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At least 19 recordsLinked to original sources
PubMed1994

Toward a statement of the principles underlying responsible conduct in biomedical research.

Biomedical research still does not have clear, written, agreed-upon underlying values (for a number of possible reasons that are discussed), and a variety of new pressures are making it necessary to formulate such principles. Toward that goal, this essay first traces the development of the underlying principles that have been formulated in the sphere of human subjects research, from the ancient Hippocratic injunction of do no harm to the three principles identified in 1979 by the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research: respect for persons; beneficence; and justice. Using these principles as a pattern, the following "candidate principles" are proposed for biomedical research to stimulate discussion and the development of consensus among biomedical scientists: honesty of scientists (which encompasses the essential values of integrity, objectivity, verifiability, and truthfulness); respect for others (including respect for research subjects--both humans and other animals--colleagues, and the environment); scholarly competence (which is related to the processes of obtaining and passing on knowledge); and stewardship of resources (involving obligations to protect society from the problems intertwined with scientific advances). Guiding principles of this type must be articulated so they can be transmitted to upcoming scientists, who then can productively and responsibly help shape the future of the research enterprise.

Animal Experimentation↗
PubMed2005

Use of dual isotope tracers in biomedical research.

Biomedical stable isotope studies involve administration of tracer and measurement of isotope enrichment in blood, urine, feces or breath. The aim of the studies is to gather quantitative information about a specific metabolic function. However, the measured isotope enrichment may be affected by other metabolic events than only this function. In this case, a correction is necessary. The best approach is to add a second tracer simultaneously which is known to be metabolised by all interfering metabolic events but not by the function of interest. This dual isotope approach also enables simultaneous measurement of two interrelated functions. A summary of selected applications involving dual isotope tracer studies is presented. The applications deal with energy expenditure (doubly labelled water technique), cholesterol absorption, starch and lactose digestion, fat digestion, bile acid metabolism and the combination of stable and radioactive carbon isotopes in breath testing.

Bile Acids and Salts↗
PubMed2006

Access to tangible research materials in biomedical research: conditions of access and their effect on research.

Biomedical discoveries often provide the basic tools for research. Such discoveries may be patentable or non-patentable products or processes, as well as the materials necessary for further research. Without rapid access to these materials on reasonable terms, there is concern that the progress of science will suffer. In 1995, the National Institutes of Health in the United States published a Master Uniform Biomaterial Transfer Agreement (UBMTA) to improve access to biomedical materials. Guidelines for transfers were published in 1999. This article analyses a survey that the author conducted in the Faculty of Medicine, Nursing and Health Science, Monash University. It observes that a significant minority of respondents experience frustration and/or adverse effects upon their research as a result of restrictions imposed upon their access to materials. It concludes that the extensive experience and precedent material in the United States provides an immediate resource to help improve access to biological materials in Australian universities.

Australia↗
PubMed2000

[Usefulness of online bibliographic research in biomedical research, with an application to the epidemiologic study of genetic osteopathy].

The bibliographic research online is an useful means of recovering information in all the subjects, particularly in the field of biomedicine. In fact, this instrument allows researchers to get information in a rapid, complete and up-to-date way. The aim of the present review is to describe the usefulness of the bibliographical research online in the field of the genetic osteopathies. These are rare disorders: so, their own rarity makes the bibliographical research online necessary to carry out a large and effective comparison of experiences. The obtained results are amply reported in the manuscript. For instance, we verified that chondrodysplasias are the diseases most represented in the literature, while melorheostosis the disorder less mentioned. Moreover, we evidenced that some hereditary disorders of connective tissue, such as Marfan's syndrome, osteogenesis imperfecta and Ehlers-Danlos syndrome, are strongly influenced by race, sex and age.

Bibliometrics↗
PubMed2006

[The use of transgenic animals in biomedical research in Germany. Part 2: Ethical evaluation of the use of transgenic animals in biomedical research and perspectives for the changeover in research to research animal-free methods].

