For decades a debate has played out in the literature about who bioethicists are, what they do, whether they can be considered professionals qua bioethicists, and, if so, what professional responsibilities they are called to uphold. Health care ethics consultants are bioethicists who work in health care settings. They have been seeking guidance documents that speak to their special relationships/duties toward those they serve. By approving a Code of Ethics and Professional Responsibilities for Health Care Ethics Consultants, the American Society (...) for Bioethics and Humanities (ASBH) has moved the professionalization debate forward in a significant way. This first code of ethics focuses on individuals who provide health care ethics consultation (HCEC) in clinical settings. The evolution of the code's development, implications for the field of HCEC and bioethics, and considerations for future directions are presented here. (shrink)

Healthcare organizations and workers are under pressure to produce increasingly complete and accurate data for multiple data-intensive endeavors. However, little research has examined the emerging occupations arising to carry out the data work necessary to produce “improved” data sets, or the specific work activities of these emerging data occupations. We describe the work of Clinical Documentation Integrity Specialists, an emerging occupation that focuses on improving clinical documentation to produce more detailed and accurate administrative datasets crucial for (...) evolving data-intensive forms of healthcare accountability, management, and research. Using ethnographic methods, we describe the core of CDIS’ work as a translation practice in which the language, interests, and concerns of clinicians and clinical documentation are translated via real-time “nudging” and ongoing education of clinicians into the language, interests, and concerns of medical coders, structured administrative datasets, and the various stakeholders of these datasets. Further, we show how the institutional context of CDIS’ work shapes the occupational virtues that guide CDIS’ translation practice, including financial reimbursement, quality measures, clinical accuracy, and protecting clinician’s time. Despite the existence of these multiple virtues, financial reimbursement is the most prominent virtue guiding CDIS’ limited attention. Thus, overall clinical documentation is “improved” in specific, partial ways. This research provides one of the first studies of the emergent data work occupations arising in the wake of digitization and big data opportunities, and shows how local data settings shape large scale data in specific ways and thus may influence outcomes of analyses based on such data. (shrink)

Background: One of the ethical imperatives for a valid consent process in clinical medication trials is that the process be guided by and recorded in an informed consent document (ICD). Concerns have been expressed, however, about readability and participant understanding of ICDs, which are often 10–20 pages long. Objective measures of readability and understanding have been used to support these concerns in several articles, but surprisingly the voice of trial participants on ICDs has not been heard in previous studies. (...) Hence, this study compares participants' subjective views on readability and their understanding of ICDs with those ICDs' objective readability scores. It also evaluates whether family, friends, and additional aids would foster better understanding of the ICD. Methods: Sixty current trial participants rated the readability and their understanding of deidentified standard ICDs. These had been sourced from two multicenter international Phase III trials on medication for diabetes mellitus and cancer. Results: Less than 10% of participants considered the ICDs difficult to read or difficult to understand in spite of objective readability scores at levels of about 12th grade education, but about a quarter considered the ICDs to be too technical. Participants gave mixed responses about friends or family members helping or the need for videos, pictures, additional reading material, and frequently answered questions (FAQ) sheets as an aid to their understanding. Conclusions: These findings suggest individual clinical trial participants should be engaged on their views of an ICD, for doing so is part of informed consent as a process rather than consent being merely focused on written information. Such participant-specific engagement should guide whether family and friends, videos, pictures, additional reading material, and FAQ sheets would be of assistance in improving understanding. (shrink)

Randomised clinical trials involve procedures such as randomisation, blinding, and placebo use, which are not part of standard medical care. Patients asked to participate in RCTs often experience difficulties in understanding the meaning of these and their justification.

The Italian debate about the role of clinical ethics and ethics consultation has brought about the need to create a working group of Healthcare Ethics Consultation. The group began to take shape an...

The aims of this study were to measure the readability of Australian based informed consent documents and determine whether informed consent readability guidelines have been established by Australian human research ethics committees (HRECs). A total of 20 informed consent documents, 10 HIV/AIDS and 10 type 2 diabetes, were measured for readability using the Simple Measure of Gobbledygook (SMOG) and Gunning Fog Index (Fog). Published guidelines and policy statements of the two local HREC who approved the 20 clinical trials under (...) study where examined to identify whether they had any formal policies/guidelines on the readability of informed consent documents. The two HRECs were contacted via e-mail to also determine whether they utilised any informal readability standards or “rules of thumb” that may not have been mentioned in the published documents. The HIV/AIDS and type 2 diabetes informed consent documents were, on average, written at a grade 13 reading level. Formal readability standards had not been established by the two local HRECs, however, they did verify the use of informal rules for assessing readability of informed consent documents. Based on Australian literacy data, the majority of informed consent documents were written well beyond the reading ability of many Australians. Unreadable informed consent documents may result in patients rejecting trial participation altogether or conversely may result in their participating in a trial with inadequate consent. Therefore, a step toward reducing the complexity of informed consent documents may be to implement objective readability assessments into the human research ethics application and review process. (shrink)

I trust my lawyer more than I trust my doctor.—Shana Alexander, 1992 [The audience laughed.]1The Hippocratic Oath makes the physician invoke external supervision of her adherence to what she affirm...

