Subjects In Biomedical Research Research Articles

Meta Data Analysis of Sex Distribution of Study Samples Reported in Summer Biomechanics, Bioengineering, and Biotransport Annual Conference Abstracts.

The biased use of male subjects in biomedical research has created limitations, underscoring the importance of including women to enhance the outcomes of evidence-based medicine and to promote human health. While federal policies (e.g., the 1993 Revitalization Act and the 2016 Sex as a Biological Variable Act) have aimed to improve sex balance in studies funded by the National Institutes of Health (NIH), data on sex inclusivity in non-NIH funded research remain limited. The objective of this study was to analyze the trend of sex inclusion in abstracts submitted to the Summer Biomechanics, Bioengineering, & Biotransport Conference (SB3C) over 7 years. We scored every abstract accepted to SB3C, and the findings revealed that approximately 20% of total abstracts included sex-related information, and this trend remained stable. Surprisingly, there was no significant increase in abstracts, including both sexes and those with balanced female and male samples. The proportion of abstracts with balanced sexes was notably lower than those including both sexes. Additionally, we examined whether the exclusion of one sex from the corresponding studies was justified by the research questions. Female-only studies had a 50% justification rate, while male-only studies had only 2% justification. Disparity in sex inclusion in SB3C abstracts was apparent, prompting us to encourage scientists to be more mindful of the sex of the research samples. Addressing sex inclusivity in biomechanics and mechanobiology research is essential for advancing medical knowledge and for promoting better healthcare outcomes for everyone.

CONSTITUTIONAL AND LEGAL PRINCIPLES OF THE LIMITS OF PERMISSIBLE INTERVENTION IN CONDUCTING BIOMEDICAL RESEARCH WITH HUMAN PARTICIPATION.

The aim: To find out the peculiarities of constitutional and legal principles of the limits of permissible intervention in conducting biomedical research with human participation. Materials and methods: The methodological basis of the study was worldview dialectical, general scientific and specific scientific methods of learning the phenomena of state and legal reality. Common ones were widely used in the work principles of scientific knowledge - comprehensiveness, objectivity, historicism, unity of theory and practice and others. The most important methodological prerequisite was a systemic approach to the issue of protecting human rights when conducting biomedical experiments with his participation, which made it possible to form a holistic view of the object and subject of research. With its help, the human rights affected by biomedical research in the context of the general legal principle of humanism were analyzed, the limits of permissible intervention in the human body were identified, and conclusions were drawn regarding the need for the separation and normative legal regulation of the complex branch of medical law. In the study, general scientific methods were widely used: historical, systematic analysis of the studied phenomena and syn¬thesis of the obtained results, inductive and deductive reasoning; special: formal-logical, sociological, statistical; and also private-scientific: comparative-legal, normative-legal, and others. Conclusions: 1) A key point in the mechanism of protection of the subject's rights in the process of conducting biomedical research is the establishment of a number of limits (maxims) that allow interference in the human body and can limit the researcher and protect the subject. These maxims should be integral elements of the process of biomedical research with human participation and determine the basic criteria for the protection of citizens' rights when conducting biomedical research. 2) The limits of permissible intervention in the conduct of biomedical research with human participation are the legal and factual consequences of the activity of bodies authorized to conduct biomedical research, which is based on the law and aimed at achieving the goals set by the researcher for conducting biomedical research with human participation, as a result of which the options for permitted by the norms of the law of behavior of the subjects of biomedical research by establishing various limits of such behavior, which necessarily have an exclusively temporary and subjective nature.

Automated Tools to Advance High-Resolution Imaging in Liquid.

Liquid-electron microscopy (EM), the room-temperature correlate to cryo-EM, is a rapidly growing field providing high-resolution insights of macromolecules in solution. Here, we describe how liquid-EM experiments can incorporate automated tools to propel the field to new heights. We demonstrate fresh workflows for specimen preparation, data collection, and computing processes to assess biological structures in liquid. Adeno-associated virus (AAV) and the SARS-CoV-2 nucleocapsid (N) were used as model systems to highlight the technical advances. These complexes were selected based on their major differences in size and natural symmetry. AAV is a highly symmetric, icosahedral assembly with a particle diameter of ~25 nm. At the other end of the spectrum, N protein is an asymmetric monomer or dimer with dimensions of approximately 5–7 nm, depending upon its oligomerization state. Equally important, both AAV and N protein are popular subjects in biomedical research due to their high value in vaccine development and therapeutic efforts against COVID-19. Overall, we demonstrate how automated practices in liquid-EM can be used to decode molecules of interest for human health and disease.

