Court Intrusion Into Science and Medicine-The Mifepristone Decisions.

This Viewpoint discusses recent US court decisions on the availability of mifepristone, a drug used to terminate pregnancies, and how these conflicting court decisions affect the scientific process and decision-making of the US Food and Drug Administration.

Jurors use mental state information to assess breach in negligence cases.

To prove guilt, jurors in many countries must find that the criminal defendant acted with a particular mental state. However, this amateur form of mindreading is not supposed to occur in civil negligence trials. Instead, jurors should decide whether the defendant was negligent by looking only at his actions, and whether they were objectively reasonable under the circumstances. Even so, across four pre-registered studies (N = 782), we showed that mock jurors do not focus on actions alone. US mock jurors spontaneously rely on mental state information when evaluating negligence cases. In Study 1, jurors were given three negligence cases to judge, and were asked to evaluate whether a reasonably careful person would have foreseen the risk (foreseeability) and whether the defendant acted unreasonably (negligence). Across conditions, we also varied the extent and content of additional information about defendant's subjective mental state: jurors were provided with evidence that the defendant either thought the risk of a harm was high or was low, or were not provided with such information. Foreseeability and negligence scores increased when mock jurors were told the defendant thought there was a high risk, and negligence scores decreased when the defendant thought there was a low risk, compared to when no background mental state information was provided. In Study 2, we replicated these findings by using mild (as opposed to severe) harm cases. In Study 3, we tested an intervention aimed at reducing jurors' reliance on mental states, which consisted in raising jurors' awareness of potential hindsight bias in their evaluations. The intervention reduced mock juror reliance on mental states when assessing foreseeability when the defendant was described as knowing of a high risk, an effect replicated in Study 4. This research demonstrates that jurors rely on mental states to assess breach, regardless of what the legal doctrine says.

Exploring the intersection of structural racism and ageism in healthcare.

The American Geriatrics Society (AGS) has consistently advocated for a healthcare system that meets the needs of older adults, including addressing impacts of ageism in healthcare. The intersection of structural racism and ageism compounds the disadvantage experienced by historically marginalized communities. Structural racism and ageism have long been ingrained in all aspects of US society, including healthcare. This intersection exacerbates disparities in social determinants of health, including poor access to healthcare and poor outcomes. These deeply rooted societal injustices have been brought to the forefront of the collective public consciousness at different points throughout history. The COVID-19 pandemic laid bare and exacerbated existing inequities inflicted on historically marginalized communities. Ageist rhetoric and policies during the COVID-19 pandemic further marginalized older adults. Although the detrimental impact of structural racism on health has been well-documented in the literature, generative research on the intersection of structural racism and ageism is limited. The AGS is working to identify and dismantle the healthcare structures that create and perpetuate these combined injustices and, in so doing, create a more just US healthcare system. This paper is intended to provide an overview of important frameworks and guide future efforts to both identify and eliminate bias within healthcare delivery systems and health professions training with a particular focus on the intersection of structural racism and ageism.

Interpretation and reporting of large regions of homozygosity and suspected consanguinity/uniparental disomy, 2021 revision: A technical standard of the American College of Medical Genetics and Genomics (ACMG).

Genomic testing, including single-nucleotide variation (formerly single-nucleotide polymorphism)-based chromosomal microarray and exome and genome sequencing, can detect long regions of homozygosity (ROH) within the genome. Genomic testing can also detect possible uniparental disomy (UPD). Platforms that can detect ROH and possible UPD have matured since the initial American College of Medical Genetics and Genomics (ACMG) standard was published in 2013, and the detection of ROH and UPD by these platforms has shown utility in diagnosis of patients with genetic/genomic disorders. The presence of these segments, when distributed across multiple chromosomes, may indicate a familial relationship between the proband's parents. This technical standard describes the detection of possible consanguinity and UPD by genomic testing, as well as the factors confounding the inference of a specific parental relationship or UPD. Current bioethical and legal issues regarding detection and reporting of consanguinity are also discussed.

Ethical concerns relating to genetic risk scores for suicide.

