Precision Medicine-Are We There Yet? A Narrative Review of Precision Medicine's Applicability in Primary Care.

Precision medicine (PM), also termed stratified, individualised, targeted, or personalised medicine, embraces a rapidly expanding area of research, knowledge, and practice. It brings together two emerging health technologies to deliver better individualised care: the many "-omics" arising from increased capacity to understand the human genome and "big data" and data analytics, including artificial intelligence (AI). PM has the potential to transform an individual's health, moving from population-based disease prevention to more personalised management. There is however a tension between the two, with a real risk that this will exacerbate health inequalities and divert funds and attention from basic healthcare requirements leading to worse health outcomes for many. All areas of medicine should consider how this will affect their practice, with PM now strongly encouraged and supported by government initiatives and research funding. In this review, we discuss examples of PM in current practice and its emerging applications in primary care, such as clinical prediction tools that incorporate genomic markers and pharmacogenomic testing. We look towards potential future applications and consider some key questions for PM, including evidence of its real-world impact, its affordability, the risk of exacerbating health inequalities, and the computational and storage challenges of applying PM technologies at scale.

Ethically cleared to launch?

Rules are needed for human research in commercial spaceflight.

MAiD as a case study in evidence for policy making: An account of the CCA assessment on medical assistance in dying.

In December 2016, the Council of Canadian Academies (CCA) was asked by the Government of Canada to undertake an assessment on Medical Assistance in Dying (MAiD), following from Parliament's passage of Bill C-14: An Act to amend the Criminal Code and to make related amendments to other Acts. The CCA was asked to undertake an assessment of the state of knowledge on three topics that Parliament excluded from C-14: requests for MAiD by mature minors, advance requests for MAiD, and requests for MAiD where a mental disorder is the sole underlying medical condition. Here, we describe the way that the CCA responded to the request from the Government of Canada using a multidisciplinary expert panel approach, how different forms of evidence were identified and used, the impact of the CCA assessment as part of the broader conversation occurring in Canada, and its implications for health leaders.

Reactions to the National Academies/Royal Society Report on Heritable Human Genome Editing.

In September 2020, a detailed report on Heritable Human Genome Editing was published. The report offers a translational pathway for the limited approval of germline editing under limited circumstances and assuming various criteria have been met. In this perspective, some three dozen experts from the fields of genome editing, medicine, bioethics, law, and related fields offer their candid reactions to the National Academies/Royal Society report, highlighting areas of support, omissions, disagreements, and priorities moving forward.

Don Chalmers: His Contributions to Legal Research and Education, Health Law, and Research Ethics, Locally and Globally.

Distinguished Professor Don Chalmers retired from the Law Faculty at the University of Tasmania on Friday 10 July 2020. This article is dedicated to Don, providing a brief account and acknowledgment of his fine contributions to legal research and education and law reform, particularly in the field of health and medical law, research ethics and policy reform. He has been an excellent colleague, mentor, leader, teacher, and researcher. He deserves to enjoy a long and rewarding retirement, though we, and many others, will not allow him to slip entirely out of the limelight. Don is still much needed, and still has so much to give in our ongoing quest to ensure that legal, research ethics and policy responses are adequate in reaping the benefits and responding to the challenges of biomedical advances.

Sharing with Strangers: Governance Models for Borderless Genomic Research in a Territorial World.

One of the practices that has defined the ethos of genomic research to date is a commitment to open and rapid sharing of genomic data and resources. As genomic research evolves into an international enterprise, this commitment is being challenged by the need to respect the interests of those it involves and implicates, from individual scientists and subjects to institutions and nations. In this essay, we first describe the types of claims that different stakeholders are making about the disposition of genomic data and samples. Next, we illustrate the complexities of these multiple claims by applying them to the case of one ongoing international genomics initiative, the H3Africa Consortium. Finally, in the light of these complexities, we conclude by comparing and contrasting four governance models for future international data-sharing policy and practices in genomics.

Women's opinions of legal requirements for drug testing in prenatal care.

PURPOSE: To explore women's attitudes and perceptions regarding legal requirements for prenatal drug testing. METHODS: Web-based survey of 500 US women (age 18-45) recruited from a market research survey panel. A 24-item questionnaire assessed their opinion of laws requiring doctors to routinely verbal screen and urine drug test patients during pregnancy; recommendations for consequences for positive drug tests during pregnancy; and opinion of laws requiring routine drug testing of newborns. Additional questions asked participants about the influence of such laws on their own care-seeking behaviors. Data were analyzed for associations between participant characteristics and survey responses using Pearson's chi-squared test. RESULTS: The majority of respondents (86%) stated they would support a law requiring verbal screening of all pregnant patients and 73% would support a law requiring universal urine drug testing in pregnancy. Fewer respondents were willing to support laws that required verbal screening or urine drug testing (68% and 61%, respectively) targeting only Medicaid recipients. Twenty-one percent of respondents indicated they would be offended if their doctors asked them about drug use and 14% indicated that mandatory drug testing would discourage prenatal care attendance. CONCLUSION: Women would be more supportive of policies requiring universal rather than targeted screening and testing for prenatal drug use. However, a noteworthy proportion of women would be discouraged from attending prenatal care - a reminder that drug testing policies may have detrimental effects on maternal child health.

