Subjective Quantitative Studies of Human Agency

ERIC Educational Resources Information Center

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…

The FDA's role in medical device clinical studies of human subjects

NASA Astrophysics Data System (ADS)

Saviola, James

2005-03-01

This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

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

PubMed

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.

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

PubMed

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.

Reducing the Time for IRB Reviews: A Case Study

ERIC Educational Resources Information Center

Liberale, Andrea Pescina; Kovach, Jamison V.

2017-01-01

Research activities often involve enrolling human subjects as volunteers to participate in research studies. Federal regulations mandate that research institutions are responsible for protecting the ethical rights and welfare of human subjects from research risks. This is usually accomplished by requiring approval of research protocols by an…

The Myth, the Truth, the NASA IRB

NASA Technical Reports Server (NTRS)

Covington, M. D.; Flores, M. P.; Neutzler, V. P.; Schlegel, T. T.; Platts, S. H.; Lioyd, C. W.

2017-01-01

The purpose of the NASA Institutional Review Board (IRB) is to review research activities involving human subjects to ensure that ethical standards for the care and protection of human subjects have been met and research activities are in compliance with all pertinent federal, state and local regulations as well as NASA policies. NASA IRB's primary role is the protection of human subjects in research studies. Protection of human subjects is the shared responsibility of NASA, the IRB, and the scientific investigators. Science investigators who plan to conduct NASA-funded human research involving NASA investigators, facilities, or funds must submit and coordinate their research studies for review and approval by the NASA IRB prior to initiation. The IRB has the authority to approve, require changes in, or disapprove research involving human subjects. Better knowledge of the NASA IRB policies, procedures and guidelines should help facilitate research protocol applications and approvals. In this presentation, the myths and truths of NASA IRB policies and procedures will be discussed. We will focus on the policies that guide a protocol through the NASA IRB and the procedures that principal investigators must take to obtain required IRB approvals for their research studies. In addition, tips to help ensure a more efficient IRB review will be provided. By understanding the requirements and processes, investigators will be able to more efficiently prepare their protocols and obtain the required NASA IRB approval in a timely manner.

Spatial Construction Skills of Chimpanzees ("Pan Troglodytes") and Young Human Children ("Homo Sapiens Sapiens")

ERIC Educational Resources Information Center

Poti, Patrizia; Hayashi, Misato; Matsuzawa, Tetsuro

2009-01-01

Spatial construction tasks are basic tests of visual-spatial processing. Two studies have assessed spatial construction skills in chimpanzees (Pan troglodytes) and young children (Homo sapiens sapiens) with a block modelling task. Study 1a subjects were three young chimpanzees and five adult chimpanzees. Study 1b subjects were 30 human children…

Theorising the 'human subject' in biomedical research: international clinical trials and bioethics discourses in contemporary Sri Lanka.

PubMed

Sariola, Salla; Simpson, Bob

2011-08-01

The global spread of clinical trials activity is accompanied by a parallel growth in research governance and human subject protection. In this paper we analyse how dominant ideas of the 'human subject' in clinical trials are played out in countries that are deemed to be scientifically under-developed. Specifically, we show how rhetorics of individualism, rationality and autonomy implicit in international ethical guidelines governing human subject research are operationalised and localised. We give insights into the ways in which new knowledge forms become embedded in practice. Using the recent upsurge in clinical trials in Sri Lanka as a case study, based on interviews with 23 doctors and researchers carried out during ethnographic fieldwork between 2008-2009, this article explores the tensions that arise for doctors involved with the promotion of bioethics and the attempts to bring local research governance up to international standards. The doctors and researchers intercept, interpret and critique the notions of human subject implicit in new forms of research governance. From their accounts we have identified two concerns. The first is a critique of dominant ideas of the 'human subject' that is informed by ideas of patiency rooted in paternalistic notions of the doctor-patient relationship. Second, 'human subjects' are seen as gendered, and located within family relationships. Both of these bring into question the research subjects' ability to give informed consent and compromise the ideal of an autonomous subject. Copyright © 2010 Elsevier Ltd. All rights reserved.

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

PubMed

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.

76 FR 80938 - Human Studies Review Board; Notification of a Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

... Agency on the EPA scientific and ethical reviews of research with human subjects. DATES: This public... of oral comments on the science and ethics issues under discussion, it is not our intent to permit... related to scientific and ethical aspects of human subjects research. The major objectives of the HSRB are...

Protecting human subjects in research.

PubMed

Orticio, Lily P

2009-01-01

The quest for advancing scientific knowledge through human experimentations using vulnerable groups is traced back to ancient history, when Herophilus performed vivisections on prisoners. The violation of the rights of human subjects through the 20th century led to the formulation of the Nuremberg Code in 1947 and the Declaration of Helsinki in 1964. In the United States, the most infamous was the Tuskegee public health study that resulted in the enactment of the National Research Act that authorized the creation of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research in 1974. In spite of existing federal regulations, the system of protecting human subjects is still flawed. Transparency of conflict ofinterest, clarity, and strict adherence to institutional guidelines are critical in safeguarding the rights and safety of human subjects and the integrity of research. Education on ethics and emerging complex ethical issues, global awareness, and governmental cooperation and sanctions are important steps in addressing the inadequacies in protecting the most vulnerable populations in experimentations worldwide. Investigators must always remember that the primary safeguards of protecting human life rest in their hands.

Effects of consuming various foods and nutrients on objective and subjective aspects of human performance and behavior

NASA Technical Reports Server (NTRS)

Wurtman, R. J.; Lieberman, H. R.

1984-01-01

A variety of behavioral tests were established and studies performed on young healthy subjects who received tryptophan, tyrosine or placeboes and on young and old subjects receiving protein and carbohydrate meals. The behavioral effect of the homone melatonin on human circadian rhythms was examined. The results are discussed.

Coming of Age of Human Biology: A Study of the Birth and Growth of a Subject in the School Curriculum.

ERIC Educational Resources Information Center

Denny, M.

1983-01-01

Human biology is a school subject whose utilitarian/pedagogical traditions enjoy support at the School Certificate level but whose academic tradition is under threat at the General Certificate of Education level. An interpretation of the issues involved are discussed in terms of the subject's historical background. (JN)

40 CFR 26.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2012 CFR

2012-07-01

... intention of involving human subjects. 26.119 Section 26.119 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human... human subjects. In the event research is undertaken without the intention of involving human subjects...

40 CFR 26.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-07-01

... intention of involving human subjects. 26.119 Section 26.119 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human... human subjects. In the event research is undertaken without the intention of involving human subjects...

40 CFR 26.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... intention of involving human subjects. 26.119 Section 26.119 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human... human subjects. In the event research is undertaken without the intention of involving human subjects...

40 CFR 26.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... intention of involving human subjects. 26.119 Section 26.119 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human... human subjects. In the event research is undertaken without the intention of involving human subjects...

Levels of Antibodies against Human Heat Shock Protein (HSP) 60 in Patients with Glaucoma in Poland

PubMed Central

Grabska-Liberek, Iwona; Skonieczna, Katarzyna; Olesińska, Marzena; Terelak-Borys, Barbara; Kocięcki, Jarosandlstrokaw; Sikora, Mariusz; Jamrozy-Witkowska, Agnieszka; Tesla, Piotr; Czarnocka, Barbara

2015-01-01

Background Although elevated intraocular pressure is a major risk factor for the development of glaucoma, there is increasing evidence that the immune system may be involved in the development of normal-tension glaucoma (NTG). The aim of this study was to determine if NTG is associated with elevated levels of antibodies against human heat shock protein (HSP) 60. Material/Methods The study was conducted in 139 subjects (35 subjects with NTG [Group 1], 34 subjects with primary open-angle glaucoma/POAG/[Group 2], 24 subjects with autoimmune rheumatic diseases [Group 3], and 36 healthy controls [Group 4]). All subjects had complete ophthalmologic examination (visual acuity, slit-lamp examination, tonometry, gonioscopy; visual-field examination, and optical coherence tomography/OCT/of the optic nerve head and the macula). Blood samples were collected for the measurements of serum levels of antibodies against human HSP60. Results The subjects with rheumatic diseases had the highest median serum level of antibodies against HSP60 – 20.49 ng/mL. The values in the subjects with NTG, POAG, and in controls were 18.79 ng/mL, 18.61 ng/mL and 17.61 ng/mL, respectively (p=0.96). Conclusions This study does not confirm the hypothesis that normal-tension glaucoma is associated with elevated blood levels of antibodies against human heat shock protein (HSP) 60. PMID:25786333

Could Intermittent Energy Restriction and Intermittent Fasting Reduce Rates of Cancer in Obese, Overweight, and Normal-Weight Subjects? A Summary of Evidence.

PubMed

Harvie, Michelle N; Howell, Tony

2016-07-01

Animal studies and human observational data link energy restriction (ER) to reduced rates of carcinogenesis. Most of these studies have involved continuous energy restriction (CER), but there is increasing public and scientific interest in the potential health and anticancer effects of intermittent energy restriction (IER) or intermittent fasting (IF), which comprise periods of marked ER or total fasting interspersed with periods of normal eating. This review summarizes animal studies that assessed tumor rates with IER and IF compared with CER or ad libitum feed consumption. The relevance of these animal data to human cancer is also considered by summarizing available human studies of the effects of IER or IF compared with CER on cancer biomarkers in obese, overweight, and normal-weight subjects. IER regimens that include periods of ER alternating with ad libitum feed consumption for 1, 2, or 3 wk have been reported to be superior to CER in reducing tumor rates in most spontaneous mice tumor models. Limited human data from short-term studies (≤6 mo) in overweight and obese subjects have shown that IER can lead to greater improvements in insulin sensitivity (homeostasis model assessment) than can CER, with comparable reductions in adipokines and inflammatory markers and minor changes in the insulin-like growth factor axis. There are currently no data comparing IER or IF with CER in normal-weight subjects. The benefits of IER in these short-term trials are of interest, but not sufficient evidence to recommend the use of IER above CER. Longer-term human studies of adherence to and efficacy and safety of IER are required in obese and overweight subjects, as well as normal-weight subjects. © 2016 American Society for Nutrition.

Could Intermittent Energy Restriction and Intermittent Fasting Reduce Rates of Cancer in Obese, Overweight, and Normal-Weight Subjects? A Summary of Evidence12

PubMed Central

2016-01-01

Animal studies and human observational data link energy restriction (ER) to reduced rates of carcinogenesis. Most of these studies have involved continuous energy restriction (CER), but there is increasing public and scientific interest in the potential health and anticancer effects of intermittent energy restriction (IER) or intermittent fasting (IF), which comprise periods of marked ER or total fasting interspersed with periods of normal eating. This review summarizes animal studies that assessed tumor rates with IER and IF compared with CER or ad libitum feed consumption. The relevance of these animal data to human cancer is also considered by summarizing available human studies of the effects of IER or IF compared with CER on cancer biomarkers in obese, overweight, and normal-weight subjects. IER regimens that include periods of ER alternating with ad libitum feed consumption for 1, 2, or 3 wk have been reported to be superior to CER in reducing tumor rates in most spontaneous mice tumor models. Limited human data from short-term studies (≤6 mo) in overweight and obese subjects have shown that IER can lead to greater improvements in insulin sensitivity (homeostasis model assessment) than can CER, with comparable reductions in adipokines and inflammatory markers and minor changes in the insulin-like growth factor axis. There are currently no data comparing IER or IF with CER in normal-weight subjects. The benefits of IER in these short-term trials are of interest, but not sufficient evidence to recommend the use of IER above CER. Longer-term human studies of adherence to and efficacy and safety of IER are required in obese and overweight subjects, as well as normal-weight subjects. PMID:27422504

Mu Opioid Mediated Discriminative-Stimulus Effects of Tramadol: An Individual Subjects Analysis

PubMed Central

Strickland, Justin C.; Rush, Craig R.; Stoops, William W.

2015-01-01

Drug discrimination procedures use dose-dependent generalization, substitution, and pretreatment with selective agonists and antagonists to evaluate receptor systems mediating interoceptive effects of drugs. Despite the extensive use of these techniques in the nonhuman animal literature, few studies have used human subjects. Specifically, human studies have not routinely used antagonist administration as a pharmacological tool to elucidate the mechanisms mediating the discriminative stimulus effects of drugs. This study evaluated the discriminative-stimulus effects of tramadol, an atypical analgesic with monoamine and mu opioid activity. Three human subjects first learned to discriminate 100 mg tramadol from placebo. A range of tramadol doses (25 to 150 mg) and hydromorphone (4 mg) with and without naltrexone pretreatment (50 mg) were then administered to subjects after acquiring the discrimination. Tramadol produced dose-dependent increases in drug-appropriate responding and hydromorphone partially or fully substituted for tramadol in all subjects. These effects were attenuated by naltrexone. Individual subject records indicated a relationship between mu opioid activity (i.e., miosis) and drug discrimination performance. Our findings indicate that mu opioid activity may mediate the discriminative-stimulus effects of tramadol in humans. The correspondence of generalization, substitution, and pretreatment findings with the animal literature supports the neuropharmacological specificity of the drug discrimination procedure. PMID:25664525

Outdoor human thermal perception in various climates: A comprehensive review of approaches, methods and quantification.

PubMed

Potchter, Oded; Cohen, Pninit; Lin, Tzu-Ping; Matzarakis, Andreas

2018-08-01

Over the past century, many research studies have been conducted in an attempt to define thermal conditions for humans in the outdoor environment and to grade thermal sensation. Consequently, a large number of indices have been proposed. The examination of human thermal indices by thermal subjective perception has become recently a methodical issue to confirm the accuracy, applicability and validation of human thermal indices. The aims of this study are: (a) to review studies containing both calculated human thermal conditions and subjective thermal perception in the outdoor environment (b) to identify the most used human thermal indices for evaluating human thermal perception (c) to examine the relation between human thermal comfort range and outdoor thermal environment conditions and (d) to compare between categories of thermal sensation in different climatic zones based on subjective perception and levels of thermal strain. A comprehensive literature review identified 110 peer-reviewed articles which investigated in-situ thermal conditions versus subjective thermal perception during 2001-2017. It seems that out of 165 human thermal indices that have been developed, only 4 (PET, PMV, UTCI, SET*) are widely in use for outdoor thermal perception studies. Examination of the relation between human thermal comfort range and outdoor thermal environment conditions for selective indices in different climatic zones shows that the range of the thermal comfort or dis-comfort is affected by the outdoor thermal environment. For the PET index, the "neutral" range for hot climates of 24-26°C is agreed by 95% of the studies where for cold climate, the "neutral" range of 15-20°C is agreed by 89% of the studies. For the UTCI, the "no thermal stress" category is common to all climates. The "no stress category" of 16-23°C is agreed by 80% of the case studies, while 100% of the case studies agreed that the range is between 18 and 23°C. Copyright © 2018 Elsevier B.V. All rights reserved.

A New Tool for Assessing Context Conditioning Induced by US-Unpredictability in Humans: The Martians Task Restyled

ERIC Educational Resources Information Center

Meulders, Ann; Vervliet, Bram; Vansteenwegen, Debora; Hermans, Dirk; Baeyens, Frank

2011-01-01

Unpredictability of an unconditioned stimulus (US) typically produces context conditioning in animals and humans. We modified the Martians task--a computer game measuring learning of Pavlovian associations through conditioned suppression--for assessing context conditioning in humans. One between-subjects and one within-subjects study are reported.…

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

EPA Science Inventory

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...

Ann Hutchinson (as subject), Dr. Joan Vernikos (R), Dee O'Hara (L), J. Evans and E. Lowe pose for

NASA Technical Reports Server (NTRS)

1993-01-01

Ann Hutchinson (as subject), Dr. Joan Vernikos (R), Dee O'Hara (L), J. Evans and E. Lowe pose for pictures in the NASA Magazine aritcle 'How it Feels to be a Human Test Subject' as they prepare for a bed rest study to simulate the efects of microgravity on the human body.

Computational Model-Based Prediction of Human Episodic Memory Performance Based on Eye Movements

NASA Astrophysics Data System (ADS)

Sato, Naoyuki; Yamaguchi, Yoko

Subjects' episodic memory performance is not simply reflected by eye movements. We use a ‘theta phase coding’ model of the hippocampus to predict subjects' memory performance from their eye movements. Results demonstrate the ability of the model to predict subjects' memory performance. These studies provide a novel approach to computational modeling in the human-machine interface.

Biomarkers of Dose and Effect of Inhaled Ozone in Resting versus Exercising Human Subjects: Comparison with Resting Rats

PubMed Central

Hatch, Gary E.; McKee, John; Brown, James; McDonnell, William; Seal, Elston; Soukup, Joleen; Slade, Ralph; Crissman, Kay; Devlin, Robert

2013-01-01

To determine the influence of exercise on pulmonary dose of inhaled pollutants, we compared biomarkers of inhaled ozone (O3) dose and toxic effect between exercise levels in humans, and between humans and rats. Resting human subjects were exposed to labeled O3 (18O3, 0.4 ppm, for 2 hours) and alveolar O3 dose measured as the concentration of excess 18O in cells and extracellular material of nasal, bronchial, and bronchoalveolar lavage fluid (BALF). We related O3 dose to effects (changes in BALF protein, LDH, IL-6, and antioxidant substances) measurable in the BALF. A parallel study of resting subjects examined lung function (FEV1) changes following O3. Subjects exposed while resting had 18O concentrations in BALF cells that were 1/5th of those of exercising subjects and directly proportional to the amount of O3 breathed during exposure. Quantitative measures of alveolar O3 dose and toxicity that were observed previously in exercising subjects were greatly reduced or non-observable in O3 exposed resting subjects. Resting rats and resting humans were found to have a similar alveolar O3 dose. PMID:23761957

45 CFR 46.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... involving human subjects. 46.119 Section 46.119 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.119 Research undertaken without the intention of involving human subjects. In the event...

45 CFR 46.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... involving human subjects. 46.119 Section 46.119 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.119 Research undertaken without the intention of involving human subjects. In the event...

45 CFR 46.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... involving human subjects. 46.119 Section 46.119 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.119 Research undertaken without the intention of involving human subjects. In the event...

45 CFR 46.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... involving human subjects. 46.119 Section 46.119 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.119 Research undertaken without the intention of involving human subjects. In the event...

Simulated Patient Studies: An Ethical Analysis

PubMed Central

Rhodes, Karin V; Miller, Franklin G

2012-01-01

Context In connection with health care reform, the U.S. Department of Health and Human Services commissioned a “mystery shopper,” or simulated patient study, to measure access to primary care. But the study was shelved because of public controversy over “government spying” on doctors. Opponents of the study also raised ethical concerns about the use of deception with human subjects without soliciting their informed consent. Methods We undertook an ethical analysis of the use of simulated patient techniques in health services research, with a particular focus on research measuring access to care. Using a case study, we explored relevant methodological considerations and ethical principles relating to deceptive research without informed consent, as well as U.S. federal regulations permitting exceptions to consent. Findings Several relevant considerations both favor and oppose soliciting consent for simulated patient studies. Making research participation conditional on informed consent protects the autonomy of research subjects and shields them from unreasonable exposure to research risks. However, scientific validity is also an important ethical principle of human subjects research, as the net risks to subjects must be justified by the value to society of the knowledge to be gained. The use of simulated patients to monitor access is a naturalistic and scientifically sound experimental design that can answer important policy-relevant questions, with minimal risks to human subjects. As interaction between researchers and subjects increases, however, so does the need for consent. Conclusions As long as adequate protections of confidentiality of research data are in place, minimally intrusive simulated patient research that gathers policy-relevant data on the health system without the consent of individuals working in that system can be ethically justified when the risks and burdens to research subjects are minimal and the research has the potential to generate socially valuable knowledge. PMID:23216428

Effects of nitrogen dioxide on pulmonary function in human subjects: an environmental chamber study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kerr, H.D.; Kulle, T.J.; McIlhany, M.L.

Twenty human subjects with asthma and chronic bronchitis and 10 healthy adults were exposed to 0.5 ppM of nitrogen dioxide for 2 hr in an environment chamber. Seven of the 13 subjects with asthma experienced symptoms with exposure, while only one each of the subjects with bronchitis and the normal group experienced symptoms. Functional residual pulmonary capacity increased for those with asthma and bronchitis. 18 references, 5 tables.

Functional correlates of the anterolateral processing hierarchy in human auditory cortex.

PubMed

Chevillet, Mark; Riesenhuber, Maximilian; Rauschecker, Josef P

2011-06-22

Converging evidence supports the hypothesis that an anterolateral processing pathway mediates sound identification in auditory cortex, analogous to the role of the ventral cortical pathway in visual object recognition. Studies in nonhuman primates have characterized the anterolateral auditory pathway as a processing hierarchy, composed of three anatomically and physiologically distinct initial stages: core, belt, and parabelt. In humans, potential homologs of these regions have been identified anatomically, but reliable and complete functional distinctions between them have yet to be established. Because the anatomical locations of these fields vary across subjects, investigations of potential homologs between monkeys and humans require these fields to be defined in single subjects. Using functional MRI, we presented three classes of sounds (tones, band-passed noise bursts, and conspecific vocalizations), equivalent to those used in previous monkey studies. In each individual subject, three regions showing functional similarities to macaque core, belt, and parabelt were readily identified. Furthermore, the relative sizes and locations of these regions were consistent with those reported in human anatomical studies. Our results demonstrate that the functional organization of the anterolateral processing pathway in humans is largely consistent with that of nonhuman primates. Because our scanning sessions last only 15 min/subject, they can be run in conjunction with other scans. This will enable future studies to characterize functional modules in human auditory cortex at a level of detail previously possible only in visual cortex. Furthermore, the approach of using identical schemes in both humans and monkeys will aid with establishing potential homologies between them.

Correlation of Respirator Fit Measured on Human Subjects and a Static Advanced Headform

PubMed Central

Bergman, Michael S.; He, Xinjian; Joseph, Michael E.; Zhuang, Ziqing; Heimbuch, Brian K.; Shaffer, Ronald E.; Choe, Melanie; Wander, Joseph D.

2015-01-01

This study assessed the correlation of N95 filtering face-piece respirator (FFR) fit between a Static Advanced Headform (StAH) and 10 human test subjects. Quantitative fit evaluations were performed on test subjects who made three visits to the laboratory. On each visit, one fit evaluation was performed on eight different FFRs of various model/size variations. Additionally, subject breathing patterns were recorded. Each fit evaluation comprised three two-minute exercises: “Normal Breathing,” “Deep Breathing,” and again “Normal Breathing.” The overall test fit factors (FF) for human tests were recorded. The same respirator samples were later mounted on the StAH and the overall test manikin fit factors (MFF) were assessed utilizing the recorded human breathing patterns. Linear regression was performed on the mean log10-transformed FF and MFF values to assess the relationship between the values obtained from humans and the StAH. This is the first study to report a positive correlation of respirator fit between a headform and test subjects. The linear regression by respirator resulted in R2 = 0.95, indicating a strong linear correlation between FF and MFF. For all respirators the geometric mean (GM) FF values were consistently higher than those of the GM MFF. For 50% of respirators, GM FF and GM MFF values were significantly different between humans and the StAH. For data grouped by subject/respirator combinations, the linear regression resulted in R2 = 0.49. A weaker correlation (R2 = 0.11) was found using only data paired by subject/respirator combination where both the test subject and StAH had passed a real-time leak check before performing the fit evaluation. For six respirators, the difference in passing rates between the StAH and humans was < 20%, while two respirators showed a difference of 29% and 43%. For data by test subject, GM FF and GM MFF values were significantly different for 40% of the subjects. Overall, the advanced headform system has potential for assessing fit for some N95 FFR model/sizes. PMID:25265037

Characterization of human plasma proteome dynamics using deuterium oxide.

PubMed

Wang, Ding; Liem, David A; Lau, Edward; Ng, Dominic C M; Bleakley, Brian J; Cadeiras, Martin; Deng, Mario C; Lam, Maggie P Y; Ping, Peipei

2014-08-01

High-throughput quantification of human protein turnover via in vivo administration of deuterium oxide ((2) H2 O) is a powerful new approach to examine potential disease mechanisms. Its immediate clinical translation is contingent upon characterizations of the safety and hemodynamic effects of in vivo administration of (2) H2 O to human subjects. We recruited ten healthy human subjects with a broad demographic variety to evaluate the safety, feasibility, efficacy, and reproducibility of (2) H2 O intake for studying protein dynamics. We designed a protocol where each subject orally consumed weight-adjusted doses of 70% (2) H2 O daily for 14 days to enrich body water and proteins with deuterium. Plasma proteome dynamics was measured using a high-resolution MS method we recently developed. This protocol was successfully applied in ten human subjects to characterize the endogenous turnover rates of 542 human plasma proteins, the largest such human dataset to-date. Throughout the study, we did not detect physiological effects or signs of discomfort from (2) H2 O consumption. Our investigation supports the utility of a (2) H2 O intake protocol that is safe, accessible, and effective for clinical investigations of large-scale human protein turnover dynamics. This workflow shows promising clinical translational value for examining plasma protein dynamics in human diseases. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Characterization of human plasma proteome dynamics using deuterium oxide

PubMed Central

Wang, Ding; Liem, David A; Lau, Edward; Ng, Dominic CM; Bleakley, Brian J; Cadeiras, Martin; Deng, Mario C; Lam, Maggie PY; Ping, Peipei

2016-01-01

Purpose High-throughput quantification of human protein turnover via in vivo administration of deuterium oxide (2H2O) is a powerful new approach to examine potential disease mechanisms. Its immediate clinical translation is contingent upon characterizations of the safety and hemodynamic effects of in vivo administration of 2H2O to human subjects. Experimental design We recruited 10 healthy human subjects with a broad demographic variety to evaluate the safety, feasibility, efficacy, and reproducibility of 2H2O intake for studying protein dynamics. We designed a protocol where each subject orally consumed weight-adjusted doses of 70% 2H2O daily for 14 days to enrich body water and proteins with deuterium. Plasma proteome dynamics was measured using a high-resolution MS method we recently developed. Results This protocol was successfully applied in 10 human subjects to characterize the endogenous turnover rates of 542 human plasma proteins, the largest such human dataset to-date. Throughout the study, we did not detect physiological effects or signs of discomfort from 2H2O consumption. Conclusions and clinical relevance Our investigation supports the utility of a 2H2O intake protocol that is safe, accessible, and effective for clinical investigations of large-scale human protein turnover dynamics. This workflow shows promising clinical translational value for examining plasma protein dynamics in human diseases. PMID:24946186

10 CFR 745.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-01-01

... human subjects. 745.119 Section 745.119 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human...

34 CFR 97.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-07-01

... human subjects. 97.119 Section 97.119 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 Subjects) § 97.119 Research undertaken without the intention of involving human...

10 CFR 745.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-01-01

... human subjects. 745.119 Section 745.119 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human...

10 CFR 745.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-01-01

... human subjects. 745.119 Section 745.119 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human...

34 CFR 97.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-07-01

... human subjects. 97.119 Section 97.119 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 Subjects) § 97.119 Research undertaken without the intention of involving human...

34 CFR 97.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... human subjects. 97.119 Section 97.119 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 Subjects) § 97.119 Research undertaken without the intention of involving human...

34 CFR 97.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... human subjects. 97.119 Section 97.119 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 Subjects) § 97.119 Research undertaken without the intention of involving human...

[Testing of the effect of classic conditioning stimuli in human experiment by means of the transfer of control paradigm].

PubMed

Wolter, J

1999-01-01

Pavlovian conditioning in animals is often evaluated by means of transfer of control experiments. With human subjects, however, only very few studies have been conducted and the outcomes were often not in accordance with theoretical explanations based on studies with animals. A theoretical framework is presented that tries to integrate the results of the human conditioning paradigm and the animal conditioning paradigm as well, with reference to the well-known Yerkes-Dodson law. The experimental study with human subjects (N = 24) confirmed the predictions out of this framework, when a procedure similar to animal research is applied.

10 CFR 35.290 - Training for imaging and localization studies.

Code of Federal Regulations, 2013 CFR

2013-01-01

...; (D) Chemistry of byproduct material for medical use; (E) Radiation biology; and (ii) Work experience... human research subject dosages; (D) Using administrative controls to prevent a medical event involving... patients or human research subjects; and (G) Eluting generator systems appropriate for preparation of...

10 CFR 35.290 - Training for imaging and localization studies.

Code of Federal Regulations, 2012 CFR

2012-01-01

...; (D) Chemistry of byproduct material for medical use; (E) Radiation biology; and (ii) Work experience... human research subject dosages; (D) Using administrative controls to prevent a medical event involving... patients or human research subjects; and (G) Eluting generator systems appropriate for preparation of...

10 CFR 35.290 - Training for imaging and localization studies.

Code of Federal Regulations, 2011 CFR

2011-01-01

...; (D) Chemistry of byproduct material for medical use; (E) Radiation biology; and (ii) Work experience... human research subject dosages; (D) Using administrative controls to prevent a medical event involving... patients or human research subjects; and (G) Eluting generator systems appropriate for preparation of...

10 CFR 35.290 - Training for imaging and localization studies.

Code of Federal Regulations, 2014 CFR

2014-01-01

...; (D) Chemistry of byproduct material for medical use; (E) Radiation biology; and (ii) Work experience... human research subject dosages; (D) Using administrative controls to prevent a medical event involving... patients or human research subjects; and (G) Eluting generator systems appropriate for preparation of...

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

PubMed

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.

RESEARCH ON ENVIRONMENTAL HEALTH INTERVENTIONS: ETHICAL PROBLEMS AND SOLUTIONS

PubMed Central

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

Study of electrical properties of meridian on human body surface

NASA Astrophysics Data System (ADS)

Wang, Feng; Uematsu, Haruyuki; Otani, Nobuo

2007-12-01

This paper presents the study of the subcutaneous electrical impedance on the human body surface. Measurements of the electrical impedance on five adult male subjects were carried out and analyzed for the possible detection of the acupuncture meridian lines of ancient Chinese medicine on the human body. The distribution of electrical impedance measured at 40 points over the volar side of the right upper limb of the subjects. The results show that electrical impedance varies at different locations of the human body surface, and the locations with lower electrical impedance coincide with the locations where the meridian is believed to exist.

Displacement activities as a behavioral measure of stress in nonhuman primates and human subjects.

PubMed

Troisi, Alfonso

2002-02-01

Traditionally, research on human stress has relied mostly on physiological and psychological measures with a relatively minor emphasis on the behavioral aspects of the phenomenon. Such an approach makes it difficult to develop valid animal models of the human stress syndrome. A promising approach to the study of the behavioral correlates of stress is to analyze those behavior patterns that ethologists have named displacement activities and that, in primates, consist mostly of self-directed behaviors. In both nonhuman primates and human subjects, displacement behavior appears in situations characterized by social tension and is likely to reflect increased autonomic arousal. Pharmacological studies of nonhuman primates have shown that the frequency of occurrence of displacement behavior is increased by anxiogenic compounds and decreased by anxiolytic drugs. Ethological studies of healthy persons and psychiatric patients during interviews have found that increased displacement behavior not only correlates with a subjective feeling state of anxiety and negative affect but also gives more veridical information about the subject's emotional state than verbal statements and facial expression. The measurement of displacement activities may be a useful complement to the physiological and psychological studies aimed at analyzing the correlates and consequences of stress.

22 CFR 225.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-04-01

... involving human subjects. 225.119 Section 225.119 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF HUMAN SUBJECTS § 225.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is...

16 CFR 1028.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-01-01

... involving human subjects. 1028.119 Section 1028.119 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects...

28 CFR 46.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... of involving human subjects. 46.119 Section 46.119 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects...

22 CFR 225.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-04-01

... involving human subjects. 225.119 Section 225.119 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF HUMAN SUBJECTS § 225.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is...

48 CFR 3452.224-72 - Research activities involving human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... involving human subjects. 3452.224-72 Section 3452.224-72 Federal Acquisition Regulations System DEPARTMENT... Text of Provisions and Clauses 3452.224-72 Research activities involving human subjects. As prescribed... human subjects covered under 34 CFR part 97: Research Activities Involving Human Subjects (MAR 2011) (a...

28 CFR 46.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... of involving human subjects. 46.119 Section 46.119 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects...

28 CFR 46.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-07-01

... of involving human subjects. 46.119 Section 46.119 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects...

14 CFR 1230.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-01-01

... involving human subjects. 1230.119 Section 1230.119 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects...

22 CFR 225.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-04-01

... involving human subjects. 225.119 Section 225.119 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF HUMAN SUBJECTS § 225.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is...

16 CFR 1028.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-01-01

... involving human subjects. 1028.119 Section 1028.119 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects...

28 CFR 46.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2012 CFR

2012-07-01

... of involving human subjects. 46.119 Section 46.119 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects...

28 CFR 46.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-07-01

... of involving human subjects. 46.119 Section 46.119 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects...

48 CFR 3452.224-72 - Research activities involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... involving human subjects. 3452.224-72 Section 3452.224-72 Federal Acquisition Regulations System DEPARTMENT... Text of Provisions and Clauses 3452.224-72 Research activities involving human subjects. As prescribed... human subjects covered under 34 CFR part 97: Research Activities Involving Human Subjects (MAR 2011) (a...

48 CFR 3452.224-72 - Research activities involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... involving human subjects. 3452.224-72 Section 3452.224-72 Federal Acquisition Regulations System DEPARTMENT... Text of Provisions and Clauses 3452.224-72 Research activities involving human subjects. As prescribed... human subjects covered under 34 CFR part 97: Research Activities Involving Human Subjects (MAR 2011) (a...

48 CFR 3452.224-72 - Research activities involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... involving human subjects. 3452.224-72 Section 3452.224-72 Federal Acquisition Regulations System DEPARTMENT... Text of Provisions and Clauses 3452.224-72 Research activities involving human subjects. As prescribed... human subjects covered under 34 CFR part 97: Research Activities Involving Human Subjects (MAR 2011) (a...

Bariatric manipulation of gastric arteries: A systematic review on the potential concept for treatment of obesity.

PubMed

Shoar, Saeed; Saber, Alan A; Aladdin, Mohammaed; Bashah, Moataz M; AlKuwari, Mohammed J; Rizwan, Mohamed; Rosenthal, Raul J

2016-12-01

Gastric artery embolization (GAE) has recently received attention as a minimally invasive intervention in bariatric setting. The current systematic review aimed to gather and categorizes the existing data in the literature regarding bariatric gastric artery manipulation. This will highlight the importance of this potential concept as a therapeutic modality. A PubMed/Medline search was conducted to identify animal and human studies investigating the effect of gastric artery manipulation on weight, ghrelin, obesity, and tissue adiposity. A total of 9 studies including 6 animal experiments with 71 subjects and 3 human studies with a total of 25 patients were retrieved. Animal subjects underwent chemical embolization while particle embolization was only used in human subjects. Five animal studies and 1 human study reported decreased ghrelin concentration. Three animal experiments and 2 human studies showed a significant weight change following GAE. There was no report regarding a serious adverse event requiring surgical or interventional management. Currently, data regarding the potential role of gastric artery manipulation in decreasing the ghrelin and potential weight loss is scarce. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

[Ethics and laws related to human subject research].

