CTS 702 - Federal Policies in Clinical and Translational Research

Institution:

Creighton University

Subject:

Clinical Translational Science

Description:

This class will provide a comprehensive overview of the History of Federal Regulations that Govern Human Subject Research. These will include: (1) Research Ethics, (2) Federal and State Regulations, (3) OHRP and FDA Documents, (4) Institutional Review Board Functions and Operations, and (5) Informed Consent. The program objective will be to: (i) provide a Historical Perspective of the Development of the IRB System and Federal Regulations, (ii) discuss the Relevant Ethical Principles and their Application, (iii) cover all Federal and State Regulations (DHHS, FDA, HIPAA), (iv) analyze guidance documents (OHRP, FDA), (v) Provide an overview of IRB functions and operations (exempt/expedited/ convened review, IRB requirements, risk/benefit analysis, vulnerable populations, subject recruitment, advertising), (vi) explore Informed Consent (required elements, practical considerations, proper documentation, helpful hints, common errors), and (vii) case Studies and Discussion (to braid together the course content with real-life work experiences).

Credits:

2.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.creighton.edu

Phone Number:

(402) 280-2700

Regional Accreditation:

North Central Association of Colleges and Schools

Calendar System:

Semester

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