Background: The importance of respecting patients and participants in clinical research is widely recognised. However, what it means to respect persons beyond recognising them as autonomous is unclear, and little is known about what patients find to be respectful. Objective: To understand patients’ conceptions of respect and what it means to be respected by medical providers. Design: Qualitative study from an academic cardiology clinic, using semistructured interviews with 18 survivors of sudden cardiac death. Results: Patients believed that respecting persons incorporates (...) the following major elements: empathy, care, autonomy, provision of information, recognition of individuality, dignity and attention to needs. Conclusions: Making patients feel respected, or valued as a person, is a multi-faceted task that involves more than recognising autonomy. While patients’ views of respect do not determine what respect means, these patients expressed important intuitions that may be of substantial conceptual relevance. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Participants in clinical research sometimes view participation as therapy or exaggerate potential benefits, especially in phase I or phase II trials. We conducted this study to discover what methods might improve cancer patients’ understanding of early-phase clinical trials. We randomly assigned 130 cancer patients from three U.S. medical centers who were considering enrollment in a phase I or phase II cancer trial to receive either a multimedia intervention or a National Cancer Institute pamphlet explaining the trial and its purpose. Intervention (...) participants were 32 times more likely to believe that the trial’s purpose was to examine safety and 60 % less likely to believe they would experience long-term benefit or cure. There was no difference in enrollment decision. However, while patients’ understanding of the trial’s purpose improved and expectations of long-term benefit diminished, half the respondents still believed they would experience long-term benefit or cure from participation. Therefore, we conclude that multimedia interventions such as this one may help oncologists to explain the risks and benefits of early-phase cancer trials in a way that patients can more easily understand, helping them to make more informed decisions about participation. But further research into other factors that influence patients’ beliefs about the outcome of enrollment is needed, both to modify the interventions and to determine how malleable patient beliefs are. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Recent legislation, such as the Patient Self-Determination Act, establishes advance directives as an acceptable procedural means of incorporating patients’ preferences for life-sustaining treatments into their medical care. Advance directives can enhance medical decision making since they provide patients with an opportunity to communicate their preferences before suffering from an acute illness that may preclude their ability to do so.Although patients expect discussions about life-sustaining therapies to be initiated by their physicians, very little is known about what prompts physicians to discuss (...) advance directives with their patients. As in other areas of clinical decision making, there is evidence that patients’ sociodemographic factors influence whether discussions about advance directives occur between patients and their physicians. In one study of persons with the acquired immunodeficiency syndrome, those who had not had discussions about advance directives with their physicians tended to be non-white, have no prior hospitalization, and were more likely to have been cared for in a health maintenance organization than in a teaching hospital. (shrink)

Recent legislation, such as the Patient Self-Determination Act, establishes advance directives as an acceptable procedural means of incorporating patients’ preferences for life-sustaining treatments into their medical care. Advance directives can enhance medical decision making since they provide patients with an opportunity to communicate their preferences before suffering from an acute illness that may preclude their ability to do so.Although patients expect discussions about life-sustaining therapies to be initiated by their physicians, very little is known about what prompts physicians to discuss (...) advance directives with their patients. As in other areas of clinical decision making, there is evidence that patients’ sociodemographic factors influence whether discussions about advance directives occur between patients and their physicians. In one study of persons with the acquired immunodeficiency syndrome, those who had not had discussions about advance directives with their physicians tended to be non-white, have no prior hospitalization, and were more likely to have been cared for in a health maintenance organization than in a teaching hospital. (shrink)

