Schizophrenia is a serious mental disease whose pathogenesis has not been fully elucidated. Its clinical evaluation and diagnosis still highly depend on the clinical experience of doctors. It is of great scientific value and clinical significance to study the inducing factors and neuropathological mechanism of schizophrenia. Based on the four research problems of schizophrenia, this paper analyzes the data types that need to be stored in clinical trials and scientific research, including basic information, case report (...) data, neuropsychological and cognitive function evaluation, magnetic resonance data, electroencephalogram data, and intestinal flora data. Through the demand analysis of the system, including the data management part, data analysis part, the functional demand of the system management part, and the overall nonfunctional demand of the system, the overall architecture design, functional module division, and database table structure design of the system are completed. Adopting Browser/Server architecture and front-end and back-end separation mode and applying Java and Python programming language, based on spring framework and database, a multidimensional information management system for schizophrenia is designed and implemented, which includes four modules: data analysis, data management, system management, and security control. In addition, each functional module of the system is designed and implemented in detail, and the software operation flow of each module is illustrated with the sequence diagram. Finally, the multidimensional data of schizophrenia collected in our laboratory were used for system test to verify whether the system can meet the needs of clinical big data management of schizophrenia and the multidimensional information management system of schizophrenia can meet the needs of clinical big data management. The information management system helps schizophrenic researchers to carry out data management and data analysis. It also has advantages that are easy to use, safe, and efficient and has strong scalability in data management, data analysis, and scalability. It reflects the innovation of the system and provides a good platform for the management, research, and analysis of clinical big data of schizophrenia. (shrink)

Due to improvements in medicine, the figures of patients with disorders of consciousness (DoC) are increasing. Diagnostics of DoC and prognostication of rehabilitation outcome is challenging but necessary to evaluate recovery potential and to decide on treatment options. Such decisions should be made by doctors and patients’ surrogates based on medico-ethical principles. Meeting information needs and communicating effectively with caregivers as the patients´ most common surrogate-decision makers is crucial, and challenging when novel tech-nologies are introduced. This qualitative study (...) aims to explore information needs of informal DoC caregivers, how they manage the obtained information and their perceptions and experiences with caregiver-physician communication in facilities that implemented innovative neurodiagnostics studies. In 2021, we conducted semi-structured interviews with nine caregivers of clinically stable DoC patients in two rehabilitation centers in Italy and Germany. Participants were selected based on consecutive purposeful sampling. Caregivers were recruited at the facilities after written informed consent. All interviews were recorded, transcribed verbatim and translated. For analysis, we used reflexive thematic analysis according to Braun & Clarke (2006). Caregivers experienced the conversations emotionally, generally based on the value of the information provided. They reported to seek positive information, comfort and empathy with-in the communication of results of examinations. They needed detailed information to gain a deep understanding and a clear picture of their loved-one’s condition. The results suggest a mismatch between the perspectives of caregivers and the perspectives of medical profession-als, and stress the need for more elaborate approaches to the communication of results of neu-rodiagnostics studies. (shrink)

As ethics committees and programs become integrated into the “usual business” of healthcare organizations, they are likely to face the predicament of responding to greater demands for service and higher expectations, without an influx of additional resources. This situation demands that ethics committees and programs allocate their scarce resources (including their time, skills and funds) strategically, rather than lurching from one ad hoc request to another; finding ways to maximize the effectiveness, efficiency, impact and quality of ethics services is essential (...) in today’s competitive environment. How can Hospital Ethics Committees (HECs) begin the process of strategic priority-setting to ensure they are delivering services where and how they are most needed? This paper describes the creation of the Clinical Ethics Needs Assessment Survey (CENAS) as a tool to understand interprofessional staff perceptions of the organization’s ethical climate, challenging ethical issues and educational priorities. The CENAS was designed to support informed resource allocation and advocacy by HECs. By sharing our process of developing and validating this ethics needs assessment survey we hope to enable strategic priority-setting in other resource-strapped ethics programs, and to empower HECs to shift their focus to more proactive, quality-focused initiatives. (shrink)

ABSTRACT In Mexico informed consent is a legal requirement that ensures that patients who are invited to participate in clinical trials are provided with all the information needed to decide whether to participate, or not, in a research protocol. To improve our understanding of the problems physicians in developing countries encounter, when obtaining informed consent (IC), we examined their opinion on the importance of IC in clinical research, the quantity and quality of the information provided to (...) the participant, and the conditions in which the IC is obtained. Investigators considered that IC was useful to the patients, providing information that helped the patient to make a decision about his/her participation. Nevertheless, they felt that for some aspects of the research, like drug development in general, the use of placebos, and the randomization process, many of the patients were not capable of fully understanding the information provided, referring to the complexity of the information and illiteracy as the main reasons. Many investigators were not acquainted with some of the guidelines established in the Mexican General Law of Health,1 36% of them admitting to not having completed their IC letters. Most investigators gave only minutes to the patient to make a decision and 20% of ICs were obtained while the patient was hospitalized. Except for one investigator, all of them considered that specific training in medical ethics would be useful for the daily clinical work. (shrink)

