Showing papers on "Informed consent published in 2020"

Explainability for artificial intelligence in healthcare: a multidisciplinary perspective.

Abstract: Explainability is one of the most heavily debated topics when it comes to the application of artificial intelligence (AI) in healthcare. Even though AI-driven systems have been shown to outperform humans in certain analytical tasks, the lack of explainability continues to spark criticism. Yet, explainability is not a purely technological issue, instead it invokes a host of medical, legal, ethical, and societal questions that require thorough exploration. This paper provides a comprehensive assessment of the role of explainability in medical AI and makes an ethical evaluation of what explainability means for the adoption of AI-driven tools into clinical practice. Taking AI-based clinical decision support systems as a case in point, we adopted a multidisciplinary approach to analyze the relevance of explainability for medical AI from the technological, legal, medical, and patient perspectives. Drawing on the findings of this conceptual analysis, we then conducted an ethical assessment using the “Principles of Biomedical Ethics” by Beauchamp and Childress (autonomy, beneficence, nonmaleficence, and justice) as an analytical framework to determine the need for explainability in medical AI. Each of the domains highlights a different set of core considerations and values that are relevant for understanding the role of explainability in clinical practice. From the technological point of view, explainability has to be considered both in terms how it can be achieved and what is beneficial from a development perspective. When looking at the legal perspective we identified informed consent, certification and approval as medical devices, and liability as core touchpoints for explainability. Both the medical and patient perspectives emphasize the importance of considering the interplay between human actors and medical AI. We conclude that omitting explainability in clinical decision support systems poses a threat to core ethical values in medicine and may have detrimental consequences for individual and public health. To ensure that medical AI lives up to its promises, there is a need to sensitize developers, healthcare professionals, and legislators to the challenges and limitations of opaque algorithms in medical AI and to foster multidisciplinary collaboration moving forward.

Principles of Clinical Ethics and Their Application to Practice.

Abstract: An overview of ethics and clinical ethics is presented in this review. The 4 main ethical principles, that is beneficence, nonmaleficence, autonomy, and justice, are defined and explained. Informed consent, truth-telling, and confidentiality spring from the principle of autonomy, and each of them is discussed. In patient care situations, not infrequently, there are conflicts between ethical principles (especially between beneficence and autonomy). A four-pronged systematic approach to ethical problem-solving and several illustrative cases of conflicts are presented. Comments following the cases highlight the ethical principles involved and clarify the resolution of these conflicts. A model for patient care, with caring as its central element, that integrates ethical aspects (intertwined with professionalism) with clinical and technical expertise desired of a physician is illustrated.

Telemedicine Practice: Review of the Current Ethical and Legal Challenges.

Abstract: Background: Telemedicine involves medical practice and information and communications technology. It has been proven to be very effective for remote health care, especially in areas with poor provision of health facilities. However, implementation of these technologies is often hampered by various issues. Among these, ethical and legal concerns are some of the more complex and diverse ones. In this study, an analysis of scientific literature was carried out to identify the ethical and legal challenges of telemedicine. Materials and Methods: English literature, published between 2010 and 2019, was searched on PubMed, Scopus, and Web of Science by using keywords, including "Telemedicine," "Ethics," "Malpractice," "Telemedicine and Ethics," "Telemedicine and Informed consent," and "telemedicine and malpractice." Different types of articles were analyzed, including research articles, review articles, and qualitative studies. The abstracts were evaluated according to the selection criteria, using the Newcastle-Ottawa Scale criteria, and the final analysis led to the inclusion of 22 articles. Discussion: From the aforementioned sample, we analyzed elements that may be indicative of the efficacy of telemedicine in an adequate time frame. Ethical aspects such as informed consent, protection data, confidentiality, physician's malpractice, and liability and telemedicine regulations were considered. Conclusions: Our objective was to highlight the current status and identify what still needs to be implemented in telemedicine with respect to ethical and legal standards. Gaps emerged between current legislation, legislators, service providers, different medical services, and most importantly patient interaction with his/her data and the use of that data.

The Declaration of Helsinki on Medical Research involving Human Subjects: A Review of Seventh Revision.

