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Participant-driven research (PDR) is a burgeoning domain of research innovation, often facilitated by mobile technologies (mHealth). Return of results and data are common hallmarks, grounded in transparency and data democracy. PDR has much to teach traditional research about these practices and successful engagement. Recommendations calling for new state laws governing research with mHealth modalities common in PDR and federal creation of review mechanisms, threaten to stifle valuable participant-driven innovation, including in return of results.

The Pre-Conception and Pre-Natal Diagnostic Techniques Act was written to prevent societally unacceptable harms including intentional sex selection. The pragmatism required to enforce this law has profound effects on the ability of rural Indians to access diagnostic ultrasonography. In so doing, it may have inadvertently placed a heavier burden on the poorest and worsened health inequity in India, creating serious ethical and justice concerns. It is time to re-examine and update the law such that diagnostic ultrasonography is widely available in even the most peripheral primary health and community health centres. Shorter, more accessible ultrasonography training courses should be offered; collaboration between radiologists and rural practitioners and facilities should be encouraged. Finally, modern ultrasound machines can carefully record all images via a "silent observer" modality. With some modifications to previously used silent observer modalities, this technology allows both greater access and better policing of potential misuse of ultrasound technology.

Being asked to write about the ethics of big data is a bit like being asked to write about the ethics of life. Big data is now integral to so many aspects of our daily lives-communication, social interaction, medicine, access to government services, shopping, and navigation. Given this diversity, there is no one-size-fits-all framework for how to ethically manage your data. With that in mind, I present seven ethical values for responsible data use.

Sharing clinic notes online with patients and parents may yield many potential benefits to patients and providers alike, but the unprecedented transparency and accessibility to notes afforded by patient portals has also raised a number of unique ethical and legal concerns. As the movement toward transparent notes (OpenNotes) grows, clinicians and health care organizations caring for pediatric and adolescent patients wrestle with how to document confidential and sensitive information, including issues such as reproductive health, misattributed paternity, or provider and parent disagreements. With OpenNotes now reaching >21 000 000 US patients, pediatricians continue to query best portal practices. In this Ethics Rounds, we discuss 3 illustrative cases highlighting common pediatric OpenNotes concerns and provide guidance for organizations and clinicians regarding documentation practices and patient portal policies to promote patient engagement and information transparency while upholding patient and parent confidentiality and the patient- and/or parent-provider relationship., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2018 by the American Academy of Pediatrics.)

Advances in DNA sequencing technology open new possibilities for public health genomics, especially in the form of general population preventive genomic sequencing (PGS). Such screening programs would sit at the intersection of public health and preventive health care, and thereby at once invite and resist the use of clinical ethics and public health ethics frameworks. Despite their differences, these ethics frameworks traditionally share a central concern for individual rights. We examine two putative individual rights-the right not to know, and the child's right to an open future-frequently invoked in discussions of predictive genetic testing, in order to explore their potential contribution to evaluating this new practice. Ultimately, we conclude that traditional clinical and public health ethics frameworks, and these two rights in particular, should be complemented by a social justice perspective in order adequately to characterize the ethical dimensions of general population PGS programs., (© The Author(s) 2018. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Patient portals enable people to access their health information electronically, but concerns about confidentiality and privacy breaches, particularly for young people, may be impeding portal adoption in New Zealand. This paper considers the legal and ethical framework relating to health information privacy and informed consent in New Zealand, and proposes an approach to implementing patient portals for young people. Shared portal access (where both a young person and their parent or guardian have access to the young person's portal) may be appropriate for young children whose parents or guardians are responsible for their health care. However, as children mature and their capacity to make health care decisions increases, general practitioners will need to consider shifting to independent portal access by competent young people. The circumstances of each young person, including their best interests and rights, cultural needs and their views on information disclosure should be taken into account.

Largely driven by the financial incentives of the HITECH Act's Meaningful Use program as part of federal US health care reform, access to portal Web sites has rapidly expanded, allowing many patients to view their medical record information online. Despite this expansion, there is little attention paid to the accessibility of portals for more vulnerable patient populations-especially patients with limited health literacy or limited English proficiency, and individuals with disabilities. We argue that there are potential legal mandates for improving portal accessibility (e.g., the Civil Rights and the Rehabilitation Acts), as well as ethical considerations to prevent the exacerbation of existing health and health care disparities. To address these legal, practical, and ethical considerations, we present standards and broad recommendations that could greatly improve the reach and impact of portal Web sites.

