Central IRBs: Where Does the UR Fit into the Picture?? Kelley O Donoghue Tiffany Gommel Emily Flagg April 15 th 2015
|
|
- William White
- 5 years ago
- Views:
Transcription
1 Central IRBs: Where Does the UR Fit into the Picture?? Kelley O Donoghue Tiffany Gommel Emily Flagg April 15 th 2015
2 University of Rochester Office for Human Subject Protection (OHSP) Director OHSP: Kelley O Donoghue Research Education & Training Director: Kelly Unsworth Research Subjects Review Board (RSRB) Director: Tiffany Gommel Quality Improvement Director: Kathleen Wessman Regulatory Systems Director: Thai Nguyen
3 History
4 NIH DRAFT Policy What s the history??? National Cancer Institute s IRB Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) Network for Stroke Research (NIH StrokeNet) Release Date: December 3, 2014 Purpose: to increase the use of single IRB for multi-site studies funded by the NIH
5 NIH DRAFT Policy Represents the current climate where review by a single IRB, rather than multiple, will: Increase the speed by which research gets approved Save time and resources Not have an effect on human subject protection
6 NIH DRAFT Policy UR Concerns Mandatory Nature does not recognize the complexity and variation across NIH-funded multi-site studies Might be appropriate in some cases Large study groups Multiple studies by the same group of sites Might be inappropriate in other situations Single study with a few sites Expedited or Exempt
7 NIH DRAFT Policy UR Concerns Liability Common Rule and assurance regulations (45 CFR 46) hold the IRB of record responsible for site conduct (compliance) Requires a federal change in accountability and regulatory liability of IRBs and institutions The Institution of the Single IRB could risk losing or restriction of their FWA for compliance problems at other sites, even if the single IRB performed their responsibilities adequately
8 NIH DRAFT Policy UR Concerns Selection of Central IRB Very little insight on the selection process for identifying the single IRB, only that the PI of the multi-site study would propose the single IRB. Allowing an investigator to select the single IRB would risk IRB shopping Requires minimum standard of qualifications AAHRPP Accreditation Restructuring of IRB Office staff (or additional)
9 NIH DRAFT Policy UR Concerns Institutional Review Institutional policy Conflicts arise between institutional policy and the protocol as drafted Need coordination with other regulatory review entities within the institution (HURC, IBC, etc.) Not impossible, but infrastructure needed to support, both at the Single IRB and the relying IRB
10 UR Institutional Process What is the process for getting approval for the use of a central IRB, reliance agreement, IRB authorization agreement? UR employee conducting human subject research requests the UR become the IRB of record for an non-ur institution or investigator RSRB wants to defer another IRB
11 Policy 504 RSRB Reliance for Review
12 Reliance Agreement or IAA Reliance or IRB Authorization Agreement (IAA): A formal, written document that provides a mechanism for an institution engaged in research to delegate Institutional Review Board (IRB) review to another IRB, such as an independent IRB or another institution s IRB. The agreement may apply to a single study or to certain categories of studies. Institutions may use different descriptive terms, e.g., reliance agreement, cooperative agreement, IRB authorization agreement (IAA), or memorandum of understanding (MOU).
13 Reliance Agreement or IAA The IRB Authorization Agreement (IAA) is used for studies with minimal subject engagement or studies with limited data access or data analysis. The Reliance Agreement is used for research where the study conduct (consent, study procedures, etc.) will take place at an non-ur site by non-ur people. Policy 504: IRB Authorization Agreement Sample Template Reliance Agreement Sample Template
14 Process for Making the Decision UR Investigator makes the request to the RSRB Director Who decides? Institutional Official (IO), with consultation from the OHSP Director and RSRB Director, is responsible for deciding when the UR will become the IRB of Record or defer to another IRB
15 When the RSRB is the IRB of Record UR PI must provide a plan for oversight of collaborating site(s) The plan should: 1. Outline the specific research activities that will occur at the collaborating site(s) 2. Ensure study and regulatory compliance, including notification to the non-ur researcher in writing of the RSRB review determinations 3. Uploaded as an amendment to an already approved protocol or included with the initial protocol submission
16 When the RSRB is the IRB of Record The RSRB conducts a regulatory and institutional review per operating procedures for the activities of the UR researcher. Ensure that plan is adequate. UR will enter into an IRB Authorization or Reliance Agreement with the non-ur institution to defer IRB review to the RSRB. The non-ur institution should conduct an institutional review of the research prior to approval of the study by the RSRB to provide any local context to the RSRB, as appropriate.
