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: 1.22). 09/2009; 4(3):21-31. DOI: 10.1525/jer.2009.4.3.21
Source: PubMed

ABSTRACT 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.


Available from: Mary Frances Luce, Apr 14, 2015
  • [Show abstract] [Hide abstract]
    ABSTRACT: The goals of the current study were to expand the content domain and further validate the Coercion Assessment Scale (CAS), a measure of perceived coercion for criminally involved substance abusers being recruited into research. Unlike the few existing measures of this construct, the CAS identifies specific external sources of pressure that may influence one's decision to participate. In Phase 1, we conducted focus groups with criminal justice clients and stakeholders to expand the instrument by identifying additional sources of pressure. In Phase 2, we evaluated the expanded measure (i.e., endorsement rates, reliability, validity) in an ongoing research trial. Results identified new sources of pressure and provided evidence supporting the CAS's utility and reliability over time as well as convergent and discriminative validity. © The Author(s) 2014.
    Journal of Empirical Research on Human Research Ethics 10/2014; 9(4):60-70. DOI:10.1177/1556264614544100 · 1.22 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    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.
    Journal of Empirical Research on Human Research Ethics 02/2015; 10(2):107-120. DOI:10.1177/1556264615571552 · 1.22 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The author summarizes emerging standards for informed consent as the underpinning of ethical research in humans.
    New England Journal of Medicine 02/2015; 372(9):855-62. DOI:10.1056/NEJMra1411250 · 54.42 Impact Factor