Background International collaborators face challenges in the design and implementation of ethical biomedical research. Evaluating community understanding of research and processes like informed consent may enable researchers to better protect research participants in a particular setting; however, there exist few studies examining community perspectives in health research, particularly in resource-limited settings, or strategies for engaging the community in research processes. Our goal was to inform ethical research practice in a biomedical research setting in western Kenya and similar resource-limited settings. Methods (...) We sought to use mabaraza , traditional East African community assemblies, in a qualitative study to understand community perspectives on biomedical research and informed consent within a collaborative, multinational research network in western Kenya. Analyses included manual, progressive coding of transcripts from mabaraza to identify emerging central concepts. Results Our findings from two mabaraza with 108 community members revealed that, while participants understood some principles of biomedical research, they emphasized perceived benefits from participation in research over potential risks. Many community members equated health research with HIV testing or care, which may be explained in part by the setting of this particular study. In addition to valuing informed consent as understanding and accepting a role in research activities, participants endorsed an increased role for the community in making decisions about research participation, especially in the case of children, through a process of community consent. Conclusions Our study suggests that international biomedical research must account for community understanding of research and informed consent, particularly when involving children. Moreover, traditional community forums, such as mabaraza in East Africa, can be used effectively to gather these data and may serve as a forum to further engage communities in community consent and other aspects of research. (shrink)

Résister à teinter l’information dans un monde polarisé, ainsi pourrait se résumer le principal défi des salles de presse contemporaines, soumises à la transmission rapide et à une circulation de l’information qui n’a pas toujours le luxe du temps et donc, du nécessaire recul pour bien témoigner des faits. Lise Millette, journaliste à la Presse Canadienne et rédactrice en chef de la revue Trente, croit que l’heure n’est plus à la hantise des médias sociaux, mais qu’en revanche, les (...) journalistes doivent s’imposer eux-mêmes des normes d’utilisation et assumer leurs responsabilités professionnelles. Les débats polarisés de la der­nière année ont plus que jamais divisé le Québec. Ces scissions ont pris d’assaut les réseaux sociaux, qui sont devenus le carrefour et le nerf d’une guerre de mots. Les journalistes ont été sur les lignes de front que sont le terrain et la couverture quotidienne, mais ils ont aussi été confrontés à leurs propres réflexions. La profession journalistique exige de la rigueur. Les responsabilités de la presse sont grandes, comme le sont les attentes du public. (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)

Background: Emergency exception to informed consent regulation was introduced to provide a venue to perform research on subjects in emergency situations before obtaining informed consent. For a study to proceed, institutional review boards need to determine if the regulations have been met.Aim: To determine IRB members’ experience reviewing research protocols using emergency exception to informed consent.Methods: This qualitative research used semistructured telephone interviews of 10 selected IRB members from around the US in the fall of 2003. IRB members were (...) chosen as little is known about their views of exception to consent, and part of their mandate is the protection of human subjects in research. Interview questions focused on the length of review process, ethical and legal considerations, training provided to IRB members on the regulations, and experience using community consultation and notification. Content analysis was performed on the transcripts of interviews. To ensure validity, data analysis was performed by individuals with varying backgrounds: three emergency physicians, an IRB member and a layperson.Results: Respondents noted that: emergency exception to informed consent studies require lengthy review; community consultation and notification regulations are vague and hard to implement; current regulations, if applied correctly, protect human subjects; legal counsel is an important aspect of reviewing exception to informed-consent protocols; and IRB members have had little or no formal training in these regulations, but are able to access materials needed to review such protocols.Conclusions: This preliminary study suggests that IRB members find emergency exception to informed consent studies take longer to review than other protocols, and that community consultation and community notification are the most difficult aspect of the regulations with which to comply but that they adequately protect human subjects. (shrink)

Objectives: To elicit the perceptions and preferences of patients with rheumatoid arthritis regarding information and participation in treatment decision-making. To analyse the patients’ narratives on the background of the ethical discourse on various approaches to treatment decision-making. Design: In-depth interviews with themes identified using principles of grounded theory. Participants: 22 patients with long-standing rheumatoid arthritis. Main outcome measures: Qualitative data on patients’ perceptions and preferences regarding information and participation in decision-making about treatment. Results: Decision-making about treatment has (...) been described by the patients as a process consisting of different stages with shifting loci of control and responsibility. Patients initially received one treatment recommendation and were not aware of alternative treatment options. Those participants in this study who wanted information about negative effects of a treatment cited “interest in one’s own health” and the potential “use of information” as reasons for their preference. The physicians’ expert knowledge and clinical experience regarding the effects of medication were cited as arguments by patients for a treatment recommendation. Conclusions: The patients’ accounts of decision-making about treatment differ from models of physician–patient relationship that have been put forward in ethical discourse. These differences may be relevant with respect to the starting point of an ethical analysis of treatment decision-making. Patients’ accounts with respect to a lack of information on treatment alternatives point to ethically relevant challenges regarding treatment decision-making in clinical practice. (shrink)

