75 FR 62738 - Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides...

Science.gov (United States)

2010-10-13

... addressed in EPA science and ethics reviews of proposed and completed human research for pesticides, based... Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides; Notification to... protection of human subjects of research that apply to third parties who conduct or support research for...

The AIR's policy on research involving the irradiation of human subjects

International Nuclear Information System (INIS)

Smith, A.N.

1995-01-01

The policy of the Australian Institute of Radiography with regards to the human subject irradiation is outlined. It is stated that members will not irradiate another individual, nor themselves, solely for the purposes of experimentation or research without gaining the prior approval of an institutional ethics committee. Where possible, researchers should consider the use of patient equivalent or human tissue equivalent phantoms. A short list of references has been compiled to assist members in designing research protocols which comply with the stated policy

The Patient-Worker: A Model for Human Research Subjects and Gestational Surrogates.

Science.gov (United States)

Ryman, Emma; Fulfer, Katy

2017-01-13

We propose the 'patient-worker' as a theoretical construct that responds to moral problems that arise with the globalization of healthcare and medical research. The patient-worker model recognizes that some participants in global medical industries are workers and are owed worker's rights. Further, these participants are patient-like insofar as they are beneficiaries of fiduciary relationships with healthcare professionals. We apply the patient-worker model to human subjects research and commercial gestational surrogacy. In human subjects research, subjects are usually characterized as either patients or as workers. Through questioning this dichotomy, we argue that some subject populations fit into both categories. With respect to commercial surrogacy, we enrich feminist discussions of embodied labor by describing how surrogates are beneficiaries of fiduciary obligations. They are not just workers, but patient-workers. Through these applications, the patient-worker model offers a helpful normative framework for exploring what globalized medical industries owe to the individuals who bear the bodily burdens of medical innovation. © 2017 John Wiley & Sons Ltd.

Where are human subjects in Big Data research? The emerging ethics divide

Directory of Open Access Journals (Sweden)

Jacob Metcalf

2016-06-01

Full Text Available There are growing discontinuities between the research practices of data science and established tools of research ethics regulation. Some of the core commitments of existing research ethics regulations, such as the distinction between research and practice, cannot be cleanly exported from biomedical research to data science research. Such discontinuities have led some data science practitioners and researchers to move toward rejecting ethics regulations outright. These shifts occur at the same time as a proposal for major revisions to the Common Rule—the primary regulation governing human-subjects research in the USA—is under consideration for the first time in decades. We contextualize these revisions in long-running complaints about regulation of social science research and argue data science should be understood as continuous with social sciences in this regard. The proposed regulations are more flexible and scalable to the methods of non-biomedical research, yet problematically largely exclude data science methods from human-subjects regulation, particularly uses of public datasets. The ethical frameworks for Big Data research are highly contested and in flux, and the potential harms of data science research are unpredictable. We examine several contentious cases of research harms in data science, including the 2014 Facebook emotional contagion study and the 2016 use of geographical data techniques to identify the pseudonymous artist Banksy. To address disputes about application of human-subjects research ethics in data science, critical data studies should offer a historically nuanced theory of “data subjectivity” responsive to the epistemic methods, harms and benefits of data science and commerce.

Ethics in action: Approving and improving medical research with human subjects

NARCIS (Netherlands)

de Jong, J.P.

2013-01-01

In this thesis, Jean Philippe de Jong presents a new understanding of ethical oversight on medical research with human subjects and proposes that two philosophies for ethical oversight exist: '(dis)approving' and 'improving'. Systems for ethical oversight on medical research have been in place for

Medical students as human subjects in educational research

Directory of Open Access Journals (Sweden)

Adina L. Kalet

2013-02-01

Full Text Available Introduction: Special concerns often arise when medical students are themselves the subjects of education research. A recently completed large, multi-center randomized controlled trial of computer-assisted learning modules for surgical clerks provided the opportunity to explore the perceived level of risk of studies where medical students serve as human subjects by reporting on: 1 the response of Institutional Review Boards (IRBs at seven institutions to the same study protocol; and 2 the thoughts and feelings of students across study sites about being research subjects. Methods: From July 2009 to August 2010, all third-year medical students at seven collaborating institutions were eligible to participate. Patterns of IRB review of the same protocol were compared. Participation burden was calculated in terms of the time spent interacting with the modules. Focus groups were conducted with medical students at each site. Transcripts were coded by three independent reviewers and analyzed using Atlas.ti. Results: The IRBs at the seven participating institutions granted full (n=1, expedited (n=4, or exempt (n=2 review of the WISE Trial protocol. 995 (73% of those eligible consented to participate, and 207 (20% of these students completed all outcome measures. The average time to complete the computer modules and associated measures was 175 min. Common themes in focus groups with participant students included the desire to contribute to medical education research, the absence of coercion to consent, and the low-risk nature of the research. Discussion: Our findings demonstrate that risk assessment and the extent of review utilized for medical education research vary among IRBs. Despite variability in the perception of risk implied by differing IRB requirements, students themselves felt education research was low risk and did not consider themselves to be vulnerable. The vast majority of eligible medical students were willing to participate as research

Human subjects and experimental irradiation

International Nuclear Information System (INIS)

Rosen, R.

1985-01-01

In recent years the public has expressed concern about the use of human subjects in scientific research. Some professional institutions have adopted codes of practice to guide them in this matter. At the University of New South Wales, where human subjects are used in teaching and research programmes, a committee ensures that high ethical standards are maintained. As the volunteer subjects do not gain any benefit themselves from the procedures, their level of risk is kept low. One type of procedure in which risk is becoming quantifiable, is the irradiation of human subjects. To assist peer review groups, the ICRP, WHO and the National Health and Medical Research Council have enunciated principles which should be followed in the irradiation of human volunteer subjects. In general the role of the Committee is advisory to protect the rights of the investigator, the subject, and the institution. Some of the inherent problems are discussed

How to do human-subjects research if you do not have an institutional review board.

Science.gov (United States)

Rice, Todd W

2008-10-01

Biomedical research with human subjects has expanded outside of traditional medical centers and hospitals into other health care entities, such as rehabilitation facilities, free-standing out-patient treatment centers, and even home-health agencies. Regardless of the location, federal regulations mandate that all human-subjects research must be overseen by an institutional review board (IRB) or ethics committee to ensure the research abide by the Code of Federal Regulations. Consequently, all human-subjects research must be reviewed and approved by an IRB prior to initiation of any research procedures. Unfortunately, many of these nontraditional research facilities do not have easy access to an IRB. This does not render such research exempt from federal oversight. Clinicians at these facilities have viable options for obtaining IRB approval and legally conducting such research. This paper outlines the available options and their pros and cons.

Administration of ionizing radiation to human subjects in medical research

International Nuclear Information System (INIS)

1985-01-01

Any administration of ionizing radiation to human subjects for the purposes of diagnostic or therapeutic research involving either irradiation or the administration of radionuclides, should be undertaken only after approval by an institutional ethics committee. The ethics committee should obtain advice from a person experienced in radiation protection before granting approval. The research proposal must conform to regulatory requirements relating to the use of ionizing radiation

Culturally Relevant Human Subjects Protection Training: A Case Study in Community-Engaged Research in the United States.

Science.gov (United States)

Kue, Jennifer; Szalacha, Laura A; Happ, Mary Beth; Crisp, Abigail L; Menon, Usha

2018-02-01

Non-academic members of research teams, such as community members, can perceive traditional human subjects protection training as lacking in cultural relevance. We present a case exemplar of the development of a human subjects protection training for research staff with limited English proficiency and/or no or limited research experience. Seven modules were adapted for language, cultural examples, etc., from the standard Collaborative Institutional Training Initiative (CITI) human subjects protection training. Non-academic research staff completed a day-long training in human subjects protection (six modules) and our research protocol (one module). We assessed comprehension of content with PowerPoint slides and module quizzes. All participants successfully passed each module quiz with ≥ 80% correct. Questions answered incorrectly were discussed before proceeding to the next module. To meet the increasing demand for collaborative community-engaged research with underserved minority populations, human subjects protection training protocols can be adapted successfully to reflect real-world situations and provide culturally relevant materials to help non-academic research staff better understand the importance and necessity of research ethics.

Bench-to-bedside review: human subjects research--are more standards needed?

Science.gov (United States)

Huang, David T; Hadian, Mehrnaz

2006-01-01

There are many controversial issues surrounding ethics in study design and conduct of human subjects research. In this review we briefly touch on the origin of ethics in clinical research and how the current regulations and standards came into practice. We then discuss current controversies regarding informed consent, conflicts of interest, institutional review boards, and other relevant issues such as innovative procedures and quality improvement projects. The question of whether we need more standards is a very important yet challenging one to which there is no simple answer. We address this question by reviewing and commenting on relevant literature. We conclude that what is needed are not more standards per se, but rather refinement and uniformity of current standards, and their interpretation and application both to protect human subjects and to advance medicine.

The Impact of the Protection of Human Subjects on Research. Working Paper No. 70.

Science.gov (United States)

Halpern, Andrew S.

The author discusses the experimenter's responsibility for the protection of human subjects (such as the handicapped) in research and the impact of this responsibility on methods of doing research. Considered are the types of human rights that are most frequently in need of protection within a research setting (such as the right to privacy); the…

Who is the research subject in cluster randomized trials in health research?

Directory of Open Access Journals (Sweden)

Brehaut Jamie C

2011-07-01

Full Text Available Abstract This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact that in a single study the units of randomization, experimentation, and observation may differ, complicate the identification of human research subjects. But the proper identification of human research subjects is important if they are to be protected from harm and exploitation, and if research ethics committees are to review CRTs efficiently. We examine the research ethics literature and international regulations to identify the core features of human research subjects, and then unify these features under a single, comprehensive definition of human research subject. We define a human research subject as any person whose interests may be compromised as a result of interventions in a research study. Individuals are only human research subjects in CRTs if: (1 they are directly intervened upon by investigators; (2 they interact with investigators; (3 they are deliberately intervened upon via a manipulation of their environment that may compromise their interests; or (4 their identifiable private information is used to generate data. Individuals who are indirectly affected by CRT study interventions, including patients of healthcare providers participating in knowledge translation CRTs, are not human research subjects unless at least one of these conditions is met.

Post-approval monitoring and oversight of U.S.-initiated human subjects research in resource-constrained countries.

Science.gov (United States)

Brown, Brandon; Kinsler, Janni; Folayan, Morenike O; Allen, Karen; Cáceres, Carlos F

2014-06-01

The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study's investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of research regulatory structures, arranging a site visit from a U.S. research ethics committee (REC) becomes difficult, thus creating a potential barrier to regulatory oversight by the parent REC. However, this barrier may be overcome through the use of digital technologies, since much of the world has at least remote access to the Internet. Empirical research is needed to pilot test the use of these technologies for research oversight to ensure the protection of human subjects taking part in research worldwide.

Reporting of ethical protection in recent oral and maxillofacial surgery research involving human subjects.

Science.gov (United States)

Pitak-Arnnop, P; Sader, R; Hervé, C; Dhanuthai, K; Bertrand, J-Ch; Hemprich, A

2009-07-01

This retrospective observational study investigated the frequency of reporting ethical approval and informed consent in recently published oral and maxillofacial surgery (OMS) research involving human subjects. All research involving human subjects published in the International Journal of Oral and Maxillofacial Surgery, Journal of Oral and Maxillofacial Surgery, British Journal of Oral and Maxillofacial Surgery, and Journal of Cranio-Maxillofacial Surgery during January to June 2005-2007 were analysed for disclosure of ethical approval by a local ethical committee and obtaining informed consent from the subjects. 534 articles were identified; ethical approval was documented in 118 (22%) and individual patient consent in 135 (25%). 355 reports (67%) did not include a statement on ethical approval or informed consent and only 74 reports (14%) disclosed statements of both. Ethical documentation in retrospective and observational studies was scant; 12% of randomised controlled trials and 38% of non-random trials did not report both of ethical protections. Most recent OMS publications involving humans failed to mention ethical review or subjects' consent. Authors must adhere to the international research ethics guidelines and journal instructions, while editors should play a gatekeeper role to protect research participants, uphold scientific integrity and maintain public trust in the experimental process and OMS profession.

Designing oversight for nanomedicine research in human subjects: systematic analysis of exceptional oversight for emerging technologies

International Nuclear Information System (INIS)

Wolf, Susan M.; Jones, Cortney M.

2011-01-01

The basic procedures and rules for oversight of U.S. human subjects research have been in place since 1981. Certain types of human subjects research, however, have provoked creation of additional mechanisms and rules beyond the Department of Health and Human Services (DHHS) Common Rule and Food and Drug Administration (FDA) equivalent. Now another emerging domain of human subjects research—nanomedicine—is prompting calls for extra oversight. However, in 30 years of overseeing research on human beings, we have yet to specify what makes a domain of scientific research warrant extra oversight. This failure to systematically evaluate the need for extra measures, the type of extra measures appropriate for different challenges, and the usefulness of those measures hampers efforts to respond appropriately to emerging science such as nanomedicine. This article evaluates the history of extra oversight, extracting lessons for oversight of nanomedicine research in human beings. We argue that a confluence of factors supports the need for extra oversight, including heightened uncertainty regarding risks, fast-evolving science yielding complex and increasingly active materials, likelihood of research on vulnerable participants including cancer patients, and potential risks to others beyond the research participant. We suggest the essential elements of the extra oversight needed.

Designing oversight for nanomedicine research in human subjects: systematic analysis of exceptional oversight for emerging technologies

Science.gov (United States)

Wolf, Susan M.; Jones, Cortney M.

2011-04-01

The basic procedures and rules for oversight of U.S. human subjects research have been in place since 1981. Certain types of human subjects research, however, have provoked creation of additional mechanisms and rules beyond the Department of Health & Human Services (DHHS) Common Rule and Food and Drug Administration (FDA) equivalent. Now another emerging domain of human subjects research—nanomedicine—is prompting calls for extra oversight. However, in 30 years of overseeing research on human beings, we have yet to specify what makes a domain of scientific research warrant extra oversight. This failure to systematically evaluate the need for extra measures, the type of extra measures appropriate for different challenges, and the usefulness of those measures hampers efforts to respond appropriately to emerging science such as nanomedicine. This article evaluates the history of extra oversight, extracting lessons for oversight of nanomedicine research in human beings. We argue that a confluence of factors supports the need for extra oversight, including heightened uncertainty regarding risks, fast-evolving science yielding complex and increasingly active materials, likelihood of research on vulnerable participants including cancer patients, and potential risks to others beyond the research participant. We suggest the essential elements of the extra oversight needed.

Bench-to-bedside review: Human subjects research – are more standards needed?

Science.gov (United States)

Huang, David T; Hadian, Mehrnaz

2006-01-01

There are many controversial issues surrounding ethics in study design and conduct of human subjects research. In this review we briefly touch on the origin of ethics in clinical research and how the current regulations and standards came into practice. We then discuss current controversies regarding informed consent, conflicts of interest, institutional review boards, and other relevant issues such as innovative procedures and quality improvement projects. The question of whether we need more standards is a very important yet challenging one to which there is no simple answer. We address this question by reviewing and commenting on relevant literature. We conclude that what is needed are not more standards per se, but rather refinement and uniformity of current standards, and their interpretation and application both to protect human subjects and to advance medicine. PMID:17184560

76 FR 5735 - Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides

Science.gov (United States)

2011-02-02

... addressed in EPA science and ethics reviews of proposed and completed human research with pesticides, drawn..., which suggest ethical considerations relevant to evaluation of human studies. Third, Petitioners argued... Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides AGENCY...

Ethical review of research on human subjects at Unilever: reflections on governance.

Science.gov (United States)

Sheehan, Mark; Marti, Vernon; Roberts, Tony

2014-07-01

This article considers the process of ethical review of research on human subjects at a very large multinational consumer products company. The commercial context of this research throws up unique challenges and opportunities that make the ethics of the process of oversight distinct from mainstream medical research. Reflection on the justification of governance processes sheds important, contrasting light on the ethics of governance of other forms and context of research. © 2013 John Wiley & Sons Ltd.

Tangible and intangible costs of "protecting human subjects": The impact of the National Research Act of 1974 onuniversity research activities

Directory of Open Access Journals (Sweden)

Frederic Jacobs

2004-11-01

Full Text Available This article (1 examines the overall structure of regulatory research oversight in the United States; (2 details the origins and evolution of federal legislation pertaining to the protection of human subjects in biomedical and behavioral treatment and research; and (3 describes the expansion of oversight regulation from biomedical and behavioral treatment areas to the social sciences. In addition, the paper describes three areas identified by compliance administrators as susceptible to abuse: (1 informed consent, (2 assessment of risks and benefits, and (3 equitable selection of human subjects. There is a discussion of existing tensions in the implementation of oversight policies and procedures. Finally, the paper identifies four issues for future consideration: (1 scope of the mandate regarding protection of human subjects, (2 impact on the nature of research being undertaken, (3 financial burden of compliance and oversight activities, and (4 ethical standards, constraints, and potential.

Canadian governance of health research involving human subjects: is anybody minding the store?

Science.gov (United States)

McDonald, M

2001-01-01

From an ethical perspective, good governance involves the translation of collective moral intentions into effective and accountable institutional actions. With respect to the use of human subjects in Canadian health research, I contend that there have been many good intentions but very little in the way of appropriate governance arrangements. Hence, the question, "who minds the store?" is especially acute with respect to the protection of vulnerable individuals and groups that are typically recruited as subjects for health research in Canada. Beyond diagnosing failures in governance and their causes, I offer suggestions for significant reforms, including evidence-based ethics assessment, independent oversight, and greater participation of research subjects in governance. I will close with some more general reflections on ethics, law, and governance.

Managing incidental findings in human subjects research: analysis and recommendations.

Science.gov (United States)

Wolf, Susan M; Lawrenz, Frances P; Nelson, Charles A; Kahn, Jeffrey P; Cho, Mildred K; Clayton, Ellen Wright; Fletcher, Joel G; Georgieff, Michael K; Hammerschmidt, Dale; Hudson, Kathy; Illes, Judy; Kapur, Vivek; Keane, Moira A; Koenig, Barbara A; Leroy, Bonnie S; McFarland, Elizabeth G; Paradise, Jordan; Parker, Lisa S; Terry, Sharon F; Van Ness, Brian; Wilfond, Benjamin S

2008-01-01

No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.

Report on {open_quotes}inspection of human subject research in intelligence and intelligence-related projects{close_quotes}

Energy Technology Data Exchange (ETDEWEB)

NONE

1996-01-16

Executive Order 12333, {open_quotes}United States Intelligence Activities,{close_quotes} (1) designates the Department`s intelligence element as a member of the Intelligence Community, and (2) states that no agency within the Intelligence community shall sponsor, contract for or conduct research on human subjects except in accordance with guidelines issued by the Department of Health and Human Services. The Federal policy for the Protection of Human Subjects, which was based on Department of Health and Human Services regulations, was promulgated in Title 10 Code of Federal Regulations Part 745 by the Department of Energy. The purpose of this inspection was to review the internal control procedures used by the Office of Nonproliferation and National Security to manage selected intelligence and intelligence-related projects that involve human subject research.

A living wage for research subjects.

Science.gov (United States)

Phillips, Trisha B

2011-01-01

Offering cash payments to research subjects is a common recruiting method, but this practice continues to be controversial because of its potential to compromise the protection of human subjects. Federal regulations and guidelines currently allow researchers to pay subjects for participation, but they say very little about how much researchers can pay their subjects. This paper argues that the federal regulations and guidelines should implement a standard payment formula. It argues for a wage payment model, and critically examines three candidates for a base wage: the nonfarm production wage, the FLSA minimum wage, and a living wage. After showing that the nonfarm production wage is too high to satisfy ethical criteria, and the minimum wage is too low, this paper concludes that the wage payment model with a base wage equivalent to a living wage is the best candidate for a standard payment formula in human subjects research. © 2011 American Society of Law, Medicine & Ethics, Inc.

Do people with intellectual disability require special human subjects research protections? The interplay of history, ethics, and policy.

Science.gov (United States)

Feudtner, Chris; Brosco, Jeffrey P

2011-01-01

People with intellectual disability (ID) have a long history of discrimination and stigmatization, and a more recent history of pride and self-advocacy. The early history suggests that people with ID are a vulnerable population and deserve special research protections as do some other groups; the disability rights movement of the late 20th century aligns people with ID more closely with the principle of autonomy that has guided clinical and research ethics for the last 40 years. In examining the history of people with ID and the prevailing framework of human subjects research protections in the United States, we conclude that people with ID do not require special protection in human subjects research. The protections that have already been put in place for all individuals, if conscientiously and effectively implemented, achieve the right balance between safeguarding the interest of human research subjects and empowering individuals who choose to do so to participate in research. Copyright © 2012 Wiley Periodicals, Inc.

The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research.

Science.gov (United States)

Resnik, David B

2017-01-01

One of the key principles of ethical research involving human subjects is that the risks of research to should be acceptable in relation to expected benefits. Institutional review board (IRB) members often rely on intuition to make risk/benefit decisions concerning proposed human studies. Some have objected to using intuition to make these decisions because intuition is unreliable and biased and lacks transparency. In this article, I examine the role of intuition in IRB risk/benefit decision-making and argue that there are practical and philosophical limits to our ability to reduce our reliance on intuition in this process. The fact that IRB risk/benefit decision-making involves intuition need not imply that it is hopelessly subjective or biased, however, since there are strategies that IRBs can employ to improve their decisions, such as using empirical data to estimate the probability of potential harms and benefits, developing classification systems to guide the evaluation of harms and benefits, and engaging in moral reasoning concerning the acceptability of risks.

Goodbye to all that. The end of moderate protectionism in human subjects research.

Science.gov (United States)

Moreno, J D

2001-01-01

Federal policies on human subjects research have undergone a progressive transformation. In the early decades of the twentieth century, federal policies largely relied on the discretion of investigators to decide when and how to conduct research. This approach gradually gave way to policies that augmented investigator discretion with externally imposed protections. We may now be entering an era of even more stringent external protections. Whether the new policies effectively absolve investigators of personal responsibility for conducting ethical research, and whether it is wise to do so, remains to be seen.

From the ideal market to the ideal clinic: constructing a normative standard of fairness for human subjects research.

Science.gov (United States)

Phillips, Trisha

2011-02-01

Preventing exploitation in human subjects research requires a benchmark of fairness against which to judge the distribution of the benefits and burdens of a trial. This paper proposes the ideal market and its fair market price as a criterion of fairness. The ideal market approach is not new to discussions about exploitation, so this paper reviews Wertheimer's inchoate presentation of the ideal market as a principle of fairness, attempt of Emanuel and colleagues to apply the ideal market to human subjects research, and Ballantyne's criticisms of both the ideal market and the resulting benchmark of fairness. It argues that the criticism of this particular benchmark is on point, but the rejection of the ideal market is mistaken. After presenting a complete account of the ideal market, this paper proposes a new method for applying the ideal market to human subjects research and illustrates the proposal by considering a sample case.

True or False, Process or Procedure: Parrhesia and a Consideration of Humanism, Subjectivity, and Ethics within Educational Research

Science.gov (United States)

Roof, David; Polush, Elena

2016-01-01

This paper seeks to examine ethics, humanism, and the concept of "parrhesia" ("pa???s?a") in the context of educational research. More specifically, it surveys Foucault's lectures on ethics to explore a framework for educational research that disrupts subjectivity and traditional forms of humanism while retaining a relational…

Ethical issues in Alzheimer's disease research involving human subjects.

Science.gov (United States)

Davis, Dena S

2017-12-01

As we aggressively pursue research to cure and prevent Alzheimer's disease, we encounter important ethical challenges. None of these challenges, if handled thoughtfully, would pose insurmountable barriers to research. But if they are ignored, they could slow the research process, alienate potential study subjects and do damage to research recruits and others. These challenges are (1) the necessity of very large cohorts of research subjects, recruited for lengthy studies, probably ending only in the subjects' death; (2) the creation of cohorts of 'study ready' volunteers, many of whom will be competent to consent at the beginning of the process, but move into cognitive impairment later; (3) reliance on adaptive trial design, creating challenges for informed consent, equipoise and justice; (4) the use of biomarkers and predictive tests that describe risk rather than certainty, and that can threaten participants' welfare if the information is obtained by insurance companies or long-term care providers; (5) the use of study partners that creates unique risks of harm to the relationship of subject and study partner. We need greater attention, at all levels, to these complex ethical issues. Work on these issues should be included in research plans, from the federal to the local, and should be supported through NIH in the same way that it supported work on the ethical, legal and social implications of genetic research. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Building research capacity with members of underserved American Indian/Alaskan Native communities: training in research ethics and the protection of human subjects.

Science.gov (United States)

Jetter, Karen M; Yarborough, Mark; Cassady, Diana L; Styne, Dennis M

2015-05-01

To develop a research ethics training course for American Indian/Alaskan Native health clinic staff and community researchers who would be conducting human subjects research. Community-based participatory research methods were used in facilitated discussions of research ethics centered around topics included in the Collaborative Institutional Training Initiative research ethics course. The community-based participatory research approach allowed all partners to jointly develop a research ethics training program that was relevant for American Indian/Alaskan Native communities. All community and clinic partners were able to pass the Collaborative Institutional Training Initiative course they were required to pass so that they could be certified to conduct research with human subjects on federally funded projects. In addition, the training sessions provided a foundation for increased community oversight of research. By using a collaborative process to engage community partners in research ethics discussions, rather than either an asynchronous online or a lecture/presentation format, resulted in significant mutual learning about research ethics and community concerns about research. This approach requires university researchers to invest time in learning about the communities in which they will be working prior to the training. © 2014 Society for Public Health Education.

Formation of Human Subjectivity in Psychological Interactions with Nature

Directory of Open Access Journals (Sweden)

S A Mudrak

2014-12-01

Full Text Available The article outlines the current trends in the environmental psychological research of the peculiarities of developing the subject-subjective human relationship with nature: considering human habitat environment as a set of natural objects; studying certain natural sites as psychologically attributive elements of the environment; determining the psychological meaning of the «Human Habitat Environment»; giving the analysis of the problem of the subjectivity development in human interaction with the natural objects.

Differential Scavenging Among Pig, Rabbit, and Human Subjects.

Science.gov (United States)

Steadman, Dawnie Wolfe; Dautartas, Angela; Kenyhercz, Michael W; Jantz, Lee M; Mundorff, Amy; Vidoli, Giovanna M

2018-04-12

Different animal species have been used as proxies for human remains in decomposition studies for decades, although few studies have sought to validate their use in research aimed at estimating the postmortem interval. This study examines 45 pig, rabbit, and human subjects placed in three seasonal trials at the Anthropology Research Facility. In an earlier paper, we found that overall decomposition trends did vary between species that could be due to differential insect and scavenger behavior. This study specifically examines if scavenger behavior differs by carrion species. Daily photographs, game camera photographs, written observations, and Total Body Score (TBS) documented scavenging and decomposition changes. Results show that raccoons were the most commonly observed vertebrate scavenger, that scavenging was most extensive in winter, and that certain human subjects were preferred over other humans and all non-human subjects. Finally, scavenging activity greatly reduces the accuracy of postmortem interval estimates based on TBS. © 2018 American Academy of Forensic Sciences.

The Public Health Service guidelines. Governing research involving human subjects: An analysis of the policy-making process

Science.gov (United States)

Frankel, M. S.

1972-01-01

The policy making process which led to development of the Public Health Service Guidelines governing research involving human subjects is outlined. Part 1 examines the evolution of PHS Guidelines, tracing (1) evolution of thought and legal interpretation regarding research using human subjects; (2) initial involvement of the Federal government; (3) development of the government's research program; (4) the social-political environment in which formal government policy was developed; and (5) various policy statements issued by the government. Part 2 analyzes the process by which PHS Guidelines were developed and examines the values and other underlying factors which contributed to their development. It was concluded that the evolution of the Guidelines is best understood within the context of a mixed-scanning strategy. In such a strategy, policy makers make fundamental decisions regarding the basic direction of policy and subsequent decisions are made incrementally and within the contexts set by the original fundamental decisions.

40 CFR 26.1703 - Prohibition of reliance on research involving intentional exposure of human subjects who are...

Science.gov (United States)

2010-07-01

...), nursing women, or children. 26.1703 Section 26.1703 Protection of Environment ENVIRONMENTAL PROTECTION... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Prohibition of reliance on research... intentional exposure of human subjects who are pregnant women (and therefore their fetuses), nursing women, or...

Can Human Subject Pool Participation Benefit Sociology Students?

Science.gov (United States)

Chin, Lynn Gencianeo; Gibbs Stayte, Patricia

2015-01-01

Instructors at non-research institutions are less able to expose their students to research firsthand. Utilizing human subject pools (HSPs) in class may be a solution. Given that HSPs tend to be used in introduction to psychology classes at research institutions, we examine a community college HSP to answer three questions: (1) Do community…

Genomic research with human samples. Points of view from scientists and research subjects about disclosure of results and risks of genomic research. Ethical and empirical approach.

Science.gov (United States)

Valle Mansilla, José Ignacio

2011-01-01

Biomedical researchers often now ask subjects to donate samples to be deposited in biobanks. This is not only of interest to researchers, patients and society as a whole can benefit from the improvements in diagnosis, treatment, and prevention that the advent of genomic medicine portends. However, there is a growing debate regarding the social and ethical implications of creating biobanks and using stored human tissue samples for genomic research. Our aim was to identify factors related to both scientists and patients' preferences regarding the sort of information to convey to subjects about the results of the study and the risks related to genomic research. The method used was a survey addressed to 204 scientists and 279 donors from the U.S. and Spain. In this sample, researchers had already published genomic epidemiology studies; and research subjects had actually volunteered to donate a human sample for genomic research. Concerning the results, patients supported more frequently than scientists their right to know individual results from future genomic research. These differences were statistically significant after adjusting by the opportunity to receive genetic research results from the research they had previously participated and their perception of risks regarding genetic information compared to other clinical data. A slight majority of researchers supported informing participants about individual genomic results only if the reliability and clinical validity of the information had been established. Men were more likely than women to believe that patients should be informed of research results even if these conditions were not met. Also among patients, almost half of them would always prefer to be informed about individual results from future genomic research. The three main factors associated to a higher support of a non-limited access to individual results were: being from the US, having previously been offered individual information and considering

40 CFR 26.1203 - Prohibition of research involving intentional exposure of any human subject who is a pregnant...

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Prohibition of research involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child. 26.1203 Section 26.1203 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL...

Undergraduate research involving human subjects should not be granted ethical approval unless it is likely to be of publishable quality.

Science.gov (United States)

Gallagher, Cathal T; McDonald, Lisa J; McCormack, Niamh P

2014-06-01

Small-scale research projects involving human subjects have been identified as being effective in developing critical appraisal skills in undergraduate students. In deciding whether to grant ethical approval to such projects, university research ethics committees must weigh the benefits of the research against the risk of harm or discomfort to the participants. As the learning objectives associated with student research can be met without the need for human subjects, the benefit associated with training new healthcare professionals cannot, in itself, justify such risks. The outputs of research must be shared with the wider scientific community if it is to influence future practice. Our survey of 19 UK universities indicates that undergraduate dissertations associated with the disciplines of medicine, dentistry and pharmacy are not routinely retained in their library catalogues, thus closing a major avenue to the dissemination of their findings. If such research is unlikely to be published in a peer-reviewed journal, presented at a conference, or otherwise made available to other researchers, then the risks of harm, discomfort or inconvenience to participants are unlikely to be offset by societal benefits. Ethics committees should be satisfied that undergraduate research will be funnelled into further research that is likely to inform clinical practice before granting ethical approval.

Status of human factors research program in Central Research Institute of Electric Power Industry

International Nuclear Information System (INIS)

Kabetani, Tetsuji

1989-01-01

The Human Factors Research Center was established within CRIEPI on July 1, 1987 as its research efforts to reduce human error during operation and maintenance at Japanese nuclear power plants. The Research Program has seven subjects, composed of the original subjects that include the human behavior monitoring method, and the subjects requested by the Federation of Electric Power Companies that include the establishment of techniques of analysing and evaluating information on human error. Some results of the activity are applied in nuclear power plants. We plan to obtain good results to apply to plants, and to improve the results already obtained. (author)

Geospatial cryptography: enabling researchers to access private, spatially referenced, human subjects data for cancer control and prevention.

Science.gov (United States)

Jacquez, Geoffrey M; Essex, Aleksander; Curtis, Andrew; Kohler, Betsy; Sherman, Recinda; Emam, Khaled El; Shi, Chen; Kaufmann, Andy; Beale, Linda; Cusick, Thomas; Goldberg, Daniel; Goovaerts, Pierre

2017-07-01

As the volume, accuracy and precision of digital geographic information have increased, concerns regarding individual privacy and confidentiality have come to the forefront. Not only do these challenge a basic tenet underlying the advancement of science by posing substantial obstacles to the sharing of data to validate research results, but they are obstacles to conducting certain research projects in the first place. Geospatial cryptography involves the specification, design, implementation and application of cryptographic techniques to address privacy, confidentiality and security concerns for geographically referenced data. This article defines geospatial cryptography and demonstrates its application in cancer control and surveillance. Four use cases are considered: (1) national-level de-duplication among state or province-based cancer registries; (2) sharing of confidential data across cancer registries to support case aggregation across administrative geographies; (3) secure data linkage; and (4) cancer cluster investigation and surveillance. A secure multi-party system for geospatial cryptography is developed. Solutions under geospatial cryptography are presented and computation time is calculated. As services provided by cancer registries to the research community, de-duplication, case aggregation across administrative geographies and secure data linkage are often time-consuming and in some instances precluded by confidentiality and security concerns. Geospatial cryptography provides secure solutions that hold significant promise for addressing these concerns and for accelerating the pace of research with human subjects data residing in our nation's cancer registries. Pursuit of the research directions posed herein conceivably would lead to a geospatially encrypted geographic information system (GEGIS) designed specifically to promote the sharing and spatial analysis of confidential data. Geospatial cryptography holds substantial promise for accelerating the

ETHICS IN HEALTH CARE: INDUCEMENT AND HUMAN SUBJECTS

Directory of Open Access Journals (Sweden)

MUNIR HOSSAIN TALUKDER

2011-05-01

Full Text Available Currently, most health researchers or donor organizations considerinducement as a vital part in promoting research. They propose benefits, such as post research free medical treatment, food, insurance facilities, or even cash, in order to meet sufficient number of subjects. So, inducement may influence one to participate in a research. Is it ethical to offer inducement to human subjects? What are the risks in such practice? What will happen if the donor agencies use subjects by hiding possible risks from them? When an inducement can satisfy ethical criteria? The CIOMS, FDA, and other ethical guidelines hold that inducement is unethical because it involves enough risk for voluntary informed consent. Supporting this position, a group of ethicists has argued that inducement undermines voluntariness especially when subjects are poor and vulnerable, and thus, unethical. In contrast to them, others argue that inducement contributes to discover new knowledge which can improve miserable condition of the poor. In their view, an inducement maintains all ethical criteria including subject’s autonomy, and therefore, morally permissible. The paper focuses this debate and analyzes both types ofargument. It examines whether inducement invalidate informed consent.Even if inducement may not violate the basic components of informedconsent, the paper concludes, subjects may claim a prima facie right to enjoy research outcomes.