IntroductionOne of the most important duties of hospital ethics committees is to provide medical ethics consultation to the staff and patients. This study was conducted with the aim of the needs assessment of the staff for optimal provision of medical ethics consultation services.Materials and methodsThe data collection tool was a self-administered questionnaire. Hospital managers, chief nursing officers, ward managers, and head nurses of all hospitals affiliated with Tehran and Iran University of Medical Sciences entered the study. The questionnaire together (...) with an invitation letter was sent to the samples. In the next stage, telephone follow-up of the incomplete forms was performed by the research team.ResultsA total of 448 persons participated in this study (response rate: 54.2%). The mean frequency of the need for ethics consultation in each ward was 5.2 times in the last 3 months with a median of 3. The highest needs for consultation, which were common in all wards, were observed in treatment rejection by the patient, providing necessary information to obtain informed consent and obtaining consent to high risk procedures, conflict between the decisions made by the patient and the family members, decision making for the high risk patient, request for futile or inappropriate treatments, giving bad news, and decision making for the incompetent patient.ConclusionThe prevalence of ethical issues in clinical wards is variably high. The ethical issues in the clinical setting are mainly related to respect for the patient’s autonomy and competency for decision making. (shrink)

Background: The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective: Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods: To gain an understanding of how clinicians (...) view clinical studies in the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results: Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion: Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies. (shrink)

Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients’ to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of (...) Helsinki, Good Clinical Practice guideline, Additional Protocol to the European Bioethical Convention concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow waivers from participants’ consent or deferred consent for emergency research, the regulations of most European Community countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting regulations on a waiver from a participant’s consent in emergency research exist and the regulations on surrogate consent of temporarily incompetent adults are too restrictive and authorise only the guardianship courts to consent, which is not or hardly feasible in practice. European Community regulations need to be amended to allow for implementation of the deferred consent or waivers from consent for emergency research in order to enable ethical research of emergency conditions that should become a large part of important public health priorities. (shrink)

The increasing use of digital image recording devices, whether they are digital cameras or mobile phone cameras, has democratised clinical photography in the UK. However, when non-professional clinical photographers take photographs of patients the issues of consent and confidentiality are either ignored or given scant attention.Whatever the status of the clinician, the taking of clinical photographs must be practised within the context of a professional etiquette. Best practice recognises the need for informed consent and the constraints associated (...) with confidentiality. Against the background of the poverty of the current discourse of these issues, as presented during the Valentine GMC Fitness to Practice1 hearing, the paper considers the need for orthopraxy in the use of clinical photography. (shrink)

The prevailing “segregated model” for understanding clinical research sharply separates it from clinical care and subjects it to extensive regulations and guidelines. This approach is based on the fact that clinical research relies on procedures and methods—research biopsies, blinding, randomization, fixed treatment protocols, placebos—that pose risks and burdens to participants in order to collect data that might benefit all patients. Reliance on these methods raises the potential for exploitation and unfairness, and thus points to the need for (...) independent ethical review and more extensive informed consent. In contrast, it is widely assumed that clinical care does not raise these ethical concerns because it is designed to promote the best interests of individual patients. The segregation of clinical research from clinical care has been largely effective at protecting research participants. At the same time, this approach ignores the fact that several aspects of standard clinical care, such as clinician training and scheduling, also pose some risks and burdens to present patients for the benefit of all patients. We argue that recently proposed learning health care systems offer a way to address this concern, and better protect patients, by developing integrated review and consent procedures. Specifically, current approaches base the need for independent ethical review and more extensive informed consent on whether an activity is categorized as clinical research or clinical care. An ethically sounder approach, which could be incorporated into learning health care systems, would be to base the need for independent ethical review and more extensive informed consent on the extent to which an activity poses risks to present patients for the benefit of all patients. (shrink)

Numerous ethical issues are raised in cancer treatment and research. Informed consent is challenging due to complex treatment modalities and prognostic uncertainty. Busy oncology clinics limit the ability of oncologists to spend time reinforcing patient understanding and facilitating end-of-life planning. Despite these issues and the ethics consultations they generate, clinical ethicists receive little if any focused education about cancer and its treatment. As the field of clinical ethics develops standards for training, we argue that a basic knowledge of (...) cancer should be included and offer an example of what cancer ethics training components might look like. We further suggest some specific steps to increase collaboration between clinical ethicists and oncology providers in the outpatient setting to facilitate informed consent and proactively identify ethical issues. (shrink)

