It has been suggested that community advisory boards can play a role in minimising exploitation in international research. To get a better idea of what this requires and whether it might be achievable, the paper first describes core elements that we suggest must be in place for a CAB to reduce the potential for exploitation. The paper then examines a CAB established by the Shoklo Malaria Research Unit under conditions common in resource-poor settings – namely, (...) where individuals join with a very limited understanding of disease and medical research and where an existing organisational structure is not relied upon to serve as the CAB. Using the Tak Province Border Community Ethics Advisory Board as a case study, we assess the extent to which it might be able to take on a role minimising exploitation were it to decide to do so. We investigate whether, after two years in operation, T-CAB is capable of assessing clinical trials for exploitative features and addressing those found to have them. The findings show that, although T-CAB members have gained knowledge and developed capacities that are foundational for one-day taking on a role to reduce exploitation, their ability to critically evaluate studies for the presence of exploitative elements has not yet been strongly demonstrated. In light of this example, we argue that CABs may not be able to perform such a role for a number of years after initial formation, making it an unsuitable responsibility for many short-term CABs. (shrink)

In response to calls to expand the scope of research ethics to address justice in global health, recent scholarship has sought to clarify how external research actors from high-income countries might discharge their obligation to reduce health disparities between and within countries. An ethical framework—‘research for health justice’—was derived from a theory of justice (the health capability paradigm) and specifies how international clinical research might contribute to improved health and research capacity in host communities. This (...) paper examines whether and how external funders, sponsors, and researchers can fulfill their obligations under the framework. (shrink)

How international research might contribute to justice in global health has not been substantively addressed by bioethics. This article describes how the provision of ancillary care can link international clinical research to the reduction of global health disparities. It identifies the ancillary care obligations supported by a theory of global justice, showing that Jennifer Ruger’s health capability paradigm requires the delivery of ancillary care to trial participants for a limited subset of conditions that cause severe morbidity and mortality. (...) Empirical research on the Shoklo Malaria Research Unit’s (SMRU) vivax malaria treatment trial was then undertaken to demonstrate whether and how these obligations might be upheld in a resource-poor setting. Our findings show that fulfilment of the ancillary care obligations is feasible where there is commitment from chief investigators and funders and is strongly facilitated by SMRU’s dual role as a research unit and medical non-governmental organization. (shrink)

Bioethicists have long debated the content of sponsors and researchers' obligations of justice in international clinical research. However, there has been little empirical investigation as to whether and how obligations of responsiveness, ancillary care, post-trial benefits and research capacity strengthening are upheld in low- and middle-income country settings. In this paper, the authors argue that research ethics guidelines need to be more informed by international research practice. Practical guidance on how to fulfil these obligations is needed (...) if research groups and other actors are to successfully translate them into practice because doing so is often a complicated, context-specific process. Case study research methods offer one avenue for collecting data to develop this guidance. The authors describe how such methods have been used in relation to the Shoklo Malaria Research Unit's vivax malaria treatment (VHX) trial (NCT01074905). Relying on the VHX trial example, the paper shows how information can be gathered from not only international clinical researchers but also trial participants, community advisory board members and research funder representatives in order to: (1) measure evidence of responsiveness, provision of ancillary care, access to post-trial benefits and research capacity strengthening in international clinical research; and (2) identify the contextual factors and roles and responsibilities that were instrumental in the fulfilment of these ethical obligations. Such empirical work is necessary to inform the articulation of obligations of justice in international research and to develop guidance on how to fulfil them in order to facilitate better adherence to guidelines' requirements. (shrink)