34 CFR 97.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Science.gov (United States)

2010-07-01

... Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.118 Applications and proposals lacking definite plans..., or contracts are submitted to departments or agencies with the knowledge that subjects may be...

Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field

Science.gov (United States)

Fatehi, Leili; Wolf, Susan M.; McCullough, Jeffrey; Hall, Ralph; Lawrenz, Frances; Kahn, Jeffrey P.; Jones, Cortney; Campbell, Stephen A.; Dresser, Rebecca S.; Erdman, Arthur G.; Haynes, Christy L.; Hoerr, Robert A.; Hogle, Linda F.; Keane, Moira A.; Khushf, George; King, Nancy M.P.; Kokkoli, Efrosini; Marchant, Gary; Maynard, Andrew D.; Philbert, Martin; Ramachandran, Gurumurthy; Siegel, Ronald A.; Wickline, Samuel

2015-01-01

The nanomedicine field is fast evolving toward complex, “active,” and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR provides an occasion to think systematically about appropriate oversight, especially early in the evolution of a technology, when hazard and risk information may remain incomplete. This paper presents the consensus recommendations of a multidisciplinary, NIH-funded project group, to ensure a science-based and ethically informed approach to HSR issues in nanomedicine, and integrate HSR analysis with analysis of occupational, bystander, and environmental concerns. We recommend creating two bodies, an interagency Human Subjects Research in Nanomedicine (HSR/N) Working Group and a Secretary’s Advisory Committee on Nanomedicine (SAC/N). HSR/N and SAC/N should perform 3 primary functions: (1) analysis of the attributes and subsets of nanomedicine interventions that raise HSR challenges and current gaps in oversight; (2) providing advice to relevant agencies and institutional bodies on the HSR issues, as well as federal and federal-institutional coordination; and (3) gathering and analyzing information on HSR issues as they emerge in nanomedicine. HSR/N and SAC/N will create a home for HSR analysis and coordination in DHHS (the key agency for relevant HSR oversight), optimize federal and institutional approaches, and allow HSR review to evolve with greater knowledge about nanomedicine interventions and greater clarity about attributes of concern. PMID:23289677

When does quality improvement count as research? Human subject protection and theories of knowledge.

Science.gov (United States)

Lynn, J

2004-02-01

The publication of insights from a quality improvement project recently precipitated a ruling by the lead federal regulatory agency that regulations providing protection for human subjects of research should apply. The required research review process did not match the rapid changes, small samples, limited documentation, clinician management, and type of information commonly used in quality improvement. Yet quality improvement can risk harm to patients, so some review might be in order. The boundaries and processes are not clear. Efforts have been made to determine what constitutes "research", but this has proved difficult and often yields irrational guidance with regard to protection of patients. Society needs a workable way to separate activities that will improve care, on the one hand, and those that constitute research, on the other. Practitioners who lead both quality improvement and research projects claim that those which rapidly give feedback to the care system that generated the data, aiming to change practices within that system, are "quality improvement" no matter whether the findings are published, whether the project is grant funded, and whether contemporaneous controls do not have the intervention. This criterion has not previously been proposed as a possible demarcation. The quandaries of which projects to put through research review and how to ensure ethical implementation of quality improvement need to be resolved.

Engaging Institutional Review Boards in Developing a Brief, Community-Responsive Human Subjects Training for Community Partners.

Science.gov (United States)

Calzo, Jerel P; Bogart, Laura M; Francis, Evelyn; Kornetsky, Susan Z; Winkler, Sabune J; Kaberry, Julie

2016-01-01

Engaging community partners as co-investigators in community-based participatory research (CBPR) requires certification in the rules, ethics, and principles governing research. Despite developments in making human research protection trainings more convenient and standardized (eg, self-paced Internet modules), time constraints and the structure of the content (which may favor academic audiences) may hinder the training of community partners. This paper is motivated by a case example in which academic and community partners, and stakeholders of a community-based organization actively engaged the leadership of a pediatric hospital-based institutional review board (IRB) in implementing a brief, community-responsive human subjects training session. A 2-hour, discussion-based human subjects training was developed via collaborations between the IRB and the community and academic partners. Interviews with trainees and facilitators after the training were used to evaluate its acceptability and possible future applications. Local IRBs have the potential to assist community partners in building sufficient knowledge of human subjects research protections to engage in specific projects, thereby expediting the progress of vital research to address community needs. We propose the need for developing truncated human subjects education materials to train and certify community partners, and creating formally organized entities within academic and medical institutions that specialize in community-based research to guide the development and implementation of alternative human subjects training certification opportunities for community partners.

Human Subjects Protection: A Source for Ethical Service-Learning Practice

Science.gov (United States)

Wendler, Rachael

2012-01-01

Human subjects research ethics were developed to ensure responsible conduct when university researchers learn by interacting with community members. As service-learning students also learn by interacting with community members, a similar set of principles may strengthen the ethical practice of service-learning. This article identifies ethical…

A 15-Year Review of Trends in Representation of Female Subjects in Islamic Bioethics Research.

Science.gov (United States)

Hussain, Zeenat; Kuzian, Edyta; Hussain, Naveed

2017-02-01

Gender representation in Islamic bioethics research in the twenty-first century has not been studied. To study temporal trends in representation of female subjects in Islamic bioethics research, PubMed-listed publications on Islamic bioethics from years 2000 to 2014 were reviewed for gender participation in human subjects' research. There were temporal trends of increasing publications of Islamic bioethics-related human subjects' research (64 papers over 15 years; R 2  = 0.72; p < 0.0004). Female subjects were well represented with a trend toward increasing participation. This was true for women from Muslim-majority countries even in non-gender-focused studies over the past 15 years.

Reflexivity and the "Acting Subject": Conceptualizing the Unit of Analysis in Qualitative Health Research.

Science.gov (United States)

Shaw, James A

2016-07-06

The ways in which social scientists conceptualize the "reflexive" human subject have important consequences for how we go about our research. Whether and how we understand human subjects to be the authors of our own actions helps to structure what we say about health, health care, and the many other topics addressed in qualitative health research. In this article, I critically discuss assumptions of human reflexivity that are built into qualitative social science of health and medicine. I describe three alternative ways of understanding reflexive thought and human action derived from the theoretical works of Pierre Bourdieu, Bruno Latour, and George Lakoff and Mark Johnson, respectively. I then apply these three different ways of thinking about reflexivity and the acting subject to the analysis of an excerpt of participant observation data from a health services research study of transitions from hospital to home, illuminating the different kinds of analyses that arise from each perspective. I conclude with a call for social scientists to commit to the search for better ways of understanding the human subject, resisting the temptation to "settle" on theoretical statements that close down the path to more sophisticated conceptualizations of human thought and action. © The Author(s) 2016.

Engaging Institutional Review Boards in Developing a Brief, Community-Responsive Human Subjects Training for Community Partners

Science.gov (United States)

Calzo, Jerel P.; Bogart, Laura M.; Francis, Evelyn; Kornetsky, Susan Z.; Winkler, Sabune J.; Kaberry, Julie M.

2017-01-01

BACKGROUND Engaging community partners as co-investigators in community-based participatory research (CBPR) requires certification in the rules, ethics, and principles governing research. Despite developments in making human research protection trainings more convenient and standardized (e.g., self-paced Internet modules), time constraints and the structure of the content (which may favor academic audiences) may hinder the training of community partners. OBJECTIVES This paper is motivated by a case example in which academic and community partners, and stakeholders of a community-based organization actively engaged the leadership of a pediatric hospital-based Institutional Review Board (IRB) in implementing a brief, community-responsive human subjects training session. METHODS A two hour, discussion-based human subjects training was developed via collaborations between the IRB and the community and academic partners. Interviews with trainees and facilitators after the training were used to evaluate its acceptability and possible future applications. CONCLUSIONS Local Institutional Review Boards have the potential to assist community partners in building sufficient knowledge of human subjects research protections to engage in specific projects, thereby expediting the progress of vital research to address community needs. We propose the need for developing truncated human subjects education materials to train and certify community partners, and creating formally organized entities within academic and medical institutions that specialize in community-based research to guide the development and implementation of alternative human subjects training certification opportunities for community partners. PMID:28230554

Protection of human subjects of biomedical research in the United States. A contrast with recent experience in the United Kingdom.

Science.gov (United States)

Levine, R J

1988-01-01

In the U.S., the development of extensive regulations for the protection of human subjects of research began in the 1960s and continued through the 1970s. The substance of these regulations reflects the American social and political climate of the time. There is a focus on rights--e.g., to be left alone, to be self-determining--reflected in elaborate requirements to assure the validity and documentation of informed consent. There is also a focus on systems of disinterested review and monitoring procedures to assure uniform adherence to the requirements of the regulations. To the extent that the U.S. has developed extensive regulations in this field, it may be viewed as more advanced than the U.K. And yet, it is apparent that there remain on both sides of the Atlantic very difficult and similar problems regarding the definition of responsible research. Such problems are illustrated by consideration of current controversies about the ethical justification of RCTs. There are some features of the U.S. regulatory system that I can commend to the attention of other nations as they develop policies for the protection of human research subjects. For example, a uniform requirement for informed consent and committee review appears to be responsive to some problems currently encountered in the conduct of RCTs in the U.K. A note of caution is in order, however. Some features of our regulatory policy and practices are excessively inflexible, wasteful of human resources, and occasionally counterproductive.

Human Subjects Protection and Technology in Prevention Science: Selected Opportunities and Challenges

OpenAIRE

Pisani, Anthony R.; Wyman, Peter A.; Mohr, David C.; Perrino, Tatiana; Gallo, Carlos; Villamar, Juan; Kendziora, Kimberly; Howe, George W.; Sloboda, Zili; Brown, C. Hendricks

2016-01-01

Internet-connected devices are changing the way people live, work, and relate to one another. For prevention scientists, technological advances create opportunities to promote the welfare of human subjects and society. The challenge is to obtain the benefits while minimizing risks. In this article, we use the guiding principles for ethical human subjects research and proposed changes to the Common Rule regulations, as a basis for discussing selected opportunities and challenges that new techn...

Compliance with National Ethics Requirements for Human-Subject Research in Non-biomedical Sciences in Brazil: A Changing Culture?

Science.gov (United States)

de Albuquerque Rocha, Karina; Vasconcelos, Sonia M R

2018-02-06

Ethics regulation for human-subject research (HSR) has been established for about 20 years in Brazil. However, compliance with this regulation is controversial for non-biomedical sciences, particularly for human and social sciences (HSS), the source of a recent debate at the National Commission for Research Ethics. We hypothesized that for these fields, formal requirements for compliance with HSR regulation in graduate programs, responsible for the greatest share of Brazilian science, would be small in number. We analyzed institutional documents (collected from June 2014 to May 2015) from 171 graduate programs at six prestigious Brazilian universities in São Paulo and Rio de Janeiro, the states that fund most of the science conducted in Brazil. Among these programs, 149 were in HSS. The results suggest that non-compliance with standard regulation seems to be the rule in most of these programs. The data may reflect not only a resistance from scientists in these fields to comply with standard regulations for ethics in HSR but also a disciplinary tradition that seems prevalent when it comes to research ethics in HSR. However, recent encounters between Brazilian biomedical and non-biomedical scientists for debates over ethics in HSR point to a changing culture in the approach to research ethics in the country.

subjective approach to subjective approach to human physiological

African Journals Online (AJOL)

eobe

the only physiological variables that influence the heat balance [4]. Yao et al [2] .... between the human responses and outdoor climate. 4.1 Subjective Response ... months seem to be influenced by cloud cover rather than the altitude.

Human subjects protection training for community workers: an example from "Faith Moves Mountains".

Science.gov (United States)

Hatcher, Jennifer; Schoenberg, Nancy E

2007-01-01

Despite widespread agreement on the necessity of protecting human subjects, questions regarding ethical treatment and protection of human subjects remain and are particularly vexing for community-based participatory research (CBPR). There has been a notable lack of attention paid to what type of training should be provided and how to balance "real-life" concerns with official requirements. The purpose of this article is to demonstrate how, in consultation with the Office of Research Integrity (ORI) at our institution and our community partners, we developed training that overcame concerns related to instruction of community workers on protection of human subjects. We developed a training module written in lay terms and containing only information pertinent to non-key personnel and their role in the CBPR project. We designed and piloted this material in collaboration with our community partners who work with us to recruit and train lay health advisors (LHAs) and oversee the day-to-day operations of the CBPR project. The educational module was presented to the community workers as a part of a day-long training session. The written materials were a part of a notebook of information accompanied by an oral Power Point presentation. Each of the workers was given a written test to evaluate knowledge of the content presented. The test was administered by the project director, a community member herself, and then sent to our institution for grading by personnel not involved in this project. To date, all community workers have passed the written test. The community members, research partners, and the ORI are satisfied with the scope and simplicity of the training program developed. Our team's collaborative approach to community-based human subjects training contributes to advancing a grounded, feasible, and rigorous process of protecting human subjects while implementing CBPR ideals.

Resident Research Fundamentals Course Human Research Curves in the Road

Science.gov (United States)

2017-09-27

MDW/SGVU SUBJECT: Professional Presentation Approval 27 JULY 2017 Your paper, entitled Resident Research Fundamentals Course - "Human Research ...Curves in the Road" (27 Sep 2017) presented at/published to Resident Research Fundamentals Course - JBSA Lackland, San Antonio, TX - 27 Sep 2017 in...are a Graduate Health Sciences Education student and your department has told you they cannot fund your publication, the 59th Clinical Research

Still Human: A Call for Increased Focus on Ethical Standards in Cadaver Research.

Science.gov (United States)

Bach, Michelle C

2016-12-01

Research on human cadavers is an important mechanism of scientific progress and comprises a large industry in the United States. However, despite its importance and influence, there is little ethical or regulatory oversight of cadaver-based research. This lack of transparency raises important ethical questions. Thus, this paper serves as a call for ethicists and regulators to pay increased attention to cadaver research. I argue that cadaver research ought to be considered a subset of human subjects research and held accountable to higher ethical standards. After describing current practices, I argue that oversight of cadaver research as a form of human subjects research is appropriate because cadaver research is similar to other types of human research, participants in cadaver research incur risks of harm, and a current lack of oversight has allowed the cadaver industry to entice research participation through ethically questionable practices. This paper urges greater dialogue among human subjects research ethicists and regulators about what constitutes appropriate protections for participants in cadaver research.

The Fiction of Respect Individual Autonomy as a Kind Of Clínical Research Human Subject Explotation

Directory of Open Access Journals (Sweden)

Natalia Petersen Nascimento Santos

2015-12-01

Full Text Available This article promotes a discussion of western legal concept which sees individuals as subjects of rights, discussing the advisability of such a formulation in the context of clinical trials in humans, since the commonly borderline situation of vulnerability in which they are volunteers who submit to such procedures. For this purpose, it was used as a theoretical framework to work "Critical Introduction to Law" Michel Mialle, in which the author states in a forceful way that the construction of the legal institute of the "subject of law" and the imposition of unrestricted recognition of individual autonomy constitute a construction of the bourgeois state to facilitate the domination of vulnerable, so that this, although not legally obliged to practice certain behaviors, see forced by circumstances to act in line with the interests of that institution. It is argued, therefore, that autonomy to consent to participation in scientific trials must be assessed in each case, with special attention to circumstances which might vulnerabilizar voluntary research and mitigate their individual autonomy in the face of the experiments, under penalty to be subjecting the individual to harmful procedures to their lives and health for the benefit of capital society's interests.

Single Subject Research: Applications to Special Education

Science.gov (United States)

Cakiroglu, Orhan

2012-01-01

Single subject research is a scientific research methodology that is increasingly used in the field of special education. Therefore, understanding the unique characteristics of single subject research methodology is critical both for educators and practitioners. Certain characteristics make single subject research one of the most preferred…

Human Participants in Engineering Research: Notes from a Fledgling Ethics Committee.

Science.gov (United States)

Koepsell, David; Brinkman, Willem-Paul; Pont, Sylvia

2015-08-01

For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social-psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices (Martensen in J Hist Med Allied Sci 56(2):168-175, 2001). Institutions such as Institutional Review Boards (in the U.S.) and Ethics Committees (in Europe and elsewhere) oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki (World Medical Association 2008). Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, the U.K. and Australia to oversee all governmental-funded research, and in other jurisdictions, the range of research covered by such committees is expanding. Social science, anthropology, and other fields are falling under more clear directives to conduct a formal ethical review for basic research involving human participants (Federman et al. in Responsible research: a systems approach to protecting research participants. National Academies Press, Washington, 2003, p. 36). The legal and institutional response for protecting human subjects in the course of developing non-medical technologies, engineering, and design is currently vague, but some universities are establishing ethics committees to oversee their human subjects research even where the experiments involved are non-medical and not technically covered by the Declaration of Helsinki. In The Netherlands, as in most of Europe, Asia, Latin America, or Africa, no laws mandate an ethical review of non-medical research. Yet, nearly 2

Wheat bran cereal, human gut bacteria and subjective wellbeing

OpenAIRE

Smith, Andrew; Deaville, Eddie; Gibson, Glenn

2018-01-01

Research has shown that consumption of high fiber breakfast cereal is associated with improved subjective well-being, especially increased energy. One possible explanation of these results is through metabolism by gut bacteria and concomitant production of metabolites that influence psychological and gastrointestinal (GI) welfare. This was examined in the present study to determine whether consumption of wheat bran could modulate the composition of the GI microbiota. This human volunteer stud...

Research report on human media; Human media no chosa kenkyu hokokusho

Energy Technology Data Exchange (ETDEWEB)

NONE

1996-03-01

The human multimedia technology corresponding to users` subjective characteristics was researched to realize information environment producing a sense of unity with human. The human media technology realizes a human sensitive information processing model and a common database easily acceptable sensitively by various users. This technology also should be able to fairly accept and transmit individual`s information and knowledge as multimedia information, and in addition it is required to supply a virtual space with presence. In fiscal 1995, the research committee studied the concrete developmental issue for integrating these advanced fundamental technologies, and as practical images planned the prototype systems such as human media interactive plant operation, supply of environment supporting personal intelligent activities, and virtual medical center. The research committee also discussed development of space mobile media to secure energy-saving and safety of automobiles, and an environment simulation system with participation of many people. 34 figs., 2 tabs.

The influence of race and ethnicity on becoming a human subject: Factors associated with participation in research

Directory of Open Access Journals (Sweden)

Mary A. Garza, PhD

2017-09-01

Full Text Available Inroduction: The purpose of this study was to explore factors associated with willingness of African Americans and Latinos to participate in biomedical and public health research and to delineate factors that influence the decision to become a human subject. Methods: We present results from a 2010 random digit-dial telephone survey of 2,455 African American (N = 1191 and Latino (N = 1264 adults. We used standard measures to assess knowledge of research, terminology, informed consent procedures, previous participation in research, health care experiences, social support, risk perception, religiousness, and trust. Results: Over 60% of both African Americans and Latinos reported they believed people in medical research are pressured into participating. Over 50% said that it was not at all important to have someone of the same race/ethnicity ask them to participate. In a sub-sample of 322 African Americans and 190 Latinos who had previously been asked to participate in a research study, 63% of African Americans and 65% of Latinos consented to participate in a study. Finally, both African Americans (57% and Latinos (68% reported willingness to participate in future research. Overall, the multivariate analysis explained 29% of the variability in willingness to participate in future research. Conclusions: Results suggest that African Americans and Latinos have no automatic predisposition to decline participation in research studies. These results can inform culturally tailored interventions for ethical recruitment of minorities into research and clinical trials.

Who is the Subject in Educational Research?

Directory of Open Access Journals (Sweden)

Alicia Gurdián-Fernández

2011-11-01

Full Text Available In this paper I argue, first, that the identity of the researcher has an impact not only in the way she/he invThis article explains, in the first place, that the identity of the researcher not only influences his way to do research, but also the teaching processes and, therefore, training of future researchers. Secondly, it states that schools and teachers play a central role in the construction of identities. Third, this paper emphasizes that those engaged in educational research are not released from this responsibility, so this is an invitation to reflect on the following: What are our responsibilities in the process of identity construction? Who is the subject of education? Who is the subject of educational research? How inclusive is our notion of both the educational and the empirical subjects? Through the analysis of questions on topics such us: the subject-object relationship; the subject in educational research; the contribution of subjectivity; the contribution of phenomenology; among others, this paper explains that: a the intellectual autobiography is a great potential instrument to understand the direction of a research process and b focusing on people, their history, social relationships and environment, as subjects and not just as objects of study, is an epistemological, political and ethical movement, which recognizes the subject’s action in and on the world. Finally, this paper states that qualitative researchers should not only understand who they are, they are ethically obliged to make it explicitly.

Basic Science Research and the Protection of Human Research Participants

Science.gov (United States)

Eiseman, Elisa

2001-03-01

Technological advances in basic biological research have been instrumental in recent biomedical discoveries, such as in the understanding and treatment of cancer, HIV/AIDS, and heart disease. However, many of these advances also raise several new ethical challenges. For example, genetic research may pose no physical risk beyond that of obtaining the initial blood sample, yet it can pose significant psychological and economic risks to research participants, such as stigmatization, discrimination in insurance and employment, invasion of privacy, or breach of confidentiality. These harms may occur even when investigators do not directly interact with the person whose DNA they are studying. Moreover, this type of basic research also raises broader questions, such as what is the definition of a human subject, and what kinds of expertise do Institutional Review Boards (IRBs) need to review the increasingly diverse types of research made possible by these advances in technology. The National Bioethics Advisory Commission (NBAC), a presidentially appointed federal advisory committee, has addressed these and other ethical, scientific and policy issues that arise in basic science research involving human participants. Two of its six reports, in particular, have proposed recommendations in this regard. "Research Involving Human Biological Materials: Ethical and Policy Guidance" addresses the basic research use of human tissues, cells and DNA and the protection of human participants in this type of research. In "Ethical and Policy Issues in the Oversight of Human Research" NBAC proposes a definition of research involving human participants that would apply to all scientific disciplines, including physical, biological, and social sciences, as well as the humanities and related professions, such as business and law. Both of these reports make it clear that the protection of research participants is key to conducting ethically sound research. By ensuring that all participants in

Parallel experience: how art and art theory can inform ethics in human research.

Science.gov (United States)

Schwartz, L

2003-12-01

Trends in ethical research involving humans emphasise the importance of collaboration, of involving research subjects, alongside the researchers in the construction and implementation of research. This paper will explore parallels derived from another tradition of investigation of the human: art and art theory. An artist's inquiry into the problems of human research will be described, followed by the application of arguments from art theory to research practice. Recently artist Christine Borland has provided examples in which the lack of collaboration in research has caused injustice. Borland's work reflects these ethical dilemmas and questions the procedures and assumptions involved. In most cases the value of subject anonymity is called into question because it reduces the subjects' control over themselves. The application of art theory, which has already considered these problems, helps question and explore the ways in which the subject turned object of artistic or scientific interpretation can maintain some control and dignity.

A comparative analysis of biomedical research ethics regulation systems in Europe and Latin America with regard to the protection of human subjects.

Science.gov (United States)

Lamas, Eugenia; Ferrer, Marcela; Molina, Alberto; Salinas, Rodrigo; Hevia, Adriana; Bota, Alexandre; Feinholz, Dafna; Fuchs, Michael; Schramm, Roland; Tealdi, Juan-Carlos; Zorrilla, Sergio

2010-12-01

The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining 'ethics regulation system for biomedical research' as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities.

76 FR 44512 - Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing...

Science.gov (United States)

2011-07-26

... regulatory requirements that can apply to a single research study have been criticized as complex... research studies, as follows: 1. The highest level of review, applied to most studies involving more than... long-range effects of applying knowledge gained in the research (for example, the possible effects of...

Researching Human Experience: video intervention/prevention assessment (VIA

Directory of Open Access Journals (Sweden)

Jennifer Patashnick

2005-05-01

Full Text Available Human experience is a critical subject for research. By discussing Video Intervention/Prevention Assessment (VIA, a patient-centered health research method where patients teach their clinicians about living with a chronic condition through the creation of visual illness narratives, this paper examines the value of qualitative inquiry and why human experience rarely is investigated directly. An analysis of a sample VIA data is presented to demonstrate how, by utilizing grounded theory and qualitative analysis, one can derive rich and unique information from human experience.

Subjective Quantitative Studies of Human Agency

Science.gov (United States)

Alkire, Sabina

2005-01-01

Amartya Sen's writings have articulated the importance of human agency, and identified the need for information on agency freedom to inform our evaluation of social arrangements. Many approaches to poverty reduction stress the need for empowerment. This paper reviews "subjective quantitative measures of human agency at the individual level." It…

42 CFR 86.33 - Human subjects; animal welfare.

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Human subjects; animal welfare. 86.33 Section 86.33... Occupational Safety and Health Direct Traineeships § 86.33 Human subjects; animal welfare. Where the...) Chapter 1-43 of the Department Grants Administration Manual 2 068 concerning animal welfare. 2 See...

42 CFR 86.19 - Human subjects; animal welfare.

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Human subjects; animal welfare. 86.19 Section 86.19... Occupational Safety and Health Training Grants § 86.19 Human subjects; animal welfare. No grant award may be... concerning animal welfare. 2 The Department Grants Administration Manual is available for inspection at the...

Research Groups & Research Subjects - RED | LSDB Archive [Life Science Database Archive metadata

Lifescience Database Archive (English)

Full Text Available rch Groups & Research Subjects Data detail Data name Research Groups & Research Sub... Number of data entries 174 entries Data item Description Research ID Research ID (Subject number) Institute...tion Download License Update History of This Database Site Policy | Contact Us Research Groups & Research Subjects - RED | LSDB Archive ... ...switchLanguage; BLAST Search Image Search Home About Archive Update History Data List Contact us RED Resea... Organization Section Section (Department) User name User name Experimental title Experimental title (Rese

Accreditation of human research protection program: An Indian perspective

Directory of Open Access Journals (Sweden)

K L Bairy

2012-01-01

Full Text Available With the increasing number of clinical trials being placed in India, it is the collective responsibility of the Investigator sites, Government, Ethics Committees, and Sponsors to ensure that the trial subjects are protected from risks these studies can have, that subjects are duly compensated, and credible data generated. Most importantly, each institution/hospital should have a strong Human Research Protection Program to safe guard the trial subjects. In order to look at research with a comprehensive objective approach, there is a need for a formal auditing and review system by a recognized body. As of now, only the sponsors are monitoring/auditing their respective trials; however, there is an increasing need to perform a more detailed review and assessment of processes of the institution and the Ethics Committee. This challenge can be addressed by going for accreditation by a reputed association that encompasses-the institutions, the ethics committees, and researcher/research staff. Starting their journey for the accreditation process in late 2010, Kasturba Medical College and Hospital [KMC], Manipal, and Manipal Hospital Bangalore [MHB] received full Association for the Accreditation of Human Research Protection Programs (AAHRPP accreditation in Dec 2011-a first in India. This article delves into the steps involved in applying for AAHRPP accreditation from an Indian Perspective, the challenges, advantages, and testimonials from the two hospitals on the application experience and how the accreditation has improved the Human Research Protection Program at these hospitals.

Human Resource Subjects Allocation and Students' Academic ...

African Journals Online (AJOL)

This study investigated human resource subjects' allocation and students' academic performance in Secondary Schools in Obudu, Nigeria. The relevant variables of teachers subject was used as independent variable while the dependent variables were students' academic performance. Six hundred teachers from 20 ...

A Comparison of National Policies on Research Involving Human Subjects to Facilitate Review and Approval of Collaborative Research

Science.gov (United States)

2008-11-26

torture Prohibition on slavery and forced labour Right to liberty and security Right to a fair trial No punishment without law Right to respect...NOT BE TOLERATED. IT IS BOTH A BREACH OF REGULATIONS AND UNETHICAL . UNAUTHORIZED RESEARCH MAY THEREFORE BE SUBJECT TO INVESTIGATION AND

Modal analysis of human body vibration model for Indian subjects under sitting posture.

Science.gov (United States)

Singh, Ishbir; Nigam, S P; Saran, V H

2015-01-01

Need and importance of modelling in human body vibration research studies are well established. The study of biodynamic responses of human beings can be classified into experimental and analytical methods. In the past few decades, plenty of mathematical models have been developed based on the diverse field measurements to describe the biodynamic responses of human beings. In this paper, a complete study on lumped parameter model derived from 50th percentile anthropometric data for a seated 54- kg Indian male subject without backrest support under free un-damped conditions has been carried out considering human body segments to be of ellipsoidal shape. Conventional lumped parameter modelling considers the human body as several rigid masses interconnected by springs and dampers. In this study, concept of mass of interconnecting springs has been incorporated and eigenvalues thus obtained are found to be closer to the values reported in the literature. Results obtained clearly establish decoupling of vertical and fore-and-aft oscillations. The mathematical modelling of human body vibration studies help in validating the experimental investigations for ride comfort of a sitting subject. This study clearly establishes the decoupling of vertical and fore-and-aft vibrations and helps in better understanding of possible human response to single and multi-axial excitations.

Research opportunities in human behavior and performance

Science.gov (United States)

Christensen, J. M. (Editor); Talbot, J. M. (Editor)

1985-01-01

Extant information on the subject of psychological aspects of manned space flight are reviewed; NASA's psychology research program is examined; significant gaps in knowledge are identified; and suggestions are offered for future research program planning. Issues of human behavior and performance related to the United States space station, to the space shuttle program, and to both near and long term problems of a generic nature in applicable disciplines of psychology are considered. Topics covered include: (1) human performance requirements for a 90 day mission; (2) human perceptual, cognitive, and motor capabilities and limitations in space; (3) crew composition, individual competencies, crew competencies, selection criteria, and special training; (4) environmental factors influencing behavior; (5) psychosocial aspects of multiperson space crews in long term missions; (6) career determinants in NASA; (7) investigational methodology and equipment; and (8) psychological support.

Enterprising or altruistic selves? Making up research subjects in genetics research.

Science.gov (United States)

Tutton, Richard; Prainsack, Barbara

2011-11-01

The emergence of direct-to-consumer (DTC) personal genomics companies in 2007 was accompanied by considerable media attention and criticism from clinical geneticists and other health professionals, regulators, policy advisors, and ethicists. As well as offering genetic testing services, some firms are also engaged in building their own databases and conducting research with the data obtained from their customers. In this paper, we examine how one of these companies, 23andMe, is creating a certain kind of 'research subject' in opposition to that constituted in conventional forms of disease research. Drawing on debates about neoliberalism, contemporary health discourses and subjectivity, we consider two kinds of subjectivities produced through the discursive and material practices of 23andMe and UK Biobank, namely, 'enterprising' and 'altruistic' selves. We argue that the 23andMe model promotes the idea that curiosity about one's genome on the one hand, and participation in research on the other, are not only compatible but complementary aspects of being an entrepreneurial subject of contemporary health and medicine framed by the technologies of web 2.0. © 2011 The Authors. Sociology of Health & Illness © 2011 Foundation for the Sociology of Health & Illness/Blackwell Publishing Ltd.

Physiological and subjective evaluation of a human-robot object hand-over task.

Science.gov (United States)

Dehais, Frédéric; Sisbot, Emrah Akin; Alami, Rachid; Causse, Mickaël

2011-11-01

In the context of task sharing between a robot companion and its human partners, the notions of safe and compliant hardware are not enough. It is necessary to guarantee ergonomic robot motions. Therefore, we have developed Human Aware Manipulation Planner (Sisbot et al., 2010), a motion planner specifically designed for human-robot object transfer by explicitly taking into account the legibility, the safety and the physical comfort of robot motions. The main objective of this research was to define precise subjective metrics to assess our planner when a human interacts with a robot in an object hand-over task. A second objective was to obtain quantitative data to evaluate the effect of this interaction. Given the short duration, the "relative ease" of the object hand-over task and its qualitative component, classical behavioral measures based on accuracy or reaction time were unsuitable to compare our gestures. In this perspective, we selected three measurements based on the galvanic skin conductance response, the deltoid muscle activity and the ocular activity. To test our assumptions and validate our planner, an experimental set-up involving Jido, a mobile manipulator robot, and a seated human was proposed. For the purpose of the experiment, we have defined three motions that combine different levels of legibility, safety and physical comfort values. After each robot gesture the participants were asked to rate them on a three dimensional subjective scale. It has appeared that the subjective data were in favor of our reference motion. Eventually the three motions elicited different physiological and ocular responses that could be used to partially discriminate them. Copyright © 2011 Elsevier Ltd and the Ergonomics Society. All rights reserved.

Human and animal research guidelines: aligning ethical constructs with new scientific developments.

Science.gov (United States)

Ferdowsian, Hope

2011-10-01

Both human research and animal research operate within established standards and procedures. Although the human research environment has been criticized for its sometimes inefficient and imperfect process, reported abuses of human subjects in research served as the impetus for the establishment of the Nuremberg Code, Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the resulting Belmont Report. No similar, comprehensive and principled effort has addressed the use of animals in research. Although published policies regarding animal research provide relevant regulatory guidance, these policies have not emerged from the process of specifying consistent and reasoned ethical principles. The lack of a fundamental effort to explore the ethical issues and principles regarding the use of animals in research has led to unclear and disparate policies. Recent studies have increased our understanding of animal cognition and emotion, suggesting that animals' potential for experiencing a wide variety of harms, such as pain and fear, is greater than has been previously appreciated. Furthermore, relationships between methods of captivity and certain laboratory procedures and the resulting adverse physical, social and psychological effects have been established. In light of this information, current protections may need to be reconsidered and modified. This paper explores the historical convergence and divergence in the creation of human and animal research guidelines, as well as opportunities to align ethical frameworks with new scientific discoveries. © 2011 Blackwell Publishing Ltd.

Subjective dimension in the analysis of human development

Directory of Open Access Journals (Sweden)

LÓPEZ NOVAL, Borja

2012-06-01

Full Text Available In recent years subjective evaluations about own quality of life, resumed in levels of life satisfactionor happiness, are gaining importance as indicators of development. Some authors state that subjectivewell-being is a necessary and sufficient condition for human development. In this work the arguments ofthese authors are explained and it is discussed the role subjective evaluations must play on developmentstudies. The main conclusion is that although it is necessary to integrate subjective well-being into humandevelopment studies we cannot identify subjective well-being and development.

