When Parents Request Nondisclosure: Rights of Adolescents to Access Their Health Information and Implications of the 21st Century Cures Act Final Rule.

AbstractDespite broad ethical consensus supporting developmentally appropriate disclosure of health information to older children and adolescents, cases in which parents and caregivers request nondisclosure continue to pose moral dilemmas for clinicians. State laws vary considerably regarding adolescents' rights to autonomy, privacy, and confidentiality, with many states not specifically addressing adolescents' right to their own healthcare information. The requirements of the 21st Century Cures Act have raised important ethical concerns for pediatricians and adolescent healthcare professionals regarding the protection of adolescent privacy and confidentiality, given requirements that chart notes and results be made readily available to patients via electronic portals. Less addressed have been the implications of the act for adolescents' access to their health information, since many healthcare systems' electronic portals are available to patients beginning at age 12, sometimes requiring that the patients themselves authorize their parents' access to the same information. In this article, we present a challenging case of protracted disagreement about an adolescent's right to honest information regarding his devastating prognosis. We then review the legal framework governing adolescents' rights to their own healthcare information, the limitations of ethics consultation to resolve such disputes, and the potential for the Cures Act's impact on electronic medical record systems to provide one form of resolution. We conclude that although parents in cases like the one presented here have the legal right to consent to medical treatment on their children's behalf, they do not have a corresponding right to direct the withholding of medical information from the patient.

Open notebook science can maximize impact for rare disease projects.

Transparency lies at the heart of the open lab notebook movement. Open notebook scientists publish laboratory experiments and findings in the public domain in real time, without restrictions or omissions. Research on rare diseases is especially amenable to the open notebook model because it can both increase scientific impact and serve as a mechanism to engage patient groups in the scientific process. Here, I outline and describe my own success with my open notebook project, LabScribbles, as well as other efforts included in the openlabnotebooks.org initiative.

International primate neuroscience research regulation, public engagement and transparency opportunities.

Scientific excellence is a necessity for progress in biomedical research. As research becomes ever more international, establishing international collaborations will be key to advancing our scientific knowledge. Understanding the similarities in standards applied by different nations to animal research, and where the differences might lie, is crucial. Cultural differences and societal values will also contribute to these similarities and differences between countries and continents. Our overview is not comprehensive for all species, but rather focuses on non-human primate (NHP) research, involving New World marmosets and Old World macaques, conducted in countries where NHPs are involved in neuroimaging research. Here, an overview of the ethics and regulations is provided to help assess welfare standards amongst primate research institutions. A comparative examination of these standards was conducted to provide a basis for establishing a common set of standards for animal welfare. These criteria may serve to develop international guidelines, which can be managed by an International Animal Welfare and Use Committee (IAWUC). Internationally, scientists have a moral responsibility to ensure excellent care and welfare of their animals, which in turn, influences the quality of their research. When working with animal models, maintaining a high quality of care ("culture of care") and welfare is essential. The transparent promotion of this level of care and welfare, along with the results of the research and its impact, may reduce public concerns associated with animal experiments in neuroscience research.

Reproducible research practices, transparency, and open access data in the biomedical literature, 2015-2017.

Currently, there is a growing interest in ensuring the transparency and reproducibility of the published scientific literature. According to a previous evaluation of 441 biomedical journals articles published in 2000-2014, the biomedical literature largely lacked transparency in important dimensions. Here, we surveyed a random sample of 149 biomedical articles published between 2015 and 2017 and determined the proportion reporting sources of public and/or private funding and conflicts of interests, sharing protocols and raw data, and undergoing rigorous independent replication and reproducibility checks. We also investigated what can be learned about reproducibility and transparency indicators from open access data provided on PubMed. The majority of the 149 studies disclosed some information regarding funding (103, 69.1% [95% confidence interval, 61.0% to 76.3%]) or conflicts of interest (97, 65.1% [56.8% to 72.6%]). Among the 104 articles with empirical data in which protocols or data sharing would be pertinent, 19 (18.3% [11.6% to 27.3%]) discussed publicly available data; only one (1.0% [0.1% to 6.0%]) included a link to a full study protocol. Among the 97 articles in which replication in studies with different data would be pertinent, there were five replication efforts (5.2% [1.9% to 12.2%]). Although clinical trial identification numbers and funding details were often provided on PubMed, only two of the articles without a full text article in PubMed Central that discussed publicly available data at the full text level also contained information related to data sharing on PubMed; none had a conflicts of interest statement on PubMed. Our evaluation suggests that although there have been improvements over the last few years in certain key indicators of reproducibility and transparency, opportunities exist to improve reproducible research practices across the biomedical literature and to make features related to reproducibility more readily visible in PubMed.

