Background Adherence to ethical guidelines and regulations and protecting and respecting the dignity and autonomy of participants by obtaining a valid informed consent form (ICF) prior to participation in research are crucial; The subjects did not add signatures next to the corrections made to signatures or dates on the ICF, Multiple signatures in other fields, ICF missing/missing signature, Incorrect ICF version Signed after modification, Correction tape used to correct signature, Impersonated signature, Non-research-member signature, however, ICFs are often not properly completed, (...) which must be addressed. This study analyzed ICF signing errors and implemented measures to reduce or prevent these errors. Methods We used the plan–do–check–act (PDCA) cycle to help improve the correctness and validity of ICF signing. Results Interim and final reports from January 2016 to February 2020 including 363 ICFs were studied. The total proportion of correct ICF signatures (200, 83.3%) following the PDCA intervention was significantly higher than that before the intervention (P < 0.05). Analysis of the types of signing error demonstrated that signature errors were significantly reduced after the intervention, particularly for subjects did not add signatures next to the corrections made to signatures or dates on the ICF (16, 6.7%) and impersonated signature (0; P < 0.05). Conclusions The proportions of other error types—multiple signatures in other fields, missing or unsigned ICF, incorrect signature order, incorrect ICF version, use of correction tape to correct signature, and non-medical profession members signing the ICF—did not differ significantly. (shrink)

Ongoing evaluation of a clinical ethics consultation service (ECS) allows for continuous quality improvement, a process-based, data-driven approach for improving the quality of a service. Evaluations by stakeholders involved in a consultation can provide realtime feedback about what is working well and what might need to be improved. Although numerous authors have previously presented data from research studies on the effectiveness of clinical ethics consultation, few ECSs routinely send evaluations as an ongoing component of their everyday (...) clinical activities. The primary purpose of this article is to equip and encourage others to engage in ongoing evaluation of their own ECS. Toward that end, the following resources are shared: (1) the survey tool used to gather the evaluation data, (2) the procedure used to elicit and collate responses, and (3) how the resulting data are used to support continuous quality improvement and justify the continued financial support of the ECS to hospital administration. (shrink)

Background: Poverty and social deprivation have adverse effects on health outcomes and place a significant burden on healthcare systems. There are some actions that can be taken to tackle them from within healthcare institutions, but clinicians who seek to make frontline services more responsive to the social determinants of health and the social context of people’s lives can face a range of ethical challenges. We summarise and consider a case in which clinicians introduced a poverty screening initiative into paediatric practice (...) using the discourse and methodology of healthcare quality improvement. -/- Discussion: Whilst suggesting that interventions like the PSI are a potentially valuable extension of clinical roles, which take advantage of the unique affordances of clinical settings, we argue that there is a tendency for such settings to continuously reproduce a narrower set of norms. We illustrate how the framing of an initiative as QI can help legitimate and secure funding for practical efforts to help address social ends from within clinical service, but also how it can constrain and disguise the value of this work. A combination of methodological emphases within QI and managerialism within healthcare institutions leads to the prioritisation, often implicitly, of a limited set of aims and governing values for healthcare. This can act as an obstacle to a genuine broadening of the clinical agenda, reinforcing norms of clinical practice that effectively push poverty ‘off limits.’ We set out the ethical dilemmas facing clinicians who seek to navigate this landscape in order to address poverty and the social determinants of health. -/- Conclusions: We suggest that reclaiming QI as a more deliberative tool that is sensitive to these ethical dilemmas can enable managers, clinicians and patients to pursue health-related values and ends, broadly conceived, as part of an expansive range of social and personal goods. (shrink)

There is a claim that clinical ethics support services (CESS) improve healthcare quality within healthcare organisations. However, there is lack of strong evidence supporting this claim. Rather, the current focus is on the quality of CESS themselves or on individual learning outcomes. In response, this article proposes a theoretical framework leading to empirical hypotheses that describe the relationship between a specific type of CESS, moral case deliberation and the quality of care at the organisational level. We combine (...) insights from the literature on CESS, organisational learning and quality improvement and argue that moral case deliberation causes healthcare professionals to acquire practical wisdom. At the organisational level, where improving quality is a continuous and collective endeavour, this practical wisdom can be aggregated into morisprudence, which is an ongoing formulation of moral judgements across cases encountered within the organisation. Focusing on the development of morisprudence enables refined scrutinisation of CESS-related quality claims. (shrink)

When clinical services aspire to quality improvement, creative and innovative approaches to old problems are needed to drive such change. Whilst new ef orts should be applauded, information on this topic can be somewhat grey from an ethical and research point of view. Within the mental health profession there is currently an expectation to routinely evaluate care and disseminate i ndings. The notion of service enhancements under the guise of routine practice is an interesting and untested ethical issue. (...) Should clinical innovation continue to enjoy such impunity as patient autonomy is often compromised as they are often compelled to accept treatment under the coercion of mental health legislation? We believe that it should not. All involvement in any form of research is voluntary, thus patients should also have the right to decline participation in quality projects if they wish to do so. (shrink)

Objective: To assess whether continuous consent, a process in which information is given to research participants at different stages in a trial, and clinician training in that process were effective when used by clinicians while gaining consent to the Total Body Hypothermia (TOBY) trial. The TOBY trial is a randomised controlled trial (RCT) investigating the use of whole-body cooling for neonates with evidence of perinatal asphyxia. Obtaining valid informed consent for the TOBY trial is difficult, but is a good (...) test of the effectiveness of continuous consent. Methods: Semistructured interviews were conducted with 30 sets of parents who consented to the TOBY trial and with 10 clinicians who sought it by the continuous consent process. Analysis was focused on the validity of parental consent based on the consent components of competence, information, understanding and voluntariness. Results: No marked problems with consent validity at the point of signature were observed in 19 of 27 (70%) couples. Problems were found mainly to lie with the competence and understanding of the parents: mothers, particularly, had problems with competence in the early stages of consent. Problems in understanding were primarily to do with side effects. Problems in both competence and understanding were observed to reduce markedly, particularly for mothers, in the post-signature phase, when further discussion took place. Randomisation was generally understood but unpopular. Information was not always given by clinicians in stages during the short period available before parents gave consent. Most clinicians, however, were able to give follow-up information. Discussion: Consent validity was found to compare favourably with similar trials examined in the Euricon study. Conclusion: Adopting the elements of the continuous consent process and clinician training in RCTs should be considered by researchers, particularly when they have concerns about the quality of consent they are likely to obtain by using a conventional process. (shrink)