Regulating stem-cell research and human cloning in an Australian context: an exercise in protecting the status of the human subject.

Science.gov (United States)

Harvey, Olivia

2005-01-01

Over 12 months prior to the recent United Nations decision to defer a decision about what type of international treaty should be developed in the global stem-cell research and human cloning debate, the Federal Parliament of Australia passed two separate pieces of legislation relating to both these concerns. After a five-year long process of community consultation, media spectacle and parliamentary debate, reproductive cloning has been banned in Australia and only embryos considered to be excess to assisted reproductive technologies in existence on the 5th of April 2002 are currently valid research material. This paper argues that underpinning both pieces of legislation is a profound belief in the disruptive potential of all types of human cloning for the very nature and integrity of human species being. A belief, moreover, that is based on a presumption that it is apparently possible to conceptualise what being human even means for all Australians.

Cranberry juice suppressed the diclofenac metabolism by human liver microsomes, but not in healthy human subjects

Science.gov (United States)

Ushijima, Kentarou; Tsuruoka, Shu-ichi; Tsuda, Hidetoshi; Hasegawa, Gohki; Obi, Yuri; Kaneda, Tae; Takahashi, Masaki; Maekawa, Tomohiro; Sasaki, Tomohiro; Koshimizu, Taka-aki; Fujimura, Akio

2009-01-01

AIM To investigate a potential interaction between cranberry juice and diclofenac, a substrate of CYP2C9. METHODS The inhibitory effect of cranberry juice on diclofenac metabolism was determined using human liver microsome assay. Subsequently, we performed a clinical trial in healthy human subjects to determine whether the repeated consumption of cranberry juice changed the diclofenac pharmacokinetics. RESULTS Cranberry juice significantly suppressed diclofenac metabolism by human liver microsomes. On the other hand, repeated consumption of cranberry juice did not influence the diclofenac pharmacokinetics in human subjects. CONCLUSIONS Cranberry juice inhibited diclofenac metabolism by human liver microsomes, but not in human subjects. Based on the present and previous findings, we think that although cranberry juice inhibits CYP2C9 activity in vitro, it does not change the pharmacokinetics of medications metabolized by CYP2C9 in clinical situations. PMID:19694738

[Adolescents as research subjects and free informed consent: knowledge and opinion of researchers and adolescents].

Science.gov (United States)

Guariglia, Fabiana; Bento, Silvana Ferreira; Hardy, Ellen

2006-01-01

This article presents the results of a study that evaluated the knowledge and opinions of researchers and adolescents that served as their research subjects on the legal norms that regulate the participation of the latter as research subjects, the capacity of adolescents to make autonomous decisions regarding participation, and the adolescent experience after agreeing to take part in a study. This was a qualitative study with a convenience sample, the size of which was defined by the criteria of informational redundancy. Interviews were conducted with three researchers who had used adolescents as research subjects and nine of these subjects. This number of interviews was sufficient to reach informational redundancy. Data was collected through recorded semi-structured interviews, with open questions. All the researchers were familiar with some legal document related to the participation of adolescents as subjects of research. On the other hand, the adolescents were surprised because they were not aware of the existence of such documents. However, they considered them necessary for their own protection. In general, researchers and adolescents believe that adolescents have the capacity to decide autonomously to participate as research subjects. The adolescents affirmed that they had decided to volunteer conscientiously.

Acute, subacute and long-term subjective effects of psilocybin in healthy humans: a pooled analysis of experimental studies.

Science.gov (United States)

Studerus, Erich; Kometer, Michael; Hasler, Felix; Vollenweider, Franz X

2011-11-01

Psilocybin and related hallucinogenic compounds are increasingly used in human research. However, due to limited information about potential subjective side effects, the controlled medical use of these compounds has remained controversial. We therefore analysed acute, short- and long-term subjective effects of psilocybin in healthy humans by pooling raw data from eight double-blind placebo-controlled experimental studies conducted between 1999 and 2008. The analysis included 110 healthy subjects who had received 1-4 oral doses of psilocybin (45-315 µg/kg body weight). Although psilocybin dose-dependently induced profound changes in mood, perception, thought and self-experience, most subjects described the experience as pleasurable, enriching and non-threatening. Acute adverse drug reactions, characterized by strong dysphoria and/or anxiety/panic, occurred only in the two highest dose conditions in a relatively small proportion of subjects. All acute adverse drug reactions were successfully managed by providing interpersonal support and did not need psychopharmacological intervention. Follow-up questionnaires indicated no subsequent drug abuse, persisting perception disorders, prolonged psychosis or other long-term impairment of functioning in any of our subjects. The results suggest that the administration of moderate doses of psilocybin to healthy, high-functioning and well-prepared subjects in the context of a carefully monitored research environment is associated with an acceptable level of risk.

[Ethics and methodology: the importance of promoting, evaluating and implementing education and humanities research in health].

Science.gov (United States)

Consejo-Y Chapela, Carolina; González-Martínez, José Francisco

2017-01-01

In this editorial we initially expose the agreements that have set the mechanisms to guarantee safety and fair treatment to human subjects in research. Later on, we offer alternatives from translational and multidisciplinary research to promote education and humanities research in health.

Regulating hematology/oncology research involving human participants.

Science.gov (United States)

Kapp, Marshall B

2002-12-01

The conduct of hematology/oncology research, particularly clinical trials involving human participants, is an extensively regulated enterprise. Professionals in the specialty of hematology/oncology have important stakes in the success of biomedical research endeavors. Knowledge about and compliance strategies regarding the pertinent regulatory parameters are essential for avoiding negative legal repercussions for involved professionals. At the same time, there is a need to be aware of and actively resist the danger that strong [legal] protectionism might inadvertently result in undermining physician investigators' sense of personal moral responsibility in the conduct of human experiments. For all the limitations of that virtue in the protection of human subjects, it is surely not one that we would want medical scientists to be without [47]. Members of the potential participant pool, financial sponsors, and the general public must be convinced that everyone involved in the research enterprise is committed to operating within acceptable legal and ethical boundaries if the atmosphere of confidence and trust that is indispensable to the continued process and progress of investigation aimed at extending and improving quality of life for all of us in the future is to continue and flourish [48].

Increasing the amount of payment to research subjects

Science.gov (United States)

Resnick, DB

2014-01-01

This article discusses some ethical issues that can arise when researchers decide to increase the amount of payment offered to research subjects to boost enrollment. Would increasing the amount of payment be unfair to subjects who have already consented to participate in the study? This article considers how five different models of payment—the free market model, the wage payment model, the reimbursement model, the appreciation model, and the fair benefits model—would approach this issue. The article also considers several practical problems related to changing the amount of payment, including determining whether there is enough money in the budget to offer additional payments to subjects who have already enrolled, ascertaining how difficult it will be to re-contact subjects, and developing a plan of action for responding to subjects who find out they are receiving less money and demand an explanation. PMID:18757614

Radar cross section of human cardiopulmonary activity for recumbent subject.

Science.gov (United States)

Kiriazi, John E; Boric-Lubecke, Olga; Lubecke, Victor M

2009-01-01

The radar cross section (RCS) corresponding to human cardio-respiratory motion is measured for a subject in two different recumbent positions. Lying face-up (supine), the subject showed an RCS of 0.326 m(2). But when lying face-down (prone), the RCS increased to 2.9 m(2). This is the first reported RCS measurement corresponding to human cardio-respiratory motion. The results obtained in this experiment suggest modeling the upper part of the human body as a half-cylinder where the front body corresponds to the cylindrical surface and the back corresponds to the rectangular one.

Subject Retrieval from Full-Text Databases in the Humanities

Science.gov (United States)

East, John W.

2007-01-01

This paper examines the problems involved in subject retrieval from full-text databases of secondary materials in the humanities. Ten such databases were studied and their search functionality evaluated, focusing on factors such as Boolean operators, document surrogates, limiting by subject area, proximity operators, phrase searching, wildcards,…

Ethics review of health research on human participants in South Africa.

Science.gov (United States)

van Wyk, Christa

2010-06-01

In terms of South African legislation, all health research on human participants must be submitted to an accredited research ethics committee for independent ethics review. Health research covers a broad spectrum of research, including clinical trials. This article sets out the ethical-legal framework for the functioning and composition of such committees. It also deals with the newly created National Health Research Ethics Council, which registers and audits health research ethics committees. Special attention is given to the conduct of clinical trials. In conclusion, it is submitted that the National Health Act, the Draft Regulations Relating to Research on Human Subjects, and two sets of ethical guidelines adopted by the Department of Health provide a much needed and coherent ethical-legal framework for research in South Africa.

Human cloning, stem cell research. An Islamic perspective.

Science.gov (United States)

Al-Aqeel, Aida I

2009-12-01

The rapidly changing technologies that involve human subjects raise complex ethical, legal, social, and religious issues. Recent advances in the field of cloning and stem cell research have introduced new hopes for the treatment of serious diseases. But this promise has raised many complex questions. This field causes debate and challenge, not only among scientists but also among ethicists, religious scholars, governments, and politicians. There is no consensus on the morality of human cloning, even within specific religious traditions. In countries in which religion has a strong influence on political decision making, the moral status of the human embryo is at the center of the debate. Because of the inevitable consequences of reproductive cloning, it is prohibited in Islam. However, stem cell research for therapeutic purposes is permissible with full consideration, and all possible precautions in the pre-ensoulment stages of early fetus development, if the source is legitimate.

Research Education: Perspectives and subjective processes involved in educational research

Directory of Open Access Journals (Sweden)

Harm H. Tillema

2009-10-01

Full Text Available Educational research acknowledges that researcher’s beliefs and training play a role in framing the outcomes of any study. Research not only consists of defining objectives and following certain methods (search but also of making decisions over the steps taking during the inquiry process (research.Establishing a conceptual framework to guide actions on the subjective processes in research is then crucial to control them. With that purpose in mind we offer researchers and Teacher Educators a heuristic tool to be conscious on the risks that can be taken when immersed in research interpretative process. This instrument could be utilised in PhD programs, masters and research projects.

Microarray expression profiling of human dental pulp from single subject.

Science.gov (United States)

Tete, Stefano; Mastrangelo, Filiberto; Scioletti, Anna Paola; Tranasi, Michelangelo; Raicu, Florina; Paolantonio, Michele; Stuppia, Liborio; Vinci, Raffaele; Gherlone, Enrico; Ciampoli, Cristian; Sberna, Maria Teresa; Conti, Pio

2008-01-01

Microarray is a recently developed simultaneous analysis of expression patterns of thousand of genes. The aim of this research was to evaluate the expression profile of human healthy dental pulp in order to find the presence of genes activated and encoding for proteins involved in the physiological process of human dental pulp. We report data obtained by analyzing expression profiles of human tooth pulp from single subjects, using an approach based on the amplification of the total RNA. Experiments were performed on a high-density array able to analyse about 21,000 oligonucleotide sequences of about 70 bases in duplicate, using an approach based on the amplification of the total RNA from the pulp of a single tooth. Obtained data were analyzed using the S.A.M. system (Significance Analysis of Microarray) and genes were merged according to their molecular functions and biological process by the Onto-Express software. The microarray analysis revealed 362 genes with specific pulp expression. Genes showing significant high expression were classified in genes involved in tooth development, protoncogenes, genes of collagen, DNAse, Metallopeptidases and Growth factors. We report a microarray analysis, carried out by extraction of total RNA from specimens of healthy human dental pulp tissue. This approach represents a powerful tool in the study of human normal and pathological pulp, allowing minimization of the genetic variability due to the pooling of samples from different individuals.

Privacy Impact Assessment for the Medical and Research Study Records of Human Volunteers

Science.gov (United States)

The Medical & Research Study Records of Human Volunteers System collects demographic and medical information on subjects who participate in research. Learn how this data is collected, used, access to the data, and the purpose of data collection.

Assessment of emerging biomarkers of liver injury in human subjects.

Science.gov (United States)

Schomaker, Shelli; Warner, Roscoe; Bock, Jeff; Johnson, Kent; Potter, David; Van Winkle, Joyce; Aubrecht, Jiri

2013-04-01

Hepatotoxicity remains a major challenge in drug development. Although alanine aminotransferase (ALT) remains the gold standard biomarker of liver injury, alternative biomarker strategies to better predict the potential for severe drug-induced liver injury (DILI) are essential. In this study, we evaluated the utility of glutamate dehydrogenase (GLDH), purine nucleoside phosphorylase (PNP), malate dehydrogenase (MDH), and paraxonase 1 (PON1) as indicators of liver injury in cohorts of human subjects, including healthy subjects across age and gender, subjects with a variety of liver impairments, and several cases of acetaminophen poisoning. In the healthy subjects, levels of GLDH and MDH were not affected by age or gender. Reference ranges for GLDH and MDH in healthy subjects were 1-10 and 79-176U/L, respectively. In contrast, the levels of PON1 and PNP were not consistent across cohorts of healthy subjects. Furthermore, GLDH and MDH had a strong correlation with elevated ALT levels and possessed a high predictive power for liver injury, as determined by ROC analysis. In contrast, PON1 and PNP did not detect liver injury in our study. Finally, evaluation of patients with acetaminophen-induced liver injury provided evidence that both GLDH and MDH might have utility as biomarkers of DILI in humans. This study is the first to evaluate GLDH, MDH, PON1, and PNP in a large number of human subjects and, and it provides an impetus for prospective clinical studies to fully evaluate the diagnostic value of GLDH and MDH for detection of liver injury.

Parental Perspectives on a Pediatric Human Non-Subjects Biobank.

Science.gov (United States)

Brothers, Kyle B; Clayton, Ellen Wright

2012-01-01

BACKGROUND: Genomic biorepositories will be important tools to help unravel the effect of common genetic variants on risk for common pediatric diseases. Our objective was to explore how parents would respond to the inclusion of children in an opt-out model biobank. METHODS: We conducted semi-structured interviews with parents in hospital-based pediatric clinics. Participants responded to a description of a biorepository already collecting samples from adults. Two coders independently analyzed and coded interviews using framework analysis. Opt-out forms were later piloted in a clinic area. Parental opt-out choices were recorded electronically, with opt-out rates reported here. RESULTS: Parents strongly supported medical research in general and expressed a high level of trust that Vanderbilt University would keep their child's medical information private. Parents were more likely to allow their child's sample to be included in the biorepository than to allow their child to participate in a hypothetical study that would not help or harm their child, but might help other children. Only a minority were able to volunteer a concern raised by the description of the biobank. The opt-out rate was initially high compared with the opt-out rate in the adult biorepository, but after the first week decreased to near the baseline in adult clinics. CONCLUSION: Parents in our study generally support an opt-out model biobank in children. Most would allow their own child's sample to be included. Institutions seeking to build pediatric biobanks may consider the human non-subjects model as a viable alternative to traditional human-subjects biobanks.

Photodegradation of carotenoids in human subjects

International Nuclear Information System (INIS)

Roe, D.A.

1987-01-01

Photodegradation of vitamins in vitro is responsible for large losses of these nutrients in foods, beverages, and semisynthetic liquid formula diets. In vivo photodegradation of vitamins has been reported for riboflavin in jaundiced infants exposed to blue light and for folate in patients with chronic psoriasis given photochemotherapy. Two recent studies of normal subjects have also shown that photodegradation of carotenoids in plasma occurs with cumulative exposure of the skin to an artificial light source having maximal spectral emission in the UVA range. Females showed a larger effect of the UV light on their plasma carotenoid levels than males. These observations have identified a need for further investigation of the role of sunlight exposure as a determinant of plasma carotenoid levels and vitamin A status in human subjects

21 CFR 1316.23 - Confidentiality of identity of research subjects.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Confidentiality of identity of research subjects. 1316.23 Section 1316.23 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Protection of Researchers and Research Subjects § 1316.23...

The Utility of Single Subject Design Research

Science.gov (United States)

Bennett, Kyle D.

2016-01-01

Single subject design (SSD) research is a quantitative approach used to investigate basic and applied research questions. It has been used for decades to examine issues of social importance such as those related to general and special education strategies, therapeutic approaches in mental health, community health practices, safety, and business…

Validating in vivo Raman spectroscopy of bone in human subjects

Science.gov (United States)

Esmonde-White, Francis W. L.; Morris, Michael D.

2013-03-01

Raman spectroscopy can non-destructively measure properties of bone related to mineral density, mineral composition, and collagen composition. Bone properties can be measured through the skin in animal and human subjects, but correlations between the transcutaneous and exposed bone measurements have only been reported for human cadavers. In this study, we examine human subjects to collect measurements transcutaneously, on surgically exposed bone, and on recovered bone fragments. This data will be used to demonstrate in vivo feasibility and to compare transcutaneous and exposed Raman spectroscopy of bone. A commercially available Raman spectrograph and optical probe operating at 785 nm excitation are used for the in vivo measurements. Requirements for applying Raman spectroscopy during a surgery are also discussed.

77 FR 58383 - Secretary's Advisory Committee on Human Research Protections

Science.gov (United States)

2012-09-20

... the public who wish to have printed materials distributed to SACHRP members for this scheduled meeting should submit materials to the Executive Director, SACHRP, prior to the close of business October 1, 2012... human subjects research adopted by various agencies or offices within HHS would benefit from...

The history of ethics in research with human subjects

OpenAIRE

Kottow, Miguel

2008-01-01

This article contextualizes the emergence of the field of research ethics in historical, social, and political events over the last 60 years. It draws a distinction between professional ethics and bioethics, focusing on the historical and philosophical precedents of the latter field. It also presents the appearance of research ethics as a result of the disclosure of cases of scientific misconduct, discussing the first regulations on research ethics, the guidelines contained in the Belmont Rep...

African Journals Online: Humanities (broad subject range)

African Journals Online (AJOL)

Items 1 - 50 of 55 ... The Eastern Africa Social Science Research Review (EASSRR) is a ... as well as research from other disciplines working on ideas of relevance to the ..... It publishes New Research from every aspect of the Humanities and the ...

Research and Exploration for Operational Research Education in Industry and Engineering Subject

Science.gov (United States)

Wu, Yu-hua; Wang, Feng-ming; Du, Gang

2007-01-01

On the basic of exploring the relationship of industry engineering and operational research technique, the thesis analyzes the location and utility of the operational research education in the whole industry engineering subject education. It brings forward the system design about operational research and relative class among industry engineering…

Justice in human research ethics. A conceptual and practical guide.

Science.gov (United States)

Pieper, Ian; Thomson, Colin J H

2013-03-01

One of the core values to be applied by a body reviewing the ethics of human research is justice. The inclusion of justice as a requirement in the ethical review of human research is relatively recent and its utility had been largely unexamined until debates arose about the conduct of international biomedical research in the late 1990s. The subsequent amendment of authoritative documents in ways that appeared to shift the meaning of conceptions of justice generated a great deal of controversy. Another difficulty has been that both the theory and the substance of justice that are applied by researchers or reviewers can be frequently seen to be subjective. Both the concept of justice--hether distributive or commutative--and what counts as a just distribution or exchange--are given different weight and meanings by different people. In this paper, the origins and more recent debates about the requirement to consider justice as a criterion in the ethical review of human research are traced, relevant conceptions of justice are distinguished, and the manner in which they can be applied meaningfully in the ethical review of all human research is identified. We also explain the way that these concepts are articulated in, and the intent and function of, specific paragraphs of the National Statement on Ethical Conduct in Human Research (2007). The National Statement identifies a number of issues that should be considered when a human research ethics committee is reviewing the justice aspects of an application. We provide guidance to researchers as to how they can show that there is a fair distribution of burdens and benefits in the participant experience and the research outcomes. We also provide practical guidance to researches on how to think through issues of justice so that they can demonstrate that the design of their research projects meets this ethical requirement.

Ethics and law in research with human biological samples: a new approach.

Science.gov (United States)

Petrini, Carlo

2014-01-01

During the last century a large number of documents (regulations, ethical codes, treatises, declarations, conventions) were published on the subject of ethics and clinical trials, many of them focusing on the protection of research participants. More recently various proposals have been put forward to relax some of the constraints imposed on research by these documents and regulations. It is important to distinguish between risks deriving from direct interventions on human subjects and other types of risk. In Italy the Data Protection Authority has acted in the question of research using previously collected health data and biological samples to simplify the procedures regarding informed consent. The new approach may be of help to other researchers working outside Italy.

[Autoshaping of a button-push response and eye movement in human subjects].

Science.gov (United States)

Kimura, H; Fukui, I; Inaki, K

1990-12-01

Two experiments were conducted with human subjects to investigate the similarities and differences between animal and human behaviors under autoshaping procedures. In these experiments, light served as CS, and display on TV served as US. Whether the pushing button response or gazing response to CS could be obtained in human subjects under Pavlovian conditioning procedure was examined. In Experiment 1, uninstructed naive subjects were placed in a room containing a push-button and a TV display. Within the experimental sessions, the push-button was lit for 8 s as CS, and then paired with the display of a soft pornographic program on TV for 10 s. The result indicated that the modeling of pushing button promoted the increase of response probability among the subjects. The trials conducted after the rest period indicated an increase of response probability. In Experiment 2, a 4 cm square translucent panel was lit for 20 s as CS, and then paired with the display of a computer graphic picture on TV for 8 s as US. Some subjects started gazing at the CS for several seconds. These results indicated that some subjects could acquire the gazing response under the autoshaping procedure.

Squeeze-Film Lubrication of the Human Ankle Joint Subjected to the Cyclic Loading Encountered in Walking

Czech Academy of Sciences Publication Activity Database

Hlaváček, Miroslav

2005-01-01

Roč. 127, č. 1 (2005), s. 141-147 ISSN 0742-4787 R&D Projects: GA ČR(CZ) GA103/04/0150 Institutional research plan: CEZ:AV0Z20710524 Keywords : cyclic loading * human ankle joint * squeeze-film lubrication * synovial fluid filtration * synovial gel formation Subject RIV: JJ - Other Materials Impact factor: 0.682, year: 2005

"SINCE I MUST PLEASE THOSE BELOW": HUMAN SKELETAL REMAINS RESEARCH AND THE LAW.

Science.gov (United States)

Holland, Thomas D

2015-01-01

The ethics of non-invasive scientific research on human skeletal remains are poorly articulated and lack a single, definitive analogue in western law. Laws governing invasive research on human fleshed remains, as well as bio-ethical principles established for research on living subjects, provide effective models for the establishment of ethical guidelines for non-invasive research on human skeletal remains. Specifically, non-invasive analysis of human remains is permissible provided that the analysis and collection of resulting data (1) are accomplished with respect for the dignity of the individual, (2) do not violate the last-known desire of the deceased, (3) do not adversely impact the right of the next of kin to perform a ceremonious and decent disposal of the remains, and (4) do not unduly or maliciously violate the privacy interests of the next of kin.

Subject/Author Index 1968-1992.

Science.gov (United States)

Kupidura, Eva, Ed.; Kupidura, Peter, Ed.

1993-01-01

This 25-year index contains annotations of feature articles by subject and by author. Representative subjects include basic education, development education, empowerment, human rights, lifelong education, peace education, popular education, rural development, social/political action, technological advancement, and transformative research. Articles…

Why the moratorium on human-animal chimera research should not be lifted.

Science.gov (United States)

Moy, Alan

2017-08-01

The National Institutes of Health (NIH) announced its plans to lift its moratorium on funding research that involves injecting human embryonic stem cells into animal embryos, which would allow for the creation of part-human and part-animal organisms known as chimeras. The NIH allowed only one month to receive public comments in the midst of a presidential election campaign. Lifting the moratorium means that, for the first time, the federal government will begin spending taxpayer dollars on the creation and manipulation of new organisms that would blur the line between humans and animals. Interestingly, this government effort is creating an uncommon coalition between pro-life groups and animal rights activists that oppose this medical research on ethical grounds; the former seeking to ensure the welfare of human embryos and the latter seeking to protect the well-being of animals. Unlike the issue of abortion, this research is complex. Yet, it is important that the pro-life laity and clergy be adequately informed on some of the basic science and ethics that surround this research. To fully understand why this research is unethical and why the NIH is pursuing this particular research, it is important to understand the ethical tenets governing human-subject research and why secular scientists are pursuing this scientific field.

The Applied Behavior Analysis Research Paradigm and Single-Subject Designs in Adapted Physical Activity Research.

Science.gov (United States)

Haegele, Justin A; Hodge, Samuel Russell

2015-10-01

There are basic philosophical and paradigmatic assumptions that guide scholarly research endeavors, including the methods used and the types of questions asked. Through this article, kinesiology faculty and students with interests in adapted physical activity are encouraged to understand the basic assumptions of applied behavior analysis (ABA) methodology for conducting, analyzing, and presenting research of high quality in this paradigm. The purposes of this viewpoint paper are to present information fundamental to understanding the assumptions undergirding research methodology in ABA, describe key aspects of single-subject research designs, and discuss common research designs and data-analysis strategies used in single-subject studies.

Human Research Program Integrated Research Plan. Revision A January 2009

Science.gov (United States)

2009-01-01

The Integrated Research Plan (IRP) describes the portfolio of Human Research Program (HRP) research and technology tasks. The IRP is the HRP strategic and tactical plan for research necessary to meet HRP requirements. The need to produce an IRP is established in HRP-47052, Human Research Program - Program Plan, and is under configuration management control of the Human Research Program Control Board (HRPCB). Crew health and performance is critical to successful human exploration beyond low Earth orbit. The Human Research Program (HRP) is essential to enabling extended periods of space exploration because it provides knowledge and tools to mitigate risks to human health and performance. Risks include physiological and behavioral effects from radiation and hypogravity environments, as well as unique challenges in medical support, human factors, and behavioral or psychological factors. The Human Research Program (HRP) delivers human health and performance countermeasures, knowledge, technologies and tools to enable safe, reliable, and productive human space exploration. Without HRP results, NASA will face unknown and unacceptable risks for mission success and post-mission crew health. This Integrated Research Plan (IRP) describes HRP s approach and research activities that are intended to address the needs of human space exploration and serve HRP customers and how they are integrated to provide a risk mitigation tool. The scope of the IRP is limited to the activities that can be conducted with the resources available to the HRP; it does not contain activities that would be performed if additional resources were available. The timescale of human space exploration is envisioned to take many decades. The IRP illustrates the program s research plan through the timescale of early lunar missions of extended duration.

Historical knowledge and the search for truth: a reading of subjectivity and objectivity in the duality between subject and object

Directory of Open Access Journals (Sweden)

Fernando Tadeu Germinatti

2018-04-01

Full Text Available The present article presents the systematization of theoretical reflections about the debate of neutrality in the human sciences. From the presentation of the conception of scientific neutrality defended by the positivist perspective, a reflection is made on the relation between researcher and object of historical research and its imbrications to the present day. The focus is on the subjective factor and its decisive contribution to research in human science. Thus, the great epistemological richness contained in subjectivity is demonstrated. The methodology used was a bibliographical study, made from researches in classic works of historical science.

Absorption of orally administered 65Zn by normal human subjects

International Nuclear Information System (INIS)

Aamodt, R.L.; Rumble, W.F.; Johnston, G.S.; Markley, E.J.; Henkin, R.I.

1981-01-01

Despite studies by several investigators of human gastrointestinal 65Zn absorption, implications of these data for evaluation of functional zinc status are unclear because limited numbers of normal subjects have been studied. To evaluated zinc absorption in normal humans, 75 subjects (31 women, 44 men, ages 18 to 84 yr) were given 10 micro Ci carrier-free 65Zn orally after an overnight fast. Absorption calculated from total body retention measured 7, 14, and 21 days after administration of tracer was 65 +/- 11% (mean +/- 1 SD), range from 40 to 86%. Comparison of these results with those for patients with a variety of diseases indicate that patients exhibit a wider range of absorption and, in four of six studies patients exhibit decreased mean zinc absorption. These results of gastrointestinal zinc absorption in a large number of normal humans offer a basis for a clearer comparison with data from patients who exhibit abnormalities of zinc absorption

Population of 224 realistic human subject-based computational breast phantoms

Energy Technology Data Exchange (ETDEWEB)

Erickson, David W. [Carl E. Ravin Advanced Imaging Laboratories, Duke University Medical Center, Durham, North Carolina 27705 and Medical Physics Graduate Program, Duke University, Durham, North Carolina 27705 (United States); Wells, Jered R., E-mail: jered.wells@duke.edu [Clinical Imaging Physics Group and Carl E. Ravin Advanced Imaging Laboratories, Duke University Medical Center, Durham, North Carolina 27705 and Medical Physics Graduate Program, Duke University, Durham, North Carolina 27705 (United States); Sturgeon, Gregory M. [Carl E. Ravin Advanced Imaging Laboratories, Duke University Medical Center, Durham, North Carolina 27705 (United States); Samei, Ehsan [Department of Radiology and Carl E. Ravin Advanced Imaging Laboratories, Duke University Medical Center, Durham, North Carolina 27705 and Departments of Physics, Electrical and Computer Engineering, and Biomedical Engineering, and Medical Physics Graduate Program, Duke University, Durham, North Carolina 27705 (United States); Dobbins, James T. [Department of Radiology and Carl E. Ravin Advanced Imaging Laboratories, Duke University Medical Center, Durham, North Carolina 27705 and Departments of Physics and Biomedical Engineering and Medical Physics Graduate Program, Duke University, Durham, North Carolina 27705 (United States); Segars, W. Paul [Department of Radiology and Carl E. Ravin Advanced Imaging Laboratories, Duke University Medical Center, Durham, North Carolina 27705 and Medical Physics Graduate Program, Duke University, Durham, North Carolina 27705 (United States); Lo, Joseph Y. [Department of Radiology and Carl E. Ravin Advanced Imaging Laboratories, Duke University Medical Center, Durham, North Carolina 27705 and Departments of Electrical and Computer Engineering and Biomedical Engineering and Medical Physics Graduate Program, Duke University, Durham, North Carolina 27705 (United States)

2016-01-15

Purpose: To create a database of highly realistic and anatomically variable 3D virtual breast phantoms based on dedicated breast computed tomography (bCT) data. Methods: A tissue classification and segmentation algorithm was used to create realistic and detailed 3D computational breast phantoms based on 230 + dedicated bCT datasets from normal human subjects. The breast volume was identified using a coarse three-class fuzzy C-means segmentation algorithm which accounted for and removed motion blur at the breast periphery. Noise in the bCT data was reduced through application of a postreconstruction 3D bilateral filter. A 3D adipose nonuniformity (bias field) correction was then applied followed by glandular segmentation using a 3D bias-corrected fuzzy C-means algorithm. Multiple tissue classes were defined including skin, adipose, and several fractional glandular densities. Following segmentation, a skin mask was produced which preserved the interdigitated skin, adipose, and glandular boundaries of the skin interior. Finally, surface modeling was used to produce digital phantoms with methods complementary to the XCAT suite of digital human phantoms. Results: After rejecting some datasets due to artifacts, 224 virtual breast phantoms were created which emulate the complex breast parenchyma of actual human subjects. The volume breast density (with skin) ranged from 5.5% to 66.3% with a mean value of 25.3% ± 13.2%. Breast volumes ranged from 25.0 to 2099.6 ml with a mean value of 716.3 ± 386.5 ml. Three breast phantoms were selected for imaging with digital compression (using finite element modeling) and simple ray-tracing, and the results show promise in their potential to produce realistic simulated mammograms. Conclusions: This work provides a new population of 224 breast phantoms based on in vivo bCT data for imaging research. Compared to previous studies based on only a few prototype cases, this dataset provides a rich source of new cases spanning a wide range

Subjective thermal sensation and human body exergy consumption rate: analysis and correlation

DEFF Research Database (Denmark)

Simone, Angela; Dovjak, M.; Kolarik, Jakub

2011-01-01

, it is reasonable to consider both the exergy flows in building and those within the human body. There is a need to verify the human-body exergy model with the Thermal-Sensation (TS) response of subjects exposed to different combinations of indoor climate parameters (temperature, humidity, etc.). First results...... available on the relation between human-body exergy consumption rates and subjectively assessed thermal sensation showed that the minimum human body exergy consumption rate is associated with thermal sensation votes close to thermal neutrality, tending to slightly cool side of thermal sensation. By applying...... the exergy concept to the built indoor environment, additional results are going to be explored. By using the data available so far of operative temperature (to), the human body exergy consumption rates increase as to increases above 24°C or decreases below 22°C at relative humidity (RH) lower than 50...

48 CFR 207.172 - Human research.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Human research. 207.172... OF DEFENSE ACQUISITION PLANNING ACQUISITION PLANNING Acquisition Plans 207.172 Human research. Any DoD component sponsoring research involving human subjects— (a) Is responsible for oversight of...

The effect of feeding frequency on insulin and ghrelin responses in human subjects

DEFF Research Database (Denmark)

Solomon, Thomas; Chambers, Edward S; Jeukendrup, Asker E

2008-01-01

Recent work shows that increased meal frequency reduces ghrelin responses in sheep. Human research suggests there is an interaction between insulin and ghrelin. The effect of meal frequency on this interaction is unknown. Therefore, we investigated the effect of feeding frequency on insulin...... and ghrelin responses in human subjects. Five healthy male volunteers were recruited from the general population: age 24 (SEM 2)years, body mass 75.7 (SEM 3.2) kg and BMI 23.8 (SEM 0.8) kg/m(2). Volunteers underwent three 8-h feeding regimens: fasting (FAST); low-frequency(two) meal ingestion (LOFREQ......(MEAL)); high-frequency (twelve) meal ingestion (HIFREQ(MEAL)). Meals were equi-energetic within trials,consisting of 64% carbohydrate, 23% fat and 13% protein. Total energy intake was equal between feeding trials. Total area under the curve for serum insulin and plasma ghrelin responses did not differ between...

Mapping Frontier Research in the Humanities

DEFF Research Database (Denmark)

Knowledge production in academia today is burgeoning and increasingly interdisciplinary in nature. Research within the humanities is no exception: it is distributed across a variety of methodic styles of research and increasingly involves interactions with fields outside the narrow confines of th...... and for the organisation of the humanities and higher education?...... of the university. As a result, the notion of liberal arts and humanities within Western universities is undergoing profound transformations. In Mapping Frontier Research in the Humanities, the contributors explore this transformative process. What are the implications, both for the modes of research......Knowledge production in academia today is burgeoning and increasingly interdisciplinary in nature. Research within the humanities is no exception: it is distributed across a variety of methodic styles of research and increasingly involves interactions with fields outside the narrow confines...

78 FR 36783 - Meeting of the Secretary's Advisory Committee on Human Research Protections

Science.gov (United States)

2013-06-19

.... Any members of the public who wish to have printed materials distributed to SACHRP members for this scheduled meeting should submit materials to the Executive Director, SACHRP, prior to the close of business... human subjects research adopted by various agencies or offices within HHS would benefit from...

