A criterion for approval of research is that risks to participants are minimized by using procedures that are consistent with sound research design and do not unnecessarily expose participants to risk, and whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes. The IRB or EC should evaluate whether research submitted for review satisfies this criterion. IRB or EC members should understand how to apply this criterion. They should recognize risks whose probability or magnitude can be reduced by using procedures that are consistent with sound research design and that do not unnecessarily expose participants to risk. If the research context involves procedures already being performed for diagnostic or treatment purposes, the IRB or EC should recognize risks whose probability or magnitude can be reduced by using those procedures. If the research context does not involve such procedures, this strategy for minimizing risks is not applicable.

Another criterion for approval of research is that risks to participants are reasonable in relation to potential benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result. The IRB or EC should evaluate whether research submitted for review satisfies this criterion. The IRB or EC should be able to recognize the likelihood and magnitude of harms and benefits, and understand the importance of the knowledge reasonably expected to result. The IRB or EC should be cognizant of the range of harms, including physical, social, economic, psychological, and legal harm. The IRB or EC should also be cognizant of the range of benefits. Direct benefits to participants can take the form of therapy, education, information, resources, or empowerment. 

In all research, the IRB or EC should evaluate the importance of the knowledge that is likely to result from the research.

The IRB or EC should evaluate each research study to ensure that it has the resources necessary to protect research participants. Such resources include staffing and personnel, in terms of availability, number, expertise, and experience; psychological, social, or medical services, including counseling or social support services that may be required because of research participation; psychological, social, or medical monitoring, ancillary care, equipment needed to protect participants, and resources for participant communication, such as language translation services.

An organization, such as an independent review board, that does not provide all necessary resources should evaluate the resources of the local site. This might be accomplished by a case-by-case review of resources at each site. For example, an IRB can evaluate the adequacy of resources based on a description of facilities and personnel provided by the researcher. The precise resources required are protocol specific.