Background The twenty-first century has witnessed an exponential increase in healthcare quality research. As such activities become more prevalent, physicians are increasingly needed to participate as subjects in research and quality improvement (QI) projects. This raises an important ethical question: how should physicians be remunerated for participating as research and/or QI subjects? Financial versus non-monetary incentives for participation Research suggests participation in research and QI is often driven by conditional altruism, the idea that although initial interest in (...) enrolling in research is altruistic or prosocial, decisions to actually perform study tasks are cost–benefit driven. Thus, the three models commonly employed to appropriately compensate participants (in-kind compensation such as travel reimbursement, paying market rates for the subject’s time, and paying market rates for the activity asked of the participant) are a poor fit when the participant is a clinician, largely due to the asymmetry between cost and benefit or value to the participant. Non-monetary alternatives such as protected time for participation, continuing education or maintenance of certification credit, or professional development materials, can provide viable avenues for reducing this asymmetry. Conclusion Research and QI are integral to the betterment of medicine and healthcare. To increase physician participation in these activities as the subject of study, new models are needed that clarify the physician’s role in research and QI as a subject. Non-monetary approaches are recommended to successfully and ethically encourage research and QI participation, and thus incorporate these activities as a normal part of the ethical clinician’s and successful learning healthcare system’s world view. (shrink)

__Improvement in Action_, Anthony S. Bryk’s sequel to _Learning to Improve_, illustrates how educators have effectively applied the six core principles of continuous improvement in practice._ The book highlights relevant examples of rigorous, high-quality improvement work in districts, schools, and professional development networks across the country. The organizations featured in the book have addressed, with remarkable results, long-standing inequitable educational outcomes in high school graduation rates, college readiness, and absenteeism. The cases emphasize the measures the educators (...) took and the thinking that motivated their actions. Bryk describes how improvers, working in different contexts and confronting different problems, used select principles, tools, and methods to make improvement come to life. Brief analytic reflections are embedded throughout the narratives, and each chapter concludes with an analysis of a set of larger lessons illuminated by the organization’s story. Taken as a set, these examples offer readers valuable insights about the actual dynamics of doing improvement work. _Improvement in Action_, paired with _Learning to Improve_, provides readers with a comprehensive understanding of the practice, method, and theory of large-scale continuous improvement in education. (shrink)

IntroductionPalliative care is an emotionally and spiritually high-demanding setting of care. The literature reports on the main issues in order to implement self-care, but there are no models for the organization of the training course. We described the structure of training on self-care and its effects for a Hospital Palliative Care Unit.MethodWe used action-research training experience based mostly on qualitative data. Thematic analysis of data on open-ended questions, researcher’s field notes, oral and written feedback from the trainer and the participants (...) on training outcomes and satisfaction questionnaires were used.ResultsFour major themes emerged: “Professional role and personal feelings”; “Inside and outside the team”; “Do I listen to my emotions in the care relationship?”; “Death: theirs vs. mine.” According to participants’ point of view and researchers’ observations, the training course resulted in ameliorative adjustments of the program; improved skills in self-awareness of own’s emotions and sharing of perceived emotional burden; practicing “compassionate presence” with patients; shared language to address previously uncharted aspects of coping; allowing for continuity of the skills learned; translation of the language learned into daily clinical practices through specific facilitation; a structured staff’s support system for emotional experiences.DiscussionSelf-care is an important enabler for the care of others. The core of our intervention was to encourage a meta-perspective in which the trainees developed greater perspicacity pertaining to their professional role in the working alliance and also recognizing the contribution of their personal emotions to impasse experienced with patients. (shrink)

The translational research community, in general, and the Clinical and Translational Science Awards (CTSA) community, in particular, share the vision of repurposing EHRs for research that will improve the quality of clinical practice. Many members of these communities are also aware that electronic health records (EHRs) suffer limitations of data becoming poorly structured, biased, and unusable out of original context. This creates obstacles to the continuity of care, utility, quality improvement, and translational research. Analogous limitations to sharing (...) objective data in other areas of the natural sciences have been successfully overcome by developing and using common ontologies. This White Paper presents the authors’ rationale for the use of ontologies with computable semantics for the improvement of clinical data quality and EHR usability formulated for researchers with a stake in clinical and translational science and who are advocates for the use of information technology in medicine but at the same time are concerned by current major shortfalls. This White Paper outlines pitfalls, opportunities, and solutions and recommends increased investment in research and development of ontologies with computable semantics for a new generation of EHRs. (shrink)

Understanding the components of clinical care that work best is a cornerstone of improving health care. And yet, the more we improve the quality of quality improvement and move to continuous learning about clinical care more broadly, the more we find ourselves in a regulatory environment that makes evaluation more difficult, expensive, and, in some situations, impossible. In their paper on the ethical underpinnings of the distinction between research and treatment, Ruth Faden and colleagues raise important (...) implications for a wide array of situations. These points give reason to rethink the definition of routine clinical operations to include evaluation of the processes and outcomes of care and dissemination of findings. We concur with the assertion by Faden and colleagues, and with previous work from The Hastings Center, that conducting continuous improvement activities such as these is an obligation of health systems and clinicians. We believe that rigorous, systematic evaluation should be considered part of normal, expected operations, rather than exceptional behavior that requires extraordinary regulatory control. (shrink)

A great need for systematic evaluation of ethics training programs exists. Those tasked with developing an ethics training program may be quick to dismiss the value of training evaluation in continuous process improvement. In the present effort, we use a case study approach to delineate how to leverage formative and summative evaluation measures to create a high-quality ethics education program. With regard to formative evaluation, information bearing on trainee reactions, qualitative data from the comments of trainees, in (...) addition to empirical findings, can ensure that the training program operates smoothly. Regarding summative evaluation, measures examining trainee cognition, behavior, and organization-level results provide information about how much trainees have changed as a result of taking the ethics training. The implications of effective training program evaluation are discussed. (shrink)

