Why is it necessary for the federal government to require that institutions review proposed research projects? Don all researchers take the appropriate steps to protect subjects on their own?
The vast majority of researchers plan and conduct their research in accordance with sound ethical principles. However, there is adequate documentation that some investigators do not take the necessary steps, either through conscious choice or as a result of ignorance, to protect the individuals who volunteer to participate in their research. When the researcher is affiliated with an academic institution, repercussions for failing to protect subjects affect not only the investigator, but the institution as well. For this reason, oversight by an institutional review board is necessary to ensure that projects include the appropriate safeguards to protect human subjects. The federal regulations postulated at 45 CFR 46 and 21 CFR describe those protections and form the basis for IRB policy.
