Minimal Risk

Minimal risk is a concept that relates to the protection of human subjects and thus to survey ethics. In Chapter 45, Subpart A, Section 46.102, Paragraph (i) of the Code of Federal Regulations, the U. S. Department of Health and Human Services Office of Human Research Protections defines minimal risk as a category of research activities in which “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those encountered in daily life or during the performance of routine physical or psychological examinations or tests.” In general, a person who participates in a survey as a respondent is thought to be exposed to minimal risk. As such, minimal risk is a classification that is associated with nearly all scientific survey research studies, although many nonsurvey research programs also may be appropriately classified as having minimal risk.

Minimal risk status is not determined by a clearly objective standard that is subject to a claim made by a research investigator. Instead, formal classification of research as minimal risk is a judgment based on the assessment of an institutional review board (IRB), a group of at least five scientists and laypeople responsible for overseeing research activities at any research institution funded by the federal government or a federal agency and subject to the Code of Federal Regulations governing research. There are widely accepted guidelines that have been developed by various government-sponsored expert panels. For example, in 2001, an analysis conducted by the National Bioethics Advisory Commission encouraged IRBs to act blindly with respect to specific characteristics of research subjects (e.g. those having cancer) in interpreting or assessing a study's risk of adverse consequence to research participants and, instead, to be guided in assessment of research risk in terms of “common risks… for example, driving to work, crossing the street, getting a blood test, or answering questions over the telephone.” At the same time, it is widely appreciated that an IRB should consider the severity of the harm should a potential adverse consequence from research participation occur. Similar review groups are used by many private sector survey organizations that have no federal funding.

In general, for the purposes of considering whether to classify a research program as minimal risk, it is useful to consider both the probabilities of adverse consequences and the severities or magnitudes of those consequences should they occur. This kind of decision calculus is depicted in Figure 1.

Figure 1 reflects the subjective nature of the assessment of minimal risk. It is within the purview of each [Page 466]individual IRB to determine the thresholds for likelihood of harm and severity of harm (should harm occur) that moves a research program beyond the realm of minimal risk.

Figure 1 Probability and severity of adverse occurrences in determining risk level

It is generally understood that, for several reasons, a system for classifying research as minimal risk is a useful and important function of an IRB. These reasons include the following:

• 1.
  It helps the IRB be more efficient and

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