Ethical Research Oversight Course (E-ROC)

Online learning is an important component of 21st century education, and PRIM&R’s Ethical Research Oversight Course (E-ROC) is a thorough, authoritative, and user-friendly way to learn how to navigate the human subject protections landscape. E-ROC is geared toward new IRB members and staff, as well as toward those seeking a refresher on the core principles of research regulations and underlying ethical principles. Simulated IRB meetings and discussions provide a practical, and interactive, introduction to all aspects of research oversight. PRIM&R developed this course after assessing a need for reliable, affordable research ethics education. 

E-ROC offers the perfect blend of critical information and adult learning pedagogy. Special features include:

  • Content: Tools to build and strengthen an effective IRB
  • Flexibility: Technology that allows users to take the course from any computer, at any time, and from any place
  • Assessment: Frequent progress checks and module assessments to strengthen the user's knowledge
  • Recognition: A certificate of completion, available after the final test

The annual fees to access the course are as follows:

  • Individual PRIM&R Member: Annual Subscription: $200
  • Individual Nonmember: Annual Subscription: $250
  • Institutional Annual Subscription: $1975 (This option is available to institutions and has no cap on the number of users. Institutions with multiple campuses/schools are required to purchase a separate subscription for each entity.)

Please see a course table of contents here.
View a webinar previewing the online course here.

*Pricing may be subject to change.

Continuing Medical Education and Certificates 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 Credit(s)™. Physicians should only claim only the credit commensurate with the extent of their participation in the activity.

More information about Continuing Medical Education (CME), continuing education credit, and certificates of completion can be found here.

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

IRB members who complete E-ROC will be able to: 

  • Define the function and purpose of IRBs
  • Describe the ethical principles and regulations that govern human subjects research
  • Apply these principles and rules to biomedical, behavioral, and social science protocols
  • Effectively express and explain one’s opinions during an IRB meeting

HRPP/IRB staff members who complete E-ROC will be able to:

  • Utilize the tools and strategies described to build and strengthen an effective IRB
  • Communicate more clearly with investigators and other institutional staff members
  • Find and utilize the resources necessary to stay abreast of regulatory changes 

The result? Improved knowledge of what is required, why it is required, and what constitutes a best practice.

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:

We recommend viewing the course in Firefox or Chrome.

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.

Susan Fish, PharmD, MPH
Course Co-Director
Professor of 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.

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.

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
Assistant Director for Professional Development
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.

For more information about E-ROC, please refer to this list of Frequently Asked Questions.

Continuing Medical Education by Boston University School of Medicine