Explore the vast range of titles available.

(1) Background: To what extent is information manipulation by doctors acceptable? To answer this question, we conducted an exploratory study aimed at obtaining basic data on descriptive ethics for considering this issue. (2) Methods: A self-administered questionnaire survey was conducted on a large sample (n = 3305) of doctors. The participants were queried on (1) whether they consider that information manipulation is necessary (awareness), (2) whether they have actually manipulated information (actual state), and (3) their ethical tolerance. (3) Result: The response rate was 28.7%. Sixty percent of the doctors responded that information manipulation to avoid harm to patients is necessary (awareness), that they have actually manipulated information (actual state), and that information manipulation is ethically acceptable. (4) Conclusion: While the present survey was conducted among doctors in Japan, previous studies have reported similar findings in the United States and Europe. Based on our analysis, we hypothesize that a relationship of trust between patients and medical personnel is crucial and that information manipulation is not needed when such a relationship has been established.

It is generally accepted that ethical research requires valid informed consent and that current informed consent practice frequently fails to attain it. Interventions concerning the content and methods of communication in informed consent have met with limited success. One explanation is that they reflect an outdated and limited model of how communication functions, the transmission model of communication. This model assumes that communication is linear, is limited in time, and succeeds when the content of a message is passed from one person to another without distortion. Later communication models have challenged the limitations and inaccuracies of this model, emphasizing the continuous, contextual, and relational nature of communication. Looking beyond these assumptions behind current interventions can open multiple paths of research and intervention that have the potential to affect and improve the informed consent process in much greater ways than have been achieved previously.

Background Poor participant understanding of research information can be a problem in community interventional studies with rural African women, whose levels of illiteracy are high. This study aimed to improve the informed consent process for women living in rural eastern Uganda. We assessed the impact of alternative consent models on participants’ understanding of clinical trial information and their contribution to the informed consent process in rural Uganda. Methods The study applied a parallel mixed-methods design for a prospective comparative cohort, nested within a pilot study on the community distribution of an alcohol-based hand rub to prevent neonatal sepsis (BabyGel pilot trial). Women of at least 34 weeks’ pregnancy, suitable for inclusion in the BabyGel pilot trial, were recruited into this study from their homes in 13 villages in Mbale District. As part of the informed consent process, information about the trial was presented using one of three consent methods: standard researcher-read information, a slide show using illustrated text on a flip chart or a video showing the patient information being read as if by a newsreader in either English or the local language. In addition, all women received the patient information sheet in their preferred language. Each information-giving method was used in recruitment for 1 week. Two days after recruitment, women’s understanding of the clinical trial was evaluated using the modified Quality of Informed Consent (QuIC) tool. They were also shown the other two methods and their preference assessed using a 5-point Likert scale. Semi-structured interviews were administered to each participant. The interviews were audio-recorded, transcribed and translated verbatim, and thematically analysed. Results A total of 30 pregnant women in their homes participated in this study. Their recall of the trial information within the planned 48 h was assessed for the majority (90%, 27/30). For all three consent models, women demonstrated a high understanding of the study. There was no statistically significant difference between the slide-show message (mean 4.7; standard deviation, SD 0.47; range 4–5), video message (mean 4.9; SD 0.33; range 4–5) and standard method (mean 4.5; SD 0.53; range 4–5; all one-way ANOVA, p  = 0.190). The slide-show message resulted in the most objective understanding of question items with the highest average QuIC score of 100 points. For women who had been recruited using any of the three models, the slide show was the most popular method, with a mean score for all items of not less than 4.2 (mean 4.8; SD 0.6; range 4–5). Most women (63%, 19/30) preferred the slide-show message, compared with 17% (5/30) and 20% (6/30) for the standard and video messages, respectively. The reasons given included the benefits of having pictures to aid understanding and the logical progression of the information. Conclusion Our results from this small study suggest that slide-show messages may be an effective and popular alternative way of presenting trial information to women in rural Uganda, many of whom have little or no literacy. Trial registration ISRCTN, ISRCTN67852437 . Registered on 18 March 2018.

Using genetic tests on deceased patients’ samples for diagnostic purposes affects the family members' health and lives but raises some ethical issues in today’s practice of medicine and research. In this paper, we address a common ethical dilemma of clinicians regarding whether to perform genetic tests on a deceased patient’s sample upon a request from first-degree relatives against the patient's wishes in the last days of life. In this paper, a real case scenario is presented that echoes the above- mentioned ethical challenge. Reviewing the genetic basis of the case, the ethical arguments for and against the reuse of genetic material in a clinical context are discussed. An ethico-legal analysis of the case is proposed based on Islamic medical ethics resources. As reusing stored samples of expired patients without their consent also challenges the researchers in the field of genetics, a debate is included on the post-mortem use of genetic data and samples for research. Finally, defining the special features of the presented case and positive benefit-risk ratio, it is concluded that reusing the patient's sample may be justified if the first-degree family members insist on genetic testing and are comprehensively informed about the benefits and harms.