The OpenNotes (ON) mandate in the 21st Century Cures Act requires that patients or their legally authorized representatives be able to access their medical information in their electronic medical record (EMR) in real time. Ethics notes fall under the domain of this policy. We argue that ethics notes are unique from other clinical documentation in a number of ways: they lack best-practice guidelines, are written in the context of common misconceptions surrounding the purpose of ethics consultation, and often (...) answer questions of a different nature than other documentation. Thus, we believe the clinical ethics community would benefit from clarification on when the withholding of ethics notes is justified. We provide recommendations for excluding information from ethics documentation based on the likelihood and magnitude of harm that may occur with particular disclosures and suggest approaches to decrease the potential harms that may occur. We define and explain six types of reasons to exclude information from ethics notes based on significant harms that are not addressed in the ON policy: (1) harmful revelations from a protected chart note; (2) negative emotional effects on patients or families; (3) the purpose of the consultation is undermined by harmful consequences; (4) avoidable negative impact on interpersonal dynamics; (5) inappropriate labeling or disclosure of medical, social, or financial information; and (6) inclusion of biasing or otherwise unfair information. We also suggest approaches to mitigate harm when excluding, including, reframing, or delaying release of information that is perceived to be relevant to an ethics case. Overall, we hope our analysis and recommendations will initiate a much-needed discussion about the impact of the ON mandate on clinical ethics documentation. (shrink)

BackgroundClinical trials should be as inclusive as possible to facilitate equitable access to research and better reflect the population towards which any intervention is aimed. Informed by the UK’s National Institute for Health and Care Research (NIHR) Innovations in Clinical Trial Design and Delivery for the Under-served (INCLUDE) guidance, we audited oncology trials conducted by the Clinical Trials and Statistics Unit at The Institute of Cancer Research, London (ICR-CTSU) to identify whether essential documents were overtly excluding any groups (...) and whether sufficient data were collected to assess diversity of trial participants from groups suggested by INCLUDE as under-served by research in the UK.MethodsThirty cancer clinical trials managed by ICR-CTSU and approved between 2011–2021 were audited. The first ethics approved version of each trial’s protocol, patient information sheet, and patient completed questionnaire, together with the first case report forms (CRFs) version were reviewed. A range of items aligned with the INCLUDE under-served groups were assessed, including age, sex and gender, socio-economic and health factors. The scope did not cover trial processes in participating hospitals.ResultsData relating to participants’ age, ethnic group and health status were well collected and no upper age limit was specified in any trials’ eligibility criteria. 23/30 (77%) information sheets used at least one gendered term to address patients. Most CRFs did not specify whether they were collecting sex or gender and only included male or female categories. The median reading age for information sheets was 15–16 years (IQR: 14–15 – 16–17). Socio-economic factors were not routinely collected and not commonly mentioned in trial protocols.ConclusionsNo systemic issues were identified in protocols which would explicitly prevent any under-served group from participating. Areas for improvement include reducing use of gendered words and improving readability of patient information. The challenge of fully assessing adequate inclusion of under-served populations remains, as socio-economic factors are not routinely collected because they fall beyond the data generally required for protocol-specified trial endpoint assessments. This audit has highlighted the need to agree and standardise demographic data collection to permit adequate monitoring of the under-served groups identified by the NIHR. (shrink)

Since 1989, clinical ethics consultation in form of hospital ethics committees was established in most of the transition countries of Central and Eastern Europe. Up to now, the similarities and differences between HECs in Central and Eastern Europe and their counterparts in the U.S. and Western Europe have not been determined. Through search in literature databases, we have identified studies that document the implementation of clinical ethics consultation in Central and Eastern Europe. These studies have been analyzed under (...) the following aspects: mode of establishment of HECs, character of consultation they provide, and their composition. The results show that HECs in the transition countries of Central and Eastern Europe differ from their western-European or U.S. counterparts with regard to these three aspects. HECs were established because of centrally imposed legal regulations. Little initiatives in this area were taken by medical professionals interested in resolving emerging ethical issues. HECs in the transition countries concentrate mostly on review of research protocols or resolution of administrative conflicts in healthcare institutions. Moreover, integration of non-professional third parties in the workings of HECs is often neglected. We argue that these differences can be attributed to the historical background and the role of medicine in these countries under the communist regime. Political and organizational structures of healthcare as well as education of healthcare staff during this period influenced current functioning of clinical ethics consultation in the transition countries. (shrink)