Bioengineering models of female reproduction.

The female reproductive system consists of the ovaries, the female gonads, and the reproductive track organs of the fallopian tubes, uterus, cervix, and vagina. It functions to provide hormonal support and anatomical structure for the production of new offspring. A number of endogenous and exogenous factors can impact female reproductive health and fertility, including genetic vulnerability, medications, environmental exposures, age, nutrition, and diseases, etc. To date, due to the ethical concerns of using human subjects in biomedical research, the majority of studies use in vivo animal models and 2D cell/tissue culture models to study female reproduction. However, the complexity and species difference of the female reproductive system in humans makes it difficult to compare to those of animals. Moreover, the monolayered cells cultured on flat plastics or glass lose their 3D architecture as well as the physical and/or biochemical contacts with other cells in vivo. Further, all reproductive organs do not work alone but interconnect with each other and also with non-reproductive organs to support female reproductive, endocrine, and systemic health. These facts suggest that there is an urgent and unmet need to develop representative, effective, and efficient in vitro models for studying human female reproduction. The prodigious advancements of bioengineering (e.g. biomaterials, 3D printing, and organ-on-a-chip) allow us to study female reproduction in an entirely new way. Here, we review recent advances that use bioengineering methods to study female reproduction, including the bioengineering models of the ovary, fallopian tube, uterus, embryo implantation, placenta, and reproductive disease.

A 10-year follow-up study of sex inclusion in the biological sciences.

In 2016, to address the historical overrepresentation of male subjects in biomedical research, the US National Institutes of Health implemented a policy requiring investigators to consider sex as a biological variable. In order to assess the impact of this policy, we conducted a bibliometric analysis across nine biological disciplines for papers published in 34 journals in 2019, and compared our results with those of a similar study carried out by Beery and Zucker in 2009. There was a significant increase in the proportion of studies that included both sexes across all nine disciplines, but in eight of the disciplines there was no change in the proportion studies that included data analyzed by sex. The majority of studies failed to provide rationale for single-sex studies or the lack of sex-based analyses, and those that did relied on misconceptions surrounding the hormonal variability of females. Together, these data demonstrate that while sex-inclusive research practices are more commonplace, there are still gaps in analyses and reporting of data by sex in many biological disciplines.

Public Health Crises and the Human Subjects of Biomedical Research: A Focus on COVID-19

Public Health Crises and the Human Subjects of Biomedical Research: A Focus on COVID-19

Development of the Hybrid Rule and the Concept of Justice: The Selection of Subjects in Biomedical Research

As biomedical research with volunteers was expanded in the United States, the rule of subject selection, constituting scientific and ethical criteria, was generated in 1981 to resolve selection bias in research. Few historical studies, however, have investigated the role of this new hybrid rule in institutional review systems. This paper describes how bioethics commissions and federal agencies have created the subject selection rule based on the concept of justice. I argue that the standardization of this rule as temporal measures, linked with risk-benefit assessment, has reformed the review mechanism, specifically investigators’ modification of research plans, thereby developing justice as balancing.

The effects of criminal damage and damage caused by research on third parties

Objective: Biomedical research and the health sciences are a key element to improve the quality and life expectancy of the citizens and to improve their well-being, which has substantially changed, both methodologically as well as conceptually in the last years. Methodology: The appearance of new analytic tools has led to great discoveries which allow us to foster reasonable hopes on the treatment and even the cure in a not very distant future of pathologies which are not capable of being dealt with at present. The incidence of serious misconduct in research, which will be referred, is the clear evidence of attention the widespread to the issue of ethics in research. In fact, ((protection of human subjects in biomedical research)) is prime mover in initiating and maintaining attention to the issue of ethics in research. Results: The purpose of this research is to try to examined the criminal aspects of this phase of the research (research on humans), Ie criminal liability arising from injury or damage to in the investigation of third parties, patients and participants will be entered explored, and on the one hand look at the criminalization and dos and don'ts that pursuant to the rules of international conventions in this field and in order to dealt with protect the rights of the subjects. Conclusion: The respective results of the experiments and research, can be very beneficial for mankind the growth and development of the science of genetics and biotechnological provide route to prevention and treatment of diseases.