Cancer care has transitioned from clinical-based to home-based care to support longterm care in a more familiar and comfortable environment. This care transition has put family caregivers (FCGs) in a strategic position as care providers. Cancer care at home involves psychological and emotional treatment at some point, making FCGs deal with the stress of cancer patients frequently. Due to their limited care competencies, they need supportive care from healthcare professionals in cancer stress management. This study aims to examine how (...) types of demanded healthcare information affect the FCG’s role in reducing the stress of female cancer patients. The mindsponge theory was used in conceptual development and interpretation. Bayesian Mindsponge Framework (BMF) analytics were used for statistical analysis on a dataset of 48 spouses (husbands) and 12 other family members in five congested communities of Surabaya, Indonesia. Results showed that among the six types of healthcare information, FCGs with higher demand for cancer-specific information were more likely to need support in reducing the stress of female cancer patients. Meanwhile, FCGs with a higher demand for information about support services were less likely to need support to reduce cancer patients’ stress. Other types of healthcare information have ambiguous effects on the need for support in reducing cancer-induced stress. This study reveals that the demanded cancer-specific information, e.g., cancer prognosis or likely outcome, must be prioritized to assist FCG’s role in managing cancer stress. (shrink)

In recent years, there has been a rapid growth in the use of autologous stem cell-based interventions to treat a wide range of medical conditions, including those for which there is limited evidence of safety and efficacy. One justification for this growth in the use of unproven interventions is that clinicians should be free to innovate, as long as consumers are adequately informed about risks and benefits. In this essay, we systematically refute the strong claim that consumer and clinician autonomy (...) provide sufficient justification for clinical innovation with autologous stem cells. While we do not deny the importance of consumer and clinician autonomy, we argue that equal consideration needs to be given... (shrink)

There is substantial published evidence showing that countless people enroll each year in ethically deficient clinical trials. Many of the trials are problematic because the quality of the science used to justify their launch may not be sufficiently vetted while many other trials may lack requisite social value. This poses the question: why do people volunteer for them? The answer resides in large part in the fact that informed consent practices have historically masked, rather than disclosed, the information (...) that would alert research candidates to the ethically problematic nature of the trials. The “reasonable person” and “key information” provisions in the revised US Common Rule create the opportunity to correct this historical shortcoming. Two sources are employed to shed light on what the “key information” is that should be disclosed to a “reasonable person”: the original disclosure aims of the Nuremberg Code, as well as an extensive body of meta-research evidence. Those sources jointly support a range of new disclosures in the informed consent process that would unmask the heretofore undisclosed information. The resulting proposed new disclosures pertain to the overall success prospects of clinical trials, the quality of the prior research that both forms the basis of clinical trials and informs assessment of their risks and benefits, the potential social value of clinical trials, and the commercial purposes of clinical trials. (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)

Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, (...) Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. (shrink)

This paper aims to show how clinical pragmatics can fruitfully inform the classical theoretical models proposed by philosophical pragmatics. In the first part of the paper I argue that theories proposed in the domain of philosophical pragmatics, as those elaborated by Austin and Grice, are not plausible from a cognitive point of view and that for this reason they cannot be useful to understand pragmatic deficits. In the second part, I show that Relevance Theory overcomes this limitation, but I (...) also argue that it offers a restricted view of human communication which has to be integrated with a model of language use that takes into account a central pragmatic property: coherence of discourse. (shrink)

ArgumentsPhysicians who counsel expectant parents about the needs for resuscitation and intensive care for an extremely preterm infant must be able to address many clinical facts and be prepared to face several ethical considerations. Such counseling is generally more than an acquisition of informed consent. It must be guided by ethical principles, values held dear by parents, relational priorities and directed toward an informed and shared decision-making process. Parents may come with a need for clinical facts, a (...) desire that they be heard as they express their values, and to help physicians realize that many are determined to follow a certain path well before such counseling occurs. They may well not be moved by counseling of the physician but still desire to be heard, respected, and allowed to contribute to their newborn’s care plans.ConclusionsRealizing this, the physician can be accepting and develop a trusting relationship with the parents that will be of value throughout the hospitalization regardless of outcome. (shrink)

