The logistics of IRB review varies from institution to institution. The major principles underlying IRB review, however, do not. First, the IRB must make a decision based on common sense and sound professional judgment as to whether or not the proposed research places the subject “at risk”. A subject is considered to be at risk if he is exposed to the possibility of harm, whether physical, psychological, sociological, or other, as a consequence of any activity which goes beyond the application of those established methods necessary to meet his needs. The IRB must consider the fact that certain subject populations (e. g., minors, pregnant women, prisoners, mentally retarded with challenged) may be at greater risk than others.
Certain risks are inherent in life itself, but the IRB is not concerned with the ordinary risks of public or private living. Risk is most obvious in medical and behavioral science research projects involving procedures that may induce a potentially harmful altered physical state or psychological condition. The most obvious examples include surgical procedures, the administration of drugs or radiation, the requirement of strenuous physical exertion, and an intervention that precipitates an emotional disturbance. There is also a wide range of medical, social, and behavioral procedures and projects in which, although there may be no immediate risk, procedures may be introduced which involve discomfort, anxiety, harassment, invasion of privacy, or constitute a threat to the subject’s dignity. There are also medical and biomedical projects concerned solely with organs, tissues, body fluids, and other materials obtained in the routine performance of medical services which obviously involve no element of physical risk to the subject, but their use for certain research, training, and service purposes may present psychological, sociological, or legal risks to the subject or authorized representatives. Finally, the risk element should be determined for those studies dependent upon existing information or stored data which have been obtained for quite different purposes but which, when used in a research context, may present risk to the human subject.
If it is judged that the proposed research project will expose a subject to risk, then the IRB must assure itself that (a) the rights and welfare of the subject are adequately protected, (b) the methods used to obtain informed consent are adequate and appropriate, (c) the risks to the subject are outweighed by the potential benefit to him or by the importance of the knowledge to be gained, and (d) the selection of subjects is equitable. The IRB is not responsible for considering scientific merit or methodology unless an alternative experimental design will decrease the potential risk(s) to the subject, and still yield the same potential benefit(s).
Upon completion of the review process and investigator compliance with all modifications recommended by the IRB, an approval to begin the study is issued. Approval is for a maximum period of one year, at which time annual review is required. If a project involves an unusual degree of risk to the subject, approval may be for a period of less than one year as determined by the IRB.