Psychological assessment has long been reported as a key component of clinical psychology. This paper examined and shed light on the complexities surrounding the clinical significance of therapeutic approach to treatment Planning. To achieve this objective, the paper searched and used the PsycINFO and PubMed databases and the reference sections of chapters and journal articles to analysed the underlying themes: 1) a strong basis for the usage of therapeutic approach to psychological assessment in treatment plans, 2) explained the (...) conceptual meaning of clinical significant change in therapeutic assessment, 3) used initial theory to explain the therapeutic mechanisms of change in clinical practice, 4) analysed the empirically documenting clinically significant change in therapeutic assessment. Finally, the study suggested that though therapeutic assessment is not sufficient for the systematic study of psychotherapy outcome and process, it is still consistent with both the lay-man and professional expectations regarding treatment outcome and also provides a precise method for classifying clients as “changed” or “unchanged” on the basis of clinical significance criteria. (shrink)

Since Clinical Ethics Consultation has become important in the public health sector in the last decade in Germany, there are on-going questions about effectiveness. Targets have been established by the Ethics Committees, in regard to assisting patients, families and health care teams at times of ethical conflicts during the decision-making process in medical care. Of all the ethics consultations over the last eight years at Erlangen University Hospital the consultations carried out in the pediatric department were chosen to be (...) reviewed by a pediatrician and an ethicist. These were evaluated on the basis of team formation, interdisciplinary orientation, ethical criteria, completeness and methods of documentation. Results of the analysis of those records show a well-organized consultation team with regard to its personnel composition. Discrepancies with ethical questions posed in the literature are revealed, and also some partially incomplete documentation regarding medical facts and descriptions of the patients' or parents' opinion. (shrink)

Background: Demand for organisational ethics capacity is growing in health organisations, particularly among managers. The role of clinical ethicists in, and perspective on, organisational ethics has not been well described or documented in the literature. Objective: To describe clinical ethicists’ perspectives on organisational ethics issues in their hospitals, their institutional role in relation to organisational ethics, and their perceived effectiveness in helping to address organisational ethics issues. Design and Setting: Qualitative case study involving semi-structured interviews with 18 (...) class='Hi'>clinical ethicists across 13 health organisations in Toronto, Canada. Results: From the clinical ethicists’ perspective, the most pressing organisational ethics issues in their organisations are: resource allocation, staff moral distress linked to the organisation’s moral climate, conflicts of interest, and clinical issues with a significant organisational dimension. Clinical ethicists were consulted in particular on issues related to staff moral distress and clinical issues with an organisational dimension. Some ethicists described being increasingly consulted on resource allocation, conflicts of interest, and other corporate decisions. Many clinical ethicists felt they lacked sufficient knowledge and understanding of organisational decision-making processes, training in organisational ethics, and access to organisational ethics tools to deal effectively with the increasing demand for organisational ethics support. Conclusion: Growing demand for organisational ethics expertise in healthcare institutions is reshaping the role of clinical ethicists. Effectiveness in organisational ethics entails a re-evaluation of clinical ethics training to include capacity building in organisational ethics and organisational decision-making processes as a complement to traditional clinical ethics education. (shrink)

The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout the (...) different steps including the registration of the trial in the European database; the preparation of documents to be submitted and their contents; the preparation of documents related to the information and consent process; the submission to competent bodies. Specific issues related to paediatric research and trials involving non EU/EEA countries have been addressed as well. Results reveal that the European legislation offers a well defined set of European rules covering different aspects of a Clinical Trial Application. However, these are not suitable to meet the challenges from multicentre and multinational clinical studies. A stronger set of rules, such as is available in a composite European Regulation has been adopted and is expected to harmonise practices and enable sponsors to carry out well conducted trials. But will the new regulation overcome the existing criticisms of Directive 2001/20/EC? (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)

BackgroundNursing documentation as a pivotal part of nursing care has many implications for patient care in terms of safety and ethics.ObjectivesTo explore factors influencing nursing documentation from nurses’ perspectives in the Iranian nursing context.MethodsThis qualitative study was carried out using a qualitative content analysis of data collected from 2018 to 2019 in two urban areas of Iran. Semi-structured interviews (n = 15), observations, and reviews of patients’ medical files were used for data collection.Ethical considerationsThis study was conducted in (...) accordance with the ethical principles of research and regulations in terms of confidentiality of data, anonymity, and provision of informed consent.FindingsThe main theme of this study was “unsafe documentation.” Two categories, “types of errors in reporting” and “reasons of errors in reporting,” and 12 subcategories were developed indicating factors influencing nursing documentation in the Iranian nursing context.ConclusionIn general, individual, organizational, and national factors affected nursing documentation in Iran. In this respect, hiring more nurses, application of reforms in the healthcare management structure, devising appropriate regulations regarding division of labor, constant education of healthcare staff, establishment of clinical governance, improvement of interpersonal relationships, development of hardware and software techniques for documentation, and provision of support should be done to improve the quality of nursing documentation. The above-mentioned suggestions can help nurses with a safe, ethical, lawful, and reliable documentation in nursing practice. (shrink)

This article briefly reviews the discussion over changes to the Declaration of Helsinki. It suggests that the final product the World Medical Association has adopted as its guiding research ethics document is superior to the version it has replaced, but falls short of what would be ethically desirable.

