The Department of Health's Review of the Human Fertilisation and Embryology Act 1990 is a comprehensive public consultation on the regulation of the storage and use of gametes and embryos for fertility treatment and research in the UK. The consultation considers a range of issues, including the model and scope of regulation and proposals for a single body, the Regulatory Authority for Tissue and Embryos, to replace both the Human Fertilisation and Embryology Authority and the Human Tissue Authority (...) by April 2008. The Department of Health published its report on the consultation in March 2006, and this is discussed here in relation to both the support and criticisms of the model and scope of the current and proposed regulatory frameworks, particularly with regard to policy decision-making by bodies such as HFEA and RATE. (shrink)

Background This article describes the issues encountered when designing a study to evaluate recruitment of minority ethnic groups into clinical cancer research in order to monitor adherence to the principles for good practice set out in the Department of Health, Research Governance Framework, England. Methods (i) A review of routine data sources to determine whether their usefulness as a source of data on prevalence of cancer in the population by ethnic category. (ii) A local case study at one (...) hospital trust to ascertain whether the ethnicity of cancer trial participants was representative of admitted cancer patients. Results (i) The lack of a comparator population makes it problematic to assess recruitment levels by ethnic group in clinical research. (ii) The odds of being in a trial were 30% lower for a member of a minority ethnic group compared to a white cancer patient after adjusting for disease, age and gender, OR 0.70 (0.53 to 0.94). These results differed for each ethnic group; Asian patients did not appear under-represented while Black and Chinese did so. However, there are important caveats to the findings based on the limited recording of ethnicity. Conclusions The lack of available data on the ethnicity of participants in clinical research and the prevalence of cancer in the population according to ethnicity makes it difficult to design a study to monitor representation of minority ethnic groups. This information is necessary to assess adherence to the Research Governance Framework principle that research evidence reflects the diversity of the population. (shrink)

This article is a response to the letter from the Department of Health that was published in the previous edition of the Research Ethics Review upon the matter of the legal duty of the research ethics committees. It also deals briefly with the article published in the current edition of Research Ethics Review by Colin Parker on what appears to be the same topic.

BackgroundThe Freedom of Information Act (FOIA) provides access to unreleased government records that can be used to enhance the transparency and integrity of biomedical research. We characterized FOIA requests to Department of Health and Human Services (HHS) agencies, including request outcomes, processing times, backlogs, and costs.MethodsUsing HHS FOIA annual reports, we extracted data on the number of FOIA requests received and processed by HHS agencies between 2008 and 2017, as well as request outcomes. Processing times were reported in (...) three time increments, < 1–20, 21–60, or 61+ days, and trends in backlog status were also described. Information about costs and fees collected were aggregated.ResultsBetween 2008 and 2017, 69.6% of 530,094 HHS FOIA requests were received by the Centers for Medicare and Medicaid Services (CMS), 18.9% by the Food and Drug Administration (FDA), and 11.6% by all other HHS agencies. During this period, CMS processed 374,728 requests, FDA 114,938, and other HHS agencies 61,890. CMS and FDA reduced backlogged requests by 9396 (89.7%) and 4289 (65.3%), respectively, leaving backlogs of 1081 and 2279 requests at the end of 2017. CMS fully or partially granted 60.3% of requests whereas FDA fully or partially granted 72.4%. Of all requests to CMS, 82.0% were considered simple and 18.0% complex; 82.2% of simple requests and 54.9% of complex requests were processed in 20 days, and 5.6% and 29.9% were processed in 61+ days. In contrast, 60.2% of requests to FDA were considered simple and 39.8% complex; 28.8% of simple requests and 9.0% of complex requests were processed in 20 days, and 58.3% and 81.5% were processed in 61+ days. The costs to HHS associated with FOIA requests totaled $446.4 million ($809 per processed request), increasing from $28.1 million ($423 per request) in 2008 to $53.3 million ($1544 per request) in 2017. In total, HHS collected $8.5 million in fees (1.9% of total costs).ConclusionsFOIA is frequently used to obtain information about HHS and its agencies. With growing costs, minimal fees collected, and lengthy processing times, HHS agencies’ FOIA programs might be made more efficient through greater proactive record disclosure. (shrink)

