Ethical problems are common in clinical medicine, so medical volunteers who practice clinical medicine in developing countries should expect to encounter them just as they would in their practice in the developed world. However, as this article argues, medical volunteers in developing countries should not expect to encounter the same ethical problems as those that dominate Western biomedicine or to address ethical problems in the same way as they do in their practice in developed countries. For (...) example, poor health and advanced disease increase the risks and decrease the potential benefits of some interventions. Consequently, when medical volunteers intervene too readily, without considering the nutritional and general health status of patients, the results can be devastating. Medical volunteers cannot assume that the outcomes of interventions in developing countries will be comparable to the outcomes of the same interventions in developed countries. Rather, they must realistically consider the complex medical conditions of patients when determining whether or not to intervene. Similarly, medical volunteers may face the question of whether to provide a pharmaceutical or perform an intervention that is below the acceptable standard of care versus the alternative of doing nothing. This article critically explores the contextual features of medical volunteer work in developing countries that differentiate it from medical practice in developed countries, arguing that this context contributes to the creation of unique ethical problems and affects the way in which these problems should be analyzed and resolved. (shrink)

Developing World Bioethics, Volume 21, Issue 3, Page 102-110, September 2021.

Global Health Needs and the Short-Term Medical Volunteer: Ethical Considerations Content Type Journal Article Pages 71-78 DOI 10.1007/s10730-011-9158-5 Authors Michele K. Langowski, Albert Gnaegi Center for Health Care Ethics, Salus Center, Saint Louis University, 3545 Lafayette, 5th Floor, St. Louis, MO 63104-1314, USA Ana S. Iltis, Department of Philosophy and Center for Bioethics, Health and Society, Wake Forest University, P.O. Box 7332, Winston-Salem, NC 27109, USA Journal HEC Forum Online ISSN 1572-8498 Print ISSN 0956-2737 Journal Volume Volume 23 Journal (...) Issue Volume 23, Number 2. (shrink)

After the COVID-19 outbreak, the health status of the general population has suffered a huge threat, and the health system has also encountered great challenges. As critical members of human capital in the health sector, medical students with specialized knowledge and skills have positively fought against the epidemic by providing volunteer services that boosted the resilience of the health system. Although volunteer behavior is associated with individual internal motivation, there is sparse evidence on this relationship among medical students, (...) especially regarding potential mechanisms. Therefore, this study had two main objectives: to examine the influence of prosocial motivation of medical students on their VB; and to verify the chain-mediating role of calling and vocation as well as social responsibility in the relationship between PM and VB. Study I: a total of 2454 Chinese full-time medical students were invited to complete an online survey. Data analysis was performed using descriptive statistics, Pearson’s correlation coefficient, and multiple linear regression analysis. The results demonstrated that PM significantly affected VB in medical students ; CV as well as SR chain-mediated the relationship between PM and VB. PM promoted the formation of SR by positively evoking CV of medical students, further resulting in increased VB. Study II: A 28 person qualitative interview was conducted. Qualitative data are added to reduce the limitations of online questionnaires. At the same time, we can also critically study the VB of Chinese medical students during COVID-19. The results showed that there were various reasons for medical students to volunteer in the process of fighting against COVID-19, and the experience of volunteer service and the impact on their future life were different. Lastly, the current findings suggest that fostering volunteerism among medical students requires the joint effort of the government, non-profit organizations, and medical colleges. (shrink)

Due to the spread of COVID-19, a key challenge was to reduce potential staff shortages in the healthcare sector. Besides recruiting retired healthcare workers, medical students were considered to support this task. Commitment of medical students in Germany during the COVID-19 pandemic was evaluated using an online survey, with particular focus on their burdens and anxieties. This survey was distributed to students within a 2-week period in April and May 2020. Ultimately, 1241 participants were included in the analysis. (...) During the pandemic, 67.9% of the participants reported that they had volunteered. Furthermore, 88.9% stated that they were against compulsory recruitment in this context. Students who volunteered had a significantly lower anxiety index than non-committed students. Additionally, students were more concerned about infecting other patients and relatives than themselves. Higher levels of anxiety were related to lower levels of commitment. A mandatory assignment during the pandemic was rejected by the students and does not seem to be necessary due to the large number of volunteers. (shrink)

A group of activist clinicians have offered to volunteer for clinical trials of live attenuated HIV vaccines. This has provided an important conceptual challenge to medical ethics, and to work on the development of HIV vaccines. In exploring these issues, this article highlights how the HIV field has altered the content as well as the tone of ethical discourse. The balance of expertise and authority between research subjects and triallists is profoundly changed, raising questions about the limits of voluntarism (...) and differing perspectives on risk-benefit analysis. Care is needed to ensure that the novelty of the situation does not confuse the central ethical and scientific issues. (shrink)

