Course Overview
This Continuing Medical Education (CME) activity, The Ethical Oversight of Human Subjects Research Course (EO Course), is a four-hour, online course that presents an in-depth exploration of the function and purpose of institutional review boards (IRBs) through an interactive, realistic interface. The course involves watching and listening to eight course modules and then completing a test that will assess your comprehension of the information presented. To successfully complete this CME activity, clinicians are required to complete the entire course, submit the post-test, achieve a score of 80% or better, and complete a course evaluation.
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Accreditation
If your profession is not listed below, please check with your certification board to determine whether you can receive credit for this CME activity. Clinicians who are not eligible to receive credit but successfully complete this activity can receive a certificate of completion.
This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Boston University School of Medicine and PRIM&R. Boston University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.
Boston University School of Medicine designates this educational activity for a maximum of 4.5 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
For more information about the Boston University School of Medicine’s Office of Continuing Education, see www.bu.edu/cme <http://www.bu.edu/cme>.
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Target Audience
The target audience for this course is IRB Members. The target audience for CME credit is physicians who serve as IRB members.
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Educational Needs Addressed
Institutional review boards (IRBs) oversee the application of ethical principles and regulations that protect human subjects, so it is essential that IRB members receive high quality education in these areas. Physicians serving on IRBs might lack adequate training regarding the ethical principles and regulations that govern the conduct of research with human subjects, and the role and scope of the IRB. This course seeks to address this knowledge gap.
PRIM&R estimates there are approximately 5,000 IRBs, with a total of about 50,000 IRB members, in the United States. A significant number of these IRB positions are filled each year by new, untrained members, and the demand for educational opportunities continues. The need for low-cost, accessible education is correspondingly growing, in part due to shrinking institutional budgets and in part to the high percentage of research that is conducted outside of the United States. The demanding work and schedule of IRB members and the unpredictable location of new members across, and beyond the United States makes traditional face-to-face training an increasingly impractical alternative for many of our constituents.
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Program Learning Objectives
At the conclusion of this program, participants will be able to:
r Define the function and purpose of IRBs;
r Utilize tools to build and strengthen an effective IRB;
r Communicate effectively within an IRB meeting, and with investigators;
r Describe the ethical principles and regulations that govern human subjects research; and
r Apply these rules and principles to both biomedical and social-behavioral case studies.
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Course Faculty
Leonard Glantz, JD
Course Director
Assoc. Dean Emer., Academic Affairs; Prof., Health Law, Bioethics, & Human Right
Boston University School of Public Health
Faculty member has nothing to disclose in regards to commercial support and does not discuss unlabeled/investigational uses of a commercial product.
Karen M. Hansen
Director, Institutional Review Office
Fred Hutchinson Cancer Research Center
Faculty member has nothing to disclose in regards to commercial support and does not discuss unlabeled/investigational uses of a commercial product.
Susan Z. Kornetsky, MPH, CIP
Director, Clinical Research Compliance
Children's Hospital Boston
Faculty member has nothing to disclose in regards to commercial support and does not discuss unlabeled/investigational uses of a commercial product.
Stewart A. Laidlaw, PhD
Director
Los Angeles Biomedical Research Institute At Harbor - UCLA Medical Center
Faculty member has nothing to disclose in regards to commercial support and does not discuss unlabeled/investigational uses of a commercial product.
Linda Lewicki, PhD, RN, CIP
Senior Nurse Researcher
Cleveland Clinic Ohio
Faculty member has nothing to disclose in regards to commercial support and does not discuss unlabeled/investigational uses of a commercial product.
Helen McGough, MA, CIP
Director, Human Subjects Division
University of Washington
Faculty member has nothing to disclose in regards to commercial support and does not discuss unlabeled/investigational uses of a commercial product.
P. Pearl O'Rourke, MD
Director, Human Research Affairs
Partners Healthcare System, Inc.
Faculty member has nothing to disclose in regards to commercial support and does not discuss unlabeled/investigational uses of a commercial product.
Terry VandenBosch, PhD, RN, CIP
Research Compliance Associate
University of Michigan Office of Research Compliance Review
Faculty member has nothing to disclose in regards to commercial support and does not discuss unlabeled/investigational uses of a commercial product.