The last two decades have witnessed a crescendo of allegations that clinical translation is rife with waste and inefficiency. Patient advocates argue that excessively demanding regulations delay access to life‐saving drugs, research funders claim that too much basic science languishes in academic laboratories, journal editors allege that biased reporting squanders public investment in biomedical research, and drug companies (and their critics) argue that far too much is expended in pharmaceutical development.But how should stakeholders evaluate the efficiency of translation and (...) proposed reforms to drug development? Effective reforms require an accurate model of the systems they aspire to improve—their components, their proper functions, and their pathologies. However, there is currently no explicit and well‐developed model of translation for evaluating such criticisms.In what follows, we offer an explicit model of clinical translation. Many discussions of clinical translation and its pathologies presume that its main output is tangible: new drugs, vaccines, devices, and diagnostics. We disagree. We argue that the principal output of clinical translation is information—in particular, information about the coordinated set of materials, practices, and constraints needed to safely unlock the therapeutic or preventive activities of drugs, biologics, and diagnostics. To develop this information calls for a process far different from a simple linear progression of clinical trials; it requires exploratory sampling of many different elements in this set. Our model points to some limitations and liabilities of influential proposals for reforming research. It also reveals some underrecognized opportunities for improving the efficiency of clinical translation. (shrink)

The process of obtaining informed consent to participate in a clinical study presents many challenges for research conducted in a population of patients with schizophrenia. Morally valid, informed consent must include information sharing, decisional capacity, and capacity for voluntarism. This paper examines the unique features of schizophrenia that may threaten each of these elements of informed consent, and it proposes additional safeguards in the process of gaining informed consent from individuals with schizophrenia in order to maximise the decision-making (...) potential of this patient population. (shrink)

Background: According to the Declaration of Helsinki, patients who take part in a clinical trial must be adequately informed about the trial's aims, methods, expected benefits, and potential risks. The declaration does not, however, elaborate on what “adequately informed” might amount to, in practice. Medical researchers and Local Research Ethics Committees attempt to ensure that the information which potential participants are given is pitched at an appropriate level, but few studies have considered whether the patients who take part (...) in such trials feel they have been given adequate information, or whether they feel able to understand that information.Objectives: To explore trial participants' views on the amount of information provided, and of their own understanding of that information.Design: Structured interviews of patients participating in clinical trials for the treatment of chronic medical condition.Findings: Patients generally felt they were given an appropriate amount of information, and that they were able to understand all or most of it. They felt they were given adequate time to ask questions before agreeing to take part. In comparison with treatment given outwith the research setting, patients generally felt they received more information when participating in a clinical trial.Conclusions: Researchers sometimes complain that patients are given too much information during clinical trials, and have limited understanding of that information. The present study shows that this perception is not necessarily shared by patients. More research is needed in this area, particularly to gauge whether patient understanding is indeed accurate. (shrink)

There is unanimous agreement regarding the need to ethically conduct research for improving therapy for patients admitted to hospital with acute conditions, including in emergency obstetric care. We present a conceptual analysis of ethical tensions inherent in the informed consent process for randomized clinical trials for emergency obstetric care and suggest ways in which these could be mitigated. A valid consenting process, leading to an informed consent, is a cornerstone of this aspect necessary for preservation and maintenance of respect (...) for autonomy and dignity. In emergency obstetric care research, obtaining informed consent can be problematic, leading to ethical tension between different moral considerations. Potential participants may be vulnerable due to severity of disease, powerlessness or impaired decisional capacity. Time for the consent process is limited, and some interventions have a narrow therapeutic window. These factors create ethical tension in allowing potentially beneficial research while avoiding potential harms and maintaining respect for dignity, human rights, justice and autonomy of the participants. Informed consent in emergency obstetric care in low- and middle-income countries poses numerous ethical challenges. Allowing research on vulnerable populations while maintaining respect for participant dignity and autonomy, protecting participants from potential harms and promoting justice underlie the ethical tensions in the research in emergency obstetric and newborn care. Those involved in research conduct or oversight have a duty of fair inclusion, to avoid denying participants the right to participate and to any potential research benefits. (shrink)

Although shared decision-making is a standard in medical care, unilateral decisions through process-based conflict resolution policies have been defended in certain cases. In patients who do not stand to receive proportional clinical benefits, the harms involved in interventions such as cardiopulmonary resuscitation seem to run contrary to the principle of non-maleficence, and provision of such interventions may cause clinicians significant moral distress. However, because the application of these policies involves taking choices out of the domain of shared decision-making, they (...) face important ethical and legal problems, including a recent challenge to their constitutionality. In light of these concerns, we suggest a re-conceptualization of informed non-dissent as an alternative approach in cases where the application of process-based policies is being considered. This clinician-directed communication model still preserves what is valuable in such policies and salvages professional integrity, while minimising ethical and legal challenges. (shrink)

There is broad agreement among research ethicists that investigators have a duty to obtain the informed consent of all subjects who participate in their research trials. On a common view, the duty to obtain this informed consent follows from the need to respect persons and their autonomous decisions. However, the nature of informed consent and the demands it places on investigators are open to dispute and recently have been challenged. Respect for persons, it has been claimed, does not require investigators (...) to guarantee that the subjects enrolled in their trials comprehend the risk/benefit information disclosed to them or even that they appreciate the difference between research and therapy. According to this critique, the significance of defects in informed consent, like therapeutic misconception or unrealistic optimism, has been greatly exaggerated. This article reevaluates informed consent in clinical research in light of this critique. It not only rebuts the main points the critics raise, but also shows that other points they raise can be accepted by a doctrine of informed consent that resembles the common view in maintaining that autonomous authorization is central to informed consent. (shrink)

