Donors to biobanks are typically asked to give blanket consent, allowing their donation to be use... more Donors to biobanks are typically asked to give blanket consent, allowing their donation to be used in any research authorized by the biobank. This type of consent ignores the evidence that some donors have moral, religious, or cultural concerns about the future uses of their donations – concerns we call “non-welfare interests”. The nature of non-welfare interests and their effect on willingness to donate to a biobank is not well understood.
In order to better undersand the influence of non-welfare interests, we surveyed a national sample of the US population (in June 2014) using a probability-based internet panel. Logistic regression models assessed the demographic and attitudinal characteristics associated with participants’ willingness to give consent for unspecified future uses of their donation when presented with 7 research scenarios that raised possible non-welfare interest concerns.
Most people had non-welfare interests that significantly affect their willingness to donate to a biobank using blanket consent. Some non-welfare interests are associated with subgroups but others are not. A positive attitude toward biomedical research in general was associated with increased willingness to donate, while concerns about privacy and being African American were associated with decreased willingness.
Non-welfare interests matter and can diminish willingness to donate to a biobank. Our data suggest that trust in research promotes willingness to donate. Ignoring non-welfare interests could erode this trust. Donors’ non-welfare interests could be accommodated through greater transparency and easier access to information about the uses of donations.
Objectives To assess whether persons with amyotrophic lateral sclerosis (ALS) are at risk of a ... more Objectives To assess whether persons with amyotrophic lateral sclerosis (ALS) are at risk of a therapeutic misconception (TM) in which they misconceive research as treatment or overestimate the likelihood of its benefit.
Methods 72 patients with ALS recruited via academic and patient organisations were surveyed using a hypothetical first-in-human intervention study scenario. We elicited their understanding of the purpose of the study (‘purpose-of-research question’) and then asked how they interpreted the question. We then asked for an estimate of the likelihood that their ALS would improve by participating and asked them to explain the meaning of their estimates.
Results Although 10 of 72 (14%) subjects incorrectly said that the intervention study was ‘mostly intending to help [me]’ in response to the purpose-of-research question, 7 of those 10 thought that the question was asking them about their own motivations for participating. Overall, only one of 72 respondents (1.4%) both understood the purpose-of-research question as intended and gave the incorrect response. Subjects’ mean estimate of likelihood of benefit was 31% (SD 26). This was due to 29 of 72 of respondents providing high estimates (50%–54% likelihood), which they said were expressions of hope and need for a positive attitude; among those who said their estimates meant ‘those are the facts’ or ‘there is a lot of uncertainty’, the estimates were much lower (12.6% and 18.5%, respectively).
Conclusions In this group of patients with ALS considering a hypothetical first-in-human intervention study, apparent TM responses have alternative explanations and the risk of true TM appears low.
IMPORTANCE Euthanasia or assisted suicide (EAS) of psychiatric patients is increasing in some jur... more IMPORTANCE Euthanasia or assisted suicide (EAS) of psychiatric patients is increasing in some jurisdictions such as Belgium and the Netherlands. However, little is known about the practice, and it remains controversial. OBJECTIVES To describe the characteristics of patients receiving EAS for psychiatric conditions and how the practice is regulated in the Netherlands. DESIGN, SETTING, AND PARTICIPANTS This investigation reviewed psychiatric EAS case summaries made available online by the Dutch regional euthanasia review committees as of June 1, 2015. Two senior psychiatrists used directed content analysis to review and code the reports. In total, 66 cases from 2011 to 2014 were reviewed. MAIN OUTCOMES AND MEASURES Clinical and social characteristics of patients, physician review process of the patients' requests, and the euthanasia review committees' assessments of the physicians' actions. RESULTS Of the 66 cases reviewed, 70% (n = 46) were women. In total, 32% (n = 21) were 70 years or older, 44% (n = 29) were 50 to 70 years old, and 24% (n = 16) were 30 to 50 years old. Most had chronic, severe conditions, with histories of attempted suicides and psychiatric hospitalizations. Most had personality disorders and were described as socially isolated or lonely. Depressive disorders were the primary psychiatric issue in 55% (n = 36) of cases. Other conditions represented were psychotic, posttraumatic stress or anxiety, somatoform, neurocognitive, and eating disorders, as well as prolonged grief and autism. Comorbidities with functional impairments were common. Forty-one percent (n = 27) of physicians performing EAS were psychiatrists. Twenty-seven percent (n = 18) of patients received the procedure from physicians new to them, 14 of whom were physicians from the End-of-Life Clinic, a mobile euthanasia clinic. Consultation with other physicians was extensive, but 11% (n = 7) of cases had no independent psychiatric input, and 24% (n = 16) of cases involved disagreement among consultants. The euthanasia review committees found that one case failed to meet legal due care criteria. CONCLUSIONS AND RELEVANCE Persons receiving EAS for psychiatric disorders in the Netherlands are mostly women and of diverse ages, with complex and chronic psychiatric, medical, and psychosocial histories. The granting of their EAS requests appears to involve considerable physician judgment, usually involving multiple physicians who do not always agree (sometimes without independent psychiatric input), but the euthanasia review committees generally defer to the judgments of the physicians performing the EAS.
