Online Class: Protecting Research Subjects
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| | Course Cost: 6 Month Subscription Course (no Certificate) = $45.00 Course with CEU Certificate* = $70.00 | * Instantly download, print, and share your CEU Certificate at course completion (additional shipping/handling charges apply for hard copy delivery).
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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.
Learning Outcomes By successfully completing this course, students will be able to:
- Describe clinical research's vulnerable population.
- Describe unethical research.
- Summarize the Belmont Report.
- Summarize the Nuremberg Code.
- Summarize the Declaration of Helsinki
- Describe code of federal regulations.
- Summarize consenting research subjects, and
- Demonstrate mastery of lesson content at levels of 70% or higher.
Course Lessons |  | Lesson 1: IntroductionThis 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 PopulationThis lesson identifies the type of person the government believes need protection from unethical individuals conducting clinical research. | Lesson 3: Unethical ResearchThis lesson discusses the two unethical research that resulted in the creation of research subject protection policies. | Lesson 4: The Belmont ReportThis lesson discusses the Belmont Report which was created in response to the syphilis clinical study at the Tuskegee Institute. | Lesson 5: The Nuremberg CodeThis 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 HelsinkiDiscusses a universal policy created by the World Medical Association to promote research subject's protection worldwide. | Lesson 7: Code of Federal RegulationsLaws implemented by the United States government in support of human research subject's well-being and privacy rights. | Lesson 8: Consenting Research SubjectsThis describes the process for obtaining informed consent from research subjects. |
Additional Information | Course Title | : | Research Quality: Protecting Research Subjects | | CEU Value | : | | | Standard | : | Course Adheres to the ANSI/IACET 1-2007 Standard | | Accreditation | : | | | Languages | : | English - United States, Canada, United Kingdom, Australia, New Zealand, and other English speaking countries | | Course Number | : | 33302 | | Course Type | : | Professional Development | | Course URL | : | | | Course Rating | : |  | | Instructor | : | | | Syllabus | : | | | Grading Policy | : | Earn a final grade of 70% or higher to receive a CEU Certificate documenting CEUs earned | | Assessment Method | : | Lesson assignments and review exams | | Duration | : | Continuous: Enroll anytime! | | Requirements | : | View Technical Requirements | | Course Fee | : | Basic Course: $45.00 (no CEU Certificate) | | | | | NOT FOR COLLEGE CREDIT 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, certification or educational requirements.
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