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Grant Details

Grant Number: 5R21CA118377-02 Interpret this number
Primary Investigator: Nelson, Robert
Organization: Children'S Hosp Of Philadelphia
Project Title: Developing a Measure of Voluntary Consent for Protocol-Based Treatment Decisions
Fiscal Year: 2007
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Abstract

DESCRIPTION (provided by applicant): The individual choice to participate in research (i.e., consent) should be both informed and voluntary. The empirical study of consent has focused on the information (i.e., what a person knows) and decision-making aspects (i.e., how a person processes information) of consent. Few empirical studies examine the voluntary nature of consent, due largely to the lack of an instrument to measure "voluntariness." Absent such an instrument, it is difficult to distinguish between appropriate and "undue" influences on informed consent. Project Summary: The primary objective is to develop a valid and reliable measure of voluntary consent (called the "decision-making control instrument" or DMCI) for single-event decisions by parents concerning protocol-based treatment of their seriously ill child. A secondary objective is to explore relationships between the DMCI and other measures of decision-making preference, coping style and affect. The long-term objective is to extend the study of informed consent beyond the information and decision-making aspects to include the influence of affect, coping style and voluntary choice. The objectives will be met through four specific aims: (1) Item Generation: To create an item pool of measures that assesses all major dimensions of decision-making control for this sample of parents; (2) Scale Construction: To construct a voluntary consent scale (DMCI) appropriate for use with these parents; (3) Construct Validity: To examine the relationship between DMCI total score and selected measures of decision-making preference, coping style and affect; and (4) Pilot Testing: To administer the DMCI and conduct qualitative interviews with a second, smaller sample of parents to explore the instrument's ability to capture their own perceptions of the control they exercised over the single-event decision. This project advances the mission of the National Cancer Institute by enhancing our knowledge of the affective processes underlying single-event decisions concerning cancer treatment so that parents can make more informed and satisfying choices. Relevance: The assessment of whether consent is informed is becoming a part of many clinical trials. Absent a measure of voluntary consent, we are left with only a partial picture of the adequacy of the consent process. An instrument to assess the voluntary choice of a research participant will be an important addition to existing instruments so we may assess whether an individual's consent is both informed and voluntary.

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Publications

Factors related to voluntary parental decision-making in pediatric oncology.
Authors: Miller VA, Nelson RM
Source: Pediatrics, 2012 May;129(5), p. 903-9.
EPub date: 2012 Apr 16.
PMID: 22508918
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The concept of voluntary consent.
Authors: Nelson RM, Beauchamp T, Miller VA, Reynolds W, Ittenbach RF, Luce MF
Source: Am J Bioeth, 2011 Aug;11(8), p. 6-16.
PMID: 21806428
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Response to open peer commentaries on "the concept of voluntary consent".
Authors: Nelson RM, Beauchamp TL
Source: Am J Bioeth, 2011 Aug;11(8), p. W1-3.
PMID: 21806424
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Relationship of external influence to parental distress in decision making regarding children with a life-threatening illness.
Authors: Miller VA, Luce MF, Nelson RM
Source: J Pediatr Psychol, 2011 Nov-Dec;36(10), p. 1102-12.
EPub date: 2011 Jun 21.
PMID: 21693541
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The decision making control instrument to assess voluntary consent.
Authors: Miller VA, Ittenbach RF, Harris D, Reynolds WW, Beauchamp TL, Luce MF, Nelson RM
Source: Med Decis Making, 2011 Sep-Oct;31(5), p. 730-41.
EPub date: 2011 Mar 14.
PMID: 21402793
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Challenges in measuring a new construct: perception of voluntariness for research and treatment decision making.
Authors: Miller VA, Reynolds WW, Ittenbach RF, Luce MF, Beauchamp TL, Nelson RM
Source: J Empir Res Hum Res Ethics, 2009 Sep;4(3), p. 21-31.
PMID: 19754231
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Empirical data and the acceptability of research risk: a commentary on the charitable participation standard.
Authors: Reynolds WW, Nelson RM
Source: Arch Pediatr Adolesc Med, 2008 Jan;162(1), p. 88-90.
PMID: 18180419
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