IRB Administration Comprehensive

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): Jaime A. Arango, EdD, CIP - CITI Program

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

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 - State University of New York at Stony Brook; Cheryl A. Savini - HRP Consulting Group, Inc.

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 - Apellis Pharmaceuticals; Eunice Yim Newbert, MPH - Boston Children's Hospital

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 - Apellis Pharmaceuticals

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

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

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

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

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

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

Explores key considerations when implementing sIRB relationships and what a participating site needs to do in preparation for relying on an external sIRB.

Recommended Use: Supplemental
ID (Language): 17387 (English)
Author(s): James Riddle, MCSE, CIP, CPIA - Advarra; Raffaella Hart, MSHS, CIP - BRANY IRB

Discusses key elements and considerations for setting up an IRB to serve as a sIRB.

Recommended Use: Supplemental
ID (Language): 17388 (English)
Author(s): James Riddle, MCSE, CIP, CPIA - Advarra; Raffaella Hart, MSHS, CIP - BRANY IRB

Introduces best practices for drafting, reviewing, and implementing authorization agreements between the sIRB and participating sites in multi-site research.

Recommended Use: Supplemental
ID (Language): 17392 (English)
Author(s): Cindy Gates, JD, RN, CIP - University of Miami