Good Clinical Practice is an international quality standard for conducting trials that involve participation of human subjects. Currently, the most widely accepted international document forming the base for GCP is the ICH Harmonised Tripartite Guideline for GCP, which defines in detail the responsibilities and obligations of parties engaged in clinical research. The purpose of this paper is to analyse how compliance with GCP provides protection of the trial subjects and assures quality and credibility of the data obtained.

Selective reporting is prevalent in the medical literature, particularly in industry-sponsored research. In this paper, we expose selective reporting that is not evident without access to internal company documents. The published report of study 329 of paroxetine in adolescents sponsored by GlaxoSmithKline claims that “paroxetine is generally well tolerated and effective for major depression in adolescents”. By contrast, documents obtained during litigation reveal that study 329 was negative for efficacy on all 8 protocol specified outcomes and positive for harm.

Background In 2001 a report on the provision of clinical ethics support in UK healthcare institutions identified 20 clinical ethics committees. Since then there has been no systematic evaluation or documentation of their work at a national level. Recent national surveys of clinical ethics services in other countries have identified wide variation in practice and scope of activities. Objective To describe the current provision of ethics support in the UK and its development since 2001. Method A (...) postal/electronic questionnaire survey administered to the chairs of all 82 clinical ethics services registered with the UK Clinical Ethics Network in July 2010. Results Response rate was 62% with the majority of responding services situated in acute trusts. All services included a clinical ethics committee with one service also having a clinical ethicist. Lay members were present in 72% of responding committees. Individual case consultation has increased since 2001 with 29% of chairs spending more than 50% of their time on this. Access to and involvement in the process of case consultation is less for patients and families than for clinical staff. There is wide variation in committee processes and levels of institutional support. Over half of the responding committees undertook some form of evaluation. Conclusion Clinical ethics services in the UK are increasing as is their involvement in case consultation. However, the significant variation in committee processes suggests that further qualitative research is needed to understand how these committees function and the role they play in their institution. (shrink)

With technical sophistication and innovation in the field of medical science, a considerable proportion of medical diagnosis now rely on laboratory analyses, which emphasises the crucial role of laboratory physicians in patient care. Sustaining high ethical standards remains crucial in both clinical biochemistry and laboratory medicine, and several ethical dilemmas are faced by laboratory physicians in day-to-day practice. In a low-resource country like Bangladesh, formal ethics education or ethical framework in laboratory practice is still absent; ethics has not received (...) that much attention it this field. This paper has considered ethical issues encountered during the daily routine work of laboratory physicians and specially focused on the ethical issues encountered during the pre-analytical, analytical and post-analytical phases of laboratory medicine practice and discuss those issues in light of ‘The Belmont Report’ (1978) perspective. It is not intended to be a comprehensive one, rather it aims to complement existing guidelines and documents that are available in some institutions and to offer a framework for addressing ethical issues encountered in the practice of clinical biochemistry and laboratory medicine in Bangladesh. (shrink)

Initiating clinical ethics support in psychiatry and maintaining its continuity appear to be easy. This is contradicted by the observed delay or lack of CESiP, e.g. ethics consultation. On the basis of a published literature search and the discussion of practical experiences over 2.5 years 10 tasks and relating challenges of initiating and maintaining CESiP are formulated and illustrated by examples. Referral to experiences is grounded on the systematic documentation of ca. 100 CESiP activities. The tasks and challenges (...) illustrate how CESiP was initiated and maintained in child and adolescent, adult and forensic psychiatry. Each example is followed by a “rule of thumb” that was found useful in our centre. Discussion: Suggestions I–III are of organisational nature, IV–X have explicit ethical content concerning the ethos or professionalism of the ethics consultant and CES practice. Their realisation requires a minimum of stability of CESiP and considerable consultancy experience. (shrink)

International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. The anticipated benefits that can justify human research consist of direct benefits to the research participant, and societal benefits, also called social value. In first-in-human research, no direct benefits are expected and the benefit component of the risks-benefit assessment thus merely exists in social value. The concept social value is ambiguous by nature and is (...) used in numerous ways in the research ethics literature. Because social value justifies involving human participants, especially in early human trials, this is problematic. (shrink)