As a rule, transgenic animals are being used in in vivo experiments to examine gene functions, their regulation or the contribution of genetic alterations to the development of diseases. Many transgenic animals already are affected in their wellbeing due to the genetic modification alone regardless of the procedures performed with them. Moreover, it is to be questioned whether the experimental use of transgenic animals led to results that were of such outstanding scientific relevance that they legitimated the suffering of the animals. In order to point to possible approaches to avoiding the use of transgenic animals in the areas of research identified, subsequent investigations aimed at collecting information on non-animal test methods that might be applied in pursuing the aforesaid questions. In particular, these were non-animal test methods that make use of genetic techniques. Amongst these are in vitro cell culture methods with genetically modified cells, such as the so called Transfected Cell Array, as well as in vitro test methods, in which specifically targeted genes can be turned on or off selectively for example by the so-called RNA interference technique or by antisense oligonucleotide genes. Since such technologies can also be applied to cell cultures with human cells, investigations with these methods enable direct information on the function of human genes. Even though a one to one replacement of animal experiments with transgenic animals by non-animal test methods is considered unlikely, from the point of view of animal welfare the broad spectrum of already available non animal test methods with which to study the function of genes and genetically caused pathophysiological reactions proves that waiving of animal tests with transgenic animals is possible without impeding biomedical research. Even if it cannot be totally excluded that some very specific questions linked to the respective animal experiment might not be pursued for the time being, nevertheless research that would be restricted to modern and ethically acceptable in vitro test methods would certainly conceive its very own questions to pursue and solve the problems currently faced by biomedical research. It is against this background that it is to be welcomed that the German Federal Government currently actively promotes the further development of genetechnological non-animal test methods. In order to ensure that these funding measures will make an effective contribution to reducing animal experiments, as spelled out by the government itself, the conversion of genetechnological research, just like biomedical research as a whole, to non-animal testing methods should be supported by concrete political actions. From the point of view of the German Animal Welfare Federation the following issues are to be requested: (1)In order to enable a fast and comprehensive advancement of promising genetechnological non-animal test methods, it should be ensured that public funding is provided with an adequate budget and over a sufficiently long period of time. (2)The legislator should initiate broad discussions on the question if society would be willing to dispense with certain pieces of knowledge if they would necessarily have to be gained at the expense of a certain degree of animal suffering. As the case may be, in the German Animal Welfare Act it should be laid down that certain procedures should not be considered acceptable as such. (3)As long as animal experiments with transgenic animals continue to be performed, concrete legal measures should be laid down in the German Animal Welfare Act to ensure that the distress of the animals (taking into account all factors relevant for transgenic animals) and the expected benefit of the research project are determined objectively so that the outcome of the ethical evaluation process becomes comprehensible. (4)The legislator should provide the authorities responsible for the licensing of research projects with concrete instructions in order to ensure that all aspects relevant for the welfare of the animals are fully taken into account when evaluating the ethical acceptability and scientific indispensability of projects and that special attention is given to research projects with transgenic animals. (5)The German Decree on the Reporting of Laboratory Animals should be amended to ensure that all individual transgenic animals are included in the official statistical reports regardless of whether they end up being used in scientific procedures or not. From the point of view of animal welfare it is possible to redesign biomedical research to do without transgenic animals without impeding necessary scientific progress. The survey in hand sought to make a contribution to providing a scientifically sound background for initiating these discussions.

Animal Testing Alternatives↗
PubMed2000

Challenges and opportunities for the biomedical research community.

