Exam 3: C: Ethics: Making Ethical Decisions in Research

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)Which of the following is an ethical issue apparent in Figure 1?

Use the following to answer questions Scenario III Scenario III is based on fabricated data inspired by the following study: Yatawara,C.J. ,Einfeld,S.L. ,Davenport,T.A. ,& Guastella,A.J.(2015).The effect of oxytocin nasal spray on social interaction deficits observed in young children with autism: a randomized clinical crossover trial [advance online publication].Molecular Psychiatry. Oxytocin and Autism Study The purpose of this study was to examine whether oxytocin could improve social bonding in autistic children.Oxytocin is a chemical affectionately known as the "love drug" because it is shown to increase mother-child and male-female bonding.Given that autism typically affects one's ability to form social bonds with others,Yatawara and colleagues (2015)hypothesized that the administration of oxytocin to autistic children may improve their ability to bond with family members.To that end,31 autistic children received either intranasal oxytocin or a placebo twice daily for five weeks after which each child's caregiver completed a self-report social responsiveness survey.The results revealed oxytocin administration significantly improved the social responsiveness of autistic children.These data suggest that oxytocin should be investigated further for the treatment of autism. -(Scenario III)Suppose Yatawara and colleagues (2015)found oxytocin had no effect on social bonding,and as a result didn't bother to publish their findings.Unaware of their null result,a different group of researchers just invested $35,000 in a study to examine oxytocin as a treatment for autism.According to your text this illustrates:

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)What ethical principle would be in question if the criteria for participating in the study included having health insurance?

Use the following to answer questions Scenario II Scenario II is based on fabricated data inspired by the following study: Ambrose,B.K. ,Rostron,B.L. ,Johnson,S.E. ,et al.(2014).Perceptions of the relative harm of cigarettes and e-cigarettes among U.S.youth.American Journal of Preventative Medicine,47,S53-S60. How Youths Perceive E-Cigarettes The purpose of this study was to investigate the perception of cigarettes and electronic cigarettes (e-cigs)held by American adolescents and teens.To that end,Ambrose and colleagues (2014)examined data obtained previously by the 2012 National Youth Tobacco Survey.This survey includes responses from 24,658 children in 6^th through 12^th grades across the United States.The results revealed that 33% of the students believed that e-cigs were safer than traditional cigarettes.Interestingly,the children who reported never having smoked were less likely to perceive e-cigs as safer than traditional cigarettes.These results suggest that e-cigs may entice kids who would normally avoid cigarettes.Although e-cigs do not contain many of the harmful chemicals found in traditional cigarettes,they do contain nicotine.Because nicotine is addictive,e-cig use may become a gateway to traditional cigarettes. -(Scenario II)Based on the current ethical guidelines,from whom did the researchers in Scenario II obtain informed consent?

Use the following to answer questions Scenario III Scenario III is based on fabricated data inspired by the following study: Yatawara,C.J. ,Einfeld,S.L. ,Davenport,T.A. ,& Guastella,A.J.(2015).The effect of oxytocin nasal spray on social interaction deficits observed in young children with autism: a randomized clinical crossover trial [advance online publication].Molecular Psychiatry. Oxytocin and Autism Study The purpose of this study was to examine whether oxytocin could improve social bonding in autistic children.Oxytocin is a chemical affectionately known as the "love drug" because it is shown to increase mother-child and male-female bonding.Given that autism typically affects one's ability to form social bonds with others,Yatawara and colleagues (2015)hypothesized that the administration of oxytocin to autistic children may improve their ability to bond with family members.To that end,31 autistic children received either intranasal oxytocin or a placebo twice daily for five weeks after which each child's caregiver completed a self-report social responsiveness survey.The results revealed oxytocin administration significantly improved the social responsiveness of autistic children.These data suggest that oxytocin should be investigated further for the treatment of autism. -(Scenario III)Because of the population studied in Scenario III,the researchers likely obtained ________ from their legal guardian and __________ from the participants.

Use the following to answer questions Scenario II Scenario II is based on fabricated data inspired by the following study: Ambrose,B.K. ,Rostron,B.L. ,Johnson,S.E. ,et al.(2014).Perceptions of the relative harm of cigarettes and e-cigarettes among U.S.youth.American Journal of Preventative Medicine,47,S53-S60. How Youths Perceive E-Cigarettes The purpose of this study was to investigate the perception of cigarettes and electronic cigarettes (e-cigs)held by American adolescents and teens.To that end,Ambrose and colleagues (2014)examined data obtained previously by the 2012 National Youth Tobacco Survey.This survey includes responses from 24,658 children in 6^th through 12^th grades across the United States.The results revealed that 33% of the students believed that e-cigs were safer than traditional cigarettes.Interestingly,the children who reported never having smoked were less likely to perceive e-cigs as safer than traditional cigarettes.These results suggest that e-cigs may entice kids who would normally avoid cigarettes.Although e-cigs do not contain many of the harmful chemicals found in traditional cigarettes,they do contain nicotine.Because nicotine is addictive,e-cig use may become a gateway to traditional cigarettes. -(Scenario II)Suppose the researchers in Scenario II only analyzed data from a select group of students without sufficient justification.This act is best described as ___________ the data.