A systematic review of patient access to medical records in the acute setting: practicalities, perspectives and ethical consequences.

BACKGROUND: Internationally, patient access to notes is increasing. This has been driven by respect for patient autonomy, often recognised as a primary tenet of medical ethics: patients should be able to access their records to be fully engaged with their care. While research has been conducted on the impact of patient access to outpatient and primary care records and to patient portals, there is no such review looking at access to hospital medical records in real time, nor an ethical analysis of the issues involved in such a change in process. METHODS: This study employed a systematic review framework in two stems, to integrate literature identified from two searches: Medline, CINAHL and Scopus databases were conducted, (for (1) hospitalised patients, patient access to records and its effects on communication and trust within the doctor-patient relationship; and (2) patient access to medical records and the ethical implications identified). The qualitative and quantitative results of both searches were integrated and critically analysed. RESULTS: 3954 empirical and 4929 ethical studies were identified; 18 papers representing 16 studies were identified for review (12 empirical and 6 ethical). The review reveals a consensus that our current approach to giving information to patients - almost exclusively verbally - is insufficient; that patient access to notes is a welcome next step for patient-centred care, but that simply allowing full access, without explanation or summary, is also insufficient. Several ethical implications need to be considered: increased information could improve patient trust and knowledge but might transfer an (unwelcome) sense of responsibility to patients; doctors and patients have conflicting views on how much information should be shared and when; sharing written information might increase the already significant disparity in access to health care, and have unforeseen opportunity costs. The impact on medical practice of sharing notes in real time will also need to be evaluated. CONCLUSIONS: The review presents encouraging data to support patient access to medical notes. However, sharing information is a critical part of clinical practice; changing how it is done could have significant empirical and ethical impacts; any changes should be carefully evaluated.

Data Access Committees.

BACKGROUND: Sharing de-identified individual-level health research data is widely promoted and has many potential benefits. However there are also some potential harms, such as misuse of data and breach of participant confidentiality. One way to promote the benefits of sharing while ameliorating its potential harms is through the adoption of a managed access approach where data requests are channeled through a Data Access Committee (DAC), rather than making data openly available without restrictions. A DAC, whether a formal or informal group of individuals, has the responsibility of reviewing and assessing data access requests. Many individual groups, consortiums, institutional and independent DACs have been established but there is currently no widely accepted framework for their organization and function. MAIN TEXT: We propose that DACs, should have the role of both promotion of data sharing and protection of data subjects, their communities, data producers, their institutions and the scientific enterprise. We suggest that data access should be granted by DACs as long as the data reuse has potential social value and provided there is low risk of foreseeable harms. To promote data sharing and to motivate data producers, DACs should encourage secondary uses that are consistent with the interests of data producers and their own institutions. Given the suggested roles of DACs, there should be transparent, simple and clear application procedures for data access. The approach to review of applications should be proportionate to the potential risks involved. DACs should be established within institutional and legal frameworks with clear lines of accountability, terms of reference and membership. We suggest that DACs should not be modelled after research ethics committees (RECs) because their functions and goals of review are different from those of RECs. DAC reviews should be guided by the principles of public health ethics instead of research ethics. CONCLUSIONS: In this paper we have suggested a framework under which DACs should operate, how they should be organised, and how to constitute them.