BackgroundThere is increasing need for peer reviewers as the scientific literature grows. Formal education in biostatistics and research methodology during residency training is lacking. In this pilot study, we addressed these issues by evaluating a novel method of teaching residents about biostatistics and research methodology using peer review of standardized manuscripts. We hypothesized that mentored peer review would improve resident knowledge and perception of these concepts more than non-mentored peer review, while improving review quality.MethodsA partially blinded, randomized, controlled multi-center study (...) was performed. Seventy-eight neurology residents from nine US neurology programs were randomized to receive mentoring from a local faculty member or not. Within a year, residents reviewed a baseline manuscript and four subsequent manuscripts, all with introduced errors designed to teach fundamental review concepts. In the mentored group, mentors discussed completed reviews with residents. Primary outcome measure was change in knowledge score between pre- and post-tests, measuring epidemiology and biostatistics knowledge. Secondary outcome measures included level of confidence in the use and interpretation of statistical concepts before and after intervention, and RQI score for baseline and final manuscripts.ResultsSixty-four residents (82%) completed initial review with gradual decline in completion on subsequent reviews. Change in primary outcome, the difference between pre- and post-test knowledge scores, did not differ between mentored (−8.5%) and non-mentored (−13.9%) residents (p = 0.48). Significant differences in secondary outcomes (using 5-point Likert scale, 5 = strongly agree) included mentored residents reporting enhanced understanding of research methodology (3.69 vs 2.61; p = 0.001), understanding of manuscripts (3.73 vs 2.87; p = 0.006), and application of study results to clinical practice (3.65 vs 2.78; p = 0.005) compared to non-mentored residents. There was no difference between groups in level of interest in peer review (3.00 vs 3.09; p = 0.72) or the quality of manuscript review assessed by the Review Quality Instrument (RQI) (3.25 vs 3.06; p = 0.50).ConclusionsWe used mentored peer review of standardized manuscripts to teach biostatistics and research methodology and introduce the peer review process to residents. Though knowledge level did not change, mentored residents had enhanced perception in their abilities to understand research methodology and manuscripts and apply study results to clinical practice. (shrink)

Public health ethics in the future will be distinguished from public health ethics in the past by this new subfield being labeled as such, acknowledged, and called upon for service. Ethical dilemmas have been present throughout the history of public health. The question of whether to force Henning Jacobson to be immunized in 1905 in accordance with the 1902 Massachusetts smallpox vaccination law was one of ethics as well as law. How Thomas Parran, Surgeon General in 1936, chose to respond (...) to a raging syphilis epidemic in the United States in the early part of the 2W century raised considerable moral debate in determining the appropriate public health response for a government? More recently, questions have arisen concerning the appropriate reach of government in controlling HIV banning smoking, or promoting healthy lifestyles. Debates over government infringement, morality, and justice recur throughout the history of public health. (shrink)

It is widely assumed that informing prospective subjects about the risks and possible benefits of research not only protects their rights as autonomous decisionmakers, but also empowers them to protect their own interests. Yet interviews with patient‐subjects conducted under the auspices of the Advisory Committee on Human Radiation Experiments suggest this is not always the case. Patient‐subjects often trust their physician to guide them through decisions on research participation. Clinicians, investigators, and IRBs must assure that such trust is not misplaced.

BackgroundCommunity engagement in research is valuable for instrumental and intrinsic reasons. Despite existing guidance on how to ensure meaningful CE, much of what it takes to achieve this goal differs across settings. Considering the emerging trend towards mandating CE in many research studies, this study aimed at documenting how CE is conceptualized and implemented, and then providing context-specific guidance on how researchers and research regulators in Uganda could think about and manage CE in research.MethodsWe conducted qualitative interviews and focus group (...) discussions involving forty-one respondents who were experienced in HIV/aids biomedical research involving CE. Thirty-eight of these were directly or indirectly associated with Uganda’s leading research institution in the field of HIV/aids. They included Principal Investigators, Community Liaisons Officers, Research Ethics Committee members and Community Advisory Board Members. Three respondents were from Uganda National Council for Science and Technology. Data were collected between August 2019 and August 2020, using audio-taped focus group discussions and key informant interviews, transcribed and analyzed manually to generate themes and subthemes.ResultsThree major themes emerged: goals or value of CE; the means of CE, and, the evaluation of CE. Goals or value of CE generated four subthemes representing the overarching goals of CE: Promote communities’ agency; Generate and sustain trust; Protect and promote communities’ rights and interests; and, Help studies optimize participation in the form of enrolment and retention of participants. What usually comes under the nomenclatures of methods, strategies, and approaches of CE, such as town-hall meetings, sports events, drama, and the like, should simply be understood as the means of CE, and it is not desirable to hold pre-conceived and fixed ideas about the best means to conduct CE in research since a lot depend on the context. Finally, the study found that despite CE’s critical importance, which suggests the need to track and evaluate it, CE is currently intermittently evaluated, and for inadequate motivations.ConclusionsExisting guidance on how to conduct robust CE in research is no substitute for creativity, flexibility, and reflexivity on the part of both researchers and research regulators. (shrink)