Background: Patients are increasingly asking for their health data. Yet, little is known about what motivates patients to engage with the electronic health record (EHR). Furthermore, quality-focused mechanisms for patients to comment about their records are lacking., Objective: We aimed to learn more about patient experiences with reading and providing feedback on their visit notes., Methods: We developed a patient feedback tool linked to OpenNotes as part of a pilot quality improvement initiative focused on patient engagement. Patients who had appointments with members of 2 primary care teams piloting the program between August 2014-2015 were eligible to participate. We asked patients what they liked about reading notes and about using a feedback tool and analyzed all patient reports submitted during the pilot period. Two researchers coded the qualitative responses (κ=.74)., Results: Patients and care partners submitted 260 reports. Among these, 98.5% (256/260) of reports indicated that the reporting tool was valuable, and 68.8% (179/260) highlighted what patients liked about reading notes and the OpenNotes patient reporting tool process. We identified 4 themes describing what patients value about note content: confirm and remember next steps, quicker access and results, positive emotions, and sharing information with care partners; and 4 themes about both patients' use of notes and the feedback tool: accuracy and correcting mistakes, partnership and engagement, bidirectional communication and enhanced education, and importance of feedback., Conclusions: Patients and care partners who read notes and submitted feedback reported greater engagement and the desire to help clinicians improve note accuracy. Aspects of what patients like about using both notes as well as a feedback tool highlight personal, relational, and safety benefits. Future efforts to engage patients through the EHR may be guided by what patients value, offering opportunities to strengthen care partnerships between patients and clinicians., (©Macda Gerard, Alan Fossa, Patricia H Folcarelli, Jan Walker, Sigall K Bell. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 14.07.2017.)

Background Lab Tests Online-UK celebrated its 10th anniversary in 2014 and to mark the occasion the first comprehensive survey of website users was undertaken. Methods A pop-up box with a link to Survey Monkey was used to offer website users the chance to participate in the survey, which was live from 4 March 2014 to 11 April 2014. Results Six hundred and sixty-one participants started the questionnaire and 338 completed all of the demographic questions. Although the website is designed and aimed at patients and the public, a significant number of respondents were health-care professionals (47%). The majority of survey participants found the Lab Tests Online-UK website via a search engine and were visiting the site for themselves. The majority of participants found what they were looking for on the website and found the information very easy or fairly easy to understand. The patient respondents were keen to see their laboratory test results (87%), but the majority did not have access (60%) at the time of the survey. Conclusions This survey provides good evidence that the Lab Tests Online-UK website is a useful resource for patients and health-care professionals alike. It comes at a poignant time as the release of results direct to patients starts with access to their medical records. The Lab Tests Online-UK website has a key role in enabling patients to understand their lab test results, and therefore empowering them to take an interest and engage in their own healthcare.

The capacity to collect and analyse data is growing exponentially. Referred to as 'Big Data', this scientific, social and technological trend has helped create destabilising amounts of information, which can challenge accepted social and ethical norms. Big Data remains a fuzzy idea, emerging across social, scientific, and business contexts sometimes seemingly related only by the gigantic size of the datasets being considered. As is often the case with the cutting edge of scientific and technological progress, understanding of the ethical implications of Big Data lags behind. In order to bridge such a gap, this article systematically and comprehensively analyses academic literature concerning the ethical implications of Big Data, providing a watershed for future ethical investigations and regulations. Particular attention is paid to biomedical Big Data due to the inherent sensitivity of medical information. By means of a meta-analysis of the literature, a thematic narrative is provided to guide ethicists, data scientists, regulators and other stakeholders through what is already known or hypothesised about the ethical risks of this emerging and innovative phenomenon. Five key areas of concern are identified: (1) informed consent, (2) privacy (including anonymisation and data protection), (3) ownership, (4) epistemology and objectivity, and (5) 'Big Data Divides' created between those who have or lack the necessary resources to analyse increasingly large datasets. Critical gaps in the treatment of these themes are identified with suggestions for future research. Six additional areas of concern are then suggested which, although related have not yet attracted extensive debate in the existing literature. It is argued that they will require much closer scrutiny in the immediate future: (6) the dangers of ignoring group-level ethical harms; (7) the importance of epistemology in assessing the ethics of Big Data; (8) the changing nature of fiduciary relationships that become increasingly data saturated; (9) the need to distinguish between 'academic' and 'commercial' Big Data practices in terms of potential harm to data subjects; (10) future problems with ownership of intellectual property generated from analysis of aggregated datasets; and (11) the difficulty of providing meaningful access rights to individual data subjects that lack necessary resources. Considered together, these eleven themes provide a thorough critical framework to guide ethical assessment and governance of emerging Big Data practices.