The aim of the research was to analyse the experience of medical volunteers during World War II in the context of nursing history. Oral history data used in the study consisted of 30 interviews with Finnish wartime medical volunteers, known locally as Lottas. Interview data were analysed both thematically and by using the oral history method. Based on the analysis, the Lottas' experiences during wartime nursing became the leitmotif of this study. The main themes consisted of (...) the following: ‘taking care of wounded and ill patients', ‘taking care of dying and deceased patients’, ‘taking care of mentally ill and psychoactive substance‐addicted patients’ and ‘confronting ethical and role dilemmas in nursing’. The interview results showed that the Lottas' duties were sometimes more demanding than basic nursing tasks and that their education was not adequate for the challenges that they faced. In this paper, the terms Lotta, medical Lotta or medical volunteer are used interchangeably and refer to people who were assigned to medical volunteer tasks, regardless of whether or not they were trained. It also includes junior members of the organisation who served as medical volunteers as minors, with special permission. (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)

Developing World Bioethics, Volume 21, Issue 3, Page 123-124, September 2021.

As part of an extended participant observation study of hospice, I present in this article some reflections on my first experiences as a hospice volunteer. Discussion of these experiences emphasizes the influences of my own socialization, but suggests the types of filters trough which people often see and behave in the world of the dying and beyond.

Healthy volunteers in biomedical research often face significant risks in studies that offer them no medical benefits. The U.S. federal research regulations and laws adopted by other countries place no limits on the risks that these participants face. In this essay, I argue that there should be some limits on the risks for biomedical research involving healthy volunteers. Limits on risk are necessary to protect human participants, institutions, and the scientific community from harm. With the exception of (...) self-experimentation, limits on research risks faced by healthy volunteers constitute a type of soft, impure paternalism because participants usually do not fully understand the risks they are taking. I consider some approaches to limiting research risks and propose that healthy volunteers in biomedical research should not be exposed to greater than a 1% chance of serious harm, such as death, permanent disability, or severe illness or injury. While this guideline would restrict research risks, the limits would not be so low that they would prevent investigators from conducting valuable research. They would, however, set a clear upper boundary for investigators and signal to the scientific community and the public that there are limits on the risks that healthy participants may face in research. This standard provides guidance for decisions made by oversight bodies, but it is not an absolute rule. Investigators can enroll healthy volunteers in studies involving a greater than 1% chance of serious harm if they show that the research addresses a compelling public health or social problem and that the risk of serious harm is only slightly more than 1%. The committee reviewing the research should use outside experts to assess these risks. (shrink)

Volunteering in Ukraine is becoming an increasingly popular phenomenon that occupies an important place in the life of society. Many people choose volunteering as a way to help people in difficult life circumstances, as well as to develop their own personality and engage in active civic participation. As a significant social phenomenon, volunteering has its own ideological foundations that define its core values and principles. Volunteering is based on the desire to help people and nature regardless of their status, nationality, (...) religion, or political beliefs. The purpose of the study. The current study examines the ideological foundations of volunteering in Ukraine in wartime and their significance for volunteering, to study the practical experience of volunteers in Ukraine in 2014-2023, and to examine the peculiarities of the legal regulation of volunteering in Ukraine in wartime. Methods. Achieving the goal and objectives of the study was made possible by using a set of interrelated modern general scientific and special methods and approaches. The systematic approach made it possible to study volunteering as a holistic set of elements in the totality of the connections between them. Through the use of the method of systematization, the author provides a review of the legal framework for volunteering, factor analysis is used to determine the factors influencing the relationship between the state and society in the field of volunteering, and system analysis is used to assess the state of relations between the state and society in Ukraine at this stage through its quantitative indicators.Results. According to the study “Volunteer Movement in Ukraine”, prepared by GfK Ukraine on behalf of the UN in Ukraine, Ukrainian citizens pay great attention to the volunteer movement in the development of social processes: 62% recognize the role of volunteers in the changes in the last year; 85% believe that the volunteer movement helps strengthen peace; 81% tend to consider the volunteer movement an essential component of civil society. Regarding the legal regulation of volunteer activities in Ukraine, the Law of Ukraine “On Volunteer Activity” of April 19, 2011, No. 3236-VI was adopted in April 2011. The Law of Ukraine of 15.08.2022 No. 2519-IX On Amendments to the Law of Ukraine “On Volunteer Activity” on Support of Volunteer Activity regulates social relations related to volunteer activity in Ukraine. Discussion. One of the key principles of volunteering in Ukraine is selflessness and the ability to work in extreme conditions. Volunteers often work in difficult and dangerous conditions that require a high level of professionalism and skills. For many volunteers, the Ukrainian revolution of 2013-2014 and the events in eastern Ukraine were turning points that forced them to change their attitude to their own lives and start helping others. Ukrainian volunteers are an example of community and state cooperation that contributes to ensuring security and helping victims. They have shown that volunteering can be an effective tool in the fight against war and its consequences. Many volunteer organizations provided free medical care, took on the responsibility of supplying the military with necessary items and military equipment, organized the evacuation of people from the war zone, and provided psychological support to the military and their families. Conclusions.Volunteering in Ukraine is not a new phenomenon, but the war with Russia has become a catalyst for its development. This is a great example of how crises can encourage people to act together and interact to achieve a common goal. Volunteerism in Ukraine demonstrates the importance of spiritual unity and cooperation in difficult times, and is one of the most striking examples of civil society in action. The ideological principles of volunteering in Ukraine include non-profitability, openness, spirituality, and humanism, transparency and openness, security, and cooperation with government agencies and the military. The volunteer movement in Ukraine, especially in times of war, is an important factor in ensuring security and helping victims. Involvement of different groups of the population in volunteer activities, as well as cooperation with state and international structures, are important to ensure the effectiveness and success of volunteer activities. (shrink)