New applications in medicine, science and technology are changing our lives. The delicate border between clinical trials and conventional diagnostic / treatment methods is becoming more evident. At this border new questions arise that need both rational and humanistic answers and that affect humankind‘s understanding of self: What are our responsibilities towards human subjects in clinical trials? What are our responsibilities towards patients and decisionally impaired psychiatry patients? What are rules about the routine techniques on decisionally incompetent psychiatry (...) patients? What are the economic parameters‘ affecting decisions?Many current research projects are concerned with the ethical problems of clinical trials of newly used medication, clinical trials of newly used measurement techniques, clinical trials proposed as conventional treatment methods, new measuring methods or conventional measuring methods on irrelevant patient groups; all being concerned with clinical trials of EEG and neuroscience. In 2009, the Ministry of Health of Turkey implemented new legislation on ―clinical trials and newly established independent ethics committees ‖. These independent and multidisiplinary IRBs analyze research projects and make recommendations about them. What should be the rationale about psychiatric patients in Turkey in a global setting? (shrink)

BackgroundInformed consent as stipulated in regulatory human research guidelines requires that a volunteer is well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the trial (...) procedures, study information and interactions with the research team.MethodsBetween January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months. They also took part in focus group discussions. Themes informed by study research questions and emerging findings were used for content analysis.ResultsVolunteers defined the informed consent process in terms of their individual welfare. Only two of the volunteers reported having referred during the trial to the participant information sheets given at the start of the trial. Volunteers remembered the information they had been given at the start of the trial on procedures that involved drawing blood and urine samples but not information about study design and randomisation. Volunteers said that they had understood the purpose of the trial. They said that signing a consent form showed that they had consented to take part in the trial but they also described it as being done to protect the researcher in case a volunteer later experienced side effects.ConclusionVolunteers pay more attention during the consent process to procedures requiring biological tests than to study design issues. Trust built between volunteers and the research team could enhance the successful conduct of clinical trials by allowing for informal discussions to identify and review volunteers’ perceptions. These results point to the need for researchers to view informed consent as a process rather than an event. (shrink)

Background Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT. Little is known about what patients really understand in consultations about RCTs. Methods Cancer patients who were asked to participate in a randomised trial were surveyed using a semi-standardised interview developed by the authors. The interview addresses understanding, satisfaction and needs of the patients. The sample included eight patients who participated in (...) a trial and two who declined. The data were analysed on the basis of Mayring's qualitative analysis. Results Patients' understanding of informed consent was less developed than anticipated, especially concerning key elements such as randomisation, content and procedure of RCTs. Analysing the result about satisfaction of the patients, most of the patients described their consultations as hectic and without advance notice. Health limitations due to cancer played a decisive role. However, most of the patients perceived their physician to be sympathetic. Analysing the needs of patients, they ask for a clear informed consent consultation with enough time and adequate advance notice. Conclusion This study fills an important empirical research gap of what is ethically demanded in an RCT consultation and what is really understood by patients. The qualitative approach enabled us to obtain new results about cancer patients' understanding of informed consent, to clarify patients' needs and to develop new ideas to optimise the informed consent. (shrink)

Informed consent is the practical application of the principle of autonomy, and two of the five core features of informed consent are related to information. Researchers have reported on patients’ expressed needs for information, such as their stated desires for the quantity of and the source of information. A separate body of research has examined patients’ unexpressed needs for information from the perspective of cognitive psychology, such as the emotional tone and order of (...) class='Hi'>information. This article suggests that the autonomy of patients is best served by meeting their expressed and unexpressed information needs in tandem. (shrink)

The COVID‐19 pandemic has reinforced the critical role of ethics and community engagement in designing and conducting clinical research during infectious disease outbreaks where no vaccine or treatment already exists. In reviewing current practices across Africa, we distinguish between three distinct roles for community engagement in clinical research that are often conflated: 1) the importance of community engagement for identifying and honouring cultural sensitivities; 2) the importance of recognising the socio‐political context in which the research is proposed; and (...) 3) the importance of understanding what is in the interest of communities recruited to research according to their own views and values. By making these distinctions, we show that current practice of clinical research could draw on anthropology in ways which are sometimes unnecessary to solicit local cultural values, overlook the importance of socio‐political contexts and wider societal structures within which it works, potentially serving to reinforce unjust political or social regimes, and threaten to cast doubt on the trustworthiness of the research. We argue that more discerning anthropological engagement as well as wider collaboration with other social scientists and those working in the humanities is urgently needed to improve the ethics of current biomedical and pharmaceutical research practice in Africa. (shrink)

