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A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration (2011)

Chapter: Appendix E: Factors Hypothesized as Important in Understanding Risk

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Suggested Citation:"Appendix E: Factors Hypothesized as Important in Understanding Risk." National Research Council and Institute of Medicine. 2011. A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/13156.
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Appendix E
Factors Hypothesized as Important in Understanding Risk

The following is a list of some characteristics of hazards that have been hypothesized as important in understanding risk. They were compiled from the following sources: Lowrance (1976); Rowe (1977); Vlek and Stallen (1980); Hohenemser et al. (1983); Litai et al. (1983); Slovic et al. (1984), Jenni (1997).


Ability to contain adverse effects

Ambiguity about probability of harm

Ambiguity about severity of effects

Availability of options or alternatives

Avoidability

Blame assignable

Caused by humans

Common vs dreaded hazards

Confidence in decision-making strategies

Confidence in experts or regulators

Consequences foreseeable

Continuous vs occasional exposure

Controllability (institutional)

Controllability (personal)

Delay or timing of effects

Distribution of effects (general population vs sensitive groups)

Ease of change or correction

Ease of escape from harm

Familiarity vs Newness

Frequency of accidents

Importance of intended benefits (for example, necessity vs luxury)

Knowledge about risks and benefits

Suggested Citation:"Appendix E: Factors Hypothesized as Important in Understanding Risk." National Research Council and Institute of Medicine. 2011. A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/13156.
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Natural vs manmade causes

Nonhuman impacts

Number of people affected

Occupational vs nonoccupational exposure

Personal awareness of risk or danger

Personal experience and knowledge

Personal influence or responsibility

Possibility of error

Preventable

Probability or frequency of adverse events or effects

Recurrence

Reversibility of effects

Severity of effect (for example, major vs minor, large vs small, fatal vs survivable, painful vs painless)

Size of the population at risk

Spatial distribution of risks

Speed with which adverse events occur

Transgenerational effects

Voluntariness

REFERENCES

Hohenemser, C., R.W. Kates, and P. Slovic. 1983. The nature of technological hazard. Science 220 (4495):378-384.

Jenni, K.E. 1997. Attributes for Risk Evaluation. Ph.D. Dissertation, Carnegie Mellon University, Pittsburgh, PA.

Litai, D., D. Lanning, and N. Rasmussen. 1983. The public perception of risk. Pp. 213-224 in The Analysis of Actual Versus Perceived Risks , V. Covello, W. Flamm, J. Rodericks and R. Tardiff, eds. New York: Plenum Press.

Lowrance, W.W. 1976. Of Acceptable Risk: Science and the Determination of Safety. Los Altos, CA: W. Kaufmann.

Rowe, W.D. 1977. An Anatomy of Risk. New York: Wiley.

Slovic, P., B. Fischhoff, and S. Lichtenstein. 1984. Behavioral decision theory perspectives on risk and safety. Acta Psychologica 56:183-203.

Vlek, C. and P.J. Stallen. 1980. Rational and personal aspects of risk. Acta Psychologica 45:273-300.

Suggested Citation:"Appendix E: Factors Hypothesized as Important in Understanding Risk." National Research Council and Institute of Medicine. 2011. A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/13156.
×
Page 191
Suggested Citation:"Appendix E: Factors Hypothesized as Important in Understanding Risk." National Research Council and Institute of Medicine. 2011. A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/13156.
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With the responsibility to ensure the safety of food, drugs, and other products, the U.S. Food and Drug Administration (FDA) faces decisions that may have public-health consequences every day. Often the decisions must be made quickly and on the basis of incomplete information. FDA recognized that collecting and evaluating information on the risks posed by the regulated products in a systematic manner would aid in its decision-making process. Consequently, FDA and the Department of Health and Human Services (DHHS) asked the National Research Council (NRC) to develop a conceptual model that could evaluate products or product categories that FDA regulates and provide information on the potential health consequences associated with them.

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration describes the proposed risk-characterization framework that can be used to evaluate, compare, and communicate the public-health consequences of decisions concerning a wide variety of products. The framework presented in this report is intended to complement other risk-based approaches that are in use and under development at FDA, not replace them. It provides a common language for describing potential public-health consequences of decisions, is designed to have wide applicability among all FDA centers, and draws extensively on the well-vetted risk literature to define the relevant health dimensions for decision-making at the FDA. The report illustrates the use of that framework with several case studies, and provides conclusions and recommendations.

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