This course provides insight on conducting clinical research using human subjects. We will review the reason regulations are needed, the regulations and guidelines implemented and the best practice for ensuring human subjects rights and privacy are protected.
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. We will discuss the elements of the informed consent, providing informed consent to subjects, why informed consents are needed and maintaining proper consent. A sample of an informed consent will be present for your use. We will also address HIPPA and research subjects rights to privacy.
Basic knowledge of clinical research and conducting clinical trials is a minimal requirement. Common terminology used in the clinical research industry will be helpful. Additionally, students should have a minimum of a high school comprehension level.
The goal of this course is to help clinicians 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.