There is a long history of medical research that involves intentionally infecting healthy people in order to study diseases and their treatments. Such research—what might be called “human challenge studies”—are an important strand of much current research—for example, in the development of vaccinations. The many international and national guidelines about the proper conduct of medical research do not specifically address human challenge studies. In this paper we review the guidelines on the risk of harm that healthy volunteers (...) may be exposed to in the course of medical research. We examine the ethical arguments that are implicit or explicit in these guidelines. We then ask whether there is reason for limiting such studies on grounds independent of risk of harm. We conclude that the major ethical concern with challenge studies is that of risk of harm and that the fact that a study is a challenge study is not a wrong in itself. (shrink)

Most of the audience were students and physicians. But this man looked more like a patient. The panel discussion, part of a third year round, Brain Death and Organ Transplantation, was open to the public.I’d been arguing, on the basis of well known data,1–4 that “brain death” is not death. So, taking a heart from a “brain dead” patient is killing. But I would not totally oppose killing patients for their organs, provided that there is informed consent, and with further (...) limitations. Truog’s proposal to take organs from persistent vegetative state patients2 is too extreme. Patients in a persistent vegetative state sometimes return to various levels of consciousness.5,6 So killing them for their organs …. (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)

The popularity and availability of global health experiences has increased, with organizations helping groups plan service trips and companies specializing in “voluntourism,” health care professionals volunteering their services through different organizations, and medical students participating in global health electives. Much has been written about global health experiences in resource poor settings, but the literature focuses primarily on the work of health care professionals and medical students. This paper focuses on undergraduate student involvement in short term medical volunteer (...) work in resource poor countries, a practice that has become popular among pre-health professions students. We argue that the participation of undergraduate students in global health experiences raises many of the ethical concerns associated with voluntourism and global health experiences for medical students. Some of these may be exacerbated by or emerge in unique ways when undergraduates volunteer. Guidelines and curricula for medical student engagement in global health experiences have been developed. Guidelines specific to undergraduate involvement in such trips and pre-departure curricula to prepare students should be developed and such training should be required of volunteers. We propose a framework for such guidelines and curricula, argue that universities should be the primary point of delivery even when universities are not organizing the trips, and recommend that curricula should be developed in light of additional data. (shrink)

Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguements that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give (...) proper consent: effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire. (shrink)

Tremendous development in recent medical science and the consequent discoveries resulting in successful prevention and also cure of different diseases are shared by clinical research involving the human volunteers. Preceding the trials in the human subjects, and to ensure safety, the proposed drug and other interventions are either tested in animals (vivo) or in laboratory (vitro) to evaluate initial safe starting dose for the human beings and to key out the benchmarks for the clinical monitoring for the potential (...) unfavorable effects. These pre human trials might not necessarily protect against the untoward effects in the human beings as happened in the case of thalidomide tragedy, which caused disability and killed thousands of babies born to the mothers, those who took this medicine. Use of healthy human volunteers in the preliminary experiments or phase I clinical trials either reduces or excludes risks of subsequent undesirable effects in the future trails (1). Phase-1 trials are conducted in order to test the safety, reactions and immunogenicity of vaccines in volunteers. Novel treatments for the cancer are first tested in phase 1 trials enrolling the patients with advanced disease, who have exhausted the standard treatment options. Phase-1 oncology trials are the pivot point in the translation of new cancer therapies from bench to bedside. Nevertheless, these trials remain ethically controversial. The controversy stems from the fact that, classically, phase-1 oncology clinical trials involve first-in-human testing of experimental treatment candidates in patients with a terminal diagnosis, who typically have exhausted standard treatment options. Commentators on the ethics of phase-1 clinical trials make diametrically opposed claims about the prospect of direct medical benefit from participation in these trials-benefits that can be attributed to receiving the experimental treatment intervention. One camp of benefit skeptics, inhabited mainly by bioethicists, characterizes this form of research as lacking any reasonable prospect of direct medical benefit. They see an ethical cloud hovering over phase-1 trials, because the vast majority of patients volunteer for phase-1 trials out of a motivation to receive medical benefit. In the view of these skeptics, such patients therefore harbor a ‘therapeutic misconception’ about research participation. This misconception calls into question the validity of informed consent and thereby undercuts the ethical basis of these trials (2). In this paper, I will discuss the ethical justification of the participation of human volunteers in phase-1 trials. (shrink)

