CITI HUMAN SUBJECTS RESEARCH EDUCATION LEARNING OBJECTIVES

The educational goals of the CITI program are to:

  • Increase knowledge of, and sensitivity to issues surrounding the responsible conduct of research with human subjects.
  • Improve the ability of program participants to make ethical and legal choices in the face of conflicts involving scientific research with human subjects.
  • Develop appreciation for the range of accepted scientific practices for conducting research with human subjects.
  • Provide information about the regulations, policies, statutes, and guidelines that govern the conduct of research with human subjects.
  • Develop positive attitudes toward life-long learning in matters involving the responsible conduct of research with human subjects.
  • Provide participants with an understanding and knowledge of the Federal Regulations, International Conference on Harmonisation (ICH) Regulations and Good Clinical Practice guidelines that apply to clinical research

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The Target Audience

This CITI Basic Course in human subjects protection and bioethics is designed specifically for all personnel that have a significant involvement in the planning, conduct and analysis of any scientific activity that employs human beings as research subjects. This course is specifically designed to meet the June 2000 PHS Policy mandate that all key personnel involved in PHS funded human subjects research, must have formal instruction in human subjects protection.

The CITI Refresher Course in the protection of human research subjects was developed to meet the needs of those institutions and organizations that required a web based vehicle to deliver a short refresher or continuing education course to meet a re-certification requirement.  The target audience is the same as for the basic course.

This CITI Good Clinical Practice Course is designed specifically for Clinical Researchers participating in Human Subjects Research to have an nderstanding and knowledge of the Federal Regulations, International Conference on Harmonisation (ICH) Regulations and Good Clinical Practice guidelines that apply to clinical research.

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The Learning Objectives for the CITI Basic Course are to provide the Target audience with:

  • An understanding of the historical perspectives, ethical principals and federal regulations associate with the conduct of research with human subjects.
  • A clear understanding of what constitutes human subjects research and how informed consent must be applied in human subjects research.
  • Basic information on the regulations and policies governing research with investigational drugs, biologicals and devices and how the findings of The International Commission on Harmonization affect the conduct of research with human subjects around the world.
  • A basic understanding of the risks to privacy and confidentiality of human subjects who participate in Social and Behavioral research.  
  • An understanding of the special considerations that must be addressed when "Vulnerable Populations" such prisoners, minors, pregnant women and fetuses in utero  are used in research activities.
  • An understanding of how to recognize and avoid conflicts of interest in human subjects research.
  • New insights into the concept of group harms in vulnerable populations such as minorities and workers in a workplace setting and the use of Community Consultation to prevent injury to special social structures.
  • An understanding of the special risks facing human subjects when they participate in research conducted over the internet.
  • A clear understanding of the ethical issues and federal regulations in force during the conduct of Social / Behavioral Research, Records Based Research and Genetics Research with human subjects.
  • An understanding of the Policies, Regulations and Risks associated with conducting research with children in public school setting.
  • A clear understanding of the special procedural and regulatory policies for human subjects research at VA research facilities.
  • New information on late breaking topics that may affect the use of human subjects in research. The intent is to provide the user with the latest guidance from regulatory agencies and to provide timely information on new human subjects issues. 

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The Learning Objectives for the CITI Refresher Course are to provide the target audience with information that reinforces specific concepts and skills derived from the CITI Basic Course.  Cases and scenarios are presented to reinforces the fundamental concepts with respect to:

  • How informed consent must be applied in human subjects research.
  • The regulations and policies governing research with investigational drugs, biologicals and devices. 
  • The risks to privacy and confidentiality of human subjects who participate in Social and Behavioral research.  
  • The special considerations that must be addressed when "Vulnerable Populations" such as prisoners, minors, pregnant women and fetuses in utero  are used in research activities.
  • Conflicts of interest in human subjects research.
  • Potential harm in vulnerable populations such as minorities and workers in a workplace setting.
  • The ethical issues and federal regulations in force during the conduct of Social / Behavioral Research, Records Based Research and Genetics Research with human subjects.
  • The special procedural and regulatory policies for human subjects research at VA research facilities.

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The Learning Objectives for the CITI Good Clinical Practice Course are to provide the Target audience with:

  • Knowledge of the Federal Regulations for clinical research and drug development
  • Knowledge of the role  of International Conference on Harmonisation
  • Kknowledge of international standards on clinical research
  • Knowledge/understanding regarding clinical researcher responsibilities

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