With the projected increase in the number of persons with dementia (who eventually lose their cap... more With the projected increase in the number of persons with dementia (who eventually lose their capacity to give informed consent to treatment and research), third-party decision-making will become even more common than it is today. We argue that, because there are situations in which an appointed proxy is preferred over a de facto surrogate, it is ethically important to understand the capacity of persons with dementia to delegate their decision-making authority regarding treatment and research decisions. In this paper, focusing mainly on the research consent context, we examine the idea that persons suffering from neurodegenerative disorders may retain significant abilities-including sufficient capacity for delegating one's authority for giving consent to research-even if they are not capable of giving independent consent themselves. We first propose a rationale for assessing the capacity to appoint a proxy and then describe a novel interview instrument for assessing the capacity to appoint a proxy for research consent.
Journal of empirical research on human research ethics : JERHRE, 2014
The ethical debate surrounding biobanks has focused on protecting donors' welfare and privacy... more The ethical debate surrounding biobanks has focused on protecting donors' welfare and privacy. However, little attention has been given to the ethical significance of donor interests that go beyond privacy and welfare (non-welfare interests [NWIs]), such as their concerns about the moral or religious implications of researchers using their donated samples. Using an experimental survey design with 1,276 participants recruited via Amazon Mechanical Turk (MTurk), we studied the potential impact of eight NWI scenarios on people's attitudes toward research studies being performed on samples donated to biobanks by assessing willingness to donate, attitudes toward disclosure of NWIs, impact of timing and format of disclosure (number of NWIs disclosed on a page), and participant factors associated with willingness to donate. Baseline willingness to donate to biobanks prior to any mention of NWIs was comparable with previous studies, at 85% to 89%. Most participants wanted NWI disclo...
The call for formal capacity assessments of potential research participants with impairments due ... more The call for formal capacity assessments of potential research participants with impairments due to illnesses such as Alzheimer's disease is increasing. Because such an evaluation of every potential subject requires significant resources, clinicians and researchers may want to know the utility and the limits of a familiar cognitive screening test, the Mini Mental State Examination (MMSE), in capacity evaluations. In this study of 37 patients with mild to moderate Alzheimer's disease, a fairly wide range of MMSE scores (21 to 25, which includes an often used cutoff for "normal") did not discriminate capacity status well. Nevertheless, there may still be approaches that enhance the practical utility of the MMSE in capacity assessment.
Academic psychiatry : the journal of the American Association of Directors of Psychiatric Residency Training and the Association for Academic Psychiatry, 2004
) surveyed the preferences and experiences of medical students and residents regarding ethics and... more ) surveyed the preferences and experiences of medical students and residents regarding ethics and professionalism education. The ideas and findings in the Roberts et al. article are too numerous to be fairly summarized here, but the essence is that medical students and ...
The authors asked whether clinicians use a risk-sensitive model for decisional-capacity determina... more The authors asked whether clinicians use a risk-sensitive model for decisional-capacity determinations; that is, whether a higher degree of capacity was required in higher-risk situations. The respondents were randomly assigned to view a videotaped "capacity" interview of a medication-randomized clinical trial scenario (N=52) or a neurosurgical clinical trial scenario (N=47). A significant scenario effect was mediated by the respondents' perception of scenario-specific risk. Respondents showed considerable disagreement within each scenario that was not explained by clinician-specific factors. Thus, clinicians, in fact, use the normative risk-sensitive model for capacity, but there remains considerable unexplained variability in their judgments.
The two most important ethical requirements for clinical studies of gene transfer are to ensure t... more The two most important ethical requirements for clinical studies of gene transfer are to ensure that: (i) a protocol's risks are minimized and acceptable in light of the potential benefit to society and to research participants; and that (ii) a valid, informed consent process takes place. The history of gene transfer studies in humans shows that the probability of harm or benefit to participating individuals is extremely low. However, because the risks and benefits of gene transfer remain unpredictable, and because increasing the potential for benefits to individuals is likely to be accompanied by increases in potential for adverse events, close monitoring of human gene transfer research will continue. Recent research on informed consent for phase I studies of serious illnesses has revealed an evolving discussion on the proper standards for disclosure; one important conclusion is that disclosures regarding potential benefits to individuals need to be less ambiguous than they cur...