BackgroundInformed consent as stipulated in regulatory human research guidelines requires volunteers to be well-informed about what will happen to them in a trial. However, researchers may be faced with the challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. This study aimed to find out volunteers’ comprehension of informed consent and voluntary participation in Human Immunodeficiency Virus (HIV) clinical trials during the registration cohort.MethodsWe conducted a qualitative study among volunteers (...) who were enrolled in the registration cohort of HIV clinical trials in Dar es Salaam, Tanzania. A purposive sampling strategy was used to obtain twenty study participants. The data were collected between June and September 2020 using a semi-structured interview guide. In-depth interviews were used to collect the data to obtain deep insights of the individual study participants on the comprehension of informed consent and participation in the clinical trial. A thematic analysis approach was used to analyze the data. Themes and subthemes were supported by the quotes from the participants.ResultsVolunteers described comprehension of informed consent from different perspectives. They reported that various components of the informed consent such as study procedure, confidentiality, risk and benefits were grasped during engagement meetings. Furthermore, the volunteers’ decision to participate in the registration cohort was voluntary. However, trial aspects such as health insurance, free condoms, and medical checkups could have indirectly influenced their reluctance to withdraw from the study.ConclusionEngagement meetings may increase the comprehension of informed consent among potential participants for HIV clinical trials. However, trial incentives may influence participation, and thus future research should focus on the challenges of giving incentives in the study. This will ensure comprehension and voluntary participation in the context of HIV clinical trials. (shrink)

Background Informed consent is considered to be the standard method for respecting the autonomy of individual participants in research and practices and is thought to be based on several conditions: (1) providing information on the purpose of the research or a specific treatment, what it will entail, (2) the participants being mentally competent to understand the information and weigh it in the balance, and (3) the participants to be free from coercion. While there are studies of informed consent (...) in other countries, especially Low and Middle Income Countries (LMICs), this study explored the experiences of clinicians regarding the process of obtaining informed consent to participate in a Randomised Controlled Trial (RCT) in particular and treatment in general in healthcare settings, both general and mental health, specifically focusing on the tension between individualistic concept of autonomy and collectivist values in cultures such as Pakistan. Methods Qualitative interviews with 20 clinicians from healthcare settings in Pakistan who also served as recruiters in a suicide prevention RCT in Pakistan. The interviews were guided by semi-structured topic guide. All interviews were audio-recorded and transcribed verbatim. Results The interviews revealed that shared decision making was more morally important than individual autonomy, the role of the family played a dominant part in the consent-taking procedure, the decision of the elder and/or family patriarch took prominence, and that clinician-researchers encountered significant challenges in consent process in Pakistan, while recruiting patients into the trial as well as during routine treatment processes in healthcare settings. Four distinct themes emerged which were (1) Family deciding for patients, (2) Benefits of involving family in consent process, (3) Gender disparity in consent process, (4) Challenges experienced by clinician-researchers during consent process in Pakistan. Conclusions The concept of consent is generally considered important in many cultures, however, there are two strands of understanding. There seems to be consensus that participant agreement is necessary to protect the participant but with regards to autonomy there are significant cultural differences whether it is the right for autonomy of the individual (individualistic concept) or family, community, or expert authority in other cultures. In Pakistan clinician-researchers sometimes preferred one approach and sometimes the other as they appreciated the interests of the patient to be. (shrink)

Background Ethics consultations are established in contemporary health care. Informal ethics consultations often occur and are possibly beneficial, yet they have not been empirically studied. We sought to describe features of informal ethics consultations and to identify facilitators and disruptors of patient participation in such ethics consultations. Methods We used a mixed methods (quantitative and qualitative) evaluation design and conveniently sampled 64 sequential informal ethics consultations over a period of 3 years in two academic health care centers in one (...) city in Canada. Data were collected by the two participating ethicists. We used statistical description for the quantitative data and thematic analysis for the qualitative data. Results Patients participated in only two (3%) of the informal ethics consultations. Factors that disrupted patient participation in ethics consultations were related to patients’ issues (mental impairments), family issues (family withholding information from the patient), and team members’ issues (efficiency considerations). Conclusion Informal ethics consultations may be used for ethics capacity building of health care providers rather than for engagement with addressed patients. Further research on informal ethics consultations is required, including in different sites. (shrink)

This research aimed to inform nursing practice and policy by identifying satisfying and problematic experiences of hospital visitors during the hospitalisation episode of a significant other. An extensive contextual review revealed that healthcare systems in advanced economies face multiple pressures and that in England, the government leaves the determination of hospital visiting rules to individual trusts. The analytic lens of liminality provides rich interpretations of visitors’ accounts and demonstrates the importance to visitors of structure (hospital rules and systems) and communitas (...) (social bonding among liminal personae). Supportive hospital structures reduce the challenges of liminality and increase satisfaction. The data further suggest an extension to current understandings of liminality. Strong structure and successful communitas permit a safe exit from liminality after the hospitalisation episode for visitors with a close emotional bond with the patient. (shrink)

To ensure informed consent is tailored to ethnic Asian communities, it is necessary to establish an ethical foundation that is relevant to the specific populations. We hypothesized that certain communitarian factors unique to traditional Kyrgyz culture may influence an individual's decision to participate in research. Guided by Seedhouse's (2005) Rational Field Theory, we conducted qualitative, in‐depth interviews with cultural experts in Kyrgyzstan to identify the ethical foundations of decision‐making for informed consent in Kyrgyz culture. The results indicate that Kyrgyz (...) people have a distinctive decision‐making style influenced by their nomadic culture and history, which values and prioritizes family integrity and reputation. These findings indicate that a multidimensional approach based on socio‐cultural sensitivities is necessary to assess the appropriateness of consent procedures. We believe our results may have implications for revising the guidelines of local and regional research ethics committees in Kyrgyzstan and other Central Asian countries. (shrink)

The use of informed consent for surgery or research has been widely studied; however, its use in other areas of clinical practice has received less attention. This study investigates how doctors and nurses understand informed consent in relation to the prescription and administration of medicines in secondary care. It uses a qualitative analysis of semi-structured in-depth interviews with 19 doctors and 6 nurses recruited from various specialties in a teaching hospital. The results indicate a striking gap between official and (...) actual standards of practice. Providing information, assuring adherence and communication about potential treatment harms were raised as key issues instead of the principal goals of informed consent. Rather than simply treating these findings as support for a 'deficit' account of professionalism, the paper concludes that we need a richer and more grounded account of exactly when hospital medication decisions need to be subjected to the highest standards of informed consent. (shrink)

Very few researchers have reported on procedures of recruiting, obtaining informed consent, and compensating participants in health research in the Arabian Gulf Region. Empirical research can inform the debate about whether to adjust these procedures for culturally diverse settings. Our objective was to delineate procedures related to recruiting, obtaining informed consent, and compensating health research participants in the extremely high-density multicultural setting of Qatar.

