IRB Administration Advanced

This advanced, role-based course provides second-level training tackling topics of importance for experienced IRB administrators and HRPP directors.

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About this Course

This unique course offers a comprehensive review of critical areas associated with IRB administrative management and IRB office operations as part of a human research protection program (HRPP). It equips IRB senior level administrators and HRPP directors to be more effective in their positions by understanding various aspects of their responsibilities. This course was designed by experienced senior IRB managers to focus on topics and issues most relevant to IRB administration.

This course covers essential leadership skills and topics, including managing an IRB board, IRB administrative staff, and a working with other HRPP components. The IRB office is typically the core of an HRPP, but oversight of all aspects of human subjects research requires a variety of expertise and input. Whether an institution has an extensive research administration program with multiple departments or a small operation where a handful of staff conduct various types of review, it is vital to understand the distinctions between IRB regulatory review and additional protocol-specific ancillary reviews.

Topic-focused modules explore contemporary IRB management issues such as working with ancillary committees, navigating single IRB review, and communicating effectively with internal and external stakeholders. The course also includes a module on designing and implementing educational programs and initiatives as well as a module on managing IRB noncompliance.

Recommended for individuals who have already completed the IRB Administration Foundations course and/or who have three or more years’ experience in IRB administration.

Course Preview:

Language Availability: English

Suggested Audiences: HRPP Directors, HRPP Professionals, IRB Administrators, IRB Chairs, IRB Directors

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $165 per person or $300 per person as part of IRB Administration Comprehensive

Demo Instructions

Course Content

Strategic Planning and Operational Management

This module provides the practical tools that HRPP and senior IRB leadership need to manage an IRB effectively and efficiently. It reviews various organizational frameworks to help leaders identify the most efficient structure for their HRPP and IRB office. It discusses useful metrics to collect and analyze for quality improvement and highlights methods to identify and reduce operational bottlenecks. Furthermore, the module briefly discusses business processes and considerations to improve operational efficiency, such as budget development, professional development, and the use of technology.

Recommended Use: Required
ID (Language): 20908 (English)
Author(s): Challace Pahlevan-Ibrekic, MBE, CIP - Northwell Health; Rachel Lally, MPH, CIP - Penn State University

Leading and Managing an IRB

This module describes best practices for effectively leading and managing IRB staff and an IRB board. From hiring practices and conflict resolution to IRB member recruitment and maintenance, IRB leaders must identify the right people for the various roles within the program. They must also train and encourage staff to do their best to align with the institution’s mission. This module identifies strategies for recruiting, training, and retaining qualified individuals to serve as IRB staff and IRB members. This module discusses ways IRB leaders can establish expectations around organizational culture, communication, and collaboration and build a program that supports those expectations.

Recommended Use: Required
ID (Language): 20909 (English)
Author(s): Rachel Lally, MPH, CIP - Penn State University ; Challace Pahlevan-Ibrekic, MBE, CIP - Northwell Health

Working with Ancillary Committees

Ancillary committees are integral to research with humans and play an important role in furthering an HRPP’s mission of promoting ethical research and protecting participants. Not all institutions have distinct ancillary committees, and their structure and organization will vary. This module reviews the roles and functions of ancillary committees and defines strategies to communicate effectively. It also provides examples of how to promote cooperation and collaboration.

Recommended Use: Required
ID (Language): 20910 (English)
Author(s): Rachel Lally, MPH, CIP - Penn State University ; Challace Pahlevan-Ibrekic, MBE, CIP - Northwell Health

Navigating Reliance Agreements and sIRB Review

In this module, learners will gain an understanding of the relationship between the relying institution and the reviewing IRB, including the reliance agreements needed to solidify that relationship. This module looks at issues from both the relying institution and reviewing IRB perspective. It highlights the need for collaboration and communication between institutions to ensure that they clearly articulate local laws and institutional requirements to the reviewing IRB. The module further discusses the IRB administrator’s role when ceding review of research and relying on another IRB, as well as when serving as the IRB of record for external research.

Recommended Use: Required
ID (Language): 20911 (English)
Author(s): Rachel Lally, MPH, CIP - Penn State University ; Challace Pahlevan-Ibrekic, MBE, CIP - Northwell Health

Developing an Education and Training Program

This module provides a framework to develop a convenient, interactive, and comprehensive education and training program. It reviews different program designs and resource considerations. The module also identifies best practices and strategies to help improve existing education and training programs.

Recommended Use: Required
ID (Language): 20912 (English)
Author(s): Challace Pahlevan-Ibrekic, MBE, CIP - Northwell Health; Rachel Lally, MPH, CIP - Penn State University

Managing Noncompliance

In this last module, learners will differentiate the different types of noncompliance in human subjects research, compare strategies for reviewing and reporting noncompliance, and consider tips for creating standard operating procedures (SOPs) to manage allegations and incidences of noncompliance. The module discusses how an effective noncompliance program can lead to institutional improvements and opportunities for increased compliance moving forward. Any sized institution can use the strategies discussed in this module.

Recommended Use: Required
ID (Language): 20913 (English)
Author(s): Rachel Lally, MPH, CIP - Penn State University ; Challace Pahlevan-Ibrekic, MBE, CIP - Northwell Health


Why should an organization subscribe to this course?

Organizational subscriptions provide access to the organization's affiliated members. This allows organizations to provide advanced training to IRB office and HRPP leadership.

Who should take the IRB Administration Advanced course?

The suggested audience includes leaders and senior administrators in Institutional Review Board (IRB) offices and human research protection programs (HRPPs). This includes IRB Directors, IRB Managers, HRPP Directors, and other individuals with leadership roles in an IRB office and HRPP.

How long does it take to complete the IRB Administration Advanced course?

This course consists of six required modules. Each module consists of detailed explanations, where appropriate, enhanced with visual graphics, and concludes with a quiz.

Modules vary in length, and learners may require different amounts of time to complete them based on their familiarity and knowledge of the topic. However, the course should take approximately three hours to complete.

What are the standard recommendations for learner groups?

This course is designed such that learners should complete all six required modules in sequence.

Is this course eligible for continuing medical education credits?

This course does not currently have CE/CME credits available.

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