Obtaining a sufficient amount of measurable and reliable results of student surveys has always posed a challenge for university teams tasked with the provision of the quality of education. This is especially visible at faculties where education is based on the classic classroom-based model, which then transfers to clinical units, hospital wards, and specialist laboratories. The highly unpredictable pandemic situation caused by the SARS-CoV-2 virus raises the bar for the evaluation of didactics. Fortunately, the continuous technological progress in (...) the area of Artificial Intelligence makes it possible to design the implementation of tools that would improve the position of systems for the management of courses of studies. The evaluation survey for didactic classes, as one of the last output data obtained during the process, may finally become a fully recognized source of information about the conducted classes and the teachers themselves. On the other hand, it may become a tool for those surveyed to influence the quality of classes, express their opinion, present suggestions and propositions generally pertaining to changes in the process of education. New information technologies not only make it possible to improve the effectiveness of reaching the recipients, but also provide completely new, very reliable methods of acquisition of credible behaviour, used as integration data in solutions based on machine communication. Using Artificial Intelligence coupled with data may make it possible to use intelligent communication for effective management of the process of surveying – a solution that has so far been used in business, in the form of the so-called bots. As a result, this would lead to an ongoing, fully quantitative and qualitative, assessment of classes. (shrink)

DUREY A, WYNADEN D, THOMPSON SC, DAVIDSON PM, BESSARAB D and KATZENELLENBOGEN JM. Nursing Inquiry 2012; 19: 144–152 [Epub ahead of print]Owning solutions: a collaborative model to improve quality in hospital care for Aboriginal AustraliansWell‐documented health disparities between Aboriginal and Torres Strait Islander (hereafter referred to as Aboriginal) and non‐Aboriginal Australians are underpinned by complex historical and social factors. The effects of colonisation including racism continue to impact negatively on Aboriginal health outcomes, despite being under‐recognised and under‐reported. Many Aboriginal (...) people find hospitals unwelcoming and are reluctant to attend for diagnosis and treatment, particularly with few Aboriginal health professionals employed on these facilities. In this paper, scientific literature and reports on Aboriginal health‐care, methodology and cross‐cultural education are reviewed to inform a collaborative model of hospital‐based organisational change. The paper proposes a collaborative model of care to improve health service delivery by building capacity in Aboriginal and non‐Aboriginal personnel by recruiting more Aboriginal health professionals, increasing knowledge and skills to establish good relationships between non‐Aboriginal care providers and Aboriginal patients and their families, delivering quality care that is respectful of culture and improving Aboriginal health outcomes. A key element of model design, implementation and evaluation is critical reflection on barriers and facilitators to providing respectful and culturally safe quality care at systemic, interpersonal and patient/family‐centred levels. Nurses are central to addressing the current state of inequity and are pivotal change agents within the proposed model. (shrink)

All farmers have their own version of what it means to be a good farmer. For many US farmers a large portion of their identity is defined by the high input, high output production systems they manage to produce food, fiber or fuel. However, the unintended consequences of highly productivist systems are often increased soil erosion and the pollution of ground and surface water. A large number of farmers have conservationist identities within their good farmer identity, however their conservation goals (...) often need to be activated to rebalance the production-conservation meanings they give to their roles in society. In this paper we analyze US Cornbelt farmer interviews and surveys to trace how the performance-based environmental management process can be used to influence the farmer social identity and shift the overall good farmer identity towards a stronger conservationist standard. We find the continuous feedback loop in performance-based environmental management mimics the hierarchically organized feedback control processes of identity verification and can be used to help farmers activate their conservationist farmer identities at the person, role, and social levels to establish new norms for the practice of more sustainable agriculture. (shrink)

Patients have the right to refuse their treatment; however, this refusal should be informed. We evaluated the quality of the informed refusal process in Iranian hospitals from patients' viewpoints. To this end, we developed a questionnaire that covered four key aspects of the informed refusal process including; information disclosure, voluntariness, comprehension, and provider-patient relationship. A total of 284 patients who refused their treatment from 12 teaching hospitals in the Isfahan Province, Iran, were recruited and surveyed to produce a convenience (...) sample. Patients' perceptions about the informed refusal process were scored and the mean scores of the four components were calculated. The findings showed that the practice of information disclosure was perceived to be moderate, however, comprehension, voluntariness and provider–patient relationship were perceived to be relatively good. We found that patients, who refused their care before any treatment had commenced, reported a lower quality of information disclosure and voluntariness. Patients informed by nurses and those who had not had a previous related admission, reported lower scores for comprehension and relationship. In conclusion, the process of obtaining informed refusal was relatively satisfactory except for levels of information disclosure. To improve current practices, Iranian patients need to be better informed about; different treatment options, consequences of treatment refusal, costs of not continuing treatment and follow-ups after refusal. Developing more informative refusal forms is needed. (shrink)

Total Quality Management (TQM) is an overall management philosophy that includes a set of principles whose application is increasing. In fact, the business world and public institutions, such as hospitals, universities or city councils, are implementing quality programs. However, despite the wide diffusion of TQM, the success rate of this type of initiative is limited and the results, heterogeneous. Academics and professionals are therefore trying to identify the keys that explain the success or failure of this kind of (...) initiative. Different explanations have been given, but most of the literature agrees that managerial commitment, implication and leadership are indispensable elements in a successful implementation of TQM. Nevertheless, a study on the specialised literature shows a terminological confusion between managerial commitment and managerial leadership. Is it the same to have a committed manager in the implementation process as to have a leader of the implementation process? The author of this paper defends the thesis that "commitment" and "leadership" are not synonymous, and states that only managerial leadership is able to promote and sustain profound organisational changes. The paper will show that, to understand the previous distinction, it is necessary to consider the ethical dimension of leadership. While committed managers may lead the process by using exclusively their power (with the necessary resource assignment), those who are leaders need authority. Authority goes further than power by generating a kind of confidence (trust) that is able to influence the members of the organisation and bring about profound changes, more than power alone can do. (shrink)