Amy Davis
Managing Director, Programs
Public Responsibility in Medicine and Research (PRIM&R)
Staff member is a stockholder/spouse in Abbott Laboratories, Allergan, Inc., Boston Scientific, Bristol-Myers Squibb Co., Celgene Corp., Intuitive Surgical, Inc., GlaxoSmithKline, Procter & Gamble, Quest Diagnostics, Merck, Fresenius Medical Care AG & Co. Johnson & Johnson CMN, Medtronic, Inc., ResMed Inc., Pfizer Inc., Teva Pharmaceutical IND LTD ADS, Roache Holding AG, Sonic Healthcare Ltd. Staff member does not discuss unlabeled/investigational uses of a commercial product.
Joan Rachlin
Executive Director
Public Responsibility in Medicine and Research (PRIM&R)
Staff member has nothing to disclose in regards to commercial support and does not discuss unlabeled/investigational uses of a commercial product.
Maeve Luthin
Project Coordinator
Public Responsibility in Medicine and Research (PRIM&R)
Staff member has nothing to disclose in regards to commercial support.
Jody Walker, MS
BUSM CME Program Manager
BUSM CME Program Manager has nothing to disclose in regards to commercial support.
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Privacy Policy
The Office of Continuing Medical Education adheres to Boston University’s Conditions of Use and Policy on Computing Ethics. <http://www.bu.edu/cme/policies/privacy_policy.html>
Data gathered from participants who participate in Boston University School of Medicine’s (BUSM) Continuing Medical Education Internet-Based CME program is confidential.
Individual identifiable information is not shared with outside parties. Cumulative data may be analyzed by CME personnel, and upon occasion, by individuals external to BUSM CME, in order to determine trends.
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Disclaimer
THESE MATERIALS AND ALL OTHER MATERIALS PROVIDED IN CONJUNCTION WITH CONTINUING MEDICAL EDUCATION ACTIVITIES ARE INTENDED SOLELY FOR PURPOSES OF SUPPLEMENTING CONTINUING MEDICAL EDUCATION PROGRAMS FOR QUALIFIED HEALTH CARE PROFESSIONALS. ANYONE USING THE MATERIALS ASSUMES FULL RESPONSIBILITY AND ALL RISK FOR THEIR APPROPRIATE USE. TRUSTEES OF BOSTON UNIVERSITY MAKES NO WARRANTIES OR REPRESENTATIONS WHATSOEVER REGARDING THE ACCURACY, COMPLETENESS, CURRENTNESS, NON INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF THE MATERIALS. IN NO EVENT WILL TRUSTEES OF BOSTON UNIVERSITY BE LIABLE TO ANYONE FOR ANY DECISION MADE OR ACTION TAKEN IN RELIANCE ON THE MATERIALS. IN NO EVENT SHOULD THE INFORMATION IN THE MATERIALS BE USED AS A SUBSTITUTE FOR PROFESSIONAL CARE..
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Topics and Educational Content
Unit 1. Welcome to the Institutional Review Board
Unit 2. Minimizing Research Risks
Unit 3. Assessment of Risks and Burdens in Comparison with Benefits
Unit 4. Subject Selection and Recruitment
Unit 5. Informed Consent: It's Not Just a Document
Unit 6. Data and Safety Monitoring
Unit 7. Privacy and Confidentiality Protections
Unit 8. IRB Meeting Dynamics: Stepping into a Group Process
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Date of original release: July 1, 2010
Date of latest review: July 1, 2012
Date of expiration: June 30, 2014
CME Course Code I.PRIMR12
Estimated time to complete: 4.5 hours
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System Requirements
Flash Player 6.0.79 or later (<http://www.adobe.com/go/getflash> ) (Flash Player 7 or later recommended), and one of the following browsers:
- Windows (Windows 2000 SP4 or later, Windows XP SP2 or later (32- or 64-bit), Windows 2003, Vista (32- or 64-bit), or Windows 7 (32- or 64-bit)): Internet Explorer 6 and later, Firefox 1.x and later, Safari 3 and later, Google Chrome, Opera 9.5 and later
- Macintosh
: Firefox 1.x and later, Safari 3 and later - Linux
: Firefox 1.x and later
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