BackgroundDecision-making in out-of-hospital cardiac arrest should ideally include clinical and ethical factors. Little is known about the extent of ethical considerations and their influence on prehospital resuscitation. We aimed to determine the transparency in medical records regarding decision-making in prehospital resuscitation with a specific focus on ethically relevant information and consideration in resuscitation providers’ documentation.MethodsThis was a Danish nationwide retrospective observational study of out-of-hospital cardiac arrests from 2016 through 2018. After an initial screening using broadly defined inclusion criteria, (...) two experienced philosophers performed a qualitative content analysis of the included medical records according to a preliminary codebook. We identified ethically relevant content in free-text fields and categorised the information according to Beauchamp and Childress’ four basic bioethical principles: autonomy, non-maleficence, beneficence, and justice. ResultsOf 16,495 medical records, we identified 759 (4.6%) with potentially relevant information; 710 records (4.3%) contained ethically relevant information, whereas 49 did not. In general, the documentation was vague and unclear. We identified four kinds of ethically relevant information: patients’ wishes and perspectives on life; relatives’ wishes and perspectives on patients’ life; healthcare professionals’ opinions and perspectives on resuscitation; and do-not-resuscitate orders. We identified some “best practice” examples that included all perspectives of decision-making. ConclusionsThere is sparse and unclear evidence on ethically relevant information in the medical records documenting resuscitation after out-of-hospital cardiac arrests. However, the “best practice” examples show that providing sufficient documentation of decision-making is, in fact, feasible. To ensure transparency surrounding prehospital decisions in cardiac arrests, we believe that it is necessary to ensure more systematic documentation of decision-making in prehospital resuscitation. (shrink)

In recent years, the rights of patients have assumed a more pivotal role in international discussion. Stricter laws on the protection of patients place greater priority on the perspective and the status of patients. The purpose of this study is to emphasize ethical aspects in communication, the role of patient advocates as contacts for the concerns and suggestions of patients, and how many problems of ethics disappear when communication is highlighted. We reviewed 680 documented cases of consultation in a 10-year (...) period of patient advocates’ activity at a big German university hospital with 1,300 beds. On the basis of this extensive material, the article will focus on the intersection of the advocate’s work with the problems of patients in hospitals. Deficits in the level of communication between health care professionals and patients were frequently uncovered. Patients primarily complain about the lack of dialogue and empathy. Middle-aged patients consulted the patients’ advocate disproportionately more often. Measured against this baseline, the group of 65 and older complained less frequently. Besides complaints the advocate was asked in more than one-third of all cases for information about medical matters, hospital regulations or administrative problems. Patients obviously see the advocate as a well-connected and ideally unbiased contact person for uncertainties concerning their malady or a potential stay in hospital. Those seeking help often set hope in the information given by the voluntary patient representative. It should be highly recommended for every German hospital to establish the position of a patient advocate. Furthermore, patients can profit from regular exchange between the advocate and the Ethics Committee, also, to help ensure that their rights are taken into account and implemented in an ethically desirable context. (shrink)

This is a study involving three HIV clinics in the Canadian provinces of Newfoundland and Labrador, and Manitoba. We sought to identify ethical issues involving health care providers and clinic clients in these settings, and to gain an understanding of how different ethical issues are managed by these groups. We used an institutional ethnographic method to investigate ethical issues in HIV clinics. Our researcher conducted in-depth semi-structured interviews, compiled participant observation notes, and studied health records in order to document ethical (...) issues in the clinics, and to understand how health care providers and clinic clients manage and resolve these issues. We found that health care providers and clinic clients have developed work processes for managing ethical issues of various types: conflicts between client-autonomy and public health priorities, difficulties associated with the criminalization of nondisclosure of HIV positive status, challenges with non-adherence to HIV treatment, the protection of confidentiality, barriers to treatment access, and negative social determinants of health and well-being. Some ethical issues resulted from structural disadvantages experienced by clinic clients. The most striking findings in our study were the negative social determinants of health and well-being experienced by some clinic clients – such as experiences of violence and trauma, poverty, racism, colonization, homelessness, and other factors affecting well-being such as problematic substance use. These negative determinants were at the root of other ethical issues, and are themselves of ethical concern. (shrink)

This article introduces Turing’s idea of a “paper machine” to identify and understand one important mode of clinical research in the modern hospital, how that research worked, and how office technology and industrialized labor shaped and helped drive it. The unusually rich archives of Berlin psychiatry allow detailed reconstruction of the making of the new diagnostic category “hyperkinetic syndrome” in the 1920s. From the generating of data to the processing of information to the visualizing of the nature and course (...) of the new syndrome in the lives of more than sixty patients, this case study shows how clinical research could be based on the apparatus of the clerks’ room (folders, registers, inventories, and the dispatch of documents), office technologies (new filing systems, preprinted forms, and duplicating machines), and the principles and paper practices of the division and rationalization of labor (charts organizing worktime in complex organizations). The result is an important example of clinical research embedded in the broader history of office technology, industrial labor, and the modern hospital. (shrink)

A formal Ethics Consultation Service (ECS) can provide significant help to patients, families and hospital staff. As with any other form of clinical consultation, documentation of the process and the advice rendered is very important. Upon review of the published consult documentation practices of other ECSs, we judged that none of them were sufficiently detailed or structured to meet the needs and purposes of a clinical ethics consultation. Thus, we decided to share our method in order (...) to advance the practice of ethics consultation. Here, we describe a method of ECS documentation practice, including use of a formal consult report template, as well as a log for maintaining a chronological record of the consultations performed. These two documents facilitate order and organisation of the ECS. They also enable the ECS to keep an account of professional time and experience, enable quick consult trend assessments (by consult theme or ward, for example) and establish a potential registry of consults for future research study. This method of documentation, we believe, not only contributes significantly to the primary purpose of the consultation—namely, the evincing and sharing of ethical opinion about a case—but also enables consultants to improve their practice and to pursue research on clinical ethics consultation. (shrink)

