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. Author manuscript; available in PMC: 2011 Jul 1.
Published in final edited form as: J Empir Res Hum Res Ethics. 2008 Mar;3(1):15–24. doi: 10.1525/jer.2008.3.1.15

Table 1.

Primary Dependent Measures

Decisional Capacity

  1. In your estimation, all other things being equal, is this type of patient capable of providing independent, sole consent? (0–1 dichotomous scale: 0 = No; 1 = Yes)

Coercion
Coercion is defined as the process of compelling a person to act, or refrain from acting, contrary to free choice. In clinical research, this may take the form of verbal persuasion or inducement to participate in a study.

  1. Based on this definition, what level of risk of coercion exists in this study with this type of patient? (0–10 Likert-type scale: 0 = Very Low; 5 = Moderate; 10 = Very High)

  2. How vulnerable is this type of patient to coercion? (0–10 Likert-type scale: 0 = Not At All; 5 = Moderately; 10 = Extremely)

Risk

  1. Do the potential benefits of this study with this type of patient outweigh the risks? (0–10 Likert-type scale: 0 = No; 5 = Possibly; 10 = Definitely)

  2. What is the level of legal risk to the institution for conducting this study? (0–10 Likert-type scale: 0 = Low; 5 = Moderate; 10 = High)