IRB for Humanists. Naomi E. Coll, MPH, CPH, CIP Manager of Research Integrity
|
|
- Alfred Payne
- 5 years ago
- Views:
Transcription
1 IRB for Humanists Naomi E. Coll, MPH, CPH, CIP Manager of Research Integrity Grace Caskie, Ph.D. Associate Professor Counseling Psychology IRB co-chair Patti Manz, Ph.D. Associate Professor School Psychology IRB co-chair
2 Today s Agenda 1. What is the IRB? 2. Defining Human Subjects Research 3. Informed Consent 4. Submitting IRB applications 5. IRB review 6. Upcoming changes to the regulations 7. FAQs and your questions
3 What is the IRB? Institutional Review Board independent committee. Review, approve, monitor research with human subjects. Scientific validity Ethical review protect human subjects Composition requirements: Diverse, at least 5 members, scientists, non-scientists, at least 1 member not affiliated with the University
4 Belmont Report Foundation for today s IRB system. Outlines ethical research principles: 1. Respect for persons = informed consent 2. Beneficence = favorable risk/benefit assessment 3. Justice = selection of subjects
5 What is human subjects research? Research = a systematic investigation designed to develop or contribute to generalizable knowledge. Systematic = system, method, plan. Generalizable = universally or widely accepted.* *Note does not apply to student research at LU
6 What is human subjects research? Human subjects = living individuals about whom an investigator conducting research obtains either: 1. Identifiable private information OR 2. Data through intervention or interaction
7 Identifiable Information Individual identities can be readily ascertained or associated with the information.
8 Private Information 1. Information about a behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. OR 2. Information provided for a specific purpose in which the individual can reasonably expect that it will not be made public.
9 Physical procedures. Intervention Manipulation of the individual or their environment for research purposes. *Interaction* Communication or interpersonal contact with individuals.
10 Interaction most common for research in the humanities Surveys/questionnaires Interviews Focus groups
11 Minimal risk 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 exams or tests
12 Informed Consent Central to the protection of participants. Both a process and a procedure: Process = exchange of information before, during, after Procedure = developing an informed consent document and having the participant sign
13 8 Required Elements of Informed 1. Activities involve research, the purpose, duration, procedures, and which procedures are experimental 2. Foreseeable risks/benefits 3. Appropriate alternatives 4. Extent to which confidentiality will be maintained
14 8 Required Elements of Informed Consent (continued) 5. [research which may result in injury does not apply] 6. IRB contact information 7. Participation is voluntary, refusal to participate will involve no penalty or loss of benefits, and subject is free to withdraw any time 8. Additional elements as appropriate
15 Informed Consent Templates that include all elements of informed consent are posted on the IRB website.
16 Waiving or Altering Informed Consent Some or all of the 8 elements may be waived or altered. Must meet regulatory criteria listed in IRB policy. Must be approved in advance by IRB.
17 Waiving Written Documentation of Informed Consent Some studies may be approved to waive documentation of informed consent (i.e. no signed consent document). Must meet regulatory criteria listed in IRB policy. Must be approved in advance by IRB. IRB may require the investigator to provide subjects with a written statement regarding the research.
18 Vulnerable Populations Regulatory and consent implications: Adults who are unable to consent Infants, teenagers, children Pregnant women Prisoners Must be indicated in your inclusion criteria. Must be approved in advance by the IRB.
19 Submitting an application to the IRB Must have advanced approval of the IRB. Submit at least six weeks in advance. Guidance, worksheets, FAQs, policy on IRB website. IRBNet - tutorials on IRB website.
20 Submitting an application to the IRB All investigators must complete NIH Protecting Human Research Participants online tutorial. All investigators must sign IRBNet package prior to submission to IRB. Faculty must serve as PI and lead the process.
21 Submitting an application to the IRB A new protocol application includes: Protocol application form NIH certificates (for faculty first time, for students each time) Consent documents Recruitment materials (flyers, , etc.) Letters of permission for research in schools or similar institutions
22 Three levels: 1. Exempt 2. Expedited 3. Full committee IRB Review
23 IRB Review Exempt Review Six categories of research are eligible for exempt review. Three categories are the most common for humanists
24 IRB Review Exempt Review Educational tests, survey procedures, interview procedures, observation of public behavior, unless: Information is recorded in such a manner that subjects can be identified, and Identification could place subjects at reasonable risk of criminal or civil liability or be damaging to their reputation, financial standing, or employability. * If children only applies for observation of public behavior if investigator not participating in activities being observed or use of educational tests
25 IRB Review Exempt Review Research using educational tests, surveys, interviews, or observation of public behavior not exempt under cat. 2, if subjects are elected or appointed public officials or candidates for office, or federal statutes require without exception that confidentiality will be maintained.
26 IRB Review Exempt Review Collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if sources are publically available and information is recorded so that subjects cannot be directly or indirectly identified.
