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

Slides:



Advertisements
Similar presentations
IRB Issues in Medical Education Research – OHRP Perspective American Association of Colleges of Osteopathic Medicine 2 nd Annual Meeting – June 24-26,
Advertisements

Human Investigation Committee  Is It Research?  Is It Human Subjects Research?  Is It Human Subjects Research that requires IRB review?
QI project or research? Thomas F. Byrd M.D. HRRC Chair Subcommitees 2 and 4 December 3, 2013.
Introduction to Human Subjects Research at the University of Michigan – Dearborn. Debra Schneider IRB Administrator (313)
THE UW HEALTH SCIENCES IRB S OVERVIEW PRACTICAL REGULATORY ISSUES IN HUMAN SUBJECTS RESEARCH.
Fundamentals of IRB Review. Regulatory Role of the IRB Authority to approve, require modifications in (to secure approval), or disapprove all research.
Exempt Research Mary Banks BS, BSN IRB Director CRC IRB and BUMC IRB.
 Federal regulations specify “engagement” at the institutional level  Cornell has a Federalwide Assurance specifying its commitment to comply with regulations.
Request For Exemption RFE. A Review of Penn’s Commitment to Research Research is a substantial and esteemed enterprise at Penn. The research community.
8 Criteria for IRB Approval of Research 45 CFR (a)
Is this Research? Exempt? Expedited?
Tasha Osafo, CIP Assistant Director IRB Office Exempt Review.
Quick Facts about Exempt Research No continuing review required IRB Reviewer makes Exempt determination 6 OHRP & 4 FDA categories(1 category overlaps)
How to Obtain Institutional Review Board (IRB) Approval Richard Wagner Associate Director UCSF Human Research Protection Program August 14, 2008.
Conducting Exempt Research An Overview of Human Subjects Protections Issues and the Review Process at ASU Office of Research Integrity and Assurance Institutional.
Expedited vs Exempt by Richard R. Riker MD Vice-Chair, IRB Maine Medical Center.
BRI Institutional Review Board (IRB) Does your project require IRB oversight? By Chris Weir, CIP BRI IRB Manager April 18 th, 2011.
Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director.
Research Ethics The Protection of Human Subjects.
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?
Conducting Exempt Research: An Overview of Human Subjects Protections Issues and the Review Process at ASU.
SLCL Human Subjects Review Committee. Who we are Four faculty from SLCL: – Melissa Bowles, Chair (SIP) – José Ignacio Hualde (Linguistics/SIP) – Jennifer.
The Institutional Review Board: A Community College Toolkit Dr. Geri J Anderson.
IRB BASICS: Issues in Ethics and Human Subject Protections Prepared by Ed Merrill Department of Psychology November 12, 2009.
SUNY Oswego Human Subjects Committee Last Revised 10/28/2011.
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.
Institutional Review Board Procedures and Implications After the applied dissertation committee has approved the proposal and the IRB package, the student.
Determining the Appropriate IRB Application for Your Research August 10, 2015.
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,
UD IRB Guidelines for Applications for: Registrations of exempt research, Expedited IRB review, Full IRB review.
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.
APPROVAL CRITERIA AN IRB INFOSHORT MAY CFR CRITERIA FOR IRB APPROVAL OF RESEARCH In order for an IRB to approve a research study, all.
Human Research Ethics: Issues and Procedures Dr. Constance Jones Chair, Committee for the Protection of Human Subjects.
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.
Human Subjects Research at Mines Colorado School of Mines New Faculty Orientation November 20, 2015.
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.
Human Research Protection Program 101 March 20, 2007 Cincinnati, OH.
 What is an IRB and why do we need one at Western?  Who needs to submit proposals to the IRB?  If approved, how long is your proposal good for?  Is.
Research Ethics Office of Research Compliance. Responsible Conduct of Research (RCR) Covers 9 content areas –Animal Subjects (IACUC) –Human Subjects (IRB)
Created by Steve Martin, PA-C IRB Application Received Exempt Complete Yes No Mississippi College IRB Application Process Determine Review Category Expedited.
 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.
Presentation prepared for GCSU ENGAGE INSTITUTION REVIEW BOARD (IRB): FUNCTION AND SERVICE Tsu-Ming Chiang, Chair Whitney Heppner, Vice Chair Qiana Wilson,
What is exempt research? Angela Bain, IRB Administrator
Institutional Review Board
Submitting human subjects research
University of Central Florida Office of Research & Commercialization
Protection of Human Subjects In Research
Changes to Exempt Categories
University of Central Florida Office of Research & Commercialization
Introduction to the Institutional Review Board
IRB Educational Session - IRB Regulations and Types of Review
Submitting human subjects research
Changes to Exempt Categories
This takes approximately 5 minutes or less from start to finish
Intro to Projects – Research with Human Subjects
What types of research are exempt and ohrp guidance on exemptions
Jeffrey M. Cohen, Ph.D. Associate Dean,
2018 Revised Common Rule: Exemptions
Common Rule Update: Exempt categories UT IRB
Common Rule Changes Effective date is January 21, 2019
IRB Educational Session - IRB Regulations on Expedited Review
Changes to Carthage College IRB processes and forms
What the IRB is looking for when reviewing your protocol
Human Participants Research
Current IRB at DMACC September 2018.
Presentation transcript:

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

What is the Institutional Review Board? The IRB’s purpose is to protect human subjects who participate in research experiments. This includes: –Making sure that subjects are not harmed physically or psychologically as a result of the experiment –Protecting the data collected so that subjects cannot be identified without their consent –Ensuring that subjects understand what they will be asked to do in the experiment, and what their data will be used for –Ensuring that subjects understand the benefits of the research relative to the risks –Ensuring that subjects are not coerced into participating

What is Human Subjects Research? Basically anything that involves collecting data from people, whether it be biological or behavioral data. Examples: –Grammaticality judgments –Elicited productions or comprehension responses in phonetic experiments –Speech data that is in the public domain –Human subjects data that was already cleared by another IRB

Does all Human Subjects Research Receive the Same Level of Scrutiny? No! –Some kinds of research can be classified as exempt according to Title 45, Part 46, Paragraph 101(b) of the Office for Human Research Protections (OHRP), part of the US Department of Health and Human Services –

Title 45, Part 46, Paragraph 101(b) (b) 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: –(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Title 45, Part 46, Paragraph 101(b) –2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. UIUC IRB has agreed to include (non-invasive) production and perception studies under this rubric

Title 45, Part 46, Paragraph 101(b) –(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Title 45, Part 46, Paragraph 101(b) –(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Title 45, Part 46, Paragraph 101(b) –(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

Title 45, Part 46, Paragraph 101(b) –(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Linguistics Department IRB The IRB committee of the Linguistics Department can review proposed research projects and grant an exemption if –The project is reasonably believed by the researcher and the committee to be exempt under (b) –The project is not funded by an outside agency –The project does not involve “vulnerable” populations “such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons” Note that “children” includes anyone under 18, so watch out if you plan to use undergraduates. Also be careful about using your own children. If any of these conditions are not met then the project must be reviewed by the UIUC IRB.

Linguistics Department IRB Review submissions by PI’s conducting human subjects’ research Classify said submissions into one or another of the six exemption categories of Title 45, Part 46, paragraph 101(b). –If a proposal clearly does not fall under one of the exemption categories, the proposal will be returned to the PI, who will be told that they have to submit it for full IRB approval –Similarly, if the committee is unsure of the proposal’s status with respect to exemptions, the committee will refer the proposal to the IRB office. File a copy of the proposal, the protocol and any consent forms associated with the proposal in the Department’s IRB Files Publish and maintain a set of guidelines for human subjects’ research. These guidelines will be available via the Linguistics Department web page.

What you will need to submit A copy of the research proposal An application form that includes a description of the protocol that highlights how the human subjects’ research will be conducted, and why the proposed research should qualify for an exemption.application form If the research involves recruited human subjects (i.e., does not involve human subjects’ data already in existence), copies of subject recruitment and consent forms. A copy of both the IRB certificate of completion and the CITI completion report, certifying that you have completed the two training modules required by the university’s IRB