Research Quality: Protecting Research Subjects

Join Class : Research Quality: Protecting Research Subjects

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Course Description

This course will discuss the informed consent process including  what to tell patients participating in clinical trials, who should consent patients into clinical trials. We will also discuss what investigators must tell the Institutional Review Board (IRB) or Ethics Committee (EC) and how often they must get approval from the IRB/EC.   We will also review the reason regulations are needed, which regulations apply to protecting research subjects and their privacy. An  Informed Consent Form template is included in the course.   Most Institutional Review Boards (IRBs) and Ethic Committees (ECs) require clinical research investigators, clinical research coordinators and other clinicians complete a course on Human Subject Protection annually. This course may satisfy that criteria.    Who will benefit:  Clinical Monitors (CRA), Sponsors, Investigators, Auditors and persons interested in conducting or participating in clinical trials will benefit from taking this course.

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Course Lessons

1. Introduction : This course discusses the regulations governing the rights for humans participating in clinical research. Individuals who are new to clinical research, clinical investigators, coordinators, CRAs and other researchers can benefit from this course.
2. Clinical Research's Vulnerable Population : This lesson identifies the type of person the government believes need protection from unethical individuals conducting clinical research.
3. Unethical Research : This lesson discusses the two unethical research that resulted in the creation of research subject protection policies.
4. The Belmont Report : This lesson discusses the Belmont Report which was created in response to the syphilis clinical study at the Tuskegee Institute.
5. The Nuremberg Code : This lesson discusses the history of the Nuremberg Code which was created in response to the crimes against humanity by Nazi doctors during World War II.
6. The Declaration of Helsinki : Discusses a universal policy created by the World Medical Association to promote research subject's protection worldwide.
7. Code of Federal Regulations : Laws implemented by the United States government in support of human research subject's well-being and privacy rights.
8. Consenting Research Subjects : This describes the process for obtaining informed consent from research subjects.

Certificates & Merits Awarded

Certificate of Attendance Certificate of Class Participation Certificate of Outstanding Achievement Certificate of Academic Excellence

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Additional Information

Course Number :	33302
Course Type :	Professional Development(non credit)
Course URL :	http://qualitytrials.onlineclasses.com
Instructor :	S. Wilson
Syllabus :	View Syllabus
Duration :	Countinous - Enroll Anytime!
Course Fee :	Basic Course: $45.00

Join Class : Research Quality: Protecting Research Subjects