Much biomedical research cannot be performed without recruiting human subjects. Increasingly, volunteer registries are being developed to assist researchers with this challenging task. Yet, volunteer registries raise confidentiality issues. Having recently developed a registry of volunteers, the authors searched for normative guidance on how to implement the principle of confidentiality. The authors found that the protection of confidentiality in registries are based on the 10 key elements which are elaborated in detail in the Canadian Standards Association Model Code. This (...) paper describes how these 10 detailed key principles can be used during the developmental stages of volunteer registries. (shrink)

Background Doctors are increasingly faced with end-of-life decisions. Little is known about how medical students approach euthanasia. The objective of this study was to evaluate, among medical students and residents, the view on euthanasia and its variants; correlate such a view with empathy and religiosity/spiritualism; and with the stages of medical training in Brazil. Methods This is an exploratory cross-sectional study using an online questionnaire to be filled out on a voluntary basis among medical students and (...) residents, consisting of: socio-demographic data, an empathy questionnaire and questions with elaborate clinical cases that typify situations of the variants of euthanasia. Results From 1550 invitations, 273 volunteer participants responded (17.6%). The percentages of strong agreement/agreement on the concepts were: passive euthanasia (72.9%); active euthanasia (22.3%), orthothanasia (90.1%), dysthanasia (18.7%), assisted suicide (33%) and sedation (82.8%). Passive euthanasia, active euthanasia, dysthanasia and assisted suicide showed greater refusal with increasing length of medical training. Religious belief and degree of empathy did not significantly influence the opinion about the concepts. Strong agreement/agreement were: passive euthanasia (72.9%); active euthanasia (22.3%), orthothanasia (90.1%), dysthanasia (18.7%), assisted suicide (33%) and sedation (82.8%). Conclusions Passive euthanasia, active euthanasia, dysthanasia and assisted suicide showed greater refusal with increasing length of medical training. The external validation of our findings relies on the distinct legal, cultural, and religious frameworks found across various countries. (shrink)

Clinical trials on healthy volunteers generate unique ethical challenges both because participants accept potential physical risks without the possibility of direct medical benefit and because participants’ financial motivations to enroll in trials could lead to their exploitation. Despite the large volume of published empirical studies and ethical analyses of healthy volunteer research, there has been little concerted effort to change how healthy‐volunteer research is overseen or regulated. A new collaborative effort to do so is the VolREthics (Volunteers (...) in Research and Ethics) Initiative. Launched in 2022, this initiative brings together an international community to engage questions about how healthy volunteers could best be protected from the risks of harm and exploitation while the validity of clinical trials is optimized. (shrink)

Death of a normal volunteer highlights problems with research review and protection of subjectsHealthy volunteer dies in asthma studyOn July 19, after investigating the death of a previously healthy volunteer, the United States Office for Human Research Protections suspended nearly all federally funded medical research involving human subjects at Johns Hopkins University. The death has been described as “particularly disturbing” because 24 year old Ellen Roche was a healthy volunteer who had nothing to gain by taking part in the (...) study.1 Her death has revived debate about the adequacy of oversight of medical research that followed the death of 18 year old Jesse Gelsinger who volunteered for a gene therapy experiment.Ellen Roche was a 24 year old technician from the Johns Hopkins Asthma and Allergy Centre who volunteered to take part in a study designed to provoke a mild asthma attack in order to help doctors discover the reflex that protects the lungs of healthy people against asthma attacks. After inhaling hexamethonium, a medication used for treating high blood pressure in the 1950s and 60s, Ms Roche became ill. She developed a cough and her condition worsened over the next week until she was put on a ventilator. With her lung tissue breaking down, blood pressure falling and her kidneys beginning to fail, nothing could be done to save her.2 She died on June 2, about a month after entering the study.The Office for Human Research Protections investigated the circumstances of Ms Roche's death and accused the Hopkins Institutional Review Board of failing to take proper precautions. It also evaluated the human subject protection system at Hopkins. The OHRP found that prior to approving the study, Hopkins researcher …. (shrink)