Driven by recent accreditation mandates, a changing legal environment, and multiple high-visibility corporate ethics scandals, many business schools are responding to the growing movement within higher education to integrate ethics into the curricula. The literature suggests that the amount of attention given to ethics varies widely among institutions, and has not been coherently developed. Moreover, institutions have struggled to tie related projects and instruction to the overall concept of assurance of student learning. The purpose of this paper is to provide (...) a framework for institutions interested in creating an interdisciplinary business ethics program that combines critical success factors, assurance of student learning and continuous quality improvement. Using a nationally recognized business school’s ethics program, we provide an example of how our model can be applied at other institutions based on their own unique vision, mission and goals. (shrink)

Mit Inkrafttreten des Sozialgesetzbuches V, das in seinem §137 auch Krankenhäuser zu Qualitätssicherung verpflichtet, kann sich seit Ende der 80er Jahre kein Fachgebiet der Medizin mehr gegenüber der Teilnahme an qualitätssichernden Maßnahmen verschließen. Die gesetzlichen Grundlagen zur Einhaltung von Normen und definierten Abläufen zur Reproduzierbarkeit von Ergebnissen, die für den labormedizinischen und apparativen Bereich in der Forschung und Technik schon länger bestehen, haben den Bereich der medizinischen Versorgung erreicht [10, 11, 18]. Ziel der Maßnahmen ist es, die Struktur-, Prozeß- und (...) Ergebnisqualität der medizinischen Versorgung zu beeinflussen und einen immer besseren Stand der Versorgung zu erreichen („continuing quality improvement“/Qualitätsspirale). So sind nicht nur Steigerungen der Lebensqualität behandelter Patienten, Verbesserungen der Versorgungsstruktur und des Arbeitsumfeldes, der Aus- und Weiterbildung der medizinischen Berufsgruppen, sondern auch ökonomisch relevante Kosteneinsparungen durch Prozeßoptimierung möglich. Allerdings sind qualitätssichernde Aspekte in der medizinischen Behandlung und das Bewußtsein für die Berufsethik durchaus nicht neu. Bereits in der Antike war der zufriedene, erfolgreich behandelte Patient ein Aushängeschild für den behandelnden Praktiker und im Interesse der Gesellschaft. In vielen Kulturen gab und gibt es oft religiös begründete, berufsethische, gesetzliche Grundlagen oder auch traditionelle Riten dazu, wie Erfolg und Mißerfolg der Behandlung eines Menschen durch einen Arzt bestraft oder eben belohnt werden sollten. (shrink)

The aim of this research is to analyze the effects of innovation strategies, Total Quality Management dimensions, and internationalization strategies that Higher Education Institutions might adopt, and their effects on their organizational performance. Due to globalization and the constant changes and demands that have taken place today, HEIs are forced to seek new quality assurance instruments in higher education, to ensure greater competitiveness in the markets and their survival. To examine the association between the independent variables, namely, TQM (...) dimensions, innovation strategies, and internationalization strategies with the dependent variable, that is organizational performance of HEIs, we have chosen to use multiple linear regression analysis. A nine-predictor multiple linear regression model was proposed. The nine predictor variables are Communication, Involvement/teacher empowerment, Development/Teacher training, Continuous improvement, Leadership/Administration’s Commitment, Data analysis/Measurement of results, Focus on students, Innovation Strategies, and Internationalization strategy. We conclude that some TQM variables have a significant association with the organizational performance of HEIs, namely, Involvement/teacher empowerment, and Development/teacher training. On the other hand, also the Innovation strategies and Internationalization strategy have a significant association with the organizational performance of HEIs. This research is of enormous importance for the study of HEIs, considering their role in the development of any country and its impact on society as creators of knowledge and science. Since these institutions increasingly must deal with extremely competitive market environments, knowledge of the factors that can assist in increasing the organizational performance of HEIs is of great relevance. (shrink)

There are not enough solid organs available to meet the needs of patients with organ failure. Thousands of patients every year die on the waiting lists for transplantation. Yet there is one currently available, underutilized, potential source of organs. Many patients die in intensive care following withdrawal of life-sustaining treatment whose organs could be used to save the lives of others. At present the majority of these organs go to waste.In this paper we consider and evaluate a range of ways (...) to improve the number and quality of organs available from this group of patients. Changes to consent arrangements (for example conscription of organs after death) or changes to organ donation practice could dramatically increase the numbers of organs available, though they would conflict with currently accepted norms governing transplantation.We argue that one alternative, Organ Donation Euthanasia, would be a rational improvement over current practice regarding withdrawal of life support. It would give individuals the greatest chance of being able to help others with their organs after death. It would increase patient autonomy. It would reduce the chance of suffering during the dying process. We argue that patients should be given the choice of whether and how they would like to donate their organs in the event of withdrawal of life support in intensive care.Continuing current transplantation practice comes at the cost of death and prolonged organ failure. We should seriously consider all of the alternatives. (shrink)

The article introduces a new international educational community based on Students’ Quality Circles, in which industry and education have learned to collaborate for mutual benefit. In each country represented in this special issue, there have been distinctive bottom-up initiatives, informed by the experience of collaboration. We emphasise Quality as Empowerment.

Reducing the global treatment gap for mental health conditions in low- and middle-income countries requires not only an expansion of clinical psychology training but also assuring that graduates of these programs have the competency to effectively and safely deliver psychological interventions. Clinical psychology training programs in LMICs require standardized tools and guidance to evaluate competency. The World Health Organization and UNICEF developed the “Ensuring Quality in Psychological Support” platform to facilitate competency-based training in psychosocial support, psychological treatments, and foundational (...) helping skills, with an initial focus on in-service training for non-specialists. Our goal was to design the first application of EQUIP to implement competency-based training into pre-service education for clinical psychology trainees. With Makerere University in Uganda as a case study, we outline an approach to develop, implement, and evaluate a competency-based curriculum that includes seven steps: Identify core clinical psychology competencies; Identify evaluation methods appropriate to each competency; Determine when competency evaluations will be integrated in the curriculum, who will evaluate competency, and how results will be used; Train faculty in competency-based education including conducting competency assessments and giving competency-based feedback; Pilot test and evaluate the competency-based education strategy with faculty and students; Modify and implement the competency-based education strategy based on pilot results; and Implement ongoing evaluation of the competency-based curriculum with continuous quality improvement. This approach will be formally evaluated and established as a foundation for pre-service training in other low-resource settings. (shrink)

