Regulatory justice following gross negligence manslaughter verdicts: Nurse/doctor differences.

Two professionals who treated Jack Adcock before his death were convicted of gross negligence manslaughter, receiving 24-month suspended sentences. His nurse, Isabel Amaro, was erased from the nursing register; but after reviews in the High Court and Court of Appeal, his doctor, Hadiza Bawa-Garba, was merely suspended. This article explores the proposition that nurses are at greater risk of erasure than doctors after gross negligence manslaughter through a close reading of the guidance for medical and nursing tribunals informed by analysis from the High Court and Court of Appeal in the Bawa-Garba cases. Examination of the relevant sections of the guidance for medical and nursing tribunals reveals no significant differences. An outline of the conduct that amounted to breach of duty of care by Amaro and Bawa-Garba shows that their conduct could satisfy the thresholds for erasure given in their professions' respective guidelines for tribunals. Both presented similar mitigating evidence, although this cannot be weighed heavily in a professional tribunal setting. Thus, Amaro was treated more harshly than Bawa-Garba without a simple explanation. However, I suggest that the Nursing and Midwifery Council's Conduct and Competence Committee made a mistaken 'presumption of erasure' for gross negligence manslaughter and misinterpreted the sway that sentencing remarks should hold over tribunals. Both of these types of error were criticised by the Court of Appeal in Bawa-Garba. Furthermore, the Conduct and Competence Committee did not flesh out its analysis of 'public confidence' or acknowledge Lord Hoffmann's caution against ending 'useful' careers for the sake of public confidence, but Bawa-Garba's legal team ensured these arguments were taken into account by the Medical Professional Tribunal. The Conduct and Competence Committee's failures are not inherent to Nursing and Midwifery Council procedure or policy. Rather Amaro's self-representation appears to have impaired her access to justice. Tribunals must accept their right, and responsibility, to reach their own conclusions.

Serious Ethical Violations in Medicine: A Statistical and Ethical Analysis of 280 Cases in the United States From 2008-2016.

Serious ethical violations in medicine, such as sexual abuse, criminal prescribing of opioids, and unnecessary surgeries, directly harm patients and undermine trust in the profession of medicine. We review the literature on violations in medicine and present an analysis of 280 cases. Nearly all cases involved repeated instances (97%) of intentional wrongdoing (99%), by males (95%) in nonacademic medical settings (95%), with oversight problems (89%) and a selfish motive such as financial gain or sex (90%). More than half of cases involved a wrongdoer with a suspected personality disorder or substance use disorder (51%). Despite clear patterns, no factors provide readily observable red flags, making prevention difficult. Early identification and intervention in cases requires significant policy shifts that prioritize the safety of patients over physician interests in privacy, fair processes, and proportionate disciplinary actions. We explore a series of 10 questions regarding policy, oversight, discipline, and education options. Satisfactory answers to these questions will require input from diverse stakeholders to help society negotiate effective and ethically balanced solutions.

Ethics of Virtual Reality in Medical Education and Licensure.

The aim of this section is to expand and accelerate advances in curriculum developments and in methods of teaching bioethics.

Mandatory reporting of impaired medical practitioners: protecting patients, supporting practitioners.

Taking action to protect patients from impaired colleagues is a long-standing ethical and professional obligation. In 2010, this responsibility was codified in law with the introduction, across Australia, of a new mandatory reporting regimen. While several concerns remain to be addressed, mandatory reporting has the potential not only to reinforce the primacy of patient safety, but also to open internal dialogue about the profession's response to concerns about practitioner health and well-being. Four years after the introduction of the scheme, key challenges include ensuring the reporting threshold is appropriately defined and clearly understood, improving access to evidence-based health programmes for practitioners, and strengthening upstream protections to prevent and minimise impairment at its roots.

Ethical and managerial considerations regarding state physician health programs.