Donors to biobanks are typically asked to give blanket consent, allowing their donation to be use... more Donors to biobanks are typically asked to give blanket consent, allowing their donation to be used in any research authorized by the biobank. This type of consent ignores the evidence that some donors have moral, religious, or cultural concerns about the future uses of their donations – concerns we call “non-welfare interests”. The nature of non-welfare interests and their effect on willingness to donate to a biobank is not well understood.
In order to better undersand the influence of non-welfare interests, we surveyed a national sample of the US population (in June 2014) using a probability-based internet panel. Logistic regression models assessed the demographic and attitudinal characteristics associated with participants’ willingness to give consent for unspecified future uses of their donation when presented with 7 research scenarios that raised possible non-welfare interest concerns.
Most people had non-welfare interests that significantly affect their willingness to donate to a biobank using blanket consent. Some non-welfare interests are associated with subgroups but others are not. A positive attitude toward biomedical research in general was associated with increased willingness to donate, while concerns about privacy and being African American were associated with decreased willingness.
Non-welfare interests matter and can diminish willingness to donate to a biobank. Our data suggest that trust in research promotes willingness to donate. Ignoring non-welfare interests could erode this trust. Donors’ non-welfare interests could be accommodated through greater transparency and easier access to information about the uses of donations.
Objectives To assess whether persons with amyotrophic lateral sclerosis (ALS) are at risk of a ... more Objectives To assess whether persons with amyotrophic lateral sclerosis (ALS) are at risk of a therapeutic misconception (TM) in which they misconceive research as treatment or overestimate the likelihood of its benefit.
Methods 72 patients with ALS recruited via academic and patient organisations were surveyed using a hypothetical first-in-human intervention study scenario. We elicited their understanding of the purpose of the study (‘purpose-of-research question’) and then asked how they interpreted the question. We then asked for an estimate of the likelihood that their ALS would improve by participating and asked them to explain the meaning of their estimates.
Results Although 10 of 72 (14%) subjects incorrectly said that the intervention study was ‘mostly intending to help [me]’ in response to the purpose-of-research question, 7 of those 10 thought that the question was asking them about their own motivations for participating. Overall, only one of 72 respondents (1.4%) both understood the purpose-of-research question as intended and gave the incorrect response. Subjects’ mean estimate of likelihood of benefit was 31% (SD 26). This was due to 29 of 72 of respondents providing high estimates (50%–54% likelihood), which they said were expressions of hope and need for a positive attitude; among those who said their estimates meant ‘those are the facts’ or ‘there is a lot of uncertainty’, the estimates were much lower (12.6% and 18.5%, respectively).
Conclusions In this group of patients with ALS considering a hypothetical first-in-human intervention study, apparent TM responses have alternative explanations and the risk of true TM appears low.
IMPORTANCE Euthanasia or assisted suicide (EAS) of psychiatric patients is increasing in some jur... more IMPORTANCE Euthanasia or assisted suicide (EAS) of psychiatric patients is increasing in some jurisdictions such as Belgium and the Netherlands. However, little is known about the practice, and it remains controversial. OBJECTIVES To describe the characteristics of patients receiving EAS for psychiatric conditions and how the practice is regulated in the Netherlands. DESIGN, SETTING, AND PARTICIPANTS This investigation reviewed psychiatric EAS case summaries made available online by the Dutch regional euthanasia review committees as of June 1, 2015. Two senior psychiatrists used directed content analysis to review and code the reports. In total, 66 cases from 2011 to 2014 were reviewed. MAIN OUTCOMES AND MEASURES Clinical and social characteristics of patients, physician review process of the patients' requests, and the euthanasia review committees' assessments of the physicians' actions. RESULTS Of the 66 cases reviewed, 70% (n = 46) were women. In total, 32% (n = 21) were 70 years or older, 44% (n = 29) were 50 to 70 years old, and 24% (n = 16) were 30 to 50 years old. Most had chronic, severe conditions, with histories of attempted suicides and psychiatric hospitalizations. Most had personality disorders and were described as socially isolated or lonely. Depressive disorders were the primary psychiatric issue in 55% (n = 36) of cases. Other conditions represented were psychotic, posttraumatic stress or anxiety, somatoform, neurocognitive, and eating disorders, as well as prolonged grief and autism. Comorbidities with functional impairments were common. Forty-one percent (n = 27) of physicians performing EAS were psychiatrists. Twenty-seven percent (n = 18) of patients received the procedure from physicians new to them, 14 of whom were physicians from the End-of-Life Clinic, a mobile euthanasia clinic. Consultation with other physicians was extensive, but 11% (n = 7) of cases had no independent psychiatric input, and 24% (n = 16) of cases involved disagreement among consultants. The euthanasia review committees found that one case failed to meet legal due care criteria. CONCLUSIONS AND RELEVANCE Persons receiving EAS for psychiatric disorders in the Netherlands are mostly women and of diverse ages, with complex and chronic psychiatric, medical, and psychosocial histories. The granting of their EAS requests appears to involve considerable physician judgment, usually involving multiple physicians who do not always agree (sometimes without independent psychiatric input), but the euthanasia review committees generally defer to the judgments of the physicians performing the EAS.
