Welcome to Tusculum University's IRB training module. Please note that this training is based heavily off of the  Protecting Human Research Participants training developed by NIH Office of Extramural Research that is no longer available after 09/27/2018.

 

Introduction

Research with human subjects can occasionally result in a dilemma for investigators. When the goals of the research are designed to make major contributions to a field, such as improving the understanding of a disease process or determining the efficacy of an intervention, investigators may perceive the outcomes of their studies to be more important than providing protections for individual participants in the research. 

Although it is understandable to focus on goals, our society values the rights and welfare of individuals. It is not considered ethical behavior to use individuals solely as means to an end.

The importance of demonstrating respect for research participants is reflected in the principles used to define ethical research and the regulations, policies, and guidance that describe the implementation of those principles. 

Who?

This course is intended for use by individuals involved in the design and/or conduct of National Institutes of Health (NIH) funded human subjects research.

 

What?

This course is designed to prepare  investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. The course material presents basic concepts, principles, and issues related to the protection of research participants.

 

Why?

As a part of NIH's commitment to the protection of human subjects and its response to Federal mandates for increased emphasis on protection for human subjects in research, the NIH Office of Extramural Research released a policy on Required Education in the Protection of Human Research Participants in June 2000. This course is specifically designed for extramural investigators and is one (of many) possibilities for meeting the policy requirement.

Because this course is intended to allow investigators to fulfill the Required Education in the Protection of Human Research Subjects, it assumes that the investigators' research will be funded by NIH and is therefore subject to all U.S. Department of Health and Human Services (HHS) regulatory and NIH policy requirements.

The information presented is neither prescriptive nor exhaustive and does not replace or supersede local, state, or Federal regulations applicable to human research or any institutional policies regarding the protection of human subjects.

 

Course Objectives

Upon completion of this course, you should be able to:

• Describe the history and importance of human subjects protections
• Identify research activities that involve human subjects
• Discover the risks a research project might pose to participants
• Understand how to minimize the risks posed by a research project
• Describe additional protections needed for vulnerable populations
• Understand additional issues that should be considered for international research
• Describe appropriate procedures for recruiting research participants and obtaining informed consent
• Identify the different committees that monitor human subjects protections
• Understand the importance of study design in the protection of research participants

The first module examines significant historical events that have contributed to the way we view the protections for participants in clinical research today.