Background Informed consent is an integral component of good medical practice. Many researchers have investigated measures to improve the quality of informed consent, but it is not clear which techniques work best and why. To address this problem, we propose developing a core outcome set to evaluate interventions designed to improve the consent process for surgery in adult patients with capacity. Part of this process involves reviewing existing research that has reported what is important to patients and doctors in the (...) informed consent process. Methods This qualitative synthesis comprises four phases: identification of published papers and determining their relevance; appraisal of the quality of the papers; identification and summary of the key findings from each paper while determining the definitiveness of each finding against the primary data; comparison of key themes between papers such that findings are linked across studies. Results Searches of bibliographic databases returned 11,073 titles. Of these, 16 studies met the inclusion criteria. Studies were published between 1996 and 2016 and included a total of 367 patients and 74 health care providers. Thirteen studies collected data using in-depth interviews and constant comparison was the most common means of qualitative analysis. A total of 94 findings were extracted from the primary papers and divided into 17 categories and ultimately 6 synthesised findings related to: patient characteristics, knowledge, communication, the model patient, trust and decision making. Conclusions This qualitative meta-aggregation is the first to examine the issue of informed consent for surgery. It has revealed several outcomes deemed important to capture by patients and clinicians when evaluating the quality of a consent process. Some of these outcomes have not been examined previously in research comparing methods for informed consent. This review is an important step in the development of a COS to evaluate interventions designed to improve the consent process for surgery. Registration The study protocol was registered on the international prospective register for systematic reviews. (shrink)

Freedom of information requests are increasingly used in sociology, criminology and other social science disciplines to examine government practices and processes. University ethical review boards in Canada have not typically subjected researchers’ FOI requests to independent review, although this may be changing in the United Kingdom and Australia, reflective of what Haggerty calls ‘ethics creep’. Here we present four arguments for why FOI requests in the social sciences should not be subject to formal ethical review by ERBs. These four (...) arguments are: existing, rigorous bureaucratic vetting; double jeopardy; infringement of citizenship rights; and unsuitable ethics paradigm. In the discussion, we reflect on the implications of our analysis for literature on ethical review and qualitative research, and for literature on FOI and government transparency. (shrink)

This qualitative cross-sectional survey, undertaken in the antenatal booking clinics of a hospital in central London, explores pregnant women’s responses to routine HIV testing, examines their reasons for declining or accepting the test, and assesses how far their responses fulfil standard criteria for informed consent. Of the 32 women interviewed, only 10 participants were prepared for HIV testing at their booking interview. None of the women viewed themselves as being particularly at risk for HIV infection. The minority of the (...) participants who declined testing differed from those who accepted, by interpreting test acceptance as risky behaviour, privileging the negative outcomes of HIV positivity and expressing an inability to cope with these, should they occur. Troublingly, only a minority of women had a broad understanding of the rationale for the test, and none fulfilled the standard criteria for informed consent. This study suggests that, although routine screening combined with professional recommendation may be successful in increasing uptake, this may be at the cost of eroding informed consent. Protecting third parties from a preventable disease may outweigh the moral duty of respecting autonomy, enshrined in Western bioethical tradition. Nevertheless, such a policy should be made transparent, debated in the public domain and negotiated with women seeking antenatal care. (shrink)

Qualitative description of the movement of objects can be very important when there are large quantity of data or incomplete information, such as in positioning technologies and movement of robots. We present a first step in the combination of fuzzy qualitative reasoning and quantitative data obtained by human interaction and external devices as GPS, in order to update and correct the qualitative information. We consider a Propositional Dynamic Logic which deals with qualitative velocity and (...) enables us to represent some reasoning tasks about qualitative properties. The use of logic provides a general framework which improves the capacity of reasoning. In this way, we can infer additional information by using axioms and the logic apparatus. In this paper we present sound and complete relational dual tableau that can be used for verification of validity of formulas of the logic in question. (shrink)

BackgroundFunctional neurodiagnostics could allow researchers and clinicians to distinguish more accurately between the unresponsive wakefulness syndrome and the minimally conscious state. It remains unclear how it informs surrogate decision-making.ObjectiveTo explore how the next of kin of patients with disorders of consciousness interpret the results of a functional neurodiagnostics measure and how/why their interpretations influence their attitudes towards medical decisions.Methods and SampleWe conducted problem-centered interviews with seven next of kin of patients with DOC who had undergone a functional HD-EEG examination at (...) a neurological rehabilitation center in Germany. The examination included an auditory oddball paradigm and a motor imagery task to detect hidden awareness. We analyzed the interview transcripts using structuring qualitative content analysis.ResultsRegardless of the diagnostic results, all participants were optimistic of the patients’ meaningful recovery. We hypothesize, that participants deal with the results of examinations according to their belief system. Thus, an unfavorable evaluation of the patient’s state had the potential to destabilize the participant’s belief system. To re-stabilize or to prevent the destabilization of their belief system, participants used different strategies. Participants accepted a “positive” HD-EEG result since it stabilized their belief system.ConclusionWe hypothesize, that a group of next of kin of patients with DOC deals with functional neurodiagnostics results on the basis of the result’s value and their high hope that the patient will recover meaningfully. A psychological mechanism seems to moderate the impact of functional neurodiagnostics on surrogate treatment decisions. (shrink)