With the projected increase in the number of persons with dementia (who eventually lose their cap... more With the projected increase in the number of persons with dementia (who eventually lose their capacity to give informed consent to treatment and research), third-party decision-making will become even more common than it is today. We argue that, because there are situations in which an appointed proxy is preferred over a de facto surrogate, it is ethically important to understand the capacity of persons with dementia to delegate their decision-making authority regarding treatment and research decisions. In this paper, focusing mainly on the research consent context, we examine the idea that persons suffering from neurodegenerative disorders may retain significant abilities-including sufficient capacity for delegating one's authority for giving consent to research-even if they are not capable of giving independent consent themselves. We first propose a rationale for assessing the capacity to appoint a proxy and then describe a novel interview instrument for assessing the capacity to appoint a proxy for research consent.
Journal of empirical research on human research ethics : JERHRE, 2014
The ethical debate surrounding biobanks has focused on protecting donors' welfare and privacy... more The ethical debate surrounding biobanks has focused on protecting donors' welfare and privacy. However, little attention has been given to the ethical significance of donor interests that go beyond privacy and welfare (non-welfare interests [NWIs]), such as their concerns about the moral or religious implications of researchers using their donated samples. Using an experimental survey design with 1,276 participants recruited via Amazon Mechanical Turk (MTurk), we studied the potential impact of eight NWI scenarios on people's attitudes toward research studies being performed on samples donated to biobanks by assessing willingness to donate, attitudes toward disclosure of NWIs, impact of timing and format of disclosure (number of NWIs disclosed on a page), and participant factors associated with willingness to donate. Baseline willingness to donate to biobanks prior to any mention of NWIs was comparable with previous studies, at 85% to 89%. Most participants wanted NWI disclo...
The call for formal capacity assessments of potential research participants with impairments due ... more The call for formal capacity assessments of potential research participants with impairments due to illnesses such as Alzheimer's disease is increasing. Because such an evaluation of every potential subject requires significant resources, clinicians and researchers may want to know the utility and the limits of a familiar cognitive screening test, the Mini Mental State Examination (MMSE), in capacity evaluations. In this study of 37 patients with mild to moderate Alzheimer's disease, a fairly wide range of MMSE scores (21 to 25, which includes an often used cutoff for "normal") did not discriminate capacity status well. Nevertheless, there may still be approaches that enhance the practical utility of the MMSE in capacity assessment.
Academic psychiatry : the journal of the American Association of Directors of Psychiatric Residency Training and the Association for Academic Psychiatry, 2004
) surveyed the preferences and experiences of medical students and residents regarding ethics and... more ) surveyed the preferences and experiences of medical students and residents regarding ethics and professionalism education. The ideas and findings in the Roberts et al. article are too numerous to be fairly summarized here, but the essence is that medical students and ...
The authors asked whether clinicians use a risk-sensitive model for decisional-capacity determina... more The authors asked whether clinicians use a risk-sensitive model for decisional-capacity determinations; that is, whether a higher degree of capacity was required in higher-risk situations. The respondents were randomly assigned to view a videotaped "capacity" interview of a medication-randomized clinical trial scenario (N=52) or a neurosurgical clinical trial scenario (N=47). A significant scenario effect was mediated by the respondents' perception of scenario-specific risk. Respondents showed considerable disagreement within each scenario that was not explained by clinician-specific factors. Thus, clinicians, in fact, use the normative risk-sensitive model for capacity, but there remains considerable unexplained variability in their judgments.
