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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.
Course Lessons
Lesson 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.
Lesson 2: Clinical Research's Vulnerable Population
This lesson identifies the type of person the government believes need protection from unethical individuals conducting clinical research.
Lesson 3: Unethical Research
This lesson discusses the two unethical research that resulted in the creation of research subject protection policies.
Lesson 4: The Belmont Report
This lesson discusses the Belmont Report which was created in response to the syphilis clinical study at the Tuskegee Institute.
Lesson 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.
Lesson 6: The Declaration of Helsinki
Discusses a universal policy created by the World Medical Association to promote research subject's protection worldwide.
Lesson 7: Code of Federal Regulations
Laws implemented by the United States government in support of human research subject's well-being and privacy rights.
Lesson 8: Consenting Research Subjects
This describes the process for obtaining informed consent from research subjects.
Optional Certificates Awarded
Certificate of Attendance
Certificate of Class Participation
Certificate of Outstanding Achievement
Certificate of Academic Excellence
In addition to the standard Certificate of Course Completion, Merit Awards may be issued by the instructor at his/her own discretion and are based on student achievement. Merit awards also incur an additional $30.00 processing fee that covers the customization, printing, and delivery of the award, as well as access to the UniversalClass™ Portfolio Service that documents your achievements online. Official Merit Awards have a serial number that verifies the authenticity of the award (great for employers to verify your achievement).
This is a non-credit course, and is provided for your personal enrichment.
This course is not intended to be a substitute for any state, government, licensing, or educational requirements.
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($54.00) Historical Research is for people who like to dig into history. more
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