Class Syllabus: Research Quality: Protecting Research Subjects
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Office Hours: |
8:00p.m. -11:00p.m. EST/EDT nightly except weekends
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Course Meeting Times: |
9:00 p.m. - 10:00 EST/EDT each Tuesday and Thursday night
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Course Description
This course will discuss the Informed Consent (IFC) process including what to tell patients participating in clinical trials and 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 review the reason regulations are needed and 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 Requirements
- Basic knowledge of clinical research and conducting clinical trials is a minimal requirement.
- Common terms suchs as FDA, IRB, EC, etc. used in the clinical research industry will be helpful.
- High school comprehension level.
Course Goals
The goal of this course is to help sponsors and investigator site staff understand the importance of treating human research subjects with respect regardless of race, religion or color. The course will teach why and how the informed consent process became so prominent and the consequences one faces if they do not adhere. You will learn
*Pertinent clinical research terminology
*Why human protection laws are needed in clinical research trials
*History of human research protection laws and guidelines
*The Belmont Report
*The Nuremburg Code
*The Declaration of Helsinki
*Informed consent process
*HIPPA regulations and how it relates to clinical research
Additionally, you will see a sample of an informed consent for research subjects.
Course Materials
All course materials are provided.
Grading Policy
Each assignment and exam indicates 100% proficiency.
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.
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