17 When the RSRB defers to another IRB Institutional Review: Education Requirements Institutional policy (erecord, Decisional impairment) Compensation for Injury Language Conflicts of Interests
18 Institutional & Investigator Considerations Type of research and the activities conducted IRB is not AAHRPP accredited May take longer to complete paperwork for IAA or reliance agreement to defer to another IRB then to get RSRB approval Institutional approval could take a month or longer
19 Central IRB Application Reason for Changes No longer just using Western IRB (WIRB) To accommodate submissions reviewed locally by RSRB and those reviewed by another IRB of record To ensure basic information about the study submission is captured for all submissions (i.e., a few more sections apply to all studies)
20 Overview of Application Pathway Section 1 Protocol & Measures Section 2 Conflict of Interest Section 90 erecord and Research Section 3 Source of Funding/Sponsorship Section 4 Nature of Study Part 1 Section 5 Nature of Study Part 2 Section 6 Sponsorship Part 2 Section 7 (Part 1 and Part 2, if applicable) Just in Time Section 95 Determine IRB of Record NO Central IRB Section 10 Central IRB Application Section 62 Institution Oversight Section 83 Informed Consent Final Instructions YES RSRB Section 8 Coordinating Ctr, Concept, etc. Section 9 Exempt..etc.
21 Central IRB Screen Shots The following slides are screen shots to show information that may be new when completing the Central IRB application
22 ***NEW*** If not using the RSRB as the IRB of record, select No Note: An IRB Reliance Agreement or an IRB Authorization Agreement is required to use another IRB as the IRB of Record. See RSRB Policy 504 RSRB Reliance for Review.
23 ***New*** Indicate if IRB Agreement in place If Yes upload copy of agreement NOTE: Documentation not required if using WIRB
24 Institutional Oversight added so applicable ancillary reviews can be managed in ROSS
25 Informed Consent section now available so consent documents may be added for RSRB review.
26 Final Instructions pertain to any central IRB submission
27 Review Level will indicate Central IRB New Field to indicate the central IRB of record
28 Additional Changes New State Names, *Activity function buttons, and Tab labeling *RSRB Only
29 Questions
IRB Reliance Models: Workshop for OSU Researchers Collaborating with External Partners
IRB Reliance Models: Workshop for OSU Researchers Collaborating with External Partners Jessica Evans, MHA, CHRC, CIP Office of Responsible Research Practices August 8, 2017 Workshop Overview Regulatory
More informationCommercial/ Central IRB An independent organization that provides IRB review services
Page 1 of 12 Reliant Review Research Conducted at Multiple Sites Introduction: Reliant Review engages reliance agreements to reduce duplicative IRB reviews, aiming to promote greater efficiency and consistency
More informationRESEARCH PROTECTIONS OFFICE
Page 1 of 5 RESEARCH PROTECTIONS OFFICE Single IRB RPO Human Subjects Research Single IRB Single IRB Definitions Authorization Agreement/Reliance Agreement written agreement between two or more institutions
More informationUniversity of Iowa External/Central IRB Reliance Process Standard Operating Procedure (SOP)
University of Iowa External/Central IRB Reliance Process Standard Operating Procedure (SOP) I. OVERVIEW The purpose of this Standard Operating Procedure is to define a process for all University of Iowa
More informationCeded IRB Review. The University of Arizona has standing agreements in place for the following entities regarding ceded IRB review:
Investigators working at multiple institutions and with multiple IRBs may choose to have one IRB become the IRB of record over some or all participating sites (commonly referred to as ceded review, reliance
More informationCentralized IRB Models
Centralized IRB Models NWABR / OHRP Conference July 31, 2014 James Riddle, MCSE, CIP, CPIA Assistant Director, Institutional Review Office Fred Hutchinson Cancer Research Center Outline Central IRB s Why
More informationCollaborative Research
University of Hawai i HRPP Standard Operating Procedures Purpose and Scope Collaborative Research SOP 120.2 Revised: December 18, 2015 This document covers procedures for establishing IRB coverage of collaborative
More informationCeded IRB Review. The project involves prisoners or other vulnerable populations that require special considerations.