In this article, the authors present an ethnography of biomedical knowledge production and science collaboration when they take place in developing country contexts. The authors focus on the arrival of international clinical trials to Sri Lanka and provide analysis of what was described as one of the first multisited trials in the country, a pharmaceutical company sponsored, phase 2, randomized, double-blind, placebo controlled trial carried out between 2009 and 2010. Using interviews with those who conducted the trial and six (...) months of participant observation at the trial hospital, the authors describe the work that goes on to perform trials according to international standards. The article describes what happens when a randomized controlled trial encounters existing epistemic virtues and documents the impacts on ideas of authority, expertise and doctor–patient relationships found in Sri Lankan medicine. (shrink)

Bruce Lincoln suggests that myth is "that small class of stories that possess both credibility and authority". When studying the history of mythology we find that myths often are understood as something other people have—as if the group in question possesses the truth while others live by falsehoods. In examining contemporary North American society, we can see how Judeo-Christian narratives structure popular and medical discourses regarding sex and gender. The idea that humans are born into male and female, and male (...) and female only, is a deeply held belief—so much so that it appears as fact rather than belief. Anthropologists such as Serena Nanda and Will Roscoe have documented the cross-cultural and historical "gender variants" who exist in societies where three or more genders are the norm. The origin of the belief in two sexes could well be the opening verses of Genesis where the origin of the human species is described in bipolar, dimorphic forms: "… in the image of God He created them; male and female created He them". In the article I explore the mythology that underlies the clinical management of transgender children. (shrink)

Background: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.Aim: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials .Patients and methods: The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of (...) patient subjects based on this questionnaire.Results: A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good , and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease.Conclusion: The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators. (shrink)

A reader confronting this collection of essays might wonder if something went awry in Jacksonville, Florida, in February 2014, when conference organizers gathered pediatric bioethicists and international child rights advocates to discuss the application of the U.N. Convention on the Rights of the Child to the work of clinical bioethics in the United States. Surely a document proclaiming a worldwide consensus on child rights would strengthen the hand of ethicists advising clinicians and researchers who face difficult decisions. Yet the (...) conference discussion—and resulting manuscripts—depict a deep divide: bioethicists largely rejected the notion that the CRC is a useful.. (shrink)

Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article, we share the experience of on-site monitoring of clinical trials by the Ethics Committee of a tertiary care, academic and research centre in India. We found a (...) large number of shortcomings in the areas of informed consent, adverse events, insurance and reimbursement, which would not have been detected by off-site document review. Interestingly, many shortcomings were also not detected by on-site monitoring arranged by clinical trial sponsors. We therefore conclude that on-site monitoring of ongoing clinical trials is a highly important activity for Indian Ethics Committees. (shrink)

The prevalence of pain in patients presenting to Emergency Departments has been well documented by both Cordell and Johnston. Equally well documented has been the apparent failure to adequately control that pain. In 1990 Selbst found that patients with long bone fractures received little analgesia in the ED, and Ngai, et al., showed that the under-treatment of pain continued after discharge. In a prospective study, Ducharme and Barber found that up to one third of patients presented with severe pain and (...) were often unrelieved at discharge. Even though specific patient subgroups appear to be at greater risk, all patients are potential victims of oligoanalgesia - the under-treatment of pain. Despite an ever increasing volume of research about pain in emergency medicine, dissemination of relevant information with widespread change in practice patterns has not been witnessed. Recent studies continue to affirm that pain management in the ED is suboptimal. (shrink)

The prevalence of pain in patients presenting to Emergency Departments has been well documented by both Cordell and Johnston. Equally well documented has been the apparent failure to adequately control that pain. In 1990 Selbst found that patients with long bone fractures received little analgesia in the ED, and Ngai, et al., showed that the under-treatment of pain continued after discharge. In a prospective study, Ducharme and Barber found that up to one third of patients presented with severe pain and (...) were often unrelieved at discharge. Even though specific patient subgroups appear to be at greater risk, all patients are potential victims of oligoanalgesia - the under-treatment of pain. Despite an ever increasing volume of research about pain in emergency medicine, dissemination of relevant information with widespread change in practice patterns has not been witnessed. Recent studies continue to affirm that pain management in the ED is suboptimal. (shrink)

Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of (...) the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. (shrink)