Recent frameworks, models, and reports highlight the critical need to address social determinants of health for achieving health equity in the United States and around the globe. In the United States, data play an important role in better understanding community‐level and population‐level disparities particularly for local health departments. However, data‐driven decision‐making—the use of data for public health activities such as program implementation, policy development, and resource allocation—is often presented theoretically or through case studies in the literature. (...) We sought to develop a preliminary model that identifies the factors that contribute to data‐driven decision‐making in US local health departments and describe relationships between them. Guided by implementation science literature, we examined organizational‐level capacity and individual‐level factors contributing to using data for decision‐making related to social determinants of health and the reduction of county‐level disparities. This model has the potential to improve implementation of public health interventions and programs aimed at upstream structural factors, by elucidating the factors critical to incorporating data in decision‐making. (shrink)

A significant number of inmates with mental illness reside within the New York State Department of Corrections (NYSDOCS). New York State has taken the initiative to provide mentally ill inmates with necessary services through a collaboration of the New York State Department of Correctional Services and the New York State Office of Mental Health (NYSOMH). The collaboration results in a mental health delivery system that provides many essential services to mentally ill inmates. This paper focuses on (...) the organization of mental health services within NYSDOCS, best practices, past and current litigation, and staff responsibilities. As the population of mentally ill inmates continues to grow, implications for the Human Services professions of OMH and DOCS needs to continue to address and provide adequate mental health care and resources for this special population. (shrink)

This book contains scholarly contributions to several current debates in the philosophy of medicine and health care regarding the nature of health and health promotion, concepts and measurements of mental illness, phenomenological conceptions of health and illness, allocation of health care resources, criteria for proper medical science, the clinical meeting, and ethical constraints in such a meeting. With one exception, the authors in this book are or have been teachers or graduate students at the interdisciplinary (...) Department of Health and Society (Tema H) at Linköping University, Sweden. While all the texts have a philosophical focus, many other disciplines have influenced the choice of specific perspectives. The university backgrounds of the authors range from medicine, psychology, sociology, and religion to philosophy. What binds the authors together is their deep interest in the theory of medicine and in the pursuit of a philosophy of humanistic medicine and health care. (shrink)

Publication date: 15 October 2018 Source: Author: Ehiosun O. Marvel NHIS was launched officially on 6th of June 2005. The Scheme is designed to provide comprehensive health care at affordable costs, covering employees of the formal sector, self-employed, as well as rural communities, the poor and the vulnerable groups. However, client satisfaction of services rendered continues to be a major concern for the improvement of NHIS. This study is designed to determine the level and causes of dissatisfaction of clients (...) accessing NHIS clinic at the Kubwa General Hospital, Kubwa, FCT, Abuja. This study employed a descriptive cross sectional survey. 279 NHIS enrollees were recruited for this study at the Kubwa General Hospital. Questionnaires were administered and the level of dissatisfaction and satisfaction of NHIS services were analyzed. The satisfaction rate was 69.2% while the dissatisfaction rate was 22.9%. The respondents were satisfied with the attitude of health workers in NHIS clinic, Kubwa. However, they were dissatisfied with waiting time, attitude of record officers and those in pharmacy department. This study found that the level of dissatisfaction with NHIS services is high despite a high satisfaction level. The Attitude of health workers may influence the dissatisfaction of enrollees. NHIS is still limited to the formal sector. (shrink)

Confidentiality of health information is increasingly relevant in the era of electronic medical records. We discuss the case of a hospitalized patient who requested a neurology consultation for an episode he described as an “LSD-like” flashback. The patient expressed concern that the episode was a residual effect of past drug use, but subsequently requested that his drug use not be documented. Involved in a custody battle, he feared that if his records were released to the court he could lose (...) custody of his children. Ethical concerns arose with regards to the physician’s competing obligations with a duty to record information accurately and honestly, respect patient autonomy, and maintain patient confidentiality. We discuss the decision of the team to document the patient’s drug use by arguing that the obligation to maintain confidentiality did not supersede the primary role of the medical record as a complete and accurate account, which cannot be altered at a patient’s behest. (shrink)