The first assessment to make when including collaborators in research is whether the collaborating entity is engaged in research (see OHRP s Guidance on Engagement in Research). IRB oversight of engaged
More informationNovember 30, Efficient Startup of Multi-site Research Studies: Central IRBs and National IRB Reliance Platforms
November 30, 2017 Efficient Startup of Multi-site Research Studies: Central IRBs and National IRB Reliance Platforms Agenda Working with a Central IRB SMART IRB IRBchoice Single IRB vs. Central IRB They
More informationUniversity of Pennsylvania Institutional Review Board. Reliance Agreement Guidance: Penn as Central IRB FAQ
Reliance Agreement Guidance: Penn as Central IRB FAQ This document is designed to answer questions frequently asked by individuals who want to know more about Penn s policies and procedures related to
More informationNIH StrokeNet Network Standard Operating Procedure
1. POLICY This policy will define the recommended process for the addition of new satellite sites. The Principal Investigator (PI) of the Regional Coordinating Center (RCC) ultimately has decision making
More informationFlorida State University IRB Standard Operational Procedures
Florida State University IRB Standard Operational Procedures 7-IRB-12 Title of Standard Operational Procedure: Cooperative Project/Multi-site projects IRB Review Responsible Executive: Approving Official:
More informationUniversity of Pennsylvania Institutional Review Board. Reliance Agreement Guidance: How to Apply for External IRB Review
Reliance Agreement Guidance: How to Apply for External IRB Review This document provides step by step instructions on how to submit a request for the Penn IRB to rely on an External IRB using the HS-ERA
More informationSingle IRB Review. Jeannie Barone Director, HRPO. Institutional Review Board
Single IRB Review Jeannie Barone Director, HRPO Presentation Agenda New NIH policy Requests for Single IRB review Investigator vs. institutional responsibilities Current Regulations 45 CFR 46.111 (DHHS):
More informationInfo Sheet - Operations Office for Human Research Studies
Guidance on Single IRB Review Process This document outlines how the DFCI IRB may rely on an external IRB to serve as the IRB of record for a DF/HCC site or Investigator. The Dana-Farber Cancer Institute
More informationA Guide to SMART IRB s Resources for IRB and HRPP Personnel
Your Roadmap to Single IRB Review A Guide to SMART IRB s Resources for IRB and HRPP Personnel Nichelle Cobb, PhD Health Sciences IRBs Office Director University of Wisconsin-Madison & Chief Regulatory
More informationThe Children s Hospital of Philadelphia Committee for the Protection of Human Subjects Policies and Procedures. Cooperative Agreements
Page: 1 of 8 I. PURPOSE This standard operating procedure describes the IRB s procedures for review and oversight of research conducted under a cooperative agreement with an external (outside) IRB. It
More informationYour Roadmap to Single IRB Review Serving as a Reviewing IRB
Your Roadmap to Single IRB Review Serving as a Reviewing IRB Funded by the NIH Clinical and Translational Science Awards (CTSA) Program, grant number 3 UL1 TR002541-01S1 Nichelle Cobb, PhD Director, Health
More informationSMART IRB Agreement Implementation Checklist and Documentation Tool
SMART IRB Agreement Implementation Checklist and Documentation Tool Purpose: (1) to highlight the flexible provisions of the SMART IRB Agreement, and (2) to document which options institutions will implement
More informationCUNY HRPP Procedures: Multisite Non-Exempt Human Subjects Research
CUNY HRPP Procedures: Multisite Non-Exempt Human Subjects Research 1. Applicability These procedures apply to non-exempt multi-site research involving human subjects in which CUNY is engaged. Please refer
More informationInvestigator Manual. If you have questions about whether an activity requires IRB review, contact the IRB Office.
CM-999 001 1 May 2015 Page 1 of 5 What is the purpose of this manual? This document is designed to guide you through policies and procedures related to the conduct of human research that are specific to
More informationSOP 801: Investigator Qualifications and Responsibilities
1. POLICY University of Oklahoma : Investigator Qualifications and Responsibilities The purpose of this policy is to outline the qualifications and responsibilities of the principal investigator and key
More informationUniversity of Iowa External/Central IRB Single IRB (sirb) Reliance Process Standard Operating Procedure (SOP)
University of Iowa External/Central IRB Single IRB (sirb) Reliance Process Standard Operating Procedure (SOP) I. OVERVIEW The purpose of this Standard Operating Procedures document is to define outline
More informationHEALTH CARE SYSTEMS RESEARCH NETWORK
IRB APPROVAL OF HCSRN MULTI-SITE RESEARCH: FREQUENTLY ASKED QUESTIONS (AND ANSWERS) The goal of SOP HCSRN-001,, is to make human subjects review as efficient and timely as possible, while still recognizing
More informationIRB Authorization Agreement Implementation Checklist and Documentation Tool
IRB Authorization Agreement Implementation Checklist and Documentation Tool This is the preferred selections version. If more flexible terms are needed, download the blank version from the IRB website.