Background: Nursing documentation is an essential aspect of ethical nursing care. Lack of awareness of ethical dilemmas in nursing documentation may increase the risk of patient harm. Considering this, ethical dilemmas within nursing documentation need to be explored. Aim: To explore ethical dilemmas in nurses’ conversations about nursing documentation. Research design, participants and context: The study used a qualitative design. Participants were registered nurses from a Patient Hotel at a Danish University Hospital. Data were collected in (...) three focus groups with a total of 12 participants. Data analysis consisted of qualitative content analysis inspired by Graneheim and Lundman. Ethical consideration: This study was conducted in accordance with the ethical principles of research and regulations in terms of confidentiality, anonymity and provision of informed consent. Findings: Ethical dilemmas were strongly present in nurses’ conversations about nursing documentation. These dilemmas were demonstrated in two themes: a dilemma between respecting patients’ autonomy and not causing harm, which was visible in nurses’ navigation between written documentation and oral tradition, and a dilemma concerning justice and fair distribution of goods, which was visible in nurses’ balancing between documenting deviations and proof of nursing practice. Discussion: Ethical dilemmas in nursing documentation regarding respecting patients’ autonomy and not causing harm accentuated discussions on professional responsibility and patient participation in clinical decisions. Dilemmas in justice and fair distribution of goods emphasised discussions on trust in relationships versus trust in electronic health records. Conclusion: Actual tendencies in the healthcare system may increase ethical dilemmas in nursing documentation. Sharing otherwise invisible and individual experiences of ethical dilemmas in nursing documentation among nurses, nurse leaders and decision-makers will enable addressing these in reflections and discussions as well as in considering adjustments of conditions for nursing documentation. (shrink)

This article provides an ethical critique of the Good Clinical Practice (GCP) and Declaration of Helsinki (DoH) documents. While the previous criticisms of GCP are entirely correct, there is much more wrong with the document than has previously been acknowledged, including a circular definition and an astonishing vagueness about ethical principles. In addition to its failure to provide adequate ethical protection of participants, the procedurally dense nature of GCP lends itself to a box-ticking culture where important ethical issues are (...) overlooked because they are not ‘mentioned on the form’. In contrast, the DoH is a much more effective ethical document, but actually goes too far in one respect. It transpires that the best ethical guidelines for clinical research would be neither over-prescriptive in regard to particular ethical issues (as the DoH is) nor neglectful of them (as GCP is); correctly framed ethical principles will provide sufficient protection to participants while also ensuring a culture of ethicovigilance in clinical trials. (shrink)

Ethical guidance from the British Medical Association about treating doctor–patients is compared and contrasted with evidence from a qualitative study of general practitioners who have been patients. Semistructured interviews were conducted with 17 GPs who had experienced a significant illness. Their experiences were discussed and issues about both being and treating doctor–patients were revealed. Interpretative phenomenological analysis was used to evaluate the data. In this article data extracts are used to illustrate and discuss three key points that summarise the BMA (...) ethical guidance, in order to develop a picture of how far experiences map onto guidance. The data illustrate and extend the complexities of the issues outlined by the BMA document. In particular, differences between experienced GPs and those who have recently completed their training are identified. This analysis will be useful for medical professionals both when they themselves are unwell and when they treat doctor–patients. It will also inform recommendations for professionals who educate medical students or trainees. (shrink)

The past few years have seen greater attention directed toward important procedural elements associated with ethics consultation. Examples include considerations about how best to document consulta...

Unlike bioethics mediators who are employed by healthcare organizations as outside consultants, mediators who are embedded in an institution must be authorized to chronicle a clinical ethics consultation (CEC) or a mediation in a patient’s medical chart. This is an important privilege, as the chart is a legal document. In this article I discuss this important part of a bioethics mediator’s tool kit in my presentation of a case illustrating how bioethics mediation may proceed, and what this approach using (...) both bioethics and mediation may add. (shrink)

The presence of stigmatizing language in the electronic health record (EHR) has been used to measure implicit biases that underlie health inequities. The purpose of this study was to identify the presence of stigmatizing language in the clinical notes of pregnant people during the birth admission. We conducted a qualitative analysis on N = 1117 birth admission EHR notes from two urban hospitals in 2017. We identified stigmatizing language categories, such as Disapproval (39.3%), Questioning patient credibility (37.7%), Difficult patient (...) (21.3%), Stereotyping (1.6%), and Unilateral decisions (1.6%) in 61 notes (5.4%). We also defined a new stigmatizing language category indicating Power/privilege. This was present in 37 notes (3.3%) and signaled approval of social status, upholding a hierarchy of bias. The stigmatizing language was most frequently identified in birth admission triage notes (16%) and least frequently in social work initial assessments (13.7%). We found that clinicians from various disciplines recorded stigmatizing language in the medical records of birthing people. This language was used to question birthing people's credibility and convey disapproval of decision‐making abilities for themselves or their newborns. We reported a Power/privilege language bias in the inconsistent documentation of traits considered favorable for patient outcomes (e.g., employment status). Future work on stigmatizing language may inform tailored interventions to improve perinatal outcomes for all birthing people and their families. (shrink)

Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication (...) of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process. (shrink)