Genome-wide association studies (GWAS) provide valuable information in research contexts regarding genomic changes that contribute to risks for complex psychiatric conditions like major depressive disorder. GWAS results can be used to calculate polygenic risk scores (PRS) for psychiatric conditions, such as bipolar disorder or schizophrenia, as well as for other traits, such as obesity or hypertension. Private companies that provide direct-to-consumer (DTC) genetic testing sometimes report PRS for a variety of traits. Recently, the first well-powered GWAS study for suicide death was published. PRS reports that claim to assess suicide risk are therefore likely to appear soon in the DTC setting. We describe ethical concerns regarding the commercial use of GWAS results related to suicide. We identify several issues that must be addressed before PRS for suicide risk is made available to the public through DTC: (a) the potential for misinterpretation of results, (b) consumers' perceptions about determinism and behavior change, (c) potential contributions to stigma, discrimination, and health disparities; and (d) ethical problems regarding the testing of children and vulnerable adults. Tests for genetic prediction of suicidality may eventually have clinical significance, but until then, the potential for individual and public harm significantly outweighs any potential benefit. Even if genetic prediction of suicidality improves significantly, information about genetic risk scores must be distributed cautiously, with genetic counseling, and with adequate safeguards.

Genomic Testing, Unexpected Consanguinity, and Adolescent Parents.

This case study about an infant with epidermolysis bullosa and his fourteen-year-old mother involves pediatric genomic testing and concerns about the adolescent parent's decision-making capacity. Four commentaries explore ethics issues in the case, including the following challenges: The current ethics guidelines regarding informed decision-making for genomic testing and return of results have been relatively silent on how to involve parents who are minors in decision-making on behalf of their children. This lack of guidance can be particularly difficult for physicians when genetic test results revealing consanguinity raise concerns about sexual abuse of a minor, provoking questions about mandatory reporting requirements. Finally, medical teams may find themselves having to evaluate an adolescent parent's capacity in making medical decisions for her child while questioning the role and relationship of her support person.

Teneille Brown, Leslie Francis, and James Tabery respond.

This is a response to the letter to the editor "Prioritizing the Prevention of Early Deaths during Covid-19," by Govind Persad.

Ethical and public health implications of genetic testing for suicide risk: family and survivor perspectives.

PURPOSE: Death from suicide has an estimated heritability of ~50%. Research may soon allow calculation of polygenic risk scores (PRS) for suicide death, which could be marketed directly to consumers. This raises ethical concerns. Understanding how consumers will utilize this information is urgent. METHODS: We conducted three focus groups involving suicide attempt survivors ("survivors") and family members of suicide decedents ("family members") to gauge their reactions to this technology. Questions focused on positive and negative implications of PRS results. Qualitative research methods were used to summarize studio results. RESULTS: Eight survivors and 13 family members participated. Both groups postulated benefits of suicide PRS, including prevention and reduced stigma. Their concerns ranged from increased stigma to adverse psychological effects. They suggested that suicide PRS should be accompanied by extensive education and counseling. Participants experienced no adverse effects. CONCLUSION: Many ethical, legal, and social implications of genetic testing for suicide risk are highly salient to community stakeholders. Our participants hoped that suicide PRS could have significant individual and community-level benefits, but had concerns about effects in several domains, including stigma, access to insurance and employment, and increased anxiety and depression.

When Is Age Choosing Ageist Discrimination?

When the Covid-19 pandemic reached the United States in spring 2020, many states and hospitals announced crisis standards of care plans that used age as a categorical exclusion criterion. Such age choosing was quickly flagged as discriminatory, and so some states and hospitals shifted to embedding age as a tiebreaker deeper in their plans. Different rationales were given for using age as a tiebreaker: that younger patients were more likely to survive than older patients, that saving younger patients would save more life years, and that younger patients deserved a chance to live through life's stages. We provide a critical analysis of these three rationales, noting the differences between them, and then questioning the ethical and legal justifications for such age choosing.

AGS Position Statement: Resource Allocation Strategies and Age-Related Considerations in the COVID-19 Era and Beyond.