27 Additional requirements for exempt research: No more than minimal risk. Equitable subject selection. If recording identifiable information must be adequate provisions to maintain confidentiality. If interacting with subjects - must be a consent process that includes: Disclosure that the activities involve research Procedures Participation is voluntary Name and contact info for investigator Adequate protection of privacy
28 IRB Review Expedited Review Minimal risk only. Apply to all ages, except where noted. May not be used when identification of subjects can be damaging to their financial standing, employability, insurability, reputation or be stigmatizing, unless protections are implemented so risk of confidentiality breach is no greater than minimal.
29 IRB Review Expedited Review Nine categories of research are eligible for expedited review. Three categories are the most common for humanists
30 IRB Review Expedited Review Research involving materials (data, documents, records, specimens) that have been collected or will be collected for research purposes.
31 IRB Review Expedited Review Collection of data from voice, video, digital, or image recordings made for research purposes.
32 IRB Review Expedited Review Research on individual or group characteristics or behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methods.
33 IRB Review Full Committee Review Protocols that are not qualified for exempt or expedited review are referred for full committee review. Must be submitted at least four weeks in advance of the IRB meeting date. IRB meetings - second Tuesday of each month.
34 IRB Review Determinations Approved Modifications Required to Secure Approval A response submission must be submitted in IRBNet If conditions are met, approval is issued Disapproved (rare) Do not proceed with any aspect of your research without approval in hand!
35 Investigator s Post-Approval Obligations Continuing Review for expedited and full review protocols. Modifications for all protocols (exempt, expedited, full review). Submit reportable events as required to the IRB. Conduct research according to IRBapproved protocol.
36 Upcoming changes to the regulations Changes to the Common Rule (federal regulations) were finalized at end of Obama s term. Take effect 2018/2019. Fairly likely that they will not be signed into law under the current administration.
37 FAQs 1. My protocol meets the exempt review criteria, do I have to submit an application to the IRB?
38 FAQs Yes IRB must make the exempt determination.
39 FAQs 2. I m not collecting any identifiable information, do I need to submit an application to the IRB?
40 FAQs Yes if you are actively collecting any data, even de-identified, through intervention or interaction. If you are using existing data (e.g. secondary datasets, biological specimens), you may not require review. You must contact the IRB first.
41 FAQs 3. When can I begin recruiting?
42 FAQs You must have official IRB approval (i.e. approval notice on IRB letterhead) prior to any interaction with subjects, including recruiting, data collection, etc.
43 FAQs 4. Can the IRB approve a project retroactively?
44 FAQs No federal regulations do not allow retroactive approval.
45 FAQs 5. How does informed consent for online research (e.g. surveys) work?
46 FAQs Implied consent by knowingly participating, i.e. completing the survey, the subject is providing consent. This is a form of waiving documentation of informed consent. Must meet criteria for approval.
47 FAQs 6. When do I have to submit a Modification for my IRB-approved project?
48 FAQs You must submit an amendment when the study design, informed consent procedures, or research personnel changes. Submit it in advance of making the change. Wait for approval *exception remove immediate hazard (must submit report to IRB afterwards).
49 Questions? Naomi E. Coll, MPH, CPH, CIP
Research. + Human Subjects Protections for. IRB Review and Approval at UW. October, Bailey Bodell, CIP. Reliance Administrator
+ Human Subjects Protections for Research IRB Review and Approval at UW October, 2017 Bailey Bodell, CIP Reliance Administrator UW Human Subjects Division (HSD) + Topics for today Human subjects regulations
More informationProtecting Human Subjects In Social-Behavioral-Educational Research:
Protecting Human Subjects In Social-Behavioral-Educational Research: Working with the IRB Lloyd Byrd, MS Chair, VCU IRB Panel E Member, VCU IRB Panel B Monika S. Markowitz, Ph.D. Director, Office of Research
More information*Explain the purpose & role of the IRB *Explain the IRB Review Categories *Discuss the potential risks to research participants
Explain the purpose & role of the IRB Explain the IRB Review Categories Discuss the potential risks to research participants Discuss the informed consent process Review the IRB Submission Process The Institutional
More informationINSTITUTIONAL REVIEW BOARD
INSTITUTIONAL REVIEW BOARD Policies and Definitions promotes and supports human research. Basic tenets of human research are voluntary participation and the ethical treatment of the subjects in the research
More informationOffice of Research Compliance. Research Involving Human Subjects
Office of Research Compliance Research Involving Human Subjects Office of Research Compliance Three FTE and one student worker Facilitate the IACUC We are not the IRB or the IACUC Best way to contact us
More informationEXEMPT RESEARCH. Investigators should contact the IRB Office if there are questions about whether an amendment consists
EXEMPT RESEARCH Introduction Many educational, behavioral, and social science studies present little or no risk to the participants. Likewise, research involving existing data, medical records, and pathologic
More informationHuman Subjects Research: Overview. Colleen Kohashi and Tani Prestage Office for the Protection of Human Subjects (OPHS) February 26, 2016
Human Subjects Research: Overview Colleen Kohashi and Tani Prestage Office for the Protection of Human Subjects (OPHS) February 26, 2016 Topics to be Covered Am I doing human subjects research?; Risk determinations
More informationProtection of Human Subjects Policies and Procedures
Protection of Human Subjects Policies and Procedures Introduction Wilmington University has a functioning committee and procedures to review and approve all research involving human subjects. All human
More informationIRB FREQUENTLY ASKED QUESTIONS. 1. Who must apply for human subjects review through the IRB (Institutional Research Board)?
