The policies, guidelines, and ethical principles for the protection of human subjects in research at the University of Michigan come from a variety of sources. One of the most important documents is the Belmont Report .
Federal policies covering human subjects generally start with the Code of Federal Regulations, 45 CFR 46, which contains a definition of research, human subjects, vulnerable (meaning subject to undue influence) populations, and minimal risk. These regulations also define what research can be determined to be exempt, research that can be approved by expedited review, and criteria to be used by the full IRB board for other activities.
Because UM conducts much of its health-related research with National Institutes of Health funding, NIH regulations also strongly influence IRB decisions.
UM applies the same criteria for un-funded research or research funded by non-federal sponsors as it does for NIH (or other federal agency) funded research.
The highest level University policy is contained in the Standard Practice Guide (SPG 303.5).
The operation of the nine UM IRBs (of which the IRB-Dearborn is one) is described in the Operations Manual. The specific procedures of the IRB-Dearborn are described in our Standard Operating Procedures manual or SOP.
Some information of interest to researchers is available from the IRB-Med website (such as a description of adverse events that must be reported, levels of risk, HIPPAA regulations, etc.).
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