As medical technology continues to improve, more people will live longer lives with multiple chronic illnesses with increasing cumulative debilitation, including cognitive dysfunction. Combined with the aging of society in most developed countries, an ever-growing number of patients will require surrogate decision-makers. While advance care planning by patients still capable of expressing their preferences about medical interventions and end-of-life care can improve the quality and accuracy of surrogate decisions, this is often not the case, not infrequently leading to demands (...) for ineffective, inappropriate and prolonged interventions. In 1980 LaFollette called for the licensing of prospective parents, basing his argument on the harm they can do to vulnerable people. In this paper, I apply his arguments to surrogate decision-makers for cognitively incapacitated patients, rhetorically suggesting that we require potential surrogates to qualify for this position by demonstrating their ability to make reasonable and rational decisions for others. I employ this theoretical approach to argue that the loose criteria by which we authorize surrogates’ generally unchallenged power should be reconsidered. (shrink)

The idea of the Internet as Gutenberg 2.0—a true revolution in disseminating information—is now a routine part of how bioethics education works. The Internet has become indispensable as a channel for sharing teaching materials and connecting learners with a central platform that houses materials to support an online or hybrid curriculum or a traditional course. A newer idea in bioethics education reflects developments in web-based medical education more broadly and draws on design principles developed for the Internet. This approach to (...) online bioethics education requires thinking about web-based learning as an engaging, potentially immersive experience, about learners' expectations concerning web-based learning, and about differences between self-directed learning and teaching to support group learning. In clinician education in bioethics, the interrelated goals of ethical reflection and practice for professionals and of continuous quality improvement in health care are supported by a focus on real-world challenges and by encouraging the habits of self-directed learning. In this paper, we describe how an international, interdisciplinary team used a web-based framework to develop a health care ethics casebook whose content, design, and pedagogy were tailored to the needs and expectations of health care professionals and other audiences in Singapore; we also explain how they used this framework to make the casebook accessible nationwide and to support cross-cultural learning. (shrink)

Assess to quality diets is a basic human right. Geographical challenges and cultural traditions have contributed to the widespread malnutrition present among ethnic minorities of mountainous areas in Northwest Vietnam. Home gardens can play a role in increased diet diversity and micronutrient intakes. However, low production yields and plant diversity in ethnic home gardens have limited their contributions to household food security and nutrition. The pilot study tested a home garden intervention in weekly vegetable harvests and increasing household production (...) and consumption of diverse vegetables year-round. Food ethics issues encountered included limited access to quality food by resource-poor groups, conflicts arising from low preference and value given to some nutritious foods, limited access to information and technology for food production and consumption, each of which were addressed in the study design. The intervention includes: (1) nutrition-focused home garden training and (2) locally-adapted home garden packages consisting of garden planning, technical assistance, and high-yielding seed varieties. Twenty households from two ethnic villages in Son La province participated in the study and were randomly assigned into two groups (intervention and non-intervention). The total vegetable supply from weekly harvests of home garden produce was significantly higher in the intervention households (226 kg) compared to the non-intervention households (39 kg). The intervention group yielded 5.8 and 1.7 times more vegetables by weight and weight per area than those without the intervention. The vegetables were mainly consumed at home for both groups, but the intervention households gave more vegetables as gifts to neighbors. The intervention group cultivated a higher diversity of vegetables with a total of 42 different vegetables compared to 24 in the non-intervention group, which is reflected in an overall higher nutritional yield of vitamin A, iron, other micronutrients and phytochemicals. The home garden training significantly improved the amount, diversity and continuity of household food and nutrient supply. The home garden model is effective and could be scaled up to improve household vegetable supply and consumption, particularly in Northwest Vietnam. (shrink)

BackgroundThe issue of stigma is very important in the battle against HIV/aids in Africa since it may affect patient attendance at healthcare centres for obtaining antiretroviral medications and regular medical check-ups. Stigmatization creates an unnecessary culture of secrecy and silence based on ignorance and fear of victimization. This study was designed to determine if there is external stigmatization of people living with HIV and AIDS by health care workers at a tertiary hospital in KwaZulu-Natal province, South Africa. The study investigated (...) the impact of knowledge of HIV/aids by HCWs on treatment of patients, as well as the comfort level and attitude of HCWs when rendering care to PLWHA.MethodsA descriptive cross sectional study was designed to collect data using an anonymous self-administered structured questionnaire from 334 HCWs. The study was conducted in clinical departments of a large multidisciplinary 922-bed tertiary care teaching hospital in Durban, KZN.ResultsOverall HCWs had an above average knowledge about HIV/aids although some gaps in knowledge were identified. Tests of statistical significance showed that there was association between level of education and knowledge of HIV/aids ; occupation and knowledge of HIV/aids ; and gender and knowledge of HIV/aids. Test for comfort level was only significant for gender, with males showing more comfort and empathy when dealing with PLWHA. The study also revealed that patients were sometimes tested for HIV without informed consent before surgery, due to fear of being infected, and there was some gossiping about patients' HIV status by HCWs, thereby compromising patient confidentiality. The majority of HCWs showed a willingness to report incidents of stigmatization and discrimination to higher authorities, for better monitoring and control.ConclusionsAlthough knowledge, attitude and comfort level of HCWs taking care of PLWHA was above average, enforcement of existing antidiscrimination laws and continuing education in medical ethics and healthcare law, would greatly improve the performance of HCWs taking care of PLWHAs. More psychological support and counselling should be provided to HCWs, to further reduce the impact of stigmatization and discrimination against PLWHA. (shrink)

An orthodoxy has arisen which claims that there is a crisis in the United States health care system such that the system needs to be reformed. This essay challenges that orthodoxy by showing that we do not have a health care system in the United States. We have a non-system of health care, just as we do for virtually all basic social institutions. Challenging the current orthodoxy surfaces two ethical issues that have been ignored: creating a health care system will (...) (a) cause resurgent paternalism and (b) pose a threat to moral pluralism. Keywords: Health care policy, managed care, paternalism, moral pluralism, institutional integrity, total quality management, continuous quality improvement CiteULike Connotea Del.icio.us What's this? (shrink)