Barriers to Working With National Health Service England's Open Data.

Open data is information made freely available to third parties in structured formats without restrictive licensing conditions, permitting commercial and noncommercial organizations to innovate. In the context of National Health Service (NHS) data, this is intended to improve patient outcomes and efficiency. EBM DataLab is a research group with a focus on online tools which turn our research findings into actionable monthly outputs. We regularly import and process more than 15 different NHS open datasets to deliver OpenPrescribing.net, one of the most high-impact use cases for NHS England's open data, with over 15,000 unique users each month. In this paper, we have described the many breaches of best practices around NHS open data that we have encountered. Examples include datasets that repeatedly change location without warning or forwarding; datasets that are needlessly behind a "CAPTCHA" and so cannot be automatically downloaded; longitudinal datasets that change their structure without warning or documentation; near-duplicate datasets with unexplained differences; datasets that are impossible to locate, and thus may or may not exist; poor or absent documentation; and withholding of data for dubious reasons. We propose new open ways of working that will support better analytics for all users of the NHS. These include better curation, better documentation, and systems for better dialogue with technical teams.

Information Access and Use by Patients With Cancer and Their Friends and Family: Development of a Grounded Theory.

BACKGROUND: Information has been identified as a commonly unmet supportive care need for those living with cancer (ie, patients and their friends and family). The information needed to help individuals plan their lives around the consequences of cancer, such as the receipt of health care, is an example of an important informational need. A suitable theory to guide the development of interventions designed to meet this informational need has not been identified by the authors. OBJECTIVE: The aim of this study is to generate a grounded theory capable of guiding the development of interventions designed to assist those living with cancer in meeting their informational needs. METHODS: Classic grounded theory was used to analyze data collected through digitally recorded one-on-one audio interviews with 31 patients with cancer and 29 friends and family members. These interviews focused on how the participants had accessed and used information to plan their lives and what barriers they faced in obtaining and using this information. RESULTS: The theory that emerged consisted of 4 variables: personal projects, cancer as a source of disruption to personal projects, information as the process of accessing and interpreting cancer-related data (CRD) to inform action, and CRD quality as defined by accessibility, credibility, applicability, and framing. CRD quality as a moderator of personal project disruption by cancer is the core concept of this theory. CONCLUSIONS: Informational resources providing accessible, credible, applicable, and positively framed CRD are likely key to meeting the information needs of those affected by cancer. Web-based informational resources delivering high-quality CRD focused on assisting individuals living with cancer in maintaining and planning their personal projects are predicted to improve quality of life. Research is needed to develop and integrate resources informed by this theoretical framework into clinical practice.

Clinical and Technical Considerations of an Open Access Telehealth Network in South Carolina: Definition and Deployment.

BACKGROUND: Today, telehealth is experiencing exponential growth in utilization. Paralleling this trend is the growth in the telehealth industry, with sharp increases in the number of platforms, functionalities, and levels of integrations within both the electronic health record and other technical systems supporting health care. When a telehealth network is intended to be used across independent health care systems, an additional layer of complexity emerges. In the context of regionalized telehealth networks that are not within the same health care system, not only are technical interoperability challenges a practical barrier, but administrative, clinical, and competitive elements also quickly emerge, resulting in fragmented, siloed technologies. OBJECTIVE: The study aimed to describe a statewide approach to deploying an interoperable open access telehealth network across multiple health systems. METHODS: One promising solution to the abovementioned concerns is an open access telehealth network. In the field of telehealth, an open access network (OAN) can be defined as a network infrastructure that can be used by health care providers without a closed or proprietary platform, specific obligatory network, or service-specific telehealth technologies. This framework for the development of an OAN is grounded in practical examples of clinical programs that function in each stage of network maturity based on the experience of the South Carolina Telehealth Alliance (SCTA). The SCTA's experience details successes and challenges in an ongoing effort to achieve an OAN. The model describes an OAN in stages of collaborative maturity and provides insights into the technological, clinical, and administrative implications of making the collaboration possible. RESULTS: The four stages of an OAN are defined according to operational maturity, ranging from feasibility to demonstration of implementation. Each stage is associated with infrastructure and resource requirements and technical and clinical activities. In stage 1, technical standards are agreed upon, and the clinical programs are designed to utilize compliant technologies. In stage 2, collaboration is demonstrated through technical teams working together to address barriers, whereas clinical and administrative teams share best practices. In stage 3, a functional interoperable network is demonstrated with different institutions providing service through common telehealth end points at different patient care sites. In stage 4, clinical workflows are streamlined and standardized across institutions, and economies of scale are achieved through technical and administrative innovations. CONCLUSIONS: The approach to OAN development described provides a roadmap for achieving a functional telehealth network across independent health systems. The South Carolina experience reveals both successes and challenges in achieving this goal. The next steps toward the development of OANs include advocacy and ongoing engagement with the developers of telehealth technologies regarding their commitment to interoperability.

