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The article focuses on the regulatory challenges and considerations surrounding the therapeutic use of psychedelics. It discuss the growing interest and research on the potential therapeutic benefits of psychedelics, including their use in combination with psychotherapy for various mental health conditions. It further highlight the complexities faced by regulators who need to navigate the existing patchwork of regulations surrounding psychedelic drugs.

The collaborative nature of citizen science raises important questions about managing ownership of its research outputs. Potential citizen science research outputs include data sets, findings, publications, and discoveries of new ideas, methods, products, and technologies. Unlike citizen science projects conducted in other disciplines, biomedical citizen science projects often include features, such as contribution of personal health data, that might heighten citizen scientists' expectations that they will be able to access, control, or share in the benefits of project outputs. Here, we refer to moral claims of access, control, and benefit as ownership claims, and a project's management of ownership claims as its ownership practices. Ethical management of ownership is widely recognized as an important consideration for citizen science projects, and practitioners and scholars have described helpful recommendations for preempting issues and engaging stakeholders on practices. Building on this literature, we propose a framework to help biomedical citizen science projects systematically evaluate the ethical soundness of their ownership practices based on four considerations: reciprocal treatment, relative treatment, risk-benefit assessment, and reasonable expectations. [ABSTRACT FROM AUTHOR]

Direct to consumer advertising (DTCA) of prescription drugs has increased dramatically in the past two decades. The effect of this increase in advertising on the frequency of inappropriate prescribing is poorly understood, as are the factors that may underly inappropriate prescribing. A review of existing observational and experimental studies that address advertising-related prescription requests and contain some measure of prescription appropriateness demonstrate that DTCA increases prescription requests, increases the likelihood of prescription, and increases both appropriate and inappropriate prescribing. Patient expectations, insufficient information sharing, and patient satisfaction surveys are proposed contributors to potentially inappropriate prescribing in response to DTCA. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has raised a host of ethical challenges, but key among these has been the possibility that health care systems might need to ration scarce critical care resources. Rationing policies for pandemics differ by institution, health system, and applicable law. Most seem to agree that a patient's ability to benefit from treatment and to survive are first-order considerations. However, there is debate about what clinical measures should be used to make that determination and about other factors that might be ethically appropriate to consider. In this paper, we discuss resource allocation and several related ethical challenges to the healthcare system and society, including how to define benefit, how to handle informed consent, the special needs of pediatric patients, how to engage communities in these difficult decisions, and how to mitigate concerns of discrimination and the effects of structural inequities. [ABSTRACT FROM AUTHOR]

As citizen science expands, questions arise regarding the applicability of norms and policies created in the context of conventional science. This article focuses on data sharing in the conduct of health-related citizen science, asking whether citizen scientists have obligations to share data and publish findings on par with the obligations of professional scientists. We conclude that there are good reasons for supporting citizen scientists in sharing data and publishing findings, and we applaud recent efforts to facilitate data sharing. At the same time, we believe it is problematic to treat data sharing and publication as ethical requirements for citizen scientists, especially where there is the potential for burden and harm without compensating benefit. [ABSTRACT FROM AUTHOR]

Psychedelic substances have great promise for the treatment of many conditions, and they are the subject of intensive research. As with other medical treatments, both research and clinical use of psychedelics depend on our ability to ensure informed consent by patients and research participants. However, some have argued that informed consent for psychedelic use may be impossible, because psychedelic experiences can be transformative in the sense articulated by L. A. Paul (2014). For Paul, transformative experiences involve either the acquisition of knowledge that cannot be obtained in any other way or changes in the self. Either of these characteristics may appear to undermine informed consent. This article argues, however, that there is limited evidence that psychedelic experiences are transformative in Paul's sense, and that they may not differ in their transformative features from other common medical experiences for which informed consent is clearly possible. Further, even if psychedelic experiences can be transformative, informed consent is still possible. Because psychedelic experiences are importantly different in several respects from other medical experiences, this article closes with recommendations for how these differences should be reflected in informed consent processes. [ABSTRACT FROM AUTHOR]

In this paper, we explore the perspectives of expert stakeholders about who owns data in a medical information commons (MIC) and what rights and interests ought to be recognized when developing a governance structure for an MIC. We then examine the legitimacy of these claims based on legal and ethical analysis and explore an alternative framework for thinking about participants' rights and interests in an MIC. [ABSTRACT FROM AUTHOR]

Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons (MIC). We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes. [ABSTRACT FROM AUTHOR]

Next-generation sequencing (NGS) is commonly used for researching the causes of genetic disorders. However, its usefulness in clinical practice for medical diagnosis is in early development. In this report, we demonstrate the value of NGS for genetic risk assessment and evaluate the limitations and barriers for the adoption of this technology into medical practice. We performed whole exome sequencing (WES) on 81 volunteers, and for each volunteer, we requested personal medical histories, constructed a three-generation pedigree, and required their participation in a comprehensive educational program. We limited our clinical reporting to disease risks based on only rare damaging mutations and known pathogenic variations in genes previously reported to be associated with human disorders. We identified 271 recessive risk alleles (214 genes), 126 dominant risk alleles (101 genes), and 3 X-recessive risk alleles (3 genes). We linked personal disease histories with causative disease genes in 18 volunteers. Furthermore, by incorporating family histories into our genetic analyses, we identified an additional five heritable diseases. Traditional genetic counseling and disease education were provided in verbal and written reports to all volunteers. Our report demonstrates that when genome results are carefully interpreted and integrated with an individual's medical records and pedigree data, NGS is a valuable diagnostic tool for genetic disease risk. [ABSTRACT FROM AUTHOR]

Sharing sequencing data sets without identifiers has become a common practice in genomics. Here, we report that surnames can be recovered from personal genomes by profiling short tandem repeats on the Y chromosome (Y-STRs) and querying recreational genetic genealogy databases. We show that a combination of a surname with other types of metadata, such as age and state, can be used to triangulate the identity of the target. A key feature of this technique is that it entirely relies on free, publicly accessible Internet resources. We quantitatively analyze the probability of identification for U.S. males. We further demonstrate the feasibility of this technique by tracing back with high probability the identities of multiple participants in public sequencing projects. [ABSTRACT FROM AUTHOR]

The article discusses contemporary bioethics and the identification of consanguinity through the use of routine genomic analysis as of December 2012, including information on the use of genetic testing programs such as chromosomal microarray analysis (CMA) to identify birth defects and intellectual impairments in children. It states that in the U.S., there is no uniform federal policy with regards to obtaining specific informed consent prior to the initiation of clinical genetic testing.

The article discusses a study which examined ethical, legal, and social implications (ESLI) issues that arose during the Human Microbiome Proejct (HMP). Semi-structured in-depth interviews were conducted with HMP investigators and National Institutes of Health (NIH) employees. Three major ESLI issues were identified are informed consent, data sharing, and return of results.

Direct-to-consumer (DTC) genetic testing has attracted a great amount of attention from policy makers, the scientific community, professional groups, and the media. Although it is unclear what the public demand is for these services, there does appear to be public interest in personal genetic risk information. As a result, many commentators have raised a variety of social, ethical, and regulatory issues associated with this emerging industry, including privacy issues, ensuring that DTC companies provide accurate information about the risks and limitations of their services, the possible adverse impact of DTC genetic testing on healthcare systems, and concern about how individuals may interpret and react to genetic risk information. [ABSTRACT FROM AUTHOR]

The article discusses several misconceptions that prevent physicians from shaping the decisions of their patients. One of the misconceptions indicates that the decisions and actions of patients are autonomous. Another misconception is the feasibility of extricating physician influence. The article also explains the importance of autonomy to ethical clinical practice.

Direct-to-consumer personal genome testing is now widely available to consumers. Proponents argue that knowledge is power but critics worry about consumer safety and potential harms resulting from misinterpretation of test information. In this article, we consider the health system implications of direct-to-consumer personal genome testing, focusing on issues of accountability, both corporate and professional. Copyright © 2010 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

There are several features of genetic and genomic research that challenge established norms of informed consent. In this paper, we discuss these challenges, explore specific elements of informed consent for genetic and genomic research conducted in the United States, and consider alternative consent models that have been proposed. All of these models attempt to balance the obligation to respect and protect research participants with the larger social interest in advancing beneficial research as quickly as possible. [ABSTRACT FROM AUTHOR]

An essay is presented on the ways in which heuristics and biases can influence the decisions of patients. It features clinical examples to show the effects of heuristics and biases and argues for the need of their understanding by physicians to rebias patients and promote their health and other values. It also describes techniques used by physicians in order to present health decisions which are likely to motivate patients towards less biased and more long term conducive decisions.

