Controlled human malaria infection (CHMI) studies involve the deliberate infection of healthy volunteers with malaria parasites under controlled conditions to study immune responses and/or test drug or vaccine efficacy. An empirical ethics study was embedded in a CHMI study at a Kenyan research programme to explore stakeholders’ perceptions and experiences of deliberate infection and moral implications of these. Data for this qualitative study were collected through focus group discussions, in‐depth interviews and non‐participant observation. Sixty‐nine participants were involved, including CHMI study (...) volunteers, community representatives and research staff. Data were managed using QSR Nvivo 10 and analysed using an inductive‐deductive approach, guided by ethics literature. CHMI volunteers had reasonable understanding of the study procedures. Decisions to join were influenced by study incentives, trust in the research institution, their assessment of associated burdens and motivation to support malaria vaccine development. However, deliberate malaria infection was a highly unusual research strategy for volunteers, community representatives and some study staff. Volunteers’ experiences of physical, emotional and social burdens or harms were often greater than anticipated initially, and fluctuated over time, related to specific procedures and events. Although unlikely to deter volunteers' participation in similar studies in furture, we argue that the dissonance between level of understanding of the burdens involved and actual experiences are morally relevant in relation to community engagement, informed consent processes, and ongoing support for volunteers and research staff. We further argue that ethics oversight of CHMI studies should take account of these issues in deciding whether consent, engagement and the balance of benefits and harms are reasonable in a given context. (shrink)

Background Universities in Cameroon are playing an active part in HIV/AIDS research and much of this research is carried out by students, usually for the purpose of a dissertation/thesis. Student theses/dissertations present research findings in a much more comprehensive manner and have been described as the stepping-stone of a budding scientist’s potential in becoming an independent researcher. It is therefore important to verify how students handle issues of research ethics. Method Theses/dissertations on HIV/AIDS that described research studies involving the use (...) of human research participants were screened to verify if research ethics approval and informed consent were obtained and documented. The contents of the consent forms were also qualitatively analyzed. Results Of 174 theses/dissertations on HIV, ethics approval was documented in 17 and informed consent in 77. Research ethics approval was first mentioned at all in 2002 and highly reported in the year 2007. Evidence of ethics approval was found for the first time in 2005 and informed consent first observed and evidenced in 1997. Ethics approval was mostly reported by students studying for an MD and was not reported in any Bachelors’ degree dissertation. Informed consent was also highly reported in MD theses followed by undergraduate theses. Voluntary participation and potential benefits of the study were some of the common aspects dealt with in most of the consent forms. The right to discontinue participation in the study and management of residual samples were scarcely ever mentioned. Conclusions Overall, and given the current state of the art of research ethics around the world, student-scientists in Cameroon would seem to be merely kidding with research ethics. It is thus essential that training in health research ethics be incorporated in the curriculum of universities in Cameroon in order that the next generation of scientists may be better equipped with thorough knowledge and practice of HRE. This, we believe, would be one way of fighting the occurrence of research scandals, which have not yet abated significantly, especially those arising from negligence or inexcusable ignorance. (shrink)

The proposed framework by Lynch et al. (2021) for promoting ethical forms of payment in Human Infection Controlled Studies (HICS) in general and SARS-Cov-2 HICS in particular is an important contri...

Sociologue et philosophe, Georg Simmel (1858-1918) fut sans aucun doute une des grandes figures de la transition socioculturelle de cette fin de siècle, face au désenchantement de cette époque où le développement technique a pris une telle ampleur que l'homme s'est senti écrasé par ses propres créations. Simmel s'est proclamé pour un renouveau dans la culture, "une spiritualité de la vie matérielle et une matérialisation de la vie spirituelle". Cette nouvelle orientation permet à l'homme de donner un sens et un (...) but à sa vie tout en gardant une unité entre l'objectivité et la subjectivité. L'objectif de cet ouvrage est de montrer l'actualité et la fécondité des analyses simmeliennes qui nous engagent à explorer la complexité des relations individu/société. Cette nouvelle thématique socio-philosophique concerne tous les domaines, aussi bien philosophiques, qu'artistiques et religieux. Simmel ne prétendait pas fonder une école, ni former des disciples, son but ultime fut d'élever la réalité sociale du présent vers un processus culturel allant du sujet vers l'objet et réciproquement. Dans son journal posthume, Simmel compare son oeuvre à de l'argent dont chacun peut s'approprier une partie qui lui servira pour ses propres recherches. La pensée simmelienne est une mine de richesse pour l'exploration de la société et de la culture et porte en elle les germes de la modernité. (shrink)