[Regulación de la donación de gametos y embriones en las técnicas de reproducción humana asistida: ¿anónima o abierta?]

The use of donated gametes and embryos in assisted reproduction techniques (ART) makes it necessary to examine interests that involve relevant ethical and legal considerations, which include the autonomy and privacy rights of the intended parents, donors' right to privacy and the right of the minors to know their genetic origin. This article presents arguments to consider policies of more openness to obtain information from donors in order to protect the child's best interest in knowing his/her genetic origins. It concludes with the situation in Mexico, where ART has been carried out with donated gametes since several years ago; however, due to the absence of regulations to control these procedures, each establishment imposes its own criteria for the operation of its programs.

El uso de gametos y embriones donados en técnicas de reproducción humana asistida hace necesario examinar intereses que implican consideraciones éticas y jurídicas relevantes, y estos incluyen los derechos de autonomía y privacidad de los padres de intención, el derecho a la privacidad de los donantes y el derecho de los menores a conocer su origen genético. En este artículo se exponen argumentos para considerar políticas de mayor apertura para la obtención de información de los donantes en aras de proteger el interés superior del niño y la niña a conocer sus orígenes genéticos. Concluye con la problemática en México, donde desde hace varios años se realizan técnicas de reproducción humana asistida con gametos donados, sin embargo, debido a la ausencia de una normatividad que regule estos procedimientos, cada establecimiento impone sus criterios para el funcionamiento de sus programas.

Pathogens collections, biobanks and related-data in a One Health legal and ethical perspective.

Research on emerging infectious diseases calls for a work on collections of pathogens (including hosts or vectors from which the pathogens were isolated), related to human and animal health, to wildlife or on the environmental material. In this respect, the adoption of a One Health perspective is determined by the need for a common approach to consider the collection, storage and use of pathogens coming from human or non-human sources, and particularly when the same pathogen is taken from different environments. In response to this development, our purpose is to delineate a flexible regulation framework concerning collections of pathogens from various origins or hosts and their associated data in order to facilitate scientific work and research partnerships. The legal and ethical cutting-edge research on Biomedical Big Data is particularly stimulating when it comes to address challenges related to collections or biobanks of pathogens such as prior informed consent and accessibility, Material Transfer Agreement or benefit sharing.

"You cannot collect data using your own resources and put It on open access": Perspectives from Africa about public health data-sharing.

