Alice considered [the idea of un-birthday presents] a little. “I llke birthday presents best,” she said at last.“You don’t know what you’re talking about!” cried Humpty Dumpty. … “[There are three hundred and sixty-four days when you might get un-birthday presents… And only one for birthday presents, you know. There’s a ‘glory’ for you!”“I don’t know what you mean by ‘glory,’” Alice said.Humpty Dumpty smiled contemptuously. “Of course you don’t—till I tell you. I meant ‘there’s a nice knock-down argument for (...) you!’”“But ‘glory’ doesn’t mean ‘a nice knock-down argument,’” Alice objected.“When I use a word,” Humpty Dumpty said in a rather scornful tone, “it means just what I choose it to mean—neither more nor less.”. (shrink)

The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary – whether on grounds of primary purpose, temporality, underlying (...) legal authority, departure from usual practice, or direct benefits to participants – have been unsatisfactory. (shrink)

Alice considered [the idea of un-birthday presents] a little. “I llke birthday presents best,” she said at last.“You don’t know what you’re talking about!” cried Humpty Dumpty. … “[There are three hundred and sixty-four days when you might get un-birthday presents… And only one for birthday presents, you know. There’s a ‘glory’ for you!”“I don’t know what you mean by ‘glory,’” Alice said.Humpty Dumpty smiled contemptuously. “Of course you don’t—till I tell you. I meant ‘there’s a nice knock-down argument for (...) you!’”“But ‘glory’ doesn’t mean ‘a nice knock-down argument,’” Alice objected.“When I use a word,” Humpty Dumpty said in a rather scornful tone, “it means just what I choose it to mean—neither more nor less.”. (shrink)

Epidemiological studies usually do not pose high risk to participants. At the same time they provide valuable knowledge and improve public and individual health. In many countries, studies involving human subjects are subject to ethics review. Research shows that the process of obtaining ethical approval from institutional research boards or research ethics committees is sometimes costly, time-consuming and seriously delays important research projects. In this article we consider arguments against and in favor of ethics review of epidemiological studies. On the (...) one hand, it seems that minimal risk epidemiological studies should not be a subject to ethics review, since any delay of an important study has its death toll and health costs. In this perspective, the calculus of costs and benefits supports rejecting the whole existing approach. Nevertheless, we argue that institutional research boards or ethics research committees protect research participants from wrongs and up till now are the best tools of social and political control over the research enterprise. (shrink)

BackgroundCare.data was a programme of work led by NHS England for the extraction of patient-identifiable and coded information from general practitioner records for secondary uses. This study analyses the forms which enabled patients to opt out.MethodsTheoretical sampling and summative content analysis were used to collect and analyse dissent forms used by patients to opt out from care.data. Domains included basic information about the programme, types of objections and personal details required for identification purposes.ResultsOne hundred opt-out forms were analysed. Fifty-four forms (...) mentioned that this programme was run by NHS England. 81 forms provided two types of objections to data-sharing, and 15 provided only one objection. Only 26 forms mentioned that direct care would not be affected and 32 that patients maintain their right to opt back anytime. All but one of the opt-out forms we reviewed requested the name of the person wishing to opt out. 94 required a date of birth and 33 an NHS number. 82 required an address, 42 a telephone number and 7 an email address.ConclusionsNumbers of patients opting out should be treated with caution, because the variability of information provided and the varied options for dissent may have caused confusion among patients. To ensure that dissent is in accordance with individual preferences and moral values, we recommend that well-designed information material and standardised opt-out forms be developed for such data-sharing initiatives. (shrink)

: The "difference position" holds that clinical research and therapeutic medical practice are sufficiently distinct activities to require different ethical rules and principles. The "similarity position" holds instead that clinical investigators ought to be bound by the same fundamental principles that govern therapeutic medicine—specifically, a duty to provide the optimal therapeutic benefit to each patient or subject. Some defenders of the similarity position defend it because of the overlap between the role of attending physician and the role of investigator in (...) a research trial. This overlap is maximal when the same physician occupies both roles with respect to a particular patient-subject. We address the ethical tensions inherent in that role conflict and argue that the tensions are real but manageable. The difference position provides a sound ethical framework within which to manage those tensions, while the similarity position is unsatisfactory because it seeks to deny the existence of the tensions. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Public health is a dynamic field. Outbreaks of new diseases, as well as changing patterns of population growth, economic development, and lifestyle trends all may threaten public health and thus demand a public health response. As the practice of public health evolves, there is an ongoing need to reassess its scientific, ethical, legal, and social underpinnings. Such a reappraisal must consider the disagreement among public health officials, public health scholars, elected officials, and the public about the proper role of public (...) health and the distinctions, for example, between public health and clinical care, and public health and health promotion.In this article I will attempt to characterize the main points of contention as well as offer my own views regarding the proper scope of public health. Greater clarity and consensus on the meaning of public health are likely to lead to more efficient and effective public health interventions as well as increased public and political support for public health activities. (shrink)

We analyse the system of ethical review of human research in the Baltic States by introducing the principle of equivalent stringency of ethical review, that is, research projects imposing equal risks and inconveniences on research participants should be subjected to equally stringent review procedures. We examine several examples of non-equivalence or asymmetry in the system of ethical review of human research: (1) the asymmetry between rather strict regulations of clinical drug trials and relatively weaker regulations of other types of clinical (...) biomedical research and (2) gaps in ethical review in the area of non-biomedical human research where some sensitive research projects are not reviewed by research ethics committees at all. We conclude that non-equivalent stringency of ethical review is at least partly linked to the differences in scope and binding character of various international legal instruments that have been shaping the system of ethical review in the Baltic States. Therefore, the Baltic example could also serve as an object lesson to other European countries which might be experiencing similar problems. (shrink)