Many physicians are referred to state physician health programs (PHPs) for evaluation, monitoring, and treatment of mental health and substance use disorders. Most PHPs are "diversion" or "safe haven" programs, meaning that physicians who suffer from alcohol or drug problems can have their case diverted to the PHP in lieu of being reported to the state licensing board. If the physician agrees to cooperate with the PHP and adhere to any recommendations it might make, the physician can avoid disciplinary action and remain in practice. These programs are therefore quite powerful and yet, to our knowledge, there has not been any systematic scrutiny of the ethical and management issues that arise in standard PHP practice. Given our 20 years of service as associate directors of one state PHP we analyze and evaluate the standard operating procedure of many PHPs and offer ethical critique as well as suggestions for improvement.

Gene patents and licensing: case studies prepared for the Secretary's Advisory Committee on Genetics, Health, and Society.

Researchers at the Center for Public Genomics at Duke University analyzed how patenting and licensing affect clinical access to genetic testing in the United States. The research was requested by the Secretary's Advisory Committee on Genetics, Health, and Society. Conditions studied were breast and ovarian cancers, colon cancers, Alzheimer disease, cystic fibrosis, hearing loss, hereditary hemochromatosis, long QT syndrome, spinocerebellar ataxia, Tay-Sachs disease, and Canavan disease.

Impact of gene patents and licensing practices on access to genetic testing for inherited susceptibility to cancer: comparing breast and ovarian cancers with colon cancers.

Genetic testing for inherited susceptibility to breast and ovarian cancer can be compared with similar testing for colorectal cancer as a "natural experiment." Inherited susceptibility accounts for a similar fraction of both cancers and genetic testing results guide decisions about options for prophylactic surgery in both sets of conditions. One major difference is that in the United States, Myriad Genetics is the sole provider of genetic testing, because it has sole control of relevant patents for BRCA1 and BRCA2 genes, whereas genetic testing for familial colorectal cancer is available from multiple laboratories. Colorectal cancer-associated genes are also patented, but they have been nonexclusively licensed. Prices for BRCA1 and 2 testing do not reflect an obvious price premium attributable to exclusive patent rights compared with colorectal cancer testing, and indeed, Myriad's per unit costs are somewhat lower for BRCA1/2 testing than testing for colorectal cancer susceptibility. Myriad has not enforced patents against basic research and negotiated a Memorandum of Understanding with the National Cancer Institute in 1999 for institutional BRCA testing in clinical research. The main impact of patenting and licensing in BRCA compared with colorectal cancer is the business model of genetic testing, with a sole provider for BRCA and multiple laboratories for colorectal cancer genetic testing. Myriad's sole-provider model has not worked in jurisdictions outside the United States, largely because of differences in breadth of patent protection, responses of government health services, and difficulty in patent enforcement.

Impact of gene patents and licensing practices on access to genetic testing and carrier screening for Tay-Sachs and Canavan disease.

Genetic testing for Tay-Sachs and Canavan disease is particularly important for Ashkenazi Jews, because both conditions are more frequent in that population. This comparative case study was possible because of different patenting and licensing practices. The role of DNA testing differs between Tay-Sachs and Canavan diseases. The first-line screening test for Tay-Sachs remains an enzyme activity test rather than genotyping. Genotyping is used for preimplantation diagnosis and confirmatory testing. In contrast, DNA-based testing is the basis for Canavan screening and diagnosis. The HEXA gene for Tay-Sachs was cloned at the National Institutes of Health, and the gene was patented but has not been licensed. The ASPA gene for Canavan disease was cloned and patented by Miami Children's Hospital. Miami Children's Hospital did not inform family members and patient groups that had contributed to the gene discovery that it was applying for a patent, and pursued restrictive licensing practices when a patent issued in 1997. This led to intense controversy, litigation, and a sealed, nonpublic 2003 settlement that apparently allowed for nonexclusive licensing. A survey of laboratories revealed a possible price premium for ASPA testing, with per-unit costs higher than for other genetic tests in the Secretary's Advisory Committee on Genetics, Health, and Society case studies. The main conclusion from comparing genetic testing for Tay-Sachs and Canavan diseases, however, is that patenting and licensing conducted without communication with patients and advocates cause mistrust and can lead to controversy and litigation, a negative model to contrast with the positive model of patenting and licensing for genetic testing of cystic fibrosis.

Patient note fabrication and consequences of unprofessional behavior in a high-stakes clinical skills licensing examination.

