimens obtained by non-invasive means Collection of data through non-invasive procedures Materials collected solely for non-research purposes Collection of data from voice, video, etc. Research employing surveys, etc. (OMB Issue) Continuing review under specific conditions