To date no one has identified or described the population of incapacitated patients being treated in an inpatient setting who lack proxy decision-makers. Nor, despite repeated calls for protocols to be developed for decision-making, has any institution reported on the utilization of such a protocol. In 2005, our urban tertiary care hospital instituted a protocol utilizing community members of the ethics committee to meet with the medical providers and engage in shared decision-making for patients without proxies. We conducted a (...) retrospective chart review and in this paper describe nearly 200 patients who were identified and treated according to the protocol over a 12 year period. After an aggressive search, family members were located for a surprising number of patients, leaving 80 patients who needed decisions to be made utilizing the PWP committee. We review the decisions required, the results of the shared decision-making meetings, and the patient outcomes. Our experience has shown that a protocol involving community volunteers to make decisions for PWPs in a timely manner is feasible and ethically defensible. The protocol has been accepted by physicians and utilized with increasing frequency. Because it was possible to gather at least minimal information on most patients, a standard of “informed best interest” was used to make decisions. PWP committee recommendations varied, but in all cases agreement was reached with the attending physicians. (shrink)

By their very nature, overseas medical missions (and even domestic medical charities such as free clinics ) are designed to serve vulnerable populations. If these groups were capable of protecting their own interests, they would not need the help of medical volunteers: their medical needs would be met through existing government health programs or by utilizing their own resources. Medical volunteerism thus seems like an unfettered good: a charitable activity provided by well-meaning doctors and (...) nurses who want to give of their time, skills, and resources to help those who would not otherwise be able to take care of their medical needs. In this article, I argue that if medical volunteerism is to be good, however, it must always meet certain basic ethical requirements. These requirements may be (and perhaps often are) overlooked in the rush to organize and carry out short-term medical missions. I illustrate my point with special reference to short-term medical missions designed to provide surgical repair of obstetric vesico-vaginal fistula, a condition in which the tissues that normally separate the bladder from the vagina are destroyed by obstetric trauma, leading to continuous and unremitting incontinence in the affected woman. (shrink)

In the United States, there is no consensus about who should make decisions in acute but non-emergent situations for incapacitated patients who lack surrogates. For more than a decade, our academic medical center has utilized community volunteers from the hospital ethics committee to engage in shared decision-making with the medical providers for these patients. In order to add a different point of view and minimize conflict of interest, the volunteers are non-clinicians who are not employed by (...) the hospital. Using case examples and interviews with the community members, this paper describes how the protocol has translated into practice over the years since its inception. Members reported comfort with the role as well as satisfaction with the thoroughness of their discussions with the medical team. They acknowledged feelings of moral uncertainty, but expressed confidence in the process. Questions raised by the experience are discussed. Overall, the protocol has provided oversight, transparency, and protection from conflict of interest to the decision-making process for this vulnerable patient population. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors (...) include the short-term and long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors (...) include the short-term and long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors (...) include the short-term and long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors (...) include the short-term and long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This essay explores some concerns about the quality of informed consent in patients whose autonomy is diminished by fatal illness. It argues that patients with diminished autonomy cannot give free and voluntary consent, and that recruitment of such patients as subjects in human experimentation exploits their vulnerability in a morally objectionable way. Two options are given to overcome this objection: (i) recruit only those patients who desire to contribute to medical knowledge, rather than gain access to experimental treatment, or (...) (ii) provide prospective subjects the choice to participate in standard doubleblind study or receive the experimental treatment. Either option would guarantee that patients in desperate conditions are given a more meaningful choice and a richer freedom, and thus a higher quality of informed consent, than under standard randomized trials. Keywords: autonomy, double-blind trials, prerandomized and randomized trials, informed consent CiteULike Connotea Del.icio.us What's this? (shrink)

Surgery is an important part of health care worldwide. Without access to surgical treatments, morbidity and mortality increase. Access to surgical treatment is a significant problem in global public health because surgical services are not equally distributed in the world. There is a disproportionate scarcity of surgical access in low-income countries. There are many charitable organizations around the world that sponsor surgical missions to under served nations. One such organization is Operation Smile International, a group with which both authors have (...) volunteered. This paper will describe the purpose and processes involved in Operation Smile and identify some of the key ethical issues that arise in short term medical volunteer work highlighting the importance of sustainability. (shrink)