BACKGROUND: The National Board of Osteopathic Medical Examiners (NBOME) administers the Comprehensive Osteopathic Medical Licensing Examination USA Level 2-PE (COMLEX-USA Level 2-PE) and has developed a process that links the competencies of written communication and professionalism by tracking fabrication in the postencounter SOAP (Subjective, Objective, Assessment, Plan) note exercise. METHOD: A process used to identify potential SOAP note fabrication was implemented in the 2007-2008 test cycle for the COMLEX-USA Level 2-PE. RESULTS: A total of 3,753 candidates took the COMLEX-USA Level 2-PE in the 2007-2008 test cycle. Forty-eight candidates were screened, and the NBOME's Subcommittee on SOAP Note Fabrication made failure decisions on eight, leading to a failure rate of 0.2% based on fabrication review. CONCLUSIONS: The NBOME has adopted the stance that postencounter note fabrication represents unprofessional behavior. Screening for and failing candidates who exhibit unprofessional behavior enhances the validity of the examination.

Doctors with disabilities: licensed to practice?

Doctors deal with patient's disabilities every day but many in the profession have been nonplussed to see the focus of the disability rights lobbies shift from the recipients of care to the carers themselves. Until recently the number of practising doctors known to have significant disabilities was very low and for many reasons potential medical students were deterred from entering medical education. This piece would not even have been commissioned 14 years ago when the U.K. Disability Discrimination Act 1995 was passed. It is a measure of the change in society's view of disability, reinforced by law, that the issue of whether there are disabilities which, in themselves, render a doctor Unfit to practise can be analysed and discussed.

Commentary: Granting medical licensure, honoring the Americans with disabilities act, and protecting the public: can we do all three?

Physicians suffer from the same illnesses as others do, and some of these illnesses may limit their ability to safely practice medicine. Individuals with of some of these same illnesses may also suffer from denial, blinding them to their limitations. Data support that, while many of these physicians do voluntarily limit their practices or seek help, not all do. Schroeder and colleagues demonstrate in this issue that in their attempts to protect the public, state medical licensing boards may have asked questions prohibited by the Americans with Disabilities Act. They point out an ethical tension between nonmaleficence (protecting the public from harm) and individual autonomy (respecting the rights of each individual physician), amplified by the different approaches lawyers and physicians use to address conflicts. The classic legal approach is adversarial, whereas the classic medical approach is collaborative. Both are valid approaches, but neither works well in tandem with the other. The time has come for all sides of the licensure debate to acknowledge the legitimacy of the others' concerns, to recognize the different approaches they each take, and to work together with others to find a common solution. The solution must allow boards to identify individuals with illnesses that impair their ability to practice safely and that also lead to denial of these very limitations. The solution must respect the autonomy of the individual licensee with a disability who can practice safely with an accommodation and who respects the need for that accommodation. The solution must protect the public.

Legal and ethical aspects of telemedicine.

There are many issues of concern regarding the legal and ethical aspects of telemedicine. These include the responsibilities and potential liabilities of the health professional, the duty to maintain the confidentiality and privacy of patient records, and the jurisdictional problems associated with cross-border consultations. There is also the issue of reimbursement for care provided using a telemedicine service. Telemedicine allows the transmission of health information across the borders of nation states. Cross-border telemedicine services have begun, particularly in specialties such as teleradiology, but questions of jurisdiction and registration have yet to be answered definitively. While this may be true of many of the legal and ethical aspects of telemedicine generally, it is also the case that health-care professionals who undertake telemedicine in a prudent manner will minimize the possibility of medicolegal complications.

Sexual boundary violations: the conduct, the code, and the consequences.

Health services professionals agree that sexual relations between treating clinicians and their patients are harmful and should not be tolerated. Minnesota law and regulations encourage identification of offending clinicians in order to protect the public. Regulatory agencies such as the Minnesota Board of Medical Practice seek to stop licensed professionals from engaging in sexual behavior with patients and also, when feasible, to restore medical professionals to competent practice. The authors recommend individualized psychiatric assessment and therapy for physicians who violate professional standards.