Coronavirus disease 2019 (COVID-19) continues to impact older adults disproportionately, from severe illness and hospitalization to increased mortality risk. Concurrently, concerns about potential shortages of healthcare professionals and health supplies to address these needs have focused attention on how resources are ultimately allocated and used. Some strategies misguidedly use age as an arbitrary criterion, inappropriately disfavoring older adults. This statement represents the official policy position of the American Geriatrics Society (AGS). It is intended to inform stakeholders including hospitals, health systems, and policymakers about ethical considerations to consider when developing strategies for allocating scarce resources during an emergency involving older adults. Members of the AGS Ethics Committee collaborated with interprofessional experts in ethics, law, nursing, and medicine (including geriatrics, palliative care, emergency medicine, and pulmonology/critical care) to conduct a structured literature review and examine relevant reports. The resulting recommendations defend a particular view of distributive justice that maximizes relevant clinical factors and deemphasizes or eliminates factors placing arbitrary, disproportionate weight on advanced age. The AGS positions include (1) avoiding age per se as a means for excluding anyone from care; (2) assessing comorbidities and considering the disparate impact of social determinants of health; (3) encouraging decision makers to focus primarily on potential short-term (not long-term) outcomes; (4) avoiding ancillary criteria such as "life-years saved" and "long-term predicted life expectancy" that might disadvantage older people; (5) forming and staffing triage committees tasked with allocating scarce resources; (6) developing institutional resource allocation strategies that are transparent and applied uniformly; and (7) facilitating appropriate advance care planning. The statement includes recommendations that should be immediately implemented to address resource allocation strategies during COVID-19, aligning with AGS positions. The statement also includes recommendations for post-pandemic review. Such review would support revised strategies to ensure that governments and institutions have equitable emergency resource allocation strategies, avoid future discriminatory language and practice, and have appropriate guidance to develop national frameworks for emergent resource allocation decisions. J Am Geriatr Soc 68:1136-1142, 2020.

Rationing Limited Healthcare Resources in the COVID-19 Era and Beyond: Ethical Considerations Regarding Older Adults.

Coronavirus disease 2019 (COVID-19) continues to impact older adults disproportionately with respect to serious consequences ranging from severe illness and hospitalization to increased mortality risk. Concurrently, concerns about potential shortages of healthcare professionals and health supplies to address these issues have focused attention on how these resources are ultimately allocated and used. Some strategies, for example, misguidedly use age as an arbitrary criterion that disfavors older adults in resource allocation decisions. This is a companion article to the American Geriatrics Society (AGS) position statement, "Resource Allocation Strategies and Age-Related Considerations in the COVID-19 Era and Beyond." It is intended to inform stakeholders including hospitals, health systems, and policymakers about ethical considerations that should be considered when developing strategies for allocation of scarce resources during an emergency involving older adults. This review presents the legal and ethical background for the position statement and discusses these issues that informed the development of the AGS positions: (1) age as a determining factor, (2) age as a tiebreaker, (3) criteria with a differential impact on older adults, (4) individual choices and advance directives, (5) racial/ethnic disparities and resource allocation, and (6) scoring systems and their impact on older adults. It also considers the role of advance directives as expressions of individual preferences in pandemics. J Am Geriatr Soc 68:1143-1149, 2020.

The double-edged sword: does biomechanism increase or decrease judges' sentencing of psychopaths?

We tested whether expert testimony concerning a biomechanism of psychopathy increases or decreases punishment. In a nationwide experiment, U.S. state trial judges (N = 181) read a hypothetical case (based on an actual case) where the convict was diagnosed with psychopathy. Evidence presented at sentencing in support of a biomechanical cause of the convict's psychopathy significantly reduced the extent to which psychopathy was rated as aggravating and significantly reduced sentencing (from 13.93 years to 12.83 years). Content analysis of judges' reasoning indicated that even though the majority of judges listed aggravating factors (86.7%), the biomechanical evidence increased the proportion of judges listing mitigating factors (from 29.7 to 47.8%). Our results contribute to the literature on how biological explanations of behavior figure into theories of culpability and punishment.

Through a scanner darkly: functional neuroimaging as evidence of a criminal defendant's past mental states.

As with phrenology and the polygraph, society is again confronted with a device that the media claims is capable of reading our minds. Functional magnetic resonance imaging ("fMRI"), along with other types of functional brain imaging technologies, is currently being introduced at various stages of a criminal trial as evidence of a defendant's past mental state. This Article demonstrates that functional brain images should not currently be admitted as evidence into courts for this purpose. Using the analytical framework provided by Federal Rule of Evidence 403 as a threshold to a Daubert/Frye analysis, we demonstrate that, when fMRI methodology is properly understood, brain images are only minimally probative of a defendant's past mental states and are almost certainly more unfairly prejudicial than probative on balance. Careful and detailed explanation of the underlying science separates this Article from others, which have tended to paint fMRI with a gloss of credibility and certainty for all courtroom-relevant applications. Instead, we argue that this technology may present a particularly strong form of unfair prejudice in addition to its potential to mislead jurors and waste the court's resources. Finally, since fMRI methodology may one day improve such that its probative value is no longer eclipsed by its extreme potential for unfair prejudice, we offer a nonexhaustive checklist that judges and counsel can use to authenticate functional brain images and assess the weight these images are to be accorded by fact finders.