Managed care is evolving in ways that pose unique ethical challenges to those interested in the intersection of clinical and organizational ethics. For example, Disease Management is a form of managed care that has emerged in response to chronic illness. DM is a healthcare management tool that coordinates resources across an entire health care delivery system and throughout the life cycle of chronic disease. Health Maintenance Organizations have reduced some costs in the delivery of acute care, but real cost savings (...) will result only with greater efficiencies in the delivery of costly chronic care. DM is a systematic, population-based approach that identifies persons at risk of chronic ailment, intervenes with specific programs of care, measures clinical and other outcomes, and provides continuous quality improvement. Characterized as a movement to patient-driven services, DM involves a complex web of provider relations. (shrink)

Managed care is evolving in ways that pose unique ethical challenges to those interested in the intersection of clinical and organizational ethics. For example, Disease Management is a form of managed care that has emerged in response to chronic illness. DM is a healthcare management tool that coordinates resources across an entire health care delivery system and throughout the life cycle of chronic disease. Health Maintenance Organizations have reduced some costs in the delivery of acute care, but real cost savings (...) will result only with greater efficiencies in the delivery of costly chronic care. DM is a systematic, population-based approach that identifies persons at risk of chronic ailment, intervenes with specific programs of care, measures clinical and other outcomes, and provides continuous quality improvement. Characterized as a movement to patient-driven services, DM involves a complex web of provider relations. (shrink)

Conventional wisdom and many published histories of “Green Chemistry” describe its start as being a result of governmental and/or regulatory actions at the US Environmental Protection Agency during the early 1990’s. But there were many Real World industrial examples of environmentally friendly commercial processes in the oil and commodity chemicals industries for decades prior to the 1990s. Some early examples of commercial “Green Chemistry” are briefly described in this article. The Boots/Hoechst Celanese Ibuprofen process was one of the earliest multiple-award-winning (...) examples of industrial “Green Chemistry” in the fine chemical/pharmaceutical industry. The author, who conceived the BHC Ibuprofen synthetic strategy in 1984, reveals and documents that the BHC Ibuprofen process was not primarily a result of governmental or regulatory mandates, or environmentalist or political motivations. The BHC ibuprofen process, and probably many other early industrial “green” inventions, evolved from, and their development and commercialization motivated and guided by, a long prior industrial culture of both scientific and technical evolution. The invention and commercialization of these early industrial commercialized processes, and the BHC Ibuprofen process were also guided by both competitive and economic market needs, personal human motivations, and a low waste culture of “Quality” and “Continuous Improvement” that the commodity chemical industry internally promoted in the 1980’s. The author comments on some perceptions of the status of Green Chemistry now, and directions it should consider going in the future. The author recommends that young Green Chemists and/or Green Engineers reconsider “Quality” approaches in order to genuinely lead Society toward a Greener future. (shrink)

Hoarding disorder is a psychiatric condition characterized by difficulty discarding items and accumulation of clutter. Although studies have established the negative impact of HD and compulsive hoarding behavior, fewer have examined the impact on quality of life of hoarding behavior independent of obsessive–compulsive disorder. Moreover, specific aspects of QoL such as success in work/academics or satisfaction with interpersonal relationships have not been well-investigated. In this study, we examined, in a sample of 2100 adult participants obtained from Amazon Mechanical Turk, (...) the relationships between hoarding, OCD, and depression symptomatology and four QoL domains derived from a factor analysis of the Quality of Life Inventory. We performed linear regressions to examine associations between psychiatric symptomatology and QoL domains and then conducted mediation analyses to investigate the role of depressive symptomatology in the identified relationships. We found that while hoarding and obsessive–compulsive symptoms were both negatively associated with QoL, they were associated with different domains [hoarding was significantly associated, and was less strongly associated with success or enrichment. Mediation analyses confirmed the role of depression as a complete mediator of hoarding’s effect on total, environment, and family QoL, and as a partial mediator of hoarding’s effect on success and enrichment QoL. Further examination of the relationship between hoarding symptoms and QoL in those with mild, moderate, and severe depression indicated that in those with more severe depression, hoarding was associated with improved QoL, indicating a possible buffering or compensatory effect. The findings suggest a differential impact of hoarding and obsessive–compulsive symptoms on QoL and emphasize the importance of considering co-morbid depressive symptoms in designing more targeted interventions. Future studies should continue to investigate these complex relationships, given the high co-morbidity of hoarding and depression. (shrink)

Background The recent proliferation of health care report cards, especially in cardiac care, has occurred in the absence of an ethical framework to guide in their development and implementation. An ethical framework is a consistent and comprehensive theoretical foundation in ethics, and is formed by integrating ethical theories, relevant literature, and other critical information (such as the views of stakeholders). An ethical framework in the context of cardiac care provides guidance for developing cardiac report cards (CRCs) that are relevant and (...) legitimate to all stakeholders. The purpose of this study is to develop an ethical framework for CRCs. Methods Delphi technique – 13 panelists: 2 administrators, 2 cardiac nurses, 5 cardiac patients, 2 cardiologists, 1 member of the media, and 1 outcomes researcher. Panelists' views regarding the ethics of CRCs were analyzed and organized into themes. Results We have organized panelists' views into ten principles that emerged from the data: 1) improving quality of care, 2) informed understanding, 3) public accountability, 4) transparency, 5) equity, 6) access to information 7) quality of information, 8) multi-stakeholder collaboration, 9) legitimacy, and 10) evaluation and continuous quality improvement. Conclusion We have developed a framework to guide the development and dissemination of CRCs. This ethical framework can provide necessary guidance for those generating CRCs and may help them avoid a number of difficult issues associated with existing ones. (shrink)

This work is developed to improve the current quality of e-commerce logistics services. From the perspective of multiple consumer psychology, based on e-commerce, consumer psychology, and other related theories, vegetable e-commerce B is selected as the research object. The commodity quality, accuracy, and timeliness of commodity distribution and other factors of e-commerce B are discussed through questionnaire survey. Then, according to customers’ opinions about “e-commerce B’s distribution and professional aspects that need to be improved,” the research is conducted. (...) Finally, the direction of follow-up optimization is proposed from four different perspectives of multiple consumption psychology. The research results show that more than 89% of the surveyed customers believe that e-commerce B does a good job in terms of commodity quality, accuracy, and timeliness of commodity distribution, and has a high level of logistics service. However, 26.34% of customers hope that e-commerce B can strengthen the protection of personal privacy, 24.97% hope that the platform can add “delay insurance” for goods, and 39.54% hope that the logistics information of purchased goods can be updated in real time. Therefore, e-commerce B needs to be optimized and improved continuously in the future development. Therefore, research on the optimization of logistics service quality of e-commerce is performed under multiple consumption psychology, which provides certain help for the rapid development of subsequent e-commerce. (shrink)