Although the world has experienced remarkable progress in health care since the last half of the 20th century, global health inequalities still persist. In some poor countries life expectancy is between 37-40 years lower than in rich countries; furthermore, maternal and infant mortality is high and there is lack of access to basic preventive and life-saving medicines, as well a high prevalence of neglected diseases, HIV/AIDS, tuberculosis, and malaria. Moreover, globalization has made the world more connected than before such that (...) health challenges today are no longer limited within national or regional boundaries, making all persons equally vulnerable. Because of this, diseases in the most affluent countries are closely connected with diseases in the poorest countries. In this paper, we argue that, because of global health inequalities, in a situation of equal vulnerability, there is need for global solidarity not only as a means of reducing health inequalities, but also as a way of putting up a united force against global health challenges. We argue for an African approach to solidarity in which the humanity of a person is not determined by his/her being human or rational capacity, but by his/her capacity to live a virtuous life. According to this view of solidarity, because no one is self-sufficient, no individual can survive alone. If we are to collectively flourish in a world where no individual, nation or region has all the health resources or protection needed for survival, we must engage in solidarity where we remain compassionate and available to one another at all times. (shrink)

A critical issue in executive control is how the nervous system exerts flexibility to inhibit a prepotent response and adapt to sudden changes in the environment. In this study, force measurement was used to capture “partial” unsuccessful trials that are highly relevant in extending the current understanding of motor inhibition processing. Moreover, a modified version of the stop-signal task was used to control and eliminate potential attentional capture effects from the motor inhibition index. The results illustrate that the non-canceled force (...) and force rate increased as a function of stop-signal delay, offering new objective indices for gauging the dynamic inhibitory process. Motor response was a function of delay in the presentation of novel/infrequent stimuli. A larger lateralized readiness potential amplitude in go and novel stimuli indicated an influence of the novel stimuli on central motor processing. Moreover, an early N1 component reflects an index of motor inhibition in addition to the N2 component reported in previous studies. Source analysis revealed that the activation of N2 originated from inhibitory control associated areas: the right inferior frontal gyrus, pre-motor cortex, and primary motor cortex. Regarding partial responses, LRP and error-related negativity were associated with error correction processes, whereas the N2 component may indicate the functional overlap between inhibition and error correction. In sum, the present study has developed reliable and objective indices of motor inhibition by introducing force, force-rate and electrophysiological measures, further elucidating our understandings of dynamic motor inhibition and error correction. (shrink)

Human Infection Studies have emerged as an important research approach with the potential to fast track the global development of vaccines and treatments for infectious diseases, including in low resource settings. Given the high level of burdens involved in many HIS, particularly prolonged residency and biological sampling requirements, it can be challenging to identify levels of study payments that provide adequate compensation but avoid ‘undue’ levels of inducement to participate. Through this embedded ethics study, involving 97 healthy volunteers and other (...) research stakeholders in a malaria HIS programme in Kenya, and using in-depth interviews, focus group discussions and observations during and after a malaria HIS, we give a grounded account of ethical issues emerging in relation to study payments in this setting. While careful community, national, international scientific and ethics review processes meant that risks of serious harm were highly unlikely, the levels of motivation to join HIS seen could raise concerns about study payments being too high. Particular value was placed on the reliability, rather than level, of study payment in this setting, where subsistence livelihoods are common. Study volunteers were generally clear about the study aims at the point of recruitment, and this knowledge was retained over a year later, although most reported experiencing more burdens than anticipated at enrolment. Strict study screening procedures, regular clinical and laboratory monitoring of volunteers, with prompt treatment with antimalarial at predetermined endpoints suggested that the risks of serious harm were highly unlikely. Ethical concerns emerged in relation to volunteers’ attempts to conceal symptoms, hoping to prolong residency periods and increase study payments; and volunteers making decisions that compromised important family relationships and personal values. Our findings support an interpretation that, although study volunteers were keen to join the study to access cash payments, they also paid attention to other features of the study and the general clinical research landscape, including levels of risk associated with study participation. Overall, our analysis shows that the ethical concerns emerging from the study payments can be addressed through practical measures, hinged on reducing burdens and strengthening communication, raising important issues for research policy and planning. (shrink)