IRB FREQUENTLY ASKED QUESTIONS 1. Who must apply for human subjects review through the IRB (Institutional Research Board)? All Regis University faculty, students (graduate and undergraduate), and staff
More informationPhone Numbers: (work) (cell/home) Phone Numbers: (work) (cell/home)
CLARKSON COLLEGE Institutional Review Board (IRB) Application INSTRUCTIONS: Applicants, please complete the following sections accordingly Section 1 and Section IV completed by ALL applicants; Section
More informationPROTECTION OF HUMAN SUBJECTS
PROTECTION OF HUMAN SUBJECTS Human Subjects Policy Statement Lesley University is committed to the ethical principles for the protection of human subjects in research set forth in the Belmont Report of
More informationIRB, IDEATE, AND HSR. February, 2018 Manuel Gonzalez
IRB, IDEATE, AND HSR February, 2018 Manuel Gonzalez Outline What is the IRB? Human Subjects Research and Researcher Responsibilities Citi Certification Ethical Principles Revisions etc. Submitting Studies
More informationREQUIRED INSTITUTIONAL REVIEW BOARD (IRB) EDUCATIONAL READING FOR FLETCHER SCHOOL RESEARCHERS APPLYING FOR EXEMPTION FROM IRB
REQUIRED INSTITUTIONAL REVIEW BOARD (IRB) EDUCATIONAL READING FOR FLETCHER SCHOOL RESEARCHERS APPLYING FOR EXEMPTION FROM IRB Please read the following text, adapted from the CITI Education Module (Braunschweiger,
More informationIRB EXPEDITED REVIEW
IRB EXPEDITED REVIEW Research activities that (1) present no more than minimal risk* to human research participants, and (2) involve only procedures listed in one or more of the following categories may
More informationIRB GRAND ROUNDS SOCIAL AND BEHAVIORAL RESEARCH: NEED TO KNOW
IRB GRAND ROUNDS SOCIAL AND BEHAVIORAL RESEARCH: NEED TO KNOW Vivienne Carrasco, MPH,CIP Senior IRB Regulatory Analyst, Social and Behavioral Sciences Human Subject Research Office University of Miami
More informationPOLICIES GOVERNING PROCEDURES FOR THE USE OF ANIMALS IN RESEARCH AND TEACHING AT WESTERN WASHINGTON UNIVERSITY and REVIEW OF HUMAN SUBJECT RESEARCH
Appendix 9 POLICIES GOVERNING PROCEDURES FOR THE USE OF ANIMALS IN RESEARCH AND TEACHING AT WESTERN WASHINGTON UNIVERSITY and REVIEW OF HUMAN SUBJECT RESEARCH INTRODUCTION It is the policy of Western Washington
More informationINSTITUTIONAL REVIEW BOARD (IRB) PROCESS AND GUIDELINES FOR CONDUCTING RESEARCH AT ORANGE COAST COLLEGE
1 INSTITUTIONAL REVIEW BOARD (IRB) PROCESS AND GUIDELINES FOR CONDUCTING RESEARCH AT ORANGE COAST COLLEGE Developed by: Dr. Eduardo Jesús Arismendi-Pardi Department of Mathematics Sheri Sterner Office
More informationQ5 If there is more than one faculty researcher, then enter co-researchers information (Name, address)
IRB Online Submission 2015 Q1 IRB Online Submission for Review Name) Primary Investigator's Name (Last Name, First Q2 E-mail address of primary investigator Q3 Nature of Project Faculty Research Project
More informationInstitutional Review of Research Involving Human Participants. IRB Presentation. University of Central Florida Office of Research & Commercialization
Institutional Review of Research Involving Human Participants IRB Presentation University of Central Florida Office of Research & Commercialization 407-823-2901 or fax 407-823-3299 www.research.ucf.edu/compliance/irb.html
More informationType of Review Requested:
Type of Review Requested: FOR OFFICE USE ONLY IRB Protocol # Exempt [Status (see RR 101)] Expedited Full Board For details regarding types of review, please see Levels of Review under FAQ at www.seu.edu/irb
More informationIDENTIFYING, ASSESSING, AND RESOLVING ISSUES IN SOCIAL, BEHAVIORAL, AND EDUCATIONAL RESEARCH (SBER)
IDENTIFYING, ASSESSING, AND RESOLVING ISSUES IN SOCIAL, BEHAVIORAL, AND EDUCATIONAL RESEARCH (SBER) Cynthia Monahan, MBA, CIP IRB Director Boston University Charles River Campus Objectives Overview of
More informationAPPLICATION/RESEARCH PROTOCOL REVIEW FORM
APPLICATION/RESEARCH PROTOCOL REVIEW FORM For Research Involving Human Participants Institutional Review Board (IRB) Contact Information: The Office of Research and Sponsored Programs (Billy C. Black Building,
