The social licence for data-intensive health research: towards co-creation, public value and trust

BACKGROUND: The rise of Big Data-driven health research challenges the assumed contribution of medical research to the public good, raising questions about whether the status of such research as a common good should be taken for granted, and how public trust can be preserved. Scandals arising out of sharing data during medical research have pointed out that going beyond the requirements of law may be necessary for sustaining trust in data-intensive health research. We propose building upon the use of a social licence for achieving such ethical governance. MAIN TEXT: We performed a narrative review of the social licence as presented in the biomedical literature. We used a systematic search and selection process, followed by a critical conceptual analysis. The systematic search resulted in nine publications. Our conceptual analysis aims to clarify how societal permission can be granted to health research projects which rely upon the reuse and/or linkage of health data. These activities may be morally demanding. For these types of activities, a moral legitimation, beyond the limits of law, may need to be sought in order to preserve trust. Our analysis indicates that a social licence encourages us to recognise a broad range of stakeholder interests and perspectives in data-intensive health research. This is especially true for patients contributing data. Incorporating such a practice paves the way towards an ethical governance, based upon trust. Public engagement that involves patients from the start is called for to strengthen this social licence. CONCLUSIONS: There are several merits to using the concept of social licence as a guideline for ethical governance. Firstly, it fits the novel scale of data-related risks; secondly, it focuses attention on trustworthiness; and finally, it offers co-creation as a way forward. Greater trust can be achieved in the governance of data-intensive health research by highlighting strategic dialogue with both patients contributing the data, and the public in general. This should ultimately contribute to a more ethical practice of governance

What do international ethics guidelines say in terms of the scope of medical research ethics?

BACKGROUND: In research ethics, the most basic question would always be, "which is an ethical issue, which is not?" Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus (or lack thereof). In this manuscript, we attempted to do just that. METHODS: We extracted the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative. RESULTS: We found that there is no consensus on the majority of the imperatives and that in only 8.2% of the imperatives were there at least moderate consensus (i.e., consensus of at least 3 of the 5 ethics guidelines). Of the 12 clusters (Basic Principles; Research Collaboration; Social Value; Scientific Validity; Participant Selection; Favorable Benefit/Risk Ratio; Independent Review; Informed Consent; Respect for Participants; Publication and Registration; Regulatory Sanctions; and Justified Research on the Vulnerable Population), Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least. CONCLUSION: There was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences

Нарушение репродуктивной функции при простатите/синдроме хронической тазовой боли

Показано, что нелеченное хроническое воспаление предстательной железы приводит к нарушению показателей спермограммы и в ряде случаев к бесплодию при нормальном развитии половых желез и достаточном гормональном обеспечении организма. Бактерии, вирусы, лейкоциты, свободные радикалы, цитокины, иммунологические изменения и обструкция семявыводящих путей при простате являются кофакторами в развитии бесплодия.It is shown that untreated chronic inflammation of the prostate gland causes disturbances of spermogram count and strility in a number of cases at normal development of sex glands and sufficient hormone supply of the organism. Bacteria, viruses, leukocytes, free radicals, cytokines, immunological changes and obstruction of the deferent ducts in prostatitis are co−factors of sterility development

End-of-Life Decision-Making in Canada: The Report by the Royal Society of Canada Expert Panel on End-of-Life Decision-Making

This report on end-of-life decision-making in Canada was produced by an international expert panel and commissioned by the Royal Society of Canada. It consists of five chapters

Визначення вальпроєвої кислоти у крові методом реакційної високоефективної рідинної хроматографії

Здійснена взаємодія вальпроєвої кислоти з 3-(2'-бромацетил)-7-метоксикумарином і розроблено її визначення у крові методом реакційної високоефективної рідинної хроматографії. Вивчений вплив різних методів депротоїнізації на вивільнення вальпроєвої кислоти та оптимізовані умови пробопідготовки.Осуществлено взаимодействие вальпроевой кислоты с 3-(2'-бромацетил)-7-метоксикумарином и разработано ее определение в крови методом реакционной высокоэффективной жидкостной хроматографии. Изучено влияние различных методов депротеинизации на выходы вальпроевой кислоты и оптимизированы условия пробоподготовки.The interaction of the valproic acid with 3-(2'-bromoacetyl)-7-methoxicoumarin has been carried out and its determination in blood by the reaction high performance liquid chromatography method has been developed. The influence of various methods of deproteinization on the yields of the valproic acid has been studied and the conditions of the sample preparing has been optimized

Комбинированные гестаген/эстрогенные препараты в лечении гиперандрогении

Рассмотрены биохимические механизмы действия гестаген/эстрогенных препаратов при лечении синдрома гиперандрогении. Описаны преимущества комбинации дроспиренона с этинидэстрадиолом для лечения акне, себореи и гирсутизма у женщин, одновременно нуждающихся в контрацепции.The biochemical mechanisms of action of gestagen/estrogen drugs in treatment for syndrome of hyperandrogeny are featured. The advantages of Drospirenon and Etinidestradiol combination in treatment of acne, seborrhea and hirsutism in women simultaneously requiring contraception are described

Commentary: Can an effective end-of-life intervention for advanced dementia be viewed as moral?

We comment on Dr. Terman's considerations on the moral justification of ceasing assisted feeding and hydration for people with advanced dementia. The core idea of his paper is that an advance directive can solve future dilemmas regarding assisted feeding. We submit that this static instrument is unfit for the complex and dynamic nature of assessing how to deal with refusals to eat, in particular for people with dementia. It overvalues the past in relation to the present situation and leaves no room for the possibility of changing wishes. Moreover, the perspectives of professional caregivers and families are not addressed because the focus is entirely on individual autonomy in early dementia. Multiple perspectives should be considered in interpreting directives and the actual situation in light of the patient's view of life in order to realistically account for what is morally justifiable in care in advanced dementia

Barriers and facilitators for healthcare professionals to the implementation of Multidisciplinary Timely Undertaken Advance Care Planning conversations at the outpatient clinic (the MUTUAL intervention): a sequential exploratory mixed-methods study

BACKGROUND: Advance Care Planning (ACP) enables patients to define and discuss their goals and preferences for future medical treatment and care. However, the structural implementation of ACP interventions remains challenging. The Multidisciplinary Timely Undertaken Advance Care Planning (MUTUAL) intervention has recently been developed which takes into account existing barriers and facilitators. We aimed to evaluate the MUTUAL intervention and identify the barriers and facilitators healthcare professionals experience in the implementation of the MUTUAL intervention and also to identify suggestions for improvement. METHODS: We performed a sequential exploratory mixed-methods study at five outpatient clinics of one, 300-bed, non-academic hospital. Firstly, semi-structured interviews were performed with a purposive sample of healthcare professionals. The content of these interviews was used to specify the Measurement Instrument for Determinants of Innovations (MIDI). The MIDI was sent to all healthcare professionals. The interviews and questionnaires were used to clarify the results. RESULTS: Eleven healthcare professionals participated in the interviews and 37 responded to the questionnaire. Eight barriers and 20 facilitators were identified. Healthcare professionals agreed that the elements of the MUTUAL intervention are clear, correct, complete, and simple - and the intervention is relevant for patients and their proxies. The main barriers are found within the user and the organisational domain. Barriers related to the organisation include: inadequate replacement of staff, insufficient staff, and insufficient time to introduce and invite patients. Several suggestions for improvement were made. CONCLUSION: Our results show that healthcare professionals positively evaluate the MUTUAL intervention and are very receptive to implementing the MUTUAL intervention. Taking into account the suggestions for improvement may enhance further implementation