Abstract: The pinnacle of success achieved by the medical science and the benefits accrued to the patients have become possible through the medical research where human participants in the research are exposed to hazards inherent to the experiments. To protect the human subjects and to maintain high ethical standards, the World Medical Association has adopted "The Declaration of Helsinki" in 1964. After two years of consultation with the experts throughout the world, the seventh revision of the Declaration was adopted on 19th October 2013 in Brazil. The aim of this article is to review the seventh revision of the Declaration of Helsinki in relation to medical research involving human subjects and highlight the amendments made in the latest revision which are relevant to clinical research in human subjects. The latest revision has made four substantial changes on the existing Declaration, whch include dealing with the compensation of the trial-related injuries, approval of use of placebos in the clinical trials, protection of vulnerable groups and the post-trial provisions. The implications of these amendments in the clinical research are highlighted. Keywords: Consent; Declaration of Helsinki; ethics; experimental medicine; research; seventh revision.

Ethical Challenges Arising in the COVID-19 Pandemic: An Overview from the Association of Bioethics Program Directors (ABPD) Task Force.

Abstract: The COVID-19 pandemic has raised a host of ethical challenges, but key among these has been the possibility that health care systems might need to ration scarce critical care resources. Rationing policies for pandemics differ by institution, health system, and applicable law. Most seem to agree that a patient's ability to benefit from treatment and to survive are first-order considerations. However, there is debate about what clinical measures should be used to make that determination and about other factors that might be ethically appropriate to consider. In this paper, we discuss resource allocation and several related ethical challenges to the healthcare system and society, including how to define benefit, how to handle informed consent, the special needs of pediatric patients, how to engage communities in these difficult decisions, and how to mitigate concerns of discrimination and the effects of structural inequities.

Action at a Distance: Geriatric Research during a Pandemic.

Abstract: Background "Action at a distance" may be the new norm for clinical researchers in the context of the COVID-19 pandemic that may require social distancing for the next 18 months. We must minimize face-to-face contact with vulnerable populations. But we must also persist, adapt, and help our older patients and study participants during the pandemic. Methods Clinical researchers have an obligation to help, and we can. Recommendations for clinical researchers working with older adults during the COVID-19 pandemic are discussed. Results Implement technology now: Minimize face-to-face contact with participants by utilizing digital tools, such as shifting to electronic informed consent and digital HIPAA-compliant tools such as e-mailed surveys or telehealth assessments. Assess the psychological and social impact of COVID-19: How are participants coping? What health or social behaviors have changed? How are they keeping up with current events? What are they doing to stay connected to their families, friends, and communities? Are their healthcare needs being met? Current studies should be adapted immediately to these ends. Mobilize research platforms for patient needs: Leverage our relationships with participants and rapidly deploy novel clinical engagement techniques such as digital tools to intervene remotely and reduce the negative effects of social isolation on our participants. Equip research staff with tangible resources, and provide timely population-specific health information to support patients and healthcare providers. Conclusions We have an opportunity to make an impact on our older adult patients now as this pandemic continues to unfold. Above all, clinical researchers need to continue working, to help as many people as possible through the crisis. J Am Geriatr Soc 68:922-925, 2020.

Collecting Survey and Smartphone Sensor Data With an App: Opportunities and Challenges Around Privacy and Informed Consent:

Abstract: The new European General Data Protection Regulation (GDPR) imposes enhanced requirements on digital data collection. This article reports from a 2018 German nationwide population-based probability ...

Community engagement and ethical global health research.

Abstract: Community engagement is increasingly recognized as a critical element of medical research, recommended by ethicists, required by research funders and advocated in ethics guidelines. The benefits of community engagement are often stressed in instrumental terms, particularly with regard to promoting recruitment and retention in studies. Less emphasis has been placed on the value of community engagement with regard to ethical good practice, with goals often implied rather than clearly articulated. This article outlines explicitly how community engagement can contribute to ethical global health research by complementing existing established requirements such as informed consent and independent ethics review. The overarching and interlinked areas are (1) respecting individuals, communities and stakeholders; (2) building trust and social relationships; (3) determining appropriate benefits; minimizing risks, burdens and exploitation; (4) supporting the consent process; (5) understanding vulnerabilities and researcher obligations; (6) gaining permissions, approvals and building legitimacy and (7) achieving recruitment and retention targets.