Background: In medical ethics there is broad agreement that patients should be empowered to make autonomous decisions about their health and that objective, detailed information promotes these decisions. According to German law patients have a right of access to their own medical records., Objectives: Which advantages and disadvantages does the access to records have for doctors and patients in psychiatry? Which requirements should be met to make access reasonable for patients?, Material and Methods: This article presents an analysis of the legal situation and the state of research, evaluation of empirical studies, discussion of features of psychiatry, its language and patients as well as their influence on access to medical records., Results: Psychiatrists are sometimes concerned about patient access to medical records and some psychiatric patients feel upset or uncomfortable after having inspected their records. The misunderstanding and stigmatization of psychiatric terms, the vulnerability of psychiatric patients and the nature of psychiatric disorders, the description of which affects fundamental aspects of personality, all play a role in this. In addition, in having access to their records patients use a source of information that was originally written for other addressees. Information content and language are not adapted to their needs. Possible solutions could involve improvements in patient education and (stylistic) changes in writing records.

Ethics should guide the design of electronic health records (EHR), and recognized principles of bioethics can play an important role. This approach was recently adopted by a team of informaticists who are designing and testing a system where patients exert granular control over who views their personal health information. While this method of building ethics in from the start of the design process has significant benefits, questions remain about how useful the application of bioethics principles can be in this process, especially when principles conflict. For instance, while the ethical principle of respect for autonomy supports a robust system of granular control, the principles of beneficence and nonmaleficence counsel restraint due to the danger of patients being harmed by restrictions on provider access to data. Conflict between principles has long been recognized by ethicists and has even motivated attacks on approaches that state and apply principles. In this paper, we show how using ethical principles can help in the design of EHRs by first explaining how ethical principles can and should be used generally, and then by discussing how attention to details in specific cases can show that the tension between principles is not as bad as it initially appeared. We conclude by suggesting ways in which the application of these (and other) principles can add value to the ongoing discussion of patient involvement in their health care. This is a new approach to linking principles to informatics design that we expect will stimulate further interest.

This paper discusses the nature of genomic information, and the moral arguments in support of an individual's right to access it. It analyses the legal avenues an individual might take to access their sequence information. The authors describe the policy implications in this area and conclude that, for now, the law appears to strike an appropriate balance, but new policy will need to be developed to address this issue.

As more research studies incorporate next-generation sequencing (including whole-genome or whole-exome sequencing), investigators and institutional review boards face difficult questions regarding which genomic results to return to research participants and how. An American College of Medical Genetics and Genomics 2013 policy paper suggesting that pathogenic mutations in 56 specified genes should be returned in the clinical setting has raised the question of whether comparable recommendations should be considered in research settings. The Clinical Sequencing Exploratory Research (CSER) Consortium and the Electronic Medical Records and Genomics (eMERGE) Network are multisite research programs that aim to develop practical strategies for addressing questions concerning the return of results in genomic research. CSER and eMERGE committees have identified areas of consensus regarding the return of genomic results to research participants. In most circumstances, if results meet an actionability threshold for return and the research participant has consented to return, genomic results, along with referral for appropriate clinical follow-up, should be offered to participants. However, participants have a right to decline the receipt of genomic results, even when doing so might be viewed as a threat to the participants' health. Research investigators should be prepared to return research results and incidental findings discovered in the course of their research and meeting an actionability threshold, but they have no ethical obligation to actively search for such results. These positions are consistent with the recognition that clinical research is distinct from medical care in both its aims and its guiding moral principles., (Copyright © 2014 The American Society of Human Genetics. Published by Elsevier Inc. All rights reserved.)

Objective: Radiologists' delivery of imaging results to patients remains controversial. One model of communication suggests limiting disclosure to normal results. We argue that disclosing radiologic findings to patients is justified in all categories of results., Conclusion: Once a doctor-patient relationship has been established, we claim that it is morally justifiable for radiologists to communicate findings directly to their patients. The practice guidelines that we advocate employ a sliding scale based on the diagnostic confidence of imaging results.

Radiologists, referring physicians, and patients all have certain legal rights regarding access to medical records, including imaging data. The degree of patient access is likely to increase with the growing adoption of patient portals and personal health records. In addition, referring physicians and radiologists have a collective responsibility to ensure that important findings are transferred appropriately between their practices. In some cases when this is not possible, communicating directly with patients is the best way to protect the interests of both patients and radiologists. Even when not required, some radiologists have extensive experience communicating results directly to patients. Direct communication of radiology results to patients may present an opportunity to satisfy patients and reassert the importance of the physician-patient relationship in radiology., (Copyright © 2011 American College of Radiology. Published by Elsevier Inc. All rights reserved.)

