About

Jointly provided by Prim&R

This Continuing Medical Education (CME) activity, E-ROC: Ethical Research Oversight 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.

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 accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership 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 Enduring material for a maximum of 4.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Target Audience

The target audience for this course is IRB Members.  The target audience for CME credit is physicians who serve as IRB members.

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.

Program Learning Objectives

Upon completion of this activity, IRB members will be able to:

  • Understand the function and purpose of an IRB
  • Apply the principles and rules that govern human subjects research to biomedical, behavioral, and social science protocols
  • Effectively express and explain their opinions during an IRB meeting

Upon completion of this activity, HRPP/IRB staff will be able to:

  • Utilize the tools and strategies addressed in the course to build and strengthen an effective IRB
  • Communicate more clearly with investigators and other institutional staff members
  • Increase their understanding of what constitutes a best practice and how to apply those strategies to their work

Course Faculty

Boston University School of Medicine asks all individuals involved in the development and presentation of Continuing Medical Education (CME) activities to disclose all relevant relationships with commercial interests. This information is disclosed to CME activity participants. Boston University School of Medicine has procedures to resolve conflicts of interest. In addition, faculty members are asked to disclose when any discussion of unapproved use of pharmaceuticals and devices occurs.

Leonard Glantz, JD
Course Co-Director
Professor, Health Law, Bioethics, & Human Rights
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.

Susan Fish, PharmD, MPH
Course Co-Director
Professor, Biostatistics and Epidemiology
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
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
Co-Chair, Regulatory Knowledge and Support, Industry Relations, and Research Ethics
UCLA Clinical and Translational Science Institute
Director of Educational Outreach
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
Independent Research Professional
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, CCRP
Managing Director, Office of Human Research Compliance Review
University of Michigan
Faculty member has nothing to disclose in regards to commercial support and does not discuss unlabeled/investigational uses of a commercial product.

Amy Davis, JD, MPH
Consultant
Public Responsibility in Medicine and Research (PRIM&R)
Staff member/spouse is a stockholder in Abbott Laboratories, Allergan Inc., Amgen 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, JD, MPH
Executive Director Emerita
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, JD
Professional Development Manager
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.

Disclaimer

THIS CONTINUING MEDICAL EDUCATION PROGRAM IS INTENDED SOLELY FOR EDUCATIONAL PURPOSES FOR QUALIFIED HEALTH CARE PROFESSIONALS. IN NO EVENT SHALL BOSTON UNIVERSITY BE LIABLE FOR ANY DECISION MADE OR ACTION TAKEN IN RELIANCE ON THE INFORMATION CONTAINED IN THE PROGRAM. IN NO EVENT SHOULD THE INFORMATION CONTAINED IN THE PROGRAM BE USED AS A SUBSTITUTE FOR PROFESSIONAL CARE.  NO PHYSICIAN-PATIENT RELATIONSHIP IS BEING ESTABLISHED.

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

Date of original release: July 1, 2010
Accredited from July 1, 2016-June 30, 2018
CME Course Code I.PRIMR16
Estimated time to complete: 4.5 hours

How to Receive Credit

  1. Participants wishing to earn CME credit must: watch the presentation and study the program slides
  2. Relate the content material to the learning objectives
  3. Complete the course assessment questions and evaluation form online: http://www.primrelearning.com/course/view.php?id=2  (login required)

Successful completion of the course assessment is required to earn CME credit. Successful completion is defined as a score of at least 80%. Certificates of Completion are automatically generated when a course participant completes the course assessment with a score of 80 percent or higher. If a participant does not achieve a passing score after the first try, it is possible to retake the course assessment multiple times.

Such certificates are useful for obtaining Continuing Education Credits from professional associations. Note that guidelines around Continuing Education Credits may differ, and you should consult the appropriate professional association representative for further guidance.

System Requirements 

The following technical requirements are necessary to access the audio, video, and interactive features of this course:

Computer hardware

  • Computer: 500 megahertz (MHz) processor or higher (32- or 64-bit)
  • Memory: 256 MB minimum
  • Display: 800 X 600 screen resolution (1,024 x 768 or higher recommended)
  • Multimedia: Sound card and headphones or speakers

Internet connection

  • A minimum 256+ Kbps connection (higher connection speeds are recommended).

Acceptable browsers

  • PC users (running Windows): Internet Explorer 6 and later, Firefox 1.x and later, Safari 3 and later, Google Chrome, or Opera 9.5 and later.
  • Macintosh users: Safari 3 and later, Firefox 1.x and later, or Google Chrome.

Other requirements

  • Adobe Flash Player 6.0.79 or later (Flash Player 7 or later recommended). You can download it for free at the following links:
  • Mac: http://www.adobe.com/go/getflash
  • PC: http://get.adobe.com/flashplayer/otherversions/

Contact Information

For general information about E-ROC, please email info@primr.org or call PRIM&R at 617.423.4112, ext. 0.

For CME questions, please contact cme@bu.edu. The BUSM CME course code for this program is I.PRIMR.16.

For information on the Boston University School of Medicine Privacy Policy, please visit: http://www.bu.edu/cme/policies/privacy_policy.html.

For information on PRIM&R’s Privacy Policy, please visit: http://www.primr.org/SubPageNoRightNav.aspx?id=1839

Last modified: Friday, 1 July 2016, 8:06 AM