InterOrganizational practice committee recommendations/guidance for teleneuropsychology (TeleNP) in response to the COVID-19 pandemic.

Abstract: Objective: The Inter Organizational Practice Committee (IOPC) convened a workgroup to provide rapid guidance about teleneuropsychology (TeleNP) in response to the COVID-19 pandemic.Method: A collaborative panel of experts from major professional organizations developed provisional guidance for neuropsychological practice during the pandemic. The stakeholders included the American Academy of Clinical Neuropsychology/American Board of Clinical Neuropsychology, the National Academy of Neuropsychology, Division 40 of the American Psychological Association, the American Board of Professional Neuropsychology, and the American Psychological Association Services, Inc. The group reviewed literature, collated federal, regional and state regulations and information from insurers, and surveyed practitioners to identify best practices.Results: Literature indicates that TeleNP may offer reliable and valid assessments, but clinicians need to consider limitations, develop new informed consent procedures, report modifications of standard procedures, and state limitations to diagnostic conclusions and recommendations. Specific limitations affect TeleNP assessments of older adults, younger children, individuals with limited access to technology, and individuals with other individual, cultural, and/or linguistic differences. TeleNP may be contraindicated or infeasible given specific patient characteristics, circumstances, and referral questions. Considerations for billing TeleNP services are offered with reservations that clinicians must verify procedures independently. Guidance about technical issues and "tips" for TeleNP procedures are provided.Conclusion: This document provides provisional guidance with links to resources and established guidelines for telepsychology. Specific recommendations extend these practices to TeleNP. These recommendations may be revised as circumstances evolve, with updates posted continuously at OPC.online.

Pragmatic Randomized Trials Without Standard Informed Consent

Abstract: Experts debate whether written informed consent from participants is ethically necessary for pragmatic trials that evaluate standard care interventions whose true comparative effectiveness is unkno...

Ethics Committee Reviews of Applications for Research Studies at 1 Hospital in China During the 2019 Novel Coronavirus Epidemic.

Abstract: This study reviews research ethics committee applications for COVID-19–related research at a Chinese hospital in February 2020 to characterize study type, approval rate and review time, reason for revision or denial, and issues with informed consent.

Interest in COVID-19 vaccine trials participation among young adults in China: Willingness, reasons for hesitancy, and demographic and psychosocial determinants.

Abstract: Background With the demand for rapid COVID-19 vaccine development and evaluation, this paper aimed to describe the prevalence and correlates of willingness to participate in COVID-19 vaccine trials among university students in China. Methods A cross-sectional survey with 1,912 Chinese university students was conducted during March and April 2020. Bivariate and multivariate analyses were performed to identify variables associated with willingness to participate. Results The majority of participants (64.01%) indicated willingness to participate in COVID-19 vaccine trials. Hesitancy over signing informed consent documents, concerns over time necessary for participating in a medical study, and perceived COVID-19 societal stigma were identified as deterrents, whereas lower socioeconomic status, female gender, perception of likely COVID-19 infection during the pandemic, and COVID-19 prosocial behaviors were facilitative factors. Further, public health mistrust and hesitancy over signing informed consent documents had a significant interactive effect on vaccine trial willingness. Conclusions High standards of ethical and scientific practice are needed in COVID-19 vaccine research, including providing potential participants full and accurate information and ensuring participation free of coercion, socioeconomic inequality, and stigma. Attending to the needs of marginalized groups and addressing psychosocial factors including stigma and public health mistrust may also be important to COVID-19 vaccine development and future uptake.

Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders' Perspectives: Systematic Review.

Abstract: Background: Informed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers. Objective: We aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research. Methods: We conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials. Results: A total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies’ populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants. Conclusions: Electronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979

Informed Consent and Medical Artificial Intelligence: What to Tell the Patient?