BackgroundClinical ethics case consultations (CECCs) provide a structured approach in situations of ethical uncertainty or conflicts. There have been increasing calls in recent years to assess the quality of CECCs by means of empirical research. This study provides detailed data of a descriptive quantitative and qualitative evaluation of a CECC service in a department of cardiology and intensive care at a German university hospital.MethodsSemi-structured document analysis of CECCs was conducted in the period of November 1, 2018, to May 31, (...) 2020. All documents were analysed by two researchers independently.ResultsTwenty-four CECCs were requested within the study period, of which most (n = 22; 92%) had been initiated by physicians of the department. The patients were an average of 79 years old (R: 43–96), and 14 (58%) patients were female. The median length of stay prior to request was 12.5 days (R: 1–65 days). The most frequent diagnoses (several diagnoses possible) were cardiology-related (n = 29), followed by sepsis (n = 11) and cancer (n = 6). Twenty patients lacked decisional capacity. The main reason for a CECC request was uncertainty about the balancing of potential benefit and harm related to the medically indicated treatment (n = 18). Further reasons included differing views regarding the best individual treatment option between health professionals and patients (n = 3) or between different team members (n = 3). Consensus between participants could be reached in 18 (75%) consultations. The implementation of a disease specific treatment intervention was recommended in five cases. Palliative care and limitation of further disease specific interventions was recommended in 12 cases.ConclusionsTo the best of our knowledge, this is the first in-depth evaluation of a CECC service set up for an academic department of cardiology and intensive medical care. Patient characteristics and the issues deliberated during CECC provide a starting point for the development and testing of more tailored clinical ethics support services and research on CECC outcomes. (shrink)

Senior lecturers/lecturers in mental health nursing (11 in round one, nine in round two, and eight in the final round) participated in a three-round Delphi study into the teaching of health care ethics (HCE) to students of nursing. The participants were drawn from six (round one) and four (round three) UK universities. Information was gathered on the organization, methods used and content of HCE modules. Questionnaire responses were transcribed and the content analysed for patterns of interest and areas (...) of convergence or divergence. Findings include: the majority (72.8%) of the sample believed that insufficient time was allocated to the teaching of HCE; case studies were considered a popular, although problematic, teaching method; the ‘four principles’ approach was less than dominant in the teaching of HCE; and virtue ethics was taught by only 36.4% of the participants. The Delphi technique proved adequate and worth while for the purposes of this study. Further empirical research could aim to replicate or contradict these findings, using a larger sample and recruiting more university departments. Reflection is required on several issues, including the depth and breadth to which ethics theory and, more controversially, meta-ethics, are taught to nursing students. (shrink)

The basic work for this book was carried out during the spring of 1989 in Edinburgh, where I had been granted a research position at The Institute for Advanced Studies in the Humanities. I should like to express here my indebtedness to the Institute for the opportunity thus afforded me. I should also like to say how very grateful I am for the stimulating conversations I had there with Professor Timothy Sprigge and Dr. Elizabeth Telfer. Dr. Telfers’s own treatise Happiness (...) has been a major influence on my view of the questions involved. The basic view of health and illness presented in this book is more fully set out in my On the Nature of Health. As in the case of my previous larger projects, I have received a great amount of support and may wise comments from Professor Ingmar Pörn, Helsinki. Three Danish experts – Anton Aggernaes, Erik Ostenfeld and Peter Sandøe – have made valuable comments. Professor Heng ten Have, Nijmegen, has improved my reading of the philosophy of Jeremy Bentham. I should also like to thank my colleagues at the Department of Health and Society, University of Linköping, for helping me to avoid a number of the pitfalls that can so easily stumble into when it comes to a treatise like this. Especially I should like to mentioned Per-Erik Liss, Ingemar Nordin and Bo Petersson, all three of whom have read and commented on the entire manuscript. A Swedish version of this book, Livskvalitet och hälsa, came out in 1991. I have been made quite a number of corrections and additions, one type of addition being replies to critical points made in reviews of the Swedish version. I should like to thank Malcolm Forbes for valuable help putting my English into publishable condition. Linköping, May 1993 Lennart Noredenfelt. (shrink)

Population health has recently grown from a series of loosely connected critiques of twentieth-century public health and medicine into a theoretical framework with a corresponding field of research—population health science. Its approach is to promote the public’s health through improving everyday human life: affordable nutritious food, clean air, safe places where children can play, living wages, etc. It recognizes that addressing contemporary health challenges such as the prevalence of type 2 diabetes will take much more (...) than good hospitals and public health departments. -/- Blending philosophy of science/medicine, public health ethics and history, this book offers a framework that explains, analyses and largely endorses the features that define this relatively new field. Presenting a philosophical perspective, Valles helps to clarify what these features are and why they matter, including: searching for health’s “upstream” causes in social life, embracing a professional commitment to studying and ameliorating the staggering health inequities in and between populations; and reforming scientific practices to foster humility and respect among the many scientists and non- scientists who must work collaboratively to promote health. -/- Featuring illustrative case studies from around the globe at the end of all main chapters, this radical monograph is written to be accessible to all scholars and advanced students who have an interest in health—from public health students to professional philosophers. (shrink)