More informationIRB Chair Responsibilities
IRB Chair Responsibilities Introduction: The Saint Luke s Health System (SLHS) Institutional Review Board (IRB) Human Research Protection Program (HRPP) is guided by the ethical principles regarding research
More informationIRBMED: Ceding IRB Review to an External IRB
: Ceding IRB Review to an External IRB Angela Faber, BS, CIP Senior Associate Regulatory Analyst, Seminar Series April 10, 2018 TERMINOLOGY For the purposes of this presentation: IRB of Record External
More informationWhat s New in GCP? FDA, OHRP Issue Harmonized Guidance on Transferring IRB Oversight of Clinical Studies
Vol. 8, No. 8, August 2012 Happy Trials to You What s New in GCP? FDA, OHRP Issue Harmonized Guidance on Transferring IRB Oversight of Clinical Studies Reprinted from the Guide to Good Clinical Practice
More informationChildren s Hospital of Philadelphia Committees for the Protection of Human Subjects Policies and Procedures Continuing Review of Approved Research
Page: 1 of 6 I. PURPOSE The purpose of this SOP is to describe the submission requirements for investigators and the review requirements for the IRB for the conduct of continuing review in accordance with
More informationMISSISSIPPI STATE UNIVERSITY HUMAN RESEARCH PROTECTION PROGRAM. Collaborative Research and Performance Sites (01-23) Approved
MISSISSIPPI STATE UNIVERSITY HUMAN RESEARCH PROTECTION PROGRAM Collaborative Research and Performance Sites (01-23) Approved 02-04-2013 Policy It is the policy of the MSU HRPP that all human subjects research
More informationUNIVERSITY OF GEORGIA Institutional Review Board
UNIVERSITY OF GEORGIA Institutional Review Board Continuing Review Number: Date: Author: Approved By: Page(s): UGAHRP-057-2 01/20/2017 HSO IRB Page 1 of 7 1. PURPOSE 1.1. The UGA IRB has developed this
More informationInitial Review. Approved By: Michele Kennett, JD, MSN, LLM Associate Vice Chancellor for Research. Table of Contents
Institutional Review Board University of Missouri-Columbia Standard Operating Procedure Initial Review Initial Review Effective Date: September 1, 2004 Original Approval Date: September 1, 2004 Revision
More informationYour Roadmap to Single IRB Review Getting Started with SMART IRB & the Online Reliance System
Your Roadmap to Single IRB Review Getting Started with SMART IRB & the Online Reliance System Now that your institution has joined SMART IRB, what s next? Start using the Agreement right away for IRB reliance
More informationFrequently Asked Questions (FAQs)
Frequently Asked Questions (FAQs) Introduction... 1 The SMART IRB Reliance Model... 2 Scope of Covered Research... 3 Eligibility to Participate... 5 How to Join SMART IRB... 9 The Agreement: selected provisions
More informationAUTHORITY AND PURPOSE
AUTHORITY AND PURPOSE SOP #: 101 VERSION #: 1 THIS POLICY PERTAINS TO: RESPONSIBILITY FOR EXECUTING POLICY: EFFECTIVE DATE: 5/1/09 ALL ACTIVITIES OF THE IRB SUPERSEDES DOCUMENT: IRB STAFF, IRB CHAIRPERSON,
More informationSingle IRB Policy. Leslie Cooper, CIP Interim Director, Office of the IRB University of Alabama at Birmingham
Single IRB Policy Leslie Cooper, CIP Interim Director, Office of the IRB University of Alabama at Birmingham What is meant by Single IRB? One IRB reviews the research study for multiple sites/institutions.