PubMed

Chiu, Hui-Ju; Lee, Ya-Ling; Chang, Su-Fen

2011-10-01

Advances in medical technology rely on human subject research to test the effects on real patients of unproven new drugs, equipment and techniques. Illegal human subject research happens occasionally and has led to subject injury and medical disputes. Familiarity with the laws and established ethics related to human subject research can minimize both injury and disputes. History is a mirror that permits reflection today on past experience. Discussing the Nuremberg Code, the Declaration of Helsinki and Belmont Report, this article describes the laws, ethics, history and news related to human subject research as well as the current definition and characteristics of human subject research. Increasing numbers of nurses serve as research nurses and participate in human subject research. The authors hope this article can increase research nurse knowledge regarding laws and ethics in order to protect human research subjects adequately.

Developing and Evaluating Medical Humanities Problem-Based Learning Classes Facilitated by the Teaching Assistants Majored in the Liberal Arts: A Longitudinal Crossover Study.

PubMed

Tseng, Fen-Yu; Shieh, Jeng-Yi; Kao, Tze-Wah; Wu, Chau-Chung; Chu, Tzong-Shinn; Chen, Yen-Yuan

2016-02-01

Although medical humanities courses taught by teachers from nonmedical backgrounds are not unusual now, few studies have compared the outcome of medical humanities courses facilitated by physicians to that by teaching assistants majored in the liberal arts. The objectives of this study were to (1) analyze the satisfaction of medical students with medical humanities problem-based learning (PBL) classes facilitated by nonmedical teaching assistants (TAF) majored in the liberal arts, and those facilitated by the attending physicians (APF) and (2) examine the satisfaction of medical students with clinical medicine-related and clinical medicine-unrelated medical humanities PBL classes.A total of 123 medical students, randomly assigned to 16 groups, participated in this study. There were 16 classes in the course: 8 of them were TAF classes; and the others were APF classes. Each week, each group rotated from 1 subject of the 16 subjects of PBL to another subject. All of the 16 groups went through all the 16 subjects in the 2013 spring semester. We examined the medical students' satisfaction with each class, based on a rating score collected after each class was completed, using a scale from 0 (the lowest satisfaction) to 100 (the highest satisfaction). We also conducted multivariate linear regression analysis to examine the association between the independent variables and the students' satisfaction.Medical students were more satisfied with the TAF (91.35 ± 7.75) medical humanities PBL classes than APF (90.40 ± 8.42) medical humanities PBL classes (P = 0.01). Moreover, medical students were more satisfied with the clinical medicine-unrelated topics (92.00 ± 7.10) than the clinical medicine-related topics (90.36 ± 7.99) in the medical humanities PBL course (P = 0.01).This medical humanities PBL course, including nonmedical subjects and topics, and nonmedical teaching assistants from the liberal arts as class facilitators, was satisfactory. This pedagogical approach of student-centered, nonmedical topics, nonmedical facilitators, and small groups, which is associated with a deep approach to learning medical humanities, should be highly encouraged.

A model of human event detection in multiple process monitoring situations

NASA Technical Reports Server (NTRS)

Greenstein, J. S.; Rouse, W. B.

1978-01-01

It is proposed that human decision making in many multi-task situations might be modeled in terms of the manner in which the human detects events related to his tasks and the manner in which he allocates his attention among his tasks once he feels events have occurred. A model of human event detection performance in such a situation is presented. An assumption of the model is that, in attempting to detect events, the human generates the probability that events have occurred. Discriminant analysis is used to model the human's generation of these probabilities. An experimental study of human event detection performance in a multiple process monitoring situation is described and the application of the event detection model to this situation is addressed. The experimental study employed a situation in which subjects simulataneously monitored several dynamic processes for the occurrence of events and made yes/no decisions on the presence of events in each process. Input to the event detection model of the information displayed to the experimental subjects allows comparison of the model's performance with the performance of the subjects.

49 CFR 11.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... involving human subjects. 11.119 Section 11.119 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is...

49 CFR 11.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... involving human subjects. 11.119 Section 11.119 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is...

49 CFR 11.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... involving human subjects. 11.119 Section 11.119 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is...

Dynamic transcriptional signatures and network responses for clinical symptoms in influenza-infected human subjects using systems biology approaches.

PubMed

Linel, Patrice; Wu, Shuang; Deng, Nan; Wu, Hulin

2014-10-01

Recent studies demonstrate that human blood transcriptional signatures may be used to support diagnosis and clinical decisions for acute respiratory viral infections such as influenza. In this article, we propose to use a newly developed systems biology approach for time course gene expression data to identify significant dynamically response genes and dynamic gene network responses to viral infection. We illustrate the methodological pipeline by reanalyzing the time course gene expression data from a study with healthy human subjects challenged by live influenza virus. We observed clear differences in the number of significant dynamic response genes (DRGs) between the symptomatic and asymptomatic subjects and also identified DRG signatures for symptomatic subjects with influenza infection. The 505 common DRGs shared by the symptomatic subjects have high consistency with the signature genes for predicting viral infection identified in previous works. The temporal response patterns and network response features were carefully analyzed and investigated.

An automated image processing method for classification of diabetic retinopathy stages from conjunctival microvasculature images

NASA Astrophysics Data System (ADS)

Khansari, Maziyar M.; O'Neill, William; Penn, Richard; Blair, Norman P.; Chau, Felix; Shahidi, Mahnaz

2017-03-01

The conjunctiva is a densely vascularized tissue of the eye that provides an opportunity for imaging of human microcirculation. In the current study, automated fine structure analysis of conjunctival microvasculature images was performed to discriminate stages of diabetic retinopathy (DR). The study population consisted of one group of nondiabetic control subjects (NC) and 3 groups of diabetic subjects, with no clinical DR (NDR), non-proliferative DR (NPDR), or proliferative DR (PDR). Ordinary least square regression and Fisher linear discriminant analyses were performed to automatically discriminate images between group pairs of subjects. Human observers who were masked to the grouping of subjects performed image discrimination between group pairs. Over 80% and 70% of images of subjects with clinical and non-clinical DR were correctly discriminated by the automated method, respectively. The discrimination rates of the automated method were higher than human observers. The fine structure analysis of conjunctival microvasculature images provided discrimination of DR stages and can be potentially useful for DR screening and monitoring.

Using subject-specific three-dimensional (3D) anthropometry data in digital human modelling: case study in hand motion simulation.

PubMed

Tsao, Liuxing; Ma, Liang

2016-11-01

Digital human modelling enables ergonomists and designers to consider ergonomic concerns and design alternatives in a timely and cost-efficient manner in the early stages of design. However, the reliability of the simulation could be limited due to the percentile-based approach used in constructing the digital human model. To enhance the accuracy of the size and shape of the models, we proposed a framework to generate digital human models using three-dimensional (3D) anthropometric data. The 3D scan data from specific subjects' hands were segmented based on the estimated centres of rotation. The segments were then driven in forward kinematics to perform several functional postures. The constructed hand models were then verified, thereby validating the feasibility of the framework. The proposed framework helps generate accurate subject-specific digital human models, which can be utilised to guide product design and workspace arrangement. Practitioner Summary: Subject-specific digital human models can be constructed under the proposed framework based on three-dimensional (3D) anthropometry. This approach enables more reliable digital human simulation to guide product design and workspace arrangement.

Physical Activity Associated with Prayer Regimes Improves Standing Dynamic Balance of Healthy People

PubMed Central

AlAbdulwahab, Sami Saleh; Kachanathu, Shaji John; Oluseye, Kamaldeen

2014-01-01

[Purpose] Preparing for prayers, practicing religious meditation and performing prayers are believed to stimulate the visual, vestibular and somatosensory systems, which provide the sensory information that influences human balance. The purpose of this study was to determine the effect of the Islamic prayer regime on balance. [Subjects and Methods] Sixty healthy male subjects with a mean age of 31 ± 5 years and a mean body mass index of 27 ± 2 kg/cm2 voluntarily participated in this study. The subjects were divided into two equal groups: one group of subjects who regularly practiced Islamic prayer, and another group of non-practicing subjects. The dynamic balance of individuals in both groups was measured using a Balance Master. [Results] Adult healthy subjects practicing Islamic prayer regimes exhibited statistically significantly better dynamic balance than the non-practicing healthy subjects. [Conclusions] The results of this study support the hypothesis that religious meditation and prayers benefit human physiological function, especially balance. PMID:24409021

ARC-1993-AC93-0230-25

NASA Image and Video Library

1993-05-05

Ann Hutchinson (as subject), Dr. Joan Vernikos (R), Dee O'Hara (L), J. Evans and E. Lowe pose for pictures in the NASA Magazine aritcle 'How it Feels to be a Human Test Subject' as they prepare for a bed rest study to simulate the efects of microgravity on the human body.

The Electric Humanities: An Interdisciplinary Perspective.

ERIC Educational Resources Information Center

Marsden, Michael T.; Litwin, James L.

An interdisciplinary "Coordinated Quarter of Mass Media Studies," instituted at Bowling Green State University with funding from the National Endowment for the Humanities, is the subject of this paper. The first part of the paper tells how instructors from the subject areas of popular culture, psychology, sociology, speech communication, and…

The rise of soluble TWEAK levels in severely obese subjects after bariatric surgery may affect adipocyte-cytokine production induced by TNFα.

PubMed

Maymó-Masip, Elsa; Fernández-Veledo, Sonia; Garcia España, Antonio; Vázquez-Carballo, Ana; Tinahones, Francisco Jóse; García-Fuentes, Eduardo; Garrifo-Sanchez, Lourdes; Rodriguez, Maria del Mar; Vendrell, Joan; Chacón, Matilde R

2013-08-01

Soluble TNF-like weak inducer of apoptosis (sTWEAK) is generated by the intracellular proteolytic cleavage of full-length membrane-bound TNF-like weak inducer of apoptosis (mTWEAK). sTWEAK levels are reduced in diseases with an inflammatory component. Additionally, sTWEAK hampers TNFα activity in human cells. The objectives of the study were as follows: 1) to determine circulating sTWEAK in severe obesity and after bariatric surgery; 2) to study m/sTWEAK and its receptor fibroblast growth factor-inducible 14 (Fn14) protein expression in sc adipose tissue (SAT) of severely obese subjects, in SAT stromal vascular fraction (SVF), and isolated adipocytes and in human monocyte-derived macrophages; and 3) to explore, on human adipocytes, the sTWEAK effect on TNFα proinflammatory activity. sTWEAK levels were measured in cohort 1: severely obese subjects (n = 23) and a control group (n = 35); and in cohort 2: (n = 23) severely obese subjects before and after surgery. The m/sTWEAK and Fn14 expressions were determined in SAT biopsies, SVF, and isolated adipocytes from severely obese and control subjects and in human monocyte-derived macrophages. In human primary cultured adipocytes, sTWEAK pretreated and TNFα challenged, IL-6, IL-8, and adiponectin protein and gene expressions were determined and nuclear factor-κ B and MAPK signaling analyzed. sTWEAK levels were reduced in severely obese subjects. After surgery, sTWEAK levels rose in 69% of patients. mTWEAK protein expression was increased in SAT and SVF of severely obese subjects, whereas Fn14 was up-regulated in isolated adipocytes. M2 human monocyte-derived macrophages overexpress mTWEAK. In human adipocytes, sTWEAK down-regulates TNFα cytokine production by hampering TNFα intracellular signaling events. The decrease of sTWEAK in severely obese patients may favor the proinflammatory activity elicited by TNFα.

7 CFR 1c.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-01-01

... human subjects. 1c.119 Section 1c.119 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is later proposed...

7 CFR 1c.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-01-01

... human subjects. 1c.119 Section 1c.119 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is later proposed...

77 FR 74004 - Human Studies Review Board; Notification of a Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-12

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2012-0892; FRL-9761-4] Human Studies Review Board... EPA Office of the Science Advisor announces a public meeting of the Human Studies Review Board to advise the Agency on the EPA scientific and ethical reviews of research with human subjects. DATES: This...

75 FR 61748 - Human Studies Review Board; Notice of Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-06

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2010-0797' FRL-9211-1] Human Studies Review Board... of the Human Studies Review Board (HSRB) to advise the Agency on EPA's scientific and ethical reviews of research with human subjects. DATES: This public meeting will be held on October 27-28, 2010, from...

76 FR 2107 - Human Studies Review Board; Notice of Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-12

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2011-0970; FRL-9252-3] Human Studies Review Board... of the Human Studies Review Board (HSRB) to advise the Agency on EPA's scientific and ethical reviews of research with human subjects. DATES: This public meeting will be held on January 26, 2011, from...

Infrared thermography based studies on the effect of age on localized cold stress induced thermoregulation in human

NASA Astrophysics Data System (ADS)

Lahiri, B. B.; Bagavathiappan, S.; Nishanthi, K.; Mohanalakshmi, K.; Veni, L.; Saumya; Yacin, S. M.; Philip, John

2016-05-01

Thermoregulatory control of blood flow plays an important role in maintaining the human body temperature and it provides physiological resistance against extreme environmental thermal stresses. To understand the role of age on thermal signals from veins and the thermoregulatory mechanism, the dynamic variation of the vein temperature on the hands of 17 human subjects, under a localized cold stress, was studied using infrared thermography. It was observed that the vein temperature of the stimulated hand initially decreased with time up to a time interval (called 'inversion time'), which was attributed to the localized cutaneous vasoconstriction. Beyond inversion time, a rise in the vein temperature of the stimulated hand was observed. A shift in the inversion time to higher values was observed for the older subjects, which was attributed to the reduced efficiency and responsiveness of the cutaneous vasoconstriction mechanism in these subjects. Our studies indicated that the inversion time increased linearly with subject age with strong positive Pearson's correlation coefficient of 0.94. It was also observed that the contralateral symmetry in vasoconstriction was much lower in older subjects than the younger subjects. The absolute difference between the left and right inversion time varied between 11-118 s and 5-28 s for the older and younger subjects, respectively. Our study clearly demonstrated that infrared thermography is one of the most effective experimental tool for studying dynamic variation in vein pixel temperature under localized thermal stresses.

Cough induced by mechanical stimulation of the upper airway in humans.

PubMed

Lee, Patrick; Eccles, Ronald

2004-08-01

Cough has previously been induced in animals by means of mechanical stimulation of the upper airway but this method has not previously been applied to humans. The aims of this study were to determine if cough could be induced in humans on mechanical stimulation of the upper airway and to see if this mechanically induced cough was reproducible. We also wished to investigate if there was any difference in cough sensitivity between healthy subjects and those with acute upper respiratory tract infection (URTI). In the first investigation, 2 groups were studied: 15 healthy subjects and 30 subjects with URTI with a mean age of 20 years. Cough was induced by vibration of the airway at the level of the trachea using a modified men's shaver. In the second investigation to determine the reproducibility of this mechanically induced cough, two groups from a different population were studied: 15 healthy subjects and 29 subjects with URTI with a mean age of 20.3 years. Cough was induced by airway vibration before and after a 90-min rest period. In the first investigation it was demonstrated that cough can be induced within 2 s of vibration; subjects with URTI are more sensitive to cough induction and cough approximately five times more than healthy subjects; cough increases with repeated stimulation and reaches a maximum after three periods of vibration; the cough response may be mediated by rapidly adapting airway sensory receptors. In the second investigation there was no significant difference in mean cough counts before and after a 90-min rest period in both groups, which demonstrates that the mechanically induced cough is reproducible. This is the first study to elicit cough in humans by mechanical stimulation of the upper airway. This new method of inducing cough in subjects with URTI may be useful for studying both the mechanism of cough and the effects of antitussive medicines.

Comparison of Object Recognition Behavior in Human and Monkey

PubMed Central

Rajalingham, Rishi; Schmidt, Kailyn

2015-01-01

Although the rhesus monkey is used widely as an animal model of human visual processing, it is not known whether invariant visual object recognition behavior is quantitatively comparable across monkeys and humans. To address this question, we systematically compared the core object recognition behavior of two monkeys with that of human subjects. To test true object recognition behavior (rather than image matching), we generated several thousand naturalistic synthetic images of 24 basic-level objects with high variation in viewing parameters and image background. Monkeys were trained to perform binary object recognition tasks on a match-to-sample paradigm. Data from 605 human subjects performing the same tasks on Mechanical Turk were aggregated to characterize “pooled human” object recognition behavior, as well as 33 separate Mechanical Turk subjects to characterize individual human subject behavior. Our results show that monkeys learn each new object in a few days, after which they not only match mean human performance but show a pattern of object confusion that is highly correlated with pooled human confusion patterns and is statistically indistinguishable from individual human subjects. Importantly, this shared human and monkey pattern of 3D object confusion is not shared with low-level visual representations (pixels, V1+; models of the retina and primary visual cortex) but is shared with a state-of-the-art computer vision feature representation. Together, these results are consistent with the hypothesis that rhesus monkeys and humans share a common neural shape representation that directly supports object perception. SIGNIFICANCE STATEMENT To date, several mammalian species have shown promise as animal models for studying the neural mechanisms underlying high-level visual processing in humans. In light of this diversity, making tight comparisons between nonhuman and human primates is particularly critical in determining the best use of nonhuman primates to further the goal of the field of translating knowledge gained from animal models to humans. To the best of our knowledge, this study is the first systematic attempt at comparing a high-level visual behavior of humans and macaque monkeys. PMID:26338324

Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

PubMed

2010-09-29

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

Development and human factors analysis of neuronavigation vs. augmented reality.

PubMed

Pandya, Abhilash; Siadat, Mohammad-Reza; Auner, Greg; Kalash, Mohammad; Ellis, R Darin

2004-01-01

This paper is focused on the human factors analysis comparing a standard neuronavigation system with an augmented reality system. We use a passive articulated arm (Microscribe, Immersion technology) to track a calibrated end-effector mounted video camera. In real time, we superimpose the live video view with the synchronized graphical view of CT-derived segmented object(s) of interest within a phantom skull. Using the same robotic arm, we have developed a neuronavigation system able to show the end-effector of the arm on orthogonal CT scans. Both the AR and the neuronavigation systems have been shown to be within 3mm of accuracy. A human factors study was conducted in which subjects were asked to draw craniotomies and answer questions to gage their understanding of the phantom objects. The human factors study included 21 subjects and indicated that the subjects performed faster, with more accuracy and less errors using the Augmented Reality interface.

Journalists, district attorneys and researchers: why IRBs should get in the middle.

PubMed

Chodos, Anna H; Lee, Sei J

2015-03-29

Federal regulations in the United States have shaped Institutional Review Boards (IRBs) to focus on protecting individual human subjects. Health services research studies focusing on healthcare institutions such as hospitals or clinics do not have individual human subjects. Since U.S. federal regulations are silent on what type of review, if any, these studies require, different IRBs may approach similar studies differently, resulting in undesirable variation in the review of studies focusing on healthcare institutions. Further, although these studies do not focus on individual human subjects, they may pose risks to participating institutions, as well as individuals who work at those institutions, if identifying information becomes public. Using two recent health services research studies conducted in the U.S. as examples, we discuss variations in the level of IRB oversight for studies focusing on institutions rather than individual human subjects. We highlight how lack of IRB guidance poses challenges for researchers who wish to both protect their subjects and work appropriately with the public, journalists or the legal system in the U.S. Competing interests include the public's interest in transparency, the researcher's interest in their science, and the research participants' interests in confidentiality. Potential solutions that may help guide health services researchers to balance these competing interests include: 1) creating consensus guidelines and standard practices that address confidentiality risk to healthcare institutions and their employees; and 2) expanding the IRB role to conduct a streamlined review of health services research studies focusing on healthcare institutions to balance the competing interest of stakeholders on a case-by-case basis. For health services research studies focusing on healthcare institutions, we outline the competing interests of researchers, healthcare institutions and the public. We propose solutions to decrease undesirable variations in the review of these studies.

Predictive Modeling of Human Perception Subjectivity: Feasibility Study of Mammographic Lesion Similarity

DOE Office of Scientific and Technical Information (OSTI.GOV)

Xu, Songhua; Tourassi, Georgia

2012-01-01

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 withmore » 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.« less

The application of robotics to microlaryngeal laser surgery.

PubMed

Buckmire, Robert A; Wong, Yu-Tung; Deal, Allison M

2015-06-01

To evaluate the performance of human subjects, using a prototype robotic micromanipulator controller in a simulated, microlaryngeal operative setting. Observational cross-sectional study. Twenty-two human subjects with varying degrees of laser experience performed CO2 laser surgical tasks within a simulated microlaryngeal operative setting using an industry standard manual micromanipulator (MMM) and a prototype robotic micromanipulator controller (RMC). Accuracy, repeatability, and ablation consistency measures were obtained for each human subject across both conditions and for the preprogrammed RMC device. Using the standard MMM, surgeons with >10 previous laser cases performed superior to subjects with fewer cases on measures of error percentage and cumulative error (P = .045 and .03, respectively). No significant differences in performance were observed between subjects using the RMC device. In the programmed (P/A) mode, the RMC performed equivalently or superiorly to experienced human subjects on accuracy and repeatability measures, and nearly an order of magnitude better on measures of ablation consistency. The programmed RMC performed significantly better for repetition error when compared to human subjects with <100 previous laser cases (P = .04). Experienced laser surgeons perform better than novice surgeons on tasks of accuracy and repeatability using the MMM device but roughly equivalently using the novel RMC. Operated in the P/A mode, the RMC performs equivalently or superior to experienced laser surgeons using the industry standard MMM for all measured parameters, and delivers an ablation consistency nearly an order of magnitude better than human laser operators. NA. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

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

Code of Federal Regulations, 2012 CFR

2012-07-01

... 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 2012-07-01 2012-07-01 false Operation of the Human Studies Review...

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

Code of Federal Regulations, 2010 CFR

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...

40 CFR 26.1605 - Operation of the Human Studies Review Board.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 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 2014-07-01 2014-07-01 false Operation of the Human Studies Review...

40 CFR 26.1605 - Operation of the Human Studies Review Board.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 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 2013-07-01 2013-07-01 false Operation of the Human Studies Review...

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

Code of Federal Regulations, 2011 CFR

2011-07-01

... 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 2011-07-01 2011-07-01 false Operation of the Human Studies Review...

Gendered Subjectivities of Spacetimematter

ERIC Educational Resources Information Center

Juelskjaer, Malou

2013-01-01

This paper investigates enactments of human subjectivities with a focus on how subjectivities may be studied if spatiality and temporality are taken up as constituting forces in the production of subjectivities. By reading poststructuralist feminist theorising, agential realism and empirical material diffractively through each other I re-situate…

48 CFR 1552.223-70 - Protection of human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Protection of human... 1552.223-70 Protection of human subjects. As prescribed in 1523.303-70, insert the following contract clause when the contract involves human test subjects. Protection of Human Subjects (APR 1984) (a) The...

48 CFR 1552.223-70 - Protection of human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Protection of human... 1552.223-70 Protection of human subjects. As prescribed in 1523.303-70, insert the following contract clause when the contract involves human test subjects. Protection of Human Subjects (APR 1984) (a) The...

48 CFR 1552.223-70 - Protection of human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Protection of human... 1552.223-70 Protection of human subjects. As prescribed in 1523.303-70, insert the following contract clause when the contract involves human test subjects. Protection of Human Subjects (APR 1984) (a) The...

48 CFR 1552.223-70 - Protection of human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Protection of human... 1552.223-70 Protection of human subjects. As prescribed in 1523.303-70, insert the following contract clause when the contract involves human test subjects. Protection of Human Subjects (APR 1984) (a) The...

48 CFR 1552.223-70 - Protection of human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Protection of human... 1552.223-70 Protection of human subjects. As prescribed in 1523.303-70, insert the following contract clause when the contract involves human test subjects. Protection of Human Subjects (APR 1984) (a) The...

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

USDA-ARS?s Scientific Manuscript database

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...

Genetic variations in the human cannabinoid receptor gene are associated with happiness.

PubMed

Matsunaga, Masahiro; Isowa, Tokiko; Yamakawa, Kaori; Fukuyama, Seisuke; Shinoda, Jun; Yamada, Jitsuhiro; Ohira, Hideki

2014-01-01

Happiness has been viewed as a temporary emotional state (e.g., pleasure) and a relatively stable state of being happy (subjective happiness level). As previous studies demonstrated that individuals with high subjective happiness level rated their current affective states more positively when they experience positive events, these two aspects of happiness are interrelated. According to a recent neuroimaging study, the cytosine to thymine single-nucleotide polymorphism of the human cannabinoid receptor 1 gene is associated with sensitivity to positive emotional stimuli. Thus, we hypothesized that our genetic traits, such as the human cannabinoid receptor 1 genotypes, are closely related to the two aspects of happiness. In Experiment 1, 198 healthy volunteers were used to compare the subjective happiness level between cytosine allele carriers and thymine-thymine carriers of the human cannabinoid receptor 1 gene. In Experiment 2, we used positron emission tomography with 20 healthy participants to compare the brain responses to positive emotional stimuli of cytosine allele carriers to that of thymine-thymine carriers. Compared to thymine-thymine carriers, cytosine allele carriers have a higher subjective happiness level. Regression analysis indicated that the cytosine allele is significantly associated with subjective happiness level. The positive mood after watching a positive film was significantly higher for the cytosine allele carriers compared to the thymine-thymine carriers. Positive emotion-related brain region such as the medial prefrontal cortex was significantly activated when the cytosine allele carriers watched the positive film compared to the thymine-thymine carriers. Thus, the human cannabinoid receptor 1 genotypes are closely related to two aspects of happiness. Compared to thymine-thymine carriers, the cytosine allele carriers of the human cannabinoid receptor 1 gene, who are sensitive to positive emotional stimuli, exhibited greater magnitude positive emotions when they experienced positive events and had a higher subjective happiness level.

Detecting Underlying Stance Adopted When Human Construe Behavior of Entities

NASA Astrophysics Data System (ADS)

Terada, Kazunori; Ono, Kouhei; Ito, Akira

Whether or not humans can construe the behaviors of entities depends on their psychological stance. The philosopher Dennett proposed human cognitive strategies (three stances) in which humans construe the behavior of other animated objects, including other humans, artifacts, and physical phenomena:‘intentional’, ‘design’ and ‘physical’ stances. Detecting the psychological stance taken toward entities is difficult, because such mental state attribution is a subjective cognitive process and hard to measure. In the present study, we proposed a novel method for detecting underlying stance adopted when human construe behavior of entities. In our method the subject was asked to select the most suitable action sequence shown in three movies each of which representing Dennett’s three stances. To valid our method we have conducted an experiment in which the subjects were presented thirty short videos and asked to compare them to the three movies. The result indicated that the subjects did not focused on prior knowledge about the entity but could focused on motion characteristics per se, owing to simple and typical motion of an abstract shaped object.

Effects of nitrogen dioxide on pulmonary function in human subjects: an environmental chamber study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kerr, H.D.; Kulle, T.J.; McIlhany, M.L.

Twenty human subjects with asthma and chronic bronchitis and 10 normal, healthy adults were exposed to 0.5 ppM of nitrogen dioxide for 2 h in an environmental chamber. Seven of the 13 subjects with asthma experienced symptoms with exposure, while only one each of the subjects with chronic bronchitis and the healthy, normal group experienced symptoms. Significant pulmonary function changes from control values with exposure to NO/sub 2/ were observed in decreased quasistatic compliance for the 10 normal subjects and the 20 subjects with asthma and chronic bronchitis. In addition, functional residual capacity increased significantly for the 20 subjects withmore » asthma and chronic bronchitis. The subjects with asthma and the subjects with chronic bronchitis as separate groups, however, did not show any significant changes with exposure. With this study we are reasonably confident that exposure of subjects with asthma and chronic bronchitis to 0.5 ppM NO/sub 2/ for 2 h does not produce a significant decrement in their pulmonary function.« less

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

Code of Federal Regulations, 2010 CFR

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...

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

Code of Federal Regulations, 2010 CFR

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...

Developing and Evaluating Medical Humanities Problem-Based Learning Classes Facilitated by the Teaching Assistants Majored in the Liberal Arts

PubMed Central

Tseng, Fen-Yu; Shieh, Jeng-Yi; Kao, Tze-Wah; Wu, Chau-Chung; Chu, Tzong-Shinn; Chen, Yen-Yuan

2016-01-01

Abstract Although medical humanities courses taught by teachers from nonmedical backgrounds are not unusual now, few studies have compared the outcome of medical humanities courses facilitated by physicians to that by teaching assistants majored in the liberal arts. The objectives of this study were to (1) analyze the satisfaction of medical students with medical humanities problem-based learning (PBL) classes facilitated by nonmedical teaching assistants (TAF) majored in the liberal arts, and those facilitated by the attending physicians (APF) and (2) examine the satisfaction of medical students with clinical medicine-related and clinical medicine-unrelated medical humanities PBL classes. A total of 123 medical students, randomly assigned to 16 groups, participated in this study. There were 16 classes in the course: 8 of them were TAF classes; and the others were APF classes. Each week, each group rotated from 1 subject of the 16 subjects of PBL to another subject. All of the 16 groups went through all the 16 subjects in the 2013 spring semester. We examined the medical students’ satisfaction with each class, based on a rating score collected after each class was completed, using a scale from 0 (the lowest satisfaction) to 100 (the highest satisfaction). We also conducted multivariate linear regression analysis to examine the association between the independent variables and the students’ satisfaction. Medical students were more satisfied with the TAF (91.35 ± 7.75) medical humanities PBL classes than APF (90.40 ± 8.42) medical humanities PBL classes (P = 0.01). Moreover, medical students were more satisfied with the clinical medicine-unrelated topics (92.00 ± 7.10) than the clinical medicine-related topics (90.36 ± 7.99) in the medical humanities PBL course (P = 0.01). This medical humanities PBL course, including nonmedical subjects and topics, and nonmedical teaching assistants from the liberal arts as class facilitators, was satisfactory. This pedagogical approach of student-centered, nonmedical topics, nonmedical facilitators, and small groups, which is associated with a deep approach to learning medical humanities, should be highly encouraged. PMID:26871828

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

PubMed

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.

Validating in vivo Raman spectroscopy of bone in human subjects

NASA Astrophysics Data System (ADS)

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.

Metabolic effects of dark chocolate consumption on energy, gut microbiota, and stress-related metabolism in free-living subjects.

PubMed

Martin, Francois-Pierre J; Rezzi, Serge; Peré-Trepat, Emma; Kamlage, Beate; Collino, Sebastiano; Leibold, Edgar; Kastler, Jürgen; Rein, Dietrich; Fay, Laurent B; Kochhar, Sunil

2009-12-01

Dietary preferences influence basal human metabolism and gut microbiome activity that in turn may have long-term health consequences. The present study reports the metabolic responses of free living subjects to a daily consumption of 40 g of dark chocolate for up to 14 days. A clinical trial was performed on a population of 30 human subjects, who were classified in low and high anxiety traits using validated psychological questionnaires. Biological fluids (urine and blood plasma) were collected during 3 test days at the beginning, midtime and at the end of a 2 week study. NMR and MS-based metabonomics were employed to study global changes in metabolism due to the chocolate consumption. Human subjects with higher anxiety trait showed a distinct metabolic profile indicative of a different energy homeostasis (lactate, citrate, succinate, trans-aconitate, urea, proline), hormonal metabolism (adrenaline, DOPA, 3-methoxy-tyrosine) and gut microbial activity (methylamines, p-cresol sulfate, hippurate). Dark chocolate reduced the urinary excretion of the stress hormone cortisol and catecholamines and partially normalized stress-related differences in energy metabolism (glycine, citrate, trans-aconitate, proline, beta-alanine) and gut microbial activities (hippurate and p-cresol sulfate). The study provides strong evidence that a daily consumption of 40 g of dark chocolate during a period of 2 weeks is sufficient to modify the metabolism of free living and healthy human subjects, as per variation of both host and gut microbial metabolism.

15 CFR 27.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-01-01

... intention of involving human subjects. 27.119 Section 27.119 Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION OF HUMAN SUBJECTS § 27.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

48 CFR 352.270-6 - Restriction on use of human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... human subjects. 352.270-6 Section 352.270-6 Federal Acquisition Regulations System HEALTH AND HUMAN....270-6 Restriction on use of human subjects. As prescribed in 370-304(b), the Contracting Officer shall insert the following clause: Restriction on Use of Human Subjects (January 2006) Pursuant to 45 CFR part...

16 CFR § 1028.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-01-01

... involving human subjects. § 1028.119 Section § 1028.119 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

48 CFR 352.270-6 - Restriction on use of human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... human subjects. 352.270-6 Section 352.270-6 Federal Acquisition Regulations System HEALTH AND HUMAN....270-6 Restriction on use of human subjects. As prescribed in 370-304(b), the Contracting Officer shall insert the following clause: Restriction on Use of Human Subjects (January 2006) Pursuant to 45 CFR part...

15 CFR 27.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-01-01

... intention of involving human subjects. 27.119 Section 27.119 Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION OF HUMAN SUBJECTS § 27.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

48 CFR 352.270-6 - Restriction on use of human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... human subjects. 352.270-6 Section 352.270-6 Federal Acquisition Regulations System HEALTH AND HUMAN....270-6 Restriction on use of human subjects. As prescribed in 370-304(b), the Contracting Officer shall insert the following clause: Restriction on Use of Human Subjects (January 2006) Pursuant to 45 CFR part...

15 CFR 27.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-01-01

... intention of involving human subjects. 27.119 Section 27.119 Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION OF HUMAN SUBJECTS § 27.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

48 CFR 352.270-6 - Restriction on use of human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... human subjects. 352.270-6 Section 352.270-6 Federal Acquisition Regulations System HEALTH AND HUMAN....270-6 Restriction on use of human subjects. As prescribed in 370-304(b), the Contracting Officer shall insert the following clause: Restriction on Use of Human Subjects (January 2006) Pursuant to 45 CFR part...

48 CFR 352.270-6 - Restriction on use of human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... human subjects. 352.270-6 Section 352.270-6 Federal Acquisition Regulations System HEALTH AND HUMAN....270-6 Restriction on use of human subjects. As prescribed in 370-304(b), the Contracting Officer shall insert the following clause: Restriction on Use of Human Subjects (January 2006) Pursuant to 45 CFR part...

Differential migratory properties of monocytes isolated from human subjects naïve and non-naïve to Cannabis

PubMed Central

Silvestroni, Aurelio; Möller, Thomas; Stella, Nephi

2015-01-01

This study evaluates the migratory potential of monocytes isolated from two groups of human subjects: naïve and non-naïve to Cannabis. Phytocannabinoids (pCB), the bioactive agents produced by the plant Cannabis, regulate the phenotype and function of immune cells by interacting with CB1 and CB2 receptors. It has been shown that agents influencing the phenotype of circulating monocytes influence the phenotype of macrophages and the outcome of immune responses. To date, nothing is known about the acute and long-term effects of pCB on human circulating monocytes. Healthy subjects were recruited for a single blood draw. Monocytes were isolated, fluorescently labeled and their migration quantified using a validated assay that employs near infrared fluorescence and modified Boyden chambers. CB1 and CB2 receptor mRNA expression was quantified by qPCR. Monocytes from all subjects (n = 10) responded to chemokine (c–c motif) ligand 2 (CCL2) and human serum stimuli. Acute application of pCB significantly inhibited both the basal and CCL2-stimulated migration of monocytes, but only in subjects non-naïve to Cannabis. qPCR analysis indicates that monocytes from subjects non-naïve to Cannabis express significantly more CB1 mRNA. The phenotype of monocytes isolated from subjects non-naïve to Cannabis is significantly different from monocytes isolated from subjects naïve to Cannabis. Only monocytes from subjects non-naïve to Cannabis respond to acute exposure to pCB by reducing their overall migratory capacity. Our study suggests that chronic exposure to Cannabis affects the phenotype of circulating monocytes and accordingly could influence outcome of inflammatory responses occurring in injured tissues. PMID:22492174

Differential migratory properties of monocytes isolated from human subjects naïve and non-naïve to Cannabis.