78 FR 56233 - Meeting of the Secretary's Advisory Committee on Human Research Protections

Science.gov (United States)

2013-09-12

.... Any members of the public who wish to have printed materials distributed to SACHRP members for this scheduled meeting should submit materials to the Executive Director, SACHRP, prior to the close of business... human subjects research adopted by various agencies or offices within HHS would benefit from...

Single-Subject Research Methodology: An Underutilized Tool in the Field of Deafness.

Science.gov (United States)

Bullis, Michael; Anderson, Glenn

1986-01-01

Single-subject research methods are simple, powerful, and very applicable to selected study of deafness. This article considers group versus single-subject designs; an example of withdrawal single-subject design; and an example of the multiple baseline single-subject design. (CB)

Robot Tracking of Human Subjects in Field Environments

Science.gov (United States)

Graham, Jeffrey; Shillcutt, Kimberly

2003-01-01

Future planetary exploration will involve both humans and robots. Understanding and improving their interaction is a main focus of research in the Intelligent Systems Branch at NASA's Johnson Space Center. By teaming intelligent robots with astronauts on surface extra-vehicular activities (EVAs), safety and productivity can be improved. The EVA Robotic Assistant (ERA) project was established to study the issues of human-robot teams, to develop a testbed robot to assist space-suited humans in exploration tasks, and to experimentally determine the effectiveness of an EVA assistant robot. A companion paper discusses the ERA project in general, its history starting with ASRO (Astronaut-Rover project), and the results of recent field tests in Arizona. This paper focuses on one aspect of the research, robot tracking, in greater detail: the software architecture and algorithms. The ERA robot is capable of moving towards and/or continuously following mobile or stationary targets or sequences of targets. The contributions made by this research include how the low-level pose data is assembled, normalized and communicated, how the tracking algorithm was generalized and implemented, and qualitative performance reports from recent field tests.

The human subject in the organization

Directory of Open Access Journals (Sweden)

Marcela Pérez Pazmiño

2015-12-01

Full Text Available This article puts the human subject into the center of the discussion, by finding common factors of representative authors in the field, revealing what was their predominant concern. From the Weberian bureaucratic tradition, organizational theory has witnessed that economic target was in the very center of organizations. For current assumptions, legitimate forms of domination would be substantiated by the inability to resolve most everyday affairs, those that handle to the rentability. It starts to show that organizations, far from being a rational set of actions, are places of unsound decisions, most often used for personal than community goals. The conclusion brings a new topic of discussion for organizational theory: the concept of a free agent within the organization.

45 CFR 46.114 - Cooperative research.

Science.gov (United States)

2010-10-01

... Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.114 Cooperative research. Cooperative... conduct of cooperative research projects, each institution is responsible for safeguarding the rights and...

Trends in research involving human beings in Brazil

Directory of Open Access Journals (Sweden)

Ricardo Eccard da Silva

2015-02-01

Full Text Available Developing countries have experienced a dramatic increase in the number of clinical studies in the last decades. The aim of this study was to describe 1 the number of clinical trials submitted to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, Anvisa from 2007 to 2012 and the number of human-subject research projects approved by research ethics committees (RECs and the National Research Ethics Committee (Comissão Nacional de Ética em Pesquisa, CONEP in Brazil from 2007 to 2011 and 2 the diseases most frequently studied in Brazilian states in clinical trials approved in the country from 2009 to 2012, based on information from an Anvisa databank. Two databases were used: 1 the National Information System on Research Ethics Involving Human Beings (Sistema Nacional de Informação Sobre Ética em Pesquisa envolvendo Seres Humanos, SISNEP and 2 Anvisa's Clinical Research Control System (Sistema de Controle de Pesquisa Clínica, SCPC. Data from the SCPC indicated an increase of 32.7% in the number of clinical trials submitted to Anvisa, and data from the SISNEP showed an increase of 69.9% in those approved by RECs and CONEP (from 18 160 in 2007 to 30 860 in 2011. Type 2 diabetes (26.0% and breast cancer (20.5%-related to the main causes of mortality in Brazil-were the two most frequently studied diseases. The so-called “neglected diseases,” such as dengue fever, were among the least studied diseases in approved clinical trials, despite their significant impact on social, economic, and health indicators in Brazil. Overall, the data indicated 1 a clear trend toward more research involving human beings in Brazil, 2 good correspondence between diseases most studied in clinical trials approved by Anvisa and the main causes of death in Brazil, and 3 a low level of attention to neglected diseases, an issue that should be considered in setting future research priorities, given their socioeconomic and health effects.

40 CFR 26.1704 - Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults...

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults conducted before April 7, 2006. 26.1704 Section 26.1704 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS...

40 CFR 26.1705 - Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults...

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults conducted after April 7, 2006. 26.1705 Section 26.1705 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS...

Generation of a suite of 3D computer-generated breast phantoms from a limited set of human subject data

International Nuclear Information System (INIS)

Hsu, Christina M. L.; Palmeri, Mark L.; Segars, W. Paul; Veress, Alexander I.; Dobbins, James T. III

2013-01-01

three human subject datasets, were used in a preliminary observer evaluation where four board certified breast radiologists with varying amounts of experience ranked the level of realism (from 1 =“fake” to 10 =“real”) of the simulated images. Results: The morphing technique was able to successfully generate new and unique morphed datasets from the original human subject data. The radiologists evaluated the realism of simulated mammograms generated from the morphed and unmorphed human subject datasets and scored the realism with an average ranking of 5.87 ± 1.99, confirming that overall the phantom image datasets appeared more “real” than “fake.” Moreover, there was not a significant difference (p > 0.1) between the realism of the unmorphed datasets (6.0 ± 1.95) compared to the morphed datasets (5.86 ± 1.99). Three of the four observers had overall average rankings of 6.89 ± 0.89, 6.9 ± 1.24, 6.76 ± 1.22, whereas the fourth observer ranked them noticeably lower at 2.94 ± 0.7. Conclusions: This work presents a technique that can be used to generate a suite of realistic computerized breast phantoms from a limited number of human subjects. This suite of flexible breast phantoms can be used for multimodality imaging research to provide a known truth while concurrently producing realistic simulated imaging data.

Implementation of Subjective Cognitive Decline criteria in research studies

Science.gov (United States)

Molinuevo, José L; Rabin, Laura A.; Amariglio, Rebecca; Buckley, Rachel; Dubois, Bruno; Ellis, Kathryn A.; Ewers, Michael; Hampel, Harald; Klöppel, Stefan; Rami, Lorena; Reisberg, Barry; Saykin, Andrew J.; Sikkes, Sietske; Smart, Colette M.; Snitz, Beth E.; Sperling, Reisa; van der Flier, Wiesje M.; Wagner, Michael; Jessen, Frank

2017-01-01

INTRODUCTION Subjective Cognitive Decline (SCD) manifesting prior to clinical impairment could serve as a target population for early intervention trials in Alzheimer’s disease (AD). A working group, the Subjective Cognitive Decline Initiative (SCD-I), published SCD research criteria in the context of preclinical AD. To successfully apply them, a number of issues regarding assessment and implementation of SCD needed to be addressed. METHODS Members of the SCD-I met to identify and agree upon topics relevant to SCD criteria operationalization in research settings. Initial ideas and recommendations were discussed with other SCD-I working group members and modified accordingly. RESULTS Topics included SCD inclusion and exclusion criteria, together with the informant’s role in defining SCD presence and the impact of demographic factors. DISCUSSION Recommendations for the operationalization of SCD in differing research settings, with the aim of harmonization of SCD measurement across studies are proposed, to enhance comparability and generalizability across studies. PMID:27825022

A Subject-Specific Kinematic Model to Predict Human Motion in Exoskeleton-Assisted Gait

Science.gov (United States)

Torricelli, Diego; Cortés, Camilo; Lete, Nerea; Bertelsen, Álvaro; Gonzalez-Vargas, Jose E.; del-Ama, Antonio J.; Dimbwadyo, Iris; Moreno, Juan C.; Florez, Julian; Pons, Jose L.

2018-01-01

The relative motion between human and exoskeleton is a crucial factor that has remarkable consequences on the efficiency, reliability and safety of human-robot interaction. Unfortunately, its quantitative assessment has been largely overlooked in the literature. Here, we present a methodology that allows predicting the motion of the human joints from the knowledge of the angular motion of the exoskeleton frame. Our method combines a subject-specific skeletal model with a kinematic model of a lower limb exoskeleton (H2, Technaid), imposing specific kinematic constraints between them. To calibrate the model and validate its ability to predict the relative motion in a subject-specific way, we performed experiments on seven healthy subjects during treadmill walking tasks. We demonstrate a prediction accuracy lower than 3.5° globally, and around 1.5° at the hip level, which represent an improvement up to 66% compared to the traditional approach assuming no relative motion between the user and the exoskeleton. PMID:29755336

A Subject-Specific Kinematic Model to Predict Human Motion in Exoskeleton-Assisted Gait.

Science.gov (United States)

Torricelli, Diego; Cortés, Camilo; Lete, Nerea; Bertelsen, Álvaro; Gonzalez-Vargas, Jose E; Del-Ama, Antonio J; Dimbwadyo, Iris; Moreno, Juan C; Florez, Julian; Pons, Jose L

2018-01-01

The relative motion between human and exoskeleton is a crucial factor that has remarkable consequences on the efficiency, reliability and safety of human-robot interaction. Unfortunately, its quantitative assessment has been largely overlooked in the literature. Here, we present a methodology that allows predicting the motion of the human joints from the knowledge of the angular motion of the exoskeleton frame. Our method combines a subject-specific skeletal model with a kinematic model of a lower limb exoskeleton (H2, Technaid), imposing specific kinematic constraints between them. To calibrate the model and validate its ability to predict the relative motion in a subject-specific way, we performed experiments on seven healthy subjects during treadmill walking tasks. We demonstrate a prediction accuracy lower than 3.5° globally, and around 1.5° at the hip level, which represent an improvement up to 66% compared to the traditional approach assuming no relative motion between the user and the exoskeleton.

Human Research Program

Data.gov (United States)

National Aeronautics and Space Administration — Strategically, the HRP conducts research and technology development that: 1) enables the development or modification of Agency-level human health and performance...

COMMUNICATIVE COMPETENCE AS THE SUBJECT OF EDUCATIONAL RESEARCH

Directory of Open Access Journals (Sweden)

Yuliya I. Аleyevskaya

2016-09-01

Full Text Available Introduction: the issue of development of the communicative competence is well studied in pedagogical theory and practice. Nevertheless there is no consensus among researchers regarding the interpretation of the notion. This fact determines the relevance of the subject in the context of the reform of the national higher education. The labour market puts forward increasing requirements to graduates’ adaption potential within the system “human – human”. This draws special attention to the problem of communicative co mpetence. Materials and Methods: the authors carried out a sociological research on the communicative component of the competence cluster among master’s degree students who specialise in pedagogical education in order to determine “the importance of weight indicators” of separate competencies. Results: the authors substantiate the necessity of broadening a communicative competence in conditions of transition to a multilevel system of higher education; define its essence and structure taking into account the generic unity of Bachelor’s and Master’s degree programmes. The article presents the informative content of communication components in accordance with the proposed structure of communicative competence, containing motivation-value-based, cognitive, activity-based, reflective and evaluative components. The authors show the potential of communicative competence in the context of the new federal state educational standards (FGOS VO 3+. Further the authors make analysis of the requirements set to graduates upon completion of undergraduate and graduate programmes in “Pedagogical Education”, specify the role of separate competencies in extending graduates’ communicative competence. Discussion and Conclusions: the results of the research presented in the article enable to specify the structure and content of the communicative competence of a university graduate, reflecting the willingness and ability to productive

Social Media Research, Human Behavior, and Sustainable Society

Directory of Open Access Journals (Sweden)

Quan Li

2017-03-01

Full Text Available A bibliometric analysis was conducted to review social media research from different perspectives during the period of 2008–2014 based on the Science Citation Index and Social Science Citation Index database. Using a collection of 10,042 articles related to social media, the bibliometric analysis revealed some interesting patterns and trend of the scientific outputs, major journals, subject categories, spatial distribution, international collaboration, and temporal evolution in keywords usage in social media studies. The research on social media has been characterized by rapid growth and dynamic collaboration, with a rising number of publications and citation. Communication, Sociology, Public, Environment & Occupational Health, Business, and Multidisciplinary Psychology were the five most common categories. Computers in Human Behavior was the journal with the most social media publications, and Computers & Education ranked first according to the average citations. The two most productive countries were the U.S. and UK, delivering about half of the publications. The proportion of China’s internationally collaborative publications was the highest. The University of Wisconsin, the University of Michigan, and Harvard University were three most productive institutions. Several keywords, such as “Facebook”, “Twitter”, “communication”, “Social Networking Sites”, “China”, “climate change”, “big data” and “social support” increasingly gained the popularity during the study period, indicating the research trends on human behavior and sustainability.

Guidelines for Biomedical and Pharmacological Research Procedures and the Protection of Human Subjects in Residential Facilities for Mentally Retarded Persons.

Science.gov (United States)

National Association for Retarded Citizens, Arlington, TX. Research and Demonstration Inst.

Guidelines are presented which were developed to aid federal, state, and local agencies prepare regulations concerning the use of mentally retarded subjects in biomedical and pharmacological research projects. Guidelines are set forth for the following topic areas (sample subtopics in parentheses): the formation of a Professional Review Committee…

Metabolic mapping of functional activity in human subjects with the [18F]fluorodeoxyglucose technique

International Nuclear Information System (INIS)

Greenberg, J.H.; Reivich, M.; Alavi, A.

1981-01-01

The 2-[ 18 F]fluoro-2-deoxy-D-glucose technique was used to measure regional cerebral glucose utilization by human subjects during functional activation. Normal male volunteers subjected to one or more sensory stimuli exhibited focal increases in glucose metabolism in response to the stimulus. These results demonstrate that the technique is capable of providing functional maps in vivo related to both body region and submodality of sensory information in the human brain

Predictive modeling of human perception subjectivity: feasibility study of mammographic lesion similarity

Science.gov (United States)

Xu, Songhua; Hudson, Kathleen; Bradley, Yong; Daley, Brian J.; Frederick-Dyer, Katherine; Tourassi, Georgia

2012-02-01

The majority of clinical content-based image retrieval (CBIR) studies disregard human perception subjectivity, aiming to duplicate the consensus expert assessment of the visual similarity on example cases. The purpose of our study is twofold: i) discern better the extent of human perception subjectivity when assessing the visual similarity of two images with similar semantic content, and (ii) explore the feasibility of personalized predictive modeling of visual similarity. We conducted a human observer study in which five observers of various expertise were shown ninety-nine triplets of mammographic masses with similar BI-RADS descriptors and were asked to select the two masses with the highest visual relevance. Pairwise agreement ranged between poor and fair among the five observers, as assessed by the kappa statistic. The observers' self-consistency rate was remarkably low, based on repeated questions where either the orientation or the presentation order of a mass was changed. Various machine learning algorithms were explored to determine whether they can predict each observer's personalized selection using textural features. Many algorithms performed with accuracy that exceeded each observer's self-consistency rate, as determined using a cross-validation scheme. This accuracy was statistically significantly higher than would be expected by chance alone (two-tailed p-value ranged between 0.001 and 0.01 for all five personalized models). The study confirmed that human perception subjectivity should be taken into account when developing CBIR-based medical applications.

78 FR 69455 - Meetings of Humanities Panel

Science.gov (United States)

2013-11-19

... applications on the subjects of Music and Performing Arts for the Humanities Collections and Reference... meeting will discuss applications on the subject of Research for the Digital Humanities Start Up Grants... discuss applications on the subject of Research for the Digital Humanities Start Up Grants grant program...

Bioavailability and Pharmacodynamics of Promethazine in Human Subjects

Science.gov (United States)

Boyd, J. L.; Boster, B.; Wang, Z.; Shah, V.; Berens, K. L.; Sipes, W. E.; Anderson, K. E.; Putcha, L.

2004-01-01

The acute effects of exposure to microgravity include the development of space motion sickness, which usually requires therapeutic intervention. The current drug of choice, promethazine (PMZ), is available to astronauts in three different dosage forms during space flight; its side effects include nausea, dizziness, sedation and impaired psychomotor performance. This ground-based study is designed to validate flight-suitable methods for pharmacodynamic evaluation of PMZ and to estimate bioavailability and pharmacodynamics of PMZ. Experimental design consists of intramuscular administration of three doses of PMZ (12.5,25 and 50 mg) and placebo in a randomized double blind fashion to human subjects and collecting blood, urine and saliva samples for 72 h. Subjects also complete cognitive performance test batteries, WinSCAT (Windows based Space Cognitive Assessment Test) and ARES (ANAM Readiness Evaluation System). Preliminary results indicate a significant relationship (p=9.88e-05) between circulating PMZ levels and cognitive performance parameters. Time to accurately complete memory tasks increases significantly with concentrations; higher concentrations also increase response time and decrease accuracy of substitution and matching tasks. AUC and half-life estimates for PMZ ranged between 0.12 and 1.7 mg.h/L and 15 and 50 h, respectively. These preliminary results indicate that PMZ may exhibit dose-dependent pharmacokinetics in humans; also, WinSCAT and ARES are sensitive for pharmacodynamic assessment of PMZ, and may be applicable for assessing the pharmacodynamics of other neurocognitive drugs.

Specifics of Educational Texts Selection for Schoolchildren Doing the Humanities Subjects

Directory of Open Access Journals (Sweden)

T. V. Oblasova

2012-01-01

Full Text Available The paper proposes the new approach to educational text selection for the humanities teaching. Its specifics is based on the wide interpretation of educational texts, as the culture texts involved in cognitive learning activity and fulfilling the multiple tasks of the related subjects and personal development. The educational text is taken as a generalized model, its content and structure determining the scheme of a speech cognitive activity, as well as the meaning formation mechanism responsible for understanding and personal development. The texts and tasks selection is oriented on schoolchildren’s understanding with the reference to the psycholinguistic, psychological and hermeneutic approaches; information extraction and interpretation level related to the author’s and student’s context. The given approach could provide the basis for developing and structuring the textbooks content for the humanities subjects. 

The persistence of the subjective in neuropsychopharmacology: observations of contemporary hallucinogen research.

Science.gov (United States)

Langlitz, Nicolas

2010-01-01

The elimination of subjectivity through brain research and the replacement of so-called "folk psychology" by a neuroscientifically enlightened worldview and self-conception has been both hoped for and feared. But this cultural revolution is still pending. Based on nine months of fieldwork on the revival of hallucinogen research since the "Decade of the Brain," this paper examines how subjective experience appears as epistemic object and practical problem in a psychopharmacological laboratory. In the quest for neural correlates of (drug-induced altered states of) consciousness, introspective accounts of test subjects play a crucial role in neuroimaging studies. Firsthand knowledge of the drugs' flamboyant effects provides researchers with a personal knowledge not communicated in scientific publications, but key to the conduct of their experiments. In many cases, the "psychedelic experience" draws scientists into the field and continues to inspire their self-image and way of life. By exploring these domains the paper points to a persistence of the subjective in contemporary neuropsychopharmacology.

A relation between calculated human body exergy consumption rate and subjectively assessed thermal sensation

Energy Technology Data Exchange (ETDEWEB)

Simone, Angela; Kolarik, Jakub; Olesen, Bjarne W. [ICIEE/BYG, Technical University of Denmark (Denmark); Iwamatsu, Toshiya [Faculty of Urban Environmental Science, Tokyo Metropolitan University (Japan); Asada, Hideo [Architech Consulting Co., Tokyo (Japan); Dovjak, Mateja [Faculty of Civil and Geodetic Engineering, University of Ljubljana (Slovenia); Schellen, Lisje [Eindhoven University of Technology, Faculty of Architecture Building and Planning (Netherlands); Shukuya, Masanori [Laboratory of Building Environment, Tokyo City University, Yokohama (Japan)

2011-01-15

Application of the exergy concept to research on the built environment is a relatively new approach. It helps to optimize climate conditioning systems so that they meet the requirements of sustainable building design. As the building should provide a healthy and comfortable environment for its occupants, it is reasonable to consider both the exergy flows in building and those within the human body. Until now, no data have been available on the relation between human-body exergy consumption rates and subjectively assessed thermal sensation. The objective of the present work was to relate thermal sensation data, from earlier thermal comfort studies, to calculated human-body exergy consumption rates. The results show that the minimum human body exergy consumption rate is associated with thermal sensation votes close to thermal neutrality, tending to the slightly cool side of thermal sensation. Generally, the relationship between air temperature and the exergy consumption rate, as a first approximation, shows an increasing trend. Taking account of both convective and radiative heat exchange between the human body and the surrounding environment by using the calculated operative temperature, exergy consumption rates increase as the operative temperature increases above 24 C or decreases below 22 C. With the data available so far, a second-order polynomial relationship between thermal sensation and the exergy consumption rate was established. (author)

34 CFR 97.114 - Cooperative research.

Science.gov (United States)

2010-07-01

... Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.114 Cooperative... safeguarding the rights and welfare of human subjects and for complying with this policy. With the approval of...

Human Research Program Science Management: Overview of Research and Development Activities

Science.gov (United States)

Charles, John B.

2007-01-01

An overview of research and development activities of NASA's Human Research Science Management Program is presented. The topics include: 1) Human Research Program Goals; 2) Elements and Projects within HRP; 3) Development and Maintenance of Priorities; 4) Acquisition and Evaluation of Research and Technology Proposals; and 5) Annual Reviews

Justice, fairness, and membership in a class: conceptual confusions and moral puzzles in the regulation of human subjects research.

Science.gov (United States)

Iltis, Ana S

2011-01-01

This essay examines conceptual difficulties with one of the ways in which justice has been understood and applied the ethical and regulatory review of human research. Justice requires the fair distribution of the benefits and burdens of research. Class membership is seen as justifying inclusion in higher hazard-no benefit research from which members of potentially vulnerable classes, such as children, typically would be excluded. I argue that class membership does not do the justificatory work it is thought to do and that the use of class membership to justify inclusion in higher hazard-no benefit research leads to unjustified discrimination of sick children and offers special protections to healthy children. © 2011 American Society of Law, Medicine & Ethics, Inc.

3 CFR - Guidelines for Human Stem Cell Research

Science.gov (United States)

2010-01-01

... 3 The President 1 2010-01-01 2010-01-01 false Guidelines for Human Stem Cell Research Presidential Documents Other Presidential Documents Memorandum of July 30, 2009 Guidelines for Human Stem Cell Research..., scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent...

UK Library and Information Science Research is Having a Significant Influence on Research in Other Subject Disciplines

Directory of Open Access Journals (Sweden)

Mathew Lee Stone

2014-04-01

Full Text Available Objective – To quantify the value of librarianship and information science (LIS exports knowledge to other subject disciplines. Design – Bibliometric study. Setting – LIS departments in U.K. universities. Subjects – 232 LIS research articles published between 2001 and 2007. Methods – Data from the 2008 U.K. Research Assessment Exercise were checked to identify 405 research articles submitted by 10 selected university departments (out of a total of 21, which submitted research in the LIS category. The Web of Science database was then searched to see how many of these articles had been cited in other articles (n=232. If the citing article was published in a non-LIS journal it was considered a knowledge export. Journals were defined as non-LIS if they had not been assigned the subject category of Information Science & Library Science by the Journal of Citation Reports. The journal Impact Factors (IFs of citing journals were then normalized to measure the value of individual knowledge exports to their respective subject disciplines. This was done by comparing a citing journal’s IF with the median journal IF within that subject category. If the citing journal’s IF was above this median it was considered to be a valuable knowledge export. Main Results – The sample of LIS research articles produced a total of 1,061 knowledge exports in 444 unique non-LIS journals. These non-LIS journals covered 146 unique subject categories of which those related to computer science and chemistry/pharmacology cited LIS research with the greatest frequency. Just over three-quarters (n=798 of these citations were considered to be valuable knowledge exports. A sub-analysis showed that LIS articles published in non-LIS journals were significantly more valuable than the knowledge exports published in LIS journals. Conclusion – The validity of bibliometric studies can be improved by adopting the two methodological innovations presented in this study. The

Research on disaster prevention by human factor

Energy Technology Data Exchange (ETDEWEB)

Kim, Bok Youn; Kang, Chang Hee; Kang, Sun Duck; Jo, Young Do [Korea Institute of Geology Mining and Materials, Taejon (Korea)

1998-12-01

Mining, by its very nature, requires workers and technology to function in an unpredictable environment that can not easily be engineered to accommodate human factors. Miners' physical and cognitive capabilities are sometimes stretched to the point that 'human error' in performance result. Mine safety researchers estimate that 50-85% of all mining injuries are due, in large part, to human error. Further research suggests that the primary causes of these errors in performance lie outside the individual and can be minimized by improvements in equipment design, work environments, work procedures and training. The human factors research is providing the science needed to determine which aspects of the mining environment can be made more worker-friendly and how miners can work more safely in environments that can not be improved. Underground mines have long been recognized as an innately hazardous and physically demanding work environment. Recently, mining is becoming a more complicated process as more sophisticated technologies are introduced. The more complicated or difficult the tasks to be performed, the more critical it is to have a systematic understanding of the humans, the technology, the environments, and how they interact. Human factors is a key component in solving most of today's mine safety and health problems. Human factors research primarily centered around solving problems in the following four areas: 1) How mining methods and equipment affect safety, 2) Evaluating the fit between miner's physical capabilities and the demands of their job, 3) Improving miner's ability to perceive and react to hazards, 4) Understanding how organizational and managerial variables influence safety. Human factor research was begun during the World war II. National Coal Board (British Coal) of Great Britain commenced ergonomics in 1969, and Bureau of Mine of United States started human factor researches in same year. Japan has very short history

Management and research priorities of NASA 'Human Research Program'

International Nuclear Information System (INIS)

Zhou Weijun; Diao Tianxi; Li Lijuan; Li Zulan

2013-01-01

Research on humans has been the focus of the United States space biomedical research, while 'Human Research Program', as an important project initiated by NASA, aims to reduce the risks to the health and performance of astronauts. This paper analyzed this project in terms of organization and management, funding investment and research directions. (authors)

45 CFR 46.109 - IRB review of research.

Science.gov (United States)

2010-10-01

... Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.109 IRB review of research. (a) An... judgment the information would meaningfully add to the protection of the rights and welfare of subjects. (c...

Human Research Ethics Committees in Technical Universities

NARCIS (Netherlands)

Koepsell, D.R.; Brinkman, W.P.; Pont, S.C.

2014-01-01

Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although

34 CFR 97.123 - Early termination of research support: Evaluation of applications and proposals.

Science.gov (United States)

2010-07-01

... PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.123 Early termination of research support: Evaluation of... the protection of the rights and welfare of human subjects (whether or not the research was subject to...

Development, implementation and critique of a bioethics framework for pharmaceutical sponsors of human biomedical research.

Science.gov (United States)

Van Campen, Luann E; Therasse, Donald G; Klopfenstein, Mitchell; Levine, Robert J

2015-11-01

Pharmaceutical human biomedical research is a multi-dimensional endeavor that requires collaboration among many parties, including those who sponsor, conduct, participate in, or stand to benefit from the research. Human subjects' protections have been promulgated to ensure that the benefits of such research are accomplished with respect for and minimal risk to individual research participants, and with an overall sense of fairness. Although these protections are foundational to clinical research, most ethics guidance primarily highlights the responsibilities of investigators and ethics review boards. Currently, there is no published resource that comprehensively addresses bioethical responsibilities of industry sponsors; including their responsibilities to parties who are not research participants, but are, nevertheless key stakeholders in the endeavor. To fill this void, in 2010 Eli Lilly and Company instituted a Bioethics Framework for Human Biomedical Research. This paper describes how the framework was developed and implemented and provides a critique based on four years of experience. A companion article provides the actual document used by Eli Lilly and Company to guide ethical decisions regarding all phases of human clinical trials. While many of the concepts presented in this framework are not novel, compiling them in a manner that articulates the ethical responsibilities of a sponsor is novel. By utilizing this type of bioethics framework, we have been able to develop bioethics positions on various topics, provide research ethics consultations, and integrate bioethics into the daily operations of our human biomedical research. We hope that by sharing these companion papers we will stimulate discussion within and outside the biopharmaceutical industry for the benefit of the multiple parties involved in pharmaceutical human biomedical research.

The self as subject autoethnographic research into identity, culture, and academic librarianship

CERN Document Server

Deitering, Anne-Marie; Stoddart, Richard

2017-01-01

Using autoethnography as their research method, the 21 academic librarian authors of The Self as Subject: Autoethnographic Research into Identity, Culture, and Academic Librarianship investigate aspects of what it means to be a librarian. Starting with a reflective examination of themselves, they each investigate questions of culture, values, and identity. The Self as Subject presents a collection of reflective narratives that, taken together, explore the varied dimensions of librarianship in the present moment. It also examines autoethnography's potential to help librarians answer questions that cannot be answered by traditional, empirical research methods and to reveal voices that are obscured by aggregations of data.

Salivary alpha amylase activity in human beings of different age groups subjected to psychological stress.

Science.gov (United States)

Sahu, Gopal K; Upadhyay, Seema; Panna, Shradha M

2014-10-01

Salivary alpha-amylase (sAA) has been proposed as a sensitive non-invasive biomarker for stress-induced changes in the body that reflect the activity of the sympathetic nervous system. Though several experiments have been conducted to determine the validity of this salivary component as a reliable stress marker in human subjects, the effect of stress induced changes on sAA level in different age groups is least studied. This article reports the activity of sAA in human subjects of different age groups subjected to psychological stress induced through stressful video clip. Differences in sAA level based on sex of different age groups under stress have also been studied. A total of 112 subjects consisting of both the male and female subjects, divided into two groups on basis of age were viewed a video clip of corneal transplant surgery as stressor. Activity of sAA from saliva samples of the stressed subjects were measured and compared with the activity of the samples collected from the subjects before viewing the clip. The age ranges of subjects were 18-25 and 40-60 years. The sAA level increased significantly in both the groups after viewing the stressful video. The increase was more pronounced in the younger subjects. The level of sAA was comparatively more in males than females in the respective groups. No significant change in sAA activity was observed after viewing the soothed video clip. Significant increase of sAA level in response to psychological stress suggests that it might act as a reliable sympathetic activity biochemical marker in different stages of human beings.

Military chemical warfare agent human subjects testing: part 1--history of six-decades of military experiments with chemical warfare agents.

Science.gov (United States)

Brown, Mark

2009-10-01

Military chemical warfare agent testing from World War I to 1975 produced thousands of veterans with concerns of possible long-term health consequences. Clinical and research evaluation of potential long-term health effects has been difficult because the exposures occurred decades ago, the identity of troops exposed and exposure magnitudes are uncertain, and acute effects during experiments poorly documented. In contrast, a companion article describes the large amount of information available about the specific agents tested and their long-term health effects. This short history describes U.S. military chemical-agent experiments with human subjects and identifies tested agents. Finally, the demonstrated need to anticipate future health concerns from military personnel involved in such military testing suggests current and future military researchers should be required, by law and regulation, to fully record the identity of those exposed, relevant exposure magnitude, and complete medical information for all subjects. New study protocols and institutional review board approvals for research involving military personnel should reflect this need.

Insulin resistance in human subjects having impaired glucose regulation

International Nuclear Information System (INIS)

Khan, S.H.; Khan, F.A.; Ijaz, A.

2007-01-01

To determine insulin resistance in human subjects having impaired glucose regulation (IGR) by Homeostasis Model Assessment for Insulin Resistance (HOMA-IR). A total of 100 subjects with impaired glucose regulation were selected for evaluation of metabolic syndrome as per the criteria of National Cholesterol Education Program, Adult Treatment Panel III (NCEP, ATP III), along with 47 healthy age and gender-matched controls. Physical examination to determine blood pressure and waist circumference was carried out and so was sampling for plasma glucose, serum triglycerides, HDL-cholesterol and insulin. Insulin resistance was calculated by the HOMA-IR. Finally, subjects with and without metabolic syndrome were compared with controls (n=47), using one-way ANOVA for studying insulin resistance between groups, with Tukey's post-hoc comparison. The frequency of finding metabolic syndrome in cases of IGR remained 47%. The insulin resistance demonstrated stepwise worsening from control population (mean=1.54, 95 % CI: 1.77 - 2.37) to subjects suffering from only IGR (mean=2.07, 95 % CI: 1.77- 2.37) to metabolic syndrome (mean=2.67, 95 %, CI: 2.34 - 3.00) (p < 0.001). Patients with impaired glucose regulation may have significant insulin resistance. It is, thus, recommended that a vigorous search be made to measure insulin resistance in all cases diagnosed to have impaired glucose regulation. (author)

Problematizing Digital Research Evaluation using DOIs in Practice-Based Arts, Humanities and Social Science Research.

Science.gov (United States)

Swijghuisen Reigersberg, Muriel

2015-01-01

This paper explores emerging practices in research data management in the arts, humanities and social sciences (AHSS). It will do so vis-à-vis current citation conventions and impact measurement for research in AHSS. Case study findings on research data inventoried at Goldsmiths', University of London will be presented. Goldsmiths is a UK research-intensive higher education institution which specialises in arts, humanities and social science research. The paper's aim is to raise awareness of the subject-specific needs of AHSS scholars to help inform the design of future digital tools for impact analysis in AHSS. Firstly, I shall explore the definition of research data and how it is currently understood by AHSS researchers. I will show why many researchers choose not to engage with digital dissemination techniques and ORCID. This discussion must necessarily include the idea that practice-based and applied AHSS research are processes which are not easily captured in numerical 'sets' and cannot be labelled electronically without giving careful consideration to what a group or data item 'represents' as part of the academic enquiry, and therefore how it should be cited and analysed as part of any impact assessment. Then, the paper will explore: the role of the monograph and arts catalogue in AHSS scholarship; how citation practices and digital impact measurement in AHSS currently operate in relation to authorship and how digital identifiers may hypothetically impact on metrics, intellectual property (IP), copyright and research integrity issues in AHSS. I will also show that, if we are to be truly interdisciplinary, as research funders and strategic thinkers say we should, it is necessary to revise the way we think about digital research dissemination. This will involve breaking down the boundaries between AHSS and other types of research.

Leptin in humans: lessons from translational research.