The generation of route descriptions is a fundamental task of navigation systems. A particular problem in this context is to identify routes that can easily be described and processed by users. In this work, we present a framework for representing route networks with the qualitative information necessary to evaluate and optimize route descriptions with regard to ambiguities in them. We identify different agent models that differ in how agents are assumed to process route descriptions while navigating through route (...) networks and discuss which agent models can be translated into PDL programs. Further, we analyze the computational complexity of matching route descriptions and paths in route networks in dependency of the agent model. Finally, we empirically evaluate the influence of the agent model on the optimization and the processing of route instructions. (shrink)

Background: The increase in medical ethical regulations and bureaucracy handled by institutional review boards and healthcare institutions puts the researchers using qualitative methods in a challenging position. Method: Based on three different cases from three different research studies, the article explores and discusses research ethical dilemmas. Objectives and ethical considerations: First, and especially, the article addresses the challenges for gatekeepers who influence the informant’s decisions to participate in research. Second, the article addresses the challenges in following research ethical guidelines (...) related to informed consent and doing no harm. Third, the article argues for the importance of having research ethical guidelines and review boards to question and discuss the possible ethical dilemmas that occur in qualitative research. Discussion and conclusion: Research ethics must be understood in qualitative research as relational, situational, and emerging. That is, that focus on ethical issues and dilemmas has to be paid attention on the spot and not only at the desktop. (shrink)

Prehospital ambulance based research has unique ethical considerations due to urgency, time limitations and the locations involved. We sought to explore these issues through interviews with experts in this research field. We undertook semi-structured interviews with expert informants, primarily based in the UK, seeking their views and experiences of ethics in ambulance based clinical research. Participants were questioned regarding their experiences of ambulance based research, their opinions on current regulations and guidelines, and views about their general ethical considerations. Participants were (...) chosen because they were actively involved in, or in their expert capacity expressed an interest in, ambulance based research. Fourteen participants were interviewed including principal investigators, researchers, ethicists and medical lawyers. Five major themes were identified: Capacity, Consent, Clinical Considerations, Consultation and Regulation. Questions regarding consent and capacity were foremost in the discussions as all participants highlighted these as areas for concern. The challenges and use of multiple consent models reflected the complexity of research in this environment. The clinical theme referred to the role of paramedics in research and how research involving ambulance services is increasingly informing improvements to patient care and outcomes and reducing the burden on hospital services. Most felt that, although current regulations were fit for purpose, more specific guidance on implementing these in the ambulance setting would be beneficial. This related closely to the theme of consultation, which examined the key role of ethics committees and other regulatory bodies, as well as public engagement. By interviewing experts in research or ethics in this setting we were able to identify key concerns and highlight areas for future development such as improved guidance. (shrink)

Informed consent (IC) is a fundamental principle in medical ethics that upholds respect for patient autonomy. Although widely applied in healthcare, its feasibility and implementation in herbal medicine have been underexplored. This study therefore aimed to explore the practices and attitudes of herbalists regarding informed consent. To achieve these objectives, a qualitative cross-sectional study was conducted from June to December 2020. Twenty-one in-depth interviews with herbalists and four key informant interviews with leaders of the different traditional medicine organizations were (...) conducted. The data were analyzed thematically using NVivo version 12 software. Sixteen of the twenty-one participants acquired oral herbal medicine knowledge from their relatives. Although a positive inclination toward obtaining IC was evident, the focus was on disclosing basic information. Discussions of alternative treatments and herbal specifics were less frequent. Disease management decisions often involve shared responsibility within families or societies. Documented IC procedures are rare among herbalists, who deem consent forms unnecessary, although they recognize the potential benefits of IC in fostering trust and professionalism. Challenges hindering IC implementation included regulatory gaps, inadequate skills, and the absence of mechanisms to protect the intellectual property rights of herbal medicine. This study illuminates how educational, cultural, familial, and regulatory factors influence herbalists’ practices and attitudes toward informed consent. (shrink)

Weak Quantum Theory (WQT) and the Model of Pragmatic Information (MPI) are two psychophysical concepts developed on the basis of quantum physics. The present study contributes to their empirical examination. The issue of the study is whether WQT and MPI can not only explain ‘psi’-phenomena theoretically but also prove to be consistent with the empirical phenomenology of extrasensory perception (ESP). From the main statements of both models, 33 deductions for psychic readings are derived. Psychic readings are defined as settings, (...) in which psychics support or counsel clients by using information not mediated through the five senses. A qualitative approach is chosen to explore how the psychics experience extrasensory perceptions. Eight psychics are interviewed with a half-structured method. The reports are examined regarding deductive and inductive aspects, using a multi-level structured content analysis. The vast majority of deductions is clearly confirmed by the reports. Even though the study has to be seen as an explorative attempt with many aspects to be specified, WQT and MPI prove to be coherent and helpful concepts to explain ESP in psychic readings. (shrink)