Abstract: Imagine you are a patient who has been diagnosed with prostate cancer. The two main approaches to treating it in the United States are active surveillance versus the surgical option of radical prostatectomy. Your physician recommends the surgical option, and spends considerable time explaining the steps in the surgery, the benefits of (among other things) eliminating the tumor and the risks of (among other things) erectile dysfunction and urinary incontinence after the surgery. What your physician does not tell you is that she has arrived at her recommendation of prostatectomy over active surveillance based on the analysis of an Artificial Intelligence (AI)/Machine Learning (ML) system, which recommended this treatment plan based on analysis of your age, tumor size, and other personal characteristics found in your electronic health record. Has the doctor secured informed consent from a legal perspective? From an ethical perspective? If the doctor actually chose to “overrule” the AI system, and the doctor fails to tell you that, has she violated your legal or ethical right to informed consent? If you were to find out that the AI/ML system was used to make recommendations on your care and no one told you, how would you feel? Well, come to think of it, do you know whether an AI/ML system was used the last time you saw a physician? This Article, part of a Symposium in the Georgetown Law Journal, is the first to examine in depth how medical AI/ML interfaces with our concept of informed consent. Part I provides a brief primer on medical Artificial Intelligence and Machine Learning. Part II sets out the core and penumbra of U.S. informed consent law and then seeks to determine to what extent AI/ML involvement in a patient’s health should be disclosed under the current doctrine. Part III examines whether the current doctrine “has it right,” examining more openly empirical and normative approaches to the question. To forefront my conclusions: while there is some play in the joints, my best reading of the existing legal doctrine is that in general, liability will not lie for failing to inform patients about the use of medical AI/ML to help formulate treatment recommendations. There are a few situations where the doctrine may be more capacious, which I try to draw out (such as when patients inquire, when the medical AI/ML is more opaque, when it is given an outsized role in the final decision-making, or when the AI/ML is used to reduce costs rather than improve patient health), though extending it even here is not certain. I also offer some thoughts on the question: if there is room in the doctrine (either via common law or legislative action), what would it be desirable for the doctrine to look like when it comes to medical AI/ML? I also briefly touch on the question of how the doctrine of informed consent should interact with concerns about biased training data for AI/ML.

Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke

Abstract: Health-care professionals and researchers have a legal and ethical responsibility to inform patients before carrying out diagnostic tests or treatment interventions as part of a clinical study. Interventional research in emergency situations can involve patients with some degree of acute cognitive impairment, as is regularly the case in traumatic brain injury and ischaemic stroke. These patients or their proxies are often unable to provide informed consent within narrow therapeutic time windows. International regulations and national laws are criticised for being inconclusive or restrictive in providing solutions. Currently accepted consent alternatives are deferred consent, exception from consent, or waiver of consent. However, these alternatives appear under-utilised despite being ethically permissible, socially acceptable, and regulatorily compliant. We anticipate that, when the requirements for medical urgency are properly balanced with legal and ethical conduct, the increased use of these alternatives has the potential to improve the efficiency and quality of future emergency interventional studies in patients with an inability to provide informed consent.

The Role of Consent in the Context of BDSM

Abstract: Consent represents a central focus in the controversial realm of BDSM-an overlapping acronym referring to the practices of Bondage and Discipline, Dominance and Submission, and Sadism and Masochism. Many authors have argued that the hallmark feature that distinguishes BDSM activity from abuse and psychopathology is the presence of mutual informed consent of all those involved. This review examines the relevant literature on consent in BDSM, including discussions on safety precautions, consent violations, North American laws pertaining to BDSM practice, and the role of the BDSM community with respect to education and etiquette surrounding consent. Practical information relevant to professionals who work toward the prevention of sexual exploitation and abuse is provided. The explicit approach to consent practiced by those in the BDSM community is proposed as a model for discussions around consent in clinical and educational contexts. Criteria for distinguishing abuse from BDSM and identifying abuse within BDSM relationships are outlined. It is our hope to demystify the consent process and add to the growing body of literature that destigmatizes consensual BDSM practices.