In the past ten years, there has been growing interest in and concern about protecting the privacy of personal medical information. Insofar as medical records increasingly are stored electronically, and electronic information can be shared easily and widely, there have been legislative efforts as well as scholarly analyses calling for greater privacy protections to ensure that patients can feel safe disclosing personal information to their health-care providers. At the same time, the volume of biomedical research conducted in this country continues (...) to grow. The budget of the National Institutes of Health, for example, was $20,298 million in 2001, having more than doubled from a budget of $9,218 million 10 years before. This growing body of research includes increased efforts to use stored medical records as a source of data for health services, epidemiologic, and clinical studies. (shrink)

In the past ten years, there has been growing interest in and concern about protecting the privacy of personal medical information. Insofar as medical records increasingly are stored electronically, and electronic information can be shared easily and widely, there have been legislative efforts as well as scholarly analyses calling for greater privacy protections to ensure that patients can feel safe disclosing personal information to their health-care providers. At the same time, the volume of biomedical research conducted in this country continues (...) to grow. The budget of the National Institutes of Health, for example, was $20,298 million in 2001, having more than doubled from a budget of $9,218 million 10 years before. This growing body of research includes increased efforts to use stored medical records as a source of data for health services, epidemiologic, and clinical studies. (shrink)

Genetic testing raises concerns that individuals will be denied health insurance (and thus, effectively, access to health care), or that employers will screen to eliminate potentially costly workers. Although we as a society do not yet concur on the degree to which private businesses have a responsibility to promote social justice, several different policy alternatives might allow us to weigh the interests of insurers, as businesses, against the interests of citizens in a responsible manner.

Since the beginning of the AIDS epidemic, the proportion of AIDS cases among women has continued to rise. Women constituted 23 percent of the AIDS cases reported to the Centers for Disease Control and Prevention in 1995, and 81 percent of these women were of childbearing age. It was not until 1991, however, that epidemiological studies of women were initiated. By comparison, the representation of HIV-infected women in clinical trials gradually has grown. Undoubtedly, a consequence of the increased numbers of (...) women in clinical and epidemiological research is the earlier identification of and more appropriate treatments for HIV-related syndromes when women present in the clinical setting. Despite this expanded focus on women, however, clear information to guide the treatment of HIV-infected women who are pregnant is still lagging behind. (shrink)

Since the beginning of the AIDS epidemic, the proportion of AIDS cases among women has continued to rise. Women constituted 23 percent of the AIDS cases reported to the Centers for Disease Control and Prevention in 1995, and 81 percent of these women were of childbearing age. It was not until 1991, however, that epidemiological studies of women were initiated. By comparison, the representation of HIV-infected women in clinical trials gradually has grown. Undoubtedly, a consequence of the increased numbers of (...) women in clinical and epidemiological research is the earlier identification of and more appropriate treatments for HIV-related syndromes when women present in the clinical setting. Despite this expanded focus on women, however, clear information to guide the treatment of HIV-infected women who are pregnant is still lagging behind. (shrink)

ABSTRACT Research ethics remains a cornerstone of the scientific enterprise as it defines the boundaries of responsible conduct of research. Our aim was to systematically identify, review and test online training courses in research ethics which could be considered most appropriate for future training at the University of Botswana (UB). We used an evaluative tool that included both descriptive and evaluative criteria for assessing the strengths, weaknesses and appropriateness of 10 online research ethics courses which are publicly accessible. We then (...) assembled Focus Group Discussions (FGDs) to engage the UB community to select the best 2–3 online courses that are considered most suited for use in future training of research ethics at UB. Twenty respondents participated in three FGDs. Our findings show that there is limited research ethics training capacity in low resourced academic institutions like UB. Online training opportunities could be used to address this challenge. Our analysis reveal that out of the 10 online courses reviewed, CITI program, Family Health International, and Training and Resource in Research Ethics Evaluation have characteristics that would make them suitable for utilization in Botswana. We believe the findings from this case study will be of value to other similarly situated research institutions. (shrink)