The falling cost of sequencing means that we are rapidly approaching an era in which access to personalized genomic information is likely to be widespread. Here, four experts with different insights into the field of genomic medicine answer questions about the prospects for using this type of information. Their responses highlight the diverse range of issues that must be addressed - ranging from scientific to ethical and logistical - to ensure that the potential benefits of personal genomic information outweigh the costs to both individuals and societies. [ABSTRACT FROM AUTHOR]

The article discusses the legality of direct-to-consumer (DTC) genetic testing in the U.S. The introduction of personal genome testing services has led to arguments over the legal issues related to services offered by DTC genetic testing. In addition, the types of genetic testing services available complicate the issue because companies might be using information for recreational purposes only or for medical diagnostic information.

Interest in whole-genome research has grown substantially over the past few months. This article explores the challenging ethics issues associated with this work. [ABSTRACT FROM AUTHOR]

The recent completion of the first two individual whole-genome sequences is a research milestone. As personal genome research advances, investigators and international research bodies must ensure ethical research conduct. We identify three major ethical considerations that have been implicated in whole-genome research: the return of research results to participants; the obligations, if any, that are owed to participants' relatives; and the future use of samples and data taken for whole-genome sequencing. Although the issues are not new, we discuss their implications for personal genomics and provide recommendations for appropriate management in the context of research involving individual whole-genome sequencing. [ABSTRACT FROM AUTHOR]

The article looks at the demands of genetic research. Elias A. Zerhouni, the Director of the National Institutes of Health (NIH), predicted that comprehensive, genomics-based health care will become the norm, with individualized preventive medicine and early detection of illnesses. The excitement about the potential scientific an clinical advances has led NIH institutions to launch initiatives for genome-wide association studies. It also called on researchers and institutions to utilize new DNA analysis technologies.

Discusses the ethics of lawyer-ethicists in the hospital setting in the U.S. Common tasks of ethics committees; Introduction of the concept of a hospital ethics committee; Mechanism for the consideration of ethical issues arising in the care of patients.

Enhancing patient choice is a central theme of medical ethics and law. Informed consent is the legal process used to promote patient autonomy; shared decision making is a widely promoted ethical approach. These processes may most usefully be seen as distinct in clinically and ethically important respects. The approach outlined in this article uses a model that arrays all medical decisions along 2 axes: risk and certainty. At the extremes of these continua, 4 decision types are produced, each of which constrains the principal actors in predictable ways. Shared decision making is most appropriate in situations of uncertainty, in which 2 or more clinically reasonable alternatives exist. When there is only 1 realistic choice, patient and physician may gather and exchange information; however, the patient cannot be empowered to make choices that do not exist. In contrast, informed consent does not require the presence of clinical choice; it is appropriate for all decisions of significant risk, even if there is only one option. When a clinical decision contains both risk and uncertainty, shared decision making and informed consent are both appropriate. For decisions of lower risk, consent should still be present, but it can be simple rather than informed. Clinicians may use this analysis as a guide to their own interactions with patients. In the continuing effort to provide patients with appropriate decisional authority over their own medical choices, shared decision making, informed consent, and simple consent each has a distinct role to play.. [ABSTRACT FROM AUTHOR]

The article provides insights for U.S. pediatricians on dealing with the hesitations of parents toward a COVID-19 vaccine. A study discovered that a fifth of adults are unwilling to be vaccinated due to misinformation-led fears. Pediatricians are advised to consider the decisional rights of the parent when deciding about the ethical justification of dismissing them. It emphasizes the need for pediatricians to attend to the concern of patients about COVID-19 vaccines.

Should the results of whole genome sequencing research be disclosed to participants, in particular when the results have uncertain or indeterminate phenotypic consequences? This controversial question is considered in light of one author''s (J.L.) experience as a geneticist who recently had his own genome sequenced. [Copyright &y& Elsevier]

The authors express their opinion that patient concerns about direct-to-consumer genome testing could strain health care resources. They cite the competing demands faced by primary care physicians. The unproven clinical value of the tests is addressed. The potential harm from unnecessary or unproven health care is discussed. The authors discuss premarket review of tests and issues regarding genomic risk information. They explain that there is no information on the outcomes of testing.