The paper identifies common barriers and challenges to Pre-Exposure Prophylaxis (PrEP) uptake and offers considerations for state and local public health departments to address barriers and retool infrastructure to increase access to PrEP to new users. Authors identify synergistic opportunities with federal agencies and funders to advance PrEP-related HIV prevention efforts, that prioritize strategies and investments to provide PrEP to people who could benefit from the intervention but are unaware of PrEP or struggle to access it. Barriers discussed and (...) examined include financing strategies to reduce financial burden of PrEP medication, expanding PrEP access and outreach beyond clinical settings, and increasing the network and reach of the provider community to serve people we oppress through policy choices and discourses of racial and socioeconomic inferiority. (shrink)

State health departments are at the core of the United States public health infrastructure. Surveillance to monitor trends in disease and injury; the development, coordination, and delivery of services; and public education are some of the core functions health department employees oversee every day. As such, agencies and their employees are well positioned to inform policy decisions that affect the public’s health. However, little is known about the role of health department staff — (...) a sizeable proportion of the public health workforce — as advocates for public health policies, independent of their agency roles. Anecdotally, some health department employees with whom we have spoken expressed reluctance to engage in policy advocacy for fear of violating little known or understood agency or state rules. (shrink)

The Emergency Department is a crucial medical treatment unit of hospital specializing in emergency medicine. EDs are responsible for providing immediate healthcare facilities to patients arriving without prior appointment. Thus, evaluating patient satisfaction is of immense importance for efficient service delivery. Very few studies are found in Pakistan, related to patients’ satisfaction and utilization of ED services both from demand and supply perspective of ED-Services Supply Chains. Data was collected to assess 200 patient’s satisfaction towards quality of healthcare services (...) of ED of Sindh Government Qatar Hospital, Orangi town-a tertiary care hospital in Karachi. Structured questionnaire was developed to interview patients and their attendants. Results of SPSS analysis revealed that 55% of patients were transferred to ED within 5 minutes, which shows efficient patient queues and flow management. 64.5% patient’s average LOS was between 40-60 minutes. 71% get the availability of basic facilities in ED. Majority of patients i.e. 96.5% and 90.5%, showed satisfaction with the time spent and treatment given by the doctor. Majority of the patients are satisfied with the services and performance of ED of a tertiary care hospital and 76% patients showed willingness to recommend ED of Government Qatar Hospital, Karachi to others. (shrink)

Objectives—To evaluate a departmental computer system.Design—a. Direct comparison of the time taken to use a manual system with the time taken to use a computer system for lung function evaluation, loan of equipment and production of correspondence. b. Analysis of the accuracy of data capture before and after the introduction of the computer system. c. Analysis of the comparative running costs of the manual and computer systems.Setting—Within a department of respiratory medicine serving a hospital of 1323 beds.Main Outcome Measures—a. (...) Time taken to perform functions with the assistance of computerised methods, in comparison to the manual method used alone. b. Accuracy of data capture. c. Relative running costs.Results—a. The computer system (CS) was significantly faster than the manual system (MS) for lung function evaluation (CS=7.63 min/test, MS=12.25 min/test), loan of equipment (CS=0.40 min/loan, MS=2.07 min/loan), and checking for overdue equipment (CS=0.49 s/record, MS=9 s/record). The production of correspondence was slightly slower with the computer (CS=9.30 min/letter, MS=8.54 min/letter). b. All outpatient episodes, but only 43 of 65 (66%) of inpatient episodes, were captured. Lung function and managerial report data were accurate using both manual and computerised methods. The manual system for equipment loans was inefficient, and use of the computer resulted in the recovery of 221 nebulisers. c. Development costs for 1988–1990 were high (£72 178). Only £1200 to £1845 per year was recovered directly from staff time saved by the computer but larger savings resulted from changes in work practice (£4049–4765). After 10 years the projected deficit is £10 000 per annum in running costs.Conclusions—In comparison with the manual methods, the computer system has shown significant advantages which provide accurate information, with significant favourable effects on working practices. In evaluating computer systems used in clinical practice it is essential to ensure that the projected work practice benefits are achieved without unacceptable costs in staff time, inaccurate data and high financial outlay. (shrink)