More informationInstitutional Review Board Submission Requirement Presentation
Institutional Review Board Submission Requirement Presentation Institutional Review Board Office Dean of Graduate Studies and Research Lebanese American University OVERVIEW What is Research? Required Steps
More informationIRB-REQUIRED INVESTIGATOR ACTIONS
Version No: 2 Effective Date: 11/01/02 Revised: 06/10/2005 09/08, 05/2009 1. POLICY IRB-REQUIRED INVESTIGATOR ACTIONS SOP: RI 801 Page 1 of 4 Between IRB initial approval of a protocol and the time of
More informationHuman Research Protections Program Medical College of Wisconsin and Froedtert Memorial Lutheran Hospital
Human Research Protections Program Medical College of Wisconsin and Froedtert Memorial Lutheran Hospital To Whom It May Concern: The Medical College of Wisconsin (MCW) has an approved Federal Wide Assurance
More informationYour Roadmap to Single IRB Review Getting Started with SMART IRB & the Online Reliance System
Your Roadmap to Single IRB Review Getting Started with SMART IRB & the Online Reliance System Now that your institution has joined SMART IRB, what s next? Start using the Agreement right away for IRB reliance
More informationElizabeth Witte, MFA SMART IRB Regulatory Officer Regulatory Foundations, Ethics, and Law Program, Harvard Catalyst
Supporting single IRB review. Advancing collaborative research. Together. Nichelle Cobb, PhD Chief Regulatory Operations Officer for Implementation for SMART IRB Director, Health Sciences IRBs Office,
More informationDOCUMENTATION OF IRB DISCUSSIONS AND DECISIONS ( IRB MINUTES)
POLICY # RESEARCH POLICY & PROCEDURE Approval Date: 12-19-2008 CTM Review Cycle: 1 2 3 Revision Dates: AAHRPP DOC # 54 Responsible Office: Research Compliance DOCUMENTATION OF IRB DISCUSSIONS AND DECISIONS
More informationHOW TO CONDUCT AN IRB RELIANCE AGREEMENT. What Reliance Agreements Are, How They Are Reviewed, and What It Means for Submitting Research
HOW TO CONDUCT AN IRB RELIANCE AGREEMENT What Reliance Agreements Are, How They Are Reviewed, and What It Means for Submitting Research Agenda for Course: Discuss what reliance agreements are and what
More informationReview of Research by the Convened IRB
Office for the Protection of Research Subjects (OPRS) Institutional Review Board FWA# 00000083 Review of Research by the Convened IRB 201 AOB (MC 672) 1737 West Polk Street Chicago, IL 60612-7227 Phone:
More informationReliance on Independent/Central IRBs for Multicenter Clinical Trials
Reliance on Independent/Central IRBs for Multicenter Clinical Trials October 15, 2013 Outline Background New policy and process Non-IRB reviews Revised fee structure Workflow Demo of IRBIS application
More informationCONTINUING REVIEW 3/7/2016
DUKE UNIVERSITY HEALTH SYSTEM Human Research Protection Program Introduction CONTINUING REVIEW 3/7/2016 Federal regulations require that DUHS has written procedures which the IRB will follow for (a) conducting
More informationPepperdine University eprotocol - IRB Student Investigator User Guide
Pepperdine University eprotocol - IRB Student Investigator User Guide 1 Welcome to eprotocol the online IRB system for Pepperdine University. To begin creating an online IRB application, please login to
More informationReporting an Unanticipated Problem Involving Risks to Subjects or Others (UPIRTSO) to the IRB
INSTITUTIONAL REVIEW BOARD (IRB) OFFICE FOR HUMAN RESEARCH PROTECTION Reporting an Unanticipated Problem Involving Risks to Subjects or Others (UPIRTSO) to the IRB UPIRTSO Flowchart Content Applies To
More informationScreening and Enrollment Log. List of all subjects screened and all subjects screened and enrolled in the study.
Contents Screening and Enrollment Log... 2 Regulatory Approval... 3 Protocol, Amendments and Signature Pages... 4 Investigational Product Information - 1... 5 Investigational Product Information - 2...
More informationPOLICY NO EXEMPT RESEARCH... 4 POLICY NO DISCLOSURE OF RESEARCH LAB TEST RESULTS... 5
Table of Contents POLICY NO. 101.01 - EXEMPT RESEARCH... 4 POLICY NO. 101.02 - DISCLOSURE OF RESEARCH LAB TEST RESULTS... 5 POLICY NO. 101.03 - IRB REVIEW OF HUMAN SUBJECTS RESEARCH... 6 POLICY NO. 101.04
More informationChildren s Hospital of Philadelphia Committees for the Protection of Human Subjects Policies and Procedures. IRB Review Processes
Page: 1 of 8 I. PURPOSE II. III. IV. The purpose of this standard operating procedure is to describe IRB review processes, including pre-review, review, and post-review procedures. POLICY STATEMENT The
More informationIRB 7. Network for Clinical Research Professionals (NCRP) Seminar June 18, 2013