The biomedical research community of the new millennium has at its disposal the resources and knowledge to bring about major changes in human health. Technological advances on a scale never before seen mean that we can consider a level of medical investigation and intervention unimaginable only 20 years ago. But with this power comes a tremendous responsibility to think carefully about how those resources should best be used. For reasons of economy, biomedical research is likely to remain focussed on the needs of rich countries. This need not, however, mean that poorer countries cannot in the future receive a greater benefit from the current community of biomedical researchers. And given the nature of disease and its disrespect for national boundaries, a more global approach to biomedical research should be attractive to rich and poor countries alike. Achieving this change, no matter how modest in scale, will require a concerted effort at all levels within the biomedical research community. Indeed, the community is at a stage when it must pay closer attention to the sensitivities and concerns of its patient population. Only then will the tremendous potential of biomedical research be embraced and supported by our societies.

Animals↗
PubMed2000

Community outreach at biomedical research facilities.

For biomedical researchers to fulfill their responsibility for protecting the environment, they must do more than meet the scientific challenge of reducing the number and volume of hazardous materials used in their laboratories and the engineering challenge of reducing pollution and shifting to cleaner energy sources. They must also meet the public relations challenge of informing and involving their neighbors in these efforts. The experience of the Office of Community Liaison of the National Institutes of Health (NIH) in meeting the latter challenge offers a model and several valuable lessons for other biomedical research facilities to follow. This paper is based on presentations by an expert panel during the Leadership Conference on Biomedical Research and the Environment held 1--2 November 1999 at NIH, Bethesda, Maryland. The risks perceived by community members are often quite different from those identified by officials at the biomedical research facility. The best antidote for misconceptions is more and better information. If community organizations are to be informed participants in the decision-making process, they need a simple but robust mechanism for identifying and evaluating the environmental hazards in their community. Local government can and should be an active and fully informed partner in planning and emergency preparedness. In some cases this can reduce the regulatory burden on the biomedical research facility. In other cases it might simplify and expedite the permitting process or help the facility disseminate reliable information to the community. When a particular risk, real or perceived, is of special concern to the community, community members should be involved in the design, implementation, and evaluation of targeted risk assessment activities. Only by doing so will the community have confidence in the results of those activities. NIH has involved community members in joint efforts to deal with topics as varied as recycling and soil testing. These ad hoc efforts are more likely to succeed if community members and groups have also been included in larger and longer term advisory committees. These committees institutionalize the outreach process. This can provide the facility with vocal and influential allies who create an independent line of communication with the larger community.

Academies and Institutes↗
PubMed1984

A classification for biomedical research reports.

Biomedical research uses a wide range of designs applied to problems in laboratory, clinical, and population settings. Whatever the nature of the study, a few key features--such as the admission rule, the method of allocating subjects to treatments, and the use of controls--largely determine the strength of scientific inferences. We used these and other features to classify the 332 Original Articles published in the New England Journal of Medicine during 1978-1979. This classification directs attention to critical aspects of study design and performance and can help in the choice of suitable research approaches and protocols. It emphasizes the critical role of the investigators' intent in performing and analyzing a study, and it alerts readers to important aspects of interpretation. We recommend that authors always report enough detail about their work for readers to apply this or a similar classification. Omission of such detail may limit the interpretation of a research study because a study that cannot be classified has probably been incompletely reported.

Clinical Trials as Topic↗
PubMed2001

[Required procedure for nominal data files processing in biomedical research].

To date, biomedical research using nominal data files for the data collection, data acquisition or data processing has had to comply with 2 French laws (Law of December, 20, 1988, modified, relating to the protection of patients participating in biomedical research, and the Law of January, 6, 1978, completed by the Law of July 1, 1994 n degrees 94-548, chapter V bis). This later law dictates rules not only for the establishment of nominal data files, but also confer individual rights to filed persons. These regulations concern epidemiological research, clinical trials, drug watch studies and economic health research. In this note, we describe the obligations and specific general and simplified procedure required for conducting biomedical research. Included in the requirements are an information and authorization procedure with the local and national consultative committees on data processing in biomedical research (CCTIRS, Comité Consultatif sur le Traitement de l'Information en Recherche Biomédicale, and CNIL, Commission Nationale Informatique et Libertés).