Introduction The goal of this project was to develop and validate a new tool to evaluate learners' knowledge and skills related to research ethics. Methods A core set of 50 questions from existing computer-based online teaching modules were identified, refined and supplemented to create a set of 74 multiple-choice, true/false and short answer questions. The questions were pilot-tested and item discrimination was calculated for each question. Poorly performing items were eliminated or refined. Two comparable assessment tools were created. These assessment (...) tools were administered as a pre-test and post-test to a cohort of 58 Indian junior health research investigators before and after exposure to a new course on research ethics. Half of the investigators were exposed to the course online, the other half in person. Item discrimination was calculated for each question and Cronbach's α for each assessment tool. A final version of the assessment tool that incorporated the best questions from the pre-/post-test phase was used to assess retention of research ethics knowledge and skills 3 months after course delivery. Results The final version of the REKASA includes 41 items and had a Cronbach's α of 0.837. Conclusion The results illustrate, in one sample of learners, the successful, systematic development and use of a knowledge and skills assessment tool in research ethics capable of not only measuring basic knowledge in research ethics and oversight but also assessing learners' ability to apply ethics knowledge to the analytical task of reasoning through research ethics cases, without reliance on essay or discussion-based examination. These promising preliminary findings should be confirmed with additional groups of learners. (shrink)

A theory of syllogistic reasoning is proposed, derived from the medieval doctrine of 'distribution of terms'. This doctrine may or may not furnish an adequate ground for the logic of the syllogism but does appear to illuminate the psychological processes involved. Syllogistic thinking is shown to have its origins in the approach and avoidance behaviour of pre-verbal organisms and, in verbal (human) organisms, to bridge the gap between the intuitive grasp shown by most of us of the validity of simple (...) logical arguments and the failure of intuition in more complex arguments that require resort to calculation. Some difficulties are considered affecting the use of syllogisms as experimental material. These include failure on the part of the investigator to take account of the fact that a syllogism is always part of a continuing argument in which the topic of the argument is known to all parties and the possibility that subjects may find ways of appearing to solve syllogisms without actually doing so. (shrink)

: In light of information uncovered about human radiation experiments conducted during the Cold War, an important charge for the Advisory Committee on Human Radiation Experiments was to assess the current state of protections for human research subjects. This assessment was designed to enhance the Committee's ability to make informed recommendations for the improvement of future policies and practices for the protection of research subjects. The Committee's examination of current protections revealed great improvement over those from the past, yet some (...) problems remain. Although the data collected by the Committee highlight specific areas in need of attention, the Committee's work should be viewed in part as the beginning of a series of ongoing assessments of the adequacy and effectiveness of the protections afforded to human subjects. (shrink)

This second edition has been revised to provide additional coherence to the themes examined and introduces sections on topical issues, for example the chapter on Utilitarianism now includes a discussion on law and economics.

Public health ethics, like the field of public health it addresses, traditionally has focused more on practice and particular cases than on theory, with the result that some concepts, methods, and boundaries remain largely undefined. This paper attempts to provide a rough conceptual map of the terrain of public health ethics. We begin by briefly defining public health and identifying general features of the field that are particularly relevant for a discussion of public health ethics.Public health is primarily concerned with (...) the health of the entire population, rather than the health of individuals. Its features include an emphasis on the promotion of health and the prevention of disease and disability; the collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment; a recognition of the multidimensional nature of the determinants of health; and a focus on the complex interactions of many factors—biological, behavioral, social, and environmental—in developing effective interventions. (shrink)

This article discusses the 2005 OUP biography of Michael Polanyi by William T. Scott and Martin X. Moleski S.J., Michael Polanyi, Scientist and Philosopher . The discussants are N. E. Wetherick, Brian G Gowenlock, and John Puddefoot; Martin X. Moleski, S. J. briefly responds, providing a previously unpulished letter from Polanyi to Reverend Dr. Knox, a Presbyterian mininster.

The essay replies to comments by Finnis, Gardner and Endicott, on my book, Law as a Moral Idea. It is questioned whether Finnis is right to suggest that governance by law is a requirement of justice. It is suggested that Hart's positivism may have rested upon an unduly private conception of morality. Gardner's suggestion that Law as a Moral Idea falsely manufactures disagreement with Hart is rejected, principally by pointing out that Gardner focuses upon only one issue, where the book (...) already acknowledges that Hart might conceivably agree, and ignores other issues where the disagreement with Hart seems indisputable. In response to Endicott, it is acknowledged that 'politics' could be understood as a moral idea comparable to the idea of 'law', but denied that this robs either thesis of interest. The nature of doctrinal reasoning and law's justificatory force is then discussed. (shrink)

Rachlin's view of self-control is rejected on the grounds that his arguments do not establish the possibility of abstract, external, stimulus patterns and that his experiments, although they show that pigeons and human beings do sometimes choose postponed rather than immediate gratification, do not challenge the commonly held view that internal factors are involved in the former choice.