The EMSI Human Subject training you are about to undergo is a comprehensive course, which covers human subject and participant protection information set by the National Institute of Health. Successful completion of this training program will qualify you to perform necessary collections for clinical trials and research programs.
The EMSI certification program requires you complete the following steps:
An On-line Training Course to introduce you to the Federal rules and guidelines for human subject research set forth by the National Institute of Health.
An Examination to measure your understanding of the material that is presented in this course.
Upon completion of the Training and Examination, you will receive a Certificate of Achievement.
Human Subject and Participant Protection Outline
Introduction  Course Goals & Objectives
Chapter 1  History
Chapter 2  The Basics
Chapter 3  Informed Consent
Chapter 4   IRB Review
Chapter 5  Ongoing Protections
Chapter 6  EMSI Human Subject Training
Appendix  Appendix Documents
Exam  Certification Examination
Appendix Content
The Appendix contains links to the following documents:
  • Nuremberg Code
  • World Medical Association Declaration of Helsinki
  • The Belmont Report
  • The Common Rule
  • Interactive Timeline of Historical Events
  • Human Subject Regulations Decision Charts
  • Are You Conducting Research Using Human Subjects?
  • NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research
  • NIH Guidelines on Inclusion of Children as Subjects in Clinical Research
  • Research Involving Individuals with Questionable Capacity to Consent
  • Summary of Basic Protections for Human Subjects
  • National Cancer Institute Certificates of Confidentiality
  • Information to Include in Informed Consent
  • Informed Consent Document Template
  • Guidance on Reporting Adverse Events
  • FDA Reporting Procedures
  • NIH Policy for Data and Safety Monitoring
(All APPENDIX material is presented in PDF format)

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Glossary of Terms
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