Ensuring adequate informed consent for surgery in a trauma setting is challenging. We developed and pilot tested an educational video containing information regarding the informed consent process for surgery in trauma patients and a knowledge measure instrument and evaluated whether the audiovisual presentation improved the patients’ knowledge regarding their procedure and aftercare and their satisfaction with the informed consent process. A modified Delphi technique in which a panel of experts participated in successive rounds of shared scoring of items to forecast (...) outcomes was applied to reach a consensus among the experts. The resulting consensus was used to develop the video content and questions for measuring the understanding of the informed consent for debridement surgery in limb trauma patients. The expert panel included experienced patients. The participants in this pilot study were enrolled as a convenience sample of adult trauma patients scheduled to receive surgery. The modified Delphi technique comprised three rounds over a 4-month period. The items given higher scores by the experts in several categories were chosen for the subsequent rounds until consensus was reached. The experts reached a consensus on each item after the three-round process. The final knowledge measure comprising 10 questions was developed and validated. Thirty eligible trauma patients presenting to the Emergency Department were approached and completed the questionnaires in this pilot study. The participants exhibited significantly higher mean knowledge and satisfaction scores after watching the educational video than before watching the video. Our process is promising for developing procedure-specific informed consent and audiovisual aids in medical and surgical specialties. The educational video was developed using a scientific method that integrated the opinions of different stakeholders, particularly patients. This video is a useful tool for improving the knowledge and satisfaction of trauma patients in the ED. The modified Delphi technique is an effective method for collecting experts’ opinions and reaching a consensus on the content of educational materials for informed consent. Institutions should prioritize patient-centered health care and develop a structured informed consent process to improve the quality of care. The ClinicalTrials.gov Identifier is NCT01338480. The date of registration was April 18, 2011. (shrink)

Background Ensuring adequate informed consent for surgery in a trauma setting is challenging. We developed and pilot tested an educational video containing information regarding the informed consent process for surgery in trauma patients and a knowledge measure instrument and evaluated whether the audiovisual presentation improved the patients’ knowledge regarding their procedure and aftercare and their satisfaction with the informed consent process. Methods A modified Delphi technique in which a panel of experts participated in successive rounds of shared scoring of items (...) to forecast outcomes was applied to reach a consensus among the experts. The resulting consensus was used to develop the video content and questions for measuring the understanding of the informed consent for debridement surgery in limb trauma patients. The expert panel included experienced patients. The participants in this pilot study were enrolled as a convenience sample of adult trauma patients scheduled to receive surgery. Results The modified Delphi technique comprised three rounds over a 4-month period. The items given higher scores by the experts in several categories were chosen for the subsequent rounds until consensus was reached. The experts reached a consensus on each item after the three-round process. The final knowledge measure comprising 10 questions was developed and validated. Thirty eligible trauma patients presenting to the Emergency Department were approached and completed the questionnaires in this pilot study. The participants exhibited significantly higher mean knowledge and satisfaction scores after watching the educational video than before watching the video. Conclusions Our process is promising for developing procedure-specific informed consent and audiovisual aids in medical and surgical specialties. The educational video was developed using a scientific method that integrated the opinions of different stakeholders, particularly patients. This video is a useful tool for improving the knowledge and satisfaction of trauma patients in the ED. The modified Delphi technique is an effective method for collecting experts’ opinions and reaching a consensus on the content of educational materials for informed consent. Institutions should prioritize patient-centered health care and develop a structured informed consent process to improve the quality of care. Trial registration The ClinicalTrials.gov Identifier is NCT01338480. The date of registration was April 18, 2011. (shrink)