Reliability of ultrasound measurements of quadriceps muscle thickness in critically ill patients

BackgroundMuscle wasting in critically ill patients is associated with negative clinical outcomes. Ultrasound quadriceps femoris muscle assessment may constitute a convenient tool to evaluate muscle wasting. Nevertheless, its reliability remains uncertain. Our primary aim was to study the intra- and inter-observer reliability of this technique. Our secondary aim was to assess the evolution of the quadriceps muscle during the first 3 weeks after ICU admission and its possible association with nutritional intake.MethodsThis observational study included patients expected to stay more than 7 days in the ICU. Ultrasound quadriceps muscle thickness was measured with a 12 MHz linear transducer, by two trained physicians, on D1, D3, D5, D7 and D21. Two measurements sites were evaluated: on the midpoint or on the two-thirds of the length between the anterior superior iliac spine and the upper border of the patella. Intra and inter-observer reliability was assessed by calculating the intra-class correlation coefficient (ICC).ResultsA total of 280 ultrasound quadriceps thickness measurements were performed on 29 critically ill patients. Intra-observer reliability’s ICC was 0.74 [95% CI 0.63; 0.84] at the “midpoint” site and 0.83 [95% CI 0.75; 0.9] at the “two-thirds” site. Inter-observer reliability’s ICC was 0.76 [95% CI, 0.66; 0.86] at the “midpoint” site and 0.81 [95% CI, 0.7; 0.9] at the “two-thirds” site. Quadriceps femoris muscle thickness decreased over 16% within the first week after ICU admission. No correlation was found between muscle loss and caloric (p = 0.96) or protein (p = 0.80) debt over the first week.ConclusionThe assessment by ultrasonography of the quadriceps muscle thickness reveals good intra- and inter-observer reliability and may constitute a promising tool to evaluate the effect of nutritional-based interventions on muscle wasting in critically ill patients.Trial registration“Committee for the Protection of Human Subjects in Biomedical Research” - Paris Ile de France VI Pitié-Salpêtrière – 10/07/2014.French Data Protection Committee (“Commission Nationale Informatique et Libertés”) - #1771144.

Legal Progress in the Protection of the Rights and Interests of Human Subjects in Biomedical Research in China

The rapid development of biomedical technology in China requires much research and a large number of human subjects have emerged in response. Chinese government has been sparing no efforts in protecting the rights of human subjects by the law and has made further achievements in 2016. This article finds that the laws are being improved, the ethical principles have been growing clearer, the validity of informed consent has been better guaranteed and the gap that the law fails to fill has been compensated for in legislation in China. Though legislative technique and legislation in this field need improvement, the legal guarantee of the rights of subjects is promising.

Bioethical considerations, the common good approach and some shortfalls of the Belmont Report

The Belmont Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research established ethical principles to shield human subjects in biomedical research from unjustifiable exploitation by researchers. This was a response to the “Tuskegee Study” in the United States, where the rights of participants were grossly violated. Today, researchers and physicians often make use of human beings as subjects in scientific investigations. One of the key issues is that of informed consent. The ethical principles stressed in the Belmont Report have significant implications for the matter of informed consent. Informed consent must be required for any legal research involving human subjects. Regulatory frameworks must ensure that human subjects in bioethical or other research are not exploited either physically or psychologically. The need for effective humanistic ethical guidelines for biomedical research is great, but how does this tie in with the Common Good Approach if at all?

