Challenges In Measuring a New Construct: Perception of Voluntariness for Research and Treatment Decision Making

The Children's Hospital of Philadelphia, Civic Center, Philadelphia, PA 19104, USA.
Journal of Empirical Research on Human Research Ethics (Impact Factor: 1.25). 09/2009; 4(3):21-31. DOI: 10.1525/jer.2009.4.3.21
Source: PubMed


RELIABLE AND VALID MEASURES OF RELEVANT constructs are critical in the developing field of the empirical study of research ethics. The early phases of scale development for such constructs can be complex. We describe the methodological challenges of construct definition and operationalization and how we addressed them in our study to develop a measure of perception of voluntariness. We also briefly present our conceptual approach to the construct of voluntariness, which we defined as the perception of control over decision making. Our multifaceted approach to scale development ensured that we would develop a construct definition of sufficient breadth and depth, that our new measure of voluntariness would be applicable across disciplines, and that there was a clear link between our construct definition and items. The strategies discussed here can be adapted by other researchers who are considering a scale development study related to the empirical study of ethics.

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Available from: Mary Frances Luce, Apr 14, 2015
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    • "The first stage entailed defining the construct. This initial stage is important because a clear definition of the construct and its boundaries will guide the generation and selection of the items (Miller et al., 2009). The second stage involved designing the scale, after which a pilot test was conducted in the third stage. "

    Full-text · Article · Dec 2015
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    • "However, as the call for a formal assessment of voluntariness to be incorporated into the consent process intensifies (Stiles, Epstein, Poythress, & Edens, 2011), more researchers are responding to the challenge of developing a suitable measure of voluntariness (cf. Appelbaum, Lidz, & Klitzman, 2009b; Dugosh, Festinger, Croft, & Marlowe, 2010; Miller et al., 2009). "
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    ABSTRACT: The conceptual complexity of the term voluntariness has resulted in relatively few empirical studies of the voluntariness component of consent to research. As the call for a formal assessment of voluntariness to be incorporated into the consent process intensifies, more researchers are responding to the challenge of developing a valid and reliable measure of voluntariness. The purpose of this article was to summarize and describe the empirical literature on voluntariness of consent. As part of a broader study on the voluntariness of consent to research, existing empirical studies of voluntariness of consent to research were reviewed to establish how voluntariness of consent to research has been assessed to date. Fifteen studies using different voluntariness assessment instruments were identified and included in the review. The review found that little attempt has been made to systematically collect data on the reliability and validity of voluntariness assessment instruments. No two instruments reviewed were found to be based on a shared conceptualization of voluntary consent to research.
    Full-text · Article · Feb 2015 · Journal of Empirical Research on Human Research Ethics
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    ABSTRACT: Informed consent that is voluntary and made by an individual who is knowledgeable and competent is a foundational requirement for protecting human subjects from harm and exploitation that could result from research participation. In 1974 Miller and Willner proposed a two-part consent process that involved disclosure of information and assessment of comprehension. The authors propose a brief third component to the consent process: assessment of voluntariness. Three steps are involved: generate a list of potential coercive influences on the basis of the research population and the study context, develop a set of questions to assess the presence and intensity of the impact of these influences, and identify alternative courses of action should coercion be identified.
    Full-text · Article · Jan 2011 · Psychiatric services (Washington, D.C.)
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