PubMed

Sexton, Michelle; Silvestroni, Aurelio; Möller, Thomas; Stella, Nephi

2013-06-01

This study evaluates the migratory potential of monocytes isolated from two groups of human subjects: naïve and non-naïve to Cannabis. Phytocannabinoids (pCB), the bioactive agents produced by the plant Cannabis, regulate the phenotype and function of immune cells by interacting with CB1 and CB2 receptors. It has been shown that agents influencing the phenotype of circulating monocytes influence the phenotype of macrophages and the outcome of immune responses. To date, nothing is known about the acute and long-term effects of pCB on human circulating monocytes. Healthy subjects were recruited for a single blood draw. Monocytes were isolated, fluorescently labeled and their migration quantified using a validated assay that employs near infrared fluorescence and modified Boyden chambers. CB1 and CB2 receptor mRNA expression was quantified by qPCR. Monocytes from all subjects (n = 10) responded to chemokine (c-c motif) ligand 2 (CCL2) and human serum stimuli. Acute application of pCB significantly inhibited both the basal and CCL2-stimulated migration of monocytes, but only in subjects non-naïve to Cannabis. qPCR analysis indicates that monocytes from subjects non-naïve to Cannabis express significantly more CB1 mRNA. The phenotype of monocytes isolated from subjects non-naïve to Cannabis is significantly different from monocytes isolated from subjects naïve to Cannabis. Only monocytes from subjects non-naïve to Cannabis respond to acute exposure to pCB by reducing their overall migratory capacity. Our study suggests that chronic exposure to Cannabis affects the phenotype of circulating monocytes and accordingly could influence outcome of inflammatory responses occurring in injured tissues.

Caries protective agents in human milk and bovine milk: an in vitro study.

PubMed

Shetty, Vabitha; Hegde, Amitha M; Nandan, S; Shetty, Suchetha

2011-01-01

To estimate Calcium and Phosphorus withdrawal from hydroxyapatite in the presence of bovine milk and human milk from which the following protective fractions namely Casein, Whey protein, Lactose and Milk fat have been individually removed and to compare the above protective fractions in human and bovine milk. Human milk obtained from lactating mothers in the labor ward of Kshema hospital was subjected to immediate analysis. Bovine milk was obtained from a local dairy. Equal quantities of human milk and bovine milk (1 ml) were separately subjected to the systematic removal of the four milk fractions. As each fraction was removed, the remaining milk samples were subjected to testing. Powdered hydroxyapatite from human dental enamel was subjected to demineralization with the addition of the milk sample under test for 20 minutes. This mixture was then centrifuged. Aliquots of the supernatant were taken for calcium and Phosphorus analysis using photospectrometry. Ten demineralization tests were similarly carried out for every milk fraction for both human and bovine milk separately. Equal samples of whole bovine milk and whole human milk were also subjected to similar testing. The calcium and phosphorus dissolution values were higher when the individual fractions were eliminated from both human milk/enamel samples and bovine milk/enamel samples as compared to the values obtained from whole human milk/whole bovine milk/enamel samples. Further higher calcium and phosphorus dissolution values were observed when the fractions were individually and separately removed from the whole human milk/enamel samples as compared to the corresponding values obtained when these fractions were removed from bovine milk/enamel samples. The evaluated milk fraction in bovine milk namely casein, whey protein, lactose and milk fat were individually more caries protective when compared to the corresponding fractions in human milk.

Performance and strategy comparisons of human listeners and logistic regression in discriminating underwater targets.

PubMed

Yang, Lixue; Chen, Kean

2015-11-01

To improve the design of underwater target recognition systems based on auditory perception, this study compared human listeners with automatic classifiers. Performances measures and strategies in three discrimination experiments, including discriminations between man-made and natural targets, between ships and submarines, and among three types of ships, were used. In the experiments, the subjects were asked to assign a score to each sound based on how confident they were about the category to which it belonged, and logistic regression, which represents linear discriminative models, also completed three similar tasks by utilizing many auditory features. The results indicated that the performances of logistic regression improved as the ratio between inter- and intra-class differences became larger, whereas the performances of the human subjects were limited by their unfamiliarity with the targets. Logistic regression performed better than the human subjects in all tasks but the discrimination between man-made and natural targets, and the strategies employed by excellent human subjects were similar to that of logistic regression. Logistic regression and several human subjects demonstrated similar performances when discriminating man-made and natural targets, but in this case, their strategies were not similar. An appropriate fusion of their strategies led to further improvement in recognition accuracy.

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

PubMed

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.

Interests of 5th through 10th Grade Students toward Human Biology

ERIC Educational Resources Information Center

Erten, Sinan

2008-01-01

This study investigated the middle and high school students' interests towards the subjects of human biology, specifically, "Human Health and Nutrition" and "Human Body and Organs." The study also investigated sources of their interests and factors that impact their interests, namely people that they interact and courses that…

Human subjects research handbook: Protecting human research subjects. Second edition

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1996-01-30

This handbook serves as a guide to understanding and implementing the Federal regulations and US DOE Orders established to protect human research subjects. Material in this handbook is directed towards new and continuing institutional review board (IRB) members, researchers, institutional administrators, DOE officials, and others who may be involved or interested in human subjects research. It offers comprehensive overview of the various requirements, procedures, and issues relating to human subject research today.

The historical, ethical, and legal background of human-subjects research.

PubMed

Rice, Todd W

2008-10-01

The current system of human-subject-research oversight and protections has developed over the last 5 decades. The principles of conducting human research were first developed as the Nuremberg code to try Nazi war criminals. The 3 basic elements of the Nuremberg Code (voluntary informed consent, favorable risk/benefit analysis, and right to withdraw without repercussions) became the foundation for subsequent ethical codes and research regulations. In 1964 the World Medical Association released the Declaration of Helsinki, which built on the principles of the Nuremberg Code. Numerous research improprieties between 1950 and 1974 in the United States prompted Congressional deliberations about human-subject-research oversight. Congress's first legislation to protect the rights and welfare of human subjects was the National Research Act of 1974, which created the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research, which issued the Belmont Report. The Belmont Report stated 3 fundamental principles for conducting human-subjects research: respect for persons, beneficence, and justice. The Office of Human Research Protections oversees Title 45, Part 46 of the Code for Federal Regulations, which pertains to human-subjects research. That office indirectly oversees human-subjects research through local institutional review boards (IRB). Since their inception, the principles of conducting human research, IRBs, and the Code for Federal Regulations have all advanced substantially. This paper describes the history and current status of human-subjects-research regulations.

Noninvasive quantification of ascorbate and glutathione concentration in the elderly human brain

USDA-ARS?s Scientific Manuscript database

In this study, Ascorbate (Asc) and glutathione (GSH) concentrations were non-invasively quantified using double edited 1H MRS at 4T in the occipital cortex of healthy young(age 18 – 22 years, N = 22) and elderly (age 70 – 89 years, N = 22) human subjects. Elderly subjects had a lower GSH concentrati...

Increased cytokine production by monocytes from human subjects who consumed grape powder was not mediated by differences in dietary intake patterns

USDA-ARS?s Scientific Manuscript database

Recently, in a randomized, double-blind cross-over study, we reported that consumption of grape powder by obese human subjects increased the production of the pro-inflammatory cytokines interleukin-1' and interleukin-6 by ex vivo-derived peripheral blood monocytes after exposure to bacterial lipopol...

Knowledge-Guided Robust MRI Brain Extraction for Diverse Large-Scale Neuroimaging Studies on Humans and Non-Human Primates

PubMed Central

Wang, Yaping; Nie, Jingxin; Yap, Pew-Thian; Li, Gang; Shi, Feng; Geng, Xiujuan; Guo, Lei; Shen, Dinggang

2014-01-01

Accurate and robust brain extraction is a critical step in most neuroimaging analysis pipelines. In particular, for the large-scale multi-site neuroimaging studies involving a significant number of subjects with diverse age and diagnostic groups, accurate and robust extraction of the brain automatically and consistently is highly desirable. In this paper, we introduce population-specific probability maps to guide the brain extraction of diverse subject groups, including both healthy and diseased adult human populations, both developing and aging human populations, as well as non-human primates. Specifically, the proposed method combines an atlas-based approach, for coarse skull-stripping, with a deformable-surface-based approach that is guided by local intensity information and population-specific prior information learned from a set of real brain images for more localized refinement. Comprehensive quantitative evaluations were performed on the diverse large-scale populations of ADNI dataset with over 800 subjects (55∼90 years of age, multi-site, various diagnosis groups), OASIS dataset with over 400 subjects (18∼96 years of age, wide age range, various diagnosis groups), and NIH pediatrics dataset with 150 subjects (5∼18 years of age, multi-site, wide age range as a complementary age group to the adult dataset). The results demonstrate that our method consistently yields the best overall results across almost the entire human life span, with only a single set of parameters. To demonstrate its capability to work on non-human primates, the proposed method is further evaluated using a rhesus macaque dataset with 20 subjects. Quantitative comparisons with popularly used state-of-the-art methods, including BET, Two-pass BET, BET-B, BSE, HWA, ROBEX and AFNI, demonstrate that the proposed method performs favorably with superior performance on all testing datasets, indicating its robustness and effectiveness. PMID:24489639

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

PubMed

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.

Statistical Analysis of Variation in the Human Plasma Proteome

DOE PAGES

Corzett, Todd H.; Fodor, Imola K.; Choi, Megan W.; ...

2010-01-01

Quantifying the variation in the human plasma proteome is an essential prerequisite for disease-specific biomarker detection. We report here on the longitudinal and individual variation in human plasma characterized by two-dimensional difference gel electrophoresis (2-D DIGE) using plasma samples from eleven healthy subjects collected three times over a two week period. Fixed-effects modeling was used to remove dye and gel variability. Mixed-effects modeling was then used to quantitate the sources of proteomic variation. The subject-to-subject variation represented the largest variance component, while the time-within-subject variation was comparable to the experimental variation found in a previous technical variability study where onemore » human plasma sample was processed eight times in parallel and each was then analyzed by 2-D DIGE in triplicate. Here, 21 protein spots had larger than 50% CV, suggesting that these proteins may not be appropriate as biomarkers and should be carefully scrutinized in future studies. Seventy-eight protein spots showing differential protein levels between different individuals or individual collections were identified by mass spectrometry and further characterized using hierarchical clustering. The results present a first step toward understanding the complexity of longitudinal and individual variation in the human plasma proteome, and provide a baseline for improved biomarker discovery.« less

Analysis of the charge exchange between the human body and ground: evaluation of "earthing" from an electrical perspective.

PubMed

Chamberlin, Kent; Smith, Wayne; Chirgwin, Christopher; Appasani, Seshank; Rioux, Paul

2014-12-01

The purpose of this study was to investigate "earthing" from an electrical perspective through measurement and analysis of the naturally occurring electron flow between the human body or a control and ground as this relates to the magnitude of the charge exchange, the relationship between the charge exchange and body functions (respiration and heart rate), and the detection of other information that might be contained in the charge exchange. Sensitive, low-noise instrumentation was designed and fabricated to measure low-level current flow at low frequencies. This instrumentation was used to record current flow between human subjects or a control and ground, and these measurements were performed approximately 40 times under varied circumstances. The results of these measurements were analyzed to determine if information was contained in the current exchange. The currents flowing between the human body and ground were small (nanoamperes), and they correlated with subject motion. There did not appear to be any information contained in this exchange except for information about subject motion. This study showed that currents flow between the environment (earth) and a grounded human body; however, these currents are small (nanoamperes) and do not appear to contain information other than information about subject motion.

Statistical analysis of variation in the human plasma proteome.

PubMed

Corzett, Todd H; Fodor, Imola K; Choi, Megan W; Walsworth, Vicki L; Turteltaub, Kenneth W; McCutchen-Maloney, Sandra L; Chromy, Brett A

2010-01-01

Quantifying the variation in the human plasma proteome is an essential prerequisite for disease-specific biomarker detection. We report here on the longitudinal and individual variation in human plasma characterized by two-dimensional difference gel electrophoresis (2-D DIGE) using plasma samples from eleven healthy subjects collected three times over a two week period. Fixed-effects modeling was used to remove dye and gel variability. Mixed-effects modeling was then used to quantitate the sources of proteomic variation. The subject-to-subject variation represented the largest variance component, while the time-within-subject variation was comparable to the experimental variation found in a previous technical variability study where one human plasma sample was processed eight times in parallel and each was then analyzed by 2-D DIGE in triplicate. Here, 21 protein spots had larger than 50% CV, suggesting that these proteins may not be appropriate as biomarkers and should be carefully scrutinized in future studies. Seventy-eight protein spots showing differential protein levels between different individuals or individual collections were identified by mass spectrometry and further characterized using hierarchical clustering. The results present a first step toward understanding the complexity of longitudinal and individual variation in the human plasma proteome, and provide a baseline for improved biomarker discovery.

Analysis of the Charge Exchange Between the Human Body and Ground: Evaluation of “Earthing” From an Electrical Perspective

PubMed Central

Chamberlin, Kent; Smith, Wayne; Chirgwin, Christopher; Appasani, Seshank; Rioux, Paul

2014-01-01

Objective The purpose of this study was to investigate “earthing” from an electrical perspective through measurement and analysis of the naturally occurring electron flow between the human body or a control and ground as this relates to the magnitude of the charge exchange, the relationship between the charge exchange and body functions (respiration and heart rate), and the detection of other information that might be contained in the charge exchange. Methods Sensitive, low-noise instrumentation was designed and fabricated to measure low-level current flow at low frequencies. This instrumentation was used to record current flow between human subjects or a control and ground, and these measurements were performed approximately 40 times under varied circumstances. The results of these measurements were analyzed to determine if information was contained in the current exchange. Results The currents flowing between the human body and ground were small (nanoamperes), and they correlated with subject motion. There did not appear to be any information contained in this exchange except for information about subject motion. Conclusions This study showed that currents flow between the environment (earth) and a grounded human body; however, these currents are small (nanoamperes) and do not appear to contain information other than information about subject motion. PMID:25435837

Is Human-Computer Interaction Social or Parasocial?

ERIC Educational Resources Information Center

Sundar, S. Shyam

Conducted in the attribution-research paradigm of social psychology, a study examined whether human-computer interaction is fundamentally social (as in human-human interaction) or parasocial (as in human-television interaction). All 30 subjects (drawn from an undergraduate class on communication) were exposed to an identical interaction with…

45 CFR 690.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... involving human subjects. 690.119 Section 690.119 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention...

14 CFR 1230.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2012 CFR

2012-01-01

... of involving human subjects. 1230.119 Section 1230.119 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving...

45 CFR 63.31 - Protection of human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Protection of human subjects. 63.31 Section 63.31 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GRANT PROGRAMS ADMINISTERED... Protection of human subjects. All grants made pursuant to this part are subject to the specific provisions of...

45 CFR 690.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... involving human subjects. 690.119 Section 690.119 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention...

32 CFR 219.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... involving human subjects. 219.119 Section 219.119 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

38 CFR 16.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2012 CFR

2012-07-01

... without the intention of involving human subjects. 16.119 Section 16.119 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention...

14 CFR 1230.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-01-01

... of involving human subjects. 1230.119 Section 1230.119 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving...

38 CFR 16.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... without the intention of involving human subjects. 16.119 Section 16.119 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention...

14 CFR 1230.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-01-01

... of involving human subjects. 1230.119 Section 1230.119 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving...

45 CFR 63.31 - Protection of human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 1 2012-10-01 2012-10-01 false Protection of human subjects. 63.31 Section 63.31 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GRANT PROGRAMS ADMINISTERED... Protection of human subjects. All grants made pursuant to this part are subject to the specific provisions of...

32 CFR 219.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-07-01

... involving human subjects. 219.119 Section 219.119 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

45 CFR 63.31 - Protection of human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 1 2011-10-01 2011-10-01 false Protection of human subjects. 63.31 Section 63.31 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GRANT PROGRAMS ADMINISTERED... Protection of human subjects. All grants made pursuant to this part are subject to the specific provisions of...

45 CFR 63.31 - Protection of human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 1 2014-10-01 2014-10-01 false Protection of human subjects. 63.31 Section 63.31 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION GRANT PROGRAMS ADMINISTERED... Protection of human subjects. All grants made pursuant to this part are subject to the specific provisions of...

45 CFR 63.31 - Protection of human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 1 2013-10-01 2013-10-01 false Protection of human subjects. 63.31 Section 63.31 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GRANT PROGRAMS ADMINISTERED... Protection of human subjects. All grants made pursuant to this part are subject to the specific provisions of...

38 CFR 16.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-07-01

... without the intention of involving human subjects. 16.119 Section 16.119 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention...

32 CFR 219.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-07-01

... involving human subjects. 219.119 Section 219.119 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

[Study of the relationship between human quality and reliability].

PubMed

Long, S; Wang, C; Wang, L i; Yuan, J; Liu, H; Jiao, X

1997-02-01

To clarify the relationship between human quality and reliability, 1925 experiments in 20 subjects were carried out to study the relationship between disposition character, digital memory, graphic memory, multi-reaction time and education level and simulated aircraft operation. Meanwhile, effects of task difficulty and enviromental factor on human reliability were also studied. The results showed that human quality can be predicted and evaluated through experimental methods. The better the human quality, the higher the human reliability.

Usefulness of 2D fusion of postmortem CT and antemortem chest radiography studies for human identification.

PubMed

Shinkawa, Norihiro; Hirai, Toshinori; Nishii, Ryuichi; Yukawa, Nobuhiro

2017-06-01

To determine the feasibility of human identification through the two-dimensional (2D) fusion of postmortem computed tomography (PMCT) and antemortem chest radiography. The study population consisted of 15 subjects who had undergone chest radiography studies more than 12 months before death. Fused images in which a chest radiograph was fused with a PMCT image were obtained for those subjects using a workstation, and the minimum distance gaps between corresponding anatomical landmarks (located at soft tissue and bone sites) in the images obtained with the two modalities were calculated. For each fused image, the mean of all these minimum distance gaps was recorded as the mean distance gap (MDG). For each subject, the MDG obtained for the same-subject fused image (i.e., where both of the images that were fused derived from that subject) was compared with the MDGs for different-subject fused images (i.e., where only one of the images that were fused derived from that subject; the other image derived from a different subject) in order to determine whether same-subject fused images can be reliably distinguished from different-subject fused images. The MDGs of the same-subject fused images were found to be significantly smaller than the MDGs of the different-subject fused images (p < 0.01). When bone landmarks were used, the same-subject fused image was found to be the fused image with the lowest MDG for 33.3% of the subjects, the fused image with the lowest or second-lowest MDG for 73.3% of the subjects, and the fused image with the lowest, second-lowest, or third-lowest MDG for 86.7% of the subjects. The application of bone landmarks rather than soft-tissue landmarks made it significantly more likely that, for each subject, the same-subject fused image would have the lowest MDG (or one of the lowest MDGs) of all the fused images compared (p < 0.05). The 2D fusion of antemortem chest radiography and postmortem CT images may assist in human identification.

Antioxidative probiotic fermented goats' milk decreases oxidative stress-mediated atherogenicity in human subjects.

PubMed

Kullisaar, Tiiu; Songisepp, Epp; Mikelsaar, Marika; Zilmer, Kersti; Vihalemm, Tiiu; Zilmer, Mihkel

2003-08-01

The increasing interest in a healthy diet is stimulating innovative development of novel scientific products in the food industry. The viable lactic acid bacteria in fermented milk products, such as yoghurt, have been associated with increased lactose tolerance, a well-balanced intestinal microflora, antimicrobial activity, stimulation of the immune system and antitumoural, anticholesterolaemic and antioxidative properties in human subjects. Recently, we have studied a human Lactobacillus spp. strain that possesses antioxidative activity. The aim of the present pilot study was to develop goats' milk fermented with the human antioxidative lactobacilli strain, Lactobacillus fermentum ME-3, and to test the effect of the fermented probiotic goats' milk on oxidative stress markers (including markers for atherosclerosis) in human blood and urine and on the gut microflora. Twenty-one healthy subjects were assigned to two treatment groups: goats' milk group and fermented goats' milk group (150 g/d) for a period of 21 d. Consumption of fermented goats' milk improved anti-atherogenicity in healthy subjects: it prolonged resistance of the lipoprotein fraction to oxidation, lowered levels of peroxidized lipoproteins, oxidized LDL, 8-isoprostanes and glutathione redox ratio, and enhanced total antioxidative activity. The consumption of fermented goats' milk also altered both the prevalence and proportion of lactic acid bacteria species in the gut microflora of the subjects. We conclude that the goats' milk fermented with our special antioxidative lactobacilli strain Lactobacillus fermentum ME-3 exhibits anti-atherogenic effects.

Using iPSC-derived human DA neurons from opioid-dependent subjects to study dopamine dynamics.

PubMed

Sheng, Yang; Filichia, Emily; Shick, Elizabeth; Preston, Kenzie L; Phillips, Karran A; Cooperman, Leslie; Lin, Zhicheng; Tesar, Paul; Hoffer, Barry; Luo, Yu

2016-08-01

The dopaminergic (DA) system plays important roles in addiction. However, human DA neurons from drug-dependent subjects were not available for study until recent development in inducible pluripotent stem cells (iPSCs) technology. In this study, we produced DA neurons differentiated using iPSCs derived from opioid-dependent and control subjects carrying different 3' VNTR (variable number tandem repeat) polymorphism in the human dopamine transporter (DAT or SLC6A3). In addition, the effects of valproic acid (VPA) exposures on iPSC-derived human DA neurons are also examined. We present the first evidence suggesting that the 3' VNTR polymorphism in the hDAT gene affects DAT expression level in iPSC-derived human DA neurons. In human DA neurons, which provide an appropriate cellular milieu, VPA treatment alters the expression of several genes important for dopaminergic neuron function including DAT, Nurr1, and TH; this might partly explain its action in regulating addictive behaviors. VPA treatment also significantly increased DA D2 receptor (Drd2) expression, especially in the opioid-dependent iPSC cell lines. Our data suggest that human iPSC-derived DA neurons may be useful in in vitro experimental model to examine the effects of genetic variation in gene regulation, to examine the underlying mechanisms in neurological disorders including drug addiction, and to serve as a platform for therapeutic development.

The biologic effects of grounding the human body during sleep as measured by cortisol levels and subjective reporting of sleep, pain, and stress.

PubMed

Ghaly, Maurice; Teplitz, Dale

2004-10-01

Diurnal cortisol secretion levels were measured and circadian cortisol profiles were evaluated in a pilot study conducted to test the hypothesis that grounding the human body to earth during sleep will result in quantifiable changes in cortisol. It was also hypothesized that grounding the human body would result in changes in sleep, pain, and stress (anxiety, depression, irritability), as measured by subjective reporting. Twelve (12) subjects with complaints of sleep dysfunction, pain, and stress were grounded to earth during sleep for 8 weeks in their own beds using a conductive mattress pad. Saliva tests were administered to establish pregrounding baseline cortisol levels. Levels were obtained at 4-hour intervals for a 24-hour period to determine the circadian cortisol profile. Cortisol testing was repeated at week 6. Subjective symptoms of sleep dysfunction, pain, and stress were reported daily throughout the 8-week test period. Measurable improvements in diurnal cortisol profiles were observed, with cortisol levels significantly reduced during night-time sleep. Subjects' 24-hour circadian cortisol profiles showed a trend toward normalization. Subjectively reported symptoms, including sleep dysfunction, pain, and stress, were reduced or eliminated in nearly all subjects. Results indicate that grounding the human body to earth ("earthing") during sleep reduces night-time levels of cortisol and resynchronizes cortisol hormone secretion more in alignment with the natural 24-hour circadian rhythm profile. Changes were most apparent in females. Furthermore, subjective reporting indicates that grounding the human body to earth during sleep improves sleep and reduces pain and stress.

34 CFR 76.681 - Protection of human subjects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false Protection of human subjects. 76.681 Section 76.681 Education Office of the Secretary, Department of Education STATE-ADMINISTERED PROGRAMS What Conditions Must... of human subjects. If a State or a subgrantee uses a human subject in a research project, the State...

10 CFR 35.6 - Provisions for the protection of human research subjects.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Provisions for the protection of human research subjects... Information § 35.6 Provisions for the protection of human research subjects. (a) A licensee may conduct research involving human research subjects only if it uses the byproduct materials specified on its license...

34 CFR 75.681 - Protection of human research subjects.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 34 Education 1 2012-07-01 2012-07-01 false Protection of human research subjects. 75.681 Section... Conditions Must Be Met by a Grantee? Other Requirements for Certain Projects § 75.681 Protection of human research subjects. If a grantee uses a human subject in a research project, the grantee shall protect the...

34 CFR 76.681 - Protection of human subjects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 34 Education 1 2014-07-01 2014-07-01 false Protection of human subjects. 76.681 Section 76.681 Education Office of the Secretary, Department of Education STATE-ADMINISTERED PROGRAMS What Conditions Must... of human subjects. If a State or a subgrantee uses a human subject in a research project, the State...

34 CFR 75.681 - Protection of human research subjects.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 34 Education 1 2013-07-01 2013-07-01 false Protection of human research subjects. 75.681 Section... Conditions Must Be Met by a Grantee? Other Requirements for Certain Projects § 75.681 Protection of human research subjects. If a grantee uses a human subject in a research project, the grantee shall protect the...

34 CFR 75.681 - Protection of human research subjects.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 34 Education 1 2011-07-01 2011-07-01 false Protection of human research subjects. 75.681 Section... Conditions Must Be Met by a Grantee? Other Requirements for Certain Projects § 75.681 Protection of human research subjects. If a grantee uses a human subject in a research project, the grantee shall protect the...

34 CFR 76.681 - Protection of human subjects.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 34 Education 1 2012-07-01 2012-07-01 false Protection of human subjects. 76.681 Section 76.681 Education Office of the Secretary, Department of Education STATE-ADMINISTERED PROGRAMS What Conditions Must... of human subjects. If a State or a subgrantee uses a human subject in a research project, the State...

34 CFR 76.681 - Protection of human subjects.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 34 Education 1 2013-07-01 2013-07-01 false Protection of human subjects. 76.681 Section 76.681 Education Office of the Secretary, Department of Education STATE-ADMINISTERED PROGRAMS What Conditions Must... of human subjects. If a State or a subgrantee uses a human subject in a research project, the State...

34 CFR 76.681 - Protection of human subjects.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 34 Education 1 2011-07-01 2011-07-01 false Protection of human subjects. 76.681 Section 76.681 Education Office of the Secretary, Department of Education STATE-ADMINISTERED PROGRAMS What Conditions Must... of human subjects. If a State or a subgrantee uses a human subject in a research project, the State...

10 CFR 35.6 - Provisions for the protection of human research subjects.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Provisions for the protection of human research subjects... Information § 35.6 Provisions for the protection of human research subjects. (a) A licensee may conduct research involving human research subjects only if it uses the byproduct materials specified on its license...

34 CFR 75.681 - Protection of human research subjects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 34 Education 1 2014-07-01 2014-07-01 false Protection of human research subjects. 75.681 Section... Conditions Must Be Met by a Grantee? Other Requirements for Certain Projects § 75.681 Protection of human research subjects. If a grantee uses a human subject in a research project, the grantee shall protect the...

10 CFR 35.6 - Provisions for the protection of human research subjects.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Provisions for the protection of human research subjects... Information § 35.6 Provisions for the protection of human research subjects. (a) A licensee may conduct research involving human research subjects only if it uses the byproduct materials specified on its license...

Conservation of streptococcal CRISPRs on human skin and saliva.

PubMed

Robles-Sikisaka, Refugio; Naidu, Mayuri; Ly, Melissa; Salzman, Julia; Abeles, Shira R; Boehm, Tobias K; Pride, David T

2014-06-06

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPRs) are utilized by bacteria to resist encounters with their viruses. Human body surfaces have numerous bacteria that harbor CRISPRs, and their content can provide clues as to the types and features of viruses they may have encountered. We investigated the conservation of CRISPR content from streptococci on skin and saliva of human subjects over 8-weeks to determine whether similarities existed in the CRISPR spacer profiles and whether CRISPR spacers were a stable component of each biogeographic site. Most of the CRISPR sequences identified were unique, but a small proportion of spacers from the skin and saliva of each subject matched spacers derived from previously sequenced loci of S. thermophilus and other streptococci. There were significant proportions of CRISPR spacers conserved over the entire 8-week study period for all subjects, and salivary CRISPR spacers sampled in the mornings showed significantly higher levels of conservation than any other time of day. We also found substantial similarities in the spacer repertoires of the skin and saliva of each subject. Many skin-derived spacers matched salivary viruses, supporting that bacteria of the skin may encounter viruses with similar sequences to those found in the mouth. Despite the similarities between skin and salivary spacer repertoires, the variation present was distinct based on each subject and body site. The conservation of CRISPR spacers in the saliva and the skin of human subjects over the time period studied suggests a relative conservation of the bacteria harboring them.

Conservation of streptococcal CRISPRs on human skin and saliva

PubMed Central

2014-01-01

Background Clustered Regularly Interspaced Short Palindromic Repeats (CRISPRs) are utilized by bacteria to resist encounters with their viruses. Human body surfaces have numerous bacteria that harbor CRISPRs, and their content can provide clues as to the types and features of viruses they may have encountered. Results We investigated the conservation of CRISPR content from streptococci on skin and saliva of human subjects over 8-weeks to determine whether similarities existed in the CRISPR spacer profiles and whether CRISPR spacers were a stable component of each biogeographic site. Most of the CRISPR sequences identified were unique, but a small proportion of spacers from the skin and saliva of each subject matched spacers derived from previously sequenced loci of S. thermophilus and other streptococci. There were significant proportions of CRISPR spacers conserved over the entire 8-week study period for all subjects, and salivary CRISPR spacers sampled in the mornings showed significantly higher levels of conservation than any other time of day. We also found substantial similarities in the spacer repertoires of the skin and saliva of each subject. Many skin-derived spacers matched salivary viruses, supporting that bacteria of the skin may encounter viruses with similar sequences to those found in the mouth. Despite the similarities between skin and salivary spacer repertoires, the variation present was distinct based on each subject and body site. Conclusions The conservation of CRISPR spacers in the saliva and the skin of human subjects over the time period studied suggests a relative conservation of the bacteria harboring them. PMID:24903519

Exploring the folkbiological conception of human nature

PubMed Central

Linquist, Stefan; Machery, Edouard; Griffiths, Paul E.; Stotz, Karola

2011-01-01

Integrating the study of human diversity into the human evolutionary sciences requires substantial revision of traditional conceptions of a shared human nature. This process may be made more difficult by entrenched, ‘folkbiological’ modes of thought. Earlier work by the authors suggests that biologically naive subjects hold an implicit theory according to which some traits are expressions of an animal's inner nature while others are imposed by its environment. In this paper, we report further studies that extend and refine our account of this aspect of folkbiology. We examine biologically naive subjects' judgments about whether traits of an animal are ‘innate’, ‘in its DNA’ or ‘part of its nature’. Subjects do not understand these three descriptions to be equivalent. Both innate and in its DNA have the connotation that the trait is species-typical. This poses an obstacle to the assimilation of the biology of polymorphic and plastic traits by biologically naive audiences. Researchers themselves may not be immune to the continuing pull of folkbiological modes of thought. PMID:21199848

Enhanced emotional responses during social coordination with a virtual partner

PubMed Central

Dumas, Guillaume; Kelso, J.A. Scott; Tognoli, Emmanuelle

2016-01-01

Emotion and motion, though seldom studied in tandem, are complementary aspects of social experience. This study investigates variations in emotional responses during movement coordination between a human and a Virtual Partner (VP), an agent whose virtual finger movements are driven by the Haken-Kelso-Bunz (HKB) equations of Coordination Dynamics. Twenty-one subjects were instructed to coordinate finger movements with the VP in either inphase or antiphase patterns. By adjusting model parameters, we manipulated the ‘intention’ of VP as cooperative or competitive with the human's instructed goal. Skin potential responses (SPR) were recorded to quantify the intensity of emotional response. At the end of each trial, subjects rated the VP's intention and whether they thought their partner was another human being or a machine. We found greater emotional responses when subjects reported that their partner was human and when coordination was stable. That emotional responses are strongly influenced by dynamic features of the VP's behavior, has implications for mental health, brain disorders and the design of socially cooperative machines. PMID:27094374

Deep Sequencing of Influenza A Virus from a Human Challenge Study Reveals a Selective Bottleneck and Only Limited Intrahost Genetic Diversification.

PubMed

Sobel Leonard, Ashley; McClain, Micah T; Smith, Gavin J D; Wentworth, David E; Halpin, Rebecca A; Lin, Xudong; Ransier, Amy; Stockwell, Timothy B; Das, Suman R; Gilbert, Anthony S; Lambkin-Williams, Robert; Ginsburg, Geoffrey S; Woods, Christopher W; Koelle, Katia

2016-12-15

Knowledge of influenza virus evolution at the point of transmission and at the intrahost level remains limited, particularly for human hosts. Here, we analyze a unique viral data set of next-generation sequencing (NGS) samples generated from a human influenza challenge study wherein 17 healthy subjects were inoculated with cell- and egg-passaged virus. Nasal wash samples collected from 7 of these subjects were successfully deep sequenced. From these, we characterized changes in the subjects' viral populations during infection and identified differences between the virus in these samples and the viral stock used to inoculate the subjects. We first calculated pairwise genetic distances between the subjects' nasal wash samples, the viral stock, and the influenza virus A/Wisconsin/67/2005 (H3N2) reference strain used to generate the stock virus. These distances revealed that considerable viral evolution occurred at various points in the human challenge study. Further quantitative analyses indicated that (i) the viral stock contained genetic variants that originated and likely were selected for during the passaging process, (ii) direct intranasal inoculation with the viral stock resulted in a selective bottleneck that reduced nonsynonymous genetic diversity in the viral hemagglutinin and nucleoprotein, and (iii) intrahost viral evolution continued over the course of infection. These intrahost evolutionary dynamics were dominated by purifying selection. Our findings indicate that rapid viral evolution can occur during acute influenza infection in otherwise healthy human hosts when the founding population size of the virus is large, as is the case with direct intranasal inoculation. Influenza viruses circulating among humans are known to rapidly evolve over time. However, little is known about how influenza virus evolves across single transmission events and over the course of a single infection. To address these issues, we analyze influenza virus sequences from a human challenge experiment that initiated infection with a cell- and egg-passaged viral stock, which appeared to have adapted during its preparation. We find that the subjects' viral populations differ genetically from the viral stock, with subjects' viral populations having lower representation of the amino-acid-changing variants that arose during viral preparation. We also find that most of the viral evolution occurring over single infections is characterized by further decreases in the frequencies of these amino-acid-changing variants and that only limited intrahost genetic diversification through new mutations is apparent. Our findings indicate that influenza virus populations can undergo rapid genetic changes during acute human infections. Copyright © 2016 Sobel Leonard et al.

48 CFR 1352.235-73 - Research involving human subjects-after initial contract award.

Code of Federal Regulations, 2012 CFR

2012-10-01

... the United States Department of Health and Human Services' Office for Human Research Protections... documentation may include: (1) Copies of the human subjects research protocol, advertisements, recruitment... human subjects research protocol, advertisements, recruitment material, and informed consent forms by...

