A number of protections for human subjects involved in research are specified in the Common Rule. IRBs are required to review and approve any nonexempt research that involves human subjects, with its membership specified, functions defined, and review processes outlined.6 The Common Rule also includes criteria for IRB approval of research and identifies certain categories of research that can be approved on an expedited basis.7 It also specifies that, when “some or all of the subjects are likely to be vulnerable to coercion or undue influence,” the IRB must find that “additional safeguards have been included to protect the rights and welfare of those subjects.”8 IRBs are empowered to suspend or terminate research that has been approved and are required to maintain records that document all IRB activities.9
In some cases, IRB review of individual research projects can be expedited if the project involves no more than minimal risk and fits certain categories (e.g., collection of small amounts of blood, analysis of existing materials) or involves minor changes to a previously approved research project. Minimal risk for the Common Rule is defined as:
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.10
Under expedited procedures that bypass the full IRB process, the IRB chair or one or more experienced IRB members who is designated by the chair can review and approve the research. Although regulations do not preclude the use of expedited review for research involving prisoners, the OHRP recommends that such research be reviewed by the full committee.
Informed consent processes are also defined in the Common Rule. The basic disclosure requirements for obtaining informed consent are (1) a description of the study and its purposes; (2) identification of any foreseeable risks or discomforts to the participant; (3) a description of any benefits that could be expected; (4) disclosure of alternative treatments that may