2012 State of the IRB Boston University Charles River Campus (CRC) Cynthia J. Monahan, MBA, CIP Director, Institutional Review Board.

Slides:



Advertisements
Similar presentations
The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects.
Advertisements

TEXAS SOUTHERN UNIVERSITY OFFICE OF RESEARCH LINDA M. GARDINER, Ph.D. DIRECTOR DEPARTMENT OF RESEARCH ENHANCEMENT AND COMPLIANCE SERVICES.
TEXAS SOUTHERN UNIVERSITY INSTITUTIONAL ANIMAL CARE AND USE PROGRAM WORKSHOP OFFICE OF RESEARCH LINDA M. GARDINER, Ph.D. DIRECTOR RESEARCH ENHANCEMENT.
Multi-Institutional Facilitated IRB Review Philip A. Cola, MA Vice President, Research and Technology University Hospitals Case Medical Center Third Annual.
Submission to Approval What happens to my protocol once I submit it to the HIC office.
The IRB Process Tony Medure, M.A., CIP, RAC Vanderbilt Human Research Protection Program.
Institutional Review Board Guidance.  Independent Ethics Committee  Ethical Review Board  Research Ethics Committee 2.
DHMH Institutional Review Board Research, Respect and Responsibility.
IACUC and Compliance Overview and Updates
1 Human Subjects Research at Johns Hopkins Medicine Introduction to Clinical Research Human Subject Protection and IRBs.
IRB 101: Introduction to Human Subject Research
Research Involving Human Subjects Review of Risk and Protection from Harm.
IRB-Investigator/ Research Coordinator Mtg. “CUMC’s New Progressive Policy For Adverse Event Reporting” April 13, 2004 George Gasparis Andrew Wit, Ph.D.
Columbia University IRB IRB 101 September 21, 2005 George Gasparis, Executive Director, CU IRB Asst. V.P. and Sr. Asst. Dean for Research Ethics.
National Cancer Institute (NCI) Central Institutional Review Board (CIRB) Research Studies UCSF HRPP Submission Process Overview Tuesday, December.
CUMC IRB Investigator Meeting Human Subjects Research Non-Compliance September 15, 2005.
Human Research Protection Program Training: Post-Approval Event Reporting March 26, 2008 Lisa Voss, MPH, CIP Assistant Director, QIU Human Research Protection.
IRB Basics Helen Panageas New York University School of Medicine Institutional Review Board Portion of slides courtesy of Suzanne M. Smith, University.
CUMC IRB Investigator Meeting Status of the IRB January 18, 2005.
October 19, 2010 Steven Hirschfeld, MD, PhD Julia Slutsman, PhD
HRPP Policies & Forms Created/Revised for AAHRPP.
Duties and Responsibilities of Budget Managers and Budget Analyst Duties and Responsibilities of Budget Managers and Budget Analyst.
Unlocking the Mystery of General Information Reporting Research Compliance Administration Training Presentation Wednesday, June 6, 2007 Presenter:Heather.
Who’s the Boss? Faculty Advisor or Principal Investigator Supervision versus Student Investigator or Study Coordinator Responsibilities Gwenn Snow, MS,
International Research & Research Involving Children K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development.
Using Technology to Strengthen Human Subject Protections Patricia Scannell Director, IRB Washington University School of Medicine.
Introduction to INSPIR OCR Seminar Series January 21, 2004 Mary Banks, RN Administrator, Office of the IRB.
New IRB Guideline Changes and Converting to eIRB - Suggestions for Maintaining Compliance. Ramesh Ghodgaonkar, BPHARM, MSITS, MSB, MBA Betsy Johnson, BA.
Resources, Recruitment, Qualifications, Complaints….Oh My! UC DAVIS OFFICE OF RESEARCH May 22, 2014 Miles McFann, CIP Outreach, Training and Education.
Michelle Groy Johnson Quality Improvement Officer Research Integrity Office Tough Love: Understanding the Purpose and Processes of Quality Assurance.
Laura M. Argys Associate Dean for Research and Creative Activities College of Liberal Arts and Sciences University of Colorado Denver.
Deciphering the Continuing Review Form Research Compliance Administration Training Presentation Wednesday, August 15, 2007 Presenter:Heather Kemp, MBA.
Human Subjects Research Cynthia Edmonds Director, Office of Research Support Committees.
How to Successfully Apply to the IRB Richard Gordin, IRB Chair True Rubal, Administrator / Director For the Protection of Human Participants in Research.
I JUST SUBMITTED TO THE IRB… WHAT NOW?. HAVE I REALLY SUBMITTED IT?? (NOT IN THIS CASE - CLICK THE YELLOW BOX)
Belinda Seto, Ph.D. Acting Deputy Director for Extramural Research National Institutes of Health Human Subjects Research Enhancements Awards Renaissance.
Western Oregon University INSTITUTIONAL REVIEW BOARD.
University of Toledo Department for Human Research Protection and Institutional Review Boards.
OHRP Guidance and Policy Development Process Secretary’s Advisory Committee on Human Research Protections Meeting October 27, 2008 Irene Stith-Coleman,
Introduces ePIRATE electronic Portal for Institutional Research at ECU East Carolina University Office for Human Research Integrity.
Post-Approval Monitoring (PAM) Program November 17, 2015.
Updates in Research Protections Karen Allen Director, Research Protections Office of Research November
Fully accredited since 2006 Tom Conquergood, CIP Working with Quorum October 13, 2015 Thomas Jefferson University.
Conducting Research at Lincoln IRB/HRPP Policies, Procedures & Good Clinical Practices B Kanna MD, MPH, FACP Associate Program Director of Internal Medicine.
Paul Hryvniak MS, CIP Alyssa Speier, MS, CIP September 30, 2014 Student Human Research Education Session Tel:
The TJU Human Research Protection Program (HRPP): Part I – Which Entities/Offices are Involved ? J. Bruce Smith, MD, CIP.
VA HRPP Accreditation October 18, 2011 Accreditation Conference Call PRIDE/Soundia Duche, MA, MS.
Institutional Review Board Procedures and Implications After the applied dissertation committee has approved the proposal and the IRB package, the student.
Marianne M. Elliott Office of Research Integrity and Ethics Bureau of Medicine and Surgery U. S Navy.
THE INSTITUTIONAL REVIEW BOARD. WHAT IS AN IRB? An IRB is committee set up by an institution to review, approve, and regulate research conducted under.
Introduction to the HRPP and IRB Human Research Protection Program (HRPP) Office.
© 2016 University at Buffalo Click Training IRB Module University at Buffalo Office of the Vice President for Research and Economic Development Electronic.
IRB BASICS BETTY WILSON, MS, CIP. CONCEPTS SUBMISSION APPROVAL RECRUITING WORKING WITH PRINCIPAL INVESTIGATOR (PI) /SPONSOR POLICIES DEVIATIONS RECORD.
HRPP METRICS Cynthia Monahan, MBA, CIP IRB Director Boston University Charles River Campus IRB.
Faculty Advisor Responsibilities
Tips for a Successful IRB Submission
Introduction to the Human Research Protections Office (HRPO)
Principal Investigator Responsibilities
University of Central Florida Office of Research & Commercialization
Introduction to IRB (Institutional Review Board)
University of Central Florida Office of Research & Commercialization
AAHRPP Accreditation Welcome to the University of Georgia’s presentation for accreditation of the human research protection program (HRPP). This presentation.
Human Subjects Office & Institutional Review Board
GSBM Presentation Updated
Everything You Wanted to Know about UOPX IRB
The Revised Common Rule
Assessment of Customer Satisfaction and Use among Faculty and Staff
GPS IRB SIX STEPS Updated
Common Rule
Research with Human Subjects
Presentation transcript:

2012 State of the IRB Boston University Charles River Campus (CRC) Cynthia J. Monahan, MBA, CIP Director, Institutional Review Board

Role of the IRB Review and approve human subjects research Assist researchers with IRB submissions Education and training

The CRC IRB The IRB Committee Meets the 3 rd Tuesday of the month Reviews all full board studies. This includes new studies, continuing reviews, amendments, deviations, adverse events, and unanticipated problems 11 Committee members Committee members include representatives from: (Social Work, CAS, Sargent, Anthropology, Education, Theology, Fine Arts)

The CRC IRB The IRB Advisory Committee Meets periodically (5-6 times/year) Meets to discuss policies and procedures and any problems Members are faculty, IRB members, and deans who represent the research community (Social Work, CAS, Sargent, Anthropology, Education, Theology, Fine Arts)

Staff Updates Cynthia Monahan—Director, CRC IRB Edward Szkutak—Senior IRB Analyst Sonia Chawla—IRB Analyst Mary McCabe—IRB Analyst Julie Cullinane—IRB Coordinator LaNeia Thomas—IRB Educator All expedited and exempt reviews are conducted in the office by an Analyst or the Director

CRC Facts 818 Active Studies 568 Investigators

CRC Facts

Average Turnaround Time (March)* New Full Board Studies51 days New Expedited Studies54 days New Exempt Studies24 days Amendments19 days Progress Reports/Final 25 days Deviation Reports30 days *Turnaround time is calculated using calendar days (this includes weekend days and holidays)

Education and Outreach School/Department-focused education sessions In-class presentations Individual meetings Open Office hours (Mondays and Thursdays: 11:30-1:00)

Continuous Quality Improvement through Post-Approval Monitoring Conduct requested and random educational reviews Assist investigators with: Navigating the IRB process Implementing study management practices Assist IRB with: Investigating issues of non-compliance Providing data to guide future education programs Improving the human subjects protection program

Continuous Quality Improvement through Post-Approval Monitoring New Education Service Goals Enhance protection of human subjects Enhance the quality of research data Enhance the education program Ensure research is being conducted in accordance with the IRB-approved protocol and applicable regulations and policies

CRC Changes Revised Policies/Procedures Website Application Forms New templates (consent, assent, etc.)

Goals Decrease turnaround time Increase customer satisfaction Collaborate with departments, researchers, and research study staff Increase efficiency and consistency Continually assess the program in order to improve practices

CRC Contact Information IRB Office Main Number: IRB Office Post-Approval Monitoring/ LaNeia Thomas: IRB Director/ Cynthia Monahan:

Feedback: Privacy Policy Feedback
Do Not Sell My Personal Information
About project: SlidePlayer Terms of Service

© 2025 SlidePlayer.com. Inc. All rights reserved.