Science.gov (United States)

Blüher, Susann; Mantzoros, Christos S

2009-03-01

Leptin has emerged over the past decade as a key hormone in not only the regulation of food intake and energy expenditure but also in the regulation of neuroendocrine and immune function as well as the modulation of glucose and fat metabolism as shown by numerous observational and interventional studies in humans with (complete) congenital or relative leptin deficiency. These results have led to proof-of-concept studies that have investigated the effect of leptin administration in subjects with complete (congenital) leptin deficiency caused by mutations in the leptin gene as well as in humans with relative leptin deficiency, including states of lipoatrophy or negative energy balance and neuroendocrine dysfunction, as for instance seen with hypothalamic amenorrhea in states of exercise-induced weight loss. In those conditions, most neuroendocrine, metabolic, or immune disturbances can be restored by leptin administration. Leptin replacement therapy is thus a promising approach in several disease states, including congenital complete leptin deficiency, states of energy deprivation, including anorexia nervosa or milder forms of hypothalamic amenorrhea, as well as syndromes of insulin resistance seen in conditions such as congenital or acquired lipodystrophy. In contrast, states of energy excess such as garden-variety obesity are associated with hyperleptinemia that reflects either leptin tolerance or leptin resistance. For those conditions, development of leptin sensitizers is currently a focus of pharmaceutical research. This article summarizes our current understanding of leptin's role in human physiology and its potential role as a novel therapeutic option in human disease states associated with a new hormone deficiency, ie, leptin deficiency.

Evolution of Attitudes in the Field of Human Research Ethics

Directory of Open Access Journals (Sweden)

Hugo Escobar-Melo

2008-05-01

Full Text Available The state of evolution of attitudes in a sample of 142 Medical Students at the Pontificia Universidad Javeriana in Bogota (at the beginning, middle and ending of their studies in the field of Human Research Ethics (HRE is analytically described. A complex scale of attitudes was used, with three components: affective, beliefs-related and behavioral, further divided into three theoretical categories taken from Bioethics: Subject-End/means- Dignity, Benefit and Justice. The relationship between the current medical education process and the attitudes regarding HRE in the sample are analyzed.A small trend towards progress in all categories and in all components of attitudes throughout medical education is described; neither the Benefit nor the Subject-End/means/Dignity categories evolve in a significant way; some significant differences were observed in the Justice category (beliefs and behavioral and in the Subject-End/means-Dignity category (beliefs component. The results allow for asking about the role of formation and evolution of those attitudes throughout the academic process. In conclusion, attitudes seem to be progressing relatively, without a decisive evolution.

40 CFR 26.114 - Cooperative research.

Science.gov (United States)

2010-07-01

....114 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.114... responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. With...

[Disability, inability and vulnerability: on ableism or the pre-eminence of ableist and biomedical approaches of the Human Subjects Ethics Committee of UFSC].

Science.gov (United States)

Mello, Anahi Guedes de

2016-10-01

Anthropology has increasingly questioned the hegemony of biomedical knowledge in ethical review processes of social research projects prevailing in Brazil, which was governed until 2012 by the Human Research Ethics Committee of each institution under the auspices of the National Research Ethics Commission (CONEP). This was mandated through Resolution No. 196/1996 prevailing in 2012 when this field research was conducted. The scope of this study is to recount and reflect upon the barriers to obtaining approval in 2012 for my master's research project from the Human Research Ethics Committee of the Federal University of Santa Catarina (CEP/UFSC) in Florianopolis. In this ethnographic experience, in the light of Crip theory, I observed how the "disability," "vulnerability" and "inability" categories are articulated to reveal the ableism and the primacy of the biomedical model in the case of an ethics review at UFSC regarding the participation and legal capacity of persons with disabilities as subjects of research.

75 FR 45130 - Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research...

Science.gov (United States)

2010-08-02

... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0125] Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research Without an...

Congenital candidiasis as a subject of research in medicine and human ecology.

Science.gov (United States)

Skoczylas, Michał M; Walat, Anna; Kordek, Agnieszka; Loniewska, Beata; Rudnicki, Jacek; Maleszka, Romuald; Torbé, Andrzej

2014-01-01

Congenital candidiasis is a severe complication of candidal vulvovaginitis. It occurs in two forms,congenital mucocutaneous candidiasis and congenital systemic candidiasis. Also newborns are in age group the most vulnerable to invasive candidiasis. Congenital candidiasis should be considered as an interdisciplinary problem including maternal and fetal condition (including antibiotic therapy during pregnancy), birth age and rare genetic predispositions as severe combined immunodeficiency or neutrophil-specific granule deficiency. Environmental factors are no less important to investigate in diagnosing, treatment and prevention. External factors (e.g., food) and microenvironment of human organism (microflora of the mouth, intestine and genitalia) are important for solving clinical problems connected to congenital candidiasis. Physician knowledge about microorganisms in a specific compartments of the microenvironment of human organism and in the course of defined disorders of homeostasis makes it easier to predict the course of the disease and allows the development of procedures that can be extremely helpful in individualized diagnostic and therapeutic process.

Human rights, politics, and reviews of research ethics.

Science.gov (United States)

Beyrer, Chris; Kass, Nancy E

2002-07-20

Although the human rights movement and the sphere of research ethics have overlapping principles and goals, there has been little attempt to incorporate external political and human rights contexts into research ethics codes or ethics reviews. Every element of a research ethics review--the balance of risks and benefits, the assurance of rights for individual participants, and the fair selection of research populations--can be affected by the political and human rights background in which a study is done. Research that at first seems to be low in risk may become high in risk if implemented in a country where the government might breach the confidentiality of study results or where results might be used to deport a refugee group. Researchers should determine whether research could or should be done by consulting human rights organisations and, when possible, a trusted colleague, to learn the background political context and human rights conditions of the settings in which they propose to do research.

Mapping frontier research in the humanities

DEFF Research Database (Denmark)

-academic fields and supplemented by new transdisciplinary methods focusing on solving grand societal challenges, such as globalisation, multiculturalism, equality, democracy, security and health. Given the nature of these challenges and the ways in which university leadership has been organised, the very notion...... of impact and styles of reasoning, both in classical and interdisciplinary fields of the humanities. From this perspective, a more composite picture of human culture, language and history can emerge from humanities research. It goes beyond the picture of rational agents, and situates human interaction...... in more complex landscapes of collective identities, networks, and constraints that open for new forms of intellectual leadership in the 21st century. Link: http://www.bloomsbury.com/uk/mapping-frontier-research-in-the-humanities-9781472597687/...

Mapping Frontier Research in the Humanities

DEFF Research Database (Denmark)

-academic fields and supplemented by new transdisciplinary methods focusing on solving grand societal challenges, such as globalisation, multiculturalism, equality, democracy, security and health. Given the nature of these challenges and the ways in which university leadership has been organised, the very notion...... of impact and styles of reasoning, both in classical and interdisciplinary fields of the humanities. From this perspective, a more composite picture of human culture, language and history can emerge from humanities research. It goes beyond the picture of rational agents, and situates human interaction...... in more complex landscapes of collective identities, networks, and constraints that open for new forms of intellectual leadership in the 21st century. Link: http://www.bloomsbury.com/uk/mapping-frontier-research-in-the-humanities-9781472597687/...

Research of Human Postural Balance Parameters

Directory of Open Access Journals (Sweden)

Julius Griškevičius

2011-02-01

Full Text Available In present article postural balance between subjects with stroke and healthy subjects, is being investigated with eyes opened and eyes closed. In the research participated 30 healthy subjects and 15 subjects with stroke. At the same time two experimental measurements were performed – postural balance was measured using balance platform and oscillations of the centre of mass were observed using two-axial accelerometer. It was noted, that amplitudes of subjects with stroke were larger almost two times than control group’s of healthy subjects. It was find out, that ratios of pressure distribution on both left and right legs are in range from 1 to 0.9 for healthy subjects, and ratios below 0.9 are common for subjects with stroke. When subjects were standing with eyes closed, sway amplitudes were higher and the ratios of load distribution on left and right legs were lower.Article in Lithuanian

Application of radioactive substances in research in nuclear medicine: current trends and radiation exposure to the study subjects

International Nuclear Information System (INIS)

Minkov, V.; Schwarz, E.R.; Bauer, B.; Nosske, D.; Erzberger, A.; Brix, G.

2001-01-01

Aim: Analysis of the application of radioactive substances in research in the field of nuclear medicine in human beings and of the resulting radiation exposure to study subjects. Methods: Assessment of applications for approval submitted in accordance with Paragraph 41 of the Radiation Protection Ordinance, evaluated by the Federal office for Radiation Protection together with the Federal Institute for Pharmaceuticals and Medical Products, within the period from 1997 to 1999. Results: The focus of the studies on the diagnostic application of radioactive substances in medicine evaluated has, since 1998, shifted from oncological to neurological and psychological aspects, while, at the same time, the number of PET studies increased constantly The proportion of healthy study subjects included in the diagnostic studies increased from 7 to 22%. The number of therapeutic applications of radioactive substances has, since 1997, undergone a three-fold increase, and in the process of this, the focus of attention lay within the area of radioimmuno-therapy and endovascular brachytherapy. The effective dose was, among up to 49% of the investigated healthy study subjects higher than 5 mSv, and among up to 6% of these subjects was at levels of over 20 mSv. Up to 22% of the patients received, within the scope of diagnostic studies, an effective dose of between 20 and 50 mSv. An exceeding of the 50 mSv limit occurred among up to 3% of the patients. Conclusions: In spite of the increasing numbers of PET applications, conventional nuclear medicine has maintained its importance in the field of medical research. Further developments in the areas of radiochemistry and molecular biology led to an increase in the importance of radio-immuno therapy. The evaluation of new radiopharmaceuticals and the extension of basic biomedical research, resulted in an increase in the proportion of healthy study subjects included in the studies. The radiation exposure among subjects resulting directly from

The "Subject of Ethics" and Educational Research OR Ethics or Politics? Yes Please!

Science.gov (United States)

Bazzul, Jesse

2017-01-01

This paper outlines a theoretical context for research into "the subject of ethics" in terms of how students come to see themselves as self-reflective actors. I maintain that the "subject of ethics," or ethical subjectivity, has been overlooked as a necessary aspect of creating politically transformative spaces in education. At…

From the Philosophy of Consciousness to the Philosophy of Difference: The Subject for Education after Humanism

Science.gov (United States)

Zhao, Guoping

2015-01-01

Biesta has suggested that education after humanism should be interested in existence, not essence, in what the subject can do, not in what the subject is--the truth about the subject--and this is the way inspired by Foucault and Levinas. In this article, I analyze Foucault's alleged deconstruction and reconfiguration of the subject and Levinas'…

The motor cortex drives the muscles during walking in human subjects

DEFF Research Database (Denmark)

Petersen, Tue Hvass; Willerslev-Olsen, Maria; Conway, B A

2012-01-01

Indirect evidence that the motor cortex and the corticospinal tract contribute to the control of walking in human subjects has been provided in previous studies. In the present study we used coherence analysis of the coupling between EEG and EMG from active leg muscles during human walking...... area and EMG from the anterior tibial muscle was found in the frequency band 24–40 Hz prior to heel strike during the swing phase of walking. This signifies that rhythmic cortical activity in the 24–40 Hz frequency band is transmitted via the corticospinal tract to the active muscles during walking...

Research strategies for human performance

International Nuclear Information System (INIS)

1998-01-01

Knowledge about factors that influence Human Performance is essential for the safety of nuclear power plant operation. Through a number of tasks, workshops and projects, experience is shared among OECD countries. At its December 1996 meeting, the CSNI endorsed the SESAR/CAF report on 'Nuclear Safety Research in OECD Countries: Capabilities and Facilities' and requested that the Principal Working Groups (PWGs) review existing co-operative programmes and develop specifications for programmes which address the identified needs. Following discussions between the chairmen of these PWGs and the NEA Secretariat, it was concluded that, for this technical area, the development of programme specifications must be preceded by the development of a strategic document that further elaborates the conclusions of the SESAR/CAF report and set out the general orientation of the research over the medium and long term. Accordingly, a group of senior experts met in August 1997 to discuss possible strategies in the area of Human Performance. The objectives of this meeting were: - To exchange information on existing plans and strategies by different Member countries; - To determine relevant issues and realistic medium/long-term targets and expectations for their resolution, and - To determine, in general sense, possible research programmes, their priority and their likelihood for success. This document is the result of this meeting. Its objective is to present to the CSNI proposals for future work on Human Performance research. The proposals are built upon the work performed to date by PWG1 and PWG5. Carrying out these proposals will continue to require close coordination on joint activities between these two PWGs. Reinforced systematic networking activities are needed particularly in management and organisational performance research to initiate and manage comparison and benchmarking activities. Synchronising the availability of funding is a specific problem in many cases. Since most

Digital music exposure reliably induces temporary threshold shift in normal-hearing human subjects.

Science.gov (United States)

Le Prell, Colleen G; Dell, Shawna; Hensley, Brittany; Hall, James W; Campbell, Kathleen C M; Antonelli, Patrick J; Green, Glenn E; Miller, James M; Guire, Kenneth

2012-01-01

One of the challenges for evaluating new otoprotective agents for potential benefit in human populations is the availability of an established clinical paradigm with real-world relevance. These studies were explicitly designed to develop a real-world digital music exposure that reliably induces temporary threshold shift (TTS) in normal-hearing human subjects. Thirty-three subjects participated in studies that measured effects of digital music player use on hearing. Subjects selected either rock or pop music, which was then presented at 93 to 95 (n = 10), 98 to 100 (n = 11), or 100 to 102 (n = 12) dBA in-ear exposure level for a period of 4 hr. Audiograms and distortion product otoacoustic emissions (DPOAEs) were measured before and after music exposure. Postmusic tests were initiated 15 min, 1 hr 15 min, 2 hr 15 min, and 3 hr 15 min after the exposure ended. Additional tests were conducted the following day and 1 week later. Changes in thresholds after the lowest-level exposure were difficult to distinguish from test-retest variability; however, TTS was reliably detected after higher levels of sound exposure. Changes in audiometric thresholds had a "notch" configuration, with the largest changes observed at 4 kHz (mean = 6.3 ± 3.9 dB; range = 0-14 dB). Recovery was largely complete within the first 4 hr postexposure, and all subjects showed complete recovery of both thresholds and DPOAE measures when tested 1 week postexposure. These data provide insight into the variability of TTS induced by music-player use in a healthy, normal-hearing, young adult population, with music playlist, level, and duration carefully controlled. These data confirm the likelihood of temporary changes in auditory function after digital music-player use. Such data are essential for the development of a human clinical trial protocol that provides a highly powered design for evaluating novel therapeutics in human clinical trials. Care must be taken to fully inform potential subjects in

Human Health Countermeasures (HHC) Element Management Plan: Human Research Program. Revision B

Science.gov (United States)

Norsk, Peter; Baumann, David

2012-01-01

NASA s Human Research Program (HRP) is an applied research and technology program within the Human Exploration and Operations Mission Directorate (HEOMD) that addresses human health and performance risk mitigation strategies in support of exploration missions. The HRP research and technology development is focused on the highest priority risks to crew health and safety with the goal of ensuring mission success and maintaining long-term crew health. Crew health and performance standards, defined by the NASA Chief Health and Medical Officer (CHMO), set the acceptable risk level for exploration missions. The HRP conducts research to inform these standards as well as provide deliverables, such as countermeasures, that ensure standards can be met to maximize human performance and mission success. The Human Health Countermeasures (HHC) Element was formed as part of the HRP to develop a scientifically-based, integrated approach to understanding and mitigating the health risks associated with human spaceflight. These health risks have been organized into four research portfolios that group similar or related risks. A fifth portfolio exists for managing technology developments and infrastructure projects. The HHC Element portfolios consist of: a) Vision and Cardiovascular; b) Exercise and Performance; c) Multisystem; d) Bone; and e) Technology and Infrastructure. The HHC identifies gaps associated with the health risks and plans human physiology research that will result in knowledge required to more fully understand risks and will result in validated countermeasures to mitigate risks.

Dream as a subject of psychological research

Directory of Open Access Journals (Sweden)

P.A. Egorova,

2014-08-01

Full Text Available We discuss the main theoretical concepts of a dream: dream definitions, ideas about its genesis, functions, dream location in the structure of activity. We analyze the similarities and differences between the approaches. The results of empirical studies of adolescent and adult dreams are generalized, dream functions in adolescence are analyzed. Based on the analysis of different approaches, we chose theoretical basis of our own research – A. Leontiev activity theory, L.S. Vygotsky concept, K. Lewin's model. We formulated and substantiated the definition of dream as emotionally colored image of the desired future, having a subjective significance. We show the significance and hypotheses of our research: 1 the content of dreams is connected not only with a situation of frustration, but also with the teenager abilities, 2 the dream is involved in regulating of values choice; 3 restoration and development of the ability to dream can be used in the practice of counseling and psychotherapy as an effective tool to help adolescents and adults

Analysis of the intellectual structure of human space exploration research using a bibliometric approach: Focus on human related factors

Science.gov (United States)

Lee, Tai Sik; Lee, Yoon-Sun; Lee, Jaeho; Chang, Byung Chul

2018-02-01

Human space exploration (HSE) is an interdisciplinary field composed of a range of subjects that have developed dramatically over the last few decades. This paper investigates the intellectual structure of HSE research with a focus on human related factors. A bibliometric approach with quantitative analytical techniques is applied to study the development and growth of the research. This study retrieves 1921 papers on HSE related to human factors from the year 1990 to the year 2016 from Web of Science and constructs a critical citation network composed of 336 papers. Edge-betweenness-based clustering is used to classify the citation network into twelve distinct research clusters based on four research themes: "biological risks from space radiation," "health and performance during long-duration spaceflight," "program and in-situ resources for HSE missions," and "habitat and life support systems in the space environment." These research themes are also similar to the classification results of a co-occurrence analysis on keywords for a total of 1921 papers. Papers with high centrality scores are identified as important papers in terms of knowledge flow. Moreover, the intermediary role of papers in exchanging knowledge between HSE sub-areas is identified using brokerage analysis. The key-route main path highlights the theoretical development trajectories. Due to the recent dramatic increase in investment by international governments and the private sector, the theoretical development trajectories of key research themes have been expanding from furthering scientific and technical knowledge to include various social and economic issues, thus encouraging massive public participation. This study contributes to an understanding of research trends and popular issues in the field of HSE by introducing a powerful way of determining major research themes and development trajectories. This study will help researchers seek the underlying knowledge diffusion flow from multifaceted

Endurance training enhances skeletal muscle interleukin-15 in human male subjects

DEFF Research Database (Denmark)

Rinnov, Anders; Yfanti, Christina; Nielsen, Søren

2014-01-01

Regular endurance exercise promotes metabolic and oxidative changes in skeletal muscle. Overexpression of interleukin-15 (IL-15) in mice exerts similar metabolic changes in muscle as seen with endurance exercise. Muscular IL-15 production has been shown to increase in mice after weeks of regular...... endurance running. With the present study we aimed to determine if muscular IL-15 production would increase in human male subjects following 12 weeks of endurance training. In two different studies we obtained plasma and muscle biopsies from young healthy subjects performing: (1) 12 weeks of ergometer...... weeks of regular endurance training induced a 40% increase in basal skeletal muscle IL-15 protein content (p...

Human research ethics committees in technical universities.

Science.gov (United States)

Koepsell, David; Brinkman, Willem-Paul; Pont, Sylvia

2014-07-01

Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although mandated in the United States, the United Kingdom, Canada, and Australia, non-medical research involving humans need not receive ethics review in much of Europe, Asia, Latin America, and Africa. Our survey of the top 50 technical universities in the world shows that, where not specifically mandated by law, most technical universities do not employ ethics committees to review human studies. As the domains of basic and applied sciences expand, ethics committees are increasingly needed to guide and oversee all such research regardless of legal requirements. We offer as examples, from our experience as an ethics committee in a major European technical university, ways in which such a committee provides needed services and can help ensure more ethical studies involving humans outside the standard medical context. We provide some arguments for creating such committees, and in our supplemental article, we provide specific examples of cases and concerns that may confront technical, engineering, and design research, as well as outline the general framework we have used in creating our committee. © The Author(s) 2014.

Inter-subject variability in human atrial action potential in sinus rhythm versus chronic atrial fibrillation.

Directory of Open Access Journals (Sweden)

Carlos Sánchez

Full Text Available Human atrial electrophysiology exhibits high inter-subject variability in both sinus rhythm (SR and chronic atrial fibrillation (cAF patients. Variability is however rarely investigated in experimental and theoretical electrophysiological studies, thus hampering the understanding of its underlying causes but also its implications in explaining differences in the response to disease and treatment. In our study, we aim at investigating the ability of populations of human atrial cell models to capture the inter-subject variability in action potential (AP recorded in 363 patients both under SR and cAF conditions.Human AP recordings in atrial trabeculae (n = 469 from SR and cAF patients were used to calibrate populations of computational SR and cAF atrial AP models. Three populations of over 2000 sampled models were generated, based on three different human atrial AP models. Experimental calibration selected populations of AP models yielding AP with morphology and duration in range with experimental recordings. Populations using the three original models can mimic variability in experimental AP in both SR and cAF, with median conductance values in SR for most ionic currents deviating less than 30% from their original peak values. All cAF populations show similar variations in G(K1, G(Kur and G(to, consistent with AF-related remodeling as reported in experiments. In all SR and cAF model populations, inter-subject variability in I(K1 and I(NaK underlies variability in APD90, variability in I(Kur, I(CaL and I(NaK modulates variability in APD50 and combined variability in Ito and I(Kur determines variability in APD20. The large variability in human atrial AP triangulation is mostly determined by I(K1 and either I(NaK or I(NaCa depending on the model.Experimentally-calibrated human atrial AP models populations mimic AP variability in SR and cAF patient recordings, and identify potential ionic determinants of inter-subject variability in human atrial AP

Human Genome Research: Decoding DNA

Science.gov (United States)

dropdown arrow Site Map A-Z Index Menu Synopsis Human Genome Research: Decoding DNA Resources with of the DNA double helix during April 2003. James D. Watson, Francis Crick, and Maurice Wilkins were company Celera announced the completion of a "working draft" reference DNA sequence of the human

[The physical therapy undergraduate students' responses to the gross human anatomy subjects].

Science.gov (United States)

Anahara, Reiko; Kawashiro, Yukiko; Matsuno, Yoshiharu; Mori, Chisato; Kohno, Toshihiko

2008-09-01

Instruction in gross human anatomy is one of the important items in the subject for co-medical students of the physical therapist course. The physical therapy undergraduate students are required to have a solid understanding of the structure and formation of the human body. Therefore, their good-understanding of the course on the gross human anatomy and their experience of the gross human anatomy laboratory (observation practice) are acquired to improve their knowledge of the human body. To clarify the student responses to the gross human anatomy course including the gross human anatomy laboratory, several questionnaires were administered to the freshman physical therapy undergraduate student for two years. We found that more than 80% of the students, who felt a negative attitude for gross human anatomy before the course started, had a positive attitude about the gross human anatomy after going through the course. The experience of the gross human anatomy laboratory increased the students' activity of learning and they thought more about the dignity of being human after the course than before viewing. In addition, the results suggested that the multiple experiences of the gross human anatomy course are useful for the physical therapy undergraduate students to improve the quality of their understanding of the human body.

"Biosphere Reserve"--The Actual Research Subject of the Sustainable Development Process"

Science.gov (United States)

Khasaev, Gabibulla R.; Sadovenko, Marina Yu.; Isaev, Roman O.

2016-01-01

The relevance of the analyzed issue is caused by the growing slippage of research funds of sustainable development in its practice. The purpose of the article is the theoretical basis of the biosphere reserve as a scientific research subject that is relevant to rules of the scientific activity. The leading approach to the study of this issue is…

The Biology of Aging: Citizen Scientists and Their Pets as a Bridge Between Research on Model Organisms and Human Subjects.

Science.gov (United States)

Kaeberlein, M

2016-03-01

A fundamental goal of research into the basic mechanisms of aging is to develop translational strategies that improve human health by delaying the onset and progression of age-related pathology. Several interventions have been discovered that increase life span in invertebrate organisms, some of which have similar effects in mice. These include dietary restriction and inhibition of the mechanistic target of rapamycin by treatment with rapamycin. Key challenges moving forward will be to assess the extent to which these and other interventions improve healthy longevity and increase life span in mice and to develop practical strategies for extending this work to the clinic. Companion animals may provide an optimal intermediate between laboratory models and humans. By improving healthy longevity in companion animals, important insights will be gained regarding human aging while improving the quality of life for people and their pets. © The Author(s) 2015.

Review on present state of human model researches in nuclear engineering and the prospect for their industrial applications

International Nuclear Information System (INIS)

Yoshikawa, Hidekazu; Furuta, Kazuo; Nakagawa, Tsuneo; Yoshimura, Seiichi; Yoshida, Kazuo; Naito, Norio

1999-01-01

Reviews have been made on the researches and developments for human models in the field of nuclear engineering. Until now, the related works have been made mainly for the modeling of plant operator and operator crew in the control room, but also there arise new tendencies of extending the modeling works for maintenance field as well as for personnel training purposes. The whole range of human model research is divided into the five areas of (a) modeling for machine system, (b) measurement and analysis of human information behavior, (c) modeling of human internal information process, (d) modeling of human interaction with machine system, and (e) that of between human themselves. The real examples of the human model developments as well as their methods, applications, and the model validations are described, and then, the further subjects and efforts are pointed out which would be needed for the broader industrial application of the human modeling. (author)

Challenges of Research and Human Capital Development in Nigeria

Science.gov (United States)

Chikwe, Christian K.; Ogidi, Reuben C.; Nwachukwu, K.

2015-01-01

The paper discussed the challenges of research and human capital development in Nigeria. Research and human capital development are critical to the development of any nation. Research facilitates human capital development. A high rating in human capital development indices places a country among the leading countries of the world. The paper…

Unsteady-state human-body exergy consumption rate and its relation to subjective assessment of dynamic thermal environments

DEFF Research Database (Denmark)

Schweiker, Marcel; Kolarik, Jakub; Dovjak, Mateja

2016-01-01

of the present study confirmed previously indicated trends that lowest human body exergy consumption rate is associated with thermal sensation close to neutrality. Moreover, higher acceptability was in general associated with lower human body exergy consumption rate. (C) 2016 Elsevier B.V. All rights reserved.......Few examples studied applicability of exergy analysis on human thermal comfort. These examples relate the human-body exergy consumption rate with subjectively obtained thermal sensation votes and had been based on steady-state calculation methods. However, humans are rarely exposed to steady...... between the human-body exergy consumption rate and subjective assessment of thermal environment represented by thermal sensation as well as to extend the investigation towards thermal acceptability votes. Comparison of steady-state and unsteady-state model showed that results from both models were...

Overview of the Human Exploration Research Analog (HERA)

Science.gov (United States)

Neigut, J.

2015-01-01

In 2013, the Human Research Program at NASA began developing a new confinement analog specifically for conducting research to investigate the effects of confinement on the human system. The HERA (Human Exploration Research Analog) habitat has been used for both 7 and 14 day missions to date to examine and mitigate exploration risks to enable safe, reliable and productive human space exploration. This presentation will describe how the Flight Analogs Project developed the HERA facility and the infrastructure to suit investigator requirements for confinement research and in the process developed a new approach to analog utilization and a new state of the art analog facility. Details regarding HERA operations will be discussed including specifics on the mission simulation utilized for the current 14-day campaign, the specifics of the facility (total volume, overall size, hardware), and the capabilities available to researchers. The overall operational philosophy, mission fidelity including timeline, schedule pressures and cadence, and development and implementation of mission stressors will be presented. Research conducted to date in the HERA has addressed risks associated with behavioral health and performance, human physiology, as well as human factors. This presentation will conclude with a discussion of future research plans for the HERA, including infrastructure improvements and additional research capabilities planned for the upcoming 30-day missions in 2016.

Pathology as the enabler of human research.

Science.gov (United States)

Crawford, James M; Tykocinski, Mark L

2005-09-01

Academic Pathology is a key player in human molecular science and in the powerful initiatives of the National Institutes of Health. Pathologists generate data crucial to virtually every molecular study of human tissue, and have the necessary skills and authority to oversee processing of human tissues for research analysis. We advocate that Academic Pathology is optimally positioned to drive the molecular revolution in study of human disease, through human tissue collection, analysis, and databasing. This can be achieved through playing a major role in human tissue procurement and management; establishing high-quality 'Pathology Resource Laboratories'; providing the scientific expertise for pathology data sharing; and recruiting and training physician scientists. Pathology should position itself to be the local institutional driver of technology implementation and development, by operating the resource laboratories, providing the expertise for technical and conceptual design of research projects, maintaining the databases that link molecular and morphological information on human tissues with the requisite clinical databases, providing education and mentorship of technology users, and nurturing new research through the development of preliminary data. We also consider that outstanding pathology journals are available for the publication of research emanating from such studies, to the benefit of the pathology profession as an academic enterprise. It is our earnest hope that Academic Pathology can play a leading role in the remarkable advances to be made as the 21st century unfolds.

Indirect detection of an epitope-specific response to HIV-1 gp120 immunization in human subjects.

Directory of Open Access Journals (Sweden)

Evgeny Shmelkov

Full Text Available A specific response of human serum neutralizing antibodies (nAb to a conformational epitope as a result of vaccination of human subjects with the surface envelope glycoprotein (gp120 of HIV-1 has not previously been documented. Here, we used computational analysis to assess the epitope-specific responses of human subjects, which were immunized with recombinant gp120 immunogens in the VAX003 and VAX004 clinical trials. Our computational methodology--a variation of sieve analysis--compares the occurrence of specific nAb targeted conformational 3D epitopes on viruses from infected individuals who received vaccination to the occurrence of matched epitopes in the viruses infecting placebo subjects. We specifically studied seven crystallographically defined nAb targeted conformational epitopes in the V3 loop, an immunogenic region of gp120. Of the six epitopes present in the immunogens and targeted by known monoclonal neutralizing antibodies, only the one targeted by the anti-V3 nAb 2219 exhibited a significant reduction in occurrence in vaccinated subjects compared to the placebo group. This difference occurred only in the VAX003 Thailand cohort. No difference was seen between vaccinated and placebo groups for the occurrence of an epitope that was not present in the immunogen. Thus, it can be theorized that a specific 2219-like human neutralizing antibody immune response to AIDSVAX immunization occurred in the VAX003 cohort, and that this response protected subjects from a narrow subset of HIV-1 viruses circulating in Thailand in the 1990s and bearing the conformational epitope targeted by the neutralizing antibody 2219.

34 CFR 97.109 - IRB review of research.

Science.gov (United States)

2010-07-01

... Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.109 IRB review... subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights...

Ethics in published brain-computer interface research

Science.gov (United States)

Specker Sullivan, L.; Illes, J.

2018-02-01

Objective. Sophisticated signal processing has opened the doors to more research with human subjects than ever before. The increase in the use of human subjects in research comes with a need for increased human subjects protections. Approach. We quantified the presence or absence of ethics language in published reports of brain-computer interface (BCI) studies that involved human subjects and qualitatively characterized ethics statements. Main results. Reports of BCI studies with human subjects that are published in neural engineering and engineering journals are anchored in the rationale of technological improvement. Ethics language is markedly absent, omitted from 31% of studies published in neural engineering journals and 59% of studies in biomedical engineering journals. Significance. As the integration of technological tools with the capacities of the mind deepens, explicit attention to ethical issues will ensure that broad human benefit is embraced and not eclipsed by technological exclusiveness.

Animal Models and Bone Histomorphometry: Translational Research for the Human Research Program

Science.gov (United States)

Sibonga, Jean D.

2010-01-01

This slide presentation reviews the use of animal models to research and inform bone morphology, in particular relating to human research in bone loss as a result of low gravity environments. Reasons for use of animal models as tools for human research programs include: time-efficient, cost-effective, invasive measures, and predictability as some model are predictive for drug effects.

Mechanical work as an indirect measure of subjective costs influencing human movement.

Directory of Open Access Journals (Sweden)

Karl E Zelik

Full Text Available To descend a flight of stairs, would you rather walk or fall? Falling seems to have some obvious disadvantages such as the risk of pain or injury. But the preferred strategy of walking also entails a cost for the use of active muscles to perform negative work. The amount and distribution of work a person chooses to perform may, therefore, reflect a subjective valuation of the trade-offs between active muscle effort and other costs, such as pain. Here we use a simple jump landing experiment to quantify the work humans prefer to perform to dissipate the energy of landing. We found that healthy normal subjects (N = 8 preferred a strategy that involved performing 37% more negative work than minimally necessary (P<0.001 across a range of landing heights. This then required additional positive work to return to standing rest posture, highlighting the cost of this preference. Subjects were also able to modulate the amount of landing work, and its distribution between active and passive tissues. When instructed to land softly, they performed 76% more work than necessary (P<0.001, with a higher proportion from active muscles (89% vs. 84%, P<0.001. Stiff-legged landings, performed by one subject for demonstration, exhibited close to the minimum of work, with more of it performed passively through soft tissue deformations (at least 30% in stiff landings vs. 16% preferred. During jump landings, humans appear not to minimize muscle work, but instead choose to perform a consistent amount of extra work, presumably to avoid other subjective costs. The degree to which work is not minimized may indirectly quantify the relative valuation of costs that are otherwise difficult to measure.

Scientific Merit Review of Directed Research Tasks Within the NASA Human Research Program

Science.gov (United States)

Charles, John B.

2010-01-01

The Human Research Program is instrumental in developing and delivering research findings, health countermeasures, and human systems technologies for spacecraft. :HRP is subdivided into 6 research entities, or Elements. Each Element is charged with providing the Program with knowledge and capabilities to conduct research to address the human health and performance risks as well as advance the readiness levels of technology and countermeasures. Project: An Element may be further subdivided into Projects, which are defined as an integrated set of tasks undertaken to deliver a product or set of products

Talinum triangulare Whole wheat meal fortified with soy flour consumed with Talinum triangulare (gbure) soup glycemic index and the test human subjects' lipid profiles.

Science.gov (United States)

Emaleku, Sunday Adeola; Omueti, Olusola D; Emaleku, Godsent Oluwakemi

2017-08-24

Cardiovascular diseases (CVDs) and diabetes mellitus (DM) are some of the leading causes of death in the world, and diet has roles in their etiology. This research study therefore investigates the glycemic index (GI) of soy flour fortified whole wheat meal (SFFWWM) consumed with Talinum triangulare (gbure) soup and the effects of the meal on the lipid profiles of the test human subjects. The control human subjects and test human subjects were fed D-glucose (DG) and whole wheat meal (WWM) with Talinum triangulare soup respectively on the first day of the experiment, and SFFWWM with the same soup the next day (for test subjects only) after 10-12h overnight fasting. Blood glucose levels of the subjects were taken before and 2h after meals' consumption at 30min interval and blood samples collected for lipid profiles evaluations. The result of the study showed that; SFFWWM consumed with Talinum trianguilare soup has a non-significant lower GI than WWM consumed with the same soup, but a significant lower GI than DG at (P<0.05). Furthermore, there was no significant difference in lipid profiles of the test human subjects between when they consumed WWM and SFFWWM with the soup however, SFFWWM reduced TC, TG, LDL-C and VDL-C and increased HDL-C and TP than WMM at (P<0.05). In addition, GI is positively correlated with TC, TG, LDL-C and VLDL-C, but is negatively correlated with TP and HDL-C. It can therefore be concluded that; fortifying WWM with soy flour would reduce the risk factors of CVDs and DM, the diseases recently claiming thousands of today. Copyright © 2017 Diabetes India. Published by Elsevier Ltd. All rights reserved.