The effects of research ethics training on medical students' attitudes about clinical research are examined. A preliminary randomized controlled trial evaluated 2 didactic approaches to ethics training compared to a no-intervention control. The participant-oriented intervention emphasized subjective experiences of research participants (empathy focused). The criteria-oriented intervention emphasized specific ethical criteria for analyzing protocols (analytic focused). Compared to controls, those in the participant-oriented intervention group exhibited greater attunement to research participants' attitudes related to altruism, trust, quality of relationships with researchers, (...) desire for information, hopes about participation and possible therapeutic misconception, importance of consent forms, and deciding quickly about participation. The participant-oriented group also agreed more strongly that seriously ill people are capable of making their own research participation decisions. The criteria-oriented intervention did not affect learners' attitudes about clinical research, ethical duties of investigators, or research participants' decision making. An empathy-focused approach affected medical students' attunement to research volunteer perspectives, preferences, and attributes, but an analytically oriented approach had no influence. These findings underscore the need to further examine the differential effects of empathy-versus analytic-focused approaches to the teaching of ethics. (shrink)

The effects of research ethics training on medical students' attitudes about clinical research are examined. A preliminary randomized controlled trial evaluated 2 didactic approaches to ethics training compared to a no-intervention control. The participant-oriented intervention emphasized subjective experiences of research participants. The criteria-oriented intervention emphasized specific ethical criteria for analyzing protocols. Compared to controls, those in the participant-oriented intervention group exhibited greater attunement to research participants' attitudes related to altruism, trust, quality of relationships with researchers, desire for information, hopes (...) about participation and possible therapeutic misconception, importance of consent forms, and deciding quickly about participation. The participant-oriented group also agreed more strongly that seriously ill people are capable of making their own research participation decisions. The criteria-oriented intervention did not affect learners' attitudes about clinical research, ethical duties of investigators, or research participants' decision making. An empathy-focused approach affected medical students' attunement to research volunteer perspectives, preferences, and attributes, but an analytically oriented approach had no influence. These findings underscore the need to further examine the differential effects of empathy-versus analytic-focused approaches to the teaching of ethics. (shrink)

Global fatalities related to COVID-19 are expected to be high in 2020–2021. Developing and delivering a vaccine may be the most likely way to end the pandemic. If it were possible to shorten this development time by weeks or months, this may have a significant effect on reducing deaths. Phase II and phase III trials could take less long to conduct if they used human challenge methods—that is, deliberately infecting participants with COVID-19 following inoculation. This article analyses arguments for and (...) against such methods and provides suggested broad guidelines for regulators, researchers and ethics committees when considering these matters. It concludes that it may be possible to maintain current ethical standards yet still permit human challenge trials in a context where delay is critical. The implications are that regulators and researchers need to work together now to design robust but short trials and streamline ethics approval processes so that they are in place when applications for trials are made. (shrink)

Few institutions have published reviews concerning the case consultation history of their ethics committees, and policies used by ethics committees to address inappropriate treatment are infrequently reviewed. We sought to characterize the operation of our institution’s ethics committee as a representative example of a volunteer ethics committee, and outline its use of a policy to address inappropriate treatment, the Conscientious Practice Policy. Patients were identified for retrospective review from the ethics consultation database. Patient demographics, medical admission information, and consultation (...) information were obtained from the medical record. Consultation notes were analyzed with directed content analysis. The use of the CPP was documented in each case. Groups of interest were compared via two-sample t-tests. There were 178 consultations between 2013 and 2018. The majority originated from medicine services. The most common consultation reasons were end-of-life balances of acute and palliative care, best interest standard, medical futility, and code status and intubation status. Average age was 65.5 years and average hospitalization before consultation was 51.4 days. 92 patients had a code status change that occurred after consultation. A policy to address inappropriate treatment was used in 42 of the consultations. Bivariate analysis demonstrated a reduction in policy use over time, with use in 32.1% of consultations from 2013 to 2016 and 11.4% of consultations 2017–2018, p = 0.002. End-of-life issues were the most common reason for consultation. Our consultation volume was lower than previously-published reports. A policy used to address inappropriate treatment was frequently used, although use decreased over time. (shrink)

The Alexandra District Ambulance Service is the only volunteer-based ambulance service in Victoria, Australia. It provides an opportunity to reflect on the ethical issues surrounding the delivery of ambulance service by volunteers, and its impact on the community.