Background: This paper describes the distinctions between major surgical and pharmaceutical trials and questions the application of a common ethical paradigm to guide their conduct and reporting., Methods: Surgical trials differ from other trials in cumulative therapeutic effects, operator dependence, the clinical setting, interdependence of short- and long-term outcomes, and equipoise. A principal tenant of randomized controlled trial management is the maintenance of interim data confidentiality. Its application to complete surgical short-term data is examined across a variety of common clinical trial circumstances that influence data integrity and the reliability of conclusions regarding the benefit-to-risk profile of experimental interventions., Results: Complete perioperative results describe important treatment ends that cannot influence primary outcomes. These short-term results may inform patient consent, teaching and provide valuable procedural insights to surgeons outside trial precincts., Conclusion: Structured experimentation standards are necessary. But, the common paradigm applied across all clinical trials and the prohibition on short term data reporting may not serve the achievement of safe and effective advancements in surgery., (© 2010 The Authors. ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons.)

Background: This study aims to determine the nature of United States Institutional Review Board (IRB) policy in a broad spectrum of research settings regarding the return of results to study participants., Method: IRB policies or standard operating procedures of 207 Medical School, Industry and Non-medical School IRBs were examined on-line to determine if they incorporated specific reference to the return of results to participants at the conclusion of the research., Results: The majority of IRBs had no available policy regarding the return of research results to participants [56% (n = 116)]. A further third 136.3% (n = 75)] had policies that were defined as vague or that only indirectly mentioned the return of results. Medical School IRBs were more likely to have a policy than Industry or Non-medical University IRBs, respectively (odds ratio, 4.63; 95% confidence interval, 1.84 to 11.66 and odds ratio, 3.03; 95 % confidence interval, 1.75 to 5.25). Few provided any guidance as to the process of return of results. Of the IRBs that had a research results policy, 54.9% (n = 50) specifically addressed genetic research., Conclusions: Our findings demonstrate a marked lack of uniformity in IRB policy regarding the return of study results with over half providing no guidance.

Purpose: The offer to return research results to participants is increasingly recognized as an ethical obligation, although few researchers routinely return results. We examined the needs and attitudes of parents of children with cancer and of adolescents with cancer to the return of research results., Methods: Seven experts in research ethics scored content validity on parent and adolescent questionnaires previously developed through focus group and phone interviews. The questionnaires were revised and provided to 30 parents and 10 adolescents in a tertiary care oncology setting., Results: The content validity index for individual questions and the overall questionnaires scored as 0.86 for both questionnaires. All 30 parents and 10 adolescents who agreed to participate returned questionnaires. The majority (>95%) indicated that they had a strong or very strong right to receive results. Letter or e-mail was a satisfactory means to return results described as good or neutral (66% parents, 100% adolescents) but more participants wished face-to-face disclosure of results with negative implications (50% parents, 60% adolescents). Very few wanted results disseminated through a Web site. The majority acknowledged the need for peer-review before disclosure (60% of adolescents and parents) but did not want "to be the last to know.", Conclusions: Our data suggest that pediatric oncology patients and parents of children with cancer strongly feel that they have a right to research results, and that they wish to receive these in a timely manner.

The National Blood Policy in India relies heavily on voluntary blood donors, as they are usually assumed to be associated with low levels of transfusion-transmitted infections (TTIs). In India, it is mandatory to test every unit of blood collected for hepatitis B, hepatitis C, HIV/AIDS, syphilis and malaria. Donors come to the blood bank with altruistic intentions. If donors test positive to any of the five infections, their blood is discarded. Although the blood policy advocates disclosure of TTI status, donors are not, in practice, informed about their results. The onus is on the donor to contact the blood bank. Out of approximately 16 000 donations in the past 2 years, 438 tested positive for TTI, including 107 for HIV. Only 20% of the donors contacted the blood bank; none of them were HIV positive. Disclosure by blood banks of TTI status by telephone or mail has resulted in serious consequences for some donors. Health providers face an ethical dilemma, in the absence of proper mechanisms in place for disclosure of test results, regarding notification to donors who may test positive but remain ignorant of their TTI status. Given the high cost of neglecting to notify infected donors, the authors strongly recommend the use of rapid tests before collecting blood, instead of the current practice, which takes 3 h to obtain results, and disclosure of results directly to the donor by a counsellor, to avoid dropouts and to ensure confidentiality.