IRB 7 Network for Clinical Research Professionals (NCRP) Seminar June 18, 2013 What is IRB 7? IRB 7 is a new electronic IRB solution from Huron Consulting Group Same underlying software as eprost, but
More informationDate Effective 4/21/2008 Identification
OHSU Research Integrity Office Human Research Protection Program Policies & Procedures Title: Research with Medical Devices Date Effective 4/21/2008 Identification Supersedes P&P dated: Page 1 of BACKGROUND
More informationProcess of IRB Submissions
Chapter 8: Process of IRB Submissions Chapter Contents 8.1 IRB Online Application (istar) 8.2 Criteria for IRB Approval of Research 8.3 Review of Exempt Research 8.4 Review of Expedited Research 8.5 Review
More informationExternal IRB Instructions for the Registration Pathway in OSIRIS
External IRB Instructions for the Registration Pathway in OSIRIS Studies approved by external IRBs are still required to be submitted to the University of Pittsburgh IRB using our electronic application
More informationPolicies & Standard Operating Procedures
Policies & Standard Operating Procedures December 2016 SPRINGFIELD COMMITTEE FOR RESEARCH INVOLVING HUMAN SUBJECTS (SCRIHS) For more information about SCRIHS Policies and Procedures, visit: http://www.siumed.edu/adrfa/scrihs.html
More informationPolicy Number: 42 Title: Investigational Devices Date of Last Revision: 06/12/2008; 07/22/2010; 05/29/2013; 05/01/2016; 10/16/2018
University of California, Irvine Human Research Protections Standard Operating Policies and Procedures Policy Number: 42 Title: Investigational Devices Date of Last Revision: 06/12/2008; 07/22/2010; 05/29/2013;
More informationUCLA Reliance on Other UC IRBs, UCLA CTSI IRBs and Beyond. Sharon Friend, OHRPP Director Research Administration Forum November 8, 2012
UCLA Reliance on Other UC IRBs, UCLA CTSI IRBs and Beyond Sharon Friend, OHRPP Director Research Administration Forum November 8, 2012 By mutual or collective written agreement, one or several IRBs agree
More informationArkansas Tech University Institutional Review Board
Arkansas Tech University Institutional Review Board Presentation Agenda IRB 1001: The Basics Levels of IRB Review IRB Decisions The Process of Consent Open Discussion IRB 1001: The Basics Human Participant
More informationINSTITUTIONAL REVIEW BOARD (IRB) PROCEDURES
INSTITUTIONAL REVIEW BOARD (IRB) PROCEDURES July 2016 Table of Contents National American University Mission...2 Purposes...2 Core Values...3 Institutional Review Board Policy...4 IRB Membership...6 Training...7
More informationPurpose: The following serves to aid Principal Investigators (PI) in the submission of Amendments to AURA-IRB. Document includes: Acronyms and Legend
AURA-IRB Amendment Guidelines Principal Investigators (PI) End Users: Principal Investigators (PI) who enter studies. Purpose: The following serves to aid Principal Investigators (PI) in the submission
More informationAdministrative Hold, Suspension, or Termination of IRB Approval
Office for the Protection of Research Subjects (OPRS) Institutional Review Board FWA# 00000083 Administrative Hold, Suspension, or Termination of IRB Approval 201 AOB (MC 672) 1737 West Polk Street Chicago,
More informationHumanitarian Use Devices Made Simple
May 25, 2017 Humanitarian Use Devices Made Simple Robert Romanchuk, BSHS, CIP, CCRC, CHRC, CCRCP IRB Vice Chairperson, Schulman IRB About Schulman IRB Established in 1983 Superior audit history with FDA
More informationRESEARCH SUBMISSION REQUIREMENTS
1. POLICY IRB members rely primarily solely on the documentation submitted by investigators for initial and continuing review. Therefore this material must provide IRB members with enough information about
More informationIRB MEETING ADMINISTRATION
1. POLICY Steering Committee approved / Effective date: 9/11/15 Except when an expedited review procedure is appropriate or an exemption determination may be made, the IRB will review proposed research
More informationEffective Date: January 16, 2012 Policy Number: MHC_RP0107. Revised Date: November 2, 2015 Oversight Level: Corporate
Policy Title: Initial Review of Human Subject Research Effective Date: January 16, 2012 Policy Number: Review Date: November 20, 2015 Section: Revised Date: November 2, 2015 Oversight Level: Corporate
More informationInstitutional Responsibilities Under A Federalwide Assurance
Institutional Responsibilities Under A Federalwide Assurance Lisa A. Rooney, JD Director Aegis Compliance & Ethics Center, LLP June 6, 2013 1 Questions There will be a q&a session at the end of the program.
