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Institutional/Signatory Official: Human Subjects Research

This course provides a foundational training for institutional/signatory officials on their roles and responsibilities as part of the human research protection program (HRPP).

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About this Course

Institutional/Signatory Official: Human Subjects Research provides a general introduction for institutional officials (IOs) in a variety of organizations – biomedical, behavioral, social sciences, and others, as well as a variety of organizational structures – academic medical centers, colleges and universities, independent IRBs, research sites, and others. It introduces the learner to the roles and responsibilities of the IO, including the regulatory role and expectations, obligations imposed on the organization by the Federalwide Assurance (FWA), and functions that are part of the human research protections program (HRPP).

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Language Availability: English

Suggested Audiences: Institutional and Signatory Officials

Organizational Subscription Price: Included in Human Subjects Research series for $1,000 per year/per site
Independent Learner Price: $129 per person

Demo Instructions

Course Content

Introduction to Being an Institutional Official (IO)

Focuses on general administrative topics that are defined/controlled by each organization. Includes who in the organization has the authority to appoint/name the IO, functions that are part of the HRPP, and typical IO duties. Covers IO leadership topics: communication, evaluation, resource allocation, delegating authority, and succession planning.

Recommended Use: Required
ID (Language): 16640 (English)
Author(s): Gary L. Chadwick, PharmD, MPH, CIP - University of Rochester / HRP Consulting Group, Inc.

IO Knowledge Requirements: Human Subject Protections

Provides an overview of the federal regulations for human subject research, the ethical principles relevant to research, and the current model for structuring portions of an organization that play a role in research involving human subjects. Includes specific “need-to-know” areas for the institutional official including functions that are part of the HRPP, the role of the IRB, the major ethical principles for human subjects research, and the regulatory expectations for research organizations.

Recommended Use: Required
ID (Language): 16641 (English)
Author(s): Gary L. Chadwick, PharmD, MPH, CIP - University of Rochester / HRP Consulting Group, Inc.

Expectations of the IO

Discusses the role and responsibilities of the IO and what federal regulators expect to be within the scope of those duties. Presents techniques that have been successfully used and ways the IO can promote an organizational culture of respect, commitment, caring, and compliance. Identifies required communications with the federal officials, as well as the processes that are part of the FDA’s Human Subject Protection/Bioresearch Monitoring (HSP/BIMO) Initiative. Reviews the role of an internal quality improvement (QI) program and how it fits into the HRPP.

Recommended Use: Required
ID (Language): 16642 (English)
Author(s): Gary L. Chadwick, PharmD, MPH, CIP - University of Rochester / HRP Consulting Group, Inc.

Challenges of Being an IO: Human Subject Protections

Defines challenges that face the IO as the designated leader of the HRPP. Examines the executive role of the IO in the HRPP, provides some effective techniques and strategies for fostering organizational communication and improving effectiveness, and describes ways in which the IO can assist the function of key parts of the HRPP. Examines IO’s role in promoting an organizational culture of respect, commitment, caring, and compliance. Provides recommendations on how to continually improve the quality of services the organization delivers while protecting subjects of research.

Recommended Use: Required
ID (Language): 16643 (English)
Author(s): Gary L. Chadwick, PharmD, MPH, CIP - University of Rochester / HRP Consulting Group, Inc.