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62 PART I: General IssuesViolation of federal regulations regarding the review of research involvinghumans or animals can bring a halt to all research at an institution, spell theloss of federal funds, and result in substantial fines (Holden, 1987). Any individualwho wants to do research should inquire of the proper authorities, prior tostarting research, about the appropriate procedure for institutional review. Helpfuladvice is available for students planning to submit a research proposal to anIRB (McCallum, 2001) or to an IACUC (LeBlanc, 2001).THE RISK/BENEFIT RATIO• A subjective evaluation of the risks and benefits of a research project is usedto determine whether the research should be conducted.Key ConceptIn addition to checking if appropriate ethical principles are being followed,an IRB considers the risk/benefit ratio for a study. Society and individuals benefitfrom research when new knowledge is gained and when treatments are identifiedthat improve people’s lives. There are also potential costs when research isnot done. We miss the opportunity to gain knowledge and, ultimately, we losethe opportunity to improve the human condition. Research can also be costlyto individual participants if they are harmed during a research study. The principalinvestigator must, of course, be the first one to consider these potentialcosts and benefits. An IRB is made up of knowledgeable individuals who do nothave a personal interest in the research. As such, an IRB is in a better position todetermine the risk/benefit ratio and, ultimately, to decide whether to approvethe proposed research.The risk/benefit ratio asks the question “Is it worth it?” There are no mathematicalanswers to the risk/benefit ratio. Instead, members of an IRB rely ona subjective evaluation of the risks and benefits both to individual participantsand to society, and ask, are the benefits greater than the risks? When the risks outweighthe potential benefits, then the IRB does not approve the research; whenthe benefits outweigh the risks, the IRB approves the research.Many factors affect the decision regarding the proper balance of risks andbenefits of a research activity. The most basic are the nature of the risk andthe magnitude of the probable benefit to the participant as well as the potentialscientific and social value of the research (Fisher & Fryberg, 1994). Greaterrisk can be tolerated when clear and immediate benefits to individuals are foreseenor when the research has obvious scientific and social value. For instance,a research project investigating a new treatment for psychotic behavior mayentail risk for the participants. If the proposed treatment has a good chanceof having a beneficial effect, however, then the possible benefits to both theindividuals and society could outweigh the risk involved in the study.In determining the risk/benefit ratio, researchers also consider the quality ofthe research, that is, whether valid and interpretable results will be produced.More specifically, “If because of the poor quality of the science no good cancome of a research study, how are we to justify the use of participants’ time,attention, and effort and the money, space, supplies, and other resources thathave been expended on the research project?” (Rosenthal, 1994b, p. 128). Thus,