Doctoral programs at U.S. universities play a critical role in the development of human resources both in the United States and abroad. This volume reports the results of an extensive study of U.S. research-doctorate programs in five broad fields: physical sciences and mathematics, engineering, social and behavioral sciences, biological sciences, and the humanities. Research-Doctorate Programs in the United States documents changes that have taken place in the size, structure, and quality of doctoral education since the widely used 1982 (...) editions. This update provides selected information on nearly 4,000 doctoral programs in 41 subdisciplines at 274 doctorate-granting institutions. This volume also reports the results of the National Survey of Graduate Faculty, which polled a sample of faculty for their views on the scholarly quality of program faculty and the effectiveness of doctoral programs in preparing research scholars/scientists. This much-anticipated update of such an essential reference will be useful to education administrators, university faculty, and students seeking authoritative information on doctoral programs. (shrink)

ABSTRACTSome people might argue that there are already too many different documents, guidelines, and regulations in bioethics. Some overlap with one another, some are advisory and lack legal force, others are legally binding in countries, and still others are directed at narrow topics within bioethics, such as HIV/AIDS and human genetics. As the latest document to enter the fray, the UNESCO Declaration has the widest scope of any previous document. It embraces not only research involving human beings, but addresses (...) broader concerns in medicine and healthcare. The UNESCO draft declaration has some minor weaknesses, but on the whole, the strengths outweigh the weaknesses. One weakness is that some items in the draft are stated in a way that is too restrictive, thereby appearing to rule out legitimate activities. A strength of the Declaration is that it is relatively brief, yet at the same time contains sufficient detail to make it something more than a rehearsal of mere pieties. As the most recent of the numerous bioethics and human rights documents, the UNESCO draft draws on many of the earlier documents and also includes some of the most recent thinking about ethical norms and obligations. Perhaps its greatest strength lies not in details of the principles or their implementation, but rather in its stature as an international declaration issued by a United Nations organization. (shrink)

Initial responses to questionnaires used to assess participants' understanding of informed consent for malaria vaccine trials conducted in the United States and Mali were tallied. Total scores were analyzed by age, sex, literacy (if known), and location. Ninety-two percent (92%) of answers by United States participants and 85% of answers by Malian participants were correct. Questions more likely to be answered incorrectly in Mali related to risk, and to the type of vaccine. For adult participants, independent predictors of higher (...) scores were younger age and female sex in the United States, and male sex in Mali. Scores in the United States were higher than in Mali (P = 0.005). Despite this difference participants at both sites were well informed overall. Although interpretation must be qualified because questionnaires were not intended as research tools and were not standardized among sites, these results do not support concerns about systematic low understanding among research participants in developing versus developed countries. (shrink)

The quality of doctoral-level chemistry (N=145), computer science (N=58), geoscience (N=91), mathematics (N=115), physics (N=123), and statistics/biostatistics (N=64) programs at United States universities was assessed, using 16 measures. These measures focused on variables related to: program size; characteristics of graduates; reputational factors (scholarly quality of faculty, effectiveness of programs in educating research scholars/scientists, improvement in program quality during the last 5 years); university library size; research support; and publication records. Chapter I discusses prior attempts to assess quality in (...) graduate education, development of the study plans, and the selection of disciplines and programs to be evaluated. Chapter II discusses the methodology used, focusing on each of the assessment measures. Chapters III to VIII present, respectively, findings from the analyses of the chemistry, computer science, geoscience, mathematics, physics, and statistics/biostatistics programs. Chapter IX includes a summary of results, correlations among measures, several additional analyses, and suggestions for future studies. Among the findings reported are those indicating that mathematics programs had, on the average, the largest number of faculty (N=33) in December 1980 followed closely by physics (N=28) and chemistry (N=23), and that 80 percent of computer science students had job commitments by graduation. (Survey instruments and supporting documentation are included in appendices.) (JN). (shrink)