Two major management philosophies of the 20th Century, scientific management and quality management, are often contrasted. Scientific management is seen as a system that focuses on task efficiencies whereas quality management is described as a collaborative, people-centered process approach to continuous improvement. This paper examines the ethical implications of these diverse approaches, particularly in the way information is used to decide which employees to lay off in times of economic difficulty. The paper uses case examples of (...) quality management as teaching tools to place the conduct of managers within utilitarian, deontological and justice approaches to ethical decision making. Finally, it suggests that a third system, open-book management, may help deal with this ethical dilemma, though not without risk. (shrink)

With the widespread application of information technology and the continuous deepening of my country’s education informatization construction, the educational field has increasingly higher requirements for teachers’ informatization quality. The advancement of the process of education informatization depends to a large extent on the level of teachers’ own level of informatization and has gradually become an important indicator to measure the informatization of education. The main body of education and the decisive factor are teachers. The scientific and reasonable evaluation (...) of informatization education is an important content of today’s education informatization. This paper uses regression analysis to evaluate the teacher education information system and uses mathematical statistics to establish a linear regression model for the city and analyze and calculate it. Through the quantitative analysis of the evaluation index system of the education informatization level, the multiple linear regression analysis method was used to establish the linear regression mathematical model of the school education informatization level on each secondary index, and the influence of various indicators on the school education informatization level was analyzed to establish a scientific evaluation system to evaluate the literacy of teachers’ informatization education and to give suggestions for improving the level of school education informatization. The design of the evaluation system is more scientific and reasonable, the regression error is small, the results obtained are more accurate, and the impact of nonlinear errors is basically eliminated. (shrink)

As we write this paper in spring 2008, many are hopeful that November’s election will open the door to some form of comprehensive health care reform. In all likelihood, we will elect a president who has campaigned to a greater or lesser extent on promises of improving access to health care, improving quality, and reducing costs. Equally important, it seems likely that the 111th Congress is preparing to undertake meaningful health care reform. And perhaps most important, despite recent attention (...) to energy issues and the economy, opinion polls consistently show that the American public continues to rank health care as one of the two or three most important domestic issues in the fall elections and supports comprehensive health care reform. (shrink)

In Quebec, a Committee on Teacher's Formation and Improvement suggested to the Ministry of Education, in 1979, that university research be carried out in collaboration with teachers and contribute to the improvement of the quality of teacher formation. The Committee proposed that university and school work together, think together and discuss together problems related to children and education.

Livestock are important assets in Africa, helping improve the nutritional status of their owners, and contributing to economic growth. Can these roles continue and can livestock production systems be further developed so that they will be sustainable? A key feature of livestock in Africa is that they fulfill multiple roles, ranging from draught power, to providing manure, milk, and meat. Constraints to increasing productivity include both physical and institutional. In the former category, constraints to adopting draught power include insufficient numbers (...) at the individual household level. Lack of adequate pasture is probably the most important constraint. Diseases are also notable constraints to improving productivity, particularly those categorized as Group I (highly contagious — e.g., rinderpest) or Group II (vector-borne parasitic and viral—e.g., trypanosomiasis). Institutional constraints include lack of research and market distortions. To improve productivity, at the macroeconomic level, governments must continue or start policies aimed at liberalizing markets and revaluing exchange rates. Also, research institutions need an increase in funding for periods of ten or more years. Research and other livestock institutions may be able to leverage limited resources by forming more collaborative relationships at the regional level. Research priorities include breeding on specific aspects, such as increased milk production. However, it must be realized that breeding programs have an inherent problem in disseminating improved breeds in a rapid and equitable manner. Quality of pasture may be improved by further research on more accurately calculating stocking rates and on developing mechanisms to control numbers on pastures (e.g., community controlled grazing schemes). Other research priorities include new technologies to improve animal health, funding of micro-enterprises to add value to livestock products, and market information systems for small-scale farmers. Schemes to increase livestock production in Africa will only occur if innovations closely match the local sets of circumstances. Given the multiple roles of livestock, research into innovations that local communities will readily adopt must take a systems approach. (shrink)

Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine of University Eduardo Mondlane and the Maputo Central Hospital established a joint Institutional Committee on Bioethics for Health. This study examines the experience of the first 4 years of the CIBS FM (...) & MCH. This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee’s respective reviews and actions. A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master’s degree research. Descriptive cross-sectional studies were the most frequently reviewed research. The majority were prospective and used quantitative methodologies. The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS’s average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS. Our results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training and ethical capacity building for CIBS across the country continue to be needed, as Mozambique develops greater capacity for research and makes progress toward improving the health of all its citizens. (shrink)

In 2012, a U.S. Institute of Medicine report called for a different approach to health care: “Left unchanged, health care will continue to underperform; cause unnecessary harm; and strain national, state, and family budgets.” The answer, they suggested, would be a “continuously learning” health system. Ethicists and researchers urged the creation of “learning health organizations” that would integrate knowledge from patient‐care data to continuously improve the quality of care. Our experience with an ongoing research study on atrial fibrillation—a trial (...) known as IMPACT‐AFib—gave us some insight into one of the challenges that will have to be dealt with in creating these organizations. Although the proposed educational intervention study placed no restrictions on what providers and health plans could do, the oversight team argued that the ethical principle of beneficence did not allow the researchers to be “bystanders” in relation to a control group receiving suboptimal care. In response, the researchers designed a “workaround” that allowed the project to go forward. We believe the experience suggests that what we call “bystander ethics” will create challenges for the kinds of quality improvement research that LHOs are designed to do. (shrink)