AbstractBackgroundMethodsResultsConclusionsInvestigative genetic genealogy (IGG) is a technique that involves uploading genotypes developed from perpetrator DNA left at a crime scene, or DNA from unidentified remains, to public genetic genealogy databases to identify genetic relatives and, through the creation of a family tree, the individual who was the source of the DNA. As policymakers demonstrate interest in regulating IGG, it is important to understand public perspectives on IGG to determine whether proposed policies are aligned with public attitudes.We conducted eight focus groups with members of the public (N = 72), sampled from four geographically diverse US regions, to explore general attitudes and perspectives regarding aspects of IGG practices, applications, and policies. Five major topics were explored in each focus group: when IGG should be used; who should perform IGG; how to approach consent for genetic database users; what systems of oversight should govern IGG practitioners; and whether to notify database users if their data are involved in law enforcement (LE) matching.Participants were supportive of IGG in most scenarios, especially for cold and violent cases. The favorable attitudes toward IGG were, however, tempered by distrust of law enforcement among some participants. All participants agreed that databases must inform users if IGG is allowed, but they did not agree on how individual database users should be allowed to opt out or whether to notify them if their data are involved in specific investigations. All participants agreed that IGG should be subject to some prescriptive guidelines, regulations, or accountability mechanisms.These findings suggest broad public support for IGG, and interest in developing systems of accountability for its practice. Our study provides useful insight for policy makers, genomic database stewards, law enforcement, and other stakeholders in IGG’s practice, and suggests multiple directions for future research. [ABSTRACT FROM AUTHOR]

Background: Understanding research participants' responses to learning Alzheimer's disease (AD) risk information is important to inform clinical implementation of precision diagnostics given rapid advances in disease modifying therapies. Objective: We assessed participants' perspectives on the meaning of their amyloid positron emission tomography (PET) imaging results for their health, self-efficacy to understand their results, psychological impact of learning their results, experience receiving their results from the clinical team, and interest in genetic testing for AD risk. Methods: We surveyed individuals who were being clinically evaluated for AD and received PET imaging six weeks after the return of results. We analyzed responses to close-ended survey items by PET result using Fisher's exact test and qualitatively coded open-ended responses. Results: A total of 88 participants completed surveys, most of whom had mild cognitive impairment due to AD (38.6%), AD (28.4%), or were cognitively unimpaired (21.6%). Participants subjectively understood their results (25.3% strongly agreed, 41.8% agreed), which could help them plan (16.5% strongly agreed, 49.4% agreed). Participants with a negative PET result (n = 25) reported feelings of relief (Fisher's exact p < 0.001) and happiness (p < 0.001) more frequently than those with a positive result. Most participants felt that they were treated respectfully and were comfortable voicing concerns during the disclosure process. Genetic testing was anticipated to be useful for medical care decisions (48.2%) and to inform family members about AD risk (42.9%). Conclusions: Participants had high subjective understanding and self-efficacy around their PET results and did not experience negative psychological effects. Interest in genetic testing was high. [ABSTRACT FROM AUTHOR]

Psychedelics have again become a subject of widespread interest, owing to the reinvigoration of research into their traditional uses, possible medical applications, and social implications. As evidence for psychedelics' clinical potential mounts, the field has increasingly focused on searching for mechanisms to explain the effects of psychedelics and therapeutic efficacy of psychedelic-assisted therapy (PAT). This paper reviews three general frameworks that encompass several prominent models for understanding psychedelics' effects—specifically, neurobiological, psychological, and spiritual frameworks. Following our review, the implications of each framework for ethics and professional competencies in the implementation of psychedelics as medicines are explored. We suggest that interdisciplinary education may be necessary to improve communication between researchers, develop models that effectively incorporate multiple levels of analysis, and facilitate collaboration between professionals with diverse backgrounds in the implementation of psychedelic medicines. We also address pitfalls associated with overemphasis on neuro-mechanisms, risks associated with instigating vulnerable states of consciousness, and hurdles associated with the integration of spiritual frameworks in medicine. Ultimately, as psychedelics push the boundaries of explanatory frameworks focused on one level of analysis, developing new and more useful models to reflect knowledge being produced in this field should be a central aim of psychedelic science going forward. [ABSTRACT FROM AUTHOR]

The article reports on ruling of the U.S. Supreme Court on business model of molecular diagnostic company Myriad Genetics regarding personal health data and commercial interests in trade secrecy. It mentions that BRCA1/2 genetic variants increase the risk of female breast and ovarian cancer. It also mentions that the Health Insurance Portability and Accountability Act (HIPAA) works for data access right.