The Pluralistic Water Research Concept: A New Human-Water System Research Approach

Directory of Open Access Journals (Sweden)

Mariele Evers

2017-11-01

Full Text Available The use and management of water systems is influenced by a number of factors, such as economic growth, global change (e.g., urbanization, hydrological-climatic changes, politics, history and culture. Despite noteworthy efforts to develop integrative approaches to analyze water-related problems, human-water research remains a major challenge for scholars and decision makers due to the increasing complexity of human and water systems interactions. Although existing concepts try to integrate the social and water dimensions, they usually have a disciplinary starting point and perspective, which can represent an obstacle to true integration in human-water research. Hence, a pluralistic approach is required to better understand the interactions between human and water systems. This paper discusses prominent human-water concepts (Integrated Water Resources Management (IWRM, socio-hydrology, and political ecology/hydrosocial approach and presents a newly developed concept termed pluralistic water research (PWR. This is not only a pluralistic but also an integrative and interdisciplinary approach which aims to coherently and comprehensively integrate human-water dimensions. The different concepts are illustrated in a synopsis, and diverse framing of research questions are exemplified. The PWR concept integrates physical and social sciences, which enables a comprehensive analysis of human-water interactions and relations. This can lead to a better understanding of water-related issues and potentially sustainable trajectories.

Researcher Story: Stuttering

Medline Plus

Full Text Available ... actually do things to mitigate the effects of the disorder. How Do Researchers Study Stuttering? Video of How Do Researchers Study Stuttering? ... the disorder. — CROSS FADE — The foundation of our studies is the human subjects who volunteer to participate. Without human ...

A distributed model: redefining a robust research subject advocacy program at the Harvard Clinical and Translational Science Center.

Science.gov (United States)

Winkler, Sabune J; Cagliero, Enrico; Witte, Elizabeth; Bierer, Barbara E

2014-08-01

The Harvard Clinical and Translational Science Center ("Harvard Catalyst") Research Subject Advocacy (RSA) Program has reengineered subject advocacy, distributing the delivery of advocacy functions through a multi-institutional, central platform rather than vesting these roles and responsibilities in a single individual functioning as a subject advocate. The program is process-oriented and output-driven, drawing on the strengths of participating institutions to engage local stakeholders both in the protection of research subjects and in advocacy for subjects' rights. The program engages stakeholder communities in the collaborative development and distributed delivery of accessible and applicable educational programming and resources. The Harvard Catalyst RSA Program identifies, develops, and supports the sharing and distribution of expertise, education, and resources for the benefit of all institutions, with a particular focus on the frontline: research subjects, researchers, research coordinators, and research nurses. © 2014 Wiley Periodicals, Inc.

78 FR 10538 - Protections for Subjects in Human Research Involving Pesticides

Science.gov (United States)

2013-02-14

... involving intentional exposure of children or of pregnant or nursing women, unless relying on the data is crucial to a decision that would impose a more stringent regulatory restriction that would improve... itself to conduct or support any research involving intentional exposure of pregnant or nursing women or...

Naturalistic Cognition: A Research Paradigm for Human-Centered Design

Directory of Open Access Journals (Sweden)

Peter Storkerson

2010-01-01

Full Text Available Naturalistic thinking and knowing, the tacit, experiential, and intuitive reasoning of everyday interaction, have long been regarded as inferior to formal reason and labeled primitive, fallible, subjective, superstitious, and in some cases ineffable. But, naturalistic thinking is more rational and definable than it appears. It is also relevant to design. Inquiry into the mechanisms of naturalistic thinking and knowledge can bring its resources into focus and enable designers to create better, human-centered designs for use in real-world settings. This article makes a case for the explicit, formal study of implicit, naturalistic thinking within the fields of design. It develops a framework for defining and studying naturalistic thinking and knowledge, for integrating them into design research and practice, and for developing a more integrated, consistent theory of knowledge in design. It will (a outline historical definitions of knowledge, attitudes toward formal and naturalistic thinking, and the difficulties presented by the co-presence of formal and naturalistic thinking in design, (b define and contrast formal and naturalistic thinking as two distinct human cognitive systems, (c demonstrate the importance of naturalistic cognition in formal thinking and real-world judgment, (d demonstrate methods for researching naturalistic thinking that can be of use in design, and (e briefly discuss the impact on design theory of admitting naturalistic thinking as valid, systematic, and knowable.

77 FR 68153 - Meetings of Humanities Panel

Science.gov (United States)

2012-11-15

... and Visualization Research, submitted to the Office of Digital Humanities. 3. DATE: December 05, 2012... on the subject of Computationally- Intensive Research, submitted to the Office of Digital Humanities... Reference Resources grant program on the subject of Music and Performing Arts, submitted to the Division of...

Digital music exposure reliably induces temporary threshold shift (TTS) in normal hearing human subjects

Science.gov (United States)

Le Prell, C. G.; Dell, S.; Hensley, B.; Hall, J. W.; Campbell, K. C. M.; Antonelli, P. J.; Green, G. E.; Miller, J. M.; Guire, K.

2012-01-01

Objectives One of the challenges for evaluating new otoprotective agents for potential benefit in human populations is availability of an established clinical paradigm with real world relevance. These studies were explicitly designed to develop a real-world digital music exposure that reliably induces temporary threshold shift (TTS) in normal hearing human subjects. Design Thirty-three subjects participated in studies that measured effects of digital music player use on hearing. Subjects selected either rock or pop music, which was then presented at 93–95 (n=10), 98–100 (n=11), or 100–102 (n=12) dBA in-ear exposure level for a period of four hours. Audiograms and distortion product otoacoustic emissions (DPOAEs) were measured prior to and after music exposure. Post-music tests were initiated 15 min, 1 hr 15 min, 2 hr 15 min, and 3 hr 15 min after the exposure ended. Additional tests were conducted the following day and one week later. Results Changes in thresholds after the lowest level exposure were difficult to distinguish from test-retest variability; however, TTS was reliably detected after higher levels of sound exposure. Changes in audiometric thresholds had a “notch” configuration, with the largest changes observed at 4 kHz (mean=6.3±3.9dB; range=0–13 dB). Recovery was largely complete within the first 4 hours post-exposure, and all subjects showed complete recovery of both thresholds and DPOAE measures when tested 1-week post-exposure. Conclusions These data provide insight into the variability of TTS induced by music player use in a healthy, normal-hearing, young adult population, with music playlist, level, and duration carefully controlled. These data confirm the likelihood of temporary changes in auditory function following digital music player use. Such data are essential for the development of a human clinical trial protocol that provides a highly powered design for evaluating novel therapeutics in human clinical trials. Care must be

Expanding subjectivities

DEFF Research Database (Denmark)

Lundgaard Andersen, Linda; Soldz, Stephen

2012-01-01

A major theme in recent psychoanalytic thinking concerns the use of therapist subjectivity, especially “countertransference,” in understanding patients. This thinking converges with and expands developments in qualitative research regarding the use of researcher subjectivity as a tool......-Saxon and continental traditions, this special issue provides examples of the use of researcher subjectivity, informed by psychoanalytic thinking, in expanding research understanding....

Ethical issues in research.

Science.gov (United States)

Artal, Raul; Rubenfeld, Sheldon

2017-08-01

Biomedical research is currently guided by ethical standards that have evolved over many centuries. Historical and political events, social and legal considerations, and continuous medical and technological advances have led to the prevailing research ethics and practice. Currently, patients and research subjects have complete autonomy while under medical care or when volunteering as research subjects. Enrolling volunteers in human subjects research includes a detailed and meaningful informed consent process that follows the cardinal principles of ethics: autonomy, beneficence, nonmaleficence, and justice. These principles were gradually adopted after World War II, primarily in response to the unethical behavior of German physicians and scientists during the Third Reich. This review emphasizes the importance of historical milestones and the essential role that ethics has in contemporary medical research. Research protocols should achieve maximum benefits for the society, have clinical and scientific value, be subject to independent review, respect human dignity, and follow the principles of informed consent, and most importantly, subjects should have complete autonomy. However, current principles and regulations cannot cover every conceivable situation, particularly in view of the new advances in science and technology. New and evolving medical technology, genetic research, therapeutic interventions, and innovations challenge society to maintain the highest moral and ethical principles. Copyright © 2017. Published by Elsevier Ltd.

Human autonomic rhythms: vagal cardiac mechanisms in tetraplegic subjects

Science.gov (United States)

Koh, J.; Brown, T. E.; Beightol, L. A.; Ha, C. Y.; Eckberg, D. L.

1994-01-01

1. We studied eight young men (age range: 20-37 years) with chronic, clinically complete high cervical spinal cord injuries and ten age-matched healthy men to determine how interruption of connections between the central nervous system and spinal sympathetic motoneurones affects autonomic cardiovascular control. 2. Baseline diastolic pressures and R-R intervals (heart periods) were similar in the two groups. Slopes of R-R interval responses to brief neck pressure changes were significantly lower in tetraplegic than in healthy subjects, but slopes of R-R interval responses to steady-state arterial pressure reductions and increases were comparable. Plasma noradrenaline levels did not change significantly during steady-state arterial pressure reductions in tetraplegic patients, but rose sharply in healthy subjects. The range of arterial pressure and R-R interval responses to vasoactive drugs (nitroprusside and phenylephrine) was significantly greater in tetraplegic than healthy subjects. 3. Resting R-R interval spectral power at respiratory and low frequencies was similar in the two groups. During infusions of vasoactive drugs, low-frequency R-R interval spectral power was directly proportional to arterial pressure in tetraplegic patients, but was unrelated to arterial pressure in healthy subjects. Vagolytic doses of atropine nearly abolished both low- and respiratory-frequency R-R interval spectral power in both groups. 4. Our conclusions are as follows. First, since tetraplegic patients have significant levels of low-frequency arterial pressure and R-R interval spectral power, human Mayer arterial pressure waves may result from mechanisms that do not involve stimulation of spinal sympathetic motoneurones by brainstem neurones. Second, since in tetraplegic patients, low-frequency R-R interval spectral power is proportional to arterial pressure, it is likely to be mediated by a baroreflex mechanism. Third, since low-frequency R-R interval rhythms were nearly abolished

Tolerability, usability and acceptability of dissolving microneedle patch administration in human subjects.

Science.gov (United States)

Arya, Jaya; Henry, Sebastien; Kalluri, Haripriya; McAllister, Devin V; Pewin, Winston P; Prausnitz, Mark R

2017-06-01

To support translation of microneedle patches from pre-clinical development into clinical trials, this study examined the effect of microneedle patch application on local skin reactions, reliability of use and acceptability to patients. Placebo patches containing dissolving microneedles were administered to fifteen human participants. Microneedle patches were well tolerated in the skin with no pain or swelling and only mild erythema localized to the site of patch administration that resolved fully within seven days. Microneedle patches could be administered by hand without the need of an applicator and delivery efficiencies were similar for investigator-administration and self-administration. Microneedle patch administration was not considered painful and the large majority of subjects were somewhat or fully confident that they self-administered patches correctly. Microneedle patches were overwhelmingly preferred over conventional needle and syringe injection. Altogether, these results demonstrate that dissolving microneedle patches were well tolerated, easily usable and strongly accepted by human subjects, which will facilitate further clinical translation of this technology. Copyright © 2017 Elsevier Ltd. All rights reserved.

Integrating spaceflight human system risk research

Science.gov (United States)

Mindock, Jennifer; Lumpkins, Sarah; Anton, Wilma; Havenhill, Maria; Shelhamer, Mark; Canga, Michael

2017-10-01

NASA is working to increase the likelihood of exploration mission success and to maintain crew health, both during exploration missions and long term after return to Earth. To manage the risks in achieving these goals, a system modelled after a Continuous Risk Management framework is in place. ;Human System Risks; (Risks) have been identified, and 32 are currently being actively addressed by NASA's Human Research Program (HRP). Research plans for each of HRP's Risks have been developed and are being executed. Inter-disciplinary ties between the research efforts supporting each Risk have been identified; however, efforts to identify and benefit from these connections have been mostly ad hoc. There is growing recognition that solutions developed to address the full set of Risks covering medical, physiological, behavioural, vehicle, and organizational aspects of exploration missions must be integrated across Risks and disciplines. This paper discusses how a framework of factors influencing human health and performance in space is being applied as the backbone for bringing together sometimes disparate information relevant to the individual Risks. The resulting interrelated information enables identification and visualization of connections between Risks and research efforts in a systematic and standardized manner. This paper also discusses the applications of the visualizations and insights into research planning, solicitation, and decision-making processes.

[Construction and validation of the "La Salle Instrument" to evaluate the ethical aspects in biomedical research on human beings].

Science.gov (United States)

Valdivia-Gómez, Gilberto Guzmán; Velasco-Jiménez, María Teresa; Domínguez-González, Alejandro; Meneses-Ruíz, Dulce María; Padilla-García, Raúl Amauri

2017-01-01

Research projects must demonstrate not only a rigorous scientific methodology, but also the ethical aspects that require profound reflection of the reviewers. Current regulations establish criteria for research projects on human health, but many of these aspects are subjective. How can the evaluation of such projects be standardized? This is the main subject of the current project. This project comprises two phases. First, the design and construction of an instrument of evaluation based on the fundamental principles of bioethics, which are autonomy, beneficence, non-maleficence, and justice, and other aspects. The second phase consists of content validation through expert. During the phase of reviewing the instrument, it was necessary to make changes by adding, removing, or changing the concepts or criteria, which lead to the construction of the second version of the format. This new instrument was reviewed and analyzed by using the AGREE II instrument, and this version was validated by experts by greater than 95%. There are some recommendations to analyze the ethical aspects in research protocols involving human subjects, but they define the concepts and criteria to be evaluated. By presenting the criteria to be evaluated individually, the "La Salle instrument" allows the evaluation to be more objective and standardized.

Human memory research: Current hypotheses and new perspectives

Directory of Open Access Journals (Sweden)

Antônio Jaeger

Full Text Available Abstract Research on human memory has increased significantly in the last few decades. Inconsistencies and controversies inherent to such research, however, are rarely articulated on published reports. The goal of the present article is to present and discuss a series of open questions related to major topics on human memory research that can be addressed by future research. The topics covered here are visual working memory, recognition memory, emotion and memory interaction, and methodological issues of false memories studies. Overall, the present work reveals a series of open questions and alternative analysis which could be useful for the process of hypothesis generation, and consequently for the design and implementation of future research on human memory.

The contribution of human/non-human animal chimeras to stem cell research

Directory of Open Access Journals (Sweden)

Sonya Levine

2017-10-01

Full Text Available Chimeric animals are made up of cells from two separate zygotes. Human/non-human animal chimeras have been used for a number of research purposes, including human disease modeling. Pluripotent stem cell (PSC research has relied upon the chimera approach to examine the developmental potential of stem cells, to determine the efficacy of cell replacement therapies, and to establish a means of producing human organs. Based on ethical issues, this work has faced pushback from various sources including funding agencies. We discuss here the essential role these studies have played, from gaining a better understanding of human biology to providing a stepping stone to human disease treatments. We also consider the major ethical issues, as well as the current status of support for this work in the United States.

Research Studies Index. Authors and Subjects. Volume 1 through Volume 43 (1929-1975).

Science.gov (United States)

Drazan, Joseph, Comp.; Scott, Paula, Comp.

This volume contains author and subject indexes for volumes 1 through 43 (1929-1975) of "Research Studies," a scholarly, multi-disciplinary quarterly published at Washington State University. Each author index entry includes the title, volume, and inclusive pagination of the article. The subject index is a keyword-out-of-context…

Human Factors Regulatory Research Program Plan, FY 1989--FY 1992

International Nuclear Information System (INIS)

Coffman, F.; Persensky, J.; Ryan, T.; Ramey-Smith, A.; Goodman, C.; Serig, D.; Trager, E; Nuclear Regulatory Commission, Washington, DC; Nuclear Regulatory Commission, Washington, DC; Nuclear Regulatory Commission, Washington, DC

1989-10-01

This report describes the currently ongoing (FY 1989) and planned (FY 1989-1992) Human Factors Regulatory Research Program in the NRC Office of Nuclear Regulatory Research (RES). Examples of the influence of human factors on nuclear safety are presented, and the role of personnel is discussed. Current regulatory issues associated with human factors in the nuclear system and the purpose of the research plan are provided. The report describes the research process applied to the human factors research issues and the program activities: Personnel Performance Measurement, Personnel Subsystem, Human-System Interface. Organization and Management, and Reliability Assessment. The research being conducted within each activity is summarized along with the objectives, background information, and expected regulatory products. Budget and personnel forecasts are provided along with a summary of contractors performing some of the ongoing research. Appendices contain a chronology of human factors research at NRC, a description of the research approach, an update on human factors programs and initiatives in RES and other NRC offices, and the integration among these programs. 46 refs., 5 tabs

Overview of NRC's human factors regulatory research program

International Nuclear Information System (INIS)

Coffman, F.D. Jr.

1989-01-01

The human factors research program is divided into distinct and interrelated program activities: (1) Personnel Performance measurement, (2) Personnel Subsystem, (3) Human-System Interface, (4) Organization and Management, and (5) a group of Reliability Assessment activities. The purpose of the Personnel Performance Measurement activity is to improve the Agency's understanding of the factors influencing personnel performance and the effects on the safety of nuclear operations and maintenance by developing improvements to methods for collecting and managing personnel performance data. Personnel Subsystem research will broaden the understanding of such factors as staffing, qualifications, and training that influence human performance in the nuclear system and will develop the technical basis for regulatory guidance to reduce any adverse impact of these influences on nuclear safety. Research in the Human-System Interface activity will provide the technical basis for ensuring that the interface between the system and the human user supports safe operations and maintenance. Organization and Management research will result in the development of tools for evaluating organization and management issues within the nuclear industry. And finally, the Reliability Assessment group of activities includes multidisciplinary research that will integrate human and hardware considerations for evaluating reliability and risk in NRC licensing, inspection, and regulatory decisions

Research trend on human error reduction

International Nuclear Information System (INIS)

Miyaoka, Sadaoki

1990-01-01

Human error has been the problem in all industries. In 1988, the Bureau of Mines, Department of the Interior, USA, carried out the worldwide survey on the human error in all industries in relation to the fatal accidents in mines. There was difference in the results according to the methods of collecting data, but the proportion that human error took in the total accidents distributed in the wide range of 20∼85%, and was 35% on the average. The rate of occurrence of accidents and troubles in Japanese nuclear power stations is shown, and the rate of occurrence of human error is 0∼0.5 cases/reactor-year, which did not much vary. Therefore, the proportion that human error took in the total tended to increase, and it has become important to reduce human error for lowering the rate of occurrence of accidents and troubles hereafter. After the TMI accident in 1979 in USA, the research on man-machine interface became active, and after the Chernobyl accident in 1986 in USSR, the problem of organization and management has been studied. In Japan, 'Safety 21' was drawn up by the Advisory Committee for Energy, and also the annual reports on nuclear safety pointed out the importance of human factors. The state of the research on human factors in Japan and abroad and three targets to reduce human error are reported. (K.I.)

Ethics and psychological research

DEFF Research Database (Denmark)

Søndergaard, Dorte Marie

Human subjects and social relations are crucial in research psychologists’ ethical considerations. Lists of ethical criteria - including how to anonymize data, avoid causing harm, handle asymmetries – are pivotal. A situated ethics inspired by new materialism and poststructuralism would, however......, elaborate these focuses to include social orders, discursive power, and more comprehensive material-discursive apparatuses. I will draw on concepts developed by Barad, Foucault and Butler to discuss how ethics can be understood as an intra-acting, emergent element of the research apparatus. Barad’s notion...... the researchers’ moral narcissism in relation to the enactment of social-subjective phenomena in research; on the other hand, it leaves researchers with a broader spectrum of phenomena to include in their ethical considerations. This invites new questions: Which perspectives of human and non-human existence...

Human-Robot Interaction Directed Research Project

Science.gov (United States)

Rochlis, Jennifer; Ezer, Neta; Sandor, Aniko

2011-01-01

Human-robot interaction (HRI) is about understanding and shaping the interactions between humans and robots (Goodrich & Schultz, 2007). It is important to evaluate how the design of interfaces and command modalities affect the human s ability to perform tasks accurately, efficiently, and effectively (Crandall, Goodrich, Olsen Jr., & Nielsen, 2005) It is also critical to evaluate the effects of human-robot interfaces and command modalities on operator mental workload (Sheridan, 1992) and situation awareness (Endsley, Bolt , & Jones, 2003). By understanding the effects of interface design on human performance, workload, and situation awareness, interfaces can be developed that support the human in performing tasks with minimal errors and with appropriate interaction time and effort. Thus, the results of research on human-robot interfaces have direct implications for design. Because the factors associated with interfaces and command modalities in HRI are too numerous to address in 3 years of research, the proposed research concentrates on three manageable areas applicable to National Aeronautics and Space Administration (NASA) robot systems. These topic areas emerged from the Fiscal Year (FY) 2011 work that included extensive literature reviews and observations of NASA systems. The three topic areas are: 1) video overlays, 2) camera views, and 3) command modalities. Each area is described in detail below, along with relevance to existing NASA human-robot systems. In addition to studies in these three topic areas, a workshop is proposed for FY12. The workshop will bring together experts in human-robot interaction and robotics to discuss the state of the practice as applicable to research in space robotics. Studies proposed in the area of video overlays consider two factors in the implementation of augmented reality (AR) for operator displays during teleoperation. The first of these factors is the type of navigational guidance provided by AR symbology. In the proposed

Designing Human Technologies

DEFF Research Database (Denmark)

Simonsen, Jesper

and the design process, in ethical and society-related concerns, and in evaluating how designs fulfill needs and solve problems. Designing Human Technologies subscribes to a broad technology concept including information and communication, mobile, environmental/sustainable and energy technologies......Design is increasingly becoming a part of the university curriculum and research agenda. The keynote present and discuss Designing Human Technologies – an initiative aiming at establishing a design oriented main subject area alongside traditional main subject areas such as Natural Science......, the Humanities, and Social Science. The initiative broadens the perspective of IS and recognize reflections on aesthetics, ethics, values, connections to politics, and strategies for enabling a better future as legitimate parts of the research agenda. Designing Human Technologies is a design-oriented Strategic...

An evaluation of human factors research for ultrasonic inservice inspection

International Nuclear Information System (INIS)

Pond, D.J.; Donohoo, D.T.; Harris, R.V. Jr.

1998-03-01

This work was undertaken to determine if human factors research has yielded information applicable to upgrading requirements in ASME Boiler and Pressure Vessel Code Section XI, improving methods and techniques in Section V, and/or suggesting relevant research. A preference was established for information and recommendations which have become accepted and standard practice. Manual Ultrasonic Testing/Inservice Inspection (UT/ISI) is a complex task subject to influence by dozens of variables. This review frequently revealed equivocal findings regarding effects of environmental variables as well as repeated indications that inspection performance may be more, and more reliably, influenced by the workers' social environment, including managerial practices, than by other situational variables. Also of significance are each inspector's relevant knowledge, skills, and abilities, and determination of these is seen as a necessary first step in upgrading requirements, methods, and techniques as well as in focusing research in support of such programs, While understanding the effects and mediating mechanisms of the variables impacting inspection performance is a worthwhile pursuit for researchers, initial improvements in industrial UTASI performance may be achieved by implementing practices already known to mitigate the effects of potentially adverse conditions. 52 refs., 2 tabs

An evaluation of human factors research for ultrasonic inservice inspection

Energy Technology Data Exchange (ETDEWEB)

Pond, D.J.; Donohoo, D.T.; Harris, R.V. Jr.

1998-03-01

This work was undertaken to determine if human factors research has yielded information applicable to upgrading requirements in ASME Boiler and Pressure Vessel Code Section XI, improving methods and techniques in Section V, and/or suggesting relevant research. A preference was established for information and recommendations which have become accepted and standard practice. Manual Ultrasonic Testing/Inservice Inspection (UT/ISI) is a complex task subject to influence by dozens of variables. This review frequently revealed equivocal findings regarding effects of environmental variables as well as repeated indications that inspection performance may be more, and more reliably, influenced by the workers` social environment, including managerial practices, than by other situational variables. Also of significance are each inspector`s relevant knowledge, skills, and abilities, and determination of these is seen as a necessary first step in upgrading requirements, methods, and techniques as well as in focusing research in support of such programs, While understanding the effects and mediating mechanisms of the variables impacting inspection performance is a worthwhile pursuit for researchers, initial improvements in industrial UTASI performance may be achieved by implementing practices already known to mitigate the effects of potentially adverse conditions. 52 refs., 2 tabs.

Relationship between eye dominance and pattern electroretinograms in normal human subjects.

Science.gov (United States)

Kamis, Umit; Gunduz, Kemal; Okudan, Nilsel; Gokbel, Hakki; Bodur, Sait; Tan, Uner

2005-02-01

The authors conducted a study in 100 non-smoker healthy normal human subjects to find a relationship between eye dominance and macular function as tested by using transient stimulus and electroretinography. Eye preference procedure was carried out using two reference points and pattern electroretinograms (PERGs) were recorded using black and white checks, each check subtending 23'. Trace averager was retriggered every 300 milliseconds (ms) with data collection time of 150 ms. The difference in PERG P50 amplitudes between right and left eyes was analyzed using Student's t test. There was no significant difference in PERG P50 amplitudes between the right and left eye dominant subjects as well as no significant differences between the right and left eyes in right eye dominants and left eye dominants, but in the left-eye dominant group the left eye PERG P50 amplitudes were significantly higher in females than males. Although pattern-reversal visual evoked potentials of healthy subjects provide electrophysiological evidence of lateralization in the nervous system, sensory eye dominance seems to have no correlation with macular function.

The contribution of human/non-human animal chimeras to stem cell research.

Science.gov (United States)

Levine, Sonya; Grabel, Laura

2017-10-01

Chimeric animals are made up of cells from two separate zygotes. Human/non-human animal chimeras have been used for a number of research purposes, including human disease modeling. Pluripotent stem cell (PSC) research has relied upon the chimera approach to examine the developmental potential of stem cells, to determine the efficacy of cell replacement therapies, and to establish a means of producing human organs. Based on ethical issues, this work has faced pushback from various sources including funding agencies. We discuss here the essential role these studies have played, from gaining a better understanding of human biology to providing a stepping stone to human disease treatments. We also consider the major ethical issues, as well as the current status of support for this work in the United States. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

The RID2 biofidelic rear impact dummy: a pilot study using human subjects in low speed rear impact full scale crash tests.

Science.gov (United States)

Croft, Arthur C; Philippens, Mathieu M G M

2007-03-01

Human subjects and the recently developed RID2 rear impact crash test dummy were exposed to a series of full scale, vehicle-to-vehicle crash tests. To evaluate the biofidelity of the RID2 anthropometric test dummy on the basis of calculated neck injury criterion (NIC) values by comparing these values to those obtained from human subjects exposed in the very same crashes. The widely used and familiar hybrid III dummy has been said to lack biofidelity in the special application of low speed rear impact crashes. Several attempts have been made to modify this dummy with only marginal success. Two completely new dummies have been developed; the BioRID and the RID2. Neither have been tested under real world crash boundary conditions in side-by-side comparisons with live human subjects. Volunteer subjects, including a 50th percentile male, a 95th percentile male, and a 50th percentile female, were placed in the driver's seat of a vehicle and subjected to a series of three low speed rear impact crashes each. The RID2 dummy, which is modeled after a 50th percentile male, was placed in the passenger seat in each case. Both subjects and dummy were fully instrumented and acceleration-time histories were recorded. From this data, velocities of the heads and torsos were determined and both were used to calculate the NIC values for both crash test subjects and the RID2. The RID2 demonstrated generally higher head accelerations and NIC values than those of the human subjects. Most of the observed variations might be explained on the basis of differing head restraint geometry, posture, and body size. The RID2 NIC values compared most favorably with those of the 50th percentile male subject. For the whole group, the correlations between RID2 and human subjects did not reach statistical significance. The small number of test subjects and crash tests limited the statistical power of this pilot study, and the correlation between the RID2 and human subject NIC values were not

NASA's Universe of Learning: The Integral Role of Research Astronomers and Other Subject Matter Experts

Science.gov (United States)

Lee, Janice; Universe of Learning Team

2018-01-01

Astronomy seeks to understand the workings of the Universe on its largest scales, and to answer fundamental questions about the story of our origins. The science of astronomy thus naturally lends itself to informal education and public outreach activities, as it broadly captures the human imagination. There are at least three overall goals for investment of resources in Astronomy E/PO: to interest students in pursuing STEM education and careers; to develop Astronomy as context for teaching more basic physical and computer science in service of US National Education Goals; to help motivate continued public support of federally funded Astronomy research and technology development. Providing a full spectrum of opportunities for the public to learn about recent Astronomy discoveries is key to achieving these societal goals. Thus, the E/PO professional community must have an understanding of recent scientific/technological results, and engage with the researchers who are creating new knowledge to explicate that knowledge to the public. It stands to reason that researchers (or “subject matter experts, SMEs”) must be involved in and remain connected to the E/PO endeavor. In this talk, I will describe how research astronomers and other SMEs play an integral role in a full range of informal education programming developed by the NASA Universe of Learning collaboration, and opportunities to get involved.

The Research on Coordinated Decision-Making Method Tax System Based on Subject Data

Directory of Open Access Journals (Sweden)

Zhaoji Yu

2015-01-01

Full Text Available Academically, the research of subject database of tax system aims to set up an efficient, harmonious virtual data application environment. Subject data, in application and management, has been on demand polymerized and autonomously collaborated and has reached a balance between instantaneity and accuracy. This paper defines the connotation and characteristics enterprise informationization, designs a value system of enterprise informationization which is subject database oriented, and builds a model for the import of the subject database of enterprise informationization. Meantime, this paper describes the structure of the subject database based information import model and forges the model’s theoretical basis of subject data import in tax system. Using the model can make an analysis on the information of data warehouse, storage information, and tax information to provide decision support for the tax administrators.

The research trends of Arts, Humanities and Social Sciences ...

African Journals Online (AJOL)

A bibliometric method was used to analyse the trends and challenges of Humanities and Social Sciences research by using research data reflecting on ongoing and completed Arts, Humanities and Social Science research publications submitted by staff and students from 1994 – 2008 to the university's Research Office.

45 CFR 46.111 - Criteria for IRB approval of research.

Science.gov (United States)

2010-10-01

... Section 46.111 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.111 Criteria for IRB... protect the rights and welfare of these subjects. ...

Nurse leaders' perceptions of the ethical recruitment of study subjects in clinical research.

Science.gov (United States)

Nurmi, Sanna-Maria; Pietilä, Anna-Maija; Kangasniemi, Mari; Halkoaho, Arja

2015-11-01

The aim of this study was to describe nurse leaders' perceptions of ethical recruitment in clinical research. Nurse leaders are expected to get involved in clinical research, but there are few studies that focus on their role, particularly the ethical issues. Qualitative data were collected from ten nurse leaders using thematic one-to-one interviews and analysed with content analysis. Nurse leaders considered clinical research at their workplace in relation to the key issues that enabled ethical recruitment of study subjects in clinical research. These were: early information and collaboration for incorporating clinical research in everyday work, an opportune and peaceful recruitment moment and positive research culture. Getting involved in clinical research is part of the nurse leader's professional responsibility in current health care. They have an essential role to play in ensuring that recruitment is ethical and that the dignity of study subjects is maintained. The duty of nurse leaders is to maintain good contact with other collaborators and to ensure good conditions for implementing clinical research at their site. This requires a comprehensive understanding of the overall situation on their wards. Implementing clinical research requires careful planning, together with educating, supporting and motivating nursing staff. © 2014 John Wiley & Sons Ltd.

Human genome and genetic sequencing research and informed consent

International Nuclear Information System (INIS)

Iwakawa, Mayumi

2003-01-01

On March 29, 2001, the Ethical Guidelines for Human Genome and Genetic Sequencing Research were established. They have intended to serve as ethical guidelines for all human genome and genetic sequencing research practice, for the purpose of upholding respect for human dignity and rights and enforcing use of proper methods in the pursuit of human genome and genetic sequencing research, with the understanding and cooperation of the public. The RadGenomics Project has prepared a research protocol and informed consent document that follow these ethical guidelines. We have endeavored to protect the privacy of individual information, and have established a procedure for examination of research practices by an ethics committee. Here we report our procedure in order to offer this concept to the patients. (authors)

40 CFR 26.203 - Prohibition of research conducted or supported by EPA involving intentional exposure of any human...

Science.gov (United States)

2010-07-01

... her fetus), a nursing woman, or child. 26.203 Section 26.203 Protection of Environment ENVIRONMENTAL... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Prohibition of research conducted or... Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nursing Women § 26.203...

National Human Genome Research Institute

Science.gov (United States)

... Care Genomic Medicine Working Group New Horizons and Research Patient Management Policy and Ethics Issues Quick Links for Patient Care Education All About the Human Genome Project Fact Sheets Genetic Education Resources for ...

Indicators for Research Performance in the Humanities? The Scholars’ View on Research Quality and Indicators

Energy Technology Data Exchange (ETDEWEB)

Ochsner, M.; Hug, S.E.

