Use the following to answer questions
Scenario I
Scenario I is based on fabricated data inspired by the following study:
Pande, A. C., Crockatt, J. C., Feltner, D. E., et al. (2003). Pregabalin in generalized anxiety disorder: a placebo-controlled trial. The American Journal of Psychiatry, 160(3), 533-540.
Effect of Pregabalin on Anxiety
Pande and colleagues examined whether pregabalin (brand name Lyrica) was as effective as lorazepam (brand name Ativan) in treating anxiety. To that end, they administered either a low dose of pregabalin, a high dose of pregabalin, lorazepam, or placebo to participants for four weeks, then measured the participants' anxiety using the Hamilton Anxiety Rating Scale. The researchers found that not only did the high dose of pregabalin significantly reduce anxiety, but that it also reduced anxiety as well as lorazepam. The results of the study (Figure 1) indicate that pregabalin may be an effective alternative to lorazepam to treat anxiety in adults.
Figure 1. Hypothetical results of Pande et al (2003) showing the impact of each treatment on anxiety level. Anxiety was measured using the Hamilton Anxiety Rating Scale.
-(Scenario I) During an IRB meeting one member notes the high dose of pregabalin proposed in this study may produce significant negative side effects. Another IRB member says that although this may be true, it should only affect a few participants. She also notes that other studies have found pregabalin to have a number of positive effects. The IRB appears to be engaged in a discussion relating to:
A) beneficence.
B) justice.
C) respect for persons.
D) anonymity.

Question

Use the following to answer questions
Scenario I
Scenario I is based on fabricated data inspired by the following study:
Pande, A. C., Crockatt, J. C., Feltner, D. E., et al. (2003). Pregabalin in generalized anxiety disorder: a placebo-controlled trial. The American Journal of Psychiatry, 160(3), 533-540.
Effect of Pregabalin on Anxiety
Pande and colleagues examined whether pregabalin (brand name Lyrica) was as effective as lorazepam (brand name Ativan) in treating anxiety. To that end, they administered either a low dose of pregabalin, a high dose of pregabalin, lorazepam, or placebo to participants for four weeks, then measured the participants' anxiety using the Hamilton Anxiety Rating Scale. The researchers found that not only did the high dose of pregabalin significantly reduce anxiety, but that it also reduced anxiety as well as lorazepam. The results of the study (Figure 1) indicate that pregabalin may be an effective alternative to lorazepam to treat anxiety in adults.
  Figure 1. Hypothetical results of Pande et al (2003) showing the impact of each treatment on anxiety level. Anxiety was measured using the Hamilton Anxiety Rating Scale.
-(Scenario I) During an IRB meeting one member notes the high dose of pregabalin proposed in this study may produce significant negative side effects. Another IRB member says that although this may be true, it should only affect a few participants. She also notes that other studies have found pregabalin to have a number of positive effects. The IRB appears to be engaged in a discussion relating to:
A) beneficence. 
B) justice. 
C) respect for persons. 
D) anonymity.

Quizplus · Accepted Answer

The IRB members are discussing the principle of beneficence, which requires that the potential benefits of a study outweigh the risks to the participants. The member who is concerned about the potential negative side effects is raising a valid point about the need to balance the benefits of the study with the risks to the participants.

Use the Following to Answer Questions