Although the explosive growth of direct-to-consumer (DTC) genetic testing has moderated, a substantial number of patients are choosing to undergo genetic testing outside the purview of their regular healthcare providers. Further, many industry leaders have been expanding reports to cover many more genes, as well as partnering with employers and others to expand access. This review addresses continuing concerns about DTC genetic testing quality, psychosocial impact, integration with medical practice, effects on the healthcare system, and privacy, as well as emerging concerns about third-party interpretation services and non-health-related uses such as investigative genetic genealogy. It concludes with an examination of two possible futures for DTC genetic testing: merger with traditional modes of healthcare delivery or continuation as a parallel system for patient-driven generation of health-relevant information. Each possibility is associated with distinctive questions related to value and risk. [ABSTRACT FROM AUTHOR]

Sharing human brain data can yield scientific benefits, but because of various disincentives, only a fraction of these data is currently shared. We profile three successful data-sharing experiences from the NIH BRAIN Initiative Research Opportunities in Humans (ROH) Consortium and demonstrate benefits to data producers and to users. Sharing human brain data can yield scientific benefits, but because of various disincentives only a fraction of these data is currently shared. Rahimzadeh et al. profile three successful data-sharing experiences from the NIH BRAIN Initiative Research Opportunities in Humans (ROH) Consortium and demonstrate benefits to data producers and to users. [ABSTRACT FROM AUTHOR]

Purpose: With increased use of genomic testing in cancer research and clinical care, it is important to understand the perspectives and decision-making preferences of adolescents and young adults (AYAs) with cancer and their treating oncologists. Methods: We conducted an interview substudy of the BASIC3 Study, which enrolled newly diagnosed cancer patients <18 years of age with assent. Of 32 young adults (YAs) with cancer who reached the age of majority (AOM; 18 years) while on study, 12 were successfully approached and all consented to study continuation at AOM. Of those, seven completed an interview. Patients' oncologists, who enrolled and participated in return of clinical genomic results, were also interviewed (n = 12). Interviews were transcribed, deidentified, and analyzed using thematic analysis. Results: YAs cited the possibility of helping others and advancing science as major reasons for their assent to initial study enrollment and their willingness to consent at AOM. YAs thought obtaining informed consent from research participants for study continuation at AOM was a good idea in case they changed their minds or wanted to make their own decisions, and to keep them aware of study activities. There was diversity in what YAs understood and learned from genomic testing: some recalled specific findings, while some remembered minimal information about their results. Oncologists varied in their assessment of adolescents' engagement with the study and understanding of their results. Conclusion: Given the different ways AYAs engage with genomic information, careful assessment of AYAs' diverse communication and decision-making preferences is needed to tailor interactions accordingly. [ABSTRACT FROM AUTHOR]

In this paper, we contend with whether we still need traditional ethics education as part of healthcare professional training given the abilities of chatGPT (generative pre-trained transformer) and other large language models (LLM). We reflect on common programmatic goals to assess the current strengths and limitations of LLMs in helping to build ethics competencies among future clinicians. Through an actual case analysis, we highlight areas in which chatGPT and other LLMs are conducive to common bioethics education goals. We also comment on where such technologies remain an imperfect substitute for human-led ethics teaching and learning. Finally, we conclude that the relative strengths of chatGPT warrant its consideration as a teaching and learning tool in ethics education in ways that account for current limitations and build in flexibility as the technology evolves. [ABSTRACT FROM AUTHOR]