The quality of doctoral-level biochemistry (N=139), botany (N=83), cellular/molecular biology (N=89), microbiology (N=134), physiology (N=101), and zoology (N=70) programs at United States universities was assessed, using 16 measures. These measures focused on variables related to: (1) program size; (2) characteristics of graduates; (3) reputational factors (scholarly quality of faculty, effectiveness of programs in educating research scholars/scientists, improvement in program quality during the last 5 years); (4) university library size; (5) research support; and (6) publication records. Chapter I discusses (...) prior attempts to assess quality in graduate education, development of the study plans, and the selection of disciplines and programs to be evaluated. Chapter II discusses the methodology used, focusing on each of the assessment measures. Chapters III to VIII present, respectively, findings from the analyses of the biochemistry, botany, cellular/molecular biology, microbiology, physiology, and zoology programs. Chapter IX includes a summary of results, correlations among measures, several additional analyses, and suggestions for future studies. Among the findings reported are those indicating that cellular/molecular biology programs had, on the average, the largest number of faculty and that students in cellular/molecular biology, biology, biochemistry, microbiology, and physiology received a relatively high fraction of financial support. (Survey instruments and supporting documentation are included in appendices.) (JN). (shrink)

On March 8, 2005, the General Assembly adopted the United Nations Declaration on Human Cloning in which Member States are called upon toa) protect adequately human life in the application of life sciencesb) prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human lifec) prohibit the application of genetic engineering techniques that may be contrary to human dignityd) prevent the exploitation of women in the application of life sciencese) adopt and implement (...) national legislation to bring into effect paragraphs a to df) take into account the pressing global issues such as HIV/AIDS, tuberculosis, and malaria, which affect in particular the developing countries. a. (shrink)

In a military-sponsored research project begun during the Second World War, inmates of the Stateville Penitentiary in Illinois were infected with malaria and treated with experimental drugs that sometimes had vicious side effects. They were made into reservoirs for the disease and they provided a food supply for the mosquito cultures. They acted as secretaries and technicians, recording data on one another, administering malarious mosquito bites and experimental drugs to one another, and helping decide who was admitted to (...) the project and who became eligible for early parole as a result of his participation. Thus, the prisoners were not simply research subjects; they were deeply constitutive of the research project. Because a prisoners time on the project was counted as part of his sentence, and because serving on the project could shorten ones sentence, the project must be seen as simultaneously serving the functions of research and punishment. Michel Foucault wrote about such mixed mechanisms in his Discipline and punish. His shining example of such a transparent and subtle style of punishment was the panopticon, Jeremy Benthams architectural invention of prison cellblocks arrayed around a central guard tower. Stateville prison was designed on Benthams model; Foucault featured it in his own discussion. This paper, then, explores the power relations in this highly idiosyncratic experimental system, in which the various roles of model organism, reagent, and technician are all occupied by sentient beings who move among them fluidly. This, I argue, created an environment in the Stateville hospital wing more panoptic than that in the cellblocks. Research and punishment were completely interpenetrating, and mutually reinforcing. (shrink)

In a military-sponsored research project begun during the Second World War, inmates of the Stateville Penitentiary in Illinois were infected with malaria and treated with experimental drugs that sometimes had vicious side effects. They were made into reservoirs for the disease and they provided a food supply for the mosquito cultures. They acted as secretaries and technicians, recording data on one another, administering malarious mosquito bites and experimental drugs to one another, and helping decide who was admitted to (...) the project and who became eligible for early parole as a result of his participation. Thus, the prisoners were not simply research subjects; they were deeply constitutive of the research project. Because a prisoner’s time on the project was counted as part of his sentence, and because serving on the project could shorten one’s sentence, the project must be seen as simultaneously serving the functions of research and punishment. Michel Foucault wrote about such ‘mixed mechanisms’ in his Discipline and punish. His shining example of such a ‘transparent’ and subtle style of punishment was the panopticon, Jeremy Bentham’s architectural invention of prison cellblocks arrayed around a central guard tower. Stateville prison was designed on Bentham’s model; Foucault featured it in his own discussion. This paper, then, explores the power relations in this highly idiosyncratic experimental system, in which the various roles of model organism, reagent, and technician are all occupied by sentient beings who move among them fluidly. This, I argue, created an environment in the Stateville hospital wing more panoptic than that in the cellblocks. Research and punishment were completely interpenetrating, and mutually reinforcing. (shrink)