Vitamin concentrations in human milk vary with time within feed, circadian rhythm, and single-dose supplementation

USDA-ARS?s Scientific Manuscript database

Importance: Human milk is the subject of many nutrition studies but methods for representative sample collection are not established. Our recently improved, validated methods for analyzing micronutrients in human milk now enable systematic study of factors affecting their concentration. Objective...

Fat- and water-soluble vitamin concentrations in human milk: effects of collection protocol, circadian variation and acute maternal supplementation

USDA-ARS?s Scientific Manuscript database

Importance: Human milk is the subject of many nutrition studies but methods for representative sample collection are not established. Our recently improved, validated methods for analyzing micronutrients in human milk now enable systematic study of factors affecting their concentration. Objective:...

Aroma-therapeutic effects of massage blended essential oils on humans.

PubMed

Hongratanaworakit, Tapanee

2011-08-01

Although blended essential oils are increasingly being used for the improvement of the quality of life and for the relief of various symptoms in patients, the scientific evaluation of the aroma-therapeutic effects of blended essential oils in humans is rather scarce. In this study, we hypothesized that applying blended essential oil would provide a synergistic effect that would have a chance for success in treating depression or anxiety. Therefore, the main objective of this study was to investigate the effects of the blended essential oil on autonomic parameters and on emotional responses in humans following transdermal absorption. The blended essential oil consisted of lavender and bergamot oils. Human autonomic parameters, i.e. blood pressure, pulse rate, breathing rate, and skin temperature, were recorded as indicators of the arousal level of the autonomic nervous system. In addition, subjects had to rate their emotional condition in terms of relaxation, vigor, calmness, attentiveness, mood, and alertness in order to assess subjective behavioral arousal. Forty healthy volunteers participated in the experiments. Blended essential oil was applied topically to the skin of the abdomen of each subject. Compared with placebo, blended essential oil caused significant decreases of pulse rate, and systolic and diastolic blood pressure, which indicated a decrease of autonomic arousal. At the emotional level, subjects in the blended essential oil group rated themselves as 'more calm' and 'more relaxed' than subjects in the control group. This finding suggests a decrease of subjective behavioral arousal. In conclusion, our investigation demonstrates the relaxing effect of a mixture of lavender and bergamot oils. This synergistic blend provides evidence for its use in medicine for treating depression or anxiety in humans.

Discomfort Evaluation of Truck Ingress/Egress Motions Based on Biomechanical Analysis

PubMed Central

Choi, Nam-Chul; Lee, Sang Hun

2015-01-01

This paper presents a quantitative discomfort evaluation method based on biomechanical analysis results for human body movement, as well as its application to an assessment of the discomfort for truck ingress and egress. In this study, the motions of a human subject entering and exiting truck cabins with different types, numbers, and heights of footsteps were first measured using an optical motion capture system and load sensors. Next, the maximum voluntary contraction (MVC) ratios of the muscles were calculated through a biomechanical analysis of the musculoskeletal human model for the captured motion. Finally, the objective discomfort was evaluated using the proposed discomfort model based on the MVC ratios. To validate this new discomfort assessment method, human subject experiments were performed to investigate the subjective discomfort levels through a questionnaire for comparison with the objective discomfort levels. The validation results showed that the correlation between the objective and subjective discomforts was significant and could be described by a linear regression model. PMID:26067194

Human subjects in dental research: coping with the regulations. Council on Dental Research.

PubMed

Gibson, W A

1985-02-01

The rules and regulations pertaining to human subjects in research have evolved in response to ethical concerns for the protection of the rights and welfare of such subjects. However, investigators quite often are not well informed on what is required of them in the conduct of their clinical studies. Failure to be provided with sufficient information may be part of the problem, but the nature of such rules and regulations and their diversity and complexity certainly are sources of confusion. This article presents an overview of some of the major components and processes involved in the implementation of the federal regulations. It is hoped that this presentation will lead to a better understanding of the roles of the investigator, the institutional review boards, and the institutional and the federal agencies involved in the protection of human research subjects.

14 CFR § 1230.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-01-01

... of involving human subjects. § 1230.119 Section § 1230.119 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS (Eff. until 2-14-14) § 1230.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

Vestibulosympathetic reflex during orthostatic challenge in aging humans

NASA Technical Reports Server (NTRS)

Monahan, Kevin D.; Ray, Chester A.

2002-01-01

Aging attenuates the increase in muscle sympathetic nerve activity (MSNA) and elicits hypotension during otolith organ engagement in humans. The purpose of the present study was to determine the neural and cardiovascular responses to otolithic engagement during orthostatic stress in older adults. We hypothesized that age-related impairments in the vestibulosympathetic reflex would persist during orthostatic challenge in older subjects and might compromise arterial blood pressure regulation. MSNA, arterial blood pressure, and heart rate responses to head-down rotation (HDR) performed with and without lower body negative pressure (LBNP) in prone subjects were measured. Ten young (27 +/- 1 yr) and 11 older subjects (64 +/- 1 yr) were studied prospectively. HDR performed alone elicited an attenuated increase in MSNA in older subjects (Delta106 +/- 28 vs. Delta20 +/- 7% for young and older subjects). HDR performed during simultaneous orthostatic stress increased total MSNA further in young (Delta53 +/- 15%; P < 0.05) but not older subjects (Delta-5 +/- 4%). Older subjects demonstrated consistent significant hypotension during HDR performed both alone (Delta-6 +/- 2 mmHg) and during LBNP (Delta-7 +/- 2 mmHg). These data provide experimental support for the concept that age-related impairments in the vestibulosympathetic reflex persist during orthostatic challenge in older adults. Furthermore, these findings are consistent with the concept that age-related alterations in vestibular function might contribute to altered orthostatic blood pressure regulation with age in humans.

Comparative performance and complementarity of four sampling methods and arthropod preference tests from human and porcine remains at the Forensic Anthropology Center in Knoxville, Tennessee.

PubMed

Schoenly, Kenneth G; Haskell, Neal H; Hall, Robert D; Gbur, J Robert

2007-09-01

Comparative performance and complementarity tests of four arthropod sampling methods (aerial netting, hand collection, pitfall traps, and sticky traps), used by forensic entomologists in death investigations, training workshops, and research trials, were conducted from simultaneously placed human and porcine subjects inside the Forensic Anthropology Center at the University of Tennessee, Knoxville, TN. A secondary aim investigated the widely held claim that pig carcasses are reliable surrogates for human corpses. Over a 35-d period in summer 1989, >72,000 invertebrates from three subjects (one human, two pigs) were sampled of which 93% were members of the forensically important (FI) fauna. Performance tests revealed that hand collections, when performed by an experienced forensic entomologist, consistently yielded the largest fraction of FI arthropods from the total invertebrate catch, followed by aerial netting, sticky traps, and pitfall traps, regardless of subject. Pitfall traps and hand collections were broadly effective at sampling both fly and beetle populations, whereas aerial netting and sticky traps mostly targeted flies. The best two-method combination, based on the highest combined catches of FI taxa, were hand collections and pitfall traps, regardless of subject. Between-subject comparisons revealed negligible preference by FI arthropods for human over pig remains. Insofar as our limited comparisons allow with only three study subjects, these results validated the concept of transferability of "best practices" from one subject to another and confirmed the claim that pig carcasses (of 23-27-kg starting mass) can substitute for human corpses in research and training programs, at least for summer-exposed and unconcealed remains in the first 5 wk postmortem.

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

PubMed

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.

40 CFR 26.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or... policy, no investigator may involve a human being as a subject in research covered by this policy unless... subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently...

Microstructural changes in the substantia nigra of asymptomatic agricultural workers.

PubMed

Du, Guangwei; Lewis, Mechelle M; Sterling, Nicholas W; Kong, Lan; Chen, Honglei; Mailman, Richard B; Huang, Xuemei

2014-01-01

Parkinson's disease (PD) is marked by the loss of dopamine neurons in the substantia nigra (SN). Although the exact etiology is unknown, sporadic PD is hypothesized to be a result of genetic susceptibility interacting with environmental insult. Epidemiological studies suggest that pesticide exposure is linked to higher PD risk, but there are no studies demonstrating SN changes with chronic pesticide exposure in human subjects. Thus, high resolution T2-weighted magnetic resonance imaging (MRI) and diffusion tensor (DTI) images were obtained from 12 agricultural workers with chronic pesticide exposure, 12 controls, and 12 PD subjects. Neither controls nor pesticide-exposed subjects, had any parkinsonian symptoms. Exposure history to pesticides was assessed by a structured questionnaire. DTI measures in the SN, including fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD), and radial diffusivity (RD), were obtained for all subjects and compared among groups. Compared to controls, PD patients showed the expected significant changes in all DTI measurements in the SN. The pesticide-exposed subjects, compared to controls, had significantly lower FA values (p=0.022, after multiple comparisons correction), but no significant differences in RD, MD, or AD measures. The study is the first to demonstrate microstructural changes in the SN of human subjects with chronic pesticide exposure. The changes detected by MRI may mark "one of the hits" leading to PD, and underlie the increased risk of PD in pesticide users found in epidemiological studies. Further human studies assisted by these imaging markers may be useful in understanding the etiology of PD. Copyright © 2013 Elsevier Inc. All rights reserved.

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

Code of Federal Regulations, 2010 CFR

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...

An ultrastructural study of the effect of neomycin on the colon in the human subject and in the conventional and the germ-free mouse.

PubMed

Aluwihare, A P

1971-05-01

An electron microscopic study of the colon of normal mice and human subjects and those treated with neomycin is reported; there is a close resemblance between the mouse and human colons. After rapid disinfection of the colon, there is epithelial cell damage due to a toxic effect of the drug, a reduction in epithelial turnover accompanying the change in flora, and an important reduction in the cellularity of the lamina propria mainly due to a reduction in inflammatory cells. The changes in the lamina propria probably represent changes in the antipathogenetic defences of the host.

No auditory experience, no tinnitus: Lessons from subjects with congenital- and acquired single-sided deafness.

PubMed

Lee, Sang-Yeon; Nam, Dong Woo; Koo, Ja-Won; De Ridder, Dirk; Vanneste, Sven; Song, Jae-Jin

2017-10-01

Recent studies have adopted the Bayesian brain model to explain the generation of tinnitus in subjects with auditory deafferentation. That is, as the human brain works in a Bayesian manner to reduce environmental uncertainty, missing auditory information due to hearing loss may cause auditory phantom percepts, i.e., tinnitus. This type of deafferentation-induced auditory phantom percept should be preceded by auditory experience because the fill-in phenomenon, namely tinnitus, is based upon auditory prediction and the resultant prediction error. For example, a recent animal study observed the absence of tinnitus in cats with congenital single-sided deafness (SSD; Eggermont and Kral, Hear Res 2016). However, no human studies have investigated the presence and characteristics of tinnitus in subjects with congenital SSD. Thus, the present study sought to reveal differences in the generation of tinnitus between subjects with congenital SSD and those with acquired SSD to evaluate the replicability of previous animal studies. This study enrolled 20 subjects with congenital SSD and 44 subjects with acquired SSD and examined the presence and characteristics of tinnitus in the groups. None of the 20 subjects with congenital SSD perceived tinnitus on the affected side, whereas 30 of 44 subjects with acquired SSD experienced tinnitus on the affected side. Additionally, there were significant positive correlations between tinnitus characteristics and the audiometric characteristics of the SSD. In accordance with the findings of the recent animal study, tinnitus was absent in subjects with congenital SSD, but relatively frequent in subjects with acquired SSD, which suggests that the development of tinnitus should be preceded by auditory experience. In other words, subjects with profound congenital peripheral deafferentation do not develop auditory phantom percepts because no auditory predictions are available from the Bayesian brain. Copyright © 2017 Elsevier B.V. All rights reserved.

[Activities of Psychology Dept., California Univ.

NASA Technical Reports Server (NTRS)

Bridgeman, Bruce

1998-01-01

We have completed two studies during the grant period, with manuscripts published or ready for submission for publication: (1) Dual adaptation and adaptive generalization in the human vestibuloocular reflex and (2) Frequency vs. acceleration specificity in human VOR adaptation. In the 1st study two studies examined the possibility that rotational VOR plasticity is subject to dual adaptation and adaptive generalization. Subjects in the experimental condition were exposed to an altered visual-vestibular environment for about four minutes every day for five consecutive days. The working hours between these testing sessions constituted re-exposure to the normal visual environment. Thus, subjects were repeatedly adapting and re-adapting to both environments which is a condition designed to produce dual adaptation. In each training session a measure of baseline VOR gain was obtained (in the dark). A small laser spot (the only visual stimulus) was systematically moved in the same direction as the subject's head, but by half the angle of rotation (target/head gain = 0.5). This resulted in adaptation values relativized to the non-adapted gain of each subject. These values were then analyzed using an analysis of variance with day and session (within a day) as factors. In the 2nd study human VOR adaption has been assumed to be frequency specific, despite the fact that the semicircular canals are simulated by rotational acceleration and not frequency per se.

Prodromal disease: Immune responses of the host macrophage system to humoral factors

NASA Technical Reports Server (NTRS)

Criswell, B. S.; Knight, V.

1973-01-01

A composite is presented of nine studies, each yielding information contributing toward an understanding of methods designed to detect disease during the prodromal stages. The data further point to new areas of study that might be useful in early diagnoses. Five of the none experiments were done in mice. Four of these involved acute infectious disease states and one involved a chronic autoimmune type disease. Of the numerous perimeters studied of the acute diseases, the uptake of H3- thymidine by peripheral blood lymphocytes appeared to yield the earliest indication of disease. This test was not useful in studying the chronic disease state. Four of the nine studies involved application of diagnostic technics to human disease. A normal baseline for H3-thymidine incorporation by human lymphocytes was determined. A subject with severe combined immunodeficiency disease was studied. A human volunteer study was done using Influenza A live attenuated vaccine. Finally, a human volunteer study of subjects infected with Influenza A was done.

Human-robot interaction: kinematics and muscle activity inside a powered compliant knee exoskeleton.

PubMed

Knaepen, Kristel; Beyl, Pieter; Duerinck, Saartje; Hagman, Friso; Lefeber, Dirk; Meeusen, Romain

2014-11-01

Until today it is not entirely clear how humans interact with automated gait rehabilitation devices and how we can, based on that interaction, maximize the effectiveness of these exoskeletons. The goal of this study was to gain knowledge on the human-robot interaction, in terms of kinematics and muscle activity, between a healthy human motor system and a powered knee exoskeleton (i.e., KNEXO). Therefore, temporal and spatial gait parameters, human joint kinematics, exoskeleton kinetics and muscle activity during four different walking trials in 10 healthy male subjects were studied. Healthy subjects can walk with KNEXO in patient-in-charge mode with some slight constraints in kinematics and muscle activity primarily due to inertia of the device. Yet, during robot-in-charge walking the muscular constraints are reversed by adding positive power to the leg swing, compensating in part this inertia. Next to that, KNEXO accurately records and replays the right knee kinematics meaning that subject-specific trajectories can be implemented as a target trajectory during assisted walking. No significant differences in the human response to the interaction with KNEXO in low and high compliant assistance could be pointed out. This is in contradiction with our hypothesis that muscle activity would decrease with increasing assistance. It seems that the differences between the parameter settings of low and high compliant control might not be sufficient to observe clear effects in healthy subjects. Moreover, we should take into account that KNEXO is a unilateral, 1 degree-of-freedom device.

A study of the human skin-whitening effects of resveratryl triacetate.

PubMed

Ryu, Ja Hyun; Seok, Jin Kyung; An, Sang Mi; Baek, Ji Hwoon; Koh, Jae Sook; Boo, Yong Chool

2015-04-01

Resveratrol has a variety of bioactivities that include its anti-melanogenic effects, but its use in cosmetics has been challenging partly because of its chemical instability. Resveratryl triacetate (RTA) is a prodrug that can enhance stability. The purpose of this study was to examine the skin safety and whitening effects of RTA in human subjects. The primary skin irritation potentials of RTA and resveratrol were tested at 0.1 and 0.5 % on human subjects. Resveratrol at a concentration of 0.5 % induced weak skin irritation, whereas RTA did not induce any skin responses. The skin-whitening efficacy of a cosmetic formulation containing 0.4 % RTA was evaluated in two different test models. In the artificial tanning model, the test product and the control product were applied twice daily to the skin of the forearms of 22 human subjects after pigmentation induction by ultraviolet irradiation. Applying the test and the control products to the artificial tanning model for 8 weeks increased the individual topology angles (ITA°) by 17.06 and 13.81 %, respectively, a difference that was statistically significant (p < 0.05). In the hyperpigmentation model, the test product and the control product were applied twice daily to the faces of 21 human subjects. The averaged intensity of the hyperpigmented spots decreased by 2.67 % in the test group and 1.46 % in the control group, a difference that was statistically significant (p < 0.05). Therefore, RTA incorporated into cosmetic formulations can whiten human skin without inducing skin irritation.

Human body odour, symmetry and attractiveness.

PubMed Central

Rikowski, A; Grammer, K

1999-01-01

Several studies have found body and facial symmetry as well as attractiveness to be human mate choice criteria. These characteristics are presumed to signal developmental stability. Human body odour has been shown to influence female mate choice depending on the immune system, but the question of whether smell could signal general mate quality, as do other cues, was not addressed in previous studies. We compared ratings of body odour, attractiveness, and measurements of facial and body asymmetry of 16 male and 19 female subjects. Subjects wore a T-shirt for three consecutive nights under controlled conditions. Opposite-sex raters judged the odour of the T-shirts and another group evaluated portraits of the subjects for attractiveness. We measured seven bilateral traits of the subject's body to assess body asymmetry. Facial asymmetry was examined by distance measurements of portrait photographs. The results showed a significant positive correlation between facial attractiveness and sexiness of body odour for female subjects. We found positive relationships between body odour and attractiveness and negative ones between smell and body asymmetry for males only if female odour raters were in the most fertile phase of their menstrual cycle. The outcomes are discussed in the light of different male and female reproductive strategies. PMID:10380676

Rifaximin Reduces the Number and Severity of Intestinal Lesions Associated With Use of Nonsteroidal Anti-Inflammatory Drugs in Humans.

PubMed

Scarpignato, Carmelo; Dolak, Werner; Lanas, Angel; Matzneller, Peter; Renzulli, Cecilia; Grimaldi, Maria; Zeitlinger, Markus; Bjarnason, Ingvar

2017-04-01

The intestinal microbiota might contribute to enteropathy associated with use of nonsteroidal anti-inflammatory drugs (NSAIDs), but there have been few human studies of this association. We performed a placebo-controlled study to determine whether a delayed-release antibiotic formulation (rifaximin-extended intestinal release [EIR]) prevents the development of intestinal lesions in subjects taking daily NSAIDs. Sixty healthy volunteers (median age, 26 y; 42% female) were given the NSAID diclofenac (75 mg twice daily) plus omeprazole (20 mg once daily), and either rifaximin-EIR (400 mg) or placebo, twice daily for 14 days. Subjects were assessed by videocapsule endoscopy at baseline and after 2 weeks of treatment. The primary end point was the proportion of subjects developing at least 1 small-bowel mucosal break at week 2. Secondary end points were the change in the mean number of mucosal lesions and the number of subjects with large erosions and/or ulcers after 14 days of exposure. We detected mucosal breaks in 20% of subjects given rifaximin and in 43% of subjects given placebo (P = .05 in the post hoc sensitivity analysis). None of the subjects in the rifaximin group developed large lesions, compared with 9 subjects in the placebo group (P < .001). Our findings indicate that intestinal bacteria contribute to the development of NSAID-associated enteropathy in human beings. Clinical trial no: EudraCT 2013-000730-36. Copyright © 2017. Published by Elsevier Inc.

Genetic Variations in the Human Cannabinoid Receptor Gene Are Associated with Happiness

PubMed Central

Matsunaga, Masahiro; Isowa, Tokiko; Yamakawa, Kaori; Fukuyama, Seisuke; Shinoda, Jun; Yamada, Jitsuhiro; Ohira, Hideki

2014-01-01

Happiness has been viewed as a temporary emotional state (e.g., pleasure) and a relatively stable state of being happy (subjective happiness level). As previous studies demonstrated that individuals with high subjective happiness level rated their current affective states more positively when they experience positive events, these two aspects of happiness are interrelated. According to a recent neuroimaging study, the cytosine to thymine single-nucleotide polymorphism of the human cannabinoid receptor 1 gene is associated with sensitivity to positive emotional stimuli. Thus, we hypothesized that our genetic traits, such as the human cannabinoid receptor 1 genotypes, are closely related to the two aspects of happiness. In Experiment 1, 198 healthy volunteers were used to compare the subjective happiness level between cytosine allele carriers and thymine-thymine carriers of the human cannabinoid receptor 1 gene. In Experiment 2, we used positron emission tomography with 20 healthy participants to compare the brain responses to positive emotional stimuli of cytosine allele carriers to that of thymine-thymine carriers. Compared to thymine-thymine carriers, cytosine allele carriers have a higher subjective happiness level. Regression analysis indicated that the cytosine allele is significantly associated with subjective happiness level. The positive mood after watching a positive film was significantly higher for the cytosine allele carriers compared to the thymine-thymine carriers. Positive emotion-related brain region such as the medial prefrontal cortex was significantly activated when the cytosine allele carriers watched the positive film compared to the thymine-thymine carriers. Thus, the human cannabinoid receptor 1 genotypes are closely related to two aspects of happiness. Compared to thymine-thymine carriers, the cytosine allele carriers of the human cannabinoid receptor 1 gene, who are sensitive to positive emotional stimuli, exhibited greater magnitude positive emotions when they experienced positive events and had a higher subjective happiness level. PMID:24690898

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-05

... soliciting nominations of people qualified in the areas of bioethics, biostatistics, human health risk... nominations of individuals with expertise in bioethics, biostatistics, human health risk assessment and/or... of the following areas: Bioethics: expertise in the ethics of research with human subjects...

10 CFR 35.604 - Surveys of patients and human research subjects treated with a remote afterloader unit.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Surveys of patients and human research subjects treated... Stereotactic Radiosurgery Units § 35.604 Surveys of patients and human research subjects treated with a remote... shall survey the patient or the human research subject and the remote afterloader unit with a portable...

10 CFR 35.604 - Surveys of patients and human research subjects treated with a remote afterloader unit.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Surveys of patients and human research subjects treated... Stereotactic Radiosurgery Units § 35.604 Surveys of patients and human research subjects treated with a remote... shall survey the patient or the human research subject and the remote afterloader unit with a portable...

10 CFR 35.604 - Surveys of patients and human research subjects treated with a remote afterloader unit.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Surveys of patients and human research subjects treated... Stereotactic Radiosurgery Units § 35.604 Surveys of patients and human research subjects treated with a remote... shall survey the patient or the human research subject and the remote afterloader unit with a portable...

10 CFR 35.604 - Surveys of patients and human research subjects treated with a remote afterloader unit.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Surveys of patients and human research subjects treated... Stereotactic Radiosurgery Units § 35.604 Surveys of patients and human research subjects treated with a remote... shall survey the patient or the human research subject and the remote afterloader unit with a portable...

10 CFR 35.604 - Surveys of patients and human research subjects treated with a remote afterloader unit.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Surveys of patients and human research subjects treated... Stereotactic Radiosurgery Units § 35.604 Surveys of patients and human research subjects treated with a remote... shall survey the patient or the human research subject and the remote afterloader unit with a portable...

Stimulating effect of aromatherapy massage with jasmine oil.

PubMed

Hongratanaworakit, Tapanee

2010-01-01

The aim of this study was to investigate the effect of aromatherapy massage with jasmine oil (Jasminum sambac L., Oleaceae) on humans. Human autonomic parameters, i.e. blood pressure, pulse rate, blood oxygen saturation, breathing rate, and skin temperature, were recorded as indicators of the arousal level of the autonomic nervous system. In addition, subjects had to rate their emotional condition in terms of relaxation, vigor, calmness, attentiveness, mood, and alertness in order to assess subjective behavioral arousal. Forty healthy volunteers participated in the experiments. Jasmine oil was applied topically to the skin of the abdomen of each subject. Compared with placebo, jasmine oil caused significant increases of breathing rate, blood oxygen saturation, and systolic and diastolic blood pressure, which indicated an increase of autonomic arousal. At the emotional level, subjects in the jasmine oil group rated themselves as more alert, more vigorous and less relaxed than subjects in the control group. This finding suggests an increase of subjective behavioral arousal. In conclusion, our results demonstrated the stimulating/activating effect of jasmine oil and provide evidence for its use in aromatherapy for the relief of depression and uplifting mood in humans.

Effects of Inhibition of Interleukin-6 Signalling on Insulin Sensitivity and Lipoprotein (A) Levels in Human Subjects with Rheumatoid Diseases

PubMed Central

Schultz, Olaf; Oberhauser, Frank; Saech, Jasemine; Rubbert-Roth, Andrea; Hahn, Moritz; Krone, Wilhelm; Laudes, Matthias

2010-01-01

Background Interleukin-6 (IL-6) is a pro-inflammatory cytokine that has been found to be increased in type 2 diabetic subjects. However, it still remains unclear if these elevated IL-6 levels are co-incidental or if this cytokine is causally related to the development of insulin resistance and type 2 diabetes in humans. Therefore, in the present study we examined insulin sensitivity, serum adipokine levels and lipid parameters in human subjects before and after treatment with the IL-6 receptor antibody Tocilizumab. Methodology/Principal Findings 11 non-diabetic patients with rheumatoid disease were included in the study. HOMA-IR was calculated and serum levels for leptin, adiponectin, triglycerides, LDL-cholesterol, HDL-cholesterol and lipoprotein (a) (Lp (a)) were measured before as well as one and three months after Tocilizumab treatment. The HOMA index for insulin resistance decreased significantly. While leptin concentrations were not altered by inhibition of IL-6 signalling, adiponectin concentrations significantly increased. Thus the leptin to adiponectin ratio, a novel marker for insulin resistance, exhibited a significant decrease. Serum triglycerides, LDL-cholesterol and HDL-cholesterol tended to be increased whereas Lp (a) levels significantly decreased. Conclusions/Significance Inhibition of IL-6 signalling improves insulin sensitivity in humans with immunological disease suggesting that elevated IL-6 levels in type 2 diabetic subjects might be causally involved in the pathogenesis of insulin resistance. Furthermore, our data indicate that inhibition of IL-6 signalling decreases Lp (a) serum levels, which might reduce the cardiovascular risk of human subjects. PMID:21179199

45 CFR 46.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 1 2012-10-01 2012-10-01 false Research undertaken without the intention of involving human subjects. 46.119 Section 46.119 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research...

Combined effect of whole-body vibration and ambient lighting on human discomfort, heart rate, and reaction time.

PubMed

Monazzam, Mohammad Reza; Shoja, Esmaeil; Zakerian, Seyed Abolfazl; Foroushani, Abbas Rahimi; Shoja, Mohsen; Gharaee, Masoumeh; Asgari, Amin

2018-07-01

This study aimed to investigate the effect of whole-body vibration and ambient lighting, as well as their combined effect on human discomfort, heart rate, and reaction time in laboratory conditions. 44 men were recruited with an average age of 25.4 ± 1.9 years. Each participant was subjected to 12 experimental steps, each step lasting five minutes for four different vibration accelerations in X, Y, and Z axes at a fixed frequency; three different lighting intensities of 50, 500, and 1000 lx were also considered. At each step, a visual computerized reaction test was taken from subjects and their heart rate recorded by pulse oximeter. In addition, the discomfort rate of subjects was measured using Borg scale. Increasing vibration acceleration significantly increased the discomfort rate and heart beat but not the reaction time. Lack of lighting caused more discomfort in the subjects, but there was no significant correlation between lighting intensity with heart rate and reaction time. The results also showed that the combined effect of vibration and lighting had no significant effect on any of the discomfort, heart rate, and reaction time variables. Whole-body vibration is an important factor in the development of human subjective and physiological reactions compared to lighting. Therefore, consideration of the level of vibration to which an individual is exposed in workplaces subject to vibration plays an important role in reducing the level of human discomfort, but its interaction with ambient lighting does not have a significant effect on human subjective and physiological responses.

Modulation of induced gamma band activity in the human EEG by attention and visual information processing.

PubMed

Müller, M M; Gruber, T; Keil, A

2000-12-01

Here we present a series of four studies aimed to investigate the link between induced gamma band activity in the human EEG and visual information processing. We demonstrated and validated the modulation of spectral gamma band power by spatial selective visual attention. When subjects attended to a certain stimulus, spectral power was increased as compared to when the same stimulus was ignored. In addition, we showed a shift in spectral gamma band power increase to the contralateral hemisphere when subjects shifted their attention to one visual hemifield. The following study investigated induced gamma band activity and the perception of a Gestalt. Ambiguous rotating figures were used to operationalize the law of good figure (gute Gestalt). We found increased gamma band power at posterior electrode sites when subjects perceived an object. In the last experiment we demonstrated a differential hemispheric gamma band activation when subjects were confronted with emotional pictures. Results of the present experiments in combination with other studies presented in this volume are supportive for the notion that induced gamma band activity in the human EEG is closely related to visual information processing and attentional perceptual mechanisms.

Ethical Considerations in Human Movement Research.

ERIC Educational Resources Information Center

Olivier, Steve

1995-01-01

Highlights ethical issues for human subject research, identifying principles that form the construct of a code of research ethics and evaluating against this construct past human experimentation and current research in human movement studies. The efficacy of legislation and self-regulation is examined. Particular attention is given to the context…

34 CFR 97.101 - To what does this policy apply?

Code of Federal Regulations, 2014 CFR

2014-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.101... applies to all research involving human subjects conducted, supported or otherwise subject to regulation...

34 CFR 97.101 - To what does this policy apply?

Code of Federal Regulations, 2010 CFR

2010-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.101... applies to all research involving human subjects conducted, supported or otherwise subject to regulation...

34 CFR 97.101 - To what does this policy apply?

Code of Federal Regulations, 2012 CFR

2012-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.101... applies to all research involving human subjects conducted, supported or otherwise subject to regulation...

34 CFR 97.101 - To what does this policy apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.101... applies to all research involving human subjects conducted, supported or otherwise subject to regulation...

34 CFR 97.101 - To what does this policy apply?

Code of Federal Regulations, 2013 CFR

2013-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.101... applies to all research involving human subjects conducted, supported or otherwise subject to regulation...

Lifestyle and geographic insights into the distinct gut microbiota in elderly women from two different geographic locations.

PubMed

Shin, Ji-Hee; Sim, Minju; Lee, Joo-Young; Shin, Dong-Mi

2016-12-12

A large number of microorganisms reside within the gastrointestinal tract, especially in the colon, and play important roles in human health and disease. The composition of the human gut microbiota is determined by intrinsic host factors and environmental factors. While investigating environmental factors to promote human health is of great interest, few studies have focused on their effect on the gut microbiota. This study aimed to investigate differences in gut microbiota composition according to lifestyle and geographical area, even in people with similar genetic background. We enrolled ten and nine elderly women in their seventies from island and inland areas, respectively. Fecal samples were obtained from individuals, and bacterial 16S ribosomal RNA genes were analyzed by next-generation sequencing to define the gut microbiota composition. We assessed their diet, which can influence the gut microbial community. We also conducted physical examination and determined the physical activity levels of the subjects. The inland subjects had a significantly higher rectal temperature, systolic blood pressure, and heart rate and a significantly lower physical activity score than the island subjects. Fecal samples from the island group showed a tendency to have greater microbial diversity than those from the inland group. Interestingly, the microbial community composition differed significantly between the two groups. Catenibacterium was enriched in subjects from the island area. Catenibacterium showed a negative correlation with rectal temperature and a positive correlation with the dietary level of animal fat. In contrast, Butyricimonas was enriched in the inland subjects. A positive correlation was found between Butyricimonas and mean arterial pressure. This study identified differences in the gut microbiota composition between elderly women from different parts of South Korea, and our findings suggest that further studies of the human gut microbiota should evaluate aspects of the living environment.

Heparin binding epidermal growth factor in renal ischaemia/reperfusion injury.

PubMed

Mulder, Gemma M; Nijboer, Willemijn N; Seelen, Marc A; Sandovici, Maria; Bos, Eelke M; Melenhorst, Wynand B W H; Trzpis, Monika; Kloosterhuis, Niels J; Visser, Lydia; Henning, Rob H; Leuvenink, Henri G D; Ploeg, Rutger J; Sunnarborg, Susan W; van Goor, Harry

2010-06-01

The epidermal growth factor (EGF) receptor and its ligands are crucially involved in the renal response to ischaemia. We studied the heparin binding-epidermal growth factor (HB-EGF), a major ligand for the EGF receptor, in experimental and human ischaemia/reperfusion injury (IRI). HB-EGF mRNA and protein expression was studied in rat kidneys and cultured human tubular (HK-2) cells that were subjected to IRI and in human donor kidneys during transplantation. The effect of EGF receptor inhibition was investigated in vivo and in vitro. Furthermore, urinary HB-EGF protein excretion was studied after renal transplantation. Finally, HB-EGF KO and WT mice were subjected to IRI to study the role of HB-EGF in renal injury. HB-EGF mRNA was significantly up-regulated in the early phase of IRI in rats, cells, and human donor biopsies. Treatment with PKI-166 reduces macrophage accumulation and interstitial alpha-SMA in the early phase of IRI in rats. In vitro, PKI-166 causes a marked reduction in HB-EGF-induced cellular proliferation. Urinary HB-EGF is increased after transplantation compared with control urines from healthy subjects. HB-EGF KO mice subjected to IRI revealed significantly less morphological damage after IRI, compared with WT mice. We conclude that IRI results in early induction of HB-EGF mRNA and protein in vivo and in vitro. Absence of HB-EGF and inhibition of the EGF receptor in the early phase of IRI has protective effects, suggesting a modulating role for HB-EGF.

Human infection by Brucella melitensis: an outbreak attributed to contact with infected goats.

PubMed

Wallach, J C; Samartino, L E; Efron, A; Baldi, P C

1997-12-01

Although several outbreaks of Brucella melitensis infection have been reported among laboratory workers or goat cheese consumers, outbreaks related to rural labour have been rarely studied. An outbreak of human brucellosis among farm workers of Argentina was studied and revealed a close relationship with an epidemic of caprine abortions which occurred shortly before on the same farm. High rates of B. melitensis infection were found among goats. Active brucellosis was diagnosed in 33 subjects (14 with positive blood culture for B. melitensis), while other 27 did not show evidence of illness. While 25 of the brucellosis active patients were rural workers, only 5 of the healthy subjects were engaged in rural labour. Active brucellosis was diagnosed in 91.3% of the subjects in continuous contact with goats and in 32% of those having an occasional contact with the animals. All the 60 subjects denied consumption of goat cheese or milk. As shown here, epidemic human infections by B. melitensis may develop among people frequently in contact with infected goat herds or goat manure.

The ethics of HIV research in developing nations.