Many challenges face developers of secure computer-based clinical systems but the technical problems are overshadowed by many obstacles, key amongst them being social and ethical issues. A sound Knowledge Management (KM) structure within clinical environments can recognise the responsibility of healthcare professionals to keep patient clinical data (for example, electronic care record (ECR) systems) secure. An arrangement is proposed that gives the most senior clinician in a healthcare facility the ultimate responsibility for security of clinical data held in the organisation. Ideally, the senior clinician would possess training and experience in information systems and their security. Contracts should be developed between healthcare facilities and their patients, defining the limits to the use and disclosure of clinical health data. However, we are observing increasing confusion about the term 'Knowledge Management' which may be limited both its efficacy and effectiveness. Health organisations are referring to the term in various contexts and health informatics articles frequently use the term and interpret it in diverse ways. Given the divergence of views, this paper will attempt to establish KM's efficacy for the implementation of electronic care record systems.

Offering to provide research results to study participants is gaining increasing support based, in part, on the principle of respect for persons. The frequency and means of this practice is unknown in national and international research communities. All investigators who presented oral abstracts involving human research at the American Society of Hematology Annual Meeting (December 2003) were surveyed. Responses were received from 197 (42%) of 472 eligible investigators. Nonrespondents did not differ in study type or country of origin. Only 30% (n = 48) of those who completed the survey had a formal plan for the return of research results; 40% of these would return both a summary plus individual level results. Of the respondents, 69% (n = 109) supported or strongly supported the practice; only 3% opposed the practice. The most commonly cited reasons for not returning results were: did not consider it (38%), anticipated contact difficulties (32%), and participant difficulty understanding results (26%). Only 11 (7%) indicated that their institutional review board (IRB) mandates the offer to provide results to all participants; this did not vary significantly by country. Given the high level of support in the international research community, evaluation of well-planned interventions for offering to provide research results to participants should be a priority.

The access to health information is one of the rights of the user of the public health care system, but it is little respected in health services. This study investigates the problem from the perspective of the female clientele. A qualitative study was carried out with a sample of seventeen low-income mothers, which reside in the outskirts of the Federal District. The mothers are frequent users of the health care services, but their adherence to prescribed conducts depends on social and economic factors and how they perceive the various alternatives at their hand. Access to health information is hampered by the mother's low level of instruction, use of folklore medicine, faulty communication and lack of receptive/nurturing environment, indifference to social rights on the part of health providers.

The right of patient to information is closely connected with the problems of consent to medical procedures. The prerequisite of adequate expression of consent is sufficient amount of knowledge about own health condition, accurate picture of the illness, probable advantages and risk of suggested treatment as well as possible alternative medical techniques with their benefits and risks and consequences of giving them up. Full and reliable information given in understandable form leads to more humane therapy and favours patients' trust for the knowledge and experience of medical staff and partnership of patient-health service worker relationship. Examination of doctors' and patients' opinions concerning the assessment of patients' access to information on different aspects connected with hospitalisation was carried out in 49 wards of 13 health care units in the Lublin region from 24.08. to 06.09.1999. To solve research problems of this paper the method of diagnostic survey was applied with the use of questionnaire technique. The study carried out among 141 doctors and 353 patients has shown that: the range of information given by doctors depends on their position, degree of specialization and general knowledge of patient's rights (p < 0.05) and the range and quality of information obtained by patients from doctors depend on the sex of patients, their age, marital status and educational level (p < 0.05).

Irrespective of the level of care, possible objections and even complaints lodged to various institutions concerning functioning of health care units, expectations of patients from doctors and middle medical staff as for health services and respecting their rights are of very different character. Investigations of patients' opinions on their expectations from health service personnel in hospitals were carried out in 49 wards of 13 hospitals in the Lublin district from 24.08. to 06.09.1999. For solving research problems of this study the method of diagnostic survey was used with the use of questionnaire technique. Patients in individual wards were randomly selected on the basis of hospital discharge sequence. Opinions on the subject under study were collected from patients leaving investigated wards in whom: the awareness of discharge and independence of the staff allowed frank opinions, the fact of hospitalisation gave experience, hospital stay enabled comprehensive assessment of problems under discussion. The study comprising 353 patients has shown that: patients expect from doctors, first of all, respecting the right to information (31.8%) on the whole subject range from diagnosis, assessment of health condition, and prognosis to the aim, risk, benefits and ways of carrying out medical procedures (20.02%); expectations of patients from middle medical staff mainly concern respecting the right to partner treatment, with dignity and respect (29.5%); over two thirds of patients (41.5%) also express their expectations from auxiliary medical staff concerning their manners in contacts with them.

This article highlights notable developments in consent in psychiatry over the last year. In particular, it identifies increasingly sophisticated conceptualizations of consent and competence, and discusses advances in the process of decision-making and informed consent to non-treatment areas within psychiatry.