The two most important ethical requirements for clinical studies of gene transfer are to ensure t... more The two most important ethical requirements for clinical studies of gene transfer are to ensure that: (i) a protocol's risks are minimized and acceptable in light of the potential benefit to society and to research participants; and that (ii) a valid, informed consent process takes place. The history of gene transfer studies in humans shows that the probability of harm or benefit to participating individuals is extremely low. However, because the risks and benefits of gene transfer remain unpredictable, and because increasing the potential for benefits to individuals is likely to be accompanied by increases in potential for adverse events, close monitoring of human gene transfer research will continue. Recent research on informed consent for phase I studies of serious illnesses has revealed an evolving discussion on the proper standards for disclosure; one important conclusion is that disclosures regarding potential benefits to individuals need to be less ambiguous than they cur...
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In order to better undersand the influence of non-welfare interests, we surveyed a national sample of the US population (in June 2014) using a probability-based internet panel. Logistic regression models assessed the demographic and attitudinal characteristics associated with participants’ willingness to give consent for unspecified future uses of their donation when presented with 7 research scenarios that raised possible non-welfare interest concerns.
Most people had non-welfare interests that significantly affect their willingness to donate to a biobank using blanket consent. Some non-welfare interests are associated with subgroups but others are not. A positive attitude toward biomedical research in general was associated with increased willingness to donate, while concerns about privacy and being African American were associated with decreased willingness.
Non-welfare interests matter and can diminish willingness to donate to a biobank. Our data suggest that trust in research promotes willingness to donate. Ignoring non-welfare interests could erode this trust. Donors’ non-welfare interests could be accommodated through greater transparency and easier access to information about the uses of donations.
Methods 72 patients with ALS recruited via academic and patient organisations were surveyed using a hypothetical first-in-human intervention study scenario. We elicited their understanding of the purpose of the study (‘purpose-of-research question’) and then asked how they interpreted the question. We then asked for an estimate of the likelihood that their ALS would improve by participating and asked them to explain the meaning of their estimates.
Results Although 10 of 72 (14%) subjects incorrectly said that the intervention study was ‘mostly intending to help [me]’ in response to the purpose-of-research question, 7 of those 10 thought that the question was asking them about their own motivations for participating. Overall, only one of 72 respondents (1.4%) both understood the purpose-of-research question as intended and gave the incorrect response. Subjects’ mean estimate of likelihood of benefit was 31% (SD 26). This was due to 29 of 72 of respondents providing high estimates (50%–54% likelihood), which they said were expressions of hope and need for a positive attitude; among those who said their estimates meant ‘those are the facts’ or ‘there is a lot of uncertainty’, the estimates were much lower (12.6% and 18.5%, respectively).
Conclusions In this group of patients with ALS considering a hypothetical first-in-human intervention study, apparent TM responses have alternative explanations and the risk of true TM appears low.
In order to better undersand the influence of non-welfare interests, we surveyed a national sample of the US population (in June 2014) using a probability-based internet panel. Logistic regression models assessed the demographic and attitudinal characteristics associated with participants’ willingness to give consent for unspecified future uses of their donation when presented with 7 research scenarios that raised possible non-welfare interest concerns.
Most people had non-welfare interests that significantly affect their willingness to donate to a biobank using blanket consent. Some non-welfare interests are associated with subgroups but others are not. A positive attitude toward biomedical research in general was associated with increased willingness to donate, while concerns about privacy and being African American were associated with decreased willingness.
Non-welfare interests matter and can diminish willingness to donate to a biobank. Our data suggest that trust in research promotes willingness to donate. Ignoring non-welfare interests could erode this trust. Donors’ non-welfare interests could be accommodated through greater transparency and easier access to information about the uses of donations.
Methods 72 patients with ALS recruited via academic and patient organisations were surveyed using a hypothetical first-in-human intervention study scenario. We elicited their understanding of the purpose of the study (‘purpose-of-research question’) and then asked how they interpreted the question. We then asked for an estimate of the likelihood that their ALS would improve by participating and asked them to explain the meaning of their estimates.
Results Although 10 of 72 (14%) subjects incorrectly said that the intervention study was ‘mostly intending to help [me]’ in response to the purpose-of-research question, 7 of those 10 thought that the question was asking them about their own motivations for participating. Overall, only one of 72 respondents (1.4%) both understood the purpose-of-research question as intended and gave the incorrect response. Subjects’ mean estimate of likelihood of benefit was 31% (SD 26). This was due to 29 of 72 of respondents providing high estimates (50%–54% likelihood), which they said were expressions of hope and need for a positive attitude; among those who said their estimates meant ‘those are the facts’ or ‘there is a lot of uncertainty’, the estimates were much lower (12.6% and 18.5%, respectively).
Conclusions In this group of patients with ALS considering a hypothetical first-in-human intervention study, apparent TM responses have alternative explanations and the risk of true TM appears low.