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)In the study described in Scenario I,some participants received a placebo pill.Thinking you are receiving a drug when you are not is a classic example of:

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:

Use the following to answer questions Scenario III Scenario III is based on fabricated data inspired by the following study: Yatawara,C.J. ,Einfeld,S.L. ,Davenport,T.A. ,& Guastella,A.J.(2015).The effect of oxytocin nasal spray on social interaction deficits observed in young children with autism: a randomized clinical crossover trial [advance online publication].Molecular Psychiatry. Oxytocin and Autism Study The purpose of this study was to examine whether oxytocin could improve social bonding in autistic children.Oxytocin is a chemical affectionately known as the "love drug" because it is shown to increase mother-child and male-female bonding.Given that autism typically affects one's ability to form social bonds with others,Yatawara and colleagues (2015)hypothesized that the administration of oxytocin to autistic children may improve their ability to bond with family members.To that end,31 autistic children received either intranasal oxytocin or a placebo twice daily for five weeks after which each child's caregiver completed a self-report social responsiveness survey.The results revealed oxytocin administration significantly improved the social responsiveness of autistic children.These data suggest that oxytocin should be investigated further for the treatment of autism. -(Scenario III)At the IRB meeting during which the study described in Scenario III was discussed,one committee member stated "If we don't approve this study a potentially effective treatment for autism may not be identified." Which of the following best characterizes this committee members train of thought?

Use the following to answer questions Scenario II Scenario II is based on fabricated data inspired by the following study: Ambrose,B.K. ,Rostron,B.L. ,Johnson,S.E. ,et al.(2014).Perceptions of the relative harm of cigarettes and e-cigarettes among U.S.youth.American Journal of Preventative Medicine,47,S53-S60. How Youths Perceive E-Cigarettes The purpose of this study was to investigate the perception of cigarettes and electronic cigarettes (e-cigs)held by American adolescents and teens.To that end,Ambrose and colleagues (2014)examined data obtained previously by the 2012 National Youth Tobacco Survey.This survey includes responses from 24,658 children in 6^th through 12^th grades across the United States.The results revealed that 33% of the students believed that e-cigs were safer than traditional cigarettes.Interestingly,the children who reported never having smoked were less likely to perceive e-cigs as safer than traditional cigarettes.These results suggest that e-cigs may entice kids who would normally avoid cigarettes.Although e-cigs do not contain many of the harmful chemicals found in traditional cigarettes,they do contain nicotine.Because nicotine is addictive,e-cig use may become a gateway to traditional cigarettes. -(Scenario II)The level of IRB review most appropriate for the National Youth Tobacco Survey is:

Use the following to answer questions Scenario II Scenario II is based on fabricated data inspired by the following study: Ambrose,B.K. ,Rostron,B.L. ,Johnson,S.E. ,et al.(2014).Perceptions of the relative harm of cigarettes and e-cigarettes among U.S.youth.American Journal of Preventative Medicine,47,S53-S60. How Youths Perceive E-Cigarettes The purpose of this study was to investigate the perception of cigarettes and electronic cigarettes (e-cigs)held by American adolescents and teens.To that end,Ambrose and colleagues (2014)examined data obtained previously by the 2012 National Youth Tobacco Survey.This survey includes responses from 24,658 children in 6^th through 12^th grades across the United States.The results revealed that 33% of the students believed that e-cigs were safer than traditional cigarettes.Interestingly,the children who reported never having smoked were less likely to perceive e-cigs as safer than traditional cigarettes.These results suggest that e-cigs may entice kids who would normally avoid cigarettes.Although e-cigs do not contain many of the harmful chemicals found in traditional cigarettes,they do contain nicotine.Because nicotine is addictive,e-cig use may become a gateway to traditional cigarettes. -(Scenario II)The researchers in Scenario II want to conduct a follow-up to determine whether children behave in a way consistent with their perception of e-cigs and cigarettes.In the IRB application,the researchers propose giving kids in 6^th through 12^th grades e-cigs and traditional cigarettes and then recording which type of cigarette the child chooses to smoke.They also indicate that if a child says they don't want either,they will be told they must select one and smoke it for the sake of the study.This procedure goes against which ethical principle?

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)Patty was a participant in the study described in Scenario I.She told her friend she volunteered because she suffers from social anxiety and thought her participation might help her.Patty appears to be motivated based on:

Use the following to answer questions Scenario III Scenario III is based on fabricated data inspired by the following study: Yatawara,C.J. ,Einfeld,S.L. ,Davenport,T.A. ,& Guastella,A.J.(2015).The effect of oxytocin nasal spray on social interaction deficits observed in young children with autism: a randomized clinical crossover trial [advance online publication].Molecular Psychiatry. Oxytocin and Autism Study The purpose of this study was to examine whether oxytocin could improve social bonding in autistic children.Oxytocin is a chemical affectionately known as the "love drug" because it is shown to increase mother-child and male-female bonding.Given that autism typically affects one's ability to form social bonds with others,Yatawara and colleagues (2015)hypothesized that the administration of oxytocin to autistic children may improve their ability to bond with family members.To that end,31 autistic children received either intranasal oxytocin or a placebo twice daily for five weeks after which each child's caregiver completed a self-report social responsiveness survey.The results revealed oxytocin administration significantly improved the social responsiveness of autistic children.These data suggest that oxytocin should be investigated further for the treatment of autism. -(Scenario III)Prior to the study described in Scenario III,the researchers examined the effect of oxytocin on bonding between male and female rats.They found that oxytocin strengthened the bond between the rat pairs.Before they conducted their rat study they must have obtained approval from what group?