Introduction Patients require an accurate knowledge about placebos and their possible effects to ensure consent for placebo-controlled clinical trials is adequately informed. However, few previous studies have explored patients’ baseline levels of understanding and knowledge about placebos. The present online survey aimed to assess knowledge about placebos among patients with a history of back pain. Design A 15-item questionnaire was constructed to measure knowledge about placebos. Additional questions assessed sociodemographic characteristics, duration and severity of back pain, and previous experience (...) of receiving placebos. Setting Participants recruited from community settings completed the study online. Results 210 participants completed the questionnaire. 86.7% had back pain in the past 6 months, 44.3% currently had back pain. 4.3% had received a placebo intervention as part of a clinical trial and 68.1% had previously read or heard information about placebos. Overall knowledge of placebos was high, with participants on average answering 12.07 of 15 questions about placebos correctly. However, few participants correctly answered questions about the nocebo effect and the impact of the colour of a placebo pill. Conclusions The findings identified key gaps in knowledge about placebos. The lack of understanding of the nocebo effect in particular has implications for the informed consent of trial participants. Research ethics committees and investigators should prioritise amending informed consent procedures to incorporate the fact that participants in the placebo arm might experience adverse side effects. (shrink)

Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information. Design: Focus groups, short self-administered questionnaires. Setting: Boston, Dallas, Detroit, Oklahoma City. Participants: Current and recent subjects in clinical trials, primarily for chronic diseases. Results: 93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to (...) the trial drug, if it benefited the subject, or to a therapeutic equivalent. Some thought PTA obligations include providing transition care (referrals to non-trial physicians or other trials, limited follow-up, short-term drug supply) or care for long-term adverse events. Others held, in contrast, that there are no PTA obligations regarding drugs or care. However, there was agreement that former subjects should receive information (drug name, dosage received, market approval date, long-term adverse effects, trial results). Participants frequently appealed to health need, cost, relationships, reciprocity, free choice and sponsor self-interest to support their views. Many of their reasons overlapped with those commonly discussed by bioethicists. Conclusion: Many participants in US trials for chronic conditions thought there are obligations to facilitate PTA to the trial drug at a “fair” price; these views were less demanding than those of non-US subjects in other studies. However, our participants’ views about informational obligations were broader than those of other subjects and many bioethicists. Our results suggest that the PTA debate should expand beyond the trial drug and aggregate results. (shrink)

BackgroundThe landscape of clinical research has evolved over the past decade. With technological advances, the practice of using electronic informed consent (eIC) has emerged. However, a number of challenges hinder the successful and widespread deployment of eIC in clinical research. Therefore, we aimed to investigate the views of various stakeholders on the potential advantages and challenges of eIC.MethodsSemi-structured interviews were conducted with 39 participants from 5 stakeholder groups from across 11 European countries. The stakeholder groups included physicians, patient (...) organization representatives, regulator representatives, ethics committee members, and pharmaceutical industry representatives, and all were involved in clinical research. Interviews were analyzed using the framework method.ResultsInterviewees identified that a powerful feature of eIC is its personalized approach as it may increase participant empowerment. However, they identified several ethical and practical challenges, such as ensuring research participants are not overloaded with information and offering the same options to research participants who would prefer a paper-based informed consent rather than eIC. According to the interviewees, eIC has the potential to establish efficient long-term interactions between the research participants and the research team in order to keep the participants informed during and after the study. Interviewees emphasized that a personal interaction with the research team is of utmost importance and this cannot be replaced by an electronic platform. In addition, interviewees across the stakeholder groups supported the idea of having a harmonized eIC approach across the European Member States.ConclusionsInterviewees reported a range of design and implementation challenges which needs to be overcome to foster innovation in informing research participants and obtaining their consent electronically. It was considered important that the implementation of eIC runs alongside the face-to-face contact between research participants and the research team. Moreover, interviewees expect that eIC could offer the opportunity to enable a personalized approach and to strengthen continuous communication over time. If successfully implemented, eIC may facilitate the engagement of research participants in clinical research. (shrink)

Decision theorists recognise that information is valuable only insofar as it has the potential to change a decision. This means that since acquiring more information is time-consuming and sometimes expensive, judgements need to be made about what information is most valuable to acquire, and whether it is worth acquiring at all. In this article I apply this idea to informed consent and argue that the most valuable information relates not to what the best treatment option may (...) be but to possible futures a patient may regret. I conclude by proposing a regret-minimisation framework for informed consent that I contend better captures the true nature of shared decision making than existing formulations. (shrink)