Introduction: Uncertainty is omnipresent in cancer care, including the ambiguity of diagnostic tests, efficacy and side effects of treatments, and/or patients' long-term prognosis. During second opinion consultations, uncertainty may be particularly tangible: doubts and uncertainty may drive patients to seek more information and request a second opinion, whereas the second opinion in turn may also affect patients' level of uncertainty. Providers are tasked to clearly discuss all of these uncertainties with patients who may feel overwhelmed by it. The aim (...) of this study was to explore how oncologists communicate about uncertainty during second opinion consultations in medical oncology.Methods: We performed a secondary qualitative analysis of audio-recorded consultations collected in a prospective study among cancer patients who sought a second opinion in medical oncology. We purposively selected 12 audio-recorded second opinion consultations. Any communication about uncertainty by the oncologist was double coded by two researchers and an inductive analytic approach was chosen to allow for novel insights to arise.Results: Seven approaches in which oncologists conveyed or addressed uncertainty were identified: specifying the degree of uncertainty, explaining reasons of uncertainty, providing personalized estimates of uncertainty to patients, downplaying or magnifying uncertainty, reducing or counterbalancing uncertainty, and providing support to facilitate patients in coping with uncertainty. Moreover, oncologists varied in their choice of words/language to convey uncertainty.Discussion: This study identified various approaches of how oncologists communicated uncertain issues during second opinion consultations. These different approaches could affect patients' perception of uncertainty, emotions provoked by it, and possibly even patients' behavior. For example, by minimizing uncertainty, oncologists may consciously steer patients toward specific medical decisions). Future research is needed to examine how these different ways of communicating about uncertainty affect patients. This could also facilitate a discussion about the desirability of certain communication strategies. Eventually, practical and evidence-based guidance needs to be developed for clinicians to optimally inform patients about uncertain issues and support patients in dealing with these. (shrink)

Research Ethics, Volume 18, Issue 3, Page 193-209, July 2022. This study aimed to explore experiences and practices of key research team members in obtaining informed consent for pharmacogenetics research and to identify the approaches used for enhancing understanding during the consenting process. Data collection involved 15 qualitative, in-depth interviews with key researchers who were involved in obtaining informed consent from HIV infected individuals in Uganda for participation in pharmacogenetic clinical trials. The study explored two prominent themes: approaches used (...) to convey information and enhance research participants’ understanding and challenges faced during the consenting process. Several barriers and facilitators for obtaining consent were identified. Innovative and potentially effective consenting strategies were identified in this study that should be studied and independently verified. (shrink)

BackgroundThe Western-European concept of libertarian rights-based autonomy, which advocates respect for individual rights, may conflict with African cultural values and norms. African communitarian ethics focuses on the interests of the collective whole or community, rather than rugged individualism. Hence collective decision-making processes take precedence over individual autonomy or consent. This apparent conflict may impact informed consent practice during biomedical research in African communities and may hinder ethical principlism in African bioethics. This study explored African biomedical researchers' perspectives regarding informed consent (...) and potential limitations to the principle of respect for autonomy in African communities.MethodsWe conducted a qualitative study based on in-depth interviews with 12 biomedical researchers, five females and seven males aged 34 to 74 years, currently working at an African university. Interviews lasted 35–40 min each and involved semi-structured open-ended interviews, which allowed participants to offer information about their perceptions and feelings regarding respect for autonomy and informed consent as practised in Africa. Empirical data from the interviews were recorded, transcribed, and analysed using thematic content analysis, together with an interrogation of relevant scientific literature about African communitarian ethics, making evaluations and drawing inferences consistent with the empirical bioethics approach.ResultsBased on these interviews and analysis of relevant literature, we found that informed consent is difficult to apply in an African context because it derives from a Western conception of libertarian rights-based autonomy. Most respondents pointed out that it was challenging to implement informed consent in the African setting. Furthermore, communalism, customary beliefs, spirituality, and relational autonomy are predominant in most African communities, as exemplified by the African moral philosophies of Ubuntu/botho and Ukama, which emphasize communitarianism over individual rights. We also found that language, education, poverty, and cultural beliefs are barriers to obtaining proper informed consent in African communities.ConclusionsWe conclude that there are limitations to applying the principle of respect for autonomy and informed consent in African communities, especially in the context of human biomedical research. We recommend using a more relational approach, such as Ross’s prima facie duties, to implement informed consent in African communities. (shrink)

Many different approaches to describing the players’ knowledge and beliefs can be found in the literature on the epistemic foundations of game theory. We focus here on non-probabilistic approaches. The two most prominent are the so-called Kripkeor Aumann- structures and knowledge structures (non-probabilistic variants of Harsanyi type spaces). Much of the recent work on Kripke structures has focused on dynamic extensions and simple ways of incorporating these. We argue that many of these ideas can be applied to knowledge structures as (...) well. Our main result characterizes precisely when one type can be transformed into another type by a specific type of information update. Our work in this paper suggest that it would be interesting to pursue a theory of “information dynamics” for knowledge structures (and eventually Harsanyi type spaces). (shrink)

Although Responsible Conduct of Research (RCR) training is common in the sciences, the effectiveness of RCR training is open to question. Three key factors appear to be particularly important in ensuring the effectiveness of ethics education programs: (1) educational efforts should be tied to day-to-day practices in the field, (2) educational efforts should provide strategies for working through the ethical problems people are likely to encounter in day-to-day practice, and (3) educational efforts should be embedded in a broader program of (...) on-going career development efforts. This article discusses a complex qualitative approach to RCR training development, based on a sensemaking model, which strives to address the afore-mentioned training concerns. Ethnographic observations and prior RCR training served the purpose of collecting information specific to a multi-disciplinary and multi-university research center with the goal of identifying metacognitive reasoning strategies that would facilitate ethical decision-making. The extensive qualitative analyses resulted in the identification of nine metacognitive reasoning strategies on which future RCR training will be developed. The implications of the findings for RCR training in the sciences are discussed. (shrink)