The informed-consent process should be one of meaningful information exchange between researchers and study participants. One of the responsibilities of research ethics committees is to oversee appropriate informed consent. The committee must consider various matters before deciding whether the process is appropriate, including the adequacy and completeness of the written information provided to study participants, and the process of obtaining informed consent. This study aimed to identify, quantitatively and qualitatively, consent-related issues in different types of malaria proposals submitted (...) to the Faculty of Tropical Medicine, Ethics Committee. This study reviewed proposal documentation submitted to two panels of the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, from 2011 to 2015. The documentation included proposals, notifications to researchers of review outcomes and ethical issues of concern to committee members. Each element of the informed-consent process was identified and analyzed by study classification, design, and specimen use, including whether the study involved a vulnerable population. Summative content analysis was used to analyze patterns of common issues raised in reviews. Of the 112 proposals reviewed, 63 required an informed consent process. All researchers proposed communicating with their study participants; however, about two-thirds needed to improve their explanations of study procedures to participants. About 40% of the proposals attracted comments on informed-consent process elements--risk and discomfort, vulnerable status, and compensation. Studies that planned to collect or use new/linked specimens raised more issues around informed consent than studies using linked data/records. Studies that involved vulnerable populations raised more issues than those that did not. The committee usually asked researchers to clarify, elaborate, revise, or paraphrase the consent process elements that were considered to involve inadequate information exchange between researcher and study participant. This study aimed to describe lessons for malaria researchers about common informed-consent process issues in different types of malaria proposals. The information and analysis of informed-consent elements should assist the preparation of malaria-research proposals. (shrink)

Scholars see Israel as a settler state, comparable with North American, South African and Oceanian cases. But how was Jewish settlement-colonization in pre-Israel Palestine even possible? In the North American, Oceanian and South African cases, European settlers did not encounter diseases like malaria that scholars argue impede settlement. Palestine, however, had high malaria morbidity rates. The disease incapacitated and killed settlers and was one of the most serious threats to Jewish settlement and political economic development. I argue that (...) the exigencies caused by malaria are exactly what fostered Jewish settlement-colonization in Palestine because they prompted the formation of socio-technical arrangements in order to combat the disease. These arrangements included, among other things, people, organizations, scientific knowledge, procedures and larvicides as well as considering the agency of mosquitos and other elements in the environment in disrupting settlement. These arrangements were marshalled by medical-national and political institutions that developed to combat malaria. Only then were Jewish settlers able to effectively colonize Palestine, make their colonies economically viable and make Palestine habitable for future Jewish immigrants. I demonstrate this argument by drawing on archival and library materials that describe the work of an important Zionist Malaria Research Unit (MRU) as well as malaria control efforts in Hefer Valley in the 1930s–1940s, after the unit’s disbandment. Then, I discuss the theoretical implications of this paper to settler-colonial and state-building literatures that, for the most part, neglected the socio-technical nature of state-building and settlement. (shrink)

The informed-consent process should be one of meaningful information exchange between researchers and study participants. One of the responsibilities of research ethics committees is to oversee appropriate inf...