This chapter introduces basic concepts related to Internet of Things (IoT) data privacy, and discusses the approaches to IoT data privacy. It then describes the Privacy Preference Manager (PPM), which is an IoT data platform component that can provide data privacy by registering users’ consent and privacy preferences, providing a way to modify or update them, providing rules for data flow according to users’ preferences, and recording all transactions. Next, the chapter discusses how the emergence of IoT is impacting data privacy, and describes some existing approaches to address both online‐ and IoT‐related privacy. It further provides information on a generalized personal data handling architecture for IoT that fulfills the requirements identified along with a description of how this has been realized by the oneM2M IoT platform standard and in particular its PPM component.

Within the context of health and insurance law, an important question that arises is “to what extent is an applicant for private insurance truly capable of giving his/her ‘free’ and informed consent for a medical examination?”. It should be borne in mind that it is the private insurer who requires a medical examination in order to gather medical information, and, moreover, that the insurer will not be inclined to conclude or carry out an insurance contract without this medical information. A distinction has to be made between not being free by legal coercion and not being (completely) free by factual circumstances. Exercising the right to informed consent involves exactly weighing up the consequences of the decision. Hence the applicant must be put in a position of being able to weigh up the consequences and take them into consideration.

This chapter contains sections titled: The Moral Foundation The Legal Requirement for Consent in Therapeutic Settings The Exceptions References

In Europe, within the scope of the General Data Protection Regulation, more and more digital infrastructures are created to allow for large-scale access to patients' health data and their use for research. When the research is performed on the basis of patient consent, traditional study-specific consent appears too cumbersome for many researchers. Alternative models of consent are currently being discussed and introduced in different contexts. This study explores stakeholder perspectives on ethical, legal, and practical concerns regarding models of consent for health data research at German university medical centers. Semistructured focus group interviews were conducted with medical researchers at German university medical centers, health IT specialists, data protection officers, and patient representatives. The interviews were analyzed using a software-supported structuring qualitative content analysis. Stakeholders regarded broad consent to be only marginally less laborious to implement and manage than tiered consent. Patient representatives favored specific consent, with tiered consent as a possible alternative. All stakeholders lamented that information material was difficult to understand. Oral information and videos were mentioned as a means of improvement. Patient representatives doubted that researchers had a sufficient degree of data security expertise to act as sole information providers. They were afraid of undue pressure if obtaining health data research consent were part of medical appointments. IT specialists and other stakeholders regarded the withdrawal of consent to be a major challenge and called for digital consent management solutions. On the one hand, the transfer of health data to non-European countries and for-profit organizations is seen as a necessity for research. On the other hand, there are data security concerns with regard to these actors. Research without consent is legally possible under certain conditions but deemed problematic by all stakeholder groups, albeit for differing reasons and to different degrees. More efforts should be made to determine which options of choice should be included in health data research consent. Digital tools could improve patient information and facilitate consent management. A unified and strict regulation for research without consent is required at the national and European Union level. Obtaining consent for health data research should be independent of medical appointments, and additional personnel should be trained in data security to provide information on health data research.

Biomedical research is being transformed through the application of information technologies that allow ever greater amounts of data to be shared on an unprecedented scale. However, the methods for involving participants have not kept pace with changes in research capability. In an era when information is shared digitally at the global level, mechanisms of informed consent remain static, paper-based and organised around national boundaries and legal frameworks. Dynamic consent (DC) is both a specific project and a wider concept that offers a new approach to consent; one designed to meet the needs of the twenty-first century research landscape. At the heart of DC is a personalised, digital communication interface that connects researchers and participants, placing participants at the heart of decision making. The interface facilitates two-way communication to stimulate a more engaged, informed and scientifically literate participant population where individuals can tailor and manage their own consent preferences. The technical architecture of DC includes components that can securely encrypt sensitive data and allow participant consent preferences to travel with their data and samples when they are shared with third parties. In addition to improving transparency and public trust, this system benefits researchers by streamlining recruitment and enabling more efficient participant recontact. DC has mainly been developed in biobanking contexts, but it also has potential application in other domains for a variety of purposes.

Collaborative networks and data sharing initiatives are broadening the opportunities for the advancement of science. These initiatives offer greater transparency in science, with the opportunity for external research groups to reproduce, replicate, and extend research findings. Further, larger datasets offer the opportunity to identify homogeneous patterns within subgroups of individuals, where these patterns may be obscured by the heterogeneity of the neurobiological measure in smaller samples. However, data sharing and data pooling initiatives are not without their challenges, especially with new laws that may at first glance appear quite restrictive for open science initiatives. Interestingly, what is key to some of these new laws (i.e, the European Union's general data protection regulation) is that they provide greater control of data to those who “give” their data for research purposes. Thus, the most important element in data sharing is allowing the participants to make informed decisions about how they want their data to be used, and, within the law of the specific country, to follow the participants' wishes. This framework encompasses obtaining thorough informed consent and allowing the participant to determine the extent that they want their data shared, many of the ethical and legal obstacles are reduced to just monsters under the bed. In this manuscript we discuss the many options and obstacles for data sharing, from fully open, to federated learning, to fully closed. Importantly, we highlight the intersection of data sharing, privacy, and data ownership and highlight specific examples that we believe are informative to the neuroimaging community. Collaborative networks and data sharing initiatives are broadening the opportunities for the advancement of science. However, data sharing initiatives are not without their challenges, especially with new laws that may at first glance appear quite restrictive for open science initiatives. This article discusses the opportunities, challenges, benefits for sharing neuroimaging data, including the missed opportunities in not providing participants greater say in opportunities for data sharing initiatives.