Once a neural implant has shown some efficacy during initial research trials, it begins to enter the world of clinical application. This culminates when the implant becomes approved for a particular indication. However, the ethical challenges continue as the technology is adopted as a standard of practice. Patient eligibility criteria, as documented by inclusion and exclusion criteria with any new treatment, are not always clearly quantified and defined. These vagaries can result in considerable debate regarding who should or should (...) not proceed with surgery. There is often considerable room for clinical judgment that can result in extension of the treatment to a wider range of patients. The ethical questions that arise in clinical decisionmaking differ significantly from those inherent in engineering design and research development. (shrink)

BackgroundIt has been well documented that patients can feel abused in health care and that many patients suffer from these experiences. Insight lacks into contributing factors behind such events. Silence surrounding the abuse has been suggested as a possible mechanism. The present study explores silence surrounding the abuse as a possible contributing factor. We have explored whether this silence is connected with the staff’s hierarchical position and with the staff’s own experiences as patients abused in health care.MethodsDuring January 2008, a (...) paper questionnaire was sent to all staff members at a Swedish women’s clinic. The questionnaire included questions on sociodemography and profession and multiple questions about abuse in health care. After univariate testing, a binary logistic regression model including variables concerning profession and staff’s own experiences of abuse was built.ResultsOur data show that in contrast to midwives and gynaecologists, auxiliary nurses seldom report hearing about cases of abuse in health care. Staff who themselves experienced abuse in health care as patients, so-called wounded healers, were more likely to have heard about abuse in health care during the last 12 months.ConclusionsThis study suggests that a form of silence reigns over events of abuse in health care that is not randomly distributed over staff. Professional hierarchies and staff’s own experiences of abuse as patients could be considered in the design of interventions to break the silence surrounding patients’ experiences of abuse in health care. (shrink)

Background Although the importance of clinical ethics in contemporary clinical environments is established, development of formal clinical ethics services in the Australia health system has, to date, been ad hoc. This study was designed to systematically follow and reflect upon the first 18 months of activity by a newly established service, to examine key barriers and facilitators to establishing a new service in an Australian hospital setting. Methods: how the study was performed and statistical tests used A (...) qualitative case study approach was utilised. The study gathered and analysed data using observations of service committee meetings, document analysis of agendas and minutes, and semi-structured interviews with committee members to generate semantic themes. By interpreting the thematic findings in reference to national capacity building resources, this study also aimed to provide practice-based reflections for other health agencies. Results: the main findings An overarching theme identified in the data was a strong commitment to supporting clinicians facing difficult patient care decisions and navigating difficult discussions with patients and families. Another key theme was the role of the new clinical ethics support service in providing clinicians with a pathway to raise system-wide issues with the organisation Executive. While there was strong clinical engagement, consumer and community participation remained a challenge, as did unresolved governance issues and a need for clearer policy relationship between the service and the organisation. Conclusions: brief summary and potential implications Considering these themes in relation to the national capacity building resources, the study identifies three areas likely to require ongoing development and negotiation. These are: the role of the clinical ethics support service as a link between the workforce and the Executive; the incorporation of consumers and patients; and ethical reasoning. To improve the effectiveness of the service, it is necessary to increase clarity on the service’s role at the governance and policy level, as well as develop strategies for engaging consumers, patients and families. Finally, the capacity of the service to reflect on complex cases may be enhanced through explicit discussions of various different ethical frameworks and ways of deliberating. (shrink)

Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about (...) research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol Includes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industry Includes internet resources and worldwide web addresses for important research ethics documents and regulations Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations. (shrink)

For valid informed consent, it is crucial that patients or research participants fully understand all that their consent entails. Testing and revising informed consent documents with the assistance of their addressees can improve their understandability. In this study we aimed at further developing a method for testing and improving informed consent documents with regard to readability and test-readers’ understanding and reactions. We tested, revised, and retested template informed consent documents for biobank research by means of 11 focus group interviews with (...) members from the documents’ target population. For the analysis of focus group excerpts we used qualitative content analysis. Revisions were made based on focus group feedback in an iterative process. Focus group participants gave substantial feedback on the original and on the revised version of the tested documents. Revisions included adding and clarifying explanations, including an info-box summarizing the main points of the text and an illustrative graphic. Our results indicate positive effects on the tested and revised informed consent documents in regard to general readability and test-readers’ understanding and reactions. Participatory methods for improving informed consent should be more often applied and further evaluated for both, medical interventions and clinical research. Particular conceptual and methodological challenges need to be addressed in the future. (shrink)

Secondary use of clinical data in research or learning activities (SeConts) has the potential to improve patient care and biomedical knowledge. Given this potential, the ethical question arises whether physicians have a professional duty to support SeConts. To investigate this question, we analyze prominent international declarations on physicians’ professional ethics to determine whether they include duties that can be considered as good reasons for a physicians’ professional duty to support SeConts. Next, we examine these documents to identify professional duties (...) that might conflict with a potential duty of physicians to support SeConts. (shrink)