Researchers seeking to engage in projects related to Tribal communities and their citizens, lands, and non-human relatives are responsible for understanding and abiding by each Tribal nation’s research laws and review processes. Few studies, however, have described the many diverse forms of Tribal research review systems across the United States (US). This study provides one of the most comprehensive examinations of research review processes administered by Tribal Research Review Boards (TRRBs) in the US. Through a systematic (...) analysis, we consider TRRBs’ online presence, online documentation, and themes across documents, for five entity types: Tribal nations and Tribal consortiums, Tribal colleges and universities, Tribal health organizations, Indian Health Services, and other Tribal organizations. Results include an assessment of online presence for 98 potential TRRBs, identification of 118 publicly available online documents, and analysis of 41 themes across four document types: Tribal research codes and TRRBs’ guidelines, applications, and post-approval documents. Altogether, this research provides a macro-level analysis of the most common types of TRRBs in the US in an effort to increase researchers’ understanding of these important processes as they prepare to ethically engage Tribal communities in research. These results aim to empower Tribal decision makers as they align their TRRBs’ online visibility and documentation with community priorities and strengthen their protections for the rights and wellbeing of their citizens and community. Ultimately, by expanding our knowledge of TRRBs across the US, this contribution seeks to uphold Tribal sovereignty in research and promote ethical approaches to research with Indigenous communities. (shrink)

BackgroundThis study aims to quantitatively and qualitatively evaluate the activities of a Bioethics Unit (BU) 5 years since its implementation (2016–2020). The BU is a research unit providing empirical research on ethical issues related to clinical practice, clinical ethics consultation, and ethical education for health care professionals (HPS).MethodsWe performed an explanatory, sequential, mixed-method, observational study, using the subsequent qualitative data to explain the initial quantitative findings. Quantitative data were collected from an internal database and analyzed by (...) descriptive analysis. Qualitative evaluation was performed by semi-structured interviews with 18 HPs who were differently involved in the BU’s activities and analyzed by framework analysis.ResultsQuantitative results showed an extensive increment of the number of BU research projects over the years and the number of work collaborations with other units and wards. Qualitative findings revealed four main themes, concerning: 1. the reasons for contacting the BU and the type of collaboration; 2. the role of the bioethicist; 3. the impact of BU activities on HPs, in terms of developing deeper and more mature thinking; 4. the need to extend ethics support to other settings. Overall, our results showed that performing both empirical bioethics research and more traditional clinical ethics activities at the same unit would produce an impetus to increase collaboration and spread an 'ethical culture' among local HPs.ConclusionsOur findings contribute to a growing body of literature on the models of clinical ethics support services and the role of empirical research in bioethics internationally. They also prepare the ground for the implementation of a multidisciplinary Clinical Ethics Committee (CEC) that aims to support the BU’s ethics consultation service within the local context. (shrink)

Internationally, calls for feedback of findings to be made an ‘ethical imperative’ or mandatory have been met with both strong support and opposition. Challenges include differences in issues by type of study and context, disentangling between aggregate and individual study results, and inadequate empirical evidence on which to draw. In this paper we present data from observations and interviews with key stakeholders involved in feeding back aggregate study findings for two Phase II malaria vaccine trials among children under the (...) age of 5 years old on the Kenyan Coast. In our setting, feeding back of aggregate findings was an appreciated set of activities. The inclusion of individual results was important from the point of view of both participants and researchers, to reassure participants of trial safety, and to ensure that positive results were not over-interpreted and that individual level issues around blinding and control were clarified. Feedback sessions also offered an opportunity to re-evaluate and re-negotiate trial relationships and benefits, with potentially important implications for perceptions of and involvement in follow-up work for the trials and in future research. We found that feedback of findings is a complex but key step in a continuing set of social interactions between community members and research staff (particularly field staff who work at the interface with communities), and among community members themselves; a step which needs careful planning from the outset. We agree with others that individual and aggregate results need to be considered separately, and that for individual results, both the nature and value of the information, and the context, including social relationships, need to be taken into account. (shrink)

Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act Privacy Rule and the Federal Policy for Protection of Human Subjects. Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In (...) addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU–US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations. (shrink)