An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

Abstract: There is increasing international recognition that populations included in trials should adequately represent the population treated in clinical practice; however, adults who lack the capacity to provide informed consent are frequently excluded from trials. Addressing the under-representation of groups such as those with impaired capacity to consent is essential to develop effective interventions and provide these groups with the opportunity to benefit from evidence-based care. While the spotlight has been on ensuring only appropriate and justifiable exclusion criteria are used in trials, barriers to the inclusion of adults lacking capacity are multifactorial and complex, and addressing their under-representation will require more than merely widening eligibility criteria. This commentary draws on the literature exploring the inclusion of adults lacking the capacity to consent in research and a number of recent studies to describe the methodological, structural, and systemic factors that have been identified. A number of potentially modifiable factors contributing to the under-representation of adults lacking the capacity to consent in trials have been identified. In addition to restrictive eligibility criteria, methodological issues include developing appropriate interventions and outcome measures for populations with impaired capacity. Structurally determined factors include the resource-intensive nature of these trials, the requirement for more appropriate research infrastructure, and a lack of interventions to inform and support proxy decision-makers. Systemic factors include the complexities of the legal frameworks, the challenges of ethical review processes, and paternalistic attitudes towards protecting adults with incapacity from the perceived harms of research. Measures needed to address under-representation include greater scrutiny of exclusion criteria by those reviewing study proposals, providing education and training for personnel who design, conduct, and review research, ensuring greater consistency in the reviews undertaken by research ethics committees, and extending processes for advance planning to include prospectively appointing a proxy for research and documenting preferences about research participation. Negative societal and professional attitudes towards the inclusion of adults with impaired capacity in research should also be addressed, and the development of trials that are more person-centred should be encouraged. Further work to conceptualise under-representation in trials for such populations may also be helpful.

Illicit drug use while admitted to hospital: Patient and health care provider perspectives.

Abstract: BACKGROUND: Across North America, the opioid overdose epidemic is leading to increasing hospitalizations of people who use drugs (PWUD). However, hospitals are ill-prepared to meet the needs of PWUD. We focus on illicit drug use while admitted to hospital and how PWUD and health care providers describe, respond, and attempt to manage its use. METHODS AND FINDINGS: Using varied purposive methods in Toronto and Ottawa, we recruited n = 24 PWUD (who self-reported that they were living with HIV and/or HCV infection; currently or had previously used drugs or alcohol in ways that were harmful; had a hospital admission in the past five years) and n = 26 health care providers (who were: currently working in an academic hospital as a physician, nurse, social worker or other allied health professional; and 2) providing care to this patient group). All n = 50 participants completed a short, socio-demographic questionnaire and an audio-recorded semi-structured interview about receiving or providing acute care in a hospital between 04/2014 and 05/2015. Patient participants received $25 CAD and return transit fare; provider participants received a $50 CAD gift card for a bookseller. All participants provided informed consent. Audio-recordings were transcribed verbatim, corrected, and uploaded to NVivo 10. Using the seven-step framework method, transcripts were coded line-by-line and managed using NVvivo. An analytic framework was created by grouping and mapping the codes. Preliminary analyses were presented to advisory group members for comment and used to refine the interpretation. Questionnaire data were managed using SPSS version 22.0 and descriptive statistics were used to describe the participants. Many but not all patient participants spoke about using psycho-active substances not prescribed to them during a hospital admission. Attempts to avoid negative experiences (e.g., withdrawal, boredom, sadness, loneliness and/or untreated pain) were cited as reasons for illicit drug use. Most tried to conceal their illicit drug use from health care providers. Patients described how their self-reported level of pain was not always believed, tolerance to opioids was ignored, and requests for higher doses of pain medications denied. Some health care providers were unaware of on-site illicit drug use; others acknowledged it occurred. Few could identify a hospital policy specific to illicit drug use and most used their personal beliefs to guide their responses to it (e.g., ignore it, increase surveillance of patients, reprimands, loss of privileges/medications, threats of immediate discharge should it continue, and substitution dosing of medication). CONCLUSIONS: Providers highlighted gaps in institutional guidance for how they ought to appropriately respond to in-hospital substance use. Patients attempted to conceal illicit drug use in environments with no institutional policies about such use, leading to varied responses that were inconsistent with the principles of patient centred care and reflected personal beliefs about illicit drug use. There are increasing calls for implementation of harm reduction approaches and interventions in hospitals but uptake has been slow. Our study contributes to this emerging body of literature and highlights areas for future research, the development of interventions, and changes to policy and practice.