Background There is broad international agreement from clinicians and academics that healthcare rationing should be undertaken as explicitly as possible, and the BMA have publicly supported the call for more accountable priority setting for some time. However, studies in the UK and elsewhere suggest that clinicians experience a number of barriers to rationing openly, and the information needs of patients at the point of provision are largely unknown. Methodology In-depth interviews were undertaken with NHS professionals working at the community (...) level of provision, and with patients and professionals receiving or providing treatment for morbid obesity and breast cancer (n=52). Results Nearly all patients wanted to know about healthcare rationing and had high expectations of their clinical professionals to provide all relevant information about treatment options. However, professionals did not always understand these information requirements, and cases of implicit rationing were common. The existence of relevant national guidance was not always known about, meaning that patients were often reliant on other sources of information about treatment options, which included the popular media, the internet, patient advocacy groups and informal networks of support. Discussion Clinical professionals need to understand patients' need for detailed information when it comes to rationing, and to understand that they are the main gateway for this to be provided. However, disclosure could be distressing for both patients and professionals, and thus the most sensitive and acceptable ways to make this information available requires further investigation. (shrink)

Purpose The manner in which people, businesses and governments perform is changing because of the spread of technology. Digitalization of governments can be considered a necessity as we are now entering the era of the Internet-of-Things. The advantages and disadvantages of electronic governments have been examined in several research studies. This study aims to examine the attitudes of decision-makers towards e-government. The research aims are as follows: to determine the problems related with e-government usage, to establish the factors which decrease (...) the usage of e-government services and to propose recommendations for the effective application of e-government practices. Design/methodology/approach Qualitative research has been used for the study. Participants were chosen by the snowball sampling method, and face-to-face in-depth interviews were conducted with all decision-makers. In-depth interviews are more efficient and enable the acquisition of better qualitative information, in-depth knowledge and statistics, as the distance between the interviewer and interviewee is reduced. Questions asked can be categorized under two sections, where the questions in the first section are related to the decision-maker’s management style/managerial proposition, and in the second section, technological questions are asked in terms of the preferred communication method and the decision-makers’ attitudes towards e-government practices. Findings Decision-makers perceive electronic government to be important, while the level of importance is observed to be different among the decision-makers. Chronic problems exist in many countries, such as nepotism, where the decision-makers have conflicting arguments about e-government and the resulting effect on nepotism. Furthermore, the study also indicates that decision-makers are aware of the importance of mobile government, although they acknowledge that more time is required, as their country is still developing. Electronic voting is also perceived to be important, although the decision-makers believe that security and privacy issues need to be solved before related projects can be initiated. Originality/value This research can be a benchmark study for the decision-makers of small island developing states by means of e-government. The impediments preventing the effective application of e-government practices are also discussed in the study. This study will be useful to highlight the triggers and obstacles for e-government development in the context of a developing country. Internet penetration has increased significantly since the 2000s, and therefore, decision-makers need to consider the shift in citizens’ behaviour, such as the high usage of smartphones and the emergence of the Internet-of-Things. (shrink)

BackgroundThe consent process for a genetic study is challenging when the research is conducted in a group stigmatized because of beliefs that the disease is familial. Podoconiosis, also known as 'mossy foot', is an example of such a disease. It is a condition resulting in swelling of the lower legs among people exposed to red clay soil. It is a very stigmatizing problem in endemic areas of Ethiopia because of the widely held opinion that the disease runs in families and (...) is untreatable. The aim of this study was to explore the impact of social stigma on the process of obtaining consent for a study on the genetics of podoconiosis in Southern Ethiopia.MethodsWe adapted a rapid assessment tool validated in The Gambia. The methodology was qualitative involving focus-group discussions (n = 4) and in-depth interviews (n = 25) with community members, fieldworkers, researchers and staff of the Mossy Foot Treatment and Prevention Association (MFTPA) working on prevention and treatment of podoconiosis.ResultsWe found that patients were afraid of participation in a genetic study for fear the study might aggravate stigmatization by publicizing the familial nature of the disease. The MFTPA was also concerned that discussion about the familial nature of podoconiosis would disappoint patients and would threaten the trust they have in the organization. In addition, participants of the rapid assessment stressed that the genetic study should be approved at family level before prospective participants are approached for consent. Based on this feedback, we developed and implemented a consent process involving community consensus and education of fieldworkers, community members and health workers. In addition, we utilized the experience and established trust of the MFTPA to diminish the perceived risk.ConclusionThe study showed that the consent process developed based on issues highlighted in the rapid assessment facilitated recruitment of participants and increased their confidence that the genetic research would not fuel stigma. Therefore, investigators must seek to assess and address risks of research from prospective participants' perspectives. This involves understanding the issues in the society, the culture, community dialogues and developing a consent process that takes all these into consideration. (shrink)

