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In most U.S. jurisdictions, clinicians providing informal “curbside” consults are protected from medical malpractice liability due to the absence of a doctor-patient relationship. A recent Minnesota Supreme Court case, Warren v. Dinter, offers the opportunity to reassess whether the majority rule is truly serving the best interests of patients.
The random]ized clinical trial is widely accepted as the optimal approach to evaluating the safety and efficacy of medical treatments. Resistance to randomized treatment assignment arises regularly, most commonly in situations where the disease is life-threatening and treatments are either unavailable or unsatisfactory. Historical control designs, in which all participants receive the experimental treatment with results compared to a prior cohort, are advocated by some as more ethical in such circumstances; however, such studies are often highly biased in favor of the new treatment and frequently yield misleading results. Alternative controlled designs motivated by the desire to maximize the number of patients with the treatment ultimately determined to be superior have been proposed, but have been challenged on both methodological and ethical grounds. Debates about appropriate and ethical study designs recurred during the recent Ebola Virus Disease (EVD) epidemic in West Africa. Despite its devastating nature, the EVD epidemic showed the ongoing necessity of conducting randomized trials to obtain convincing evidence of the safety and efficacy of therapeutic interventions.
Consulting relationships between medical school faculty and the biopharmaceutical and medical device industries offer the potential to advance research and promote the translation of academic discoveries into technologies that can benefit the health of individuals and populations. Such relationships are common, and studies suggest that faculty with industry relationships are more productive than their peers without such relationships. These benefits notwithstanding, numerous academic studies, government hearings, and litigation have called attention to the potential risks associated with these relationships.
Consulting includes a broad range of activities in which a faculty member provides advice or services to a company related to his/her area of professional expertise, typically in exchange for payment. Many universities permit faculty members to devote a portion of their faculty time to consulting (e.g., one business day per week), and faculty members are typically paid directly by the company, rather than through the university.
Large-scale sequencing tests, including whole-exome and whole-genome sequencing (WES/WGS), are rapidly moving into clinical use. Sequencing is already being used clinically to identify therapeutic opportunities for cancer patients who have run out of conventional treatment options, to help diagnose children with puzzling neurodevelopmental conditions, and to clarify appropriate drug choices and dosing in individuals. To evaluate and support clinical applications of these technologies, the National Human Genome Research Institute (NHGRI) and National Cancer Institute (NCI) have funded studies on clinical and research sequencing under the Clinical Sequencing Exploratory Research (CSER) program as well as studies on return of results (RoR). Most of these studies use sequencing in real-world clinical settings and collect data on both the application of sequencing and the impact of receiving genomic findings on study participants. They are occurring in the context of controversy over how to obtain consent for exome and genome sequencing.
Public disclosure of industry payments to physicians is one way to address financial conflicts of interest in medicine. As part of the Patient Protection and Affordable Care Act, the Physician Payment Sunshine Act (PPSA) requires pharmaceutical, medical device, and biologics manufacturers who have at least one product reimbursed by Medicare or Medicaid to disclose payments to physicians and teaching hospitals on a public website starting in 2014. The physician payment data will contain individual physician names, monetary values, and specific products connected to payments.
According to the Final Regulations issued by the Centers for Medicare and Medicaid Services (CMS) in February 2013, the law will make transparent the extent and nature of relationships between physicians, teaching hospitals, and manufacturers.
Over the past 40 years, a complex review and oversight system has grown within the United States and internationally to regulate the conduct of human subjects research. This system developed in response to revelations of abuses of human subjects in experiments such as those conducted in the Nazi concentration camps, the Tuskegee Study of Untreated Syphilis in the Negro Male, the Willowbrook Hepatitis Studies, and the studies described by Beecher in his 1966 article in the New England Journal of Medicine. The oversight system is based on a foundation, first implemented by the U.S. Public Health Service (PHS) in 1966 and by the U.S. Food and Drug Administration in 1971, of prior review and approval of a written experimental protocol by an independent committee. The World Medical Association articulated the ethical centrality of independent review in its 1975 revision of the Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research endorsed the requirement in its flagship Belmont Report.
A physician-investigator conducting brain imaging research to study the pathophysiology of depression detects a suspicious finding in a healthy volunteer that suggests a possible brain tumor. Must the investigator disclose this finding to the research subject? Further, is there a duty to ensure that brain scans performed to answer research questions are evaluated clinically to identify potential health problems? If so, what in the nature of the investigator-subject relationship gives rise to such an obligation?
Investigators and Institutional Review Boards (IRBs) commonly struggle with the question of how to address incidental findings — that is, “a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of the study.” A working group convened by the National Institutes of Health has recommended that brain imaging research studies should establish protocols for handling incidental findings. However, there is little ethical guidance available to steer such efforts, and practices appear to vary widely. Although several articles have catalogued the ethical dilemmas surrounding incidental findings, with the exception of seminal work by Henry Richardson and Leah Belsky on the more general topic of researchers’ obligations to provide ancillary clinical care to research subjects, systematic ethical analysis of the incidental findings problem is lacking.
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