PubMed

Resnik, David B

1998-10-01

This paper discusses a dispute concerning the ethics of research on preventing the perinatal transmission of HIV in developing nations. Critics of this research argue that it is unethical because it denies a proven treatment to placebo-control groups. Since studies conducted in developed nations would not deny this treatment to subjects, the critics maintain that these experiments manifest a double standard for ethical research and that a single standard of ethics should apply to all research on human subjects. Proponents of the research, however, argue that these charges fail to understand the ethical complexities of research in developing nations, and that study designs can vary according to the social, economic, and scientific conditions of research. This essay explores some of the ethical issues raised by this controversial case in order to shed some light on the deeper, meta-ethical questions. The paper argues that standards of ethical research on human subjects are universal but not absolute: there are some general ethical principles that apply to all cases of human subjects research but the application of these principles must take into account factors inherent in particular situations.

A Study to Investigate the Sleeping Comfort of Mattress using Finite Element Method

NASA Astrophysics Data System (ADS)

Yoshida, Hiroaki; Kamijo, Masayoshi; Shimizu, Yoshio

Sleep is an essential physiological activity for human beings and many studies have so far investigated sleeping comfort of mattresses. The appropriate measurement of stress distribution within the human body would provide valuable information to us. For the appropriate measurement to estimate stress distribution within the human body, numerical analysis is considered one of the most desirable techniques, and Finite Element Method (FEM), which is widely accepted as a useful numerical technique, was utilized in this study. Since human body dimensions have individual differences, however, it is presumed that the way of the internal stress distribution also changes due to the differences and that the mattress preference varies among different body forms. Thus, we developed three human FEM models reproducing the body forms of three types of male subjects, and investigated the sleeping comfort of mattress based on the relationship between FEM analysis findings and sensory testing results. In comparison with the results of both FEM analysis and sensory testing in the neck region, we found, the sensory testing results corresponded to the FEM analysis findings, and it was possible to estimate subjects' preferences of mattress and comfort in the neck region using the FEM analysis. In this study, we believe, the FEM analysis managed to quantify the subjects' preferences for mattress and to prove itself that it is the valuable tools to examine the sleeping comfort of mattress.

Simulations of light effects on the human circadian pacemaker: implications for assessment of intrinsic period

NASA Technical Reports Server (NTRS)

Klerman, E. B.; Dijk, D. J.; Kronauer, R. E.; Czeisler, C. A.

1996-01-01

The sensitivity of the human circadian system to light has been the subject of considerable debate. Using computer simulations of a recent quantitative model for the effects of light on the human circadian system, we investigated these effects of light during different experimental protocols. The results of the simulations indicate that the nonuniform distribution over the circadian cycle of exposure to ordinary room light seen in classical free-run studies, in which subjects select their exposure to light and darkness, can result in an observed period of approximately 25 h, even when the intrinsic period of the subject's endogenous circadian pacemaker is much closer to 24 h. Other simulation results suggest that accurate assessment of the true intrinsic period of the human circadian pacemaker requires low ambient light intensities (approximately 10-15 lx) during scheduled wake episodes, desynchrony of the imposed light-dark cycle from the endogenous circadian oscillator, and a study length of at least 20 days. Although these simulations await further experimental substantiation, they highlight the sensitivity to light of the human circadian system and the potential confounding influence of light on the assessment of the intrinsic period of the circadian pacemaker.

34 CFR 97.109 - IRB review of research.

Code of Federal Regulations, 2010 CFR

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...

Report: Improvements to EPA Policies and Guidance Could Enhance Protection of Human Study Subjects

EPA Pesticide Factsheets

Report #14-P-0154, March 31, 2014. The EPA can enhance its human studies by improving how it obtains approval for studies; how it communicates risk to people who participate in EPA studies; and how it addresses adverse events in its guidance.

Quantitative determination of caffeine and alcohol in energy drinks and the potential to produce positive transdermal alcohol concentrations in human subjects.

PubMed

Ayala, Jessica; Simons, Kelsie; Kerrigan, Sarah

2009-01-01

The purpose of this study was to determine whether non-alcoholic energy drinks could result in positive "alcohol alerts" based on transdermal alcohol concentration (TAC) using a commercially available electrochemical monitoring device. Eleven energy drinks were quantitatively assayed for both ethanol and caffeine. Ethanol concentrations for all of the non-alcoholic energy drinks ranged in concentration from 0.03 to 0.230% (w/v) and caffeine content per 8-oz serving ranged from 65 to 126 mg. A total of 15 human subjects participated in the study. Subjects consumed between 6 and 8 energy drinks over an 8-h period. The SCRAM II monitoring device was used to determine TACs every 30 min before, during, and after the study. None of the subjects produced TAC readings that resulted in positive "alcohol alerts". TAC measurements for all subjects before, during and after the energy drink study period (16 h total) were <0.02% (w/v). Subjects in the study consumed a quantity of non-alcoholic energy drink that greatly exceeds what would be considered typical. Based on these results, it appears that energy drink consumption is an unlikely explanation for elevated TACs that might be identified as potential drinking episodes or "alcohol alerts" using this device.

48 CFR 352.270-4 - Protection of human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... regulatory requirements or ethical issues pertaining to research involving human subjects. (End of provision... 48 Federal Acquisition Regulations System 4 2014-10-01 2014-10-01 false Protection of human subjects. 352.270-4 Section 352.270-4 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES...

48 CFR 352.270-4 - Protection of human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... regulatory requirements or ethical issues pertaining to research involving human subjects. (End of provision... 48 Federal Acquisition Regulations System 4 2013-10-01 2013-10-01 false Protection of human subjects. 352.270-4 Section 352.270-4 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES...

48 CFR 352.270-4 - Protection of human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... regulatory requirements or ethical issues pertaining to research involving human subjects. (End of provision... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Protection of human subjects. 352.270-4 Section 352.270-4 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES...

48 CFR 352.270-4 - Protection of human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... regulatory requirements or ethical issues pertaining to research involving human subjects. (End of provision... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Protection of human subjects. 352.270-4 Section 352.270-4 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES...

48 CFR 352.270-4 - Protection of human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... regulatory requirements or ethical issues pertaining to research involving human subjects. (End of provision... 48 Federal Acquisition Regulations System 4 2012-10-01 2012-10-01 false Protection of human subjects. 352.270-4 Section 352.270-4 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-14

... the basis of animal data or human observational research. (2) Whether the proposed research is... Protections for Subjects in Human Research Involving Pesticides AGENCY: Environmental Protection Agency (EPA... for the protection of human subjects of research applying to third parties who conduct or support...

A putative human pheromone, androstadienone, increases cooperation between men.

PubMed

Huoviala, Paavo; Rantala, Markus J

2013-01-01

Androstadienone, a component of male sweat, has been suggested to function as a human pheromone, an airborne chemical signal causing specific responses in conspecifics. In earlier studies androstadienone has been reported to increase attraction, affect subjects' mood, cortisol levels and activate brain areas linked to social cognition, among other effects. However, the existing psychological evidence is still relatively scarce, especially regarding androstadienone's effects on male behaviour. The purpose of this study was to look for possible behavioural effects in male subjects by combining two previously distinct branches of research: human pheromone research and behavioural game theory of experimental economics. Forty male subjects participated in a mixed-model, double-blind, placebo-controlled experiment. The participants were exposed to either androstadienone or a control stimulus, and participated in ultimatum and dictator games, decision making tasks commonly used to measure cooperation and generosity quantitatively. Furthermore, we measured participants' salivary cortisol and testosterone levels during the experiment. Salivary testosterone levels were found to positively correlate with cooperative behaviour. After controlling for the effects of participants' baseline testosterone levels, androstadienone was found to increase cooperative behaviour in the decision making tasks. To our knowledge, this is the first study to show that androstadienone directly affects behaviour in human males.

Discriminative-Stimulus, Subject-rated and Physiological Effects of Methamphetamine in Humans Pretreated with Aripiprazole

PubMed Central

Sevak, Rajkumar J.; Vansickel, Andrea R.; Stoops, William W.; Glaser, Paul E. A.; Hays, Lon R.; Rush, Craig R.

2013-01-01

Methamphetamine is thought to produce its behavioral effects by releasing dopamine (DA), serotonin (5-HT) and norepinephrine. Results from animal studies support this notion, while results from human laboratory studies have not consistently demonstrated the importance of monoamine systems in the behavioral effects of methamphetamine. Human laboratory procedures of drug-discrimination are well suited to assess neuropharmacological mechanisms of the training drug by studying pharmacological manipulation. In this human laboratory study, six participants with a history of recreational stimulant use learned to discriminate 10 mg oral methamphetamine. After acquiring the discrimination (i.e., ≥80% correct responding on 4 consecutive sessions), the effects of a range of doses of methamphetamine (0, 2.5, 5, 10 and 15 mg), alone and in combination with 0 and 20 mg aripiprazole (a partial agonist at D2 and 5-HT1A receptors), were assessed. Methamphetamine alone functioned as a discriminative stimulus, produced prototypical stimulant-like subject-rated drug effects (e.g., increased ratings of Good Effects, Talkative-Friendly, and Willing to Pay For) and elevated cardiovascular indices. These effects were generally a function of dose. Aripiprazole alone did not occasion methamphetamine-appropriate responding or produce subject-rated effects, but modestly impaired performance. Administration of aripiprazole significantly attenuated the discriminative-stimulus and cardiovascular effects of methamphetamine, as well as some of the subject-rated drug effects. These results indicate that monoamine systems likely play a role in the behavioral effects of methamphetamine in humans. Moreover, given the concordance between past results with d-amphetamine and the present findings, d-amphetamine can likely serve as a model for the pharmacological effects of methamphetamine. PMID:21694622

Human connectome module pattern detection using a new multi-graph MinMax cut model.

PubMed

De, Wang; Wang, Yang; Nie, Feiping; Yan, Jingwen; Cai, Weidong; Saykin, Andrew J; Shen, Li; Huang, Heng

2014-01-01

Many recent scientific efforts have been devoted to constructing the human connectome using Diffusion Tensor Imaging (DTI) data for understanding the large-scale brain networks that underlie higher-level cognition in human. However, suitable computational network analysis tools are still lacking in human connectome research. To address this problem, we propose a novel multi-graph min-max cut model to detect the consistent network modules from the brain connectivity networks of all studied subjects. A new multi-graph MinMax cut model is introduced to solve this challenging computational neuroscience problem and the efficient optimization algorithm is derived. In the identified connectome module patterns, each network module shows similar connectivity patterns in all subjects, which potentially associate to specific brain functions shared by all subjects. We validate our method by analyzing the weighted fiber connectivity networks. The promising empirical results demonstrate the effectiveness of our method.

Mild Normobaric Hypoxia Exposure for Human-Autonomy System Testing

NASA Technical Reports Server (NTRS)

Stephens, Chad L.; Kennedy, Kellie D.; Crook, Brenda L.; Williams, Ralph A.; Schutte, Paul

2017-01-01

An experiment investigated the impact of normobaric hypoxia induction on aircraft pilot performance to specifically evaluate the use of hypoxia as a method to induce mild cognitive impairment to explore human-autonomous systems integration opportunities. Results of this exploratory study show that the effect of 15,000 feet simulated altitude did not induce cognitive deficits as indicated by performance on written, computer-based, or simulated flight tasks. However, the subjective data demonstrated increased effort by the human test subject pilots to maintain equivalent performance in a flight simulation task. This study represents current research intended to add to the current knowledge of performance decrement and pilot workload assessment to improve automation support and increase aviation safety.

A systematic review on human exposure to organophosphorus pesticides in Iran.

PubMed

Shadboorestan, Amir; Vardanjani, Hossein Molavi; Abdollahi, Mohammad; Goharbari, Mohammad Hadi; Khanjani, Narges

2016-07-02

Human exposure to organophosphorus (OP) pesticides is a serious health challenge. We conducted a systematic review by searching international and national databases for published literature on any human exposure to OPs in Iran from 1990 to March 2015. Qualified papers were in two categories including studies in which biomarkers of exposure were assessed (n = 13; total no. of subjects = 759) and studies that had reported prevalence of OPs-induced poisoning (OPP) and mortality (n = 26; total no. of subjects = 5428). The mean level of activity of acetyl-cholinesterase and butyryl-cholinesterase were 68.65% and 74.2%, respectively. Overall proportion (%) of OPP was estimated (16; 95% CI, 14 to 19).

IL-9 expression by human eosinophils: regulation by IL-1beta and TNF-alpha.

PubMed

Gounni, A S; Nutku, E; Koussih, L; Aris, F; Louahed, J; Levitt, R C; Nicolaides, N C; Hamid, Q

2000-09-01

IL-9 is a pleiotropic cytokine that exhibits biologic activity on cells of diverse hemopoietic lineage. IL-9 stimulates the proliferation of activated T cells, enhances the production of IgE from B cells, and promotes the proliferation and differentiation of mast cells and hematopoietic progenitors. In this study we evaluated the expression of IL-9 messenger (m)RNA and protein by human peripheral blood eosinophils. We also investigated the role of IL-1beta and TNF-alpha in the release of IL-9 from human peripheral blood eosinophils. RT-PCR, in situ hybridization, and immunocytochemistry were used to investigate the presence of IL-9 mRNA and protein in human peripheral blood eosinophils from asthmatic patients and normal control subjects. Furthermore, biologic assay was used to investigate the release of IL-9 protein from IL-1beta- or TNF-alpha-stimulated eosinophils in vitro. RT-PCR analysis showed the presence of IL-9 mRNA in human peripheral blood eosinophil RNA preparations from subjects with atopic asthma, as well as in the eosinophil-differentiated HL-60 cell line. By using in situ hybridization, a significant difference (P <.01) in IL-9 mRNA expression was detected in human peripheral blood eosinophils freshly isolated from asthmatic subjects compared with those isolated from normal control subjects. Furthermore, the percentage of IL-9 immunoreactive eosinophils from asthmatic patients was increased compared with that found in normal control subjects (P <.01). We also demonstrate that cultured human peripheral blood eosinophils from asthmatic subjects synthesize and release IL-9 protein, which is upregulated on stimulation with TNF-alpha and IL-1beta. Human eosinophils express biologically active IL-9, which suggests that these cells may influence the recruitment and activation of effector cells linked to the pathogenesis of allergic disease. These observations provide further evidence for the role of eosinophils in regulating airway immune responses.

40 CFR 26.1101 - To what does this subpart apply?

Code of Federal Regulations, 2013 CFR

2013-07-01

... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving... after April 15, 2013 involving intentional exposure of a human subject to: (1) Any substance if, at any... regulations which provide additional protections for human subjects. (f) This subpart does not affect any...

40 CFR 26.1101 - To what does this subpart apply?

Code of Federal Regulations, 2012 CFR

2012-07-01

... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving... initiated after April 7, 2006 involving intentional exposure of a human subject if, at any time prior to... additional protections for human subjects. (e) This subpart does not affect any State or local laws or...

40 CFR 26.1101 - To what does this subpart apply?

Code of Federal Regulations, 2014 CFR

2014-07-01

... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving... after April 15, 2013 involving intentional exposure of a human subject to: (1) Any substance if, at any... regulations which provide additional protections for human subjects. (f) This subpart does not affect any...

40 CFR 26.1101 - To what does this subpart apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving... initiated after April 7, 2006 involving intentional exposure of a human subject if, at any time prior to... additional protections for human subjects. (e) This subpart does not affect any State or local laws or...

34 CFR 97.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Section 97.116 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..., no investigator may involve a human being as a subject in research covered by this policy unless the...

48 CFR 3424.170 - Protection of human subjects.

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2013-10-01

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48 CFR 1523.303-70 - Protection of human subjects.

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2012-10-01

... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Protection of human... Hazardous Material and Material Safety Data 1523.303-70 Protection of human subjects. Contracting Officers shall insert the contract clause at 1552.223-70 when the contract involves human test subjects. ...

48 CFR 3424.170 - Protection of human subjects.

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2012-10-01

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48 CFR 1523.303-70 - Protection of human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Protection of human... Hazardous Material and Material Safety Data 1523.303-70 Protection of human subjects. Contracting Officers shall insert the contract clause at 1552.223-70 when the contract involves human test subjects. ...

48 CFR 3424.170 - Protection of human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 7 2014-10-01 2014-10-01 false Protection of human... Individual Privacy 3424.170 Protection of human subjects. In this subsection, “Research” means a systematic... generalizable knowledge. (34 CFR 97.102(d)) Research is considered to involve human subjects when a researcher...

48 CFR 1523.303-70 - Protection of human subjects.

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2014-10-01

... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Protection of human... Hazardous Material and Material Safety Data 1523.303-70 Protection of human subjects. Contracting Officers shall insert the contract clause at 1552.223-70 when the contract involves human test subjects. ...

48 CFR 1523.303-70 - Protection of human subjects.

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2011-10-01

... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Protection of human... Hazardous Material and Material Safety Data 1523.303-70 Protection of human subjects. Contracting Officers shall insert the contract clause at 1552.223-70 when the contract involves human test subjects. ...

48 CFR 1523.303-70 - Protection of human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

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48 CFR 3424.170 - Protection of human subjects.

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2011-10-01

... 48 Federal Acquisition Regulations System 7 2011-10-01 2011-10-01 false Protection of human... Individual Privacy 3424.170 Protection of human subjects. In this subsection, “Research” means a systematic... generalizable knowledge. (34 CFR 97.102(d)) Research is considered to involve human subjects when a researcher...

48 CFR 1252.223-72 - Protection of human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false Protection of human....223-72 Protection of human subjects. As prescribed in (TAR) 48 CFR 1223.7000(b), insert the following clause: Protection of Human Subjects (APR 2005) The Contractor shall comply with the National Highway...

48 CFR 1252.223-72 - Protection of human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Protection of human....223-72 Protection of human subjects. As prescribed in (TAR) 48 CFR 1223.7000(b), insert the following clause: Protection of Human Subjects (APR 2005) The Contractor shall comply with the National Highway...

48 CFR 1252.223-72 - Protection of human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Protection of human....223-72 Protection of human subjects. As prescribed in (TAR) 48 CFR 1223.7000(b), insert the following clause: Protection of Human Subjects (APR 2005) The Contractor shall comply with the National Highway...

48 CFR 1252.223-72 - Protection of human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

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48 CFR 1252.223-72 - Protection of human subjects.

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2010-10-01

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34 CFR 97.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Section 97.116 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..., no investigator may involve a human being as a subject in research covered by this policy unless the...

Robust estimation of fractal measures for characterizing the structural complexity of the human brain: optimization and reproducibility

PubMed Central

Goñi, Joaquín; Sporns, Olaf; Cheng, Hu; Aznárez-Sanado, Maite; Wang, Yang; Josa, Santiago; Arrondo, Gonzalo; Mathews, Vincent P; Hummer, Tom A; Kronenberger, William G; Avena-Koenigsberger, Andrea; Saykin, Andrew J.; Pastor, María A.

2013-01-01

High-resolution isotropic three-dimensional reconstructions of human brain gray and white matter structures can be characterized to quantify aspects of their shape, volume and topological complexity. In particular, methods based on fractal analysis have been applied in neuroimaging studies to quantify the structural complexity of the brain in both healthy and impaired conditions. The usefulness of such measures for characterizing individual differences in brain structure critically depends on their within-subject reproducibility in order to allow the robust detection of between-subject differences. This study analyzes key analytic parameters of three fractal-based methods that rely on the box-counting algorithm with the aim to maximize within-subject reproducibility of the fractal characterizations of different brain objects, including the pial surface, the cortical ribbon volume, the white matter volume and the grey matter/white matter boundary. Two separate datasets originating from different imaging centers were analyzed, comprising, 50 subjects with three and 24 subjects with four successive scanning sessions per subject, respectively. The reproducibility of fractal measures was statistically assessed by computing their intra-class correlations. Results reveal differences between different fractal estimators and allow the identification of several parameters that are critical for high reproducibility. Highest reproducibility with intra-class correlations in the range of 0.9–0.95 is achieved with the correlation dimension. Further analyses of the fractal dimensions of parcellated cortical and subcortical gray matter regions suggest robustly estimated and region-specific patterns of individual variability. These results are valuable for defining appropriate parameter configurations when studying changes in fractal descriptors of human brain structure, for instance in studies of neurological diseases that do not allow repeated measurements or for disease-course longitudinal studies. PMID:23831414

Dream Deprivation and Facilitation with Hypnosis

ERIC Educational Resources Information Center

Albert, Ira B.; Boone, Donald

1975-01-01

The present study attempted to deprive human subjects of dreaming through the administration of a posthypnotic suggestion and to increase or facilitate dreaming through a second suggestion that was used with another group of subjects. (Author/RK)

Experimental infection of human volunteers with Haemophilus ducreyi: fifteen years of clinical data and experience.

PubMed

Janowicz, Diane M; Ofner, Susan; Katz, Barry P; Spinola, Stanley M

2009-06-01

Haemophilus ducreyi causes chancroid, which facilitates transmission of human immunodeficiency virus type 1. To better understand the biology of H. ducreyi, we developed a human inoculation model. In the present article, we describe clinical outcomes for 267 volunteers who were infected with H. ducreyi. There was a relationship between papule formation and estimated delivered dose. The outcome (either pustule formation or resolution) of infected sites for a given subject was not independent; the most important determinants of pustule formation were sex and host effects. When 41 subjects were infected a second time, their outcomes segregated toward their initial outcome, confirming the host effect. Subjects with pustules developed local symptoms that required withdrawal from the study after a mean of 8.6 days. There were 191 volunteers who had tissue biopsy performed, 173 of whom were available for follow-up analysis; 28 (16.2%) of these developed hypertrophic scars, but the model was otherwise safe. Mutant-parent trials confirmed key features in H. ducreyi pathogenesis, and the model has provided an opportunity to study differential human susceptibility to a bacterial infection.

High prevalence of human parvovirus 4 infection in HBV and HCV infected individuals in shanghai.

PubMed

Yu, Xuelian; Zhang, Jing; Hong, Liang; Wang, Jiayu; Yuan, Zhengan; Zhang, Xi; Ghildyal, Reena

2012-01-01

Human parvovirus 4 (PARV4) has been detected in blood and diverse tissues samples from HIV/AIDS patients who are injecting drug users. Although B19 virus, the best characterized human parvovirus, has been shown to co-infect patients with hepatitis B or hepatitis C virus (HBV, HCV) infection, the association of PARV4 with HBV or HCV infections is still unknown.The aim of this study was to characterise the association of viruses belonging to PARV4 genotype 1 and 2 with chronic HBV and HCV infection in Shanghai.Serum samples of healthy controls, HCV infected subjects and HBV infected subjects were retrieved from Shanghai Center for Disease Control and Prevention (SCDC) Sample Bank. Parvovirus-specific nested-PCR was performed and results confirmed by sequencing. Sequences were compared with reference sequences obtained from Genbank to derive phylogeny trees.The frequency of parvovirus molecular detection was 16-22%, 33% and 41% in healthy controls, HCV infected and HBV infected subjects respectively, with PARV4 being the only parvovirus detected. HCV infected and HBV infected subjects had a significantly higher PARV4 prevalence than the healthy population. No statistical difference was found in PARV4 prevalence between HBV or HCV infected subjects. PARV4 sequence divergence within study groups was similar in healthy subjects, HBV or HCV infected subjects.Our data clearly demonstrate that PARV4 infection is strongly associated with HCV and HBV infection in Shanghai but may not cause increased disease severity.

75 FR 47592 - Final Test Guideline; Product Performance of Skin-applied Insect Repellents of Insect and Other...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

... considerations affecting the design and conduct of repellent studies when human subjects are involved. Any... recommendations for the design and execution of studies to evaluate the performance of pesticide products intended... recommends appropriate study designs and methods for selecting subjects, statistical analysis, and reporting...

Correlation of human S100A12 (EN-RAGE) and high-sensitivity C-reactive protein as gingival crevicular fluid and serum markers of inflammation in chronic periodontitis and type 2 diabetes.

PubMed

Pradeep, A R; Martande, Santosh S; Singh, Sonender Pal; Suke, Deepak Kumar; Raju, Arjun P; Naik, Savitha B

2014-04-01

The aim of the present study was to evaluate the levels and correlation of human S100A12 and high-sensitivity C-reactive protein (hs-CRP) in gingival crevicular fluid (GCF) and serum in chronic periodontitis (CP) subjects with and without type 2 diabetes mellitus (DM). A total of 44 subjects were divided into three groups: group 1 had 10 periodontally healthy subjects, group 2 consisted of 17 CP subjects and group 3 had 17 type 2 DM subjects with CP. GCF and serum levels of human S100A12 and hs-CRP were quantified using enzyme-linked immunosorbent assay and immunoturbidimetric analysis, respectively. The clinical outcomes evaluated were gingival index, probing depth and clinical attachment level and the correlations of the two inflammatory mediators with clinical parameters were evaluated. Both human S100A12 and hs-CRP levels increased from group 1 to group 2 to group 3. The GCF and serum values of both these inflammatory mediators correlated positively with each other and with the periodontal parameters evaluated (p < 0.05). Human S100A12 and hs-CRP can be considered as possible GCF and serum markers of inflammatory activity in CP and DM.

Effects of partner beauty on opposite-sex attractiveness judgments.

PubMed

Little, Anthony C; Caldwell, Christine A; Jones, Benedict C; DeBruine, Lisa M

2011-12-01

Many studies show mate choice copying effects on mate preferences in non-human species in which individuals follow or copy the mate choices of same-sex conspecifics. Recent studies suggest that social learning also influences mate preferences in humans. Studies on heterosexual humans have focused on rating the attractiveness of potential mates (targets) presented alongside individuals of the opposite sex to the target (models). Here, we examined several different types of pairing to examine how specific social learning is to mate preferences. In Study 1, we replicated a previous effect whereby target faces of the opposite sex to the subject were rated as more attractive when paired with attractive than unattractive partner models of the same sex as the subject. Using the same paired stimuli, Study 2 demonstrated no effect of a paired model if subjects were asked to rate targets who were the same sex as themselves. In Study 3, we used pairs of the same sex, stating the pair were friends, and subjects rated targets of the opposite sex to themselves. Attractive models decreased targets' attractiveness, opposite to the effect in Study 1. Finally, Study 4 examined if attractive versus unattractive non-face stimuli might influence attraction. Unlike in Study 1, pairing with attractive stimuli either had no effect or decreased the attractiveness of paired target face images. These data suggest that social transmission of preferences via pairing with attractive/unattractive images is relatively specific to learning about mate preferences but does not influence attractiveness judgments more generally.

40 CFR 26.116 - General requirements for informed consent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... welfare of the subjects; (3) The research could not practicably be carried out without the waiver or... PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or... policy, no investigator may involve a human being as a subject in research covered by this policy unless...

40 CFR 26.116 - General requirements for informed consent.

Code of Federal Regulations, 2013 CFR

2013-07-01

... welfare of the subjects; (3) The research could not practicably be carried out without the waiver or... PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or... policy, no investigator may involve a human being as a subject in research covered by this policy unless...

40 CFR 26.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Applications and proposals lacking definite plans for involvement of human subjects. 26.118 Section 26.118 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects...

Construction and Validation of an Instrument Measuring Attitudes towards Human Rights of Liberal Studies Teachers in Hong Kong

ERIC Educational Resources Information Center

Lo, Yan Lam; Leung, Yan Wing; Chow, Joseph

2015-01-01

In 2009, Liberal Studies, which can be used as a platform for human rights education, was newly introduced as a compulsory subject for the senior secondary students in Hong Kong. As teacher's attitudes impact students' learning largely, a survey was conducted in 2010 to measure Liberal Studies teachers' attitudes towards human rights. This article…

48 CFR 1352.235-71 - Protection of human subjects-exemption.

Code of Federal Regulations, 2014 CFR

2014-10-01

... a systematic investigation, including research development, testing and evaluation, designed to...; (2) Documentation of approval for the human subjects research protocol, questionnaires, surveys... contractor modifies a human subjects research protocol, questionnaire, survey, advertisement, or informed...

48 CFR 1352.235-71 - Protection of human subjects-exemption.

Code of Federal Regulations, 2010 CFR

2010-10-01

... a systematic investigation, including research development, testing and evaluation, designed to...; (2) Documentation of approval for the human subjects research protocol, questionnaires, surveys... contractor modifies a human subjects research protocol, questionnaire, survey, advertisement, or informed...

48 CFR 1352.235-71 - Protection of human subjects-exemption.

Code of Federal Regulations, 2013 CFR

2013-10-01

... a systematic investigation, including research development, testing and evaluation, designed to...; (2) Documentation of approval for the human subjects research protocol, questionnaires, surveys... contractor modifies a human subjects research protocol, questionnaire, survey, advertisement, or informed...

48 CFR 1352.235-71 - Protection of human subjects-exemption.

Code of Federal Regulations, 2011 CFR

2011-10-01

... a systematic investigation, including research development, testing and evaluation, designed to...; (2) Documentation of approval for the human subjects research protocol, questionnaires, surveys... contractor modifies a human subjects research protocol, questionnaire, survey, advertisement, or informed...

48 CFR 1352.235-71 - Protection of human subjects-exemption.

Code of Federal Regulations, 2012 CFR

2012-10-01

... a systematic investigation, including research development, testing and evaluation, designed to...; (2) Documentation of approval for the human subjects research protocol, questionnaires, surveys... contractor modifies a human subjects research protocol, questionnaire, survey, advertisement, or informed...

Effects of income on drug choice in humans.

PubMed Central

DeGrandpre, R J; Bickel, W K; Rizvi, S A; Hughes, J R

1993-01-01

The effects of income (money available to spend during the experimental session) on human choice were examined in a concurrent-schedule arrangement. Subjects were 7 nicotine-dependent smokers, and reinforcers were puffs on the subject's usual brand of cigarette ("own") and puffs on a less preferred brand of cigarette with equal nicotine content ("other"). Across sessions, income varied and the price of the two reinforcers was held constant, with the other puffs one fifth the price of the own puffs. As income increased, consumption of own puffs increased while consumption of the less expensive other puffs decreased. These effects of income on choice were highly consistent across subjects. For some subjects, however, income had little effect on total puff consumption. Finally, an additional condition examined whether price and income manipulations would have functionally equivalent effects on choice by repeating an income condition in which the price of the other brand was increased. Although the increased price of the other puffs decreased their consumption in 4 subjects, 2 subjects showed increased consumption of the other puffs at the higher price. The results, when defined in economic terms, indicate that the own puffs were a normal good (consumption and income are directly related), the other puffs were an inferior good (consumption and income are inversely related), and the direct relationship between consumption of the other puffs and their price is defined as a Giffengood effect. The latter result also suggests that for these 2 subjects, price and income manipulations had equivalent effects on choice. These results extend findings from previous studies that have examined the effects of income on choice responding to human subjects and drug reinforcers, and provide a framework for further experimental tests of the effects of income on human choice behavior. Methodological and theoretical implications for the study of choice and for behavioral pharmacology are discussed. PMID:8315366

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

EPA Pesticide Factsheets

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.

Analysis of spatial mobility in subjects from a Dengue endemic urban locality in Morelos State, Mexico.

PubMed

Falcón-Lezama, Jorge Abelardo; Santos-Luna, René; Román-Pérez, Susana; Martínez-Vega, Ruth Aralí; Herrera-Valdez, Marco Arieli; Kuri-Morales, Ángel Fernando; Adams, Ben; Kuri-Morales, Pablo Antonio; López-Cervantes, Malaquías; Ramos-Castañeda, José

2017-01-01

Mathematical models and field data suggest that human mobility is an important driver for Dengue virus transmission. Nonetheless little is known on this matter due the lack of instruments for precise mobility quantification and study design difficulties. We carried out a cohort-nested, case-control study with 126 individuals (42 cases, 42 intradomestic controls and 42 population controls) with the goal of describing human mobility patterns of recently Dengue virus-infected subjects, and comparing them with those of non-infected subjects living in an urban endemic locality. Mobility was quantified using a GPS-data logger registering waypoints at 60-second intervals for a minimum of 15 natural days. Although absolute displacement was highly biased towards the intradomestic and peridomestic areas, occasional displacements exceeding a 100-Km radius from the center of the studied locality were recorded for all three study groups and individual displacements were recorded traveling across six states from central Mexico. Additionally, cases had a larger number of visits out of the municipality´s administrative limits when compared to intradomestic controls (cases: 10.4 versus intradomestic controls: 2.9, p = 0.0282). We were able to identify extradomestic places within and out of the locality that were independently visited by apparently non-related infected subjects, consistent with houses, working and leisure places. Results of this study show that human mobility in a small urban setting exceeded that considered by local health authority's administrative limits, and was different between recently infected and non-infected subjects living in the same household. These observations provide important insights about the role that human mobility may have in Dengue virus transmission and persistence across endemic geographic areas that need to be taken into account when planning preventive and control measures. Finally, these results are a valuable reference when setting the parameters for future mathematical modeling studies.

Analysis of spatial mobility in subjects from a Dengue endemic urban locality in Morelos State, Mexico

PubMed Central

Falcón-Lezama, Jorge Abelardo; Santos-Luna, René; Román-Pérez, Susana; Martínez-Vega, Ruth Aralí; Herrera-Valdez, Marco Arieli; Kuri-Morales, Ángel Fernando; Adams, Ben; Kuri-Morales, Pablo Antonio; López-Cervantes, Malaquías

2017-01-01

Introduction Mathematical models and field data suggest that human mobility is an important driver for Dengue virus transmission. Nonetheless little is known on this matter due the lack of instruments for precise mobility quantification and study design difficulties. Materials and methods We carried out a cohort-nested, case-control study with 126 individuals (42 cases, 42 intradomestic controls and 42 population controls) with the goal of describing human mobility patterns of recently Dengue virus-infected subjects, and comparing them with those of non-infected subjects living in an urban endemic locality. Mobility was quantified using a GPS-data logger registering waypoints at 60-second intervals for a minimum of 15 natural days. Results Although absolute displacement was highly biased towards the intradomestic and peridomestic areas, occasional displacements exceeding a 100-Km radius from the center of the studied locality were recorded for all three study groups and individual displacements were recorded traveling across six states from central Mexico. Additionally, cases had a larger number of visits out of the municipality´s administrative limits when compared to intradomestic controls (cases: 10.4 versus intradomestic controls: 2.9, p = 0.0282). We were able to identify extradomestic places within and out of the locality that were independently visited by apparently non-related infected subjects, consistent with houses, working and leisure places. Conclusions Results of this study show that human mobility in a small urban setting exceeded that considered by local health authority’s administrative limits, and was different between recently infected and non-infected subjects living in the same household. These observations provide important insights about the role that human mobility may have in Dengue virus transmission and persistence across endemic geographic areas that need to be taken into account when planning preventive and control measures. Finally, these results are a valuable reference when setting the parameters for future mathematical modeling studies. PMID:28225820

Sex Bias Exists in Human Surgical Clinical Research

PubMed Central

Mansukhani, Neel A.; Yoon, Dustin Y.; Teter, Katherine A.; Stubbs, Vanessa C.; Helenowski, Irene B.; Woodruff, Teresa K.; Kibbe, Melina R.