Virtual Clinical Trials: Perspectives in Dermatology.

Abstract: Background The cost of developing a new drug is approximately USD 2.6 billion, and over two-thirds of the total cost is embedded in the clinical-testing phase. Patient recruitment is the single biggest cause of clinical trial delays, and these delays can result in up to USD 8 million per day in lost revenue for pharmaceutical companies. Further, clinical trials struggle to keep participants engaged in the study and as many as 40% drop out. To overcome these challenges pharmaceutical companies and research institutions (e.g., universities) increasingly use an emerging concept: virtual clinical trials (VCT) based on a remote approach. Summary VCT (site-less) are a relatively new method of conducting a clinical trial, taking full advantage of technology (apps, monitoring devices, etc.) and inclusion of web platforms (recruitment, informed consent, counselling, measurement of endpoints, and any adverse reactions) to allow the patient to be home-based at every stage of the clinical trial. Studies have shown that VCT are not only operationally feasible, but also successful. They have higher recruitment rates, better compliance, lower drop-out rates, and are conducted faster than traditional clinical trials. The visual nature of dermatological conditions, the relative ease in evaluating skin diseases virtually, and the fact that skin diseases often are not life-threatening and rarely require complex examinations make VCT very attractive for dermatological research. Further, making correct diagnoses based on photographs and patient symptomatology has always been part of the dermatologist's routine. Thus, VCT are in many ways made for dermatology. Herein we describe VCT and their implications in dermatological research.

Replacing Paper Informed Consent with Electronic Informed Consent for Research in Academic Medical Centers: A Scoping Review

Abstract: Although experts have identified benefits to replacing paper with electronic consent (eConsent) for research, a comprehensive understanding of strategies to overcome barriers to adoption is unknown. To address this gap, we performed a scoping review of the literature describing eConsent in academic medical centers. Of 69 studies that met inclusion criteria, 81% (n=56) addressed ethical, legal, and social issues; 67% (n=46) described user interface/user experience considerations; 39% (n=27) compared electronic versus paper approaches; 33% (n=23) discussed approaches to enterprise scalability; and 25% (n=17) described changes to consent elections. Findings indicate a lack of a leading commercial eConsent vendor, as articles described a myriad of homegrown systems and extensions of vendor EHR patient portals. Opportunities appear to exist for researchers and commercial software vendors to develop eConsent approaches that address the five critical areas identified in this review.

Dynamic Consent: An Evaluation and Reporting Framework.

Abstract: Dynamic consent (DC) is an approach to consent that enables people, through an interactive digital interface, to make granular decisions about their ongoing participation. This approach has been explored within biomedical research, in fields such as biobanking and genomics, where ongoing contact is required with participants. It is posited that DC can enhance decisional autonomy and improve researcher-participant communication. Currently, there is a lack of evidence about the measurable effects of DC-based tools. This article outlines a framework for DC evaluation and reporting. The article draws upon the evidence for enhanced modes of informed consent for research as the basis for a logic model. It outlines how future evaluations of DC should be designed to maximize their quality, replicability, and relevance based on this framework. Finally, the article considers best-practice for reporting studies that assess DC, to enable future research and implementation to build upon the emerging evidence base.

The 'patient voice': patients who experience antidepressant withdrawal symptoms are often dismissed, or misdiagnosed with relapse, or a new medical condition.

Abstract: Background:Stopping antidepressants commonly causes withdrawal symptoms, which can be severe and long-lasting. National Institute for Health and Care Excellence (NICE) guidance has been recently up...

Dynamic-informed consent: A potential solution for ethical dilemmas in population sequencing initiatives.