To research (or not) that is the question: ethical issues in research when medical care is disrupted by political action: a case study from Eldoret, Kenya.

While considerable attention has been focused on understanding the myriad of ethical analysis in international research in low and middle income countries, new issues always arise that have not been anticipated in guidelines or studied extensively. The disruption of medical care arising as a direct result of political actions, including strikes, postelection violence and related activities, is one such issue that leaves physician-researchers struggling to manage often conflicting professional responsibilities. This paper discusses the ethical conflicts that arise for physician-researchers, particularly when disruption threatens the completion of a study or completion is possible but at the expense of not addressing unmet medical needs of patients. We review three pragmatic strategies and the ethical issues arising from each: not starting research, stopping research that has already started, and continuing research already initiated. We argue that during episodes of medical care disruption, research that has been started can be continued only if the ethical standards imposed at the beginning of the study can continue to be met; however, studies that have been approved but not yet started should not begin until the disruption has ended and ethical standards can again be assured.

Ethics and Childhood Vaccination Policy in the United States.

Childhood immunization involves a balance between parents' autonomy in deciding whether to immunize their children and the benefits to public health from mandating vaccines. Ethical concerns about pediatric vaccination span several public health domains, including those of policymakers, clinicians, and other professionals. In light of ongoing developments and debates, we discuss several key ethical issues concerning childhood immunization in the United States and describe how they affect policy development and clinical practice. We focus on ethical considerations pertaining to herd immunity as a community good, vaccine communication, dismissal of vaccine-refusing families from practice, and vaccine mandates. Clinicians and policymakers need to consider the nature and timing of vaccine-related discussions and invoke deliberative approaches to policy-making.

Industry Support of Medical Research: Important Opportunity or Treacherous Pitfall?

Pharmaceutical and device manufacturers fund more than half of the medical research in the U.S. Research funding by for-profit companies has increased over the past 20 years, while federal funding has declined. Research funding from for-profit medical companies is seen as tainted by many academicians because of potential biases and prior misbehavior by both investigators and companies. Yet NIH is encouraging partnerships between the public and private sectors to enhance scientific discovery. There are instances, such as methods for improving drug adherence and post-marketing drug surveillance, where the interests of academician researchers and industry could be aligned. We provide examples of ethically performed industry-funded research and a set of principles and benchmarks for ethically credible academic-industry partnerships that could allow academic researchers, for-profit companies, and the public to benefit.

Protecting Ideas: Ethical and Legal Considerations When a Grant's Principal Investigator Changes.

Ethical issues related the responsible conduct of research involve questions concerning the rights and obligations of investigators to propose, design, implement, and publish research. When a principal investigator (PI) transfers institutions during a grant cycle, financial and recognition issues need to be addressed to preserve all parties' obligations and best interests in a mutually beneficial way. Although grants often transfer with the PI, sometimes they do not. Maintaining a grant at an institution after the PI leaves does not negate the grantee institution's obligation to recognize the PI's original ideas, contributions, and potential rights to some forms of expression and compensation. Issues include maintaining a role for the PI in determining how to take credit for, share and publish results that involve his or her original ideas. Ascribing proper credit can become a thorny issue. This paper provides a framework for addressing situations and disagreements that may occur when a new PI continues the work after the original PI transfers. Included are suggestions for proactively developing institutional mechanisms that address such issues. Considerations include how to develop solutions that comply with the responsible conduct of research, equitably resolve claims regarding reporting of results, and avoid the possibility of plagiarism.

Benchmarks for ethically credible partnerships between industry and academic health centers: beyond disclosure of financial conflicts of interest.

Relationships between industry and university-based researchers have been commonplace for decades and have received notable attention concerning the conflicts of interest these relationships may harbor. While new efforts are being made to update conflict of interest policies and make industry relationships with academia more transparent, the development of broader institutional partnerships between industry and academic health centers challenges the efficacy of current policy to effectively manage these innovative partnerships. In this paper, we argue that existing strategies to reduce conflicts of interest are not sufficient to address the emerging models of industry-academic partnerships because they focus too narrowly on financial matters and are not comprehensive enough to mitigate all ethical risk. Moreover, conflict-of-interest strategies are not designed to promote best practices nor the scientific and social benefits of academic-industry collaboration. We propose a framework of principles and benchmarks for "ethically credible partnerships" between industry and academic health centers and describe how this framework may provide a practical and comprehensive approach for designing and evaluating such partnerships.