2016-01-01

Importance Sex is a variable that is poorly controlled for in clinical research. Objective Determine if sex bias exists in human surgical clinical research, determine if data are reported and analyzed using sex as an independent variable, and identify specialties where the greatest and least sex biases exist. Design Review and data abstraction from published peer-reviewed manuscripts. Setting All original peer-reviewed manuscripts published in 2011 and 2012 in Annals of Surgery, American Journal of Surgery, JAMA Surgery, Journal of Surgical Research, and Surgery. Main Outcome Measures Study type, location, number and sex of subjects, sex matching, and inclusion of sex-based reporting, statistical analysis, and discussion of data. Results Of 2,347 articles reviewed, 1,668 included human subjects. After excluding 365 articles, 1,303 manuscripts remained: 17 (1%) included only males, 41 (3%) included only females, 1,020 (78%) included males and females, and 225 (17%) did not document the sex of the subjects. While females represent over 50% of the total number of subjects included, considerable variability existed with the number of male, female, and unspecified subjects included among the journals, between US domestic and international studies, and between single versus multi-center studies. For manuscripts included in the study, only 38% reported these data by sex, 33% analyzed these data by sex, and 23% included a discussion of sex-based results. Sex matching of the subjects included in the research was poor, with only 18% of the studies matching the inclusion of both sexes by 80%. Upon analysis of the different surgical specialties, a wide variation in sex-based inclusion, matching, and data reporting existed, with colorectal surgery having the best matching of males and females and cardiac surgery having the worst. Conclusion Our data show that sex bias exists in human surgical clinical research. Few studies included men and women equally, less than one-third performed data analysis by sex, and there was wide variation in inclusion and matching of the sexes among the specialties and the journals reviewed. Because clinical research serves as the foundation for evidence-based medicine, it is imperative that this disparity be addressed so that therapies benefit both sexes. PMID:27551816

76 FR 74691 - Import Restrictions Imposed on Certain Archaeological and Ethnological Material From Greece

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-01

... Statuary--Subject matter is varied and includes human and animal figures, human body parts, groups of..., including fragments of statues. Subject matter includes human and animal figures and groups of figures in... marble and other stone. Subject matter includes human and animal figures and groups of figures in the...

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

Code of Federal Regulations, 2010 CFR

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). ...

An Evolutionary Game Theory Model of Revision-Resistant Motivations and Strategic Reasoning

DTIC Science & Technology

2008-08-01

The model also is consistent with a number of findings on the nature of emotions and related forms of motivation. 15. SUBJECT TERMS...because human beings have some kinds of motivations that are not reducible to the economist’s traditional notion of ordered preferences. These...simulation is designed in light of the most current human subject research on a widely studied game: the Ultimatum Game. This allows us to test

Signal Analysis of Visual Evoked Responses.

DTIC Science & Technology

1983-12-01

T-IE PRO3LEM The interest of the Air Force was in the study of: initially, animal VERs; and, later, human subject VERs. Fo,. obvious reasons, the...data re- oorded from human subjects were restricted to scalp electrode recordings. By ;ontrast, in the animal preparations, epitural bipolar electrode...left em sherechannel # 1 rigt hemisphere_______ _______ channel # 3 HP HPJ HP bT channel # 4 it 5 #t 6 Figure 6.4. Specification of channels. HP

Protections for Subjects in Human Research with Pesticides

EPA Pesticide Factsheets

All pesticide research using human subjects must meet our strict protective standards before we would consider using them in evaluating pesticides. EPA's regulation “Protections for Subjects in Human Research” was promulgated in 2006 and amended in 2013.

45 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human... departments or agencies with the knowledge that subjects may be involved within the period of support, but...

Human figure drawing distinguishes Alzheimer's patients: a cognitive screening test study.

PubMed

Stanzani Maserati, Michelangelo; D'Onofrio, Renato; Matacena, Corrado; Sambati, Luisa; Oppi, Federico; Poda, Roberto; De Matteis, Maddalena; Naldi, Ilaria; Liguori, Rocco; Capellari, Sabina

2018-05-01

To study human figure drawing in a group of Alzheimer's disease (AD) patients and compare it with a group of patients with mild cognitive impairment (MCI) and controls. We evaluated consecutive outpatients over a one-year period. Patients were classified as affected by AD or by MCI. All patients and controls underwent a simplified version of the human-figure drawing test and MMSE. A qualitative and quantitative analysis of all human figures was obtained. 112 AD, 100 MCI patients and 104 controls were enrolled. AD patients drew human figures poor in details and globally smaller than MCI patients and controls. Human figures drawn by MCI patients are intermediate in body height between those of the AD patients and the healthy subjects. The head-to-body ratio of human figures drawn by AD patients is greater than controls and MCI patients, while the human figure size-relative-to-page space index is significantly smaller. Body height is an independent predictor of cognitive impairment correlating with its severity and with the number of the figure's details. Human figures drawn by AD patients are different from those drawn by healthy subjects and MCI patients. Human figure drawing test is a useful tool for orienting cognitive impairment's diagnosis.

Participation of women in human biology, 1975-2001.

PubMed

Stinson, Sara

2003-01-01

This study examines trends in women's participation in human biology as indicated by women's membership in the Human Biology Council/Association, first authorship of articles in the Human Biology Council/Association journal, and the extent to which women have been the subjects of research published in the organization's journal. Gender of members was determined from seven membership lists published in the organization's journal from 1977 to 1998, and the gender of the first authors was determined for 1616 articles published in Human Biology or the American Journal of Human Biology from 1975 to 2001. Each journal article was also coded as to the first author's country and whether the subjects of the research were only females, only males, or both males and females. From the late 1970s to the late 1990s, the percent of women members of the Human Biology Council/Association increased from under 25% to over 40%. Women were the first authors of fewer than 20% of articles in the organization's journal in the late 1970s; by the late 1990s over 30% of articles had a female first author. The clearest increase in female authorship through time is seen for articles with a first author from the U.S. Even when women were not well represented as human biologists, a substantial proportion of human biology research published in the organization's journal dealt with females, and over the last 15 years there have been more research articles having only females as research subjects than articles having only males as research subjects. Copyright 2003 Wiley-Liss, Inc.

34 CFR 97.120 - Evaluation and disposition of applications and proposals for research to be conducted or...

Code of Federal Regulations, 2010 CFR

2010-07-01

... 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 Subjects) § 97.120... adequacy of protection against these risks, the potential benefits of the research to the subjects and...

Long-term administration of inulin-type fructans has no significant lipid-lowering effect in normolipidemic humans.

PubMed

Forcheron, Fabien; Beylot, Michel

2007-08-01

Short-term studies have shown that the addition to diet of inulin-type fructans, a nondigestible carbohydrate, may have a plasma lipid-lowering effect in humans. Whether this beneficial effect persists during long-term administration has not been determined. The study was aimed at determining whether a prolonged (6 months) administration of inulin-type fructans to healthy subjects has a lipid-lowering action. In a double-blind, randomized, placebo-controlled study, 17 healthy subjects were studied before and after 6 months of daily administration of placebo (8 subjects) or 10 g of a mix of inulin and oligofructose (9 subjects). During this 6-month period, they consumed their usual diet and did not modify their everyday way of life. We measured plasma lipid concentrations; cholesterol synthesis and hepatic lipogenesis; and adipose tissue and circulating mononuclear cell messenger RNA concentrations of key regulatory genes of cholesterol metabolism. Compared with the administration of placebo, the administration of inulin-type fructans had no effect on plasma triacylglycerol concentrations and hepatic lipogenesis and induced only a nonsignificant trend for decreased plasma total and low-density lipoprotein cholesterol levels and increased high-density lipoprotein cholesterol concentration. Cholesterol synthesis was not significantly modified. Of all the messenger RNA concentrations measured, none was significantly modified by the administration of inulin-type fructans. In conclusion, contrary to what was observed in short-term studies, we observed no significant beneficial effect of a long-term (6-month) administration of inulin-type fructans on plasma lipids in healthy human subjects.

State Dependent Valuation: The Effect of Deprivation on Risk Preferences

PubMed Central

Levy, Dino J.; Thavikulwat, Amalie C.; Glimcher, Paul W.

2013-01-01

The internal state of an organism affects its choices. Previous studies in various non-human animals have demonstrated a complex, and in some cases non-monotonic, interaction between internal state and risk preferences. Our aim was to examine the systematic effects of deprivation on human decision-making across various reward types. Using both a non-parametric approach and a classical economic analysis, we asked whether the risk attitudes of human subjects towards money, food and water rewards would change as a function of their internal metabolic state. Our findings replicate some previous work suggesting that, on average, humans become more risk tolerant in their monetary decisions, as they get hungry. However, our specific approach allowed us to make two novel observations about the complex interaction between internal state and risk preferences. First, we found that the change in risk attitude induced by food deprivation is a general phenomenon, affecting attitudes towards both monetary and consumable rewards. But much more importantly, our data indicate that rather than each subject becoming more risk tolerant as previously hypothesized based on averaging across subjects, we found that as a population of human subjects becomes food deprived the heterogeneity of their risk attitudes collapses towards a fixed point. Thus subjects who show high-risk aversion while satiated shift towards moderate risk aversion when deprived but subjects who are risk tolerant become more risk averse. These findings demonstrate a more complicated interaction between internal state and risk preferences and raise some interesting implications for both day-to-day decisions and financial market structures. PMID:23358126

State dependent valuation: the effect of deprivation on risk preferences.

PubMed

Levy, Dino J; Thavikulwat, Amalie C; Glimcher, Paul W

2013-01-01

The internal state of an organism affects its choices. Previous studies in various non-human animals have demonstrated a complex, and in some cases non-monotonic, interaction between internal state and risk preferences. Our aim was to examine the systematic effects of deprivation on human decision-making across various reward types. Using both a non-parametric approach and a classical economic analysis, we asked whether the risk attitudes of human subjects towards money, food and water rewards would change as a function of their internal metabolic state. Our findings replicate some previous work suggesting that, on average, humans become more risk tolerant in their monetary decisions, as they get hungry. However, our specific approach allowed us to make two novel observations about the complex interaction between internal state and risk preferences. First, we found that the change in risk attitude induced by food deprivation is a general phenomenon, affecting attitudes towards both monetary and consumable rewards. But much more importantly, our data indicate that rather than each subject becoming more risk tolerant as previously hypothesized based on averaging across subjects, we found that as a population of human subjects becomes food deprived the heterogeneity of their risk attitudes collapses towards a fixed point. Thus subjects who show high-risk aversion while satiated shift towards moderate risk aversion when deprived but subjects who are risk tolerant become more risk averse. These findings demonstrate a more complicated interaction between internal state and risk preferences and raise some interesting implications for both day-to-day decisions and financial market structures.

Electromagnetic perception and individual features of human beings.

PubMed

Lebedeva, N N; Kotrovskaya, T I

2001-01-01

An investigation was made of the individual reactions of human subjects exposed to electromagnetic fields. We performed the study on 86 volunteers separated into two groups. The first group was exposed to the electromagnetic field of infralow frequencies, whereas the second group was exposed to the electromagnetic field of extremely high frequencies. We found that the electromagnetic perception of human beings correlated with their individual features, such as EEG parameters, the critical frequency of flash merging, and the electric current sensitivity. Human subjects who had a high-quality perception of electromagnetic waves showed an optimal balance of cerebral processes, an excellent functional state of the central nervous system, and a good decision criterion.

Concurrent performance in a three-alternative choice situation: response allocation in a Rock/Paper/Scissors game.

PubMed

Kangas, Brian D; Berry, Meredith S; Cassidy, Rachel N; Dallery, Jesse; Vaidya, Manish; Hackenberg, Timothy D

2009-10-01

Adult human subjects engaged in a simulated Rock/Paper/Scissors game against a computer opponent. The computer opponent's responses were determined by programmed probabilities that differed across 10 blocks of 100 trials each. Response allocation in Experiment 1 was well described by a modified version of the generalized matching equation, with undermatching observed in all subjects. To assess the effects of instructions on response allocation, accurate probability-related information on how the computer was programmed to respond was provided to subjects in Experiment 2. Five of 6 subjects played the counter response of the computer's dominant programmed response near-exclusively (e.g., subjects played paper almost exclusively if the probability of rock was high), resulting in minor overmatching, and higher reinforcement rates relative to Experiment 1. On the whole, the study shows that the generalized matching law provides a good description of complex human choice in a gaming context, and illustrates a promising set of laboratory methods and analytic techniques that capture important features of human choice outside the laboratory.

EEG slow waves in traumatic brain injury: Convergent findings in mouse and man

PubMed Central

Modarres, Mo; Kuzma, Nicholas N.; Kretzmer, Tracy; Pack, Allan I.; Lim, Miranda M.

2016-01-01

Objective Evidence from previous studies suggests that greater sleep pressure, in the form of EEG-based slow waves, accumulates in specific brain regions that are more active during prior waking experience. We sought to quantify the number and coherence of EEG slow waves in subjects with mild traumatic brain injury (mTBI). Methods We developed a method to automatically detect individual slow waves in each EEG channel, and validated this method using simulated EEG data. We then used this method to quantify EEG-based slow waves during sleep and wake states in both mouse and human subjects with mTBI. A modified coherence index that accounts for information from multiple channels was calculated as a measure of slow wave synchrony. Results Brain-injured mice showed significantly higher theta:alpha amplitude ratios and significantly more slow waves during spontaneous wakefulness and during prolonged sleep deprivation, compared to sham-injured control mice. Human subjects with mTBI showed significantly higher theta:beta amplitude ratios and significantly more EEG slow waves while awake compared to age-matched control subjects. We then quantified the global coherence index of slow waves across several EEG channels in human subjects. Individuals with mTBI showed significantly less EEG global coherence compared to control subjects while awake, but not during sleep. EEG global coherence was significantly correlated with severity of post-concussive symptoms (as assessed by the Neurobehavioral Symptom Inventory scale). Conclusion and implications Taken together, our data from both mouse and human studies suggest that EEG slow wave quantity and the global coherence index of slow waves may represent a sensitive marker for the diagnosis and prognosis of mTBI and post-concussive symptoms. PMID:28018987

EEG slow waves in traumatic brain injury: Convergent findings in mouse and man.

PubMed

Modarres, Mo; Kuzma, Nicholas N; Kretzmer, Tracy; Pack, Allan I; Lim, Miranda M

2016-07-01

Evidence from previous studies suggests that greater sleep pressure, in the form of EEG-based slow waves, accumulates in specific brain regions that are more active during prior waking experience. We sought to quantify the number and coherence of EEG slow waves in subjects with mild traumatic brain injury (mTBI). We developed a method to automatically detect individual slow waves in each EEG channel, and validated this method using simulated EEG data. We then used this method to quantify EEG-based slow waves during sleep and wake states in both mouse and human subjects with mTBI. A modified coherence index that accounts for information from multiple channels was calculated as a measure of slow wave synchrony. Brain-injured mice showed significantly higher theta:alpha amplitude ratios and significantly more slow waves during spontaneous wakefulness and during prolonged sleep deprivation, compared to sham-injured control mice. Human subjects with mTBI showed significantly higher theta:beta amplitude ratios and significantly more EEG slow waves while awake compared to age-matched control subjects. We then quantified the global coherence index of slow waves across several EEG channels in human subjects. Individuals with mTBI showed significantly less EEG global coherence compared to control subjects while awake, but not during sleep. EEG global coherence was significantly correlated with severity of post-concussive symptoms (as assessed by the Neurobehavioral Symptom Inventory scale). Taken together, our data from both mouse and human studies suggest that EEG slow wave quantity and the global coherence index of slow waves may represent a sensitive marker for the diagnosis and prognosis of mTBI and post-concussive symptoms.

40 CFR 26.102 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 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 § 26.102 Definitions...) Human subject means a living individual about whom an investigator (whether professional or student...

40 CFR 26.102 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 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 § 26.102 Definitions...) Human subject means a living individual about whom an investigator (whether professional or student...

40 CFR 26.102 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 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 § 26.102 Definitions...) Human subject means a living individual about whom an investigator (whether professional or student...

Ethical issues in action-oriented research in Indonesia.

PubMed

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 understand the research ethics on human subjects and apply it into their practice.

Dietary supplementation with purified citrus limonin glucoside does not alter ex vivo functions of circulating T lymphocytes or monocytes in overweight/obese human adults

USDA-ARS?s Scientific Manuscript database

Overweight/obesity is associated with chronic inflammation and impairs both innate and adaptive immune responses. Limonoids found in citrus fruits have shown health benefits in human and animal studies. In a double-blind, randomized, crossover study, 10 overweight/obese human subjects were fed pur...

Individual differences in human annoyance response to noise

NASA Technical Reports Server (NTRS)

Pearson, R. G.; Hart, F. D.; Obrien, J. F.

1975-01-01

Individual variations in annoyance and in susceptibility to noise were studied to establish a finer definition of the ingredients of the human annoyance response. The study involved interactions among a heterogeneous sample of human subjects, various noise stimuli, and different physical environments of exposure. Significant differences in annoyance ratings among the six noise stimuli, all equated for peak sound pressure level, were found.

ACID AIR AND AEROBIOLOGY RELATED TO THE MATURING HUMAN LUNG

EPA Science Inventory

The effect of 'acid air' on human health was studied by considering the effects of hygroscopicity upon aerosol deposition in the lung as a function of human subject age. Children are a critical sub-population to be incorporated into health effects analyses following ambient expos...

EFFECT OF ANTIOXIDANT SUPPLEMENTATION ON OZONE-INDUCED LUNG INJURY IN HUMAN SUBJECTS

EPA Science Inventory

Epidemiological, in vitro and animal studies suggest that dietary antioxidants can modulate the cellular and physiologic effects of ozone (O3) inhalation in humans. To determine whether antioxidants can influence human susceptibility to O3-induced changes in lung function and a...

Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.

PubMed

Lawrence, Dana J

2011-11-01

To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers. Copyright © 2011 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

Impact of suggestion on the human experimental model of cold hyperalgesia after topical application of high-concentration menthol [40%].

PubMed

Helfert, S; Reimer, M; Barnscheid, L; Hüllemann, P; Rengelshausen, J; Keller, T; Baron, R; Binder, A

2018-05-14

Human experimental pain models in healthy subjects offer unique possibilities to study mechanisms of pain within a defined setting of expected pain symptoms, signs and mechanisms. Previous trials in healthy subjects demonstrated that topical application of 40% menthol is suitable to induce cold hyperalgesia. The objective of this study was to evaluate the impact of suggestion on this experimental human pain model. The study was performed within a single-centre, randomized, placebo-controlled, double-blind, two-period crossover trial in a cohort of 16 healthy subjects. Subjects were tested twice after topical menthol application (40% dissolved in ethanol) and twice after ethanol (as placebo) application. In the style of a balanced placebo trial design, the subjects received during half of the testing the correct information about the applied substance (topical menthol or ethanol) and during half of the testing the incorrect information, leading to four tested conditions (treatment conditions: menthol-told-menthol and menthol-told-ethanol; placebo conditions: ethanol-told-menthol and ethanol-told-ethanol). Cold but not mechanical hyperalgesia was reliably induced by the model. The cold pain threshold decreased in both treatment conditions regardless whether true or false information was given. Minor suggestion effects were found in subjects with prior ethanol application. The menthol model is a reliable, nonsuggestible model to induce cold hyperalgesia. Mechanical hyperalgesia is not as reliable to induce. Cold hyperalgesia may be investigated under unbiased and suggestion-free conditions using the menthol model of pain. © 2018 European Pain Federation - EFIC®.

Geographic Information System and tools of spatial analysis in a pneumococcal vaccine trial.

PubMed

Tanskanen, Antti; Nillos, Leilani T; Lehtinen, Antti; Nohynek, Hanna; Sanvictores, Diozele Hazel M; Simões, Eric Af; Tallo, Veronica L; Lucero, Marilla G

2012-01-20

The goal of this Geographic Information System (GIS) study was to obtain accurate information on the locations of study subjects, road network and services for research purposes so that the clinical outcomes of interest (e.g., vaccine efficacy, burden of disease, nasopharyngeal colonization and its reduction) could be linked and analyzed at a distance from health centers, hospitals, doctors and other important services. The information on locations can be used to investigate more accurate crowdedness, herd immunity and/or transmission patterns. A randomized, placebo-controlled, double-blind trial of an 11-valent pneumococcal conjugate vaccine (11PCV) was conducted in Bohol Province in central Philippines, from July 2000 to December 2004. We collected the information on the geographic location of the households (N = 13,208) of study subjects. We also collected a total of 1982 locations of health and other services in the six municipalities and a comprehensive GIS data over the road network in the area. We calculated the numbers of other study subjects (vaccine and placebo recipients, respectively) within the neighborhood of each study subject. We calculated distances to different services and identified the subjects sharing the same services (calculated by distance). This article shows how to collect a complete GIS data set for human to human transmitted vaccine study in developing country settings in an efficient and economical way. The collection of geographic locations in intervention trials should become a routine task. The results of public health research may highly depend on spatial relationships among the study subjects and between the study subjects and the environment, both natural and infrastructural. ISRCTN: ISRCTN62323832.

Repeated or long-duration TASER electronic control device exposures: acidemia and lack of respiration.

PubMed

Jauchem, James R

2010-03-01

Conducted energy weapons (CEWs), such as TASER devices, may be applied to subjects in repeated or long-duration modes. Such applications may result in more potentially harmful effects (as reflected in blood factor changes) than shorter exposures. In this review, results from a number of studies of repeated and long-duration CEW exposures in an animal model are examined. Additionally, a few limited investigations of shorter CEW applications to human subjects are considered. Specifically, in anesthetized swine, increased blood acidity (acidemia) and lack of effective respiration were found to be common during or immediately after CEW exposure. The acidemia could have been due to both metabolic and respiratory acidosis. A relatively rapid recovery toward baseline pH levels occurred. The lack of effective respiration has not been verified in experiments of CEW applications to human subjects; however, in some incidents of human deaths after CEW exposures subjects have been reported to stop breathing immediately after the exposure. It is not known if all human subjects exposed to CEW applications in the field (often "on drugs" or "in excited delirium") would be able to maintain adequate breathing. Since a limited number of short CEW applications would be less likely to cause adverse effects, however, CEWs can still be a valuable tool for law enforcement activities.

The use of team-based, guided inquiry learning to overcome educational disadvantages in learning human physiology: a structural equation model.

PubMed

Rathner, Joseph A; Byrne, Graeme

2014-09-01

The study of human bioscience is viewed as a crucial curriculum in allied health. Nevertheless, bioscience (and particularly physiology) is notoriously difficult for undergraduates, particularly academically disadvantaged students. So endemic are the high failure rates (particularly in nursing) that it has come to be known as "the human bioscience problem." In the present report, we describe the outcomes for individual success in studying first-year human physiology in a subject that emphasises team-based active learning as the major pedagogy for mastering subject learning outcomes. Structural equation modeling was used to develop a model of the impact team learning had on individual performance. Modeling was consistent with the idea that students with similar academic abilities (as determined by tertiary entrance rank) were advantaged (scored higher on individual assessment items) by working in strong teams (teams that scored higher in team-based assessments). Analysis of covariance revealed that students who studied the subject with active learning as the major mode of learning activities outperformed students who studied the subject using the traditional didactic teaching format (lectures and tutorials, P = 0.000). After adjustment for tertiary entrance rank (via analysis of covariance) on two individual tests (the final exam and a late-semester in-class test), individual student grades improved by 8% (95% confidence interval: 6-10%) and 12% (95% confidence interval: 10-14%) when students engaged in team-based active learning. These data quantitatively support the notion that weaker students working in strong teams can overcome their educational disadvantages. Copyright © 2014 The American Physiological Society.

The use of team-based, guided inquiry learning to overcome educational disadvantages in learning human physiology: a structural equation model

PubMed Central

Byrne, Graeme

2014-01-01

The study of human bioscience is viewed as a crucial curriculum in allied health. Nevertheless, bioscience (and particularly physiology) is notoriously difficult for undergraduates, particularly academically disadvantaged students. So endemic are the high failure rates (particularly in nursing) that it has come to be known as “the human bioscience problem.” In the present report, we describe the outcomes for individual success in studying first-year human physiology in a subject that emphasises team-based active learning as the major pedagogy for mastering subject learning outcomes. Structural equation modeling was used to develop a model of the impact team learning had on individual performance. Modeling was consistent with the idea that students with similar academic abilities (as determined by tertiary entrance rank) were advantaged (scored higher on individual assessment items) by working in strong teams (teams that scored higher in team-based assessments). Analysis of covariance revealed that students who studied the subject with active learning as the major mode of learning activities outperformed students who studied the subject using the traditional didactic teaching format (lectures and tutorials, P = 0.000). After adjustment for tertiary entrance rank (via analysis of covariance) on two individual tests (the final exam and a late-semester in-class test), individual student grades improved by 8% (95% confidence interval: 6–10%) and 12% (95% confidence interval: 10–14%) when students engaged in team-based active learning. These data quantitatively support the notion that weaker students working in strong teams can overcome their educational disadvantages. PMID:25179611

45 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 1 2014-10-01 2014-10-01 false Applications and proposals lacking definite plans for involvement of human subjects. 46.118 Section 46.118 Public Welfare Department of Health and Human... Research Subjects § 46.118 Applications and proposals lacking definite plans for involvement of human...

45 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 1 2011-10-01 2011-10-01 false Applications and proposals lacking definite plans for involvement of human subjects. 46.118 Section 46.118 Public Welfare DEPARTMENT OF HEALTH AND HUMAN... Research Subjects § 46.118 Applications and proposals lacking definite plans for involvement of human...

45 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 1 2012-10-01 2012-10-01 false Applications and proposals lacking definite plans for involvement of human subjects. 46.118 Section 46.118 Public Welfare DEPARTMENT OF HEALTH AND HUMAN... Research Subjects § 46.118 Applications and proposals lacking definite plans for involvement of human...

45 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 1 2013-10-01 2013-10-01 false Applications and proposals lacking definite plans for involvement of human subjects. 46.118 Section 46.118 Public Welfare DEPARTMENT OF HEALTH AND HUMAN... Research Subjects § 46.118 Applications and proposals lacking definite plans for involvement of human...

On the Growth of Scientific Knowledge: Yeast Biology as a Case Study

PubMed Central

He, Xionglei; Zhang, Jianzhi

2009-01-01

The tempo and mode of human knowledge expansion is an enduring yet poorly understood topic. Through a temporal network analysis of three decades of discoveries of protein interactions and genetic interactions in baker's yeast, we show that the growth of scientific knowledge is exponential over time and that important subjects tend to be studied earlier. However, expansions of different domains of knowledge are highly heterogeneous and episodic such that the temporal turnover of knowledge hubs is much greater than expected by chance. Familiar subjects are preferentially studied over new subjects, leading to a reduced pace of innovation. While research is increasingly done in teams, the number of discoveries per researcher is greater in smaller teams. These findings reveal collective human behaviors in scientific research and help design better strategies in future knowledge exploration. PMID:19300476

On the growth of scientific knowledge: yeast biology as a case study.

PubMed

He, Xionglei; Zhang, Jianzhi

2009-03-01

The tempo and mode of human knowledge expansion is an enduring yet poorly understood topic. Through a temporal network analysis of three decades of discoveries of protein interactions and genetic interactions in baker's yeast, we show that the growth of scientific knowledge is exponential over time and that important subjects tend to be studied earlier. However, expansions of different domains of knowledge are highly heterogeneous and episodic such that the temporal turnover of knowledge hubs is much greater than expected by chance. Familiar subjects are preferentially studied over new subjects, leading to a reduced pace of innovation. While research is increasingly done in teams, the number of discoveries per researcher is greater in smaller teams. These findings reveal collective human behaviors in scientific research and help design better strategies in future knowledge exploration.

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

PubMed

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 future TTS studies, including protective agent evaluations, that some noise exposures have resulted in neural degeneration in animal models, even when both audiometric thresholds and DPOAE levels returned to pre-exposure values.

Disability, human rights, and the International Classification of Functioning, Disability, and Health: systematic review.

PubMed

Aluas, Maria; Colombetti, Elena; Osimani, Barbara; Musio, Alessio; Pessina, Adriano

2012-02-01

This literature review focuses on the literature on disability from the ethical and human rights perspective in the light of the International Classification of Functioning, Disability, and Health in the period from January 1, 2008, to June 30, 2010. This article identifies and examines studies that deal with the subject of disability with reference to rights, ethical issues, and justice. A total of 42 articles and 33 books were selected. The subject most frequently dealt with in studies on disability is that of human rights (76% of the articles and 79% of the books examined), followed by topics relating to welfare (52% of articles and 64% of books), International Classification of Functioning, Disability, and Health (38% of articles and 45% of books), justice (24% of articles and 48% of books), education (21% of articles and 61% of books), and work (19% of articles and 39% of books). The subject of disability is dealt with in various fields of study and various disciplines. Most of the studies are based on the legal approach. It is to be hoped that there will be an increase in the philosophical and ethical study of disability, which has only recently entered the European debate.

Are Liberal Studies Teachers Ready to Prepare Human Rights Respecting Students? A Portrait of Teachers' Attitudes towards Human Rights

ERIC Educational Resources Information Center

Leung, Yan Wing; Lo, Yan Lam

2012-01-01

As in most countries, human rights education (HRE) in Hong Kong has never been high on the educational agenda. In 2009, a compulsory subject, Liberal Studies (LS), which could be used as a platform for HRE, was introduced. The Hong Kong Institute of Education launched a research and development project which, as one of its objectives, studied LS…

The Validity of Communication Experiments Using Human Subjects: A Review

ERIC Educational Resources Information Center

Rossiter, Charles M.

1976-01-01

Reviews sixty-eight experiments published in various journals in 1973 and 1974 and concludes that communication experimentation may be severely limited by the nature of the subjects studied and the inappropriate handling of experimental reactivity. (MH)

Model for Predicting the Performance of Planetary Suit Hip Bearing Designs

NASA Technical Reports Server (NTRS)

Cowley, Matthew S.; Margerum, Sarah; Hharvill, Lauren; Rajulu, Sudhakar

2012-01-01

Designing a space suit is very complex and often requires difficult trade-offs between performance, cost, mass, and system complexity. During the development period of the suit numerous design iterations need to occur before the hardware meets human performance requirements. Using computer models early in the design phase of hardware development is advantageous, by allowing virtual prototyping to take place. A virtual design environment allows designers to think creatively, exhaust design possibilities, and study design impacts on suit and human performance. A model of the rigid components of the Mark III Technology Demonstrator Suit (planetary-type space suit) and a human manikin were created and tested in a virtual environment. The performance of the Mark III hip bearing model was first developed and evaluated virtually by comparing the differences in mobility performance between the nominal bearing configurations and modified bearing configurations. Suited human performance was then simulated with the model and compared to actual suited human performance data using the same bearing configurations. The Mark III hip bearing model was able to visually represent complex bearing rotations and the theoretical volumetric ranges of motion in three dimensions. The model was also able to predict suited human hip flexion and abduction maximums to within 10% of the actual suited human subject data, except for one modified bearing condition in hip flexion which was off by 24%. Differences between the model predictions and the human subject performance data were attributed to the lack of joint moment limits in the model, human subject fitting issues, and the limited suit experience of some of the subjects. The results demonstrate that modeling space suit rigid segments is a feasible design tool for evaluating and optimizing suited human performance. Keywords: space suit, design, modeling, performance

ISRUC-Sleep: A comprehensive public dataset for sleep researchers.

PubMed

Khalighi, Sirvan; Sousa, Teresa; Santos, José Moutinho; Nunes, Urbano

2016-02-01

To facilitate the performance comparison of new methods for sleep patterns analysis, datasets with quality content, publicly-available, are very important and useful. We introduce an open-access comprehensive sleep dataset, called ISRUC-Sleep. The data were obtained from human adults, including healthy subjects, subjects with sleep disorders, and subjects under the effect of sleep medication. Each recording was randomly selected between PSG recordings that were acquired by the Sleep Medicine Centre of the Hospital of Coimbra University (CHUC). The dataset comprises three groups of data: (1) data concerning 100 subjects, with one recording session per subject; (2) data gathered from 8 subjects; two recording sessions were performed per subject, and (3) data collected from one recording session related to 10 healthy subjects. The polysomnography (PSG) recordings, associated with each subject, were visually scored by two human experts. Comparing the existing sleep-related public datasets, ISRUC-Sleep provides data of a reasonable number of subjects with different characteristics such as: data useful for studies involving changes in the PSG signals over time; and data of healthy subjects useful for studies involving comparison of healthy subjects with the patients, suffering from sleep disorders. This dataset was created aiming to complement existing datasets by providing easy-to-apply data collection with some characteristics not covered yet. ISRUC-Sleep can be useful for analysis of new contributions: (i) in biomedical signal processing; (ii) in development of ASSC methods; and (iii) on sleep physiology studies. To evaluate and compare new contributions, which use this dataset as a benchmark, results of applying a subject-independent automatic sleep stage classification (ASSC) method on ISRUC-Sleep dataset are presented. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Nonlinearity in the vertical transmissibility of seating: the role of the human body apparent mass and seat dynamic stiffness

NASA Astrophysics Data System (ADS)

Tufano, Saverio; Griffin, Michael J.

2013-01-01

The efficiency of a seat in reducing vibration depends on the characteristics of the vibration, the dynamic characteristics of the seat, and the dynamic characteristics of the person sitting on the seat. However, it is not known whether seat cushions influence the dynamic response of the human body, whether the human body influences the dynamic response of seat cushions, or the relative importance of human body nonlinearity and seat nonlinearity in causing nonlinearity in measures of seat transmissibility. This study was designed to investigate the nonlinearity of the coupled seat and human body systems and to compare the apparent mass of the human body supported on rigid and foam seats. A frequency domain model was used to identify the dynamic parameters of seat foams and investigate their dependence on the subject-sitting weight and hip breadth. With 15 subjects, the force and acceleration at the seat base and acceleration at the subject interface were measured during random vertical vibration excitation (0.25-25 Hz) at each of five vibration magnitudes, (0.25-1.6 ms-2 r.m.s.) with four seating conditions (rigid flat seat and three foam cushions). The measurements are presented in terms of the subject's apparent mass on the rigid and foam seat surfaces, and the transmissibility and dynamic stiffness of each of the foam cushions. Both the human body and the foams showed nonlinear softening behaviour, which resulted in nonlinear cushion transmissibility. The apparent masses of subjects sitting on the rigid seat and on foam cushions were similar, but with an apparent increase in damping when sitting on the foams. The foam dynamic stiffness showed complex correlations with characteristics of the human body, which differed between foams. The nonlinearities in cushion transmissibilities, expressed in terms of changes in resonance frequencies and moduli, were more dependent on human body nonlinearity than on cushion nonlinearity.

Are juvenile domestic pigs (Sus scrofa domestica) sensitive to the attentive states of humans?--The impact of impulsivity on choice behaviour.

PubMed

Nawroth, Christian; Ebersbach, Mirjam; von Borell, Eberhard

2013-06-01

Previous studies have shown that apes, dogs and horses seem to be able to attribute attentive states to humans. Subjects had to choose between two persons: one who was able to see the animal and one who was not. Using a similar paradigm, we tested a species that does not rely strongly on visual cues, the domestic pig (Sus scrofa domestica). Subjects could choose between two unfamiliar persons, with only one showing attention, in three different conditions (body, head away, body turned - head front). Subjects (n=16) only showed a tendency towards the attentive human in the head away condition. However, by pooling those two conditions where the position of the human head was the only salient cue, we found a significant preference for the attentive person. Moreover, two approach styles could be distinguished - an impulsive style with short response times and a non-impulsive style where response times were relatively long. With the second approach style, pigs chose the attentive person significantly more often than expected by chance level, which was not the case when subjects chose impulsively. These first results suggest that pigs are able to use head cues to discriminate between different attentive states of humans. Copyright © 2013 Elsevier B.V. All rights reserved.

Statistical Challenges in "Big Data" Human Neuroimaging.