Background: The coronavirus disease 2019 pandemic has or threatens to overwhelm health care systems. Many institutions are developing ventilator triage policies.Objective: To characterize the development of ventilator triage policies and compare policy content.Design: Survey and mixed-methods content analysis.Setting: North American hospitals associated with members of the Association of Bioethics Program Directors.Participants: Program directors.Measurements: Characteristics of institutions and policies, including triage criteria and triage committee membership.Results: Sixty-seven program directors responded (response rate, 91.8%); 36 (53.7%) hospitals did not yet have a policy, and 7 (10.4%) hospitals' policies could not be shared. The 29 institutions providing policies were relatively evenly distributed among the 4 U.S. geographic regions (range, 5 to 9 policies per region). Among the 26 unique policies analyzed, 3 (11.3%) were produced by state health departments. The most frequently cited triage criteria were benefit (25 policies [96.2%]), need (14 [53.8%]), age (13 [50.0%]), conservation of resources (10 [38.5%]), and lottery (9 [34.6%]). Twenty-one (80.8%) policies use scoring systems, and 20 of these (95.2%) use a version of the Sequential Organ Failure Assessment score. Among the policies that specify the triage team's composition (23 [88.5%]), all require or recommend a physician member, 20 (87.0%) a nurse, 16 (69.6%) an ethicist, 8 (34.8%) a chaplain, and 8 (34.8%) a respiratory therapist. Thirteen (50.0% of all policies) require or recommend that those making triage decisions not be involved in direct patient care, but only 2 (7.7%) require that their decisions be blinded to ethically irrelevant considerations.Limitation: The results may not be generalizable to institutions without academic bioethics programs.Conclusion: Over one half of respondents did not have ventilator triage policies. Policies have substantial heterogeneity, and many omit guidance on fair implementation.Primary Funding Source: None. [ABSTRACT FROM AUTHOR]

The authors conveys their concerns about behavioral economics and the future of genomic medicine. Topics discussed include the increase in colorectal cancer screening through individualized risk assessment and counseling, the average lifetime risk for breast cancer, and the need to abandon the neutral measures that have qualified the field of generic counseling.

Newborn genomic sequencing (NBSeq) to screen for medically important genetic information is of considerable interest but data characterizing the actionability of such findings, and the downstream medical efforts in response to discovery of unanticipated genetic risk variants, are lacking. From a clinical trial of comprehensive exome sequencing in 127 apparently healthy infants and 32 infants in intensive care, we previously identified 17 infants (10.7%) with unanticipated monogenic disease risks (uMDRs). In this analysis, we assessed actionability for each of these uMDRs with a modified ClinGen actionability semiquantitative metric (CASQM) and created radar plots representing degrees of penetrance of the condition, severity of the condition, effectiveness of intervention, and tolerability of intervention. In addition, we followed each of these infants for 3–5 years after disclosure and tracked the medical actions prompted by these findings. All 17 uMDR findings were scored as moderately or highly actionable on the CASQM (mean 9, range: 7–11 on a 0–12 scale) and several distinctive visual patterns emerged on the radar plots. In three infants, uMDRs revealed unsuspected genetic etiologies for existing phenotypes, and in the remaining 14 infants, uMDRs provided risk stratification for future medical surveillance. In 13 infants, uMDRs prompted screening for at-risk family members, three of whom underwent cancer-risk-reducing surgeries. Although assessments of clinical utility and cost-effectiveness will require larger datasets, these findings suggest that large-scale comprehensive sequencing of newborns will reveal numerous actionable uMDRs and precipitate substantial, and in some cases lifesaving, downstream medical care in newborns and their family members. Among 17 infants found to have unanticipated monogenic disease risks through genome screening to date in the BabySeq Project, all of the genomic findings were actionable. After 3–5 years, there had been interventions in the families of 13 of these infants, including three risk-reducing surgeries among mothers of infants sequenced. [ABSTRACT FROM AUTHOR]

The literature on deep brain stimulation (DBS) and adaptive DBS (aDBS) raises concerns that these technologies may affect personality, mood, and behavior. We conducted semi-structured interviews with researchers (n = 23) involved in developing next-generation DBS systems, exploring their perspectives on ethics and policy topics including whether DBS/aDBS can cause such changes. The majority of researchers reported being aware of personality, mood, or behavioral (PMB) changes in recipients of DBS/aDBS. Researchers offered varying estimates of the frequency of PMB changes. A smaller majority reported changes in personality specifically. Some expressed reservations about the scientific status of the term 'personality,' while others used it freely. Most researchers discussed negative PMB changes, but a majority said that DBS/aDBS can also result in positive changes. Several researchers viewed positive PMB changes as part of the therapeutic goal in psychiatric applications of DBS/aDBS. Finally, several discussed potential causes of PMB changes other than the device itself. [ABSTRACT FROM AUTHOR]