2016-07-01

In this paper, we present indicators for research quality in the humanities collected in our previous work (Ochsner, Hug, & Daniel, 2012). We focus on how these indicators are accepted by humanities scholars. We also investigate differences between different subgroups of the humanities scholars we surveyed with regard to their preferences for such indicators. We address the theme of the conference (‘peripheries frontiers and beyond’) regarding two notions of (scientometric) periphery: First, we investigate indicators for research quality in the humanities, a field where there is a lack on knowledge on how to assess or even measure research quality, in fact, there is a quite broad consensus that (evaluative) bibliometrics cannot be readily applied in the humanities (Hicks, 2004; Nederhof, 2006). Second, we fully cover three humanities disciplines at Swiss universities and member universities of the League of European Research Universities (LERU). Scholars are a neglected stakeholder when it comes to the design of research assessment procedures or the selection of research indicators. However, they are directly affected, they know best what research quality in their field is and what impact the use of certain indicators could have on their research practices. The paper is structured as follows: first, we present the background for selecting indicators for research quality. This is followed by a description of our analysis methods and the presentation of the results. We finally discuss the results with regard to their use in research evaluation. (Author)

Moral perspectives on covert research

Directory of Open Access Journals (Sweden)

Anton van Niekerk

2014-11-01

Full Text Available The term ‘covert research’ refers to research on human subjects for which informed consent is not, and allegedly cannot, be solicited – not because of wilful negligence or the deliberate transgression of research ethics guidelines on the part of the researcher(s, but because the revelation of the nature of the research to the involved research participants would necessarily invalidate the research results. While covert research is deemed necessary in a number of sciences, such as ethnography, such research nevertheless elicits major ethical concern due to the fact that it seemingly violates the values of respect for autonomy and the protection of research subjects – values that have, since the first formulations of the Nuremberg Code, the Belmont Declaration and the series of Helsinki accords, become almost axiomatic in our understanding of the basic tenets of responsible and ethical research on human subjects. In this article, I contend that while subject autonomy is a pivotal value in morally legitimate research generally, there is more to morally legitimate research than informed consent. I conclude by formulating a few guidelines for the identification of circumstances under which covert research might and might not be morally in order.

Distortion-Product Otoacoustic Emission Measured Below 300 Hz in Normal-Hearing Human Subjects

DEFF Research Database (Denmark)

Christensen, Anders Tornvig; Ordoñez Pizarro, Rodrigo Eduardo; Hammershøi, Dorte

2017-01-01

, a custom-built low-frequency acoustic probe was put to use in 21 normal-hearing human subjects (of 34 recruited). Distortion-product otoacoustic emission (DPOAE) was measured in the enclosed ear canal volume as the response to two simultaneously presented tones with frequencies f1 and f2. The stimulus...

The ethics of cloning and human embryo research.

Science.gov (United States)

Saran, Madeleine

2002-01-01

The successful cloning experiments that led to Dolly in 1997 have raised many ethical and policy questions. This paper will focus on cloning research in human embryonic cells. The possible gains of the research will be judged against the moral issues of doing research on a person. This paper concludes that while the embryo has some moral status, its moral status is outweighed by the multitude of benefits that embryonic stem cell research will bring to humanity. Policy suggestions are given for dealing with this new and developing field of stem cell research.

Research strategies for human performance

International Nuclear Information System (INIS)

Carlsson, Lennart

1998-01-01

This document reflects basic proposals derived from the discussions and results by the expert group on human performance within the frame of an OECD study on nuclear safety research. Different topics have identified which are herein briefly presented: cognitive models and errors of commission, organizational practices, validation of existing techniques for human reliability analysis, control room design and man-machine interactions, use of simulators, improvement of methods for evaluation of operating experience, safety culture, operator aids, shutdown, decommissioning

Human body contour data based activity recognition.

Science.gov (United States)

Myagmarbayar, Nergui; Yuki, Yoshida; Imamoglu, Nevrez; Gonzalez, Jose; Otake, Mihoko; Yu, Wenwei

2013-01-01

This research work is aimed to develop autonomous bio-monitoring mobile robots, which are capable of tracking and measuring patients' motions, recognizing the patients' behavior based on observation data, and providing calling for medical personnel in emergency situations in home environment. The robots to be developed will bring about cost-effective, safe and easier at-home rehabilitation to most motor-function impaired patients (MIPs). In our previous research, a full framework was established towards this research goal. In this research, we aimed at improving the human activity recognition by using contour data of the tracked human subject extracted from the depth images as the signal source, instead of the lower limb joint angle data used in the previous research, which are more likely to be affected by the motion of the robot and human subjects. Several geometric parameters, such as, the ratio of height to weight of the tracked human subject, and distance (pixels) between centroid points of upper and lower parts of human body, were calculated from the contour data, and used as the features for the activity recognition. A Hidden Markov Model (HMM) is employed to classify different human activities from the features. Experimental results showed that the human activity recognition could be achieved with a high correct rate.

Report on achievements of commissioned studies on research and development of a technology to apply human senses to measurements in fiscal 1994. 2. Main issue (Part 5 for research and development of a correlation and evaluation technology); 1994 nendo ningen kankaku keisoku oyo gijutsu no kenkyu kaihatsu. 2. Honronhen (Sokan hyoka gijutsu no kenkyu kaihatsu)

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-03-01

This paper describes the research and development of (1) working environment having human senses and affinity at nuclear electric power plants, (2) a correlation technology for comfort in composite environments composed mainly of warm heat environment, (3) space-type human interface adapted to human senses, and (4) a human comfort meter. With regard to the subject (1), improvements were made on the experimental facilities, data processing systems, and environment improving devices, and data were collected and evaluated from subject experiments. With regard to the subject (2), 'development of a system to investigate correlation among externally stimulating environment, physiological effects, and sense volume based on a physiological reaction model', and 'research and development of a quantitative evaluation technology for comfort in composite environments composed mainly of warm heat environment' were executed. With respect to the subject (3), 'measurement of factors in visual sense operating environment affecting mental burden feeling', 'development of space-type human interface', and 'research on a method to utilize the eyeball movement information' were carried out. With regard to the subject (4), a warm heat sensing element structure was developed. In addition, a comfort determining software was completed that calculates hot-cold heat sense of a human body from different conditions of the warm heat sensing elements. (NEDO)

34 CFR 97.103 - Assuring compliance with this policy-research conducted or supported by any Federal Department or...

Science.gov (United States)

2010-07-01

... Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.103 Assuring compliance with this... responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by...

Fruit Flies Help Human Sleep Research

Science.gov (United States)

... like us, without enough sleep, flies feel the effects of sleep deprivation. Cirelli has shown that they are a good model for researching human sleep. She has found fruit fly genes that seem to have a powerful effect on sleep. In time, her research could lead ...

Using a community of inquiry framework to teach a nursing and midwifery research subject: An evaluative study.

Science.gov (United States)

Mills, Jane; Yates, Karen; Harrison, Helena; Woods, Cindy; Chamberlain-Salaun, Jennifer; Trueman, Scott; Hitchins, Marnie

2016-08-01

Postgraduate nursing students' negative perceptions about a core research subject at an Australian university led to a revision and restructure of the subject using a Communities of Inquiry framework. Negative views are often expressed by nursing and midwifery students about the research process. The success of evidence-based practice is dependent on changing these views. A Community of Inquiry is an online teaching, learning, thinking, and sharing space created through the combination of three domains-teacher presence (related largely to pedagogy), social presence, and cognitive presence (critical thinking). Evaluate student satisfaction with a postgraduate core nursing and midwifery subject in research design, theory, and methodology, which was delivered using a Communities of Inquiry framework. This evaluative study incorporated a validated Communities of Inquiry survey (n=29) and interviews (n=10) and was conducted at an Australian university. Study participants were a convenience sample drawn from 56 postgraduate students enrolled in a core research subject. Survey data were analysed descriptively and interviews were coded thematically. Five main themes were identified: subject design and delivery; cultivating community through social interaction; application-knowledge, practice, research; student recommendations; and technology and technicalities. Student satisfaction was generally high, particularly in the areas of cognitive presence (critical thinking) and teacher presence (largely pedagogy related). Students' views about the creation of a "social presence" were varied but overall, the framework was effective in stimulating both inquiry and a sense of community. The process of research is, in itself, the creation of a "community of inquiry." This framework showed strong potential for use in the teaching of nurse research subjects; satisfaction was high as students reported learning, not simply the theory and the methods of research, but also how to engage

Evaluating variation in human gut microbiota profiles due to DNA extraction method and inter-subject differences.

Science.gov (United States)

Wagner Mackenzie, Brett; Waite, David W; Taylor, Michael W

2015-01-01

The human gut contains dense and diverse microbial communities which have profound influences on human health. Gaining meaningful insights into these communities requires provision of high quality microbial nucleic acids from human fecal samples, as well as an understanding of the sources of variation and their impacts on the experimental model. We present here a systematic analysis of commonly used microbial DNA extraction methods, and identify significant sources of variation. Five extraction methods (Human Microbiome Project protocol, MoBio PowerSoil DNA Isolation Kit, QIAamp DNA Stool Mini Kit, ZR Fecal DNA MiniPrep, phenol:chloroform-based DNA isolation) were evaluated based on the following criteria: DNA yield, quality and integrity, and microbial community structure based on Illumina amplicon sequencing of the V4 region of bacterial and archaeal 16S rRNA genes. Our results indicate that the largest portion of variation within the model was attributed to differences between subjects (biological variation), with a smaller proportion of variation associated with DNA extraction method (technical variation) and intra-subject variation. A comprehensive understanding of the potential impact of technical variation on the human gut microbiota will help limit preventable bias, enabling more accurate diversity estimates.

Evaluating variation in human gut microbiota profiles due to DNA extraction method and inter-subject differences

Directory of Open Access Journals (Sweden)

Brett eWagner Mackenzie

2015-02-01

Full Text Available The human gut contains dense and diverse microbial communities which have profound influences on human health. Gaining meaningful insights into these communities requires provision of high quality microbial nucleic acids from human fecal samples, as well as an understanding of the sources of variation and their impacts on the experimental model. We present here a systematic analysis of commonly used microbial DNA extraction methods, and identify significant sources of variation. Five extraction methods (Human Microbiome Project protocol, MoBio PowerSoil DNA Isolation Kit, QIAamp DNA Stool Mini Kit, ZR Fecal DNA MiniPrep, phenol:chloroform-based DNA isolation were evaluated based on the following criteria: DNA yield, quality and integrity, and microbial community structure based on Illumina amplicon sequencing of the V4 region of bacterial and archaeal 16S rRNA genes. Our results indicate that the largest portion of variation within the model was attributed to differences between subjects (biological variation, with a smaller proportion of variation associated with DNA extraction method (technical variation and intra-subject variation. A comprehensive understanding of the potential impact of technical variation on the human gut microbiota will help limit preventable bias, enabling more accurate diversity estimates.

Human subjects concerns in ground based ECLSS testing - Managing uncertainty in closely recycled systems

Science.gov (United States)

Crump, William J.; Janik, Daniel S.; Thomas, L. Dale

1990-01-01

U.S. space missions have to this point used water either made on board or carried from earth and discarded after use. For Space Station Freedom, long duration life support will include air and water recycling using a series of physical-chemical subsystems. The Environmental Control and Life Support System (ECLSS) designed for this application must be tested extensively at all stages of hardware maturity. Human test subjects are required to conduct some of these tests, and the risks associated with the use of development hardware must be addressed. Federal guidelines for protection of human subjects require careful consideration of risks and potential benefits by an Institutional Review Board (IRB) before and during testing. This paper reviews the ethical principles guiding this consideration, details the problems and uncertainties inherent in current hardware testing, and presents an incremental approach to risk assessment for ECLSS testing.

A relation between calculated human body exergy consumption rate and subjectively assessed thermal sensation

DEFF Research Database (Denmark)

Simone, Angela; Kolarik, Jakub; Iwamatsu, Toshiya

2011-01-01

occupants, it is reasonable to consider both the exergy flows in building and those within the human body. Until now, no data have been available on the relation between human-body exergy consumption rates and subjectively assessed thermal sensation. The objective of the present work was to relate thermal...... sensation data, from earlier thermal comfort studies, to calculated human-body exergy consumption rates. The results show that the minimum human body exergy consumption rate is associated with thermal sensation votes close to thermal neutrality, tending to the slightly cool side of thermal sensation....... Generally, the relationship between air temperature and the exergy consumption rate, as a first approximation, shows an increasing trend. Taking account of both convective and radiative heat exchange between the human body and the surrounding environment by using the calculated operative temperature, exergy...

77 FR 2735 - National Human Genome Research Institute; Notice of Meetings

Science.gov (United States)

2012-01-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... personal privacy. Name of Committee: National Advisory Council for Human Genome Research. Date: February 13... Extramural Research National Human Genome Research Institute, 5635 Fishers Lane, Suite 4076, MSC 9305...

75 FR 51828 - National Human Genome Research Institute; Notice of Meetings

Science.gov (United States)

2010-08-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... personal privacy. Name of Committee: National Advisory Council for Human Genome Research. Date: February 7... Research, National Human Genome Research Institute, 5635 Fishers Lane, Suite 4076, MSC 9305, Bethesda, MD...

40 CFR 26.123 - Early termination of research support: Evaluation of applications and proposals.

Science.gov (United States)

2010-07-01

... PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human... the protection of the rights and welfare of human subjects (whether or not the research was subject to...

75 FR 2147 - National Human Genome Research Institute; Notice of Meetings

Science.gov (United States)

2010-01-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Council for Human Genome Research. The meetings will be open to the public as indicated below, with... Extramural Research, National Human Genome Research Institute, 5635 Fishers Lane, Suite 4076, MSC 9305...

Collaborative Research in the Digital Humanities

CERN Document Server

Deegan, Marilyn

2012-01-01

Collaboration within digital humanities is both a pertinent and a pressing topic as the traditional mode of the humanist, working alone in his or her study, is supplemented by explicitly co-operative, interdependent and collaborative research. This is particularly true where computational methods are employed in large-scale digital humanities projects. This book, which celebrates the contributions of Harold Short to this field, presents fourteen essays by leading authors in the digital humanities. It addresses several issues of collaboration, from the multiple perspectives of institutions, pro

Research using blogs for data: public documents or private musings?

Science.gov (United States)

Eastham, Linda A

2011-08-01

Nursing and other health sciences researchers increasingly find blogs to be valuable sources of information for investigating illness and other human health experiences. When researchers use blogs as their exclusive data source, they must discern the public/private aspects inherent in the nature of blogs in order to plan for appropriate protection of the bloggers' identities. Approaches to the protection of human subjects are poorly addressed when the human subject is a blogger and the blog is used as an exclusive source of data. Researchers may be assisted to protect human subjects via a decisional framework for assessing a blog author's intended position on the public/private continuum. Copyright © 2011 Wiley Periodicals, Inc.

40 CFR 26.109 - IRB review of research.

Science.gov (United States)

2010-07-01

... 26.109 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.109 IRB... subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights...

Using non-human primates to benefit humans: research and organ transplantation.

Science.gov (United States)

Shaw, David; Dondorp, Wybo; de Wert, Guido

2014-11-01

Emerging biotechnology may soon allow the creation of genetically human organs inside animals, with non-human primates (henceforth simply "primates") and pigs being the best candidate species. This prospect raises the question of whether creating organs in primates in order to then transplant them into humans would be more (or less) acceptable than using them for research. In this paper, we examine the validity of the purported moral distinction between primates and other animals, and analyze the ethical acceptability of using primates to create organs for human use.

Environmental research - ecological research. Annual report 1996

International Nuclear Information System (INIS)

1997-01-01

In the annual report 1996 of the Federal Ministry of Research and Technology, the points of emphasis of the ecological research programme and their financing are discussed. The individual projects in the following subject areas are described in detail: urban-industrial landscapes, forests, agricultural landscapes, river and lake landscapes, other ecosystems and landscapes, terrestrial ecosystem research, environmental pollution and human health and cross-sectional activities in ecological research. (vhe) [de

Attempting to train a digital human model to reproduce human subject reach capabilities in an ejection seat aircraft

NARCIS (Netherlands)

Zehner, G.F.; Hudson, J.A.; Oudenhuijzen, A.

2006-01-01

From 1997 through 2002, the Air Force Research Lab and TNO Defence, Security and Safety (Business Unit Human Factors) were involved in a series of tests to quantify the accuracy of five Human Modeling Systems (HMSs) in determining accommodation limits of ejection seat aircraft. The results of these

Human Body as Subjectivity in Edith Stein. A Discussion on Anthropological Monism

Directory of Open Access Journals (Sweden)

Diego I. Rosales Meana

2014-11-01

Full Text Available This text aims to explain why «anthropological monism» is the most adequate perspective in order to understand human reality, and that this ‘monism’ must not be necessarily considered as materialist. I will divide my work in four sections. First, I will explain briefly the Cartesian paradigm and what I consider some of its ontological mistakes. Then, I will try to build a phenomenology of the self with Edith Stein’s anthropology as its base, in order to reunite the two realities separated by Descartes: body and subjectivity. Third, I will talk about the concept of ‘form’ as the inseparable vital principle of living beings and, finally, I will talk about empathy as the phenomenon by which we constitute the idea of ‘I’ and the notion of ‘human being’. This way, monism will be presented as the best option to explain human reality and its activity.

Recruiting phobic research subjects: effectiveness and cost.

Science.gov (United States)

Kaakko, T; Murtomaa, H; Milgrom, P; Getz, T; Ramsay, D S; Coldwell, S E

2001-01-01

Efficiently enrolling subjects is one of the most important and difficult aspects of a clinical trial. This prospective study evaluated strategies used in the recruitment of 144 dental injection phobics for a clinical trial evaluating the effectiveness of combining alprazolam with exposure therapy. Three types of recruitment strategies were evaluated: paid advertising, free publicity, and professional referral. Sixty-three percent of subjects were enrolled using paid advertising (the majority of them from bus advertisements [27.0%], posters on the University of Washington campus [20.1%], and newspaper advertisements [13.2%]). Free publicity (eg, television coverage, word of mouth) yielded 18.8% of enrolled subjects and professionaL referrals 14.6% of subjects. The average cost (1996 dollars) of enrolling 1 subject was $79. Bus and poster advertising attracted more initial contacts and yielded the greatest enrollment.

Ethical issues in action-oriented research in Indonesia.

Science.gov (United States)

Rachmawaty, Rini

2017-09-01

Action-oriented research is one of the most frequent research types implemented to transform community health in Indonesia. Three researchers and 11 graduate students from a developed country in East Asia conducted a fieldwork program in a remote area in South Sulawesi Province. Although the project was completed, whether or not the international standards for human subject research were applied into that study remains unclear. This study aimed to examine ethical issues raised from that case, analyze constraints to the problems, and recommend alternatives to protect vulnerable populations from being exploited by local/international researchers. A problem-solving approach was used in this study. It began with problem identification, evaluation of the action-oriented research goal, investigation of the constraints to the problem, and recommendation of some relevant alternatives to address the central issue. Ethical Consideration: The approval for conducting the action-oriented research that being investigated in this work was only obtained from the Head of local district. Some ethical issues were found in this case. No special protection for this population, no informed consent was obtained from the participants, exposure to social and economic risks, no future benefits for the subjects, and conflict of interests. Lack of control from the local research ethics committee and lack of competence of local researchers on human subject research were considered as the constraints to the problems. Creating an independent research ethics committee, providing research ethics training to the local researchers, obtaining written/video consents from underserved populations, and meeting local health needs were recommended alternatives to solve these problems. Indonesian government bodies should reform their international collaborative system on research involving human subjects. Exploitation may not occur if all participants as well as all local and national governing bodies

Guidelines for human embryonic stem cell research

National Research Council Canada - National Science Library

Committee on Guidelines for Human Embryonic Stem Cell Research, National Research Council

2005-01-01

Since 1998, the volume of research being conducted using human embryonic stem (hES) cells has expanded primarily using private funds because of restrictions on the use of federal funds for such research...

Memory and subjective workload assessment

Science.gov (United States)

Staveland, L.; Hart, S.; Yeh, Y. Y.

1986-01-01

Recent research suggested subjective introspection of workload is not based upon specific retrieval of information from long term memory, and only reflects the average workload that is imposed upon the human operator by a particular task. These findings are based upon global ratings of workload for the overall task, suggesting that subjective ratings are limited in ability to retrieve specific details of a task from long term memory. To clarify the limits memory imposes on subjective workload assessment, the difficulty of task segments was varied and the workload of specified segments was retrospectively rated. The ratings were retrospectively collected on the manipulations of three levels of segment difficulty. Subjects were assigned to one of two memory groups. In the Before group, subjects knew before performing a block of trials which segment to rate. In the After group, subjects did not know which segment to rate until after performing the block of trials. The subjective ratings, RTs (reaction times) and MTs (movement times) were compared within group, and between group differences. Performance measures and subjective evaluations of workload reflected the experimental manipulations. Subjects were sensitive to different difficulty levels, and recalled the average workload of task components. Cueing did not appear to help recall, and memory group differences possibly reflected variations in the groups of subjects, or an additional memory task.

Clinical Trials: A Crucial Key to Human Health Research

Science.gov (United States)

... Past Issues Clinical Trials: A Crucial Key to Human Health Research Past Issues / Summer 2006 Table of Contents ... Javascript on. Photo: PhotoDisc At the forefront of human health research today are clinical trials—studies that use ...

What's Wrong with Human/Nonhuman Chimera Research?

Science.gov (United States)

Hyun, Insoo

2016-08-01

The National Institutes of Health (NIH) is poised to lift its funding moratorium on research involving chimeric human/nonhuman embryos, pending further consideration by an NIH steering committee. The kinds of ethical concerns that seem to underlie this research and chimera research more generally can be adequately addressed.

Improving subject recruitment, retention, and participation in research through Peplau's theory of interpersonal relations.

Science.gov (United States)

Penckofer, Sue; Byrn, Mary; Mumby, Patricia; Ferrans, Carol Estwing

2011-04-01

Recruitment and retention of persons participating in research is one of the most significant challenges faced by investigators. Although incentives are often used to improve recruitment and retention, evidence suggests that the relationship of the patient to study personnel may be the single, most important factor in subject accrual and continued participation. Peplau's theory of interpersonal relations provides a framework to study the nurse-patient relationship during the research process. In this paper the authors provide a brief summary of research strategies that have been used for the recruitment and retention of subjects and an overview of Peplau's theory of interpersonal relations including its use in research studies. In addition, a discussion of how this theory was used for the successful recruitment and retention of women with type 2 diabetes who participated in a clinical trial using a nurse-delivered psychoeducational intervention for depression is addressed.

Report on achievements of commissioned studies on research and development of a technology to apply human senses to measurements in fiscal 1994. 2. Main issue (Part 5 for research and development of a correlation and evaluation technology); 1994 nendo ningen kankaku keisoku oyo gijutsu no kenkyu kaihatsu. 2. Honronhen (Sokan hyoka gijutsu no kenkyu kaihatsu)

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-03-01

This paper describes the research and development of (1) working environment having human senses and affinity at nuclear electric power plants, (2) a correlation technology for comfort in composite environments composed mainly of warm heat environment, (3) space-type human interface adapted to human senses, and (4) a human comfort meter. With regard to the subject (1), improvements were made on the experimental facilities, data processing systems, and environment improving devices, and data were collected and evaluated from subject experiments. With regard to the subject (2), 'development of a system to investigate correlation among externally stimulating environment, physiological effects, and sense volume based on a physiological reaction model', and 'research and development of a quantitative evaluation technology for comfort in composite environments composed mainly of warm heat environment' were executed. With respect to the subject (3), 'measurement of factors in visual sense operating environment affecting mental burden feeling', 'development of space-type human interface', and 'research on a method to utilize the eyeball movement information' were carried out. With regard to the subject (4), a warm heat sensing element structure was developed. In addition, a comfort determining software was completed that calculates hot-cold heat sense of a human body from different conditions of the warm heat sensing elements. (NEDO)

34 CFR 97.111 - Criteria for IRB approval of research.

Science.gov (United States)

2010-07-01

... 97.111 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research... protect the rights and welfare of these subjects. (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and...

Teaching Earth Sciences as an interdisciplinary subject: Novel module design involving research literature

Science.gov (United States)

Tong, Vincent C. H.

2010-05-01

The study of Earth Sciences requires an interdisciplinary approach as it involves understanding scientific knowledge originating from a wide spectrum of research areas. Not only does it include subjects ranging from, for instance, hydrogeology to deep crustal seismology and from climate science to oceanography, but it also has many direct applications in closely related disciplines such as environmental engineering and natural resources management. While research crossing traditional disciplinary boundaries in geosciences is becoming increasingly common, there is only limited integration of interdisciplinary research in the teaching of the subject. Given that the transition from undergraduate education based on subject modules to postgraduate interdisciplinary research is never easy, such integration is a highly desirable pedagogical approach at both undergraduate and postgraduate levels. My presentation is based on a recent teaching project involving novel design of an undergraduate course. The course is implemented in order to address the synergy between research and teaching (Tong, 2009). This project has been shown to be effective and successful in teaching geosciences undergraduates at the University of London. The module consists of studying core geophysical principles and linking them directly to a selection of recently published research papers in a wide range of interdisciplinary applications. Research reviewing and reporting techniques are systematically developed, practised and fully integrated into teaching of the core scientific theories. A fully-aligned assignment with a feedback website invites the students to reflect on the scientific knowledge and the study skills related to research literature they have acquired in the course. This teaching project has been recognized by a teaching award (http://www.clpd.bbk.ac.uk/staff/BETA). In this presentation, I will discuss how undergraduate teaching with a focus on research literature in Earth Sciences can

Brain-derived neurotrophic factor in human subjects with function-altering melanocortin-4 receptor variants

Science.gov (United States)

In rodents, hypothalamic brain-derived neurotrophic factor (BDNF) expression appears to be regulated by melanocortin-4 receptor (MC4R) activity. The impact of MC4R genetic variation on circulating BDNF in humans is unknown. The objective of this study is to compare BDNF concentrations of subjects wi...

Usability: Human Research Program - Space Human Factors and Habitability

Science.gov (United States)

Sandor, Aniko; Holden, Kritina L.

2009-01-01

The Usability project addresses the need for research in the area of metrics and methodologies used in hardware and software usability testing in order to define quantifiable and verifiable usability requirements. A usability test is a human-in-the-loop evaluation where a participant works through a realistic set of representative tasks using the hardware/software under investigation. The purpose of this research is to define metrics and methodologies for measuring and verifying usability in the aerospace domain in accordance with FY09 focus on errors, consistency, and mobility/maneuverability. Usability metrics must be predictive of success with the interfaces, must be easy to obtain and/or calculate, and must meet the intent of current Human Systems Integration Requirements (HSIR). Methodologies must work within the constraints of the aerospace domain, be cost and time efficient, and be able to be applied without extensive specialized training.

What's Wrong with Human/Nonhuman Chimera Research?

Directory of Open Access Journals (Sweden)

Insoo Hyun

2016-08-01

Full Text Available The National Institutes of Health (NIH is poised to lift its funding moratorium on research involving chimeric human/nonhuman embryos, pending further consideration by an NIH steering committee. The kinds of ethical concerns that seem to underlie this research and chimera research more generally can be adequately addressed.

Discovering subjectivity: A subjective world of meanings in the stories of the twilight of life

OpenAIRE

Zagórska Wanda

2017-01-01

Pointing to the subjective nature of human life, theorists argue that only in a dialogue with another person does the human disclose meanings important to him or her. The interpretation and analysis of stories with regard to the included subjective meanings included in them as manifestations of human subjectivity seem to be the most effective when undertaken in the hermeneutic approach where psychology and philosophy meet. In the paper advantages of a self-narrative method based on the princi...

Disposable swim diaper retention of Cryptosporidium-sized particles on human subjects in a recreational water setting.

Science.gov (United States)

Amburgey, James E; Anderson, J Brian

2011-12-01

Cryptosporidium is a chlorine-resistant protozoan parasite responsible for the majority of waterborne disease outbreaks in recreational water venues in the USA. Swim diapers are commonly used by diaper-aged children participating in aquatic activities. This research was intended to evaluate disposable swim diapers for retaining 5-μm diameter polystyrene microspheres, which were used as non-infectious surrogates for Cryptosporidium oocysts. A hot tub recirculating water without a filter was used for this research. The microsphere concentration in the water was monitored at regular intervals following introduction of microspheres inside of a swim diaper while a human subject undertook normal swim/play activities. Microsphere concentrations in the bulk water showed that the majority (50-97%) of Cryptosporidium-sized particles were released from the swim diaper within 1 to 5 min regardless of the swim diaper type or configuration. After only 10 min of play, 77-100% of the microspheres had been released from all swim diapers tested. This research suggests that the swim diapers commonly used by diaper-aged children in swimming pools and other aquatic activities are of limited value in retaining Cryptosporidium-sized particles. Improved swim diaper solutions are necessary to efficiently retain pathogens and effectively safeguard public health in recreational water venues.

RESEARCH ON ENVIRONMENTAL HEALTH INTERVENTIONS: ETHICAL PROBLEMS AND SOLUTIONS

Science.gov (United States)

RESNIK, DAVID B.; ZELDIN, DARRYL C.; SHARP, RICHARD R.

2014-01-01

This article reviews a variety of ethical issues one must consider when conducting research on environmental health interventions on human subjects. The paper uses the Kennedy Krieger Institute lead abatement study as well as a hypothetical asthma study to discuss questions concerning benefits and risks, risk minimization, safety monitoring, the duty to warn, the duty to report, the use of control groups, informed consent, equitable subject selection, privacy, conflicts of interest, and community consultation. Research on environmental health interventions can make an important contribution to our understanding of human health and disease prevention, provided it is conducted in a manner that meets prevailing scientific, ethical, and legal standards for research on human subjects. PMID:16220621

75 FR 10261 - Request for Nominations to the EPA Human Studies Review Board

Science.gov (United States)

2010-03-05

... scientific and ethical aspects of human subjects research. The major objectives of the HSRB are to provide... of the following areas: Bioethics: expertise in the ethics of research with human subjects... EPA Human Studies Review Board AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY...

Human Research Program Advanced Exercise Concepts (AEC) Overview

Science.gov (United States)

Perusek, Gail; Lewandowski, Beth; Nall, Marsha; Norsk, Peter; Linnehan, Rick; Baumann, David

2015-01-01

countermeasures systems. Numerous technologies have been considered and evaluated against HRP-approved functional device requirements for these extreme mission profiles, and include wearable sensors, exoskeletons, flywheel, pneumatic, and closed-loop microprocessor controlled motor driven systems. Each technology has unique advantages and disadvantages. The Advanced Exercise Concepts project oversees development of candidate next generation exercise countermeasures hardware, performs trade studies of current and state of the art exercise technologies, manages and supports candidate systems physiological evaluations with human test subjects on the ground, in flight analogs and flight. The near term goal is evaluation of candidate systems in flight, culminating in an integrated candidate next generation exercise countermeasures suite on the ISS which coalesces research findings from HRP disciplines in the areas of exercise performance for muscle, bone, cardiovascular, sensorimotor, behavioral health, and nutrition for optimal benefit to the crew.

Exploration of Web Users' Search Interests through Automatic Subject Categorization of Query Terms.

Science.gov (United States)

Pu, Hsiao-tieh; Yang, Chyan; Chuang, Shui-Lung

2001-01-01

Proposes a mechanism that carefully integrates human and machine efforts to explore Web users' search interests. The approach consists of a four-step process: extraction of core terms; construction of subject taxonomy; automatic subject categorization of query terms; and observation of users' search interests. Research findings are proved valuable…

Human Resources for Health Research in Africa | IDRC ...

International Development Research Centre (IDRC) Digital Library (Canada)

Human Resources for Health Research in Africa ... the management of research systems for optimal use of results;; packaging research for policymakers; ... Call for new OWSD Fellowships for Early Career Women Scientists now open.

Relevant Information and Informed Consent in Research: In Defense of the Subjective Standard of Disclosure.

Science.gov (United States)

Dranseika, Vilius; Piasecki, Jan; Waligora, Marcin

2017-02-01

In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the cultural context, talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups.

Uterine transplantation: Review in human research.

Science.gov (United States)

Favre-Inhofer, A; Rafii, A; Carbonnel, M; Revaux, A; Ayoubi, J M

2018-06-01

Uterine transplantation is the solution to treat absolute uterine fertility. In this review, we present the historical, medical, technical, psychological and ethical perspectives in human uterine transplantation research. We reviewed the PubMed database following PRISMA guidelines and added data presented by several research teams during the first international congress on uterine transplantation. Copyright © 2018. Published by Elsevier Masson SAS.

SUBJECTIVE METHODS FOR ASSESSMENT OF DRIVER DROWSINESS

Directory of Open Access Journals (Sweden)

Alina Mashko

2017-12-01

Full Text Available The paper deals with the issue of fatigue and sleepiness behind the wheel, which for a long time has been of vital importance for the research in the area of driver-car interaction safety. Numerous experiments on car simulators with diverse measurements to observe human behavior have been performed at the laboratories of the faculty of the authors. The paper provides analysis and an overview and assessment of the subjective (self-rating and observer rating methods for observation of driver behavior and the detection of critical behavior in sleep deprived drivers using the developed subjective rating scales.

The Impact of Regulating Social Science Research with Biomedical Regulations

Science.gov (United States)

Durosinmi, Brenda Braxton

2011-01-01

The Impact of Regulating Social Science Research with Biomedical Regulations Since 1974 Federal regulations have governed the use of human subjects in biomedical and social science research. The regulations are known as the Federal Policy for the Protection of Human Subjects, and often referred to as the "Common Rule" because 18 Federal…

Poultry studies and anthropological research strategies

International Nuclear Information System (INIS)

Whyte, M.

2002-01-01

Poultry are not simply birds; they are also a human creation, a social and cultural practice. The human element is the justification for an anthropology of poultry. Such an anthropology combines the objective research strategies familiar to the natural sciences with what is often called 'subjective' or qualitative research. In the study of poultry management, it is important that both research strategies focus on differences and variation. The subjective approach is particularly useful in identifying and understanding how the motivations and strategies of local actors are dependent on the social positions, which they occupy in their specific societies. (author)

Metaphysical and ethical perspectives on creating animal-human chimeras.

Science.gov (United States)

Eberl, Jason T; Ballard, Rebecca A

2009-10-01

This paper addresses several questions related to the nature, production, and use of animal-human (a-h) chimeras. At the heart of the issue is whether certain types of a-h chimeras should be brought into existence, and, if they are, how we should treat such creatures. In our current research environment, we recognize a dichotomy between research involving nonhuman animal subjects and research involving human subjects, and the classification of a research protocol into one of these categories will trigger different ethical standards as to the moral permissibility of the research in question. Are a-h chimeras entitled to the more restrictive and protective ethical standards applied to human research subjects? We elucidate an Aristotelian-Thomistic metaphysical framework in which to argue how such chimeras ought to be defined ontologically. We then examine when the creation of, and experimentation upon, certain types of a-h chimeras may be morally permissible.

40 CFR 26.1109 - IRB review of research.

Science.gov (United States)

2010-07-01

... 26.1109 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional... meaningfully add to the protection of the rights and welfare of subjects. (c) An IRB shall require...