Objective: To survey members of the American Society for Bioethics and Humanities and of the Society for Medical Decision Making to elicit the similarities and differences in their reasoning about two clinical cases that involved ethical dilemmas.Cases: Case 1 was that of a patient refusing treatment that a surgeon thought would be beneficial. Case 2 dealt with end-of-life care. The argument was whether intensive treatment should be continued of an unconscious patient with multiorgan failure.Method: Four questions, with structured multiple (...) alternatives, were asked about each case: identified core problems, needed additional information, appropriate next steps and who the decision maker should be.Observations and results: Substantial similarities were noticed between the two groups in identifying the core problems, the information needed and the appropriate next steps. SMDM members gave more weight to outcomes and trade-offs and ASBH members had patient autonomy trump other considerations more strongly. In case 1, more than 60% of ASBH respondents identified the patient alone as the decision maker, whereas members of SMDM were almost evenly divided between having the patient as the solo decision maker or preferring a group of some sort as the decision maker, a significant difference . In case 2, both groups agreed that the question of discontinuing treatment should be discussed with the family and that the family alone should not be the decision maker.Conclusion: Despite distinctively different methods of case analysis and little communication between the two professional communities, many similarities were observed in the actual decisions they reached on the two clinical dilemmas. (shrink)

Clinical next generation sequencing is a term that refers to a variety of technologies that permit rapid sequencing of large numbers of DNA segments, up to and including entire genomes. As an approach that is playing an increasingly important role in obtaining genetic information from patients, it may be viewed by public and private payers either positively, as an enabler of the promised benefits of personalized medicine, or as “the perfect storm” resulting from the confluence of high market (...) demand, an uproven technology, and an unprepared delivery system. A number of recent studies have noted that coverage and reimbursement will be critical for clinical integration of NGS, yet the evidentiary pathway for payer decision-making is unclear. Although there are multiple reasons for this uncertain reimbursement environment, the situation stems in large part from a long-standing lack of alignment between the information needs of regulators and post-regulatory decision-makers such as payers. (shrink)

Informed consent, decision-making styles and the role of patient-physician relationships are imperative aspects of clinical medicine worldwide. We present the case of a 74-year-old woman afflicted with advanced liver cancer whose attending physician, per request of the family, did not inform her of her true diagnosis. In our analysis, we explore the differences in informed-consent styles between patients who hold an "independent" and "interdependent" construal of the self and then highlight the possible implications maintained by this position in the (...) context of international clinical ethics. Finally, we discuss the need to reassess informed-consent styles suitable to the needs of each patient regardless of whether he or she resides in the United States or in Japan. (shrink)

Background: International developments suggest that providing clinical ethics services to help clinicians negotiate ethical issues that arise in clinical practice is beneficial and reflects best practice in promoting high ethical standards and patient-centered care. The aim of this study was to explore the needs and experiences of clinical staff members to inform the development of future clinical ethics support. Methods: Health professionals at a large regional health service completed an online survey containing questions about the (...) frequency of ethical and legal issues encountered in clinical practice, the type of situations that gave rise to the ethical and/or legal uncertainty or concern, how clinicians currently address these issues, and what support would be welcome. Results: The survey was completed by 369 staff members, including 61% with more than 10 years in the profession and 51% in nursing/midwifery. Two-thirds (66%) indicated they often considered ethical implications of their clinical decisions, and half (49%) often considered the legal implications. More than half (58%) were often/occasionally concerned about the ethically right thing to do. Patient requests for borderline treatment (47%), staff disagreements about patient care (48%), and patients declining recommended treatment (54%) were the most frequent reasons given for ethical or legal uncertainty. Sixty-nine percent of respondents indicated that the way their department addressed ethical issues could be improved and 85% agreed that there is a need for more discussion on ethical issues. The majority (82%) of respondents had encountered ethically challenging clinical situations where additional support would have helped. Common approaches to issues were discussion with colleagues/supervisor (91.1%), discussion at handover/group forums (50.8%), and consultation with guidelines/protocols (60.9%). Conclusions: A majority of clinical staff members surveyed have encountered ethically/legally challenging cases daily for which they have often sought additional advice. This study indicates that many clinical staff members would welcome some form of additional clinical ethics support including advice and education. (shrink)