This chapter aims to examine the configuration of the sharing economy in the United Kingdom. The chapter provides an examination of the key opportunities and challenges that this socio-economic model generates in the country. It includes an account of different sharing economy initiatives in the United Kingdom, including crowdfunding projects, tool libraries, timesharing banks, men’s sheds, and shared workspaces, commercial sharing economy services, micro-libraries, community-gardening projects, and paid online peer-to-peer accommodation. Increased consumer choice and economic benefits derived from an extended (...) economy around the sharing economy are identified as key opportunities. Key challenges relate to policymaking and taxation of businesses and participants in the sharing economy, as well as the wider enforcement of health and safety regulations and the impact that the recent pandemic is having on the industry. The chapter also provides an examination of the latest developments and regulations in this area. In addition, the chapter identifies the most pressing issues and possible future directions of research in this context. (shrink)

Pathological archival tissue has been used as a source of research material for many years. The advancement in molecular techniques led to an escalated interest in genetic research on archival tissue. Research on archival tissue has been used without obtaining consents from patients, although the ethical justification for such a practice is unlikely to apply for genetic research that involves whole genome sequencing, for instance. Issues of confidentiality and patients’ autonomy are being raised as institutions consider (...) when approval for this type of research should be granted. In addition, patients’ advocate is mandating some of these changes. In the context of the United Arab Emirates, this paper makes clear the current uncertainties arising from the use of archival tissue in genetic research, as it could be highly invasive of privacy interests and also fails to respect autonomous choice. It further explains what needs to change in order to support such research that is directed at promoting public good, but in a way that is not detrimental to the welfare of patients as research participants. (shrink)

Original research is of course what scientists are expected to do. Therefore the research project is in many ways the unit of science in the making: it is the center of the professional life of the individual scientist and his coworkers. It is also the means towards the culmination of their specific activities: the original publication they hope to contribute to the scientific literature. The scientific project should therefore be of central interest to all the students of (...) science, particularly the philosophers and sociologists of science. We shall focus on the preliminary evaluation of research projects—the specific task of referees—and will emphasize the problem of their scientificity—the chief concern of scientific gatekeepers. In the past such an examination aimed only at protecting the taxpayer from swindlers and incompetent amateurs, such as the inventors of continuous motion artifacts. In recent times a similar issue has resurfaced with regard to some of the most prestigious and most handsomely funded projects, namely work on string theory and many-worlds cosmology. Indeed, some of their faithful have claimed that these theories are so elegant, and so full of high-grade mathematics, that they should be exempted from empirical tests. This claim provoked the spirited rebuttal of the well-known cosmologists Ellis and Silk, which the present paper is intended to reinforce. Indeed, we shall try to show why empirical testability is necessary though insufficient for a piece of work to qualify as scientific. Finally, the present paper may also be regarded as an indirect contribution to the current debate over the reliability of quantitative indicators of scientific worth, such as the h-index of scientific productivity. But we shall touch only tangentially on the sociological, political, and economics of research teams: our focus will be the acquisition of new scientific knowledge. (shrink)

ArgumentThe Uppsala school in separation science, under the leadership of Nobel laureates, The Svedberg and Arne Tiselius, was by all counts a half-century-long success story. Chemists at the departments for physical chemistry and biochemistry produced a number of separation techniques that were widely adopted by the scientific community and in various technological applications. Success was also commercial and separation techniques, such as gel filtration, were an important factor behind the meteoric rise of the drug company Pharmacia from the 1950s. The (...) paper focuses on the story behind the invention of gel filtration and the product Sephadex in the 1950s and the emergence of streamlined commercially oriented separation science as a main activity at the department of biochemistry in the 1960s. The dynamics of this development is analyzed from the perspectives of moral economy and storytelling framed by the larger question of the social construction of innovation. The latter point is addressed in a brief discussion about the uses of stories like the one about Sephadex in current research policy. (shrink)