Enhancing Interdisciplinary Human System Risk Research Through Modeling and Network Approaches

Science.gov (United States)

Mindock, Jennifer; Lumpkins, Sarah; Shelhamer, Mark

2015-01-01

NASA's Human Research Program (HRP) supports research to reduce human health and performance risks inherent in future human space exploration missions. Understanding risk outcomes and contributing factors in an integrated manner allows HRP research to support development of efficient and effective mitigations from cross-disciplinary perspectives, and to enable resilient human and engineered systems for spaceflight. The purpose of this work is to support scientific collaborations and research portfolio management by utilizing modeling for analysis and visualization of current and potential future interdisciplinary efforts.

Review-Research on the physical training model of human body based on HQ.

Science.gov (United States)

Junjie, Liu

2016-11-01

Health quotient (HQ) is the newest health culture and concept in the 21st century, and the analysis of the human body sports model is not enough mature at present, what's more, the purpose of this paper is to study the integration of the two subjects the health quotient and the sport model. This paper draws the conclusion that physical training and education in colleges and universities can improve the health quotient, and it will make students possess a more healthy body and mind. Then through a new rigid body model of sports to simulate the human physical exercise. After that this paper has an in-depth study on the dynamic model of the human body movement on the basis of establishing the matrix and equation. The simulation results of the human body bicycle riding and pole throwing show that the human body joint movement simulation can be realized and it has a certain operability as well. By means of such simulated calculation, we can come to a conclusion that the movement of the ankle joint, knee joint and hip joint's motion law and real motion are basically the same. So it further verify the accuracy of the motion model, which lay the foundation of other research movement model, also, the study of the movement model is an important method in the study of human health in the future.

Research Ethics: Institutional Review Board Oversight of Art Therapy Research

Science.gov (United States)

Deaver, Sarah P.

2011-01-01

By having their research proposals reviewed and approved by Institutional Review Boards (IRBs), art therapists meet important ethical principles regarding responsibility to research participants. This article provides an overview of the history of human subjects protections in the United States; underlying ethical principles and their application…

How children can be respected as 'ends' yet still be used as subjects in non-therapeutic research.

OpenAIRE

Redmon, R B

1986-01-01

The question of whether or not children may be used as subjects in non-therapeutic research projects has generated a great deal of debate and received answers varying from 'no, never' to 'yes, if societal interests are served'. It has been claimed that a Kantian, deontological ethics would necessarily rule out such research, since valid consent would be impossible. The present paper gives a deontological argument for allowing children to be subjects in certain types of research.

How children can be respected as 'ends' yet still be used as subjects in non-therapeutic research.

Science.gov (United States)

Redmon, R B

1986-06-01

The question of whether or not children may be used as subjects in non-therapeutic research projects has generated a great deal of debate and received answers varying from 'no, never' to 'yes, if societal interests are served'. It has been claimed that a Kantian, deontological ethics would necessarily rule out such research, since valid consent would be impossible. The present paper gives a deontological argument for allowing children to be subjects in certain types of research.

How children can be respected as 'ends' yet still be used as subjects in non-therapeutic research.

Science.gov (United States)

Redmon, R B

1986-01-01

The question of whether or not children may be used as subjects in non-therapeutic research projects has generated a great deal of debate and received answers varying from 'no, never' to 'yes, if societal interests are served'. It has been claimed that a Kantian, deontological ethics would necessarily rule out such research, since valid consent would be impossible. The present paper gives a deontological argument for allowing children to be subjects in certain types of research. PMID:3735361

Theoretical modeling of the subject: Western and Eastern types of human reflexion.

Science.gov (United States)

Lefebvre, Vladimir A

2017-12-01

The author puts forth the hypothesis that mental phenomena are connected with thermodynamic properties of large neural network. A model of the subject with reflexion and capable for meditation is constructed. The processes of reflexion and meditation are presented as the sequence of heat engines. Each subsequent engine compensates for the imperfectness of the preceding engine by performing work equal to the lost available work of the preceding one. The sequence of heat engines is regarded as a chain of the subject's mental images of the self. Each engine can be interpreted as an image of the self that the engine next to it has, and the work performed by engines as the emotions that the subject and his images are experiencing. Two types of meditation are analyzed: The dissolution in nothingness and union with the Absolute. In the first type, the initial engine is the one that yields heat to the coldest reservoir, and in the second type, the initial engine is the one that takes heat from the hottest reservoir. The main concepts of thermodynamics are reviewed in relation to the process of human reflexion. Copyright © 2017 Elsevier Ltd. All rights reserved.

77 FR 2304 - National Human Genome Research Institute; Notice of Meeting

Science.gov (United States)

2012-01-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome....S.C. 281(d)(4)), notice is hereby given that the National Human Genome Research Institute (NHGRI... meeting of the National Advisory Council for Human Genome Research. Background materials on the proposed...

Research Ethics

Science.gov (United States)

Dooly, Melinda; Moore, Emilee; Vallejo, Claudia

2017-01-01

Qualitative research, especially studies in educational contexts, often brings up questions of ethics because the study design involves human subjects, some of whom are under age (e.g. data collected in primary education classrooms). It is not always easy for young researchers to anticipate where ethical issues might emerge while designing their…

Researcher Story: Stuttering

Medline Plus

Full Text Available ... to mitigate the effects of the disorder. How Do Researchers Study Stuttering? Video of How Do Researchers Study Stuttering? A large portion of the ... human geneticists really can’t make progress. How do we find our subjects? Well, we find them ...

Inhalation of road dust by human subjects.

Science.gov (United States)

Takishima, T; Nakamura, M; Sasaki, M; Miyano, M; Yamaya, M; Sasaki, H

1987-11-01

We measured pneumomagnetic field strength (PMFS) in 42 healthy control subjects living in districts of Northern Japan with low levels of road dust pollution and in 39 healthy subjects living in areas with high levels of road dust pollution. Suspended road dust produced by studded tires increases from 30 micrograms/m3 during the summer season to levels as high as 400 micrograms/m3 during the snow season in the downtown areas of Sendai, Japan. Road dust retained in the lungs, containing 3% iron, was magnetized from the surface of the chest wall, and PMFS was measured. Three to 5 sequential PMFS measurements were made in each subject in March and October of 1984 and 1985, and in March 1986. The PMFS in control subjects in March 1984 was 37 +/- 14 pico-Tesla (mean +/- SD) and did not significantly differ from the PMFS in October 1984 or that in March 1985. In March 1984, the PMFS of the subjects in highly polluted areas was 95 +/- 100 pico-Tesla (mean +/- SD) and was significantly higher than that of control subjects (p less than 0.01) and subsequently decreased in March 1985 and in March 1986, corresponding to a decrease in suspended road dust brought about by a campaign to eliminate the use of studded tires. Our findings suggest that some road dust caused by studded tires is retained in the lungs.

Differential effects of airway anesthesia on ozone-induced pulmonary responses in human subjects.

Science.gov (United States)

Schelegle, E S; Eldridge, M W; Cross, C E; Walby, W F; Adams, W C

2001-04-01

We examined the effect of tetracaine aerosol inhalation, a local anesthetic, on lung volume decrements, rapid shallow breathing, and subjective symptoms of breathing discomfort induced by the acute inhalation of 0.30 ppm ozone for 65 min in 22 ozone-sensitive healthy human subjects. After 50 min of ozone inhalation FEV(1) was reduced 24%, breathing frequency was increased 40%, tidal volume was decreased 31%, and total subjective symptom score was increased (71.2, compared with 3.8 for filtered air exposure). Inhalation of tetracaine aerosol resulted in marked reductions in ozone-induced subjective symptoms of throat tickle and/or irritation (92.1%), cough (78.5%), shortness of breath (72.5%), and pain on deep inspiration (69.4%). In contrast, inhalation of tetracaine aerosol (mass median aerodynamic diameter of 3.52 microm with a geometric standard deviation of 1.92) resulted in only minor and inconsistent rectification of FEV(1) decrements (5.0%) and breathing frequency (-3.8%) that was not significantly different from that produced by saline aerosol alone (FEV(1), 5.1% and breathing frequency, -2.7%). Our data are consistent with afferent endings located within the large conducting airways of the tracheobronchial tree being primarily responsible for ozone-induced subjective symptoms and provides strong evidence that ozone-induced inhibition of maximal inspiratory effort is not dependent on conscious sensations of inspiratory discomfort.

Misleading by Omission: Rethinking the Obligation to Inform Research Subjects about Funding Sources.

Science.gov (United States)

Manson, Neil C

2017-11-15

Informed consent requirements for medical research have expanded over the past half-century. The Declaration of Helsinki now includes an explicit positive obligation to inform subjects about funding sources. This is problematic in a number of ways and seems to oblige researchers to disclose information irrelevant to most consent decisions. It is argued here that such a problematic obligation involves an "informational fallacy." The aim in the second part of the paper is to provide a better approach to making sense of how a failure to inform about funding sources wrongs subjects: by making appeals to obligations to refrain from misleading by omission. This alternative approach-grounded in a general obligation to refrain from misleading, an obligation that is independent of informed consent-provides a basis for a norm that protects subjects' interests, without the informational fallacy. The approach developed here avoids the problems identified with the currently specified general obligation to inform about funding sources. © The Author 2017. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

45 CFR 46.123 - Early termination of research support: Evaluation of applications and proposals.

Science.gov (United States)

2010-10-01

... of applications and proposals. 46.123 Section 46.123 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human... rights and welfare of human subjects (whether or not the research was subject to federal regulation). ...

Human Research Program: 2012 Fiscal Year Annual Report

Science.gov (United States)

Effenhauser, Laura

2012-01-01

Crew health and performance are critical to successful human exploration beyond low Earth orbit. Risks to health and performance include physiologic effects from radiation, hypogravity, and planetary environments, as well as unique challenges in medical treatment, human factors, and support of behavioral health. The scientists and engineers of the Human Research Program (HRP) investigate and reduce the greatest risks to human health and performance, and provide essential countermeasures and technologies for human space exploration. In its seventh year of operation, the HRP continued to refine its management architecture of evidence, risks, gaps, tasks, and deliverables. Experiments continued on the International Space Station (ISS), on the ground in analog environments that have features similar to those of spaceflight, and in laboratory environments. Data from these experiments furthered the understanding of how the space environment affects the human system. These research results contributed to scientific knowledge and technology developments that address the human health and performance risks. As shown in this report, HRP has made significant progress toward developing medical care and countermeasure systems for space exploration missions which will ultimately reduce risks to crew health and performance.

The concept of human dignity in the ethics of genetic research.

Science.gov (United States)

Chan, David K

2015-05-01

Despite criticism that dignity is a vague and slippery concept, a number of international guidelines on bioethics have cautioned against research that is contrary to human dignity, with reference specifically to genetic technology. What is the connection between genetic research and human dignity? In this article, I investigate the concept of human dignity in its various historical forms, and examine its status as a moral concept. Unlike Kant's ideal concept of human dignity, the empirical or relational concept takes human dignity as something that is affected by one's circumstances and what others do. I argue that the dignity objection to some forms of genetic research rests on a view of human nature that gives humans a special status in nature - one that is threatened by the potential of genetic research to reduce individuals to their genetic endowment. I distinguish two main philosophical accounts of human nature. One of these, the Aristotelian view, is compatible with the use of genetic technology to help humans realize their inherent potential to a fuller extent. © 2014 John Wiley & Sons Ltd.

Research ethics across the 49th parallel: the potential value of pilot testing "equivalent protections" in Canadian research institutions.

Science.gov (United States)

Lavery, James V; McDonald, Michael; Meslin, Eric M

2005-01-01

Canada and the United States share the world's largest trade partnership and an increasing concern about divergent regulatory approaches to common industries. Canadian research institutes receive more research funding from the U.S. National Institutes of Health than any other country, much of it to fund multi-centre and collaborative research between the two countries. Because of these close economic and research ties, and the extensive similarities between the two countries in the review and oversight of ethics in human subjects research, we propose that Canada would be an ideal country for a pilot-test of the feasibility of "equivalent protections," a U.S. regulation that permits comparison of protections for human subjects between institutions in the two countries. The "equivalent protections" has been advocated by various bodies in the United States as a potentially beneficial mechanism for improving oversight of foreign trials. As well, we argue that "equivalent protections" could prove to be valuable for Canada in five specific ways: (1) by potentially reducing administrative burden on Canadian research institutions administering U.S. federal research funding; (2) by creating symbolic value of an explicit recognition by the United States that procedures normally followed for the protection of human subjects in Canadian research institutions are at least equivalent to those provided by the U.S. regulations; (3) by lowering the opportunity cost of investing in research in Canada; (4) by affording Canada an opportunity to enhance its leadership role in international research by offering an alternative to the U.S. regulatory model for the protection of human subjects; and (5) by providing a model for how the idea of equivalent protections might be addressed for research funded by Canadian agencies but conducted in other countries.

A method to evaluate performance reliability of individual subjects in laboratory research applied to work settings.

Science.gov (United States)

1978-10-01

This report presents a method that may be used to evaluate the reliability of performance of individual subjects, particularly in applied laboratory research. The method is based on analysis of variance of a tasks-by-subjects data matrix, with all sc...

Braille character discrimination in blindfolded human subjects.

Science.gov (United States)

Kauffman, Thomas; Théoret, Hugo; Pascual-Leone, Alvaro

2002-04-16

Visual deprivation may lead to enhanced performance in other sensory modalities. Whether this is the case in the tactile modality is controversial and may depend upon specific training and experience. We compared the performance of sighted subjects on a Braille character discrimination task to that of normal individuals blindfolded for a period of five days. Some participants in each group (blindfolded and sighted) received intensive Braille training to offset the effects of experience. Blindfolded subjects performed better than sighted subjects in the Braille discrimination task, irrespective of tactile training. For the left index finger, which had not been used in the formal Braille classes, blindfolding had no effect on performance while subjects who underwent tactile training outperformed non-stimulated participants. These results suggest that visual deprivation speeds up Braille learning and may be associated with behaviorally relevant neuroplastic changes.

Biomarkers of Dose and Effect of inhaled ozone in resting versus exercising human subjects: comparison with resting rats

Science.gov (United States)

Background: Human controlled exposure studies have generally focused on subjects exposed to ozone (O3) while exercising while exposures in rats have been done at rest. We exposed resting subjects to labeled O3 (18O3, 0.4 ppm, for 2 hr) and compared O3 dose and effects with our...

40 CFR 26.103 - Assuring compliance with this policy-research conducted or supported by any Federal Department or...

Science.gov (United States)

2010-07-01

... Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.103 Assuring compliance with this... responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by...

Biorepository regulatory frameworks: building parallel resources that both promote scientific investigation and protect human subjects.

Science.gov (United States)

Marko-Varga, György; Baker, Mark S; Boja, Emily S; Rodriguez, Henry; Fehniger, Thomas E

2014-12-05

Clinical samples contained in biorepositories represent an important resource for investigating the many factors that drive human biology. The biological and chemical markers contained in clinical samples provide important measures of health and disease that when combined with such medical evaluation data can aid in decision making by physicians. Nearly all disciplines in medicine and every "omic" depend upon the readouts obtained from such samples, whether the measured analyte is a gene, a protein, a lipid, or a metabolite. There are many steps in sample processing, storage, and management that need to understood by the researchers who utilize biorepositories in their own work. These include not only the preservation of the desired analytes in the sample but also good understanding of the moral and legal framework required for subject protection irrespective of where the samples have been collected. Today there is a great deal of effort in the community to align and standardize both the methodology of sample collection and storage performed in different locations and the necessary frameworks of subject protection including informed consent and institutional review of the studies being performed. There is a growing trend in developing biorepositories around the focus of large population-based studies that address both active and silent nonsymptomatic disease. Logistically these studies generate large numbers of clinical samples and practically place increasing demand upon health care systems to provide uniform sample handling, processing, storage, and documentation of both the sample and the subject as well to ensure that safeguards exist to protect the rights of the study subjects for deciding upon the fates of their samples. Currently the authority to regulate the entire scope of biorepository usage exists as national practice in law in only a few countries. Such legal protection is a necessary component within the framework of biorepositories, both now and in

Information Presentation: Human Research Program - Space Human Factors and Habitability, Space Human Factors Engineering Project

Science.gov (United States)

Holden, Kristina L.; Sandor, Aniko; Thompson, Shelby G.; Kaiser, Mary K.; McCann, Robert S.; Begault, D. R.; Adelstein, B. D.; Beutter, B. R.; Wenzel, E. M.; Godfroy, M.;

10 CFR 600.31 - Research misconduct.

Science.gov (United States)

2010-01-01

... there has been a significant departure from accepted practices of the relevant research community and..., medicine, psychology, social sciences statistics, and research involving human subjects or animals...

The Journal Project and the I in Qualitative Research: Three Theoretical Lenses on Subjectivity and Self

Science.gov (United States)

Davidson, Judith

2012-01-01

From the beginnings of qualitative research in the late 19th century to today, researchers have struggled to make sense of the notion of self or subjectivity; in other words, the I in the research. We ask ourselves: Who is the researcher? How is their notion of self present during research? How is research a site for contested notions of self? Who…

Human-Computer Interaction and Information Management Research Needs

Data.gov (United States)

Networking and Information Technology Research and Development, Executive Office of the President — In a visionary future, Human-Computer Interaction HCI and Information Management IM have the potential to enable humans to better manage their lives through the use...

The Frequency of Reporting Ethical Issues in Human Subject Articles Published in Iranian Medical Journals: 2009-2013.

Science.gov (United States)

Astaneh, Behrooz; Khani, Parisa

2017-11-10

Researchers should strictly consider the participants' rights. They are required to document such protections as an ethical approval of the study proposal, the obtaining "informed consent", the authors' "conflict of interests", and the source of "financial support" in the published articles. The purpose of this study was to assess the frequency of reporting ethical issues in human subject articles published in Iranian medical journals during 2009-2013. In this cross-sectional study, we randomly reviewed 1460 human subject articles published in Iranian medical journals during 2009-2013 in two Persian and English language groups. Data collection was carried out by assessing articles, focusing on the documentation "ethics committee approval", patients' "informed consent", "financial support", "confidentiality", and "conflict of interest". Of 1460 evaluated articles, 443 (30.3%) reported "ethics committee approval", 686 (47.0%) reported "informed consent", 594 (40.7%) reported "financial support", and 341 (23.4%) reported "conflict of interest". 13% of the articles referred to patients' confidentiality in their text. There was a significant association between these ethical documentations and the year of publication. Articles published in English language journals reported "ethics committee approval", "financial support", and "conflict of interest" significantly more than Persian language journals, but the frequency of "informed consent" was similar. Ethical documentation rate in Iranian medical journals is not up to the expected standards of reputable journals which might be related to a lack of awareness and the education of the authors and the journal's editors. Precise reporting of ethical considerations in medical articles by authors are recommended. It is suggested journals and policymakers pay more attention to reporting this issue while providing standard guidelines in this regard.

40 CFR 26.1603 - Operation of the Human Studies Review Board.

Science.gov (United States)

2010-07-01

... appropriate for the scientific and ethical review of human research, including research ethics, biostatistics... scientific and ethical aspects of research proposals and reports of completed research with human subjects... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Operation of the Human Studies Review...

Impact Response Comparison Between Parametric Human Models and Postmortem Human Subjects with a Wide Range of Obesity Levels.

Science.gov (United States)

Zhang, Kai; Cao, Libo; Wang, Yulong; Hwang, Eunjoo; Reed, Matthew P; Forman, Jason; Hu, Jingwen

2017-10-01

Field data analyses have shown that obesity significantly increases the occupant injury risks in motor vehicle crashes, but the injury assessment tools for people with obesity are largely lacking. The objectives of this study were to use a mesh morphing method to rapidly generate parametric finite element models with a wide range of obesity levels and to evaluate their biofidelity against impact tests using postmortem human subjects (PMHS). Frontal crash tests using three PMHS seated in a vehicle rear seat compartment with body mass index (BMI) from 24 to 40 kg/m 2 were selected. To develop the human models matching the PMHS geometry, statistical models of external body shape, rib cage, pelvis, and femur were applied to predict the target geometry using age, sex, stature, and BMI. A mesh morphing method based on radial basis functions was used to rapidly morph a baseline human model into the target geometry. The model-predicted body excursions and injury measures were compared to the PMHS tests. Comparisons of occupant kinematics and injury measures between the tests and simulations showed reasonable correlations across the wide range of BMI levels. The parametric human models have the capability to account for the obesity effects on the occupant impact responses and injury risks. © 2017 The Obesity Society.

Human tissue models in cancer research: looking beyond the mouse

Directory of Open Access Journals (Sweden)

Samuel J. Jackson

2017-08-01

Full Text Available Mouse models, including patient-derived xenograft mice, are widely used to address questions in cancer research. However, there are documented flaws in these models that can result in the misrepresentation of human tumour biology and limit the suitability of the model for translational research. A coordinated effort to promote the more widespread development and use of ‘non-animal human tissue’ models could provide a clinically relevant platform for many cancer studies, maximising the opportunities presented by human tissue resources such as biobanks. A number of key factors limit the wide adoption of non-animal human tissue models in cancer research, including deficiencies in the infrastructure and the technical tools required to collect, transport, store and maintain human tissue for lab use. Another obstacle is the long-standing cultural reliance on animal models, which can make researchers resistant to change, often because of concerns about historical data compatibility and losing ground in a competitive environment while new approaches are embedded in lab practice. There are a wide range of initiatives that aim to address these issues by facilitating data sharing and promoting collaborations between organisations and researchers who work with human tissue. The importance of coordinating biobanks and introducing quality standards is gaining momentum. There is an exciting opportunity to transform cancer drug discovery by optimising the use of human tissue and reducing the reliance on potentially less predictive animal models.

Human tissue models in cancer research: looking beyond the mouse.

Science.gov (United States)

Jackson, Samuel J; Thomas, Gareth J

2017-08-01

Mouse models, including patient-derived xenograft mice, are widely used to address questions in cancer research. However, there are documented flaws in these models that can result in the misrepresentation of human tumour biology and limit the suitability of the model for translational research. A coordinated effort to promote the more widespread development and use of 'non-animal human tissue' models could provide a clinically relevant platform for many cancer studies, maximising the opportunities presented by human tissue resources such as biobanks. A number of key factors limit the wide adoption of non-animal human tissue models in cancer research, including deficiencies in the infrastructure and the technical tools required to collect, transport, store and maintain human tissue for lab use. Another obstacle is the long-standing cultural reliance on animal models, which can make researchers resistant to change, often because of concerns about historical data compatibility and losing ground in a competitive environment while new approaches are embedded in lab practice. There are a wide range of initiatives that aim to address these issues by facilitating data sharing and promoting collaborations between organisations and researchers who work with human tissue. The importance of coordinating biobanks and introducing quality standards is gaining momentum. There is an exciting opportunity to transform cancer drug discovery by optimising the use of human tissue and reducing the reliance on potentially less predictive animal models. © 2017. Published by The Company of Biologists Ltd.

Japan. Human cloning ban allows some research.

Science.gov (United States)

Normile, D

2000-12-08

TOKYO--Japanese legislators last week approved a ban on human cloning that leaves room for the use of certain techniques in basic research. The action comes at the same time officials in two other countries--China and France--aired similar proposals that would prohibit so-called reproductive cloning while recognizing the possible importance of the technology in combating disease and improving human health.

38 CFR 1.468 - Relationship to Federal statutes protecting research subjects against compulsory disclosure of...

Science.gov (United States)

2010-07-01

... Information from Department of Veterans Affairs (va) Records Relating to Drug Abuse, Alcoholism Or Alcohol... on the Attorney General, respectively, the power to authorize researchers conducting certain types of... statutes protecting research subjects against compulsory disclosure of their identity. 1.468 Section 1.468...

Analysis of angiotensin II binding to human platelets: Differences in young and old subjects

International Nuclear Information System (INIS)

Siebers, M.J.; Goodfriend, T.L.; Ball, D.; Elliott, M.E.

1990-01-01

We examined the binding of radiolabeled angiotensin II (AII) to human platelets to characterize the apparent increase in AII receptors observed in older subjects. At 22 degrees C, the amount of radioactivity associated with platelets from older subjects increased continuously for more than 2 hours. The same amount of radioactivity was displaced by addition of unlabeled AII at 30 min and 60 min. In the presence of phenylarsine oxide, in the cold, or when labeled antagonist was the ligand, binding came to equilibrium by 30 min. High pressure liquid chromatography demonstrated that 125 I-AII was the major radioactive compound in the supernatant and platelets after incubation, but the platelets also contained radiolabeled AII fragments. Thus, some degradation accompanied interaction of AII and platelets. Phenylarsine oxide did not prevent degradation of bound AII, suggesting that degradation precedes internalization. On average, maximum binding was greater in older subjects whether platelets were incubated with 125 I-AII alone, with 125 I-AII and phenylarsine oxide to prevent internalization, or when the competitive inhibitor 125 I-sar1,ile8-AII was the radioligand. Variability of binding among subjects also increased with age. Thus, platelets bind, degrade, and internalize AII, and the three processes occur to a greater extent in platelets from some, but not all older subjects

21 CFR 201.129 - Drugs; exemption for radioactive drugs for research use.

Science.gov (United States)

2010-04-01

... to human research subjects during the course of a research project intended to obtain basic research... labeled drug or regarding human physiology, pathophysiology, or biochemistry (but not intended for...

The object of mobile spatial data, the subject in mobile spatial research

Directory of Open Access Journals (Sweden)

Jim Thatcher

2016-09-01

Full Text Available With an estimated one billion smartphones producing over 5 petabytes of data a day, the spatially aware mobile device has become a near ubiquitous presence in daily life. Cogent, excellent research in a variety of fields has explored what the spatial data these devices produce can reveal of society, such as analysis of Foursquare check-ins to reveal patterns of mobility for groups through a city. In such studies, the individual intentions, motivations, and desires behind the production of said data can become lost through computational aggregation and analysis. In this commentary, I argue for a rethinking of the epistemological leap from individual to data point through a (reseating of the reflexive, self-eliciting subject as an object for spatial big data research. To do so, I first situate current research on spatial big data within a computational turn in social sciences that relies overly on the data produced as a stand-in for the subject producing said data. Second, I argue that a recent shift within geography and cognate disciplines toward viewing spatial big data as a form of spatial media allows for study of the sociotechnical processes that produce modern assemblages of data and society. As spatial media, the spatial big data created through mobile device use can be understood as the data of everyday life and as part of the sociotechnical processes that produce individuals, data, and space. Ultimately, to understand the data of everyday life, researchers must write thick descriptions of the stories we tell ourselves about the data we give off to others.

Diclofenac delays micropore closure following microneedle treatment in human subjects

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Brogden, Nicole K.; Milewski, Mikolaj; Ghosh, Priyanka; Hardi, Lucia; Crofford, Leslie J.; Stinchcomb, Audra L.

2013-01-01

Drugs absorbed poorly through the skin are commonly delivered via injection with a hypodermic needle, which is painful and increases the risk of transmitting infectious diseases. Microneedles (MNs) selectively and painlessly permeabilize the outermost skin layer, allowing otherwise skin-impermeable drugs to cross the skin through micron-sized pores and reach therapeutic concentrations. However, rapid healing of the micropores prevents further drug delivery, blunting the clinical utility of this unique transdermal technique. We present the first human study demonstrating that micropore lifetime can be extended following MN treatment. Subjects received one-time MN treatment and daily topical application of diclofenac sodium. Micropore closure was measured with impedance spectroscopy, and area under the admittance–time curve (AUC) was calculated. AUC was significantly higher at MN + diclofenac sodium sites vs. placebo, suggesting slower rates of micropore healing. Colorimetry measurements confirmed the absence of local erythema and irritation. This mechanistic human proof-of-concept study demonstrates that micropore lifetime can be prolonged with simple topical administration of a non-specific cyclooxygenase inhibitor, suggesting the involvement of subclinical inflammation in micropore healing. These results will allow for longer patch wear time with MN-enhanced delivery, thus increasing patient compliance and expanding the transdermal field to a wider variety of clinical conditions. PMID:22929967

Preliminary thoughts on research in medical humanities.

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Yun, Xiaojing; Guo, Jiawei; Qian, Haihong

2017-05-23

Medical humanities (MH) is an interdisciplinary field of medicine which includes the humanities (literature, philosophy, ethics, history, and religion), social sciences (anthropology, cultural studies, psychology, sociology, and health geography), and the arts (literature, theater, film, and visual arts) and their application to medical education and practice. Studies of MH should not be limited to theoretical discussions. Research results must be translated into use of methodologies to formulate medical policies, guide clinical practices, and help resolve physical or mental problems. MH has a critical role in addressing medicine-related issues, such as human cloning legislation and the treatment of Ebola virus infection. Recently, MH has also been included in the "Healthy China 2030" project, indicating that MH has garnered more attention in China. Medical colleges, research institutes, and non-profit organizations are focusing on MH studies. Over the past few years, financial support for MH studies has also increased. Although the development of MH currently lags behind medicine and health sciences, MH has promise.

77 FR 59933 - National Human Genome Research Institute; Notice of Closed Meetings

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2012-10-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research....D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute...

76 FR 29772 - National Human Genome Research Institute; Notice of Closed Meetings

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2011-05-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research... of Scientific Review, National Human Genome Research Institute, National Institutes of Health...

77 FR 5035 - National Human Genome Research Institute; Notice of Closed Meetings

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2012-02-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research... Officer, Scientific Review Branch, National Human Genome Research Institute, National Institutes of Health...

77 FR 58402 - National Human Genome Research Institute; Notice of Closed Meetings

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2012-09-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research...: To review and evaluate grant applications. Place: National Human Genome Research Institute, 5635...

78 FR 55752 - National Human Genome Research Institute; Notice of Closed Meetings

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2013-09-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research.... Pozzatti, Ph.D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research...

78 FR 56905 - National Human Genome Research Institute; Notice of Closed Meeting

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2013-09-16

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78 FR 107 - National Human Genome Research Institute; Notice of Closed Meeting

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2013-01-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... evaluate grant applications. Place: National Human Genome Research Institute, 3rd Floor Conference Room....D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute...

Device orientation of a leadless pacemaker and subcutaneous implantable cardioverter-defibrillator in canine and human subjects and the effect on intrabody communication.

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Quast, Anne-Floor B E; Tjong, Fleur V Y; Koop, Brendan E; Wilde, Arthur A M; Knops, Reinoud E; Burke, Martin C

2018-02-14

The development of communicating modular cardiac rhythm management systems relies on effective intrabody communication between a subcutaneous implantable cardioverter-defibrillator (S-ICD) and a leadless pacemaker (LP), using conducted communication. Communication success is affected by the LP and S-ICD orientation. This study is designed to evaluate the orientation of the LP and S-ICD in canine subjects and measure success and threshold of intrabody communication. To gain more human insights, we will explore device orientation in LP and S-ICD patients. Canine subjects implanted with a prototype S-ICD and LP (both Boston Scientific, MA, USA) with anterior-posterior fluoroscopy images were included in this analysis. For comparison, a retrospective analysis of human S-ICD and LP patients was performed. The angle of the long axis of the LP towards the vertical axis of 0°, and distance between the coil and LP were measured. Twenty-three canine subjects were analysed. Median angle of the LP was 29° and median distance of the S-ICD coil to LP was 0.8 cm. All canine subjects had successful communication. The median communicating threshold was 2.5 V. In the human retrospective analysis, 72 LP patients and 100 S-ICD patients were included. The mean angle of the LP was 56° and the median distance between the S-ICD coil and LP was 4.6 cm. Despite the less favourable LP orientation in canine subjects, all communication attempts were successful. In the human subjects, we observed a greater and in theory more favourable LP angle towards the communication vector. These data suggests suitability of human anatomy for conductive intrabody communication.

75 FR 8374 - National Human Genome Research Institute; Notice of Closed Meeting

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2010-02-24

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78 FR 64222 - National Human Genome Research Institute; Notice of Closed Meetings

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2013-10-28

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77 FR 60706 - National Human Genome Research Institute; Notice of Closed Meeting

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2012-10-04

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77 FR 20646 - National Human Genome Research Institute; Notice of Closed Meetings

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2012-04-05

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78 FR 21382 - National Human Genome Research Institute; Notice of Closed Meeting

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2013-04-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... applications. Place: National Human Genome Research Institute, Suite 4076, 5635 Fisher's Lane, Bethesda, MD..., National Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane, Suite 4075...

78 FR 20933 - National Human Genome Research Institute; Notice of Closed Meeting

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2013-04-08

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76 FR 22112 - National Human Genome Research Institute; Notice of Closed Meeting

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2011-04-20

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78 FR 31953 - National Human Genome Research Institute; Notice of Closed Meeting

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2013-05-28

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75 FR 10488 - National Human Genome Research Institute; Notice of Closed Meetings

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2010-03-08

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75 FR 8373 - National Human Genome Research Institute; Notice of Closed Meeting

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2010-02-24

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77 FR 22332 - National Human Genome Research Institute; Notice of Closed Meeting

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2012-04-13

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77 FR 8268 - National Human Genome Research Institute; Notice of Closed Meetings

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2012-02-14

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75 FR 19984 - National Human Genome Research Institute; Notice of Closed Meetings

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2010-04-16

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76 FR 28056 - National Human Genome Research Institute; Notice of Closed Meeting

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2011-05-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Counselors, National Human Genome Research Institute. The meeting will be closed to the public as indicated... National Human Genome Research Institute, including consideration of personnel qualifications and...

76 FR 3642 - National Human Genome Research Institute; Notice of Closed Meetings

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2011-01-20

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76 FR 17930 - National Human Genome Research Institute; Notice of Closed Meeting

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2011-03-31

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75 FR 52537 - National Human Genome Research Institute; Notice of Closed Meeting

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2010-08-26

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76 FR 58023 - National Human Genome Research Institute; Notice of Closed Meeting

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2011-09-19

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75 FR 2148 - National Human Genome Research Institute; Notice of Closed Meeting

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2010-01-14

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77 FR 28888 - National Human Genome Research Institute Notice of Closed Meeting

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2012-05-16

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78 FR 70063 - National Human Genome Research Institute; Notice of Closed Meeting

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2013-11-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Counselors, National Human Genome Research Institute. The meeting will be closed to the public as indicated... NATIONAL HUMAN GENOME RESEARCH INSTITUTE, including consideration of personnel qualifications and...

78 FR 9707 - National Human Genome Research Institute; Notice of Closed Meetings

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2013-02-11

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77 FR 71604 - National Human Genome Research Institute; Notice of Closed Meeting

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2012-12-03

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76 FR 5390 - National Human Genome Research Institute; Notice of Closed Meeting

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2011-01-31

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75 FR 13558 - National Human Genome Research Institute; Notice of Closed Meeting

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2010-03-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Counselors, National Human Genome Research Institute. The meeting will be closed to the public as indicated... National Human Genome Research Institute, including consideration of personnel qualifications and...

75 FR 32957 - National Human Genome Research Institute; Notice of Closed Meeting

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2010-06-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research...