Description
This course included analysis of the value, function, authority, and regulations underlying scientific and research review boards, including institutional review boards (IRBs), institutional animal care and use committees (IACUCs), radiation safety committees, biosafety committees, and data and safety monitoring boards (DSMBs). Topics included FDA regulations and oversight of review boards, IRB operations and ethics, animal research review and regulations, research involving radiation, biosafety committees and biohazardous materials, and the oversight of data safety and monitoring boards during clinical trials. I was not only provided the historical basis for regulating research, but also challenged to analyze the effectiveness of the various committees and boards in protecting humans and animals in research.
Objectives
Objectives
- Justify the role and authority of the IRB in the conduct of human subject research using ethical and regulatory points of reference.
- Correlate the informed consent process with the Belmont Report and other salient historical documents to define the IRB’s role in protecting human subjects.
- Design operational procedures to comply with the regulatory requirements of scientific and research review boards.
- Apply applicable federal regulations to the unique needs and purposes of scientific and research review boards.
- Justify the roles of IACUCs, radiation review committees, biosafety committees, and DSMBs in research oversight.
- Appraise the requirements and application processes for individual IRBs, IACUCs, biosafety, and radiation safety committees.
- Compare the roles of scientific and research review boards and their members in interpreting risk levels for research and subject safety.