More informationEffective Date Revisions Date Review by the Convened Institutional Review Board
Review by the Convened Institutional Review Board Effective Date Revisions Date 8.1.2018 1.0 Purpose: The purpose of this standard operating practice (SOP) is to define and describe the process of review
More informationHarding IRB FAQ. Issue 1: General Questions
Harding IRB FAQ Issue 1: General Questions 1. What is an Institutional Review Board (IRB)? 2. What is the purpose of an IRB? 3. Is the purpose of the IRB review of informed consent to protect the institution
More informationINTRA-INSTITUTIONAL COMMUNICATION
P&P: CO 602 Version No: 1.1 Effective Date: 10/1/2009 1. POLICY INTRA-INSTITUTIONAL COMMUNICATION Supercedes: CPHS Policies and Procedures 11/1/2007 The efficiency and effectiveness of the IRB is supported
More informationHuman Research Protection Program Policy
Page 1 of 6 POLICY CONTINUING REVIEW BY THE IRB The University of Cincinnati Institutional Review Board (IRB) shall conduct continuing review of human participant research at intervals appropriate to the
More informationClick IRB Resources Frequently Asked Questions
Q: How do I log in to the Click IRB system? A: To log in to Click IRB, go to Citrix to open the list of viewable applications. Select the Click application icon. You will be presented with a Click session
More informationCONTINUING REVIEW OF APPROVED IRB PROTOCOLS
POLICY # RESEARCH POLICY & PROCEDURE Approval Date: 4-13-2012 CTM c Review Cycle: 1 2 3 Revision Dates: AAHRPP DOC # 64 Responsible Office: CONTINUING REVIEW OF APPROVED IRB PROTOCOLS Research Compliance
More informationUniversity of Pennsylvania Institutional Review Board. Reliance Agreement Guidance: Post-Approval Submissions
Reliance Agreement Guidance: Post-Approval Submissions This document is designed to provide guidance on the requirements and submission processes for Amendments, Continuing Review, Reportable Events, and
More information2 Institutional Review Board
2 Institutional Review Board 2.1 Policy The University has established two Institutional Review Boards ( IRBs ) to ensure the protection of Human Subjects in Research Under the Auspices of the Institution.
More informationUNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD CONTINUING REVIEW AND REAPPROVAL OF RESEARCH
UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD CONTINUING REVIEW AND REAPPROVAL OF RESEARCH I. PURPOSE This document outlines the required elements of University of Tennessee
More informationInstitutional Review Board (IRB)
Institutional Review Board (IRB) POLICIES AND PROCEDURES MANUAL IRB #1: Lubbock/Odessa IRB #2: Amarillo/Dallas IRB #3: Paul L. Foster School of Medicine at El Paso IRB #4: Paul L. Foster School of Medicine
More informationOHRP Guidance on Written IRB Procedures
Office for Human Research Protections (OHRP) Department of Health and Human Services Date: OHRP Guidance on Written IRB Procedures Scope: This document outlines the required elements of written Institutional
More informationAMENDMENTS TO PREVIOUSLY APPROVED RESEARCH 3/01/2016
DUKE UNIVERSITY HEALTH SYSTEM Human Research Protection Program AMENDMENTS TO PREVIOUSLY APPROVED RESEARCH 3/01/2016 The Duke University Health System Institutional Review Board (DUHS IRB) requires that
More informationBaptist Health Institutional Review Board. Study Closure Report (Expedited Review) IRB #: Study Title:
Baptist Health Institutional Review Board Study Closure Report (Expedited Review) (Please complete ALL sections of this form. Incomplete forms will be returned) Principal Investigator: E-mail: Phone #:
More informationHuman Subjects in Research Review and Monitoring Form. Not applicable
WESTERN ILLINOIS UNIVERSITY WESTERN ILLINOIS UNIVERSITY FWA 00005865 Sherman Hall, Room 320, Macomb, IL 61455-1390 Phone: 309-298-1191 FAX: 309-298-2091 Website: http://www.wiu.edu/sponsoredprojects/ E-mail:
More information1. Review and approval of the consent document is a responsibility that FDA assigns to the IRB with jurisdiction
Medical College of Wisconsin/Froedtert Hospital Guidance on Negotiating Consent Document Language For Clinical Trial Sponsors 1. Review and approval of the consent document is a responsibility that FDA
More informationChapter 4 Institutional Review Board (IRB) Roles and Authorities
Chapter 4 Institutional Review Board (IRB) Roles and Authorities HSS Institutional Review Board Guidance An Institutional Review Board (IRB) is an appropriately constituted group that has been formally
More informationIRB Staff Administration Guide
March 2013 Table of Contents IRB Process Overview 3 IRB Submission Types 3 Study Process Overview 4 Ancillary Review Overview 5 Initiating Ancillary Reviews 5 Notifications and Ancillary Review Feedback
More informationStudy Management SM STANDARD OPERATING PROCEDURE FOR Interactions with the Institutional Review Board (IRB)
Study Management SM 302.00 STANDARD OPERATING PROCEDURE FOR Interactions with the Institutional Review Board (IRB) Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature and Date) Approval:
More informationI. Summary. II. Responsibilities
IRB Procedure 11a: Continuing Review Revision Date: May 15, 2007, revised November 11, 2009, revision July 17, 2010, revised March 1, 2011, revised February 9, 2015 I. Summary The IRB policy is to make
More informationStandard Operating Policy and Procedures (SOPP) 3:
Standard Operating Policy and Procedures (SOPP) 3: INITIAL AND CONTINUING REVIEW BY THE IRB: REQUIREMENTS FOR SUBMISSION OF APPLICATIONS, APPROVAL CRITERIA, EXPEDITED AND CONVENED COMMITTEE REVIEW AND
More information7.0 DEVIATION and EXCEPTION of a PREVIOUSLY APPROVED PROTOCOL
7.0 DEVIATION and EXCEPTION of a PREVIOUSLY APPROVED PROTOCOL 7.1 OBJECTIVE To describe the policies and procedures for reviewing a modification or a deviation/exception to a previously approved protocol.