Why are computers so smart these days? And why are humans apparently still a bit smarter? Does this have something to do with the difference between data and meaning? Does this in turn mean that at least some abstract entities, such as numbers, exist independently of human thought? Wouldn’t that require an expansion of our scientific world view? And would that at all be compatible with what we know about our world from physics and chemistry, philosophy, psychology, neuroscience and the (...) theory of evolution? Finally, what would this tell us about ethical and aesthetic value theories? These and related questions will be discussed in this book. We will find that the difference between data and meaning, i.e. quantitative and qualitative information, does indeed appear to be of central importance for understanding both artificial and natural intelligence. And then the independent existence of abstract entities not only appears to be a particularly promising hypothesis, but also one that is entirely compatible with the sum of our scientific knowledge, especially with regard to value theories. The book thus arrives at the exploration of a scientifically tenable, panpsychistically inspired, objective idealism that can be derived from our most fundamental intuitions as subjects that perceive qualities, but that can also take into account the structuring of the world already at the micro-scale, found in the modern natural sciences. The result is a Platonic, but in a second step also a scientific realism and a naturalism in the sense that it is informed by the natural sciences in terms of an inductive metaphysics. An objective idealism, not in a rationalistic maximum form, but in a pragmatic minimum form; without eternal truths, but dependent on the continued philosophical-scientific and also philosophicalsocial dialog. The proposed model could offer interesting solutions to a number of problems at and near the mind/matter boundary: Proposals are being considered for the interpretation of quantum mechanics, the problem of molecular symmetry, the neuronal code and the binding problem in neuroscience, mental causation, a more holistic understanding of mental processes, and so on and so forth. However, the extent to which the model threatens to promise far too much is also being discussed. In sum, the core question is how we can imagine human thinking beyond physically conceived information processing. An alternative model of human thinking is then put up for discussion, for which not only machine-like cognitive performance, but above all the intentional perception of qualitative information, i.e. of abstract entities, would be central, as well as the free, ultimately creative linking of patterns of quantitative information (signals, data) with such qualities (meanings). (shrink)

Normative issues associated with the design and implementation of population-based lung cancer screening policies are underexamined. This study was an exposition of the ethical justification for screening and potential ethical issues and their solutions in Canadian jurisdictions. A qualitative description study was conducted. Key informants, defined as policymakers, scientists and clinicians who develop and implement lung cancer screening policies in Canada, were purposively sampled and interviewed using a semi-structured guide informed by population-based disease screening principles and ethical issues in (...) cancer screening. Interview data were analyzed using qualitative content analysis. Fifteen key informants from seven provinces were interviewed. Virtually all justified screening by beneficence, describing that population benefits outweigh individual harms if high-risk people are screened in organized programs according to disease screening principles. Equity of screening access, stigma and lung cancer primary prevention were other ethical issues identified. Key informants prioritized beneficence over concerns for group-level justice issues when making decisions about whether to implement screening policies. This prioritization, though slight, may impede the implementation of screening policies in a way that effectively addresses justice issues, a goal likely to require justice theory and critical interpretation of disease screening principles. (shrink)

Non-Invasive Prenatal Testing is a technology which provides information about fetal genetic characteristics very early in pregnancy by examining fetal DNA obtained from a sample of maternal blood. NIPT is a morally complex technology that has advanced quickly to market with a strong push from industry developers, leaving many areas of uncertainty still to be resolved, and creating a strong need for health policy that reflects women’s social and ethical values. We approach the need for ethical policy-making by studying (...) the use of NIPT and emerging policy in the province of Ontario, Canada. Using an adapted version of constructivist grounded theory, we conducted interviews with 38 women who have had personal experiences with NIPT. We used an iterative process of data collection and analysis and a staged coding strategy to conduct a descriptive analysis of ethics issues identified implicitly and explicitly by women who have been affected by this technology. The findings of this paper focus on current ethical issues for women seeking NIPT, including place in the prenatal pathway, health care provider counselling about the test, industry influence on the diffusion of NIPT, consequences of availability of test results. Other issues gain relevance in the context of future policy decisions regarding NIPT, including funding of NIPT and principles that may govern the expansion of the scope of NIPT. These findings are not an exhaustive list of all the potential ethical issues related to NIPT, but rather a representation of the issues which concern women who have personal experience with this test. Women who have had personal experience with NIPT have concerns and priorities which sometimes contrast dramatically with the theoretical ethics literature. These findings suggest the importance of engaging patients in ethical deliberation about morally complex technologies, and point to the need for more deliberative patient engagement work in this area. (shrink)

Objectives: To explore opinions and attitudes regarding the current information-giving practices in research involving adults with intellectual disabilities.Design: Qualitative focus group study with a purposive sample.Setting: An intellectual disabilities service within the NHSParticipants: A sample of 26 individuals including adults with mild intellectual disability, carers, clinicians, care managers and the charitable sector.Results: Three main themes were identified: process, format, and content. There was agreement that there is a need for improvement in the process and quality of information (...) giving. With regard to the content of information, there was little discrepancy between the study findings and existing guidance.Conclusions: Information should be presented in different formats and prepared with input from appropriate professions. Additionally the roles of peers, carers and other professionals in the process of information giving should be considered. (shrink)

Ethics consultation is a commonly applied mechanism to address clinical ethical dilemmas. However, there is little information on the viewpoints of health care providers towards the relevance of ethics committees and appropriate application of ethics consultation in clinical practice. We sought to use qualitative methodology to evaluate free-text responses to a case-based survey to identify thematically the views of health care professionals towards the role of ethics committees in resolving clinical ethical dilemmas. Using an iterative and reflexive model (...) we identified themes that health care providers support a role for ethics committees and hospitals in resolving clinical ethical dilemmas, that the role should be one of mediation, rather than prescription, but that ultimately legal exposure was dispositive compared to ethical theory. The identified theme of legal fears suggests that the mediation role of ethics committees is viewed by health care professionals primarily as a practical means to avoid more worrisome medico-legal conflict. (shrink)

We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision‐making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to (...) discuss it with partners or relatives; and perceived benefits such as quality of care, non‐cost provision of methods and medical care. For some women, participation was an opportunity to express altruism. The main obstacles for participation were perceived side effects or risks. The final risk‐benefit balance was strongly influenced by women’s needs. Women perceived that the consent form benefited the clinic, proving that participants had made a free decision, and benefited the volunteers by warranting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We concluded that a full decision‐making process enhances women’s ability to exercise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to the study. Researchers have the responsibility of conducting this process. (shrink)

