IRB Administration: Expanded

Provides foundational IRB administration course plus topic-focused webinars.

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About this Course

This course is available for organizations to offer their members of an Institutional Review Board’s (IRB) administrative office and Human Research Protection Program (HRPP) a comprehensive review of the critical areas associated with IRB and IRB office operations. This is a role-specific course designed for IRB administrators, directors, coordinators, and other staff.

This course is comprised of all the modules in the IRB Administration course plus topic-focused webinars. The additional webinars review regulatory requirements, considerations for including populations in research, administrative topics, research study design topics, and professional development.

Language Availability: English

Suggested Audiences: Coordinators, Directors, IRB and HRPP Administrators, Other Staff

Organizational Subscription Price: $900 per year/per site for government and non-profit organizations; $1,000 per year/per site for for-profit organizations
Independent Learner Price: $249 per person

Demo Instructions


Course Content

HRPP/IRB Policies and Procedures CME/CEU Badge

Provides learners with an understanding of both the requirements and best practices for IRB written procedures, procedure development and content, techniques for effective procedure implementation, and elements of effective procedure management.

Recommended Use: Required
ID (Language): 16503 (English)
Author(s): James Riddle, MCSE, CIP, CPIA - Advarra; Jaime A. Arango, EdD, CIP - CITI Program

Reporting to Federal Agencies CME/CEU Badge

Discusses when and how a HRPP should communicate reportable events to federal agencies, in a concise and efficient manner. It covers when a report must be filed with a federal agency and what to include in the report. It also contains basic information including contact information for federal agencies.

Recommended Use: Required
ID (Language): 16593 (English)
Author(s): Helene Lake Bullock, PhD, JD - University of Kentucky

Communicating with Subjects CME/CEU Badge

Provides guidance to IRB administrators on circumstances and procedures that should be considered when communicating with subjects before, during, or after their participation in a research study. It describes the circumstances, under which communication with subjects is required, identifies best practices regarding how to communicate with subjects from the IRB and IRB administrator’s perspective, and explains how subject complaints should be handled by the IRB and IRB administrator.

Recommended Use: Required
ID (Language): 16668 (English)
Author(s): Judy Matuk, MS - HRP Consulting Group, Inc.; Cheryl A. Savini - HRP Consulting Group, Inc.

Internal Quality Assurance and Quality Improvement of the HRPP CME/CEU Badge

Provides a general overview of how a HRPP quality assurance/quality improvement (QA/QI) audit program may be structured and why, and focuses on two common types of QA/QI audits: audits of the conduct of individual research studies and audits of the IRB review and approval process. It defines the types of internal QA/QI audits by intent and the responsible and participating entities, describes factors that shape the structure of different QA/QI programs, and discusses how findings and information may be used by a HRPP and IRB.

Recommended Use: Required
ID (Language): 16678 (English)
Author(s): Susan Corl, MSW, MPH, CIP, CCRP - Boston Children's Hospital; Eunice Yim Newbert, MPH - Boston Children's Hospital

External Oversight of the HRPP/IRB: Monitoring and Inspections CME/CEU Badge

Focuses on monitoring and inspections of HRPPs/IRBs. Monitoring and inspections are both types of external oversight provided by study sponsors and regulatory agencies. It defines and identifies the differences between monitoring and inspections, and discusses how each applies to a researcher, specific trial, and IRB.

Recommended Use: Required
ID (Language): 16679 (English)
Author(s): Eunice Yim Newbert, MPH - Boston Children's Hospital; Susan Corl, MSW, MPH, CIP, CCRP - Boston Children's Hospital


Additional Modules of Interest

Webinar - IRB Administrator Professional Development and Self-Advocacy

Presented by: Margaret Rankovic, MEd, CIP – CITI Program

Learning Objectives:

  • Develop a professional development plan to advance your career.
  • Discuss key areas where you can develop yourself as an IRB professional based on your strengths and weaknesses.
  • Use self-advocacy to advance your career.
  • Identify ways you can show leadership in your current position.
  • Discuss the importance of networking as it relates to professional development in this field.

