Investigator 101 Module

Office for Human Research Protection (OHRP) and PRIM&R

This two-part program provides basic information on the topics of ethics in research and investigator compliance with federal regulations. Part 1 presents the history of research ethics and key ethical issues are explored in terms of application to research design and study execution. Regulatory compliance topics as they apply to investigators are presented in Part 2. Examined is the IRB approval process, obtaining informed consent, continuing review and proper study documentation and record retention practices.

Introduction – Part 1 Transcript for Lecture 1
Ethical Decision Making Transcript for Lecture 2
The Belmont Principles Transcript for Lecture 3
History of Research Ethics Transcript for Lecture 4
Applying Research Ethics Transcript for Lecture 5
Key Issues in Research Ethics Transcript for Lecture 6
Questions and Answers – Part 1 Transcript for Lecture 7
Introduction – Part 2 Transcript for Lecture 8
Designing Ethical Research Transcript for Lecture 9  
Complying with Federal Regulations Transcript for Lecture 10  
Obtaining Prior IRB Approval   Transcript for Lecture 11
Complying with IRB Requirements Transcript for Lecture 12
Implementing the Protocol as Approved Transcript for Lecture 13
Obtaining Informed Consent/Assent Transcript for Lecture 14
Documentation of Informed Consent/Assent Transcript for Lecture 15
Submitting Progress Reports Transcript for Lecture 16
Reporting Unanticipated Problems Transcript for Lecture 17
Retaining Records Transcript for Lecture 18
Questions and Answers – Part 2 Transcript for Lecture 19