This paper addresses psychological factors that might interfere with informed consent on the part of stable patients as potential early-phase clinical trial participants. Thirty-six semistructured interviews with patients who had either diabetes or gout were conducted. We investigated stable patients’ attitudes towards participating in a fictitious first-in-human trial of a novel intervention. We focused on an in-depth analysis of those statements and explanations that indicated the existence of psychological factors impairing decision-making capacity. Three main themes emerged: insufficient comprehension of the (...) inherent logic of clinical trials (actual comprehension), the recourse to trust over comprehension (prioritization of trust), and visceral factors that override deliberative process (visceral factors). Overall, our results indicate a limited psychological capacity on the part of stable patients to meet the requirements of informed consent as set by Declaration of Helsinki. A redesigned informed consent procedure should take account of these psychological realities. (shrink)

Qualitative Reasoning (QR) is an area of research within Artificial Intelligence that automates reasoning and problem solving about the physical world. QR research aims to deal with representation and reasoning about continuous aspects of entities without the kind of precise quantitative information needed by conventional numerical analysis techniques. Order-of-magnitude Reasoning (OMR) is an approach in QR concerned with the analysis of physical systems in terms of relative magnitudes. In this paper we consider the logic OMR_N for order-of-magnitude reasoning (...) with the bidirectional negligibility relation. It is a multi-modal logic given by a Hilbert-style axiomatization that reflects properties and interactions of two basic accessibility relations (strict linear order and bidirectional negligibility). Although the logic was studied in many papers, nothing was known about its decidability. In the paper we prove decidability of OMR N by showing that the logic has the strong finite model property. (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)

This paper poses questions regarding the ethical prioritisation in qualitative research studies on assessing a person's or a group's fitness to provide informed consent, arguing that this may have unwanted as well as desirable consequences, particularly in relation to rights of citizenship for socially marginalised populations who tend to be labelled vulnerable. Drawing on three theoretical perspectives (Arendt, Honneth and Bourdieu), it is suggested that the emphasis placed on a research participant's capacity to provide informed consent cannot be regarded (...) solely as a protective measure for ?vulnerable? groups, but is also bound up with their social positioning as socially ?deficient? according to liberal (classical and neo-liberal) models of citizenship. Participation in a qualitative study can be seen as a dimension of the civil and human right to freedom of expression, and this can be particularly important for those labelled vulnerable as freedom of expression is a precondition for recognition and parity of status. Nevertheless, the importance of informed consent is not rejected; instead, it is posited that the protective rights accorded to vulnerable groups in qualitative research need to be considered alongside other human goods, such as the promotion of voice, agency and active citizenship. (shrink)

Although Responsible Conduct of Research training is common in the sciences, the effectiveness of RCR training is open to question. Three key factors appear to be particularly important in ensuring the effectiveness of ethics education programs: educational efforts should be tied to day-to-day practices in the field, educational efforts should provide strategies for working through the ethical problems people are likely to encounter in day-to-day practice, and educational efforts should be embedded in a broader program of on-going career development efforts. (...) This article discusses a complex qualitative approach to RCR training development, based on a sensemaking model, which strives to address the afore-mentioned training concerns. Ethnographic observations and prior RCR training served the purpose of collecting information specific to a multi-disciplinary and multi-university research center with the goal of identifying metacognitive reasoning strategies that would facilitate ethical decision-making. The extensive qualitative analyses resulted in the identification of nine metacognitive reasoning strategies on which future RCR training will be developed. The implications of the findings for RCR training in the sciences are discussed. (shrink)

Knowledge about aspects that influence recovery and adaptation in the postacute phase of disabling health events is key to understanding how best to provide appropriate rehabilitation and health services. Qualitative longitudinal research makes it possible to look for patterns, key time points and critical moments that could be vital for interventions and supports. However, strategies that support robust data management and analysis for longitudinal qualitative research in health‐care are not well documented in the literature. This article reviews three (...) challenges encountered in a large longitudinal qualitative descriptive study about experiences of recovery and adaptation after traumatic brain injury in New Zealand, and the strategies and technologies used to address them. These were (i) tracking coding and analysis decisions during an extended analysis period; (ii) navigating interpretations over time and in response to new data; and (iii) exploiting data volume and complexity. Concept mapping during coding review, a considered combination of information technologies, employing both cross‐sectional and narrative analysis, and an expectation that subanalyses would be required for key topics helped us manage the study in a way that facilitated useful and novel insights. These strategies could be applied in other qualitative longitudinal studies in healthcare inquiry to optimise data analysis and stimulate important insights. (shrink)

The surprising aspects of quantum information are due to two distinctly non-classical features of the quantum world: first, different quantum states need not be orthogonal and, second, quantum states may be entangled. Non-orthogonality leads to the blurring of classical distinctions. On the other hand, entanglement leads via non-locality to teleportation and other ``entanglement-assisted'' forms of communication that go beyond what is classically possible. In this article we attempt to understand these new possibilities via an analysis of the significance of (...) entanglement for the basic physical concepts of a ``particle'' and a ``localized physical system''. Classical particles can be individuated on the basis of qualitative differences in their sets of properties. But in entangled states the ``particle labels'' of the quantum formalism usually do not pick out such sets of individuating particle properties. It is sometimes nevertheless possible to think in terms of individual particles, which may be localized; but we argue that in general the structure of quantum mechanics is at odds with such a particle interpretation. This finally leads us to the conclusion that quantum mechanics is best seen as not belonging to the category of space-time theories, in which physical quantities are functions on space-time points. The resulting picture of the quantum world is relevant for our understanding of the way in which quantum theory is non-local, and it sheds light on the novel aspects of quantum information. (shrink)