Recommended Use: Supplemental
ID (Language): 20347 (English)

Webinar - U.S. Department of Defense (DoD) Regulations & Requirements for Human Subject Research

Presented by: Ann Johnson, PhD, MPH - University of Utah

Learning Objectives:

  • Determine when research is subject to DoD regulations.
  • Identify the specific DoD requirements for research including addressing 45 CFR 46 Subparts B-D, inclusion of military personnel as subjects, independent research monitor, and additional investigator responsibilities.
  • Discuss research limitations for DoD research, including waivers of consent and inclusion of certain populations.

Recommended Use: Supplemental
ID (Language): 20481 (English)

Webinar - Gender and Sexual Minorities (GSM) in Human Subjects Research

Presented by: Moore Rhys, CIP - University of California Los Angeles

Learning Objectives:

  • Understand the historical context of research in GSM communities.
  • Understand social/cultural vulnerabilities and the relationships of GSMs to care providers who may also be researchers.
  • Understand the resiliency and advocacy of the GSM community.
  • Identify best practices for researchers and IRBs when conducting/reviewing research involving or focused on GSM.

Recommended Use: Supplemental
ID (Language): 20504 (English)

Webinar - Nuts & Bolts of Running a Virtual IRB Meeting

Presented by: Angela L. Bruch, PhD - Capella University

Learning Objectives:

  • Understand virtual IRB meetings and their benefits, especially in times of emergencies.
  • Discuss how to develop a format/script for running a virtual IRB meeting.
  • Describe how to document a virtual meeting in the IRB meeting minutes.
  • Identify additional considerations for meeting regulatory requirements in a virtual convened meeting.
  • Identify key players in running virtual meetings and ways to best engage them.
  • Identify how virtual meetings may fit with emergency disaster plans and when those plans are implemented.

Recommended Use: Supplemental
ID (Language): 20060 (English)

Webinar - IRB Review of Observational Research

Presented by: Ilene Wilets, PhD, CIP - Icahn School of Medicine at Mount Sinai

Learning Objectives:

  • Identify the key characteristics of the three main types of observational research studies (cohort, cross-sectional, and case-control).
  • Recognize the risks to subjects related to each observational research design.
  • Understand the types of bias associated with each study design.
  • Apply IRB review criteria to observational studies for effective protocol review and constructive feedback for the investigator.
  • Discuss the level of IRB review typically employed for the various types of observational studies.
  • Explain when a waiver of consent and a waiver of HIPAA authorization would be appropriate.

Recommended Use: Supplemental
ID (Language): 20425 (English)


CME/CEU Credits

To purchase CE credits and units, you need to be affiliated with an organization that subscribes to this course or buy it as an independent learner first. Learn more about CE/CME Credits.

Physicians
AMA PRA Category 1 Credit
3 Credits
(5 CE certified modules)
$60
1 June 2021
31 May 2024
Psychologists
CEP Credit/Hour
3 Credits
(5 CE certified modules)
$60
1 June 2021
31 May 2024
Pharmacists
CPE Contact Hour
3 Credits
(5 CE certified modules)
$60
1 June 2021
31 May 2024
Dentists
ADA CERP Credit
3 Credits
(5 CE certified modules)
$60
1 May 2022
31 May 2024
Optometrists
COPE CE Credit
3 Credits
(5 CE certified modules)
$60
1 May 2022
31 May 2024
Nurses
Nursing Contact Hour
3 Credits
(5 CE certified modules)
$50
1 June 2021
31 May 2024
Dietitians
CDR CPEU
3 Credits
(5 CE certified modules)
$50
1 May 2022
31 May 2024
Social Workers
Ethics CE Credit
3 Credits
(5 CE certified modules)
$50
1 June 2021
31 May 2024
Athletic Trainers
Category A hour/CEU
3 Credits
(5 CE certified modules)
$50
1 May 2022
31 May 2024
Other Participants
Certificate of Participation
3 Credits
(5 CE certified modules)
$50
1 June 2021
31 May 2024


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