Through the bioethical retrospectoscope

Abstract A retrospectoscope is understood here as a fictional instrument through which the past history of certain ideas can help the understanding of their present sense, including the awareness of how our ideas may have drifted off the path. Concretely, this retrospectoscope will seek out the origins of the ethical principles that are so prominent in contemporary bioethics and show how interpretations of these principles have led contemporary bioethics astray, making paradoxes and dilemmas out of what should be resolutions and illuminations. This essay explores, in particular, how the principle of autonomy originated in the protection of subjects of biomedical research and then moved into the relationship between physicians and patients. This shift took place without sufficient recognition of the significant differences between these settings. Respect for autonomy clearly has priority as an ethical principle in the endeavor of medical research. It may not have such priority, at least not in the same sense, in medical practice. The Belmont Report (which concerned medical research) defined Respect for Persons as “the ethical conviction that individuals should be treated as autonomous agents…”, and stated that this autonomy was self-determination. Clinical medicine, however, differs from research radically. It begins with a person bringing an apparently compelling need to a practitioner. Healing is a helping activity, focused on response to a specific request from a specific person in need. The primary moral quality of this activity is the formation of a trusting alliance between physician and patient, in which the focus on the patient's needs is straight and clear, communication is honest and illuminating, and acceptance and collaboration are real. At the same time, the therapeutic relationship must often be formed at a time when the autonomy of the patient is often buried deeply under pain, debility, and physical and moral distress, or extinguished by radically altered mental status. If one wishes to express that alliance in moral terms, one might still invoke the same phrase, Respect for Persons. But that phrase should take on a quite different meaning in the therapeutic alliance than it has in the research enterprise. Unfortunately, in most of the current literature the issue of Respect is focused almost entirely on Informed Consent, the procedure in which autonomy is supposed to be realized.

Not Fit for Purpose: The Ethical Guidelines of the Indian Council of Medical Research

In 2006, the Indian Council of Medical Research (ICMR) published its 'Ethical guidelines for Biomedical Research on human participants'. The intention was to translate international ethical standards into locally and culturally appropriate norms and values to help biomedical researchers in India to conduct ethical research and thereby safeguard the interest of human subjects. Unfortunately, it is apparent that the guideline is not fit for purpose. In addition to problems with the structure and clarity of the guidelines, there are several serious omissions and contradictions in the recommendations. In this paper, we take a close look at the two key chapters and highlight some of the striking flaws in this important document. We conclude that ethics committees and national authorities should not lose sight of international ethical standards while incorporating local reality and cultural and social values, as focusing too much on the local context could compromise the safety of human subjects in biomedical research, particularly in India.

Therapeutic Hope, Spiritual Distress, and the Problem of Stem Cell Tourism

Managing patients' therapeutic hope and spiritual distress-in addition to tighter regulation of commercial therapies and improved patient understanding-may offer a more comprehensive approach to reducing the overall incidence of stem cell tourism. Such patient support must occur early in the clinical relationship after appropriate assessment and discussion.

Institutionalizing Ethical Research Behind Closed Doors IRBs and the Making of Ethical Research by Laura Stark University of Chicago Press, Chicago, 2012. 237 pp. $85. ISBN 9780226770864. Paper, $27.50. ISBN 9780226770871. Morality and Society.

Stark combines a history of rules for the treatment of human subjects in biomedical research with firsthand observations of institutional review boards.

Introduction to special issue: risk and probability in bioethics

Although thoughtful people have long pondered the uses and abuses of medical procedures, the character and importance of health and disease and the allocation of scare life-saving resources, the examination of these issues under the rubric of ‘bioethics’ is less than 50 years old. The emergence of a distinct field resulted from a confluence of several concerns. These included recurring disclosures about the harmful and deceptive treatment of human subjects in biomedical research; anxiety over the accelerating growth and uncritical embrace of biotechnologies for creating, enhancing and prolonging lives; and a strong ambivalence about the increasing use of cost–benefit analysis and other economic techniques to ‘rationalize’ medical decision making. Bioethicists have never shown the reflex aversion to numerical probability and statistics found in many areas of law. At the same time, bioethics was borne of wariness about scientific progress and economic rationalization; the field was galvanized not only by the widespread abuse of science and medicine but also by the arrogance and overconfidence of scientists and physicians concerning the superiority of their methods. Moreover, there was resistance within the practices encompassed by bioethics to various forms of quantification: from practicing physicians, who prized their clinical judgement over evidence-based medicine, with its statistical techniques for diagnosis and treatment, and from health policy makers and advocates who rejected cost–benefit and cost-effectiveness analysis as decision-making techniques, doubting that they could capture values critical to ‘tragic choices’ among competing medical needs. In creating this special issue, we sought contributions from writers who had addressed probability and risk in different areas of bioethical interest—in research ethics, where concerns about risks to human subjects have played a central role, in clinical medicine, where the resistance to quantitative approaches has traditionally been strongest, and in health and science policy, home to protracted debates about the appropriate procedures and metrics for decision making. Our contributors all address issues of risk in these areas, issues that are in most cases closely tied to the legal or administrative regulation of research and clinical practice and the shaping of public policy. Each of these essays challenges standard views about how risk should be assessed, compared or managed by public policy. Wendler and Rid review several of the leading approaches to assessing risks in research on human subjects, including approaches that impose different standards for therapeutic and nontherapeutic research or for research undertaken with different purposes. They favour