Data-sharing is a desired default in the field of public health and a source of much ethical deliberation. Sharing data potentially contributes the largest, most efficient source of scientific data, but is fraught with contextual challenges which make stakeholders, particularly those in under-resourced contexts hesitant or slow to share. Relatively little empirical research has engaged stakeholders in discussing the issue. This study sought to explore relevant experiences, contextual, and subjective explanations around the topic to provide a rich and detailed presentation of what it means to different stakeholders and contexts to share data and how that can guide practice and ethical guidance. A qualitative design involving interviews was undertaken with professionals working in public health institutions endowed with data (HDSS), ethics committees, and advisory agencies which help shape health research in Africa. A descriptive form of thematic analysis was used to summarize results into six key themes: (1) The role of HDSSs in research using public health data and data-sharing; (2) Ownership and funding are critical factors influencing data-sharing; (3) Other factors discourage data-sharing; (4) Promoting and sustaining data-sharing; (5) Ethical guidance structures; and (6) Establishing effective guidance. The themes reveal factors regarding the willingness or not to share and an intricate ethical system that current discourse could reflect. Many of the concerns resonate with the literature, but a whole other gamut of people and process issues; commitments, investments, careers, and the right ethical guidance are needed to realize a sustainable goal of reaching 'share' as a default.

The ethics of reporting all the results of clinical trials.

Introduction or background: The terms 'publication bias' and 'reporting bias' describe aspects of a phenomenon by which data from trials are not publicized, and so remain inaccessible. This may generate a false impression about the world; but those facts may have important implications for clinical decisions. Thus, the bias may leave patients worse off than they might be. Sources of data: Published journal articles. Areas of agreement: There is general agreement that the phenomenon happens, and that to the extent that it happens, it is undesirable for moral rather than simply epistemic reasons. Growing points: There is a growing demand across the board for data to be better publicized. Areas timely for developing research: There is room for further work on how protocols requiring that data be publicized might be enforced; should it be statutory, or non-statutory? Who should decide what should be made public? There is also room for work on what it is necessary to share, and on whether and how IP law should be reformed.

Aid-in-dying laws and the physician's duty to inform.

On 19 July 2016, three medical organisations filed a federal lawsuit against representatives from several Vermont agencies over the Patient Choice and Control at End of Life Act. The law is similar to aid-in-dying (AID) laws in four other US states, but the lawsuit hinges on a distinctive aspect of Vermont's law pertaining to patients' rights to information. The lawsuit raises questions about whether, and under what circumstances, there is an ethical obligation to inform terminally ill patients about AID as an end-of-life option. Much of the literature on clinical communication about AID addresses how physicians should respond to patient requests for assisted dying, but neglects the question of how physicians should approach patients who may not know enough about AID to request it. In this article, I examine the possibility of an affirmative duty to inform terminally ill patients about AID in light of ethical concerns about professional responsibilities to patients and the maintenance of the patient-provider relationship. I suggest that we should not take for granted that communication about AID ought to be patient-initiated, and that there may be circumstances in which physicians have good reasons to introduce the topic themselves. By identifying ethical considerations that ought to inform such discussions, I aim to set an agenda for future bioethical research that adopts a broader perspective on clinical communication about AID.

Pre- and post-testing counseling considerations for the provision of expanded carrier screening: exploration of European geneticists' views.

BACKGROUND: Carrier screening is generally performed with the aim of identifying healthy couples at risk of having a child affected with a monogenic disorder to provide them with reproductive options. Expanded carrier screening (ECS), which provides the opportunity for multiple conditions to be screened in one test, offers a more cost-effective and comprehensive option than screening for single disorders. However, implementation of ECS at a population level would have implications for genetic counseling practice. METHODS: We conducted semi-structured interviews with sixteen European clinical and molecular geneticists with expertise in carrier screening to explore their views on the implementation of ECS in the clinical setting. RESULTS: Using inductive content analysis, we identified content categories relevant to the pre- and post-test settings. Participants believed ECS would ideally be targeted at couples before pregnancy. There was some disagreement regarding the acceptability of performing ECS in individuals, with several participants actively opposing individual-based screening. In addition, participants discussed the importance of ensuring informed and voluntary participation in ECS, recommending measures to minimize external pressure on prospective parents to undergo testing. A need for adequate counseling to foster informed, autonomous reproductive decision-making and provide support for couples found to be at risk was emphasized. CONCLUSIONS: Practical challenges in optimizing pre-test education and post-test counseling should not be underestimated and they should be carefully addressed before implementing ECS in the clinical setting.