More informationThe Top 10 Human Research Protection Compliance Risks
The Top 10 Human Research Protection Compliance Risks Health Care Compliance Association Research Compliance Conference Kristina Borror, Ph.D. Director, Division of Compliance Oversight June 2, 2015 1
More informationUNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD PROCEDURES FOR FULL BOARD REVIEW
UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD PROCEDURES FOR FULL BOARD REVIEW I. PURPOSE This document outlines the required elements of Institutional Review Board (IRB)
More informationCONTINUING REVIEW CRITERIA FOR RENEWAL
1. POLICY Steering Committee approved / Effective Date: 9/2/19/19/11 The IRB conducts continuing review of research taking place within its jurisdiction at intervals appropriate to the degree of risk,
More informationJeffTrial IRB Submission Regulatory Coordinator Training. Kimmel Cancer Center 09/16/2013 Ver. 1.0
JeffTrial IRB Submission Regulatory Coordinator Training Kimmel Cancer Center 09/16/2013 Ver. 1.0 Role of the Regulatory Coordinator The Regulatory Coordinator will be required to enter basic information
More informationSignature Date Date First Effective: Signature Date Revision Date: 07/18/2011
University of Kentucky Office of Research Integrity and Institutional Review Board Revision #4 TITLE: HIPAA in Research Page 1 of 8 Approved By: ORI Director Signature Date Date First Effective: 06-10-05
More informationIRB COMPOSITION AND IRB MEMBER ROLES AND RESPONSIBILITIES
IRB COMPOSITION AND IRB MEMBER ROLES AND RESPONSIBILITIES 1. Overview Each IRB must be appropriately constituted for the volume and types of human research to be reviewed, in accordance with federal regulations.
More informationGuidance for IRBs, Clinical Investigators, and Sponsors IRB Continuing Review after Clinical Investigation Approval
Guidance for IRBs, Clinical Investigators, and Sponsors IRB Continuing Review after Clinical Investigation Approval Additional copies are available from: Office of Communication Division of Drug Information,
More informationIV. Basic Procedures for Human Research Protections
Human Research Protection Program Procedures IV. Basic Procedures for Human Research Protections D. IRB Membership [45CFR46.107] (21CFR56.107) (1) General considerations The IRB shall have at least twelve
More informationSupersedes Document Dated: 7/7/11. SOP: RR 401 Version No.: 07 Version Date: 9/8/15 EXPEDITED REVIEW 1. POLICY
1. POLICY Steering Committee approved / Effective Date: 9/9/15 An expedited review procedure consists of a review of research involving human subjects by an IRB Chair or by one or more experienced reviewers
More informationTo assure knowledge and compliance by documenting the annual administrative review and continuing IRB review of non-exempt projects for the IRB.
Institutional Review Board.... University of Missouri-Columbia.. Standard Operating Procedure Annual Review of Research Annual Review of Research Effective Date: January 21, 2019 Original Approval Date:
More informationThe IRB reviews and monitors human subjects research conducted by Columbia College Chicago faculty, staff, and students.
IRB FAQ s We hope that this FAQ will acquaint you with the basic policies and procedures of the IRB review and approval process. It is available to researchers from the Columbia College Chicago IRB. Although
More informationI. Introduction. Institutional Authority Under Which the IRB is Established and Empowered (45 CFR )(21 CFR (a))
Section: I. Introduction Date Last Reviewed: Jan. 2016 I. Introduction Ochsner has adopted these (IRB) Written Procedures to ensure the protection of the rights and welfare of human subjects participating
More information