2007 OHRP
Research Community Forum

Objectives

At the conclusion of this educational forum, the participant should be able to:

• Identify the principles of The Belmont Report
• Understand the regulatory provisions of 45 CFR 46 “Protection of Human Subjects”
• Understand how the regulatory provisions of 45 CFR 46 can be implemented in biomedical and social/behavioral research
• Understand the importance and regulations for protecting “Special Populations” in human subject research
• Understand the mission of the “Secretary’s Advisory Committee on Human Research Protection”
• Understand the challenges and perspectives of key players in the human subjects research enterprise
• Understand the regulations and what investigators need to know about the compassionate and emergency use of drugs and devices
• Discuss effective strategies for protecting participant privacy and confidentiality
• Understand and discuss the importance and meaning of consent form language
• Understand and identify the challenges and opportunities for using special populations in social/behavioral and biomedical research
• Understand the challenges of performing research in schools
• Understand how to promote integrity and avoid misconduct in research
• Understand data sharing, HIPAA, ethical issues, family consent and CDC guidelines in genetic research and testing
• Understand the ethical issues and IRB challenges in stem cell research
• Understand the responsibility of the principal investigator, the IRB, the institution and the Office of Research Integrity in issues concerning conflicts of interest
• Discuss the use of controls in human subjects research