More informationResearch Involving Human Subjects: Ethics, Process, and Guidance for Streamlining IRB Review
Research Involving Human Subjects: Ethics, Process, and Guidance for Streamlining IRB Review Graduate Medical Education October 9, 2013 Cortni Romaine Education and Outreach Coordinator Office of Human
More informationMDCH IRB REVIEW APPLICATION Authority: Code of Federal Regulations Title 45 Part 46
The Michigan Department of Community Health Institutional Review Board for the Protection of Human Research Subjects Capitol View Building, 7 th Floor, 201 Townsend Street, Lansing, MI 48913 Phone: 517/241-1928
More informationNorthwestern University Institutional Review Board (IRB)
Northwestern University Institutional Review Board () Kathleen E. Murphy, PhD, CIP Manager, Social and Behavioral Role in Research The sole mission of the is the protection of humans who participate in
More informationIRB Reviewer Worksheet for Expedited Reviews
IRB Reviewer Worksheet for Expedited Reviews This reviewer worksheet is copied with modifications from Khan and Kornetsky s Overview of Initial Protocol Review printed in IRB Management and Function (2006).
More informationIRB Red Flags How to Know When IRB Review May Be Needed
IRB Red Flags How to Know When IRB Review May Be Needed Human Research Protection Program Presented by Catherine Higgins, Ph.D., CIP, CIM HRPP Director Historical Ethical Atrocities Tuskegee Syphilis Study
More information1. What is your role in the AAHRPP accreditation process?
Investigator Responsibilities AAHRPP accreditation is a gold standard recognizing adherence to a rigorous set of human subjects protection standards that go beyond federal and state requirements. It communicates
More informationInstitutional Review Board. Policies and Procedures
Institutional Review Board Policies and Procedures Revised: November 2015 Originally Adopted: July 1, 1995 Office of the Provost IRB Policy and Procedures 2 Table of Contents Section 1: Overview... 3 1.2
More informationNorthwestern University Institutional Review Board (IRB)
Northwestern University Institutional Review Board () Marcella Oliver Education Specialist Role in Research The sole mission of the is the protection of humans who participate in research.. It is not to
More informationTENNESSEE STATE UNIVERSITY HUMAN SUBJECTS COMMITTEE
TENNESSEE STATE UNIVERSITY HUMAN SUBJECTS COMMITTEE RESEARCH PROPOSAL FORM This proposal is: (check where applicable) Dissertation Research: Grant Proposal: Funding Agency: Master's Thesis Research: Faculty
More informationHuman Subjects Protection Specialist October 22 nd, 2010
The Research Subjects Review Board (RSRB) Kathleen Buckwell Human Subjects Protection Specialist October 22 nd, 2010 What is Institutional Review Board (IRB)? A A University established system of ethical
More informationHSPC/IRB Description of Research Form (For research projects involving human participants)
HSPC/IRB Description of Research Form (For research projects involving human participants) This form is to be completed by the Principal Investigator (P.I.) of the research project being submitted to the
More informationProtection of Research Subjects: The IRB Process
Protection of Research Subjects: The IRB Process Ethics in Patient-Oriented Research October 13, 2010 Sharon Friend Director, OHRPP Overview Charge and Function of the IRB Conducting Risk and Benefit Assessments
More informationHuman Research Protection Program Institutional Review Board Procedure
Page 1 of 10 DESCRIPTION INSTITUTIONAL REVIEW BOARD REVIEW OF RESEARCH INVOLVING PRISONERS Prisoners may be under constraints because of their incarceration that could affect their ability to make a truly
More informationLevels of IRB Review
IRB Member s Handbook Page 41 Levels of IRB Review All research involving humans that falls under the jurisdiction of the IRB for review and approval must meet the criteria for one of the following methods
More informationRevised Common Rule: Next Steps
Revised Common Rule: Next Steps Agenda To what does this Final Rule apply? When does it become effective? How is UM preparing? New and revised definitions Changes to the exempt categories Single IRB review