Abstract: While the majority of population-level genome sequencing initiatives claim to follow the principles of informed consent, the requirements for informed consent have not been-well defined in this context. In fact, the implementation of informed consent differs greatly across these initiatives - spanning broad consent, blanket consent, and tiered consent among others. As such, this calls for an investigation into the requirements for consent to be “informed” in the context of population genomics. One particular strategy that claims to be fully informed and to continuously engage participants is called “dynamic consent”. Dynamic consent is based on a personalised communication platform that aims to facilitate the consent process. It is oriented to support continuous two-way communication between researchers and participants. In this paper, we analyze the requirements of informed consent in the context of population genomics, review various current implementations of dynamic consent, assess whether they fulfill the requirement of informed consent, and, in turn, enable participants to make autonomous and informed choices on whether or not to participate in research projects.

Legal and Ethical Considerations for Requiring Consent for Apnea Testing in Brain Death Determination.

Abstract: The past decade has witnessed escalating legal and ethical challenges to the diagnosis of death by neurologic criteria (DNC). The legal tactic of demanding consent for the apnea test, if successful, can halt the DNC. However, US law is currently unsettled and inconsistent in this matter. Consent has been required in several trial cases in Montana and Kansas but not in Virginia and Nevada. In this paper, we analyze and evaluate the legal and ethical bases for requiring consent before apnea testing and defend such a requirement by appealing to ethical and legal principles of informed consent and battery and the right to refuse medical treatment. We conclude by considering and rebutting two major objections to a consent requirement for apnea testing: (1) a justice-based objection to allocate scarce resources fairly and (2) a social utility objection that halting the diagnosis of brain death will reduce the number of organ donors.

Circumvention by design - dark patterns in cookie consent for online news outlets

Abstract: To ensure that users of online services understand what data are collected and how they are used in algorithmic decision-making, the European Union’s General Data Protection Regulation (GDPR) specifies informed consent as a minimal requirement. For online news outlets consent is commonly elicited through interface design elements in the form of a pop-up. We have manually analyzed 300 data collection consent notices from news outlets that are built to ensure compliance with GDPR. The analysis uncovered a variety of strategies or dark patterns that circumvent the intent of GDPR by design. We further study the presence and variety of these dark patterns in these “cookie consents” and use our observations to specify the concept of dark pattern in the context of consent elicitation.

The Italians in the Time of Coronavirus: Psychosocial Aspects of Unexpected COVID-19 Pandemic

Abstract: Background: The COVID-19 pandemic is a worldwide public health emergency, which forced the Italian Government to deliberate unprecedented actions, including quarantine, with a relevant impact on the population. The present study is the first Italian nationwide survey within the first period of the COVID-19 outbreak aimed to understand the social and psychological impact of the COVID-19 outbreak. Methods: An online survey collected information on socio-demographic data, history of direct or indirect contact with COVID-19, and other information concerning the COVID-19 emergency. The General Psychological Well-Being Index and a modified version of the PTSD Checklist for DSM-5 focused on COVID-19 experience assessed the general psychological condition of the respondents. Findings: Of 1639 respondents equally distributed in the Italian territory, 5.1% reported PTSD symptomatology, and 48.2% evidenced lower psychological well-being linked to COVID-19 diffusion. Lower psychological well-being was significantly higher in women, younger than 50 years old, and with health risk factors. Lower psychological well-being was also detected in individuals who did not know if they were infected, who have had direct exposure or were uncertain about their exposure to COVID-19, or who knew people affected.Regarding the social and behavioral consequences, respondents perceived worsening in demographic, economic, social, and relational conditions, and reported an increase in film viewing, cookhouse time, using social media, and a decrease in physical activity. Interpretation: COVID-19 pandemic appears to be a risk factor for psychological diseases in the Italian population, as previously reported in the Chinese population. About half of the respondents reported a significant psychological impact. Moreover, we confirmed the role of restraining measures that have to allow modifying lifestyles, social perception, and confidence in the institutions.These results underline the need for further studies aimed to develop psychological interventions to minimize the consequences of the COVID-19 pandemic. Funding Statement: None. Declaration of Interests: The authors declare no competing interests. Ethics Approval Statement: Expedited ethics approval was obtained from the Ethics Committee of the Department of Dynamic and Clinical Psychology of “Sapienza” University of Rome (protocol number: 0000266). The study is conformed to the principles of the Declaration of Helsinki. All respondents provided electronic informed consent before starting the investigation.