Objectives—To evaluate a departmental computer system.Design—a. Direct comparison of the time taken to use a manual system with the time taken to use a computer system for lung function evaluation, loan of equipment and production of correspondence. b. Analysis of the accuracy of data capture before and after the introduction of the computer system. c. Analysis of the comparative running costs of the manual and computer systems.Setting—Within a department of respiratory medicine serving a hospital of 1323 beds.Main Outcome Measures—a. (...) Time taken to perform functions with the assistance of computerised methods, in comparison to the manual method used alone. b. Accuracy of data capture. c. Relative running costs.Results—a. The computer system was significantly faster than the manual system for lung function evaluation, loan of equipment, and checking for overdue equipment. The production of correspondence was slightly slower with the computer. b. All outpatient episodes, but only 43 of 65 of inpatient episodes, were captured. Lung function and managerial report data were accurate using both manual and computerised methods. The manual system for equipment loans was inefficient, and use of the computer resulted in the recovery of 221 nebulisers. c. Development costs for 1988–1990 were high. Only £1200 to £1845 per year was recovered directly from staff time saved by the computer but larger savings resulted from changes in work practice. After 10 years the projected deficit is £10 000 per annum in running costs.Conclusions—In comparison with the manual methods, the computer system has shown significant advantages which provide accurate information, with significant favourable effects on working practices. In evaluating computer systems used in clinical practice it is essential to ensure that the projected work practice benefits are achieved without unacceptable costs in staff time, inaccurate data and high financial outlay. (shrink)

BackgroundHealth research often uses health information, a subcategory of personal information, collected during clinical encounters. Conditions under which such health information can be used for the secondary purpose of research are set out in state, national and international law. In Australia, consent is required or the relevant conditions for a waiver of consent must be met and approved by a human research ethics committee (HREC). Consent for use of health information for research is rarely sought at an (...) emergency department (ED) presentation. Research often occurs after the index visit and gaining consent can be difficult. Waiver of consent provisions are frequently used, but acceptability of this approach to patients is unclear.ObjectiveTo identify ED patients’ knowledge and attitudes towards the use of health information for research, consent preferences and acceptability of waiver of consent.MethodsAn online, anonymous survey of adult patients attending two large EDs in Melbourne, Australia.Results103 patients completed the survey. We found that 52% were unaware that health information might be used for research. A majority (77%) felt that HREC approval for use of health information without consent was acceptable. However, 36% would prefer to be contacted regarding consent.ConclusionThese findings suggest a lack of awareness that health information can be used for research and that waiver of consent is acceptable, but not necessarily preferred, in most of the ED patient population. Efforts to increase awareness and provide opportunities to express preferences about health information use for research are needed. (shrink)

Scientists and historians have often presumed that the divide between biochemistry and molecular biology is fundamentally epistemological.100 The historiography of molecular biology as promulgated by Max Delbrück's phage disciples similarly emphasizes inherent differences between the archaic tradition of biochemistry and the approach of phage geneticists, the ur molecular biologists. A historical analysis of the development of both disciplines at Berkeley mitigates against accepting predestined differences, and underscores the similarities between the postwar development of biochemistry and the emergence of molecular biology (...) as a university discipline. Stanley's image of postwar biochemistry, with its focus on viruses as key experimental systems, and its preference for following macromolecular structure over metabolism pathways, traced the outline of molecular biology in 1950.Changes in the postwar political economy of research universities enabled the proliferation of disciplines such as microbiology, biochemistry, biophysics, immunology, and molecular biology in universities rather than in medical schools and agricultural colleges. These disciplines were predominantly concerned with investigating life at the subcellular level-research that during the 1930s had often entailed collaboration with physicists and chemists. The interdisciplinary efforts of the 1930s (many fostered by the Rockefeller Foundation) yielded a host of new tools and reagents that were standardized and mass-produced for laboratories after World War II. This commercial infrastructure enabled “basic” researchers in biochemistry and molecular biology in the 1950s and 1960s to become more independent from physics and chemistry (although they were practicing a physicochemical biology), as well as from the agricultural and medical schools that had previously housed or sponsored such research. In turn, the disciplines increasingly required their practitioners to have specialized graduate training, rather than admitting interlopers from the physical sciences.These general transitions toward greater autonomy for biochemistry and allied disciplines should not mask the important particularities of these developments on each campus. At the University of Caliornia at Berkeley, agriculture had provided, with medicine, significant sponsorship for biochemistry. The proximity of Lawrence and his cyclotrons supported the early development of Berkeley as a center for the biological uses of radioisotopes, particularly in studies of metabolism and photosynthesis. Stanley arrived to establish his department and virus institute before large-scale federal funding of biomedical research was in place, and he courted the state of California for substantial backing by promising both national prominence in the life sciences and virus research pertinent to agriculture and public health. Stanley's venture benefited significantly from the expansion of California's economy after World War II, and his mobilization against viral diseases resonated with the concerns of the Cold War, which fueled the state's rapid growth. The scientific prominence of contemporary developments at Caltech and Stanford invites the historical examination of the significance of postwar biochemistry and molecular biology within the political and cultural economy of the Golden State.In 1950, Stanley presented a persuasive picture of the power of biochemistry to refurbish life science at Berkeley while answering fundamental questions about life and infection. In the words of one Rockefeller Foundation officer,There seems little doubt in [my] mind that as a personality Stanley will be well able to dominate the other personalities on the Berkeley campus and will be able to drive his dream through to completion, which, incidentally, leaves Dr. Hubert [sic] Evans and the whole ineffective Life Sciences building in the somewhat peculiar position of being by-passed by much of the truly modern biochemistry and biophysics research that will be carried out at Berkeley. Furthermore, it seems likely that Dr. S's show will throw Dr. John Lawrence's Biophysics Department strongly in the shade both figuratively and literally, but should make the University of California pre-eminent not only in physics but in biochemistry as well.101Stanley, Sproul, Weaver, and this officer (William Loomis) all testified to a perceptible postwar opportunity to capitalize on public support for biological research that relied on the technologies from physics and chemistry without being captive to them, and that addressed issues of medicine and agriculture without being institutionally subservient. What is striking, given the expectation by many that Stanley would ‘be able to drive his dream through to completion,” was that in fact he did not. Biochemists who had succeeded in making their expertise valued in specialized niches were resistant to giving up their affiliations to joint Stanley's “liberated” organization. Stanley's failure was not simply due to institutional factors: researchers as well as Rockefeller Foundation officers faulted him for his lack of scientific imagination, which made it difficult for him to gain credibility in leading the field. Moreover, many biochemists did not share Stanley's commitment to viruses as the key material for the “new biochemistry.”In the end, Stanley's free-standing department did become a first-rate department of biochemistry, but only after freeing itself from Stanley's leadership and his single-minded devotion to viruses. Nonetheless, the falling-out with the Berkeley biochemists was rapidly followed by the establishment of a Department of Molecular Biology, attesting to the unabating economic and institutional possibilities for an authoritative “general biology” (or two, for that matter) to take hold. In each case, following Stanley's dream sheds light on how the possible and the real shaped the (re)formation of biochemistry and molecular biology as postwar life sciences. (shrink)