Between 1906 and 1909 the biologist Ronald Ross and the classicist W.H.S. Jones pioneered interdisciplinary research in biology and history in advancing the claim that malaria had been crucial in the decline of golden-age Greece. The idea had originated with Ross, winner of the Nobel Prize for demonstrating the importance of mosquitoes in the spread of the disease. Jones assembled what, today, we would call an interdisciplinary network of collaborators in the sciences and humanities. But early negative reviews (...) of Jones’s Malaria and Greek History by classicists and historians ended the project, despite a positive reception among malariologists. Today, the “Jones hypothesis” is often used to exemplify the naïvete of past scholarship, and few examine Jones’s evidence and reasoning. In this age of renewed interdisciplinarity, a review of what went wrong is timely. Jones and Ross knew they were opening new methodological territory and struggled with the challenges of multiple ways of knowing. Over 100 years later, malaria remains an important site of historical-biological research, yet integration is elusive. After reviewing the Jones-Ross relationship, Jones’s interdisciplinary campaign, and the reception of the hypothesis among classicists/ancient historians and in malariology, we conclude by highlighting some of the specific challenges faced by those exploring the interface of biology and history. (shrink)

The term “hypnozoite” is derived from the Greek words hypnos and zoon. Hypnozoites are dormant forms in the life cycles of certain parasitic protozoa that belong to the Phylum Apicomplexa and are best known for their probable association with latency and relapse in human malarial infections caused by Plasmodium ovale and P. vivax. Consequently, the hypnozoite is of great biological and medical significance. This, in turn, makes the origin of the name “hypnozoite” a subject of interest. Some “missing” history that (...) is now placed on record shows that Miles B. Markus coined the term “hypnozoite”. While a PhD student at Imperial College London, he carried out research that led to the identification of an apparently dormant form of Cystoisospora. In 1976, he speculated: “If sporozoites of Isospora can behave in this fashion, then those of related Sporozoa, like malaria parasites, may have the ability to survive in the tissues in a similar way.” He adopted the term “hypnozoite” for malaria in 1978 when he wrote in a little-known journal that this name would “… describe any dormant sporozoites or dormant, sporozoite-like stages in the life cycles of Plasmodium or other Haemosporina.” At that time, the existence of a hypnozoite form in the life cycle of Plasmodium was still a hypothetical notion. In 1980, however, Wojciech A. Krotoski published details concerning his actual discovery of malarial hypnozoites, an event of considerable importance. (shrink)

Malaria is a disease of developing countries whose local health services do not have the time, resources or personnel to mount studies of drugs or vaccines without the collaboration and technology of western investigators. This investigative collaboration requires a unique bridging of cultural differences with respect to human investigation. The following debate, sponsored by The Institute of Medicine and The American Society of Tropical Medicine and Hygiene, raises questions concerning the conduct of trans-cultural clinical malaria research. Specific (...) questions are raised about the difficulties of informed consent in different cultural settings and whether there is any role for community involvement. Discussants debate whether drug and vaccine trials not approved in an industrialised country are ever defensible if performed in a third-world setting. Potential conflicting priorities between investigators are discussed and ideas regarding conflict resolution are offered. (shrink)

At the end of the 19th century, medical research in the United States was descriptive and rudimentary. American physician-investigators were primarily defining and categorizing disease entities. However, seeds of more mechanistic research had been laid in Europe, particularly in Germany, including the germ theory of disease etiology resulting from Pasteur and Koch's discoveries and the detailed descriptive pathology of the human body by Virchow and others. Prior to World War I, a graduate of an American medical school with (...) an interest in research commonly spent time in a laboratory of a productive European investigator. This European influence on American medicine and medical research was greatly respected, and a .. (shrink)

As countries around the world work to restrict unhealthy food and beverage marketing to children, the U.S. remains reliant on industry-self regulation. The First Amendment’s protection for commercial speech and previous gutting of the Federal Trade Commission’s authority pose barriers to restricting food marketing to children. However, false, unfair, and deceptive acts and practices remain subject to regulation and provide an avenue to address marketing to young children, modern practices that have evaded regulation, and gaps in the food and beverage (...) industry’s self-regulatory approach. (shrink)