We investigated whether, in the emergency department, educational video-assisted informed consent is superior to the conventional consent process, to inform trauma patients undergoing surgery about the procedure, benefits, risks, alternatives, and postoperative care. We conducted a prospective randomized controlled trial, with superiority study design. All trauma patients scheduled to receive trauma-related debridement surgery in the ED of Kaohsiung Medical University Hospital were included. Patients were assigned to one of two education protocols. Participants in the intervention group watched an educational video (...) illustrating informed consent information, whereas those in the control group read an informed consent document. The primary outcome was knowledge scores and the secondary outcome was assessment of patient satisfaction. A multivariable regression model, with predefined covariates, was used to analyze differences in knowledge scores and patient satisfaction levels between the groups. A total of 142 patients were enrolled, with 70 and 72 assigned to the intervention and control groups, respectively. Mean knowledge scores were higher in the intervention ) than in the control group. By multivariate analysis, the intervention group had significantly greater differences in knowledge scores. Age, injury severity score, and baseline knowledge score significantly affected the differences in knowledge scores. Significant improvements were observed in patients’ perception of statements addressing comprehension of the information provided, helpfulness of the supplied information for decision making, and satisfaction with the informed consent process. Multivariate analysis showed significant correlations between video education and patient satisfaction. Both the educational approach and severity of injury may have an impact on patient understanding during the informed consent process in an emergency environment. Video-assisted informed consent may improve the understanding of surgery and satisfaction with the informed consent process for trauma patients in the ED. Institutions should develop structured methods and other strategies to better inform trauma patients, facilitate treatment decisions, and improve patient satisfaction. The ClinicalTrials.gov Identifier is NCT01338480. The date of registration was April 18, 2011. (shrink)

Background: To evaluate the effectiveness of a multifaceted intervention in improving emergency department (ED) patient privacy and satisfaction in the crowded ED setting. Methods: A pre- and post-intervention study was conducted. A multifaceted intervention was implemented in a university-affiliated hospital ED. The intervention developed strategies to improve ED patient privacy and satisfaction, including redesigning the ED environment, process management, access control, and staff education and training, and encouraging ethics consultation. The effectiveness of the intervention was evaluated using patient surveys. Eligibility (...) data were collected after the intervention and compared to data collected before the intervention. Differences in patient satisfaction and patient perception of privacy were adjusted for predefined covariates using multivariable ordinal logistic regression. Results: Structured questionnaires were collected with 313 ED patients before the intervention and 341 ED patients after the intervention. There were no important covariate differences, except for treatment area, between the two groups. Significant improvements were observed in patient perception of "personal information overheard by others", being "seen by irrelevant persons", having "unintentionally heard inappropriate conversations from healthcare providers", and experiencing "providers' respect for my privacy". There was significant improvement in patient overall perception of privacy and satisfaction. There were statistically significant correlations between the intervention and patient overall perception of privacy and satisfaction on multivariable analysis. Conclusions: Significant improvements were achieved with an intervention. Patients perceived significantly more privacy and satisfaction in ED care after the intervention. We believe that these improvements were the result of major philosophical, administrative, and operational changes aimed at respecting both patient privacy and satisfaction. (shrink)

Che 1-p'yŏn. Ch'ŏndo wa inbŏp (inbŏpch'ŏn) -- 1. Kodae Chungguk ŭi inbŏpch'ŏn ch'ŏrhak sasang -- 2. Sŏnjin sidae ch'ŏnmyŏnggwan ŭi chŏn'gae -- 3. Sŏnjin sidae chŏnt'ong chaeigwan -- 4. Kunju wa minbon : Sŏnjin sidae kunju, minbollon kwa chŏhang, hyŏngmyŏng sasang -- 5. Ch'ŏndo ŭi naeyong kwa inbŏp ŭi panyŏng - Che 2-p'yŏn. Hangsang kwa pyŏnhwa -- 1. To ŭi hangsangsŏng kwa pyŏnhwasŏng -- 2. Pŏp ŭi hangsangsŏng kwa pyŏnhwasŏng -- 3. Pŏpchesasang hangsang kwa pyŏnhwa -- 4. Ch'im Ka-bon kwa (...) Yang Kye-ch'o ŭi pyŏnbŏmnon pigyo -- Che 3-p'yŏn. P'yŏnghwa ŭi pŏp kwa yebang pŏphak : punjaeng ŭi p'yŏnghwa haegyŏl kwa yebang. (shrink)

This paper considers some thesis proposed by Maurice Merleau-Ponty during his lessons on sleeping and dreaming in the mid fifties, also with reference to the contemporary scientific debate. Dreaming and sleeping constitute a privileged perspective for considering the characteristic human interweaving of natural and cultural aspects, of animality and meaning. The immediate association of sleeping with a suspension of consciousness and with an absence of worldly contacts seems problematic. Furthermore the dualistic opposition between conscious activity and bodily passivity seems far (...) less obvious. Besides it appears as not taken for granted that human acting and experiencing could be always considered as first person's phenomena. (shrink)