The authors discuss ethical issues posed by an American College of Medical Genetics and Genomics (ACMG) recommendation regarding the reporting of pathogenic mutations found in whole-genome and whole-exome sequencing (WGS-WES) disease research. Topics include patient autonomy, informed consent, and genetic testing of children. The authors argue that scientists have an obligation to disclose any clinically beneficial incidental findings from their research to relevant patients.

The article presents insights on decisions requiring professional judgment regardless of whether genome-scale sequencing (WGS) is performed in research or the clinic. It explains the need for deciding what specifically within the genome will be queried, noting that only a selected set of genes should be analyzed to minimize confusion. The methodical interpretation of WGS results is also explained, as well as the recommendations to be made to individuals who undergo sequencing.

An introduction is presented in which the authors discuss various reports within the journal on topics including data sharing in a Medical Information Commons, Findable, Accessible, Interoperable and Re-usable data principles, and tension between the open science movement and data protection laws.

The authors of current professional guidelines generally do not support the return of information about genetic carrier status for infants and children because of a perceived lack of immediate benefit and an abundance of caution regarding potential harm and desire to protect the children's future autonomy. The advent of genomic sequencing, used either as a diagnostic or a screening tool, and the increasing use of this technology in childhood creates the potential for the identification of carrier status in the pediatric period. As part of the BabySeq Project, researchers are exploring the implications of genomic sequencing in both newborns who are healthy and newborns who are sick and developing policies and procedures for the return of carrier status information to the parents and physicians of newborns. In this commentary, we review the history of carrier testing in children and explore the potential benefits, risks, and challenges of returning such results both for the children, their parents, and potential future siblings. [ABSTRACT FROM AUTHOR]

A response is presented to a letter to the editor concerning the article “Regulating Direct-to-Consumer Personal Genome Testing,” which was published in the October 8, 2010 issue.

The article discusses direct-to-consumer (DTC) personal genome tests, the information that such tests are promised to provide, and debate regarding the reliability, meaning, and interpretation of test results. Concerns regarding these tests have been raised by the U.S. Government Accountability Office (GAO) and the U.S. Food and Drug Administration (FDA), among others. It is explained that these tests are generally completed without review by an external regulator and that regulations are needed. Prospects and strategies for regulating DTC genetic tests are discussed including barriers to involving FDA in the process.

This article presents information regarding the recent changes in DNA sequencing. As DNA sequencing becomes more affordable and less time-consuming, scientists are adding DNA banking and analysis to research protocols, resulting in new disease-specific DNA databases. Without privacy protection public trust will be compromised and the scientific and medical potential of the technology will not be realized. However, scientific utility grows with increased access to sequenced DNA. DNA is publicly released and have largely been addressed by ensuring that the data are deidentified and that confidentiality is maintained. There is a large literature on the various data-management models and computer algorithms that can be used to provide access to genetic data while purportedly protecting privacy. Although individual identification from the public release of these data would currently require a reference sample, the privacy risk associated with public data release is fueled by the extraordinary pace of technological developments and the rapid proliferation of electronic databases.

Prospects have never seemed better for a truly global approach to science to improve human health, with leaders of national initiatives laying out their vision of a worldwide network of related projects. An extensive literature addresses obstacles to global genomic data sharing, yet a series of public polls suggests that the scientific community may be overlooking a significant barrier: potential public resistance to data sharing across national borders. In several large United States surveys, university researchers in other countries were deemed the least acceptable group of data users, and a just-completed US survey found a marked increase in privacy and security concerns related to data access by non-US researchers. Furthermore, diminished support for sharing beyond national borders is not unique to the US, although the limited data from outside the US suggest variation across countries as well as demographic groups. Possible sources of resistance include apprehension about privacy and security protections. Strategies for building public support include making the affirmative case for global data sharing, addressing privacy, security, and other legitimate concerns, and investigating public concerns in greater depth. [ABSTRACT FROM AUTHOR]