Background At the beginning of the coronavirus (Covid-19) pandemic, many non-Covid healthcare services were suspended. In April 2020, the Department of Health in England mandated that non-Covid services should resume, alongside the continuing pandemic response. This ‘resetting’ of healthcare services created a unique context in which it became critical to consider how ethical considerations did (and should) underpin decisions about integrating infection control measures into routine healthcare practices. We draw on data collected as part of the ‘NHS Reset (...) Ethics’ project, which explored the everyday ethical challenges of resetting England’s NHS maternity and paediatrics services during the pandemic. Methods Healthcare professionals and members of the public participated in interviews and focus group discussions. The qualitative methods are reported in detail elsewhere. The focus of this article is our use of Frith’s symbiotic empirical ethics methodology to work from our empirical findings towards the normative suggestion that clinical ethics should explicitly attend to the importance of relationships in clinical practice. This methodology uses a five-step approach to refine and develop ethical theory based on a naturalist account of ethics that sees practice and theory as symbiotically related. Results The Reset project data showed that changed working practices caused ethical challenges for healthcare professionals, and that infection prevention and control measures represented harmful barriers to the experience of receiving and offering care. For healthcare professionals, offering care as part of a relational interaction was an ethically important dimension of healthcare delivery. Conclusions Our findings suggest that foregrounding the importance of relationships across a hospital community will better promote the ethically important multi-directional expression of caring between healthcare professionals, patients, and their families. We offer two suggestions for making progress towards such a relational approach. First, that there is a change of emphasis in clinical ethics practice to explicitly acknowledge the importance of the relationships (including with their healthcare team) within which the patient is held. Second, that organisational decision-making should take into account the moral significance afforded to caring relationships by healthcare professionals, and the role such relationships can play in the negotiation of ethical challenges. (shrink)

Health care organization foundations and other fund-raising departments often function at an arm’s length from the system at large. As such, operations related to their mandate to raise funds and market the organization do not receive the same level of ethical scrutiny brought to bear on other arms within the organization. An area that could benefit from a more focused ethics lens is the use of language and rhetoric employed in order to raise funds and market the organization. Such (...) departments and divisions often utilize overblown promises of miracles and extraordinary advances to convince donors to contribute and to persuade the general public. The result can be a heightened sense of expectation on the part of patients, their families, and the general public as to what can realistically be achieved by the health care system, leading to disappointment and conflict when these expectations are not or cannot be met. This article suggests that such advertising and marketing be subject to the same advertising standards as other businesses. (shrink)