This essay explores some concerns about the quality of informed consent in patients whose autonomy is diminished by fatal illness. It argues that patients with diminished autonomy cannot give free and voluntary consent, and that recruitment of such patients as subjects in human experimentation exploits their vulnerability in a morally objectionable way. Two options are given to overcome this objection: (i) recruit only those patients who desire to contribute to medical knowledge, rather than gain access to experimental treatment, or (...) (ii) provide prospective subjects the choice to participate in standard doubleblind study or receive the experimental treatment. Either option would guarantee that patients in desperate conditions are given a more meaningful choice and a richer freedom, and thus a higher quality of informed consent, than under standard randomized trials. (shrink)

Background: We were finding volunteers for functional magnetic resonance imaging studies with abnormalities requiring referral surprisingly frequently. The bioethics surrounding the incidental findings are not straightforward and every imaging institution will encounter this situation in their normal volunteers. Yet the implications for the individuals involved may be profound. Should all participants have review of their imaging by an expert and who should be informed? Methods: The normal volunteers that were imaged with magnetic resonance (MR) which were reviewed (...) by a consultant neuroradiologist. All participants completed a volunteer consent form in addition to a standard departmental MR safety screening form. The volunteer screening form requires the general practitioner details to be completed and asks the participant to consider closely the possibility and implications of finding an unexpected but potentially serious abnormality before signing. Results: 525 different individuals were scanned as normal volunteers, the mean age was 35-years and 330 were males. Of these 525, 46 had definite significant abnormalities (8.8%), mean age 50-years. Conclusion: We have found a high rate of incidental abnormalities amongst individuals participating in imaging studies at our institution. It is our current practice to inform the research study participant of the findings, counsel them and inform their primary care physician. We think that it is advisable for researchers utilising MR imaging of the brain to have access to trained neuroradiologists, a protocol in place to deal with this problem and take consent in a way that allows the participant to realise the possibility of an abnormal finding. (shrink)

One of the important causes of bias in the medical literature is failure to publish data because it is “negative”. Usually, this is due to failure to write a manuscript and submit it for publication. Since publication is an essential part of research and patients have been recruited into a study in the belief that they are participating in medical research, there is an ethical commitment to publish the observations made on volunteer subjects. This can be enforced by (...) ethical committees if they refuse to approve studies of investigators and sponsors who have failed to publish earlier studies. (shrink)

Three standard psychometric tests were administered to parents who volunteered their children for a randomised, double-blind placebo-controlled trial of a new asthma drug and to a control group of parents whose children were eligible for the trial but had declined the invitation. The trial took place at a children's hospital in Australia. The subjects comprised 68 parents who had volunteered their children and 42 who had not, a participation rate of 94 per cent and 70 per cent, respectively. The responses (...) of these parents to the Gordon Survey of Interpersonal Values Questionnaire, the Coopersmith Self-Esteem Inventory and the Cattell Sixteen Personality Factor Questionnaire were analysed by computer. There was a marked difference between the psychological profiles of the two groups of parents. Volunteering parents put more value on benevolence while non-volunteering parents were more concerned with power and prestige. The self-esteem of volunteering parents was much lower than that of non-volunteering parents. Finally, volunteering parents were more introverted, exhibited greater anxiety and low supergo, while non-volunteering parents appeared to have greater social confidence and emotional stability. Since an individual's values, self-esteem and personality may be important antecedents of behaviour, these findings suggest that parents who volunteer their children for clinical research are not only socially disadvantaged and emotionally vulnerable, but may also be psychologically predisposed to volunteering. Furthermore, these findings provide evidence for the existence of a psychosocial 'filter' effect of the informed consent procedure, which may be discouraging the better educated, more privileged and psychologically resilient members of society from participation as research subjects. (shrink)

In a challenge trial, research subjects are purposefully exposed to some pathogen in a controlled setting, in order to test the efficacy of a vaccine or other experimental treatment. This is an example of medical effective altruism (MEA), where individuals volunteer to risk harms for the public good. Many bioethicists rejected challenge trials in the context of Covid‐19 vaccine research on ethical grounds. After considering various grounds of this objection, I conclude that the crucial question is how much harm (...) research subjects can permissibly risk. But we lack a satisfying way of making this judgment that does not appeal simply to the intuitions of doctors or bioethicists. I consider one recent and structurally plausible approach to critically evaluating the harm question. Alex London defends a social consistency test for research risks: we should compare the risks undertaken by research subjects to relevantly similar risks which are accepted in other spheres of society. I argue there is no good reason not to consider volunteer military service as a relevant social comparison. This implies there is essentially no cap on acceptable risks on the social consistency rationale. In short, if soldiers can be heroes, why can't research volunteers? (shrink)