Most writing on informed consent in Africa highlights different cultural and social attributes that influence informed consent practices, especially in research settings. This review presents a composite picture of informed consent in Nigeria using empirical studies and legal and regulatory prescriptions, as well as clinical experience. It shows that Nigeria, like most other nations in Africa, is a mixture of sociocultural entities, and, notwithstanding the multitude of factors affecting it, informed consent is evolving along a purely Western model. Empirical (...) studies show that 70–95% of Nigerian patients report giving consent for their surgical treatments. Regulatory prescriptions and adjudicated cases in Nigeria follow the Western model of informed consent. However, adversarial legal proceedings, for a multiplicity of reasons, do not play significant roles in enforcing good medical practice in Nigeria. Gender prejudices are evident, but not a norm. Individual autonomy is recognized even when decisions are made within the family. Consent practices are influenced by the level of education, extended family system, urbanization, religious practices, and health care financing options available. All limitations notwithstanding, consent discussions improved with increasing level of education of the patients, suggesting that improved physician's knowledge and increasing awareness and education of patients can override other influences. Nigerian medical schools should restructure their teaching of medical ethics to improve the knowledge and practices of physicians. More research is needed on the preferences of the Nigerian people regarding informed consent so as to adequately train physicians and positively influence physicians' behaviors. (shrink)

Background Clinical Ethics Committees are well established at healthcare institutions in resource-rich countries. However, there is limited information on established CECs in resource poor countries, especially in Africa. This study aimed to establish baseline data regarding existing formal CECs in Africa to raise awareness of and to encourage the establishment of CECs or Clinical Ethics Consultation Services on the continent. Methods A descriptive study was undertaken using an online questionnaire via SunSurveys to survey healthcare professionals and bioethicists (...) in Africa. Data were subjected to descriptive analysis and Fischer's exact test was applied to determine associations. Texts from the open-ended questions were thematically analysed. Results In total 109 participants from 37 African countries completed the survey in December 2019. A significant association was found between participants’ bioethics qualification or training and involvement in clinical ethics. All participants were familiar with Research Ethics Committees, and initially conflated RECs with CECs. When CECs were explained in detail, approximately 85.3% reported that they had no formal CECs in their institutions. The constraints to developing CECs included lack of training, limited resources, and lack of awareness of CECs. However, the majority of participants were interested in establishing CECs. Participants listed assistance required in establishing CECs including funding, resources, capacity building and collaboration with other known CECs. The results do not reflect CECs established since the onset of COVID-19 in Africa. Conclusions This study provides a first look into CECs in Africa and found very few formal CECs on the continent indicating an urgent need for the establishment of CECs or CESs in Africa. While the majority of healthcare professionals and bioethicists are aware of ethical dilemmas in healthcare, the concept of formal CECs is foreign. This study served to raise awareness of CECs. Research ethics and RECs overshadow CECs in Africa because international funders from the global north support capacity development in research ethics and establish RECs to approve the research they fund in Africa. Raising awareness via educational opportunities, research and conferences about CECs and their role in improving the quality of health care in Africa is sorely needed. (shrink)

Clinical Pharmacology is a specialty with many attributes and our association with the subject has allowed us to acquire, apply and disseminate myriad aspects of research and practice. Though clinical pharmacologists are conspicuous by virtue of their small number, recent years have shown a growing need for the course. In the review below we navigate through several aspects of the subject as we encountered them from time to time. From critical appraisal of literature, to application of knowledge of (...) drugs, to clinical practice; moving on to clinical and basic research, to drug development process, to policy making - these are but a few of the many fields which constitute the scope of clinical pharmacology. The importance of the subject lies in allowing a trainee to develop a broad overview of the entire process, from drug generation to drug distribution to drug utilization, a process meant for the greater common goal of better health for all. We foresee a bright future for the subject though with a slight skepticism thrown in. In the present article, we make use of personal experiences and reference from literature to help you get a broad view of what clinical pharmacology means to us. (shrink)

Background: Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied.Methods: The protocols of clinical research projects submitted to the research ethics committee of the University of Freiburg in (...) 2000 were analysed. Published full articles in several databases were searched and investigators contacted. Data on study and publication characteristics were extracted from protocols and corresponding publications.Results: 299 study protocols were included. The most frequent study design was randomised controlled trial , followed by uncontrolled studies , laboratory studies and non-randomised studies . 182 were multicentre studies including 97 international collaborations. 152 of 299 had commercial funding and 46 non-commercial funding. 109 of the 225 completed protocols corresponded to at least one full publication ; the publication rate was 48%. 168 of 210 identified publications were cited in articles indexed in the ISI Web of Science. The median was 11 citations per publication .Conclusions: Results of German clinical research projects conducted are largely underreported. Barriers to successful publication need to be identified and appropriate measures taken. Close monitoring of projects until publication and adequate support provided to investigators may help remedy the prevailing underreporting of research. (shrink)

BackgroundIn clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant’s true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of (...) a clinical trial on Pemba Island, Tanzania.MethodsA total of 254 caregivers were assigned to receive a pamphlet, an oral information session or a pamphlet and an oral information session about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed.ResultsIn contrast to the pamphlet, attending an information session significantly increased caregivers’ knowledge for some of the questions. Most of these questions were either related to the parasite or to the trial design.ConclusionsIn conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating information need to be found to achieve a truly informed consent. (shrink)