PubMed

Smith, Stephen M; Nichols, Thomas E

2018-01-17

Smith and Nichols discuss "big data" human neuroimaging studies, with very large subject numbers and amounts of data. These studies provide great opportunities for making new discoveries about the brain but raise many new analytical challenges and interpretational risks. Copyright © 2017 Elsevier Inc. All rights reserved.

Effects of the NMDA antagonist memantine on human methamphetamine discrimination.

PubMed

Hart, Carl L; Haney, Margaret; Foltin, Richard W; Fischman, Marian W

2002-12-01

The discriminative stimulus effects of N-methyl- D-aspartate (NMDA) antagonists have been assessed in laboratory animals. To date, no published study has assessed their ability to alter methamphetamine-related discriminative stimulus effects in humans. This study investigated the discriminative stimulus, subjective (e.g. "Good Drug Effect"), psychomotor performance, and cardiovascular effects (e.g. blood pressure) of oral methamphetamine following acute oral memantine (a non-competitive NMDA antagonist) in humans. Initially, participants were trained to discriminate 10 mg methamphetamine from placebo using a standard two-response procedure (drug versus placebo). Then, the effects of memantine (0, 40 mg) on methamphetamine discrimination were examined across several methamphetamine doses (0, 5, 10, 20 mg) using a novel-response procedure (drug versus placebo versus novel). Following placebo pretreatment, 10 mg methamphetamine produced 99% methamphetamine-appropriate responding and placebo produced 75% placebo-appropriate responding. Following memantine pretreatment, participants responded as if they had been given a novel compound, although memantine did not significantly alter most subjective-effects ratings following methamphetamine. Memantine alone produced "positive" subjective effects and novel drug-appropriate responding. These data indicate that the memantine-methamphetamine combination produced novel discriminative stimulus effects and that memantine produced some stimulant-like subjective effects.

Cytokines and immune surveillance in humans

NASA Technical Reports Server (NTRS)

Sonnenfeld, Gerald

1994-01-01

Evidence from both human and rodent studies has indicated that alterations in immunological parameters occur after space flight. Among the parameters shown, by us and others, to be affected is the production of interferons. Interferons are a family of cytokines that are antiviral and play a major role in regulating immune responses that control resistance to infection. Alterations in interferon and other cytokine production and activity could result in changes in immunity and a possible compromise of host defenses against both opportunistic and external infections. The purpose of the present study is to explore further the effects of space flight on cyotokines and cytokine-directed immunological function. Among the tests carried out are interferon-alpha production, interferon-gamma production, interleukin-1 and -2 production, signal transduction in neutrophils, signal transduction in monocytes, and monocyte phagocytic activity. The experiments will be performed using peripheral blood obtained from human subjects. It is our intent to eventually carry out these experiments using astronauts as subjects to determine the effects of space flight on cytokine production and activity. However, these subjects are not currently available. Until they become available, we will carry out these experiments using subjects maintained in the bed-rest model for microgravity.

Audiovisual material as educational innovation strategy to reduce anxiety response in students of human anatomy.

PubMed

Casado, María Isabel; Castaño, Gloria; Arráez-Aybar, Luis Alfonso

2012-08-01

This study presents the design, effect and utility of using audiovisual material containing real images of dissected human cadavers as an innovative educational strategy (IES) in the teaching of Human Anatomy. The goal is to familiarize students with the practice of dissection and to transmit the importance and necessity of this discipline, while modulating their anxiety. The study included 303 first-year Human Anatomy students, randomly assigned to two groups (Traditional and Educational Innovation). Their state of anxiety was measured using the State-Trait-Anxiety Inventory. Repeated measures ANOVA with between-subject factors was applied. The between-subject factor was Educational Innovation (EI). Two levels were established for this factor. The within-subject factor was Time, four levels being considered here. The results show that the effects of the Educational Innovation factor, Time factor and EI × Time interaction were statistically significant. These results provide an additional element of efficacy to the use of videos as an IES. That is, the use of video material as an introduction into an anxiety-provoking situation which resembles real-life viewing and interaction with human cadavers for the first time significantly diminishes the anticipatory reaction of dread against which novel students have not had the opportunity to develop any cognitive strategy of emotional control.

77 FR 34954 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-12

... protection of public health, safety, and ethical standards, FDA has established human subject protection... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0560... Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually...

MULTIPLE SOLVENT EXPOSURE IN HUMANS: CROSS-SPECIES EXTRAPOLATIONS

EPA Science Inventory

Multiple Solvent Exposures in Humans:
Cross-Species Extrapolations
(Future Research Plan)

Vernon A. Benignus1, Philip J. Bushnell2 and William K. Boyes2

A few solvents can be safely studied in acute experiments in human subjects. Data exist in rats f...

Human bone hardness seems to depend on tissue type but not on anatomical site in the long bones of an old subject.

PubMed

Ohman, Caroline; Zwierzak, Iwona; Baleani, Massimiliano; Viceconti, Marco

2013-02-01

It has been hypothesised that among different human subjects, the bone tissue quality varies as a function of the bone segment morphology. The aim of this study was to assess and compare the quality, evaluated in terms of hardness of packages of lamellae, of cortical and trabecular bones, at different anatomical sites within the human skeleton. The contralateral six long bones of an old human subject were indented at different levels along the diaphysis and at both epiphyses of each bone. Hardness value, which is correlated to the degree of mineralisation, of both cortical and trabecular bone tissues was calculated for each indentation location. It was found that the cortical bone tissue was harder (+18%) than the trabecular one. In general, the bone hardness was found to be locally highly heterogeneous. In fact, considering one single slice obtained for a bone segment, the coefficient of variation of the hardness values was up to 12% for cortical bone and up to 17% for trabecular bone. However, the tissue hardness was on average quite homogeneous within and among the long bones of the studied donor, although differences up to 9% among levels and up to 7% among bone segments were found. These findings seem not to support the mentioned hypothesis, at least not for the long bones of an old subject.

Effects of Detailed Illustrations on Science Learning: An Eye-Tracking Study

ERIC Educational Resources Information Center

Lin, Yu Ying; Holmqvist, Kenneth; Miyoshi, Kiyofumi; Ashida, Hiroshi

2017-01-01

The eye-tracking method was used to assess the influence of detailed, colorful illustrations on reading behaviors and learning outcomes. Based on participants' subjective ratings in a pre-study, we selected eight one-page human anatomy lessons. In the main study, participants learned these eight human anatomy lessons; four were accompanied by…

Evaluation of an Indoor Sonic Boom Subjective Test Facility at NASA Langley Research Center

NASA Technical Reports Server (NTRS)

Loubeau, Alexandra; Rathsam, Jonathan; Klos, Jacob

2011-01-01

A sonic boom simulator at NASA Langley Research Center has been constructed for research on human response to low-amplitude sonic booms heard indoors. Research in this facility will ultimately lead to development of a psychoacoustic model for single indoor booms. The first subjective test was designed to explore indoor human response to variations in sonic boom rise time and amplitude. Another goal was to identify loudness level variability across listener locations within the facility. Finally, the test also served to evaluate the facility as a laboratory research tool for studying indoor human response to sonic booms. Subjects listened to test sounds and were asked to rate their annoyance relative to a reference boom. Measurements of test signals were conducted for objective analysis and correlation with subjective responses. Results confirm the functionality of the facility and effectiveness of the test methods and indicate that loudness level does not fully describe indoor annoyance to the selected sonic boom signals.

78 FR 56941 - Meetings of Humanities Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-16

... subjects of the History of Science, Technology and Medicine for the Humanities Collections and Reference... discuss applications on the subjects of U.S. History and Culture for the Humanities Collections and... applications on the subject of U.S. History for America's Historical & Cultural Organizations: Implementation...

Validity of a self-administered food frequency questionnaire in the estimation of heterocyclic aromatic amines.

PubMed

Iwasaki, Motoki; Mukai, Tomomi; Takachi, Ribeka; Ishihara, Junko; Totsuka, Yukari; Tsugane, Shoichiro

2014-08-01

Clarification of the putative etiologic role of heterocyclic aromatic amines (HAAs) in the development of cancer requires a validated assessment tool for dietary HAAs. This study primarily aimed to evaluate the validity of a food frequency questionnaire (FFQ) in estimating HAA intake, using 2-amino-1-methyl-6-phenylimidazo[4,5-b]pyridine (PhIP) level in human hair as the reference method. We first updated analytical methods of PhIP using liquid chromatography-electrospray ionization/tandem mass spectrometry (LC-ESI/MS/MS) and measured 44 fur samples from nine rats from a feeding study as part-verification of the quantitative performance of LC-ESI/MS/MS. We next measured PhIP level in human hair samples from a validation study of the FFQ (n = 65). HAA intake from the FFQ was estimated using information on intake from six fish items and seven meat items and data on HAA content in each food item. Correlation coefficients between PhIP level in human hair and HAA intake from the FFQ were calculated. The animal feeding study of PhIP found a significant dose-response relationship between dosage and PhIP in rat fur. Mean level was 53.8 pg/g hair among subjects with values over the limit of detection (LOD) (n = 57). We found significant positive correlation coefficients between PhIP in human hair and HAA intake from the FFQ, with Spearman rank correlation coefficients of 0.35 for all subjects, 0.21 for subjects with over LOD values, and 0.34 for subjects with over limit of quantification. Findings from the validation study suggest that the FFQ is reasonably valid for the assessment of HAA intake.

Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix™: A retrospective laboratory analysis

PubMed Central

Han, Htay Htay; Karkada, Naveen; Jayadeva, Girish; Dubin, Gary

2017-01-01

ABSTRACT In 2010, porcine circovirus type 1 (PCV1) material was unexpectedly detected in the oral live-attenuated human rotavirus (RV) vaccine, Rotarix™ (GSK Vaccines, Belgium). An initial study (NCT01511133) found no immunologic response against PCV1 in 40 vaccinated infants. As a follow-up, the current study (NCT02153333), searched for evidence of post-vaccination serologic response to PCV1 in a larger number of archived serum samples. Unlike the previous study, serum anti-PCV1 antibodies were assessed with an adapted Immuno Peroxidase Monolayer Assay (IPMA) using a Vero-adapted PCV1 strain. Samples from 596 infants who participated in clinical trials of the human RV vaccine were randomly selected and analyzed. The observed anti-PCV1 antibody seropositivity rate 1–2 months post-dose 2 was approximately 1% [90% Confidence Interval (CI): 0.3–2.6] (3/299 samples) in infants who received the human RV vaccine and 0.3% [90% CI: 0.0–1.6] (1/297 samples) in those who received placebo; the difference between the groups was −0.66 [90% CI: −2.16–0.60]. One subject in the vaccinated group was also seropositive before vaccination. Notably, the seropositivity rate observed in vaccinated subjects was below that observed during assay qualification in samples from unvaccinated subjects outside of this study (2.5%; 5/200 samples). No serious adverse events had been reported in any of the 4 subjects providing anti-PCV1 positive samples during the 31-day post-vaccination follow-up period in the original studies. In conclusion, the presence of PCV1 in the human RV vaccine is considered to be a manufacturing quality issue and does not appear to pose a safety risk to vaccinated infants. PMID:27657348

Human Rights Education in Social Studies in the Netherlands: A Case Study Textbook Analysis

ERIC Educational Resources Information Center

de Kort, Frauke

2017-01-01

Citizenship education is one of the main aims of the mandated subject of social studies in secondary schools in the Netherlands. Moreover, the learning outcomes of social studies refer to constitutional rights. Internationally, citizenship education and human rights education are considered to be mutually reinforcing. One may, thus, expect that…

Destabilizing effects of visual environment motions simulating eye movements or head movements

NASA Technical Reports Server (NTRS)

White, Keith D.; Shuman, D.; Krantz, J. H.; Woods, C. B.; Kuntz, L. A.

1991-01-01

In the present paper, we explore effects on the human of exposure to a visual virtual environment which has been enslaved to simulate the human user's head movements or eye movements. Specifically, we have studied the capacity of our experimental subjects to maintain stable spatial orientation in the context of moving their entire visible surroundings by using the parameters of the subjects' natural movements. Our index of the subjects' spatial orientation was the extent of involuntary sways of the body while attempting to stand still, as measured by translations and rotations of the head. We also observed, informally, their symptoms of motion sickness.

Exhibition of stochastic resonance in vestibular tilt motion perception.

PubMed

Galvan-Garza, R C; Clark, T K; Mulavara, A P; Oman, C M

2018-04-03

Stochastic Resonance (SR) is a phenomenon broadly described as "noise benefit". The application of subsensory electrical Stochastic Vestibular Stimulation (SVS) via electrodes behind each ear has been used to improve human balance and gait, but its effect on motion perception thresholds has not been examined. This study investigated the capability of subsensory SVS to reduce vestibular motion perception thresholds in a manner consistent with a characteristic bell-shaped SR curve. We measured upright, head-centered, roll tilt Direction Recognition (DR) thresholds in the dark in 12 human subjects with the application of wideband 0-30 Hz SVS ranging from ±0-700 μA. To conservatively assess if SR was exhibited, we compared the proportions of both subjective and statistical SR exhibition in our experimental data to proportions of SR exhibition in multiple simulation cases with varying underlying SR behavior. Analysis included individual and group statistics. As there is not an established mathematical definition, three humans subjectively judged that SR was exhibited in 78% of subjects. "Statistically significant SR exhibition", which additionally required that a subject's DR threshold with SVS be significantly lower than baseline (no SVS), was present in 50% of subjects. Both percentages were higher than simulations suggested could occur simply by chance. For SR exhibitors, defined by subjective or statistically significant criteria, the mean DR threshold improved by -30% and -39%, respectively. The largest individual improvement was -47%. At least half of the subjects were better able to perceive passive body motion with the application of subsensory SVS. This study presents the first conclusive demonstration of SR in vestibular motion perception. Copyright © 2018 Elsevier Inc. All rights reserved.

Suppression of human anti-inflammatory plasma cytokines IL-10 and IL-1RA with elevation of proinflammatory cytokine IFN-gamma during the isolation of the Antarctic winter

NASA Technical Reports Server (NTRS)

Shearer, William T.; Lee, Bang-Ning; Cron, Stanley G.; Rosenblatt, Howard M.; Smith, E. O'Brian; Lugg, Desmond J.; Nickolls, Peter M.; Sharp, Robert M.; Rollings, Karl; Reuben, James M.

2002-01-01

Cellular immune function has been shown to be decreased and latent virus shedding to be increased in human beings isolated during the Antarctic winter, a model used for assessing some effects of space flight. However, the balance of proinflammatory (IFN-gamma) and anti-inflammatory (IL-10 and IL-1RA) cytokines has not previously been evaluated. We therefore sought to determine whether isolation during the Antarctic winter would alter the proinflammatory and anti-inflammatory cytokine balance. Cytokine levels were measured with ELISA in monthly plasma samples from January through September 1999 in 21 study subjects in the Antarctic and 7 control subjects on Macquarie Island. There was a significant time-dependent increase in plasma IFN-gamma (P =.039) as well as decreases in IL-10 (P =.042) and IL-1RA (P =.053) in the study subjects compared with the control subjects. The study subjects also had significantly increased plasma IFN-gamma levels (P < or =.045) but decreased IL-10 and IL-1RA levels (P < or =.036) at individual time points of isolation. Isolation of human beings in the Antarctic appears to shift the plasma cytokine balance toward a proinflammatory profile. These observations are consistent with T-cell activation that might be due to activation of latent viruses, and they could hold importance for determining the risks of space flight.

Human semen refrigeration at + 4 degrees C: bio-kinetic characteristics.

PubMed

Dondero, Franco; Rossi, Tiziana; Delfino, Michele; Imbrogno, Norina; Cannistrà, Stefania; Mazzilli, Fernando

2006-01-01

The aim of our study was to evaluate the bio-kinetic characteristics of human semen refrigerated for different periods and to compare the effects of refrigeration at +4 degrees C against cryopreservation of human sperm at -196 degrees C. Semen was obtained from 30 male partners of infertile couples (infertile subjects) with the following semen profile: sperm count >or=10 x 10(6)/ml; progressive motility >or=20%; atypical forms <70% and white blood cells <1.0 x 10(6)/ml. Fifteen normospermic subjects were also selected as controls (control subjects). The following tests were carried out on basal, refrigerated and cryopreserved sperm: a) sperm kinetic properties (by Superimposed Image Analysis System); b) the Hypoosmotic Viability Test (HVT) (combined Hypoosmotic Swelling and Viability Test). The results of the study showed that the percentage recovery of kinetic properties and of HVT were optimum for up to 48 h. After refrigeration for 72 h, a drastic decrease in straight motility recovery was observed. No significant differences were observed between cryopreservation and refrigeration at +4 degrees C for 48 h for motility or HVT recoveries in samples from control subjects. However, in infertile subjects, a significant decrease in straight progressive motility and HVT recoveries was observed in cryopreserved samples compared to those refrigerated for 48 h. Neither refrigeration nor cryopreservation led to the growth of pathogenic bacteria in any of the cases studied. Based on the above results, refrigeration could represent a useful alternative to the cryopreservation method.

Contingency learning in human fear conditioning involves the ventral striatum.

PubMed

Klucken, Tim; Tabbert, Katharina; Schweckendiek, Jan; Merz, Christian Josef; Kagerer, Sabine; Vaitl, Dieter; Stark, Rudolf

2009-11-01

The ability to detect and learn contingencies between fearful stimuli and their predictive cues is an important capacity to cope with the environment. Contingency awareness refers to the ability to verbalize the relationships between conditioned and unconditioned stimuli. Although there is a heated debate about the influence of contingency awareness on conditioned fear responses, neural correlates behind the formation process of contingency awareness have gained only little attention in human fear conditioning. Recent animal studies indicate that the ventral striatum (VS) could be involved in this process, but in human studies the VS is mostly associated with positive emotions. To examine this question, we reanalyzed four recently published classical fear conditioning studies (n = 117) with respect to the VS at three distinct levels of contingency awareness: subjects, who did not learn the contingencies (unaware), subjects, who learned the contingencies during the experiment (learned aware) and subjects, who were informed about the contingencies in advance (instructed aware). The results showed significantly increased activations in the left and right VS in learned aware compared to unaware subjects. Interestingly, this activation pattern was only found in learned but not in instructed aware subjects. We assume that the VS is not involved when contingency awareness does not develop during conditioning or when contingency awareness is unambiguously induced already prior to conditioning. VS involvement seems to be important for the transition from a contingency unaware to a contingency aware state. Implications for fear conditioning models as well as for the contingency awareness debate are discussed.

Development of a translational model to screen medications for cocaine use disorder II: Choice between intravenous cocaine and money in humans

PubMed Central

Lile, Joshua A.; Stoops, William W.; Rush, Craig R.; Negus, S. Stevens; Glaser, Paul E. A.; Hatton, Kevin W.; Hays, Lon R.

2016-01-01

Background A medication for treating cocaine use disorder has yet to be approved. Laboratory-based evaluation of candidate medications in animals and humans is a valuable means to demonstrate safety, tolerability and initial efficacy of potential medications. However, animal-to-human translation has been hampered by a lack of coordination. Therefore, we designed homologous cocaine self-administration studies in rhesus monkeys (see companion article) and human subjects in an attempt to develop linked, functionally equivalent procedures for research on candidate medications for cocaine use disorder. Methods Eight (N=8) subjects with cocaine use disorder completed 12 experimental sessions in which they responded to receive money ($0.01, $1.00 and $3.00) or intravenous cocaine (0, 3, 10 and 30 mg/70 kg) under independent, concurrent progressive-ratio schedules. Prior to the completion of 9 choice trials, subjects sampled the cocaine dose available during that session and were informed of the monetary alternative value. Results The allocation of behavior varied systematically as a function of cocaine dose and money value. Moreover, a similar pattern of cocaine choice was demonstrated in rhesus monkeys and humans across different cocaine doses and magnitudes of the species-specific alternative reinforcers. The subjective and cardiovascular responses to IV cocaine were an orderly function of dose, although heart rate and blood pressure remained within safe limits. Conclusions These coordinated studies successfully established drug vs. non-drug choice procedures in humans and rhesus monkeys that yielded similar cocaine choice behavior across species. This translational research platform will be used in future research to enhance the efficiency of developing interventions to reduce cocaine use. PMID:27269368

Development of a translational model to screen medications for cocaine use disorder II: Choice between intravenous cocaine and money in humans.

PubMed

Lile, Joshua A; Stoops, William W; Rush, Craig R; Negus, S Stevens; Glaser, Paul E A; Hatton, Kevin W; Hays, Lon R

2016-08-01

A medication for treating cocaine use disorder has yet to be approved. Laboratory-based evaluation of candidate medications in animals and humans is a valuable means to demonstrate safety, tolerability and initial efficacy of potential medications. However, animal-to-human translation has been hampered by a lack of coordination. Therefore, we designed homologous cocaine self-administration studies in rhesus monkeys (see companion article) and human subjects in an attempt to develop linked, functionally equivalent procedures for research on candidate medications for cocaine use disorder. Eight (N=8) subjects with cocaine use disorder completed 12 experimental sessions in which they responded to receive money ($0.01, $1.00 and $3.00) or intravenous cocaine (0, 3, 10 and 30mg/70kg) under independent, concurrent progressive-ratio schedules. Prior to the completion of 9 choice trials, subjects sampled the cocaine dose available during that session and were informed of the monetary alternative value. The allocation of behavior varied systematically as a function of cocaine dose and money value. Moreover, a similar pattern of cocaine choice was demonstrated in rhesus monkeys and humans across different cocaine doses and magnitudes of the species-specific alternative reinforcers. The subjective and cardiovascular responses to IV cocaine were an orderly function of dose, although heart rate and blood pressure remained within safe limits. These coordinated studies successfully established drug versus non-drug choice procedures in humans and rhesus monkeys that yielded similar cocaine choice behavior across species. This translational research platform will be used in future research to enhance the efficiency of developing interventions to reduce cocaine use. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Knowledge levels of adolescent girls about human papilloma virus and its vaccine.

PubMed

Çetin, Orkun; Verit, Fatma Ferda; Keskin, Seda; Zebitay, Ali Galip; Deregözü, Ayşegül; Usta, Taner; Yücel, Oğuz

2014-06-01

The aim of our study was to evaluate the level of knowledge of the adolescent girls who presented to our clinic about human papilloma virus (HPV) infection and HPV vaccine. Five hundred and one adolescent girls aged between 13 and 18 years who presented to the gynecology outpatient clinic between March 2012 and March 2013 were asked to answer the questions of the questionnaire about HPV and HPV vaccine. The "Participant Information Form" and "HPV Information Assessment Form" were used by examination of the related literature by the investigators. The data obtained were entered into the computer using the SPSS 16.5 program and evaluated. Descriptive statistics were shown with mean, standard deviation, number and percentage values. The mean age of 501 subjects who were included into the study was 15.92 years. 390 subjects (77.8%) who were included in the study had no information about HPV. 111 subjects (22.2%) stated that they heard of HPV before or had information about HPV. The mean age of the subjects who had information about human papilloma virus was found to be 16.52 years. The mean age of 390 subjects (77.8%) who had no information about human papilloma virus was 15.75 years. It was found that only one of the subjects (0.9%) was vaccinated with HPV vaccine. When the subjects who did not wish to be vaccinated were asked for the reason, 40.9% stated that the reason was inadequate information, 26.4% stated that the reason was high cost, 16.4% stated that the reason was the fact that they did not consider themselves at risk and 16.4% stated that the reason was the fact that they were afraid of side effects. In our study, it was found that the adolescent girls who constituted our study group had insufficient information about HPV and HPV vaccine. Verbal, written and visual communication tools and internet should be used intensively and efficiently for the objective of introducing HPV vaccine and teaching the precautions related with prevention of cervix cancer in terms of public health. Primarily pediatrician and gynecologists and family physicians who give service for the adolescence age group should be supported to develop appropriate attitudes and behaviors related with HPV vaccine and infection.

Learning stochastic reward distributions in a speeded pointing task.

PubMed

Seydell, Anna; McCann, Brian C; Trommershäuser, Julia; Knill, David C

2008-04-23

Recent studies have shown that humans effectively take into account task variance caused by intrinsic motor noise when planning fast hand movements. However, previous evidence suggests that humans have greater difficulty accounting for arbitrary forms of stochasticity in their environment, both in economic decision making and sensorimotor tasks. We hypothesized that humans can learn to optimize movement strategies when environmental randomness can be experienced and thus implicitly learned over several trials, especially if it mimics the kinds of randomness for which subjects might have generative models. We tested the hypothesis using a task in which subjects had to rapidly point at a target region partly covered by three stochastic penalty regions introduced as "defenders." At movement completion, each defender jumped to a new position drawn randomly from fixed probability distributions. Subjects earned points when they hit the target, unblocked by a defender, and lost points otherwise. Results indicate that after approximately 600 trials, subjects approached optimal behavior. We further tested whether subjects simply learned a set of stimulus-contingent motor plans or the statistics of defenders' movements by training subjects with one penalty distribution and then testing them on a new penalty distribution. Subjects immediately changed their strategy to achieve the same average reward as subjects who had trained with the second penalty distribution. These results indicate that subjects learned the parameters of the defenders' jump distributions and used this knowledge to optimally plan their hand movements under conditions involving stochastic rewards and penalties.

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

PubMed

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 years ago we launched a pilot ethics committee at our technical university and began soliciting our colleagues to submit their studies for review. In the past year, we have become officially recognized as a human subjects ethics committee for our university and we are beginning the process of requiring all studies using human subjects to apply for our approval. In this article, we consider some of the special problems relating to protecting human participants in a technology context, and discuss some of our experiences and insights about reviewing human subjects research at a technical university, concluding: that not less than in medical studies, human participants used in technology research benefit from ethical committees' reviews, practical requirements for publications, grants, and avoiding legal liability are also served by such committees, and ethics committees in such contexts have many similarities to, but certain other special foci than medical ethics committees. We believe that this experience, and these observations, are helpful for those seeking to establish such committees in technology research contexts, and for framing the particular issues that may arise in such contexts for the benefit of researchers, and nascent committees seeking to establish their own procedures.

34 CFR 97.124 - Conditions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false Conditions. 97.124 Section 97.124 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 Subjects) § 97.124 Conditions...

34 CFR 97.121 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false [Reserved] 97.121 Section 97.121 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 Subjects) § 97.121 [Reserved] ...

34 CFR 97.115 - IRB records.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 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) § 97.115 IRB records... in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these...

EPA Order 1000.17 on Policy and Procedures of Protection of Human Research Subjects in EPA Conducted or Supported Research

EPA Pesticide Factsheets

This Order supersedes EPA Order 1000.17 Policy and Procedures on Protection of Human Subjects, July 30, 1999 including changes thereto, and establishes EPA responsibilities and policies for the use of human subjects in research.

21 CFR 320.27 - Guidelines on the design of a multiple-dose in vivo bioavailability study.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE... subjects in the fasting or nonfasting state, depending upon the conditions reflected in the proposed...

Dynamic resetting of the human circadian pacemaker by intermittent bright light

NASA Technical Reports Server (NTRS)

Rimmer, D. W.; Boivin, D. B.; Shanahan, T. L.; Kronauer, R. E.; Duffy, J. F.; Czeisler, C. A.

2000-01-01

In humans, experimental studies of circadian resetting typically have been limited to lengthy episodes of exposure to continuous bright light. To evaluate the time course of the human endogenous circadian pacemaker's resetting response to brief episodes of intermittent bright light, we studied 16 subjects assigned to one of two intermittent lighting conditions in which the subjects were presented with intermittent episodes of bright-light exposure at 25- or 90-min intervals. The effective duration of bright-light exposure was 31% or 63% compared with a continuous 5-h bright-light stimulus. Exposure to intermittent bright light elicited almost as great a resetting response compared with 5 h of continuous bright light. We conclude that exposure to intermittent bright light produces robust phase shifts of the endogenous circadian pacemaker. Furthermore, these results demonstrate that humans, like other species, exhibit an enhanced sensitivity to the initial minutes of bright-light exposure.

29 CFR 1990.144 - Criteria for consideration of arguments on certain issues.

Code of Federal Regulations, 2011 CFR

2011-07-01

... evaluated based upon scientific and policy judgments. (a) Non-positive results obtained in human epidemiologic studies. Non-positive results obtained in human epidemiologic studies regarding the substance... years' exposure of a group of subjects to the substance and at least 30 years' observation of the...

29 CFR 1990.144 - Criteria for consideration of arguments on certain issues.

Code of Federal Regulations, 2014 CFR

2014-07-01

... evaluated based upon scientific and policy judgments. (a) Non-positive results obtained in human epidemiologic studies. Non-positive results obtained in human epidemiologic studies regarding the substance... years' exposure of a group of subjects to the substance and at least 30 years' observation of the...

29 CFR 1990.144 - Criteria for consideration of arguments on certain issues.

Code of Federal Regulations, 2010 CFR

2010-07-01

... evaluated based upon scientific and policy judgments. (a) Non-positive results obtained in human epidemiologic studies. Non-positive results obtained in human epidemiologic studies regarding the substance... years' exposure of a group of subjects to the substance and at least 30 years' observation of the...

29 CFR 1990.144 - Criteria for consideration of arguments on certain issues.

Code of Federal Regulations, 2013 CFR

2013-07-01

... evaluated based upon scientific and policy judgments. (a) Non-positive results obtained in human epidemiologic studies. Non-positive results obtained in human epidemiologic studies regarding the substance... years' exposure of a group of subjects to the substance and at least 30 years' observation of the...

29 CFR 1990.144 - Criteria for consideration of arguments on certain issues.

Code of Federal Regulations, 2012 CFR

2012-07-01

... evaluated based upon scientific and policy judgments. (a) Non-positive results obtained in human epidemiologic studies. Non-positive results obtained in human epidemiologic studies regarding the substance... years' exposure of a group of subjects to the substance and at least 30 years' observation of the...

Mechanical Kinesiology.

ERIC Educational Resources Information Center

Barham, Jerry N.

Mechanical kinesiology is defined as a study of the mechanical factors affecting human movement, i.e., applying the physical laws of mechanics to the study of human motor behavior. This textbook on the subject is divided into thirty lessons. Each lesson is organized into three parts: a part on the text proper; a part entitled "study…

Neoliberal Mechanisation of Education

ERIC Educational Resources Information Center

Sancar, Can; Sancar, Mine

2012-01-01

This paper aims at examining how neoliberalism actually functions in universities and whether human instruction can actually be replaced by computerized instruction. The study reported in this paper is a qualitative study since it takes reality as a subjective human experience happening in a social context, and in historical time. It mainly…

Chemical mapping of anxiety in the brain of healthy humans: an in vivo 1H-MRS study on the effects of sex, age, and brain region.

PubMed

Grachev, I D; Apkarian, A V

2000-12-01

We recently presented results in an in vivo study of human brain chemistry in 'physiologic' anxiety, i.e., the anxiety of normal everyday life. Normal subjects with high anxiety demonstrated increased concentration of chemicals in orbital frontal cortex (OFC) as compared to lower anxiety. In a separate study of aging we demonstrated a decrease of total chemical concentration in OFC of middle-aged subjects, as compared with younger age. This brain region also showed gender dependence; men demonstrating decreased chemical concentration compared to women. We hypothesized that these sex- and age-dependent differences in OFC chemistry changes are a result of anxiety effects on this brain region. In the present study we examined these sex- and age-differential regional brain chemistry changes (as identified by localized in vivo proton magnetic resonance spectroscopy [1H-MRS]) in relation to the state-trait-anxiety (as measured by the State-Trait Anxiety Inventory) in 35 healthy subjects. The concentrations for all nine chemicals of 1H-MRS spectra were measured relative to creatine across multiple brain regions, including OFC in the left hemisphere. Analysis of variance showed anxiety-specific effects on chemical concentration changes in OFC, which were different for both sexes and age groups. Male subjects showed larger effect of anxiety on OFC chemistry as compared to females when the same sex high-anxiety subjects were compared to lower anxiety. Similarly, middle-aged subjects showed larger effect of anxiety on OFC chemistry as compared to younger age when the same age subjects with high anxiety were compared to lower anxiety. Largest effect of anxiety on OFC chemistry was due to changes of N-Acetyl aspartate. The results indicate that the state-trait anxiety has sex- and age-differential patterns on OFC chemistry in healthy humans, providing new information about the neurobiological roots of anxiety.

Monitoring of PAEMs and beta-agonists in urine for a small group of experimental subjects and PAEs and beta-agonists in drinking water consumed by the same subjects.

PubMed

Liou, Saou-Hsing; Yang, Gordon C C; Wang, Chih-Lung; Chiu, Yu-Han

2014-07-30

This 5-month study contains two parts: (1) to monitor the concentrations of 11 phthalate esters metabolites (PAEMs) and two beta-agonists in human urine samples collected from a small group of consented participants including 16 females and five males; and (2) to analyze the residues of phthalate esters (PAEs) and beta-agonists in various categories of drinking water consumed by the same group of subjects. Each category of human urine and drinking water had 183 samples of its own. The analytical results showed that nine PAEMs were detected in human urine and eight PAEs were detected in drinking water samples. It was found that average concentrations of PAEMs increased as the age increased, but no significant difference between sexes. Further, using the principal component analysis, the loadings of age effect were found to be two times greater than that of gender effect in terms of four DEHP metabolites. Regarding beta-agonists of concern (i.e., ractopamine and salbutamol), they were neither detected in human urine nor drinking water samples in this study. Copyright © 2014 Elsevier B.V. All rights reserved.

Neural Correlates of Human Action Observation in Hearing and Deaf Subjects

PubMed Central

Corina, David; Chiu, Yi-Shiuan; Knapp, Heather; Greenwald, Ralf; Jose-Robertson, Lucia San; Braun, Allen

2007-01-01

Accumulating evidence has suggested the existence of a human action recognition system involving inferior frontal, parietal, and superior temporal regions that may participate in both the perception and execution of actions. However, little is known about the specificity of this system in response to different forms of human action. Here we present data from PET neuroimaging studies from passive viewing of three distinct action types, intransitive self-oriented actions (e.g., stretching, rubbing one’s eyes, etc.), transitive object-oriented actions (e.g., opening a door, lifting a cup to the lips to drink), and the abstract, symbolic actions–signs used in American Sign Language. Our results show that these different classes of human actions engage a frontal/parietal/STS human action recognition system in a highly similar fashion. However, the results indicate that this neural consistency across motion classes is true primarily for hearing subjects. Data from deaf signers shows a non-uniform response to different classes of human actions. As expected, deaf signers engaged left-hemisphere perisylvian language areas during the perception of signed language signs. Surprisingly, these subjects did not engage the expected frontal/parietal/STS circuitry during passive viewing of non-linguistic actions, but rather reliably activated middle-occipital temporal-ventral regions which are known to participate in the detection of human bodies, faces, and movements. Comparisons with data from hearing subjects establish statistically significant contributions of middle-occipital temporal-ventral during the processing of non-linguistic actions in deaf signers. These results suggest that during human motion processing, deaf individuals may engage specialized neural systems that allow for rapid, online differentiation of meaningful linguistic actions from non-linguistic human movements. PMID:17459349

The precuneus may encode irrationality in human gambling.