This is a comprehensive and practical guide to the ethical issues raised by different kinds of medical research, and is the first such book to be written with the needs of the researcher in mind. Clearly structured and written in a plain and accessible style, the book covers every significant ethical issue likely to be faced by researchers and research ethics committees. The author outlines and clarifies official guidelines, gives practical advice on how to adhere to these, and suggests (...) procedures in areas where official recommendations are vague or absent. This invaluable handbook will help researchers identify and address the ethical issues at an early stage in the design of their studies, to avoid unnecessary delay and to safeguard the wellbeing of patients and healthy volunteers. It will also be extremely useful to members of research ethics committees. (shrink)

The authors consider four aspects of contemporary medical ethics in France: abortion and contraception; artificial insemination; suicide and euthanasia, and drug trials on healthy human volunteers, and then outline the various ethical codes which apply to French doctors. Many in France who accept technological progress are unwilling or unable to acknowledge the impact upon medical ethics of this progress. The conflict is epitomised by the new role being demanded from the doctor. Where formerly he was regarded as (...) the guardian of traditional values today he is urged to adapt, to change, to take account of the technological innovations in medicine. `In such a situation,' the authors ask, `how is it possible to avoid a feeling of uneasiness?'. (shrink)

Professor Duncan Vere lays before us the idealised guidelines used for recruiting volunteers on which to try and test new medicines. He points out that if these were followed rigidly, few, if any volunteers would be found for this vital work. Inducements are used, but the size of these determines whether society deems it right or wrong. However, the aim is to help and advise volunteers of the need for such tests and the risks involved and therefore (...) the information leaflet reprinted as part of the article indicates how the drug testers are attempting to encourage volunteers in as ethical a way as possible. To abandon human tests with new drugs may be unethical. A balance is sought. (shrink)

Short-term humanitarian medical volunteerism has grown significantly among both clinicians and trainees over the past several years. Increasingly, both volunteers and their respective institutions have faced important challenges in regard to medical ethics and professional codes that should not be overlooked. We explore these potential concerns and their risk factors in three categories: ethical responsibilities in patient care, professional responsibility to communities and populations, and institutional responsibilities towards trainees. We discuss factors increasing the risk of harm to (...) patients and communities, including inadequate preparation, the use of advanced technology and the translation of Western medicine, issues with clinical epidemiology and test utility, difficulties with the principles of justice and clinical justice, the lack of population-based medicine, sociopolitical effects of foreign aid, volunteer stress management, and need for sufficient trainee supervision. We review existing resources and offer suggestions for future skill-based training, organisational responsibilities, and ethical preparation. (shrink)

BackgroundConsenting for retrospective medical records-based research (MR) and leftover tissue-based research (TR) continues to be controversial. Our objective was to survey Saudis attending outpatient clinics at a tertiary care hospital on their personal preference and perceptions of norm and current practice in relation to consenting for MR and TR.MethodsWe surveyed 528 Saudis attending clinics at a tertiary care hospital in Saudi Arabia to explore their preferences and perceptions of norm and current practice. The respondents selected one of 7 options (...) from each of 6 questionnaires.ResultsRespondents' mean (SD) age was 33 (11) years, 42% were males, 56% were patients, 84% had ≥ secondary school education, and 10% had previously volunteered for research. Respectively, 40% and 49% perceived that the norm is to conduct MR and TR without consent and 38% and 37% with general or proposal-specific consent; the rest objected to such research. There was significant difference in the distribution of choices according to health status (patients vs. companions) for MR (adjusted Kruskal-Wallis test P = 0.03) but not to age group, gender, education level, or previous participation in research (unadjusted P = 0.02 - 0.59). The distributions of perceptions of current practice and norm were similar (unadjusted Marginal Homogeneity test P = 0.44 for MR and P = 0.89 for TR), whereas the distributions of preferences and perceptions of norm were different (adjusted P = 0.09 for MR and P = 0.02 for TR). The distributions of perceptions of norm, preferences, and perceptions of current practice for MR were significantly different from those of TR (adjusted P < 0.009 for all).ConclusionsWe conclude that: 1) there is a considerable diversity among Saudi views regarding consenting for retrospective research which may be related to health status, 2) the distribution of perceptions of norm was similar to the distribution of perceptions of current practice but different from that of preferences, and 3) MR and TR are perceived differently in regard to consenting. (shrink)

This study aimed to determine if people would use social usefulness as a criterion when allocating a kidney to potential recipients. Participants ranked hypothetical patients in order of priority to receive the kidney, using only information on the patients’ volunteering record, intelligence, emotional intelligence, and attractiveness. The results showed that volunteers were prioritized over nonvolunteers, highly intelligent patients over those with average intelligence, patients with high emotional intelligence over those with average emotional intelligence, and good-looking patients over average-looking patients. (...) There was little evidence of personal favoritism. Implications and limitations are discussed. (shrink)