The IRB reviews all research proposed involving human subjects, including use of data and tissues. The Board has as its mission ensuring that such research fulfills these primary criteria: 
There must be adequate informed consent documentation which acknowledges potential risks, AND it must justify the risks to the subjects.

These guidelines derive from a document known as the “Belmont Report” (found in the “Resources” folder), a landmark document produced by the US Federal Department of Health and Human Services. It originated in 1974 and was updated in 1998. 

In order to fulfill this mission, we must have a broad understanding of the research and a detailed understanding of the potential risks, benefits, and protections of human subjects and data collected involving human subjects. 

Modifications in study designs may be required to minimize risks to subjects, and/or to ensure informed consent, and/or to increase the “worthwhile-ness” of the study or data collection to justify potential risk. 

One way to assist in this is to require completion of a course acceptable by NIH standards for all PIs involved in human research. For a sample course offered by the National Cancer Institute, please click here

This is the NIH training archive website: It contains much useful training given on varied research-related topics, including protection of human subjects.