The IRB will assess whether the risks to subjects are reasonable in relation to the anticipated benefits, if any, to the subjects, and the importance of the knowledge reasonably expected to result from the research. The IRB will consider only those risks and benefits that may result from the research as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research. The federal regulations do not allow the IRB to evaluate the possible long-range effect of applying the knowledge gained through the research. The IRB is required to review any possible benefits a subject may derive from participation in research, or the benefits of new knowledge that may justify asking a person to undertake the risks of the study.

According to 45 CFR § 46, minimal risk means that 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. For the prison population, minimal risk is defined as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or the routine medical, dental, or psychological examination of healthy persons.

The selection of subjects should be equitable and free of any coercion, both explicit and implied. The IRB will consider the purpose of the research and the setting of the research. The IRB will closely examine research involving vulnerable subject populations, such as children, prisoners, subjects with cognitive disorders, or economically or educationally disadvantaged subjects. Researchers should detail any extra precautions taken to safeguard the rights and welfare of subject populations.

The IRB is required to review the method for prospective identification and recruitment of subjects, to include the means of identifying and contacting potential subjects and the methods for ensuring the subjects' privacy and confidentiality. Researchers will include plans for ensuring the privacy and confidentiality of subjects in their applications for IRB approval.

Whenever appropriate, the IRB will require a research plan to make adequate provisions for monitoring the data collected to ensure the safety of subjects. The IRB will review who has been identified in the protocol as having the primary responsibility for analyzing and responding to subject safety issues and will determine whether the study should be modified to minimize risk to current or future research subjects.

The IRB may determine that a project requires more than annual review and may