The Office of Inspector General, Department of Health and Human Services, has issued a proposed rule under section 5201 of the Omnibus Consolidated and Emergency Supplemental Appropriations Act for Fiscal Year 1999 that would provide a safe harbor from civil sanctions under section 1128A of the Social Security Act for independent dialysis facilities that pay premiums for Supplementary Medical Insurance or Medicare Supplemental Health Insurance Policies for financially needy Medicare beneficiaries with end-stage renal disease.End-stage renal disease is (...) a chronic disease that requires regular dialysis treatments and monitoring of laboratory values, diet and medication. ESRD patients suffer from irreversible renal failure, often accompanied by diabetes, anemia, hypertension and congestive heart failure. (shrink)

The Office of Inspector General, Department of Health and Human Services, has issued a proposed rule under section 5201 of the Omnibus Consolidated and Emergency Supplemental Appropriations Act for Fiscal Year 1999 that would provide a safe harbor from civil sanctions under section 1128A of the Social Security Act for independent dialysis facilities that pay premiums for Supplementary Medical Insurance or Medicare Supplemental Health Insurance Policies for financially needy Medicare beneficiaries with end-stage renal disease.End-stage renal disease is (...) a chronic disease that requires regular dialysis treatments and monitoring of laboratory values, diet and medication. ESRD patients suffer from irreversible renal failure, often accompanied by diabetes, anemia, hypertension and congestive heart failure. (shrink)

A number of unique problems plague human research protection efforts at United States (U.S.) State and Territorial Departments of Health (DOHs) problems which might be ameliorated through a consolidated national or regional, independent, not-for-profit Institutional Review Board (IRB).

A number of unique problems plague human research protection efforts at United States State and Territorial Departments of Health. The first problem is related to the number of Institutional Review Boards operated by and Federalwide Assurances held by DOHs. The lack of these two essential regulatory human research protection program mechanisms points to a possible inadequacy of infrastructure at DOHs for protecting human subjects. The second and third problems are related to the use and interpretation of research protection laws (...) and regulations at DOHs. Parsing public health activities into research or practice can be vexing and likely produces variability in how individual DOHs make the determination between research and practice and the outcomes of such decisions for the same or similar projects. A related problem is that DOH or Institutional Review Board officials might misclassify public health practice activities as research, which can have costly, adverse consequences. (shrink)

Entry into the practice of medicine is heavily regulated through scope of practice and licensing laws that make it illegal for nonlicensed individuals to perform many medical services. As institutions are structured at the beginning of the twenty-first century, most regulation takes place at the state level, through state departments of health that establish criteria for performing different types of medical activities, and that restrict allowable activities for various types of health care professionals. The regulations over the activities (...) of physicians are more uniform across states than for other health care professionals because, although the regulation is done by individual state governments, the standards for physicians are set by the National Board of Medical Examiners, a group controlled by physicians themselves. The justification for this regulation is that it produces higher quality health care. Some would make an even stronger argument that regulation is necessary because patients do not have sufficient knowledge to distinguish effective practitioners from ineffective ones. (shrink)

Entry into the practice of medicine is heavily regulated through scope of practice and licensing laws that make it illegal for nonlicensed individuals to perform many medical services. As institutions are structured at the beginning of the twenty-first century, most regulation takes place at the state level, through state departments of health that establish criteria for performing different types of medical activities, and that restrict allowable activities for various types of health care professionals. The regulations over the activities (...) of physicians are more uniform across states than for other health care professionals because, although the regulation is done by individual state governments, the standards for physicians are set by the National Board of Medical Examiners, a group controlled by physicians themselves. The justification for this regulation is that it produces higher quality health care. Some would make an even stronger argument that regulation is necessary because patients do not have sufficient knowledge to distinguish effective practitioners from ineffective ones. (shrink)

This study critically examines the concept of benefit‐sharing in the context of health research involving human participants in South Africa, identifying a significant gap in the precision and application of terminology. It introduces a new terminological framework designed to provide clarity and facilitate standardisation in both national and international discourse on benefit‐sharing. The analysis extends to the complex legal landscape in South Africa, highlighting the nuances of mandated, permitted, and prohibited practices of benefit‐sharing across various statutes. This reveals substantial (...) implications for ethics committees, researchers, and participants, emphasising the need for a legal and ethical recalibration. Furthermore, the manuscript critiques South Africa's main ethics instruments for their inadequate guidance on benefit‐sharing and proposes recommendations for enhancing the Department of Health's ethics guidelines. By advocating for a coherent, legally informed approach to ethical decision‐making, the study underscores the need for integrating the proposed framework and legal insights into ethics guidelines. This comprehensive strategy aims not only to advance ethical practices within South Africa but also to contribute significantly to the global discourse on benefit‐sharing in health research. (shrink)