Eyes Wide Open: The Personal Genome Project, Citizen Science and Veracity in Informed Consent

I am a close observer of the Personal Genome Project (PGP) and one of the original ten participants. The PGP was originally conceived as a way to test novel DNA sequencing technologies on human samples and to begin to build a database of human genomes and traits. However, its founder, Harvard geneticist George Church, was concerned about the fact that DNA is the ultimate digital identifier - individuals and many of their traits can be identified. Therefore, he believed that promising participants privacy and confidentiality would be impractical and disingenuous. Moreover, deidentification of samples would impoverish both genotypic and phenotypic data. As a result, the PGP has arguably become best known for its unprecedented approach to informed consent. All participants must pass an exam testing their knowledge of genomic science and privacy issues and agree to forgo the privacy and confidentiality of their genomic data and personal health records. Church aims to scale up to 100,000 participants. This special report discusses the impetus for the project, its early history and its potential to have a lasting impact on the treatment of human subjects in biomedical research.

Stroking Characteristics during Time to Exhaustion Tests

Race analyses during swimming reveal how exercise duration affects both clean swimming speed (v), stroke rate (SR), and stroke length (SL). The aim of this study is to provide an explanation for the change of SL and SR during paced exercise swimming the front crawl through an analysis of intracycle changes in motor organization. Trained swimmers (N = 10) swam three times to exhaustion (TTE in seconds) at predetermined velocities corresponding to 95%, 100%, and 110% of the mean speed attained in a 400-m race (V 400). During TTE tests, SR, SL, durations of the glide + catch, pull, push, and recovery phases (s) were measured. Assessment of arm coordination was made through the calculation of the index of coordination (IdC). The time allotted to propulsion per distance unit was estimated (T prop). For all tested speeds, fatigue development induced a gradual increase of SR with concomitant decrease of SL. The duration of the nonpropulsive phases decreased, whereas the duration of the propulsive phases per stroke remained constant. The IdC increased reflecting a reduction of the lag time between two consecutive propulsive actions. Consequently, T prop increased. Fatigue development induced an increase of the SR to compensate for the reduced capacity to generate a propulsive impulse per stroke. The change in arm coordination allows a better chain of the propulsive actions and leads to a greater time allotted to propulsion per distance unit. Such motor adaptation ensures that the overall propulsive impulse remained constant whereas average propulsive force per arm stroke is reduced.

Mössbauer spectroscopy with high velocity resolution in the study of ferritin and Imferon: preliminary results

An increase of velocity resolution in Mossbauer spectroscopy allows increasing accuracy and decreasing experimental error in determination of hyperfine parameters. Lyophilized samples of human liver ferritin and Imferon (Fisons UK) were measured at room temperature by Mossbauer spectroscopy with high velocity resolution. Spectra were measured in 4,096 channels for further presentation in 256, 512, 1,024, 2,048 and 4,096 channels. The differences of quadrupole splitting and isomer shift revealed for both ferritin and Imferon Mossbauer spectra presented in 512 and 2,048 channels, respectively, were much better distinguished in case of higher velocity resolution. Therefore, Mossbauer spectroscopy with high velocity resolution may be very useful to reveal small differences of hyperfine parameters for biological subjects in biomedical research.

Non-human primates: the appropriate subjects of biomedical research?

Following the publication of the Weatherall report on the use of non-human primates in research, this paper reflects on how to provide appropriate and ethical models for research beneficial to...