PubMed

Sacre, P; Kerr, M S D; Subramanian, S; Kahn, K; Gonzalez-Martinez, J; Johnson, M A; Sarma, S V; Gale, J T

2016-08-01

Humans often make irrational decisions, especially psychiatric patients who have dysfunctional cognitive and emotional circuitry. Understanding the neural basis of decision-making is therefore essential towards patient management, yet current studies suffer from several limitations. Functional magnetic resonance imaging (fMRI) studies in humans have dominated decision-making neuroscience, but have poor temporal resolution and the blood oxygenation level-dependent signal is only a proxy for neural activity. On the other hand, lesion studies in humans used to infer functionality in decision-making lack characterization of neural activity altogether. Using a combination of local field potential recordings in human subjects performing a financial decision-making task, spectral analyses, and non-parametric cluster statistics, we analyzed the activity in the precuneus. In nine subjects, the neural activity modulated significantly between rational and irrational trials in the precuneus (p <; 0.001). In particular, high-frequency activity (70-100 Hz) increased when irrational decisions were made. Although preliminary, these results suggest suppression of gamma rhythms via electrical stimulation in the precuneus as a therapeutic intervention for pathological decision-making.

Sensing human physiological response using wearable carbon nanotube-based fabrics

NASA Astrophysics Data System (ADS)

Wang, Long; Loh, Kenneth J.; Koo, Helen S.

2016-04-01

Flexible and wearable sensors for human monitoring have received increased attention. Besides detecting motion and physical activity, measuring human vital signals (e.g., respiration rate and body temperature) provide rich data for assessing subjects' physiological or psychological condition. Instead of using conventional, bulky, sensing transducers, the objective of this study was to design and test a wearable, fabric-like sensing system. In particular, multi-walled carbon nanotube (MWCNT)-latex thin films of different MWCNT concentrations were first fabricated using spray coating. Freestanding MWCNT-latex films were then sandwiched between two layers of flexible fabric using iron-on adhesive to form the wearable sensor. Second, to characterize its strain sensing properties, the fabric sensors were subjected to uniaxial and cyclic tensile load tests, and they exhibited relatively stable electromechanical responses. Finally, the wearable sensors were placed on a human subject for monitoring simple motions and for validating their practical strain sensing performance. Overall, the wearable fabric sensor design exhibited advances such as flexibility, ease of fabrication, light weight, low cost, noninvasiveness, and user comfort.

Brain Consequences of Spinal Cord Injury with and without Neuropathic Pain: Translating Animal Models of Neuroinflammation onto Human Neural Networks and Back

DTIC Science & Technology

2016-10-01

During year one , we have: Obtained IRB and HRPO approval for the human studies , obtained IACUC and ACURO approval for the animal studies , refined the...human study protocol and collected PET-MR data on healthy individuals and spinal cord injured subjects, developed the rodent imaging procedures...qualtiative synthesis of the current state of the field, and 6 studies can be included in a quantitative meta-analysis. The studies eligible for inclusion in

Neural mechanisms underlying contextual dependency of subjective values: converging evidence from monkeys and humans.

PubMed

Abitbol, Raphaëlle; Lebreton, Maël; Hollard, Guillaume; Richmond, Barry J; Bouret, Sébastien; Pessiglione, Mathias

2015-02-04

A major challenge for decision theory is to account for the instability of expressed preferences across time and context. Such variability could arise from specific properties of the brain system used to assign subjective values. Growing evidence has identified the ventromedial prefrontal cortex (VMPFC) as a key node of the human brain valuation system. Here, we first replicate this observation with an fMRI study in humans showing that subjective values of painting pictures, as expressed in explicit pleasantness ratings, are specifically encoded in the VMPFC. We then establish a bridge with monkey electrophysiology, by comparing single-unit activity evoked by visual cues between the VMPFC and the orbitofrontal cortex. At the neural population level, expected reward magnitude was only encoded in the VMPFC, which also reflected subjective cue values, as expressed in Pavlovian appetitive responses. In addition, we demonstrate in both species that the additive effect of prestimulus activity on evoked activity has a significant impact on subjective values. In monkeys, the factor dominating prestimulus VMPFC activity was trial number, which likely indexed variations in internal dispositions related to fatigue or satiety. In humans, prestimulus VMPFC activity was externally manipulated through changes in the musical context, which induced a systematic bias in subjective values. Thus, the apparent stochasticity of preferences might relate to the VMPFC automatically aggregating the values of contextual features, which would bias subsequent valuation because of temporal autocorrelation in neural activity. Copyright © 2015 the authors 0270-6474/15/352308-13$15.00/0.

45 CFR 690.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 3 2014-10-01 2014-10-01 false Research undertaken without the intention of involving human subjects. 690.119 Section 690.119 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.119 Research undertaken without...

34 CFR 97.112 - Review by institution.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false Review by institution. 97.112 Section 97.112 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 Subjects) § 97.112 Review by...

34 CFR 97.117 - Documentation of informed consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false Documentation of informed consent. 97.117 Section 97.117 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 Subjects...

42 CFR 86.33 - Human subjects; animal welfare.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 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 86.33 - Human subjects; animal welfare.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 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 86.33 - Human subjects; animal welfare.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 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 86.33 - Human subjects; animal welfare.

Code of Federal Regulations, 2010 CFR

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 86.33 - Human subjects; animal welfare.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 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...

Air Force Academy Homepage

Science.gov Websites

Chaplain Corps Cadet Chapel Community Center Chapel Institutional Review Board Not Human Subjects Research Requirements 7 Not Human Subjects Research Form 8 Researcher Instructions - Activities Submitted to DoD IRB 9 Review 18 Not Human Subjects Errors 19 Exempt Research Most Frequent Errors 20 Most Frequent Errors for

21 CFR 50.25 - Elements of informed consent.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic... the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if...

45 CFR 690.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention... 45 Public Welfare 3 2011-10-01 2011-10-01 false Research undertaken without the intention of...

45 CFR 690.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention... 45 Public Welfare 3 2010-10-01 2010-10-01 false Research undertaken without the intention of...

45 CFR 46.109 - IRB review of research.

Code of Federal Regulations, 2010 CFR

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...

40 CFR 26.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or... policy, no investigator may involve a human being as a subject in research covered by this policy unless... rights, or releases or appears to release the investigator, the sponsor, the institution or its agents...

21 CFR 50.25 - Elements of informed consent.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic... pertinent questions about the research and research subjects' rights, and whom to contact in the event of a...

Some influences of touch and pressure cues on human spatial orientation

NASA Technical Reports Server (NTRS)

Lackner, J. R.; Graybiel, A.

1978-01-01

In order to evaluate the influences of touch and pressure cues on human spatial orientation, blindfolded subjects were exposed to 30 rmp rotation about the Z-axis of their bodies while the axis was horizontal or near horizontal. It was found that the manipulation of pressure patterns to which the subjects are exposed significantly influences apparent orientation. When provided with visual information about actual orientation the subjects will eliminate the postural illusions created by pressure-cue patterns. The localization of sounds is dependent of the apparent orientation and the actual pattern of auditory stimulation. The study provides a basis for investigating: (1) the postural illusions experienced by astronauts in orbital flight and subjects in the free-fall phase of parabolic flight, and (2) the spatial-constancy mechanisms distinguishing changes in sensory afflux conditioned by a subject's movements in relation to the environment, and those conditioned by movements of the environment.

Pro-Inflammatory wnt5a and Anti-Inflammatory sFRP5 Are Differentially Regulated by Nutritional Factors in Obese Human Subjects

PubMed Central

Schulte, Dominik M.; Müller, Nike; Neumann, Katrin; Oberhäuser, Frank; Faust, Michael; Güdelhöfer, Heike; Brandt, Burkhard; Krone, Wilhelm; Laudes, Matthias

2012-01-01

Background Obesity is associated with macrophage infiltration of adipose tissue. These inflammatory cells affect adipocytes not only by classical cytokines but also by the secreted glycopeptide wnt5a. Healthy adipocytes are able to release the wnt5a inhibitor sFRP5. This protective effect, however, was found to be diminished in obesity. The aim of the present study was to examine (1) whether obese human subjects exhibit increased serum concentrations of wnt5a and (2) whether wnt5a and/or sFRP5 serum concentrations in obese subjects can be influenced by caloric restriction. Methodology 23 obese human subjects (BMI 44.1±1.1 kg/m2) and 12 age- and sex-matched lean controls (BMI 22.3±0.4 kg/m2) were included in the study. Obese subjects were treated with a very low-calorie diet (approximately 800 kcal/d) for 12 weeks. Body composition was assessed by impedance analysis, insulin sensitivity was estimated by HOMA-IR and the leptin-to-adiponectin ratio and wnt5a and sFRP5 serum concentrations were measured by ELISA. sFRP5 expression in human adipose tissue biopsies was further determined on protein level by immunohistology. Principal Findings Pro-inflammatory wnt5a was not measurable in any serum sample of lean control subjects. In patients with obesity, however, wnt5a became significantly detectable consistent with low grade inflammation in such subjects. Caloric restriction resulted in a weight loss from 131.9±4.0 to 112.3±3.2 kg in the obese patients group. This was accompanied by a significant decrease of HOMA-IR and leptin-to-adiponectin ratio, indicating improved insulin sensitivity. Interestingly, these metabolic improvements were associated with a significant increase in serum concentrations of the anti-inflammatory factor and wnt5a-inhibitor sFRP5. Conclusions/Significance Obesity is associated with elevated serum levels of pro-inflammatory wnt5a in humans. Furthermore, caloric restriction beneficially affects serum concentrations of anti-inflammatory sFRP5 in such subjects. These findings suggest a novel regulatory system in low grade inflammation in obesity, which can be influenced by nutritional therapy. PMID:22384249

Thirst-Dependent Activity of the Insular Cortex Reflects its Emotion-Related Subdivision: A Cerebral Blood Flow Study.

PubMed

Meier, Lea; Federspiel, Andrea; Jann, Kay; Wiest, Roland; Strik, Werner; Dierks, Thomas

2018-04-26

Recent studies investigating neural correlates of human thirst have identified various subcortical and telencephalic brain areas. The experience of thirst represents a homeostatic emotion and a state that slowly evolves over time. Therefore, the present study aims at systematically examining cerebral perfusion during the parametric progression of thirst. We measured subjective thirst ratings, serum parameters and cerebral blood flow in 20 healthy subjects across four different thirst stages: intense thirst, moderate thirst, subjective satiation and physiological satiation. Imaging data revealed dehydration-related perfusion differences in previously identified brain areas, such as the anterior cingulate cortex, the middle temporal gyrus and the insular cortex. However, significant differences across all four thirst stages (including the moderate thirst level), were exclusively found in the posterior insular cortex. The subjective thirst ratings over the different thirst stages, however, were associated with perfusion differences in the right anterior insula. These findings add to our understanding of the insular cortex as a key player in human thirst - both on the level of physiological dehydration and the level of the subjective thirst experience. Copyright © 2018. Published by Elsevier Ltd.

Human movement analysis with image processing in real time

NASA Astrophysics Data System (ADS)

Fauvet, Eric; Paindavoine, Michel; Cannard, F.

1991-04-01

In the field of the human sciences, a lot of applications needs to know the kinematic characteristics of the human movements Psycology is associating the characteristics with the control mechanism, sport and biomechariics are associating them with the performance of the sportman or of the patient. So the trainers or the doctors can correct the gesture of the subject to obtain a better performance if he knows the motion properties. Roherton's studies show the children motion evolution2 . Several investigations methods are able to measure the human movement But now most of the studies are based on image processing. Often the systems are working at the T.V. standard (50 frame per secund ). they permit only to study very slow gesture. A human operator analyses the digitizing sequence of the film manually giving a very expensive, especially long and unprecise operation. On these different grounds many human movement analysis systems were implemented. They consist of: - markers which are fixed to the anatomical interesting points on the subject in motion, - Image compression which is the art to coding picture data. Generally the compression Is limited to the centroid coordinates calculation tor each marker. These systems differ from one other in image acquisition and markers detection.

The neurophysiology of biological motion perception in schizophrenia

PubMed Central

Jahshan, Carol; Wynn, Jonathan K; Mathis, Kristopher I; Green, Michael F

2015-01-01

Introduction The ability to recognize human biological motion is a fundamental aspect of social cognition that is impaired in people with schizophrenia. However, little is known about the neural substrates of impaired biological motion perception in schizophrenia. In the current study, we assessed event-related potentials (ERPs) to human and nonhuman movement in schizophrenia. Methods Twenty-four subjects with schizophrenia and 18 healthy controls completed a biological motion task while their electroencephalography (EEG) was simultaneously recorded. Subjects watched clips of point-light animations containing 100%, 85%, or 70% biological motion, and were asked to decide whether the clip resembled human or nonhuman movement. Three ERPs were examined: P1, N1, and the late positive potential (LPP). Results Behaviorally, schizophrenia subjects identified significantly fewer stimuli as human movement compared to healthy controls in the 100% and 85% conditions. At the neural level, P1 was reduced in the schizophrenia group but did not differ among conditions in either group. There were no group differences in N1 but both groups had the largest N1 in the 70% condition. There was a condition × group interaction for the LPP: Healthy controls had a larger LPP to 100% versus 85% and 70% biological motion; there was no difference among conditions in schizophrenia subjects. Conclusions Consistent with previous findings, schizophrenia subjects were impaired in their ability to recognize biological motion. The EEG results showed that biological motion did not influence the earliest stage of visual processing (P1). Although schizophrenia subjects showed the same pattern of N1 results relative to healthy controls, they were impaired at a later stage (LPP), reflecting a dysfunction in the identification of human form in biological versus nonbiological motion stimuli. PMID:25722951

Ultrasonic propulsion of kidney stones: preliminary results of human feasibility study.

PubMed

Bailey, Michael; Cunitz, Bryan; Dunmire, Barbrina; Paun, Marla; Lee, Franklin; Ross, Susan; Lingeman, James; Coburn, Michael; Wessells, Hunter; Sorensen, Mathew; Harper, Jonathan

2014-09-03

One in 11 Americans has experienced kidney stones, with a 50% average recurrence rate within 5-10 years. Ultrasonic propulsion (UP) offers a potential method to expel small stones or residual fragments before they become a recurrent problem. Reported here are preliminary findings from the first investigational use of UP in humans. The device uses a Verasonics ultrasound engine and Philips HDI C5-2 probe to generate real-time B-mode imaging and targeted "push" pulses on demand. There are three arms of the study: de novo stones, post-lithotripsy fragments, and the preoperative setting. A pain questionnaire is completed prior to and following the study. Movement is classified based on extent. Patients are followed for 90 days. Ten subjects have been treated to date: three de novo , five post-lithotripsy, and two preoperative. None of the subjects reported pain associated with the treatment or a treatment related adverse event, beyond the normal discomfort of passing a stone. At least one stone was moved in all subjects. Three of five post-lithotripsy subjects passed a single or multiple stones within 1-2 weeks following treatment; one subject passed two (1-2 mm) fragments before leaving clinic. In the pre-operative studies we successfully moved 7 - 8 mm stones. In four subjects, UP revealed multiple stone fragments where the clinical image and initial ultrasound examination indicated a single large stone.

Adapting human-machine interfaces to user performance.

PubMed

Danziger, Zachary; Fishbach, Alon; Mussa-Ivaldi, Ferdinando A

2008-01-01

The goal of this study was to create and examine machine learning algorithms that adapt in a controlled and cadenced way to foster a harmonious learning environment between the user of a human-machine interface and the controlled device. In this experiment, subjects' high-dimensional finger motions remotely controlled the joint angles of a simulated planar 2-link arm, which was used to hit targets on a computer screen. Subjects were required to move the cursor at the endpoint of the simulated arm.

Prophylaxis of Plasmodium falciparum Infection in a Human Challenge Model with WR 238605, a New 8-Aminoquinoline Antimalarial

PubMed Central

Brueckner, Ralf P.; Coster, Trinka; Wesche, David L.; Shmuklarsky, Moshe; Schuster, Brian G.

1998-01-01

The prophylactic efficacy of WR 238605, a primaquine analog, was studied with a human Plasmodium falciparum challenge model. A single oral dose of 600 mg, administered 1 day prior to challenge, successfully protected three of four subjects. The fourth subject developed mild, oligosymptomatic malaria on day 31, with drug concentrations one-half of those in the protected individuals. WR 238605 appears to be a promising prophylactic drug for P. falciparum malaria. PMID:9593172

A population MRI brain template and analysis tools for the macaque.

PubMed

Seidlitz, Jakob; Sponheim, Caleb; Glen, Daniel; Ye, Frank Q; Saleem, Kadharbatcha S; Leopold, David A; Ungerleider, Leslie; Messinger, Adam

2018-04-15

The use of standard anatomical templates is common in human neuroimaging, as it facilitates data analysis and comparison across subjects and studies. For non-human primates, previous in vivo templates have lacked sufficient contrast to reliably validate known anatomical brain regions and have not provided tools for automated single-subject processing. Here we present the "National Institute of Mental Health Macaque Template", or NMT for short. The NMT is a high-resolution in vivo MRI template of the average macaque brain generated from 31 subjects, as well as a neuroimaging tool for improved data analysis and visualization. From the NMT volume, we generated maps of tissue segmentation and cortical thickness. Surface reconstructions and transformations to previously published digital brain atlases are also provided. We further provide an analysis pipeline using the NMT that automates and standardizes the time-consuming processes of brain extraction, tissue segmentation, and morphometric feature estimation for anatomical scans of individual subjects. The NMT and associated tools thus provide a common platform for precise single-subject data analysis and for characterizations of neuroimaging results across subjects and studies. Copyright © 2017 ElsevierCompany. All rights reserved.

Anti-aging proof of concept study: results and summary.

PubMed

Bruce, Suzanne; Karnik, Jwala; Dryer, Laurence; Burkholder, David

2014-09-01

The etiology of aging human skin includes intrinsic physiologic changes greatly accelerated by photoaging, predominantly through exposure to UV light. Consumer interest and demand for anti-aging skin care products is extremely high especially in light of aging populations. Prenatal (fetal) tissue has been shown to possess healing characteristics and regenerative effects. A proprietary tissue engineering technology has been developed to produce a soluble human extracellular matrix material with growth factors and proteins. Neonatal cells are cultured on microbeads under conditions of low oxygen tension. This human cell-conditioned media (hCCM) contains a variety of growth factors and cytokines similar to those found in fetal cells and has been incorporated into a topical preparation for use in facial wound healing (after laser resurfacing procedures) and improving the appearance of aging skin. The objective of this study was to observe the effects of an MRCx™-containing topical skincare regimen on subjects with demonstrated aging skin damage (photodamage) when used consistently over a 3 month time period. Female subjects age 35-65 with Fitzpatrick Skin Type I-IV and mild to moderate amounts of photodamage, fine lines, and wrinkles used Regenica® Replenishing Crème and Regenica® Renew SPF 15 for 3 months. At each visit, photos were taken of subjects while investigators completed skin grading assessments and subjects completed self-assessments. Investigator assessments included evaluation of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance, and translucence on a 5-point scale. Subjects' self-assessments included assessment of fine lines and wrinkles, firmness, evenness of skin tone, brightness, resilience, clarity, and radiance. Changes from baseline were evaluated for each parameter and P values for changes from baseline to each study visit for investigator's assessments and to end-of-study for self-assessments were calculated. Eighteen of 21 enrolled female subjects completed the study. Three subjects chose to drop from the study. Statistically significant improvements in investigator assessments of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance and translucency compared to baseline were observed at weeks 4, 8, and 12 after initiating treatments. Progressive improvement was seen through the last study visit (visit 5, week 12). Similar statistically significant improvements in subjects' self-assessments were seen comparing the first post-baseline visit (visit 2, week 2) to subsequent visits. 93.5 % subjects agreed (somewhat or strongly) with all of the positive subject assessment statements at week 12. Importantly, 100 % of subjects indicated at the end of the study that they would recommend the product to a friend and would want to purchase the product. No treatment-related adverse events were recorded during the study. Regenica was safe and clinically effective in reducing anti-aging effects in this group of female subjects aged 35-65 years as measured by both investigator assessments and subjects' self-assessments.

Geographic Information System and tools of spatial analysis in a pneumococcal vaccine trial

PubMed Central

2012-01-01

Background The goal of this Geographic Information System (GIS) study was to obtain accurate information on the locations of study subjects, road network and services for research purposes so that the clinical outcomes of interest (e.g., vaccine efficacy, burden of disease, nasopharyngeal colonization and its reduction) could be linked and analyzed at a distance from health centers, hospitals, doctors and other important services. The information on locations can be used to investigate more accurate crowdedness, herd immunity and/or transmission patterns. Method A randomized, placebo-controlled, double-blind trial of an 11-valent pneumococcal conjugate vaccine (11PCV) was conducted in Bohol Province in central Philippines, from July 2000 to December 2004. We collected the information on the geographic location of the households (N = 13,208) of study subjects. We also collected a total of 1982 locations of health and other services in the six municipalities and a comprehensive GIS data over the road network in the area. Results We calculated the numbers of other study subjects (vaccine and placebo recipients, respectively) within the neighborhood of each study subject. We calculated distances to different services and identified the subjects sharing the same services (calculated by distance). This article shows how to collect a complete GIS data set for human to human transmitted vaccine study in developing country settings in an efficient and economical way. Conclusions The collection of geographic locations in intervention trials should become a routine task. The results of public health research may highly depend on spatial relationships among the study subjects and between the study subjects and the environment, both natural and infrastructural. Trial registration number ISRCTN: ISRCTN62323832 PMID:22264271

77 FR 60116 - Human Studies Review Board; Notification of a Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

... advise the Agency on the EPA scientific and ethical reviews of research with human subjects. DATES: This... and ethics issues under discussion, it is not our intent to permit organizations to expand the time..., information, and recommendations to the EPA on issues related to scientific and ethical aspects of human...

Psychoanalysis and Humanism: A Review and Critical Examination of Integrationist Efforts with Some Proposed Resolutions.

ERIC Educational Resources Information Center

Hansen, James T.

2000-01-01

Critically reviews efforts at theoretical integration of psychoanalysis and humanism along the lines of F. Pine's (1990) four psychologies of psychoanalysis. Concludes that psychoanalysis and humanism have certain compatible features, but that they generally represent opposing vantage points in the study of subjectivity. Provides recommendations…

Manipulation of arousal and its effects on human vestibular nystagmus induced by caloric irrigation and angular accelerations.

DOT National Transportation Integrated Search

1962-10-01

Alterations in the nystagmic reaction of human subjects exposed to vestibular stimulation have been frequently noted in studies of drug effects, habituation, and general features of the labyrinthine response.

Human performance measuring device

NASA Technical Reports Server (NTRS)

Michael, J.; Scow, J.

1970-01-01

Complex coordinator, consisting of operator control console, recorder, subject display panel, and limb controls, measures human performance by testing perceptual and motor skills. Device measures psychophysiological functions in drug and environmental studies, and is applicable to early detection of psychophysiological body changes.

Perceptual category learning of photographic and painterly stimuli in rhesus macaques (Macaca mulatta) and humans

PubMed Central

Jensen, Greg; Terrace, Herbert

2017-01-01

Humans are highly adept at categorizing visual stimuli, but studies of human categorization are typically validated by verbal reports. This makes it difficult to perform comparative studies of categorization using non-human animals. Interpretation of comparative studies is further complicated by the possibility that animal performance may merely reflect reinforcement learning, whereby discrete features act as discriminative cues for categorization. To assess and compare how humans and monkeys classified visual stimuli, we trained 7 rhesus macaques and 41 human volunteers to respond, in a specific order, to four simultaneously presented stimuli at a time, each belonging to a different perceptual category. These exemplars were drawn at random from large banks of images, such that the stimuli presented changed on every trial. Subjects nevertheless identified and ordered these changing stimuli correctly. Three monkeys learned to order naturalistic photographs; four others, close-up sections of paintings with distinctive styles. Humans learned to order both types of stimuli. All subjects classified stimuli at levels substantially greater than that predicted by chance or by feature-driven learning alone, even when stimuli changed on every trial. However, humans more closely resembled monkeys when classifying the more abstract painting stimuli than the photographic stimuli. This points to a common classification strategy in both species, one that humans can rely on in the absence of linguistic labels for categories. PMID:28961270

[Medical research and vulnerable subjects: unemployed people].

PubMed

Niebrój, Lesław

2006-01-01

Although the importance of medical research for the diagnosis and treatment of human diseases is unquestionable, the use of human subjects, however, still presents a complex ethical problem. Moral difficulties occur in particular when the medical research deals with vulnerable subjects. Vulnerable individuals are defined as those who experience diminished actual autonomy. Among the groups which should be considered as being vulnerable are usually listed the following: children, pregnant women, mentally or emotionally disabled, physically disabled, homeless, and institutionalized people. This study addresses key concerns that gave rise to the question of whether unemployed people had to be recognized as vulnerable subjects. The term "vulnerability" was clarified and it was assumed that the "vulnerability" of medical research subjects' had to be understood as a form of continuum from potential, through the circumstantial, temporal, episodic, permanent to inevitable vulnerability. The conclusion was drawn that unemployed people were, at least, potentially vulnerable subjects. Research involving unemployed people presents important moral challenges to researchers and should be undertaken very carefully, following special ethical guidelines.

Leptin in human physiology and pathophysiology

PubMed Central

Magkos, Faidon; Brinkoetter, Mary; Sienkiewicz, Elizabeth; Dardeno, Tina A.; Kim, Sang-Yong; Hamnvik, Ole-Petter R.; Koniaris, Anastasia

2011-01-01

Leptin, discovered through positional cloning 15 years ago, is an adipocyte-secreted hormone with pleiotropic effects in the physiology and pathophysiology of energy homeostasis, endocrinology, and metabolism. Studies in vitro and in animal models highlight the potential for leptin to regulate a number of physiological functions. Available evidence from human studies indicates that leptin has a mainly permissive role, with leptin administration being effective in states of leptin deficiency, less effective in states of leptin adequacy, and largely ineffective in states of leptin excess. Results from interventional studies in humans demonstrate that leptin administration in subjects with congenital complete leptin deficiency or subjects with partial leptin deficiency (subjects with lipoatrophy, congenital or related to HIV infection, and women with hypothalamic amenorrhea) reverses the energy homeostasis and neuroendocrine and metabolic abnormalities associated with these conditions. More specifically, in women with hypothalamic amenorrhea, leptin helps restore abnormalities in hypothalamic-pituitary-peripheral axes including the gonadal, thyroid, growth hormone, and to a lesser extent adrenal axes. Furthermore, leptin results in resumption of menses in the majority of these subjects and, in the long term, may increase bone mineral content and density, especially at the lumbar spine. In patients with congenital or HIV-related lipoatrophy, leptin treatment is also associated with improvements in insulin sensitivity and lipid profile, concomitant with reduced visceral and ectopic fat deposition. In contrast, leptin's effects are largely absent in the obese hyperleptinemic state, probably due to leptin resistance or tolerance. Hence, another emerging area of research pertains to the discovery and/or usefulness of leptin sensitizers. Results from ongoing studies are expected to further increase our understanding of the role of leptin and the potential clinical applications of leptin or its analogs in human therapeutics. PMID:21791620

Varieties of Stimulus Control in Matching-to-Sample: A Kernel Analysis

ERIC Educational Resources Information Center

Fields, Lanny; Garruto, Michelle; Watanabe, Mari

2010-01-01

Conditional discrimination or matching-to-sample procedures have been used to study a wide range of complex psychological phenomena with infrahuman and human subjects. In most studies, the percentage of trials in which a subject selects the comparison stimulus that is related to the sample stimulus is used to index the control exerted by the…

In Vivo Imaging of the Human Retinal Pigment Epithelial Mosaic Using Adaptive Optics Enhanced Indocyanine Green Ophthalmoscopy

PubMed Central

Tam, Johnny; Liu, Jianfei; Dubra, Alfredo; Fariss, Robert

2016-01-01

Purpose The purpose of this study was to establish that retinal pigment epithelial (RPE) cells take up indocyanine green (ICG) dye following systemic injection and that adaptive optics enhanced indocyanine green ophthalmoscopy (AO-ICG) enables direct visualization of the RPE mosaic in the living human eye. Methods A customized adaptive optics scanning light ophthalmoscope (AOSLO) was used to acquire high-resolution retinal fluorescence images of residual ICG dye in human subjects after intravenous injection at the standard clinical dose. Simultaneously, multimodal AOSLO images were also acquired, which included confocal reflectance, nonconfocal split detection, and darkfield. Imaging was performed in 6 eyes of three healthy subjects with no history of ocular or systemic diseases. In addition, histologic studies in mice were carried out. Results The AO-ICG channel successfully resolved individual RPE cells in human subjects at various time points, including 20 minutes and 2 hours after dye administration. Adaptive optics-ICG images of RPE revealed detail which could be correlated with AO dark-field images of the same cells. Interestingly, there was a marked heterogeneity in the fluorescence of individual RPE cells. Confirmatory histologic studies in mice corroborated the specific uptake of ICG by the RPE layer at a late time point after systemic ICG injection. Conclusions Adaptive optics-enhanced imaging of ICG dye provides a novel way to visualize and assess the RPE mosaic in the living human eye alongside images of the overlying photoreceptors and other cells. PMID:27564519

In Vivo Imaging of the Human Retinal Pigment Epithelial Mosaic Using Adaptive Optics Enhanced Indocyanine Green Ophthalmoscopy.

PubMed

Tam, Johnny; Liu, Jianfei; Dubra, Alfredo; Fariss, Robert

2016-08-01

The purpose of this study was to establish that retinal pigment epithelial (RPE) cells take up indocyanine green (ICG) dye following systemic injection and that adaptive optics enhanced indocyanine green ophthalmoscopy (AO-ICG) enables direct visualization of the RPE mosaic in the living human eye. A customized adaptive optics scanning light ophthalmoscope (AOSLO) was used to acquire high-resolution retinal fluorescence images of residual ICG dye in human subjects after intravenous injection at the standard clinical dose. Simultaneously, multimodal AOSLO images were also acquired, which included confocal reflectance, nonconfocal split detection, and darkfield. Imaging was performed in 6 eyes of three healthy subjects with no history of ocular or systemic diseases. In addition, histologic studies in mice were carried out. The AO-ICG channel successfully resolved individual RPE cells in human subjects at various time points, including 20 minutes and 2 hours after dye administration. Adaptive optics-ICG images of RPE revealed detail which could be correlated with AO dark-field images of the same cells. Interestingly, there was a marked heterogeneity in the fluorescence of individual RPE cells. Confirmatory histologic studies in mice corroborated the specific uptake of ICG by the RPE layer at a late time point after systemic ICG injection. Adaptive optics-enhanced imaging of ICG dye provides a novel way to visualize and assess the RPE mosaic in the living human eye alongside images of the overlying photoreceptors and other cells.

Dopamine D3 receptor-preferring agonist enhances the subjective effects of cocaine in humans

PubMed Central

Newton, Thomas F.; Haile, Colin N.; Mahoney, James J.; Shah, Ravi; Verrico, Christopher D.; De La Garza, Richard; Kosten, Thomas R.

2015-01-01

Pramipexole is a D3 dopamine receptor-preferring agonist indicated for the treatment of Parkinson disease. Studies associate pramipexole with pathological gambling and impulse control disorders suggesting a role for D3 receptors in reinforcement processes. Clinical studies showed pramipexole decreased cocaine craving and reversed central deficits in individuals with cocaine use disorder. Preclinical studies have shown acute administration of pramipexole increases cocaine’s reinforcing effects whereas other reports suggest chronic pramipexole produces tolerance to cocaine. In a randomized, double-blind, placebo-controlled study we examined the impact of pramipexole treatment on the subjective effects produced by cocaine in volunteers with cocaine use disorder. Volunteers received pramipexole titrated up to 3.0 mg/d or placebo over 15 days. Participants then received intravenous cocaine (0, 20 and 40 mg) on day 15. Cardiovascular and subjective effects were obtained with visual analog scales at time points across the session. Pramipexole alone increased peak heart rate following saline and diastolic blood pressure following cocaine. Pramipexole produced upwards of two-fold increases in positive subjective effects ratings following cocaine. These results indicate that chronic D3 receptor activation increases the subjective effects of cocaine in humans. Caution should be used when prescribing pramipexole to patients that may also use cocaine. PMID:26239766

Dopamine D3 receptor-preferring agonist enhances the subjective effects of cocaine in humans.

PubMed

Newton, Thomas F; Haile, Colin N; Mahoney, James J; Shah, Ravi; Verrico, Christopher D; De La Garza, Richard; Kosten, Thomas R

2015-11-30

Pramipexole is a D3 dopamine receptor-preferring agonist indicated for the treatment of Parkinson disease. Studies associate pramipexole with pathological gambling and impulse control disorders suggesting a role for D3 receptors in reinforcement processes. Clinical studies showed pramipexole decreased cocaine craving and reversed central deficits in individuals with cocaine use disorder. Preclinical studies have shown acute administration of pramipexole increases cocaine's reinforcing effects whereas other reports suggest chronic pramipexole produces tolerance to cocaine. In a randomized, double-blind, placebo-controlled study we examined the impact of pramipexole treatment on the subjective effects produced by cocaine in volunteers with cocaine use disorder. Volunteers received pramipexole titrated up to 3.0mg/d or placebo over 15 days. Participants then received intravenous cocaine (0, 20 and 40mg) on day 15. Cardiovascular and subjective effects were obtained with visual analog scales at time points across the session. Pramipexole alone increased peak heart rate following saline and diastolic blood pressure following cocaine. Pramipexole produced upwards of two-fold increases in positive subjective effects ratings following cocaine. These results indicate that chronic D3 receptor activation increases the subjective effects of cocaine in humans. Caution should be used when prescribing pramipexole to patients that may also use cocaine. Published by Elsevier Ireland Ltd.

On the subjectivity of personality theory.

PubMed

Atwood, G E; Tomkins, S S

1976-04-01

Every theorist of personality views the human condition from the unique perspective of his own individuality. As a consequence, personality theories are strongly influenced by personal and subjective factors. These influences are partially responsible for the present day lack of consensus in psychology as to basic conceptual frameworks for the study of man. The science of human personality can achieve a greater degree of consensus and generality only if it begins to turn back on itself and question its own psychological foundations. The role of subjective and personal factors in this field can be studied and made more explicit by means of a psychobiographical method which interprets the major ideas of personality theories in the light of the formative experiences in the respective theorists' lives. This method is briefly illustrated by an examination of the influence of personal experiences on theoretical concepts in the work of Carl Jung, Carl Rogers, Wilhelm Reich, and Gordon Allport. The subjective factors disclosed by psychobiographical analysis can bee seen to interact with influences stemming from the intellectual and historical context within which the theorist work. The psychobiographical study of personality theory is only one part of a larger discipline, the psychology of knowledge, which would study the role of subjective and personal factors in the structure of man's knowledge in general.

Influence of latent Toxoplasma infection on human personality, physiology and morphology: pros and cons of the Toxoplasma-human model in studying the manipulation hypothesis.

PubMed

Flegr, Jaroslav

2013-01-01

The parasitic protozoan Toxoplasma gondii infects about one-third of the population of developed countries. The life-long presence of dormant stages of this parasite in the brain and muscular tissues of infected humans is usually considered asymptomatic from the clinical point of view. In the past 20 years, research performed mostly on military personnel, university students, pregnant women and blood donors has shown that this 'asymptomatic' disease has a large influence on various aspects of human life. Toxoplasma-infected subjects differ from uninfected controls in the personality profile estimated with two versions of Cattell's 16PF, Cloninger's TCI and Big Five questionnaires. Most of these differences increase with the length of time since the onset of infection, suggesting that Toxoplasma influences human personality rather than human personality