BackgroundPromoting the social value of global health research undertaken in resource poor settings has become a key concern in global research ethics. The consideration for benefit sharing, which concerns the elucidation of what if anything, is owed to participants, their communities and host nations that take part in such research, and the obligations of researchers involved, is one of the main strategies used for promoting social value of research. In the last decade however, there has been intense debate within (...) academic bioethics literature seeking to define the benefits, the beneficiaries, and the scope of obligations for providing these benefits. Although this debate may be indicative of willingness at the international level to engage with the responsibilities of researchers involved in global health research, it remains unclear which forms of benefits or beneficiaries should be considered. International and local research ethics guidelines are reviewed here to delineate the guidance they provide.MethodsWe reviewed documents selected from the international compilation of research ethics guidelines by the Office for Human Research Protections under the US Department of Health and Human Services.ResultsAccess to interventions being researched, the provision of unavailable health care, capacity building for individuals and institutions, support to health care systems and access to medical and public health interventions proven effective, are the commonly recommended forms of benefits. The beneficiaries are volunteers, disease or illness affected communities and the population in general. Interestingly however, there is a divide between "global opinion" and the views of particular countries within resource poor settings as made explicit by differences in emphasis regarding the potential benefits and the beneficiaries.ConclusionAlthough in theory benefit sharing is widely accepted as one of the means for promoting the social value of international collaborative health research, there is less agreement amongst major guidelines on the specific responsibilities of researchers over what is ethical in promoting the social value of research. Lack of consensus might have practical implications for efforts aimed at enhancing the social value of global health research undertaken in resource poor settings. Further developments in global research ethics require more reflection, paying attention to the practical realities of implementing the ethical principles in real world context. (shrink)

Refining the model for an emergency department‐based mental health nurse practitioner outpatient service The mental health nurse practitioner (MHNP) role based in the emergency department (ED) has emerged in response to an increase in mental health‐related presentations and subsequent concerns over waiting times, co‐ordination of care and therapeutic intervention. The MHNP role also provides scope for the delivery of specialised primary care. Nursing authors are reporting on nurse‐led outpatient clinics as a method of healthcare delivery (...) that allows for enhanced access to health‐care, particularly following hospital discharge. However, due to a lack of in‐depth substantiation, this mode of service delivery requires more thorough investigation. This study describes the refinement phase undertaken before the implementation and pilot evaluation of a formalised and structured MHNP outpatient service in the ED of a large inner‐city hospital in Sydney, Australia. An expert advisory panel (EAP) consisting of key local informants was convened to provide feedback on and refinement to the proposed model. This related to issues such as target population, structure and process considerations, outcome measures and interface within the overall health service. Findings from the EAP meeting are presented and discussed. The importance of linking methods with the appropriate methodology in evaluating a healthcare program is highlighted. (shrink)

The author's aim here is to philosophically analyze the notion of positive mental health. Defining characteristics of positive mental health are described, drawing on modern psychiatric, psychoanalytical, psychological, and philosophical literature. The author finds that it is impossible to draw decisive conclusions about what characteristics constitute positive mental health, and suggests a general theory of health. Lennart Nordenfelt's holistic theory of general health is chosen to guide the rest of the discussion. The author is affiliated (...) with Malmo University, Sweden. This book is based on his PhD thesis in the Department of Health and Society at Linkoping University. Annotation copyrighted by Book News Inc., Portland, OR. (shrink)

The aim of this study was to investigate the effects of Islam as a religion and culture on Turkish women’s health. The study included 138 household members residing in the territory of three primary health care centers in Turkey: Güzelbahçe, Fahrettin Altay and Esentepe. Data were collected by means of a questionnaire prepared by a multidisciplinary team that included specialists from the departments of public health, psychiatric nursing and sociology. We found that the women’s health behavior (...) changed from traditional to rational as education levels increased, and that religious and traditional attitudes and behaviors were predominant in the countryside, especially practices related to pregnancy, delivery, the postpartum period, induced abortion and family planning. One of the most important prerequisites for the improvement of women’s health is that nurses should know the religious practices and culture of the society for which they provide care, so that their efforts to protect and improve women’s health will be effective. (shrink)