This study aims to look at the role of the practice of excellence strategies in education in achieving sustainable competitive advantage for the Higher educational institutions of the faculty of Engineering and Information Technology at Al-Azhar University in Gaza, a model, and the study considered the competitive advantage of educational institutions stems from the impact on the level of each student, employee, and the institution. The study was based on the premise that the development of strategies for excellence in education, (...) and its implementation is a vital important prerequisite to achieve sustainable competitive advantage in higher educational institutions. The study followed a systematic exploratory descriptive methodology through review of the theoretical literature, and the adoption of the experience of the Faculty of Engineering and Information Technology at Al-Azhar University in Gaza as a model for its unique experience in the field of excellence in education. The study results showed that the most important are: There is a strong correlation between the level of exercising excellence strategies in education and the achievement of higher educational institutions to the sustainable competitive advantage. The results include a general required number of important sub results on the subject of the model - Faculty of Engineering and Information Technology at Al-Azhar University in Gaza as follows: - The student considered the academic focus of the operation in the development process of the workers’ skills, particularly academics at the university helps to distinguish students and increase the employment rate after graduation. - The existence of consistency in development efforts and quality improvement for all three levels (student, employee, and the university), and this contributes to the Faculty excellence. - The Faculty has been able to achieve competitive advantages by offering excellent services without harming the efficiency, and this alone is a great success because improving service properties requires great investments, which negatively affect the continued institutional development. The study also reached a set of recommendations as follows: - The need to exercise excellence strategies in education, excellence reward at the national level, and those higher educational institutions follow the criteria for measuring the competitive advantages of its institutions always. - There is a need to increase efforts to implement programs of excellence, the allocation of adequate time, reward outstanding efforts as well. There is a necessity for each faculty to achieve competitive advantage and sustainability, using the general philosophies of competitive advantage, but with a different strategically content from what is in the private commercial sector, it reflects the Faculties mission and objectives, depending on making improvements and excellence in processes that ensure the safety of its outputs. As well as the need to find a balance between the work of teaching and research work of the faculty members, this has important implications regarding the criteria used in the process of excellence evaluation. The study recommended the adoption of strategies for excellence in education on a national public policy level mainly in the processes of change in higher education institutions. The need to support the existence of a common understanding of the efforts of excellence to create a general culture that appreciates excellence in faculties and universities. This underlines the need for transparent, fair rewards systems, to encourage innovation in education. The need to conduct a comprehensive surveys on the graduates of faculties and universities including the areas of employment and skills, because that will give accurate indications of the graduates and will help to establish a link to a more precise about the relationship of excellence strategies with the competitive advantages. (shrink)

In 2020, COVID-19 patients overwhelmed hospital beds in several Spanish cities, producing an increase in mortality derived from a lack of resources. The provision of new spaces to be reconfigured as healthcare centers for COVID patients was one of the measures implemented. In Madrid, two of these COVID centers drew enormous media and political repercussions due to their high cost and the controversy surrounding the quality of the care they offered. In this scenario of misinformation, several doctors and patients (...) rejected to be transferred to such medical centers, but they were nonetheless compelled to make the move. This manuscript underscores how this lack of transparency affects health workers, patients, and the relationship between them, and brings out the question of how many essential bioethical principles can be individually violated by a matter of public health. New guidelines for the transfer of patients should be designed from an ethical perspective and updated, as the epidemic continues, to improve the modern understanding of human factors in times of uncertainty. The lesson that these centers provide us is that we must rethink crisis resource management from a new perspective that prioritizes access to quality information. In its absence, the principle of autonomy must prevail. (shrink)

In 2012, a U.S. Institute of Medicine report called for a different approach to health care: “Left unchanged, health care will continue to underperform; cause unnecessary harm; and strain national, state, and family budgets.” The answer, they suggested, would be a “continuously learning” health system. Ethicists and researchers urged the creation of “learning health organizations” that would integrate knowledge from patient‐care data to continuously improve the quality of care. Our experience with an ongoing research study on atrial fibrillation—a trial (...) known as IMPACT‐AFib—gave us some insight into one of the challenges that will have to be dealt with in creating these organizations. Although the proposed educational intervention study placed no restrictions on what providers and health plans could do, the oversight team argued that the ethical principle of beneficence did not allow the researchers to be “bystanders” in relation to a control group receiving suboptimal care. In response, the researchers designed a “workaround” that allowed the project to go forward. We believe the experience suggests that what we call “bystander ethics” will create challenges for the kinds of quality improvement research that LHOs are designed to do. (shrink)

The Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. There has been progress in realizing the IOM's vision, but also many challenges. One of these challenges has been lingering uncertainty about whether the data collection and (...) monitoring central to learning health care systems is actually research and if so, what kind of ethical oversight it should have. This is not a new question. Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems. Two companion feature articles in this volume, by a team at Johns Hopkins, fill this void. (shrink)

The U.S. Court of Appeals for the Third Circuit held, in Brader v. Allegheny General Hospital, 167 E3d 832, that the Health Care Quality Improvement Act, 42 U.S.C. §§ 11101-11152, shields a Pennsylvania hospital from a surgeon's claims of contract violations.The plaintiff, Alan Brader, M.D., joined Allegheny General Hospital's provisional medical staff in July 1988. During the next two years, he performed several abdominal aortic aneurysm repairs and various other operations. Several of Brader's patients sustained serious injuries or (...) died during surgery from complications. In 1989, Brader's supervisors, Drs. Daniel Diamond and George Magovern, met to discuss their dissatisfaction with Brader's behavior, his departures from hospital protocol, as well as his disruptive presence in the hospital. From 1989 to 1990, Brader continued to perform surgical procedures on incoming patients, and he continued to violate hospital notification protocol and lost a patient during surgery. In spring 1990, the Quality Assurance Department compiled data on AAA procedures for the hospital's physicians. (shrink)

The Office of Human Research Protections was not justified in issuing findings against the SUPPORT Institutions. Our community can learn from the evolving healthcare transformation into learning health systems by thinking about the novel ethical issues about standard of care research raised by the SUPPORT with the same spirit of quality improvement. The current regulatory framework and the concept of foreseeable research risks is insufficient to advance the debate about the ethics of randomization of standard clinical interventions. This (...) article uses the example of the Wisconsin cystic fibrosis randomized clinical trial for newborn screening trial to explore the distinctions between risks of research and clinical care and waivers of informed consent for randomization. Collaborative exploration of these complex policy issues is needed and further deliberation, community engagement, and social science research will be critical to advance novel approaches for informed consent. (shrink)