Direct to consumer genetic testing and the libertarian right to test.

I sketch a libertarian argument for the right to test in the context of 'direct to consumer' (DTC) genetic testing. A libertarian right to genetic tests, as defined here, relies on the idea of a moral right to self-ownership. I show how a libertarian right to test can be inferred from this general libertarian premise, at least as a prima facie right, shifting the burden of justification on regulators. I distinguish this distinctively libertarian position from some arguments based on considerations of utility or autonomy, which are sometimes labelled 'libertarian' because they oppose a tight regulation of the direct to consumer genetic testing sector. If one takes the libertarian right to test as a starting point, the whole discussion concerning autonomy and personal utility may be sidestepped. Finally, I briefly consider some considerations that justify the regulation of the DTC genetic testing market, compatible with the recognition of a prima facie right to test.

An official American Thoracic Society policy statement: managing conscientious objections in intensive care medicine.

RATIONALE: Intensive care unit (ICU) clinicians sometimes have a conscientious objection (CO) to providing or disclosing information about a legal, professionally accepted, and otherwise available medical service. There is little guidance about how to manage COs in ICUs. OBJECTIVES: To provide clinicians, hospital administrators, and policymakers with recommendations for managing COs in the critical care setting. METHODS: This policy statement was developed by a multidisciplinary expert committee using an iterative process with a diverse working group representing adult medicine, pediatrics, nursing, patient advocacy, bioethics, philosophy, and law. MAIN RESULTS: The policy recommendations are based on the dual goals of protecting patients' access to medical services and protecting the moral integrity of clinicians. Conceptually, accommodating COs should be considered a "shield" to protect individual clinicians' moral integrity rather than as a "sword" to impose clinicians' judgments on patients. The committee recommends that: (1) COs in ICUs be managed through institutional mechanisms, (2) institutions accommodate COs, provided doing so will not impede a patient's or surrogate's timely access to medical services or information or create excessive hardships for other clinicians or the institution, (3) a clinician's CO to providing potentially inappropriate or futile medical services should not be considered sufficient justification to forgo the treatment against the objections of the patient or surrogate, and (4) institutions promote open moral dialogue and foster a culture that respects diverse values in the critical care setting. CONCLUSIONS: This American Thoracic Society statement provides guidance for clinicians, hospital administrators, and policymakers to address clinicians' COs in the critical care setting.

Qualitative study on custodianship of human biological material and data stored in biobanks.

BACKGROUND: Balancing the rights and obligations of custodians and applicants in relation to access to biobanks is of utmost importance to guarantee trust and confidence. This study aimed to reveal which issues divide different stakeholders in an attempt to determine the rights and/or obligations held on human biological materials (HBM) and data. METHODS: Twenty-eight informants in the Benelux and Scandinavia were interviewed in order to capture the perspectives of experts and stakeholders in relation to the rights and obligations held by custodians and applicants with respect to access to HBM and data. RESULTS: There was no consensus among the informants on whether the custodian of a biobank should decide upon the scientific merits and the utility of an access request. Nearly all informants agreed that a new request or an amendment to the initial request has to be submitted when an applicant wants to use leftover HBM in a new or follow-up project. Several informants felt that it might be justified to charge higher access fees to external or industrial applicants that did not contribute (directly or indirectly) to the collection of HBM and data. Most informants agreed that a custodian of a biobank could request the sharing and return of research results. It was furthermore argued that some of the benefits of research projects should be fed back into biobanks. CONCLUSIONS: The interviews revealed a rather complex web of rights and obligations allocated to the custodian and the applicant in relation to access to HBM and data stored in biobanks. Some rights and obligations are negotiated on a case-by-case basis, while others are stipulated in access arrangements. We did find a consensus on the attribution of certain general rights to the custodians and the applicant.