Designing a patient-centered user interface for access decisions about EHR data: implications from patient interviews.

BACKGROUND: Electronic health records change the landscape of patient data sharing and privacy by increasing the amount of information collected and stored and the number of potential recipients. Patients desire granular control over who receives what information in their electronic health record (EHR), but there are no current patient interfaces that allow them to record their preferences for EHR access. OBJECTIVE: Our aim was to derive the user needs of patients regarding the design of a user interface that records patients' individual choices about who can access data in their EHRs. DESIGN: We used semi-structured interviews. SETTING: The study was conducted in Central Indiana. PARTICIPANTS: Thirty patients with data stored in an EHR, the majority of whom (70 %) had highly sensitive health EHR data, were included in the study. APPROACH: We conducted a thematic and quantitative analysis of transcribed interview data. KEY RESULTS: Patients rarely knew what data were in their EHRs, but would have liked to know. They also wanted to be able to control who could access what information in their EHR and wanted to be notified when their data we re accessed. CONCLUSIONS: We derived six implications for the design of a patient-centered tool to allow individual choice in the disclosure of EHR: easy patient access to their EHRs; an overview of current EHR sharing permissions; granular, hierarchical control over EHR access; EHR access controls based on dates; contextual privacy controls; and notification when their EHRs are accessed.

Patient preferences in controlling access to their electronic health records: a prospective cohort study in primary care.

INTRODUCTION: Previous studies have measured individuals' willingness to share personal information stored in electronic health records (EHRs) with health care providers, but none has measured preferences among patients when they are allowed to determine the parameters of provider access. METHODS: Patients were given the ability to control access by doctors, nurses, and other staff in a primary care clinic to personal information stored in an EHR. Patients could restrict access to all personal data or to specific types of sensitive information, and could restrict access for a specific time period. Patients also completed a survey regarding their understanding of and opinions regarding the process. RESULTS: Of 139 eligible patients who were approached, 105 (75.5 %) were enrolled, and preferences were collected from all 105 (100 %). Sixty patients (57 %) did not restrict access for any providers. Of the 45 patients (43 %) who chose to limit the access of at least one provider, 36 restricted access only to all personal information in the EHR, while nine restricted access of some providers to a subset of the their personal information. Thirty-four (32.3 %) patients blocked access to all personal information by all doctors, nurses, and/or other staff, 26 (24.8 %) blocked access by all doctors and/or nurses, and five (4.8 %) denied access to all doctors, nurses, and staff. CONCLUSIONS: A significant minority of patients chose to restrict access by their primary care providers to personal information contained in an EHR, and few chose to restrict access to specific types of information. More research is needed to identify patient goals and understanding of the implications when facing decisions of this sort, and to identify the impact of patient education regarding information contained in EHRs and their use in the clinical care setting.

Provider responses to patients controlling access to their electronic health records: a prospective cohort study in primary care.

INTRODUCTION: Applying Fair Information Practice principles to electronic health records (EHRs) requires allowing patient control over who views their data. METHODS: We designed a program that captures patients' preferences for provider access to an urban health system's EHR. Patients could allow or restrict providers' access to all data (diagnoses, medications, test results, reports, etc.) or only highly sensitive data (sexually transmitted infections, HIV/AIDS, drugs/alcohol, mental or reproductive health). Except for information in free-text reports, we redacted EHR data shown to providers according to patients' preferences. Providers could "break the glass" to display redacted information. We prospectively studied this system in one primary care clinic, noting redactions and when users "broke the glass," and surveyed providers about their experiences and opinions. RESULTS: Eight of nine eligible clinic physicians and all 23 clinic staff participated. All 105 patients who enrolled completed the preference program. Providers did not know which of their patients were enrolled, nor their preferences for accessing their EHRs. During the 6-month prospective study, 92 study patients (88 %) returned 261 times, during which providers viewed their EHRs 126 times (48 %). Providers "broke the glass" 102 times, 92 times for patients not in the study and ten times for six returning study patients, all of whom had restricted EHR access. Providers "broke the glass" for six (14 %) of 43 returning study patients with redacted data vs. zero among 49 study patients without redactions (p = 0.01). Although 54 % of providers agreed that patients should have control over who sees their EHR information, 58 % believed restricting EHR access could harm provider-patient relationships and 71 % felt quality of care would suffer. CONCLUSIONS: Patients frequently preferred restricting provider access to their EHRs. Providers infrequently overrode patients' preferences to view hidden data. Providers believed that restricting EHR access would adversely impact patient care. Applying Fair Information Practice principles to EHRs will require balancing patient preferences, providers' needs, and health care quality.