Clinical Trials as Topic↗
PubMed1996

Technology transfer: trends in the federalization of biomedical research.

Federal involvement in biomedical research has increased significantly in the postwar era, particularly throughout the 1980s and early 1990s. New federal laws and regulations now offer unprecedented opportunities to commercialize federally funded and conducted research, essentially creating a new field of "technology transfer" law. As a result, the biomedical research sector of the health care industry must master a number of relatively new and still developing federal laws, regulations, policies, and concerns that will probably continue to significantly affect its operations. To assist academic medical centers and others in understanding the federal presence in biomedical research, the authors give a short history of technology transfer laws and issues and summarize some of the current main areas of federal interest, including federal oversight of federally funded research, sponsored research agreements, conflict of interest, scientific misconduct, and the prospect of government price control over some biomedical inventions. The authors caution academic medical centers to realize that recent trends favoring deregulation and budget cutting could diminish federal involvement in the future. Thus, research institutions should keep abreast not only of existing rules and policies but of ongoing legislative and regulatory activities that portend possible changes.

Academies and Institutes↗
PubMed2003

United Nations and human cloning: a slender and fortunate defence for biomedical research.

Numerous biomedical scientists have contributed to the wide knowledge on the growth of preimplantation human embryos in vitro, now improving every aspect of the form of clinical care. These data were gained ethically in many countries, to open new vistas including the alleviation of infertility, preimplantation genetic diagnosis and stem cells, combined with some recent reports on human reproductive cloning. After detailed consultations with scientists, clinicians, ethicists and lawyers, many governments passed legislation permitting research under their own particular socially-defined conditions. Virtually all of them rejected reproductive cloning; a few have accepted therapeutic cloning. These legislatures saluted the many biomedical scientists striving to improve IVF and its derivatives, recognizing their immense medical potential. A motion recently placed before the United Nations then recommended a worldwide ban on all forms of human cloning. Proponents included the Vatican and many Roman Catholic countries, the USA and others. Opponents included Belgium, China, Japan, Brazil, UK, Germany and France. Mediation was achieved by Iran and other Muslim nations, and led to a motion passed by single vote for a two-year delay. This may be the first-ever proposal to ban worldwide a particular form of research. It sounds the alarm bells for further research. It raises questions about the UN being an appropriate forum for ethical decisions affecting the entire world and its future medicine. Large blocs of nations committed to particular religions and outlooks confronted each other, a situation in total contrast to the detailed and widespread consultations made by individual governments when deciding their own individual ethics. This event was clearly a narrow escape for free research as defined by each country's own jurisprudence. It also places research on human embryology and reproductive biomedicine into a more critical situation than before. Current liberalism in studies on assisted conception, clearly threatened by powerful adversaries, will have to be fortified to maintain the current impetus into newer forms of clinical care.

Cloning, Organism↗
PubMed1986

The future of biomedical research and its impact on pathology.

Biomedical research is an enterprise that is generally active today. The future of biomedical research will be determined by the directions given it by the individual research investigators, development of new equipment and facilities, availability of money to fund research, societal attitudes about the goals and uses of research, and the character of research investigators' training. The future of biomedical research seems to be substantial because it leads to strategies and techniques for preventing or curing disease, and, thereby, results of research can enable health care to be both improved and made less costly. The condition of research in pathology seems to be less healthy than does that of biomedical research in general. Faculty members of academic pathology departments do not seem to compete well for research support from federal sources, and this lack may signal a further decline in pathology research in the future. The reasons for the perceived erosion of research in pathology are complex, but they must be addressed and reversed. Since the practice of diagnostic pathology is an applied technology that depends on research for new scientific insights and techniques to sustain it, continued erosion of the research base of pathology will adversely affect the future utility and relevance of diagnostic pathology as a clinical medical specialty.

Financing, Government↗