More informationRESEARCH INVOLVING HUMAN PARTICIPANTS EXPEDITED/FULL APPLICATION
This information listed below should be submitted to Florida Tech s IRB if the proposed research has more than minimal risk (none of the exempt conditions apply) or if the research utilizes a special population
More informationInvestigator s Handbook for the Protection of Human Participants in Research Institutional Review Board Revised February 23, 2017
Investigator s Handbook for the Protection of Human Participants in Research Institutional Review Board Revised February 23, 2017 Dear Antioch University Principal Investigator: This handbook is intended
More informationFinal Rule Material: Changes to Exempt Categories
Final Rule Material: Changes to Exempt Categories Lorna Hicks, MS Duke University 2017 Biomedical Research Alliance of New York LLC CITI Program is a division of BRANY CITI Program Final Rule Materials
More informationInstitutional Review Boards and Human Subjects Protection
Institutional Review Boards and Human Subjects Protection Professor Ron Fricker! Naval Postgraduate School! Monterey, California! 6/25/12 1 Goals for this Lecture! A nasty little bit of history! The Belmont
More informationCollegeof Central Florida Protection of Human Subjects
Collegeof Central Florida Protection of Human Subjects Presented by CF Institutional Review Board Adapted from materials provided by Frances Jeffries, Ph.D., Consultant, Bridgewater, Mass., to Sinclair
More informationINSTITUTIONAL REVIEW BOARD HANDBOOK Guide for Research involving Human Subjects Effective June 2016 with the Implementation of IRBManager
INSTITUTIONAL REVIEW BOARD HANDBOOK Guide for Research involving Human Subjects Effective June 2016 with the Implementation of IRBManager Table of Contents Page Frequently Asked Questions 2 Guidelines
More informationMC IRB Protocol No.:
APPLICATION FORM - INITIAL REVIEW INSTITUTIONAL REVIEW BOARD Room 117 Main Building 555 Broadway Dobbs Ferry NY 10522 Phone: 914-674-7814 / Fax: 914-674-7840 / mcirb@mercy.edu MC IRB Protocol No.: Date
More informationProtecting Human Subjects
Grand Canyon University Institutional Review Board 2014 Handbook Version 7.0 Protecting Human Subjects College of Doctoral Studies 3300 West Camelback Rd. Phoenix, AZ 85017 Phone: 602-639-7804 Email: irb@gcu.edu
More informationPOLICIES AND PROCEDURES FOR RESEARCH INVOLVING HUMAN SUBJECTS ST. MARY'S UNIVERSITY HUMAN SUBJECTS COMMITTEE Institutional Review Board
POLICIES AND PROCEDURES FOR RESEARCH INVOLVING HUMAN SUBJECTS ST. MARY'S UNIVERSITY HUMAN SUBJECTS COMMITTEE Institutional Review Board Approved IRB 10/6/2009 Revised IRB 7/30/2013-2/7/2014 TABLE OF CONTENTS
More informationInstitutional Review Board (IRB) Handbook
Institutional Review Board (IRB) Handbook 2013-2014 Revised July 1, 2013 University of the Rockies 555 E. Pikes Peak Avenue Colorado Springs, Colorado 80903-3612 (719) 442-0505 www.rockies.edu CONTENTS
More informationFlorida A&M University IRB & Investigator Manual
Florida A&M University Florida A&M University Institutional Review Board Room 130 Dyson Building 1520 S Martin Luther King Jr. Blvd Tallahassee, FL 32307 Phone: (850) 412-5246 Fax: (850) 412-5012 Email:IRB@famu.edu
More informationBARNARD COLLEGE Application for the Approval of the Use of Human Subjects in Research
BARNARD COLLEGE Application for the Approval of the Use of Human Subjects in Research Project Title Principal Investigator Name and highest earned degree: Office Phone: Facsimile Phone Number: Department:
More informationSALISBURY UNIVERSITY COMMITTEE ON HUMAN RESEARCH APPLICATION FOR RESEARCH INVOLVING HUMAN SUBJECTS
SALISBURY UNIVERSITY COMMITTEE ON HUMAN RESEARCH APPLICATION FOR RESEARCH INVOLVING HUMAN SUBJECTS If you have a full committee review: 1. Your proposal must be submitted at minimum 14 days before the
More informationInstitutional Review Board Application
Institutional Review Board Application Ashoka University values research that is conducted with high standards of scholarship and ethics. The Institutional Review Board (IRB) ensures that the University
More informationInstitutional Review Board Policy and Guidelines Primary Author: Dennis M. Sullivan, MD, MA (Ethics) (Revised: 2/5/2018)
Institutional Review Board Policy and Guidelines Primary Author: Dennis M. Sullivan, MD, MA (Ethics) (Revised: 2/5/2018) I. INTRODUCTION The Institutional Review Board (IRB) is a faculty panel whose task
More informationDepartment of the Navy Human Research Protection Program
Department of the Navy Human Research Protection Program Exempt Research and Expedited Review March 2013 Unclassified Statement A: Approved for public release; distribution is unlimited IRB Review Decision
More informationPROVIDENCE CHRISTIAN COLLEGE INSTITUTIONAL REVIEW BOARD APPLICATION TO USE HUMAN PARTICIPANTS IN RESEARCH
PROVIDENCE CHRISTIAN COLLEGE INSTITUTIONAL REVIEW BOARD APPLICATION TO USE HUMAN PARTICIPANTS IN RESEARCH Before completing this application, please review Procedures for Obtaining Institutional Approval
More informationSummary of Changes to Human Subjects Regulations: Effective January 21, 2019
Summary of Changes to Human Subjects Regulations: Effective January 21, 2019 The New Human Subjects Regulations - What does it all mean? This guide serves to assist Clemson University researchers to understand
More informationAPPLICATION TO INVOLVE HUMAN SUBJECTS IN RESEARCH (Form IAUPRIRB-1)
INTER AMERICAN UNIVERSITY OF PUERTO RICO INSTITUTIONAL REVIEW BOARD APPLICATION TO INVOLVE HUMAN SUBJECTS IN RESEARCH (Form IAUPRIRB-1) TITLE*: PRINCIPAL INVESTIGATOR S NAME, TELEPHONE AND POSTAL ADDRESS*:
More informationPolicies and Procedures Manual Human Subjects Institutional Review Board (IRB)
Policies and Procedures Manual Human Subjects Institutional Review Board (IRB) Northwestern State University Natchitoches, Louisiana 71497 an Institution in the University of Louisiana System Revision
More informationResearch Ethics: A Brief Introduction. February 2017 Dina Shafey, Associate Director, ORE
Research Ethics: A Brief Introduction February 2017 Dina Shafey, Associate Director, ORE dshafey@sfu.ca Why Does Research Ethics Matter? Tuskegee syphilis experiment 1932-1972 Objectives Apply the three
More informationRESEARCH INVOLVING PRISONERS
RESEARCH INVOLVING PRISONERS Office of Research 1. Overview Federal regulations require additional protections for prisoners involved in research. These requirements include, among other things, that research
More informationKate Gallin Heffernan (Chair) (617) Mark A. Borreliz (617)
Decision Charts for tice of Proposed Rulemaking for the Federal Policy for the Protection of Human Subjects 80 Fed. Reg. 53933 (Sep. 8, 2015) ( NPRM ) These decision charts were prepared on September 29,
More informationOHRP Guidance on the Involvement of Prisoners in Research
NOTE: THIS GUIDANCE REPLACES THE FOLLOWING OHRP GUIDANCE: "OHRP Guidance on Approving Research Involving Prisoners" (May 19, 2000) found on the OHRP website at: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/prison.htm
More informationDETERMINING WHETHER AN ACTIVITY IS HUMAN SUBJECTS RESEARCH AS DEFINED BY FEDERAL REGULATIONS
Page 1 of 6 Human Research Protection Page: 1 of 6 DETERMINING WHETHER AN ACTIVITY IS HUMAN SUBJECTS RESEARCH AS DEFINED BY FEDERAL REGULATIONS DESCRIPTION Any proposed activity involving contact with
More informationDepartment of the Navy Human Research Protection Program
Department of the Navy Human Research Protection Program Research Involving Human Subjects August 2013 Regulations Four sources: 32 CFR 219 (Common Rule) DoDI 3216.02 SECNAVINST 3900.39D 21 CFR 50 and
More informationThe Chinese University of Hong Kong. Survey and Behavioural Research Ethics
The Chinese University of Hong Kong Survey and Behavioural Research Ethics GUIDELINES FOR SURVEY AND BEHAVIOURAL RESEARCH ETHICS A. Scope Survey and behavioural research covers surveys as well as observation
More informationRevised August 28, 2018
Florida State University Human Subjects Committee Standard Operational Procedure (SOP) 7-IRB-26 Title: Responsible Executive: Approving Official: Prisoners as Research Subjects Gary K. Ostrander Gary K.
More informationLanguage for Consent Forms
New York University University Committee on Activities Involving Human Subjects 665 Broadway, Suite 804, New York, NY 10012 VOICE: 212-998-4808 FAX: 212-995-4304 www.nyu.edu/ucaihs/ Language for Consent
More informationHuman Research Participant Protection Program
Human Research Participant Protection Program Guidance on IRB Review of International Research Issued: 6/3/14 I. Subject: Research conducted by Cornell University investigators outside of the United States
More informationOHRP - Guidance on Research Involving Coded Private Information or Biological Specimens
OHRP - Guidance on Research Involving Coded Private Information or Biological Specimens NOTE: THIS GUIDANCE REPLACES OHRP S AUGUST 10, 2004 GUIDANCE ENTITLED GUIDANCE ON RESEARCH INVOLVING CODED PRIVATE
More informationPolicy and Procedure Regarding Use of Human Subjects in Research
(Note: all queries about this policy may be directed to Dr. Atta Gebril, Chair of the Institutional Review Board for the Protection of Human Subjects, at agebril@aucegypt.edu) Policy and Procedure Regarding
More informationNavigating the Regulatory Requirements of Pediatric Research Nathan Lee, CIP Vice Chair, Schulman IRB
December 15, 2016 Navigating the Regulatory Requirements of Pediatric Research Nathan Lee, CIP Vice Chair, Schulman IRB About Schulman IRB Established in 1983 Superior audit history with FDA five consecutive
More informationResearch Ethics: The Protection of Human Subjects. Presented by: Cindy Morgan Office of Research Integrity
Research Ethics: The Protection of Human Subjects Presented by: Cindy Morgan Office of Research Integrity WHY IS THERE AN INSTITUTIONAL REVIEW BOARD (IRB)? 1947 (26) Nazi physicians were tried at Nuremberg,
More informationHuman Subjects Application for Full IRB and Expedited Exempt Review
Human Subjects Application for Full IRB and Expedited Exempt Review 1. Project Title and Identification As Principal Investigator of this study, I assure the IRB that the following statements are true:
More informationMichigan Technological University
Michigan Technological University Human Subjects in Research Institutional Review Board (IRB) Policy and Procedures Compliance, Integrity, and Safety Office (CIS) Lakeshore Center Houghton, MI 49931 Phone:
More informationThe AAA statement on Ethnography and Institutional Review Boards (2004) provides a useful working definition:
Ethnographic Research and IRB-SBS Protocols INTRODUCTION The Department of Anthropology has drafted the following guidelines intended to help inform the process of IRB oversight of ethnographic research
More informationPreliminary Research Considerations. Lecture Overview. Stephen E. Brock, Ph.D., NCSP
Preliminary Research Considerations Stephen E. Brock, Ph.D., NCSP California State University, Sacramento 1 Lecture Overview Research Hypotheses Research Resources Exemptions from Human Subjects Committee
More informationSUBJECT: SJMHS Institutional Review Board(s): Vulnerable Populations - Research Involving Prisoners
MANUAL: Administrative Policy & Procedure Manual SJMHS Locations: St. Joseph Mercy Ann Arbor, St. Joseph Mercy Chelsea, St. Joseph Mercy Livingston, St. Mary Mercy Livonia POLICY: Persons meeting the federal
More informationFlorida State University Policy 7-IRB-26
Florida State University Policy 7-IRB-26 Title of Policy: Special Categories of Research: Prisoners as Research Subjects. Responsible Executive: Gary K. Ostrander Approving Official: Gary K. Ostrander
More informationHuman Subject Institutional Review Board Proposal Form
FOR IRB USE ONLY Protocol Number: IRB- Human Subject Institutional Review Board Proposal Form Activity Title: PRINCIPAL INVESTIGATOR ASSURANCE I agree to use procedures with respect to safeguarding human
More informationIRB Research Handbook. Research Compliance The Office of Research and Graduate Studies Southern Methodist University
IRB Research Handbook Research Compliance The Office of Research and Graduate Studies Southern Methodist University Table of Contents Resources...1 Role and Authority of the IRB...2 Composition of the
More informationBAPTIST HEALTH SOUTH FLORIDA INSTITUTIONAL REVIEW BOARD INVESTIGATOR RESPONSIBILITIES WHEN CONDUCTING HUMAN SUBJECT RESEARCH
BAPTIST HEALTH SOUTH FLORIDA INSTITUTIONAL REVIEW BOARD INVESTIGATOR RESPONSIBILITIES WHEN CONDUCTING HUMAN SUBJECT RESEARCH Original Release Date: November 2011 Course Expiration Date: November 2014 Overview:
More informationAN INVESTIGATOR S GUIDE TO RESEARCH WITH HUMAN PARTICIPANTS
Institutional Review Board Sponsored Programs Office, Buckham Hall 206 1300 Elmwood Avenue, Buffalo, NY 14222 Federalwide Assurance ID#: 00007126 AN INVESTIGATOR S GUIDE TO RESEARCH WITH HUMAN PARTICIPANTS
More informationFinal Rule Material: New and Revised Definitions
2017 Biomedical Research Alliance of New York LLC CITI Program is a division of BRANY Final Rule Material: New and Revised Definitions Content Author Gary L. Chadwick, PharmD, MPH, CIP University of Rochester
More informationFlexibility and Informed Consent Process
Flexibility and Informed Consent Process April 30, 2014 Regulatory & Ethical Requirements for Informed Consent Megan Kasimatis Singleton, JD, MBE, CIP Associate Director, IRB Dave Heagerty IRB 8 Coordinator
More informationIRB Review Points to Consider September 2016
POINTS TO CONSIDER Principal investigators 1. Does the principal investigator have the appropriate qualifications, experience, and facilities to ensure that all aspects of the project and follow-up will
More informationPHONE SCRIPTS, QUESTIONNAIRES AND WAIVERS OF DOCUMENTATION. Bertha delanda, CIP IRB Training Specialist January 2012
PHONE SCRIPTS, QUESTIONNAIRES AND WAIVERS OF DOCUMENTATION Bertha delanda, CIP IRB Training Specialist January 2012 Today s objective: To review phone screening scripts and questionnaire requirements,
More informationElements of Informed Consent. Lu Pai, Ph.D. Associate Professor, Taipei Medical University IRB member, Tri-service General Hospital
Elements of Informed Consent Lu Pai, Ph.D. Associate Professor, Taipei Medical University IRB member, Tri-service General Hospital Informed Consent Informed consent is process of ensuring that subjects
More informationUniversity of Ghana. Research Ethics Policy
University of Ghana Research Ethics Policy March, 2013 Table of Content 1. Purpose of Policy 3 2. Aims 3 3. Key Definitions.4 4. Scope of Policy.5 5. Basic Ethical Principles..5 6. Institutional Authority
More informationStudent Handbook: Making Sense of Human Subjects Research
Student Handbook: Making Sense of Human Subjects Research 2013 Office for the Protection of Research Subjects (OPRS) Susan L. Rose, Executive Director Jennifer Hagemann, Program Director Monica Aburto,
More informationInstitutional Review Board for the Protection of Human Subjects in Research
Institutional Review Board for the Protection of Human Subjects in Research GUIDE FOR RESEARCHERS August 2013 2013 University of New Hampshire Preface This Guide was approved on December 4, 2002 by the
More informationInstitutional Review Board (IRB) at SMU. Dr. Maribeth Kuenzi, Chair Ms. Shannon Lunt, SMU Director of Research Compliance
Institutional Review Board (IRB) at SMU Dr. Maribeth Kuenzi, Chair Ms. Shannon Lunt, SMU Director of Research Compliance slunt@smu.edu 214.768.2029 Permission granted 11/24/14 What does the IRB review?
More informationMelbourne IVF Human Research Ethics Committee. Guidelines for the Review of Quality Assurance, Negligible Risk & Low Risk Studies
Melbourne IVF Human Research Ethics Committee Guidelines for the Review of Quality Assurance, Negligible Risk & Low Risk Studies In most cases, research involving humans requires ethical review. The level
More informationHuman Participants Protection Guidebook. Stephens College 1200 East Broadway Avenue Columbia, Missouri (573)
Human Participants Protection Guidebook Stephens College 1200 East Broadway Avenue Columbia, Missouri 65215 (573) 876-7227 0 TABLE OF CONTENTS IRB - Human Participants Protection Guidebook Table of Contents
More informationOctober 2017 INSTITUTIONAL REVIEW BOARD MANUAL
INSTITUTIONAL REVIEW BOARD MANUAL October 2017 1 Institutional Review Board I. PURPOSE Indiana Wesleyan University (IWU or the institution ) is committed to the protection of the rights and welfare of
More informationPolicies, Regulations and Guidelines. For. Research Involving Human Subjects
Policies, Regulations and Guidelines For Research Involving Human Subjects QATAR SUPREME COUNCIL OF HEALTH Department of Research Preface There exist endless debates concerning the application of guidelines
More informationCAPE PENINSULA UNIVERSITY OF TECHNOLOGY HEALTH AND WELLNESS SCIENCES RESEARCH ETHICS COMMITTEE
CAPE PENINSULA UNIVERSITY OF TECHNOLOGY HEALTH AND WELLNESS SCIENCES RESEARCH ETHICS COMMITTEE HUMAN PARTICIPANTS' REVIEW APPLICATION External Researchers wanting CPUT as a data collection site This application
More informationIRB Policy 5 Research Activities
IRB Policy 5: Research Activities Revision Date: April 16, 2008, revision 12/23/09, revised 1/5/2010, revised January 27, 2011, revised January 14, 2016, revised April 2, 2018, revised 9/14/18 I. Definitions:
More informationRockhurst University Institutional Review Board
Rockhurst University Institutional Review Board Policies and Procedures October 2008 The policies and procedures described in the following pages were established to guide the conduct of research involving
More informationPOLICY. Institutional Research Projects/Data Requests #7220
POLICY 1. This policy is intended to ensure that data requests and research projects conducted by any college office, employee, student, or affiliate are sound and that they do not violate board policy,
More informationGuidance on Benign Behavioral Interventions: Exempt Category Three 45 CFR (d)(3)(i)
Wayne State University Institutional Review Board (IRB) WSU IRB Administration Office 87 East Canfield, Second Floor Detroit, MI, 48201 313-577-1628 irb.wayne.edu Guidance on Benign Behavioral Interventions:
More informationPolicies and Procedures of the McKendree University Institutional Review Board
Policies and Procedures of the McKendree University Institutional Review Board 1 Table of Contents Page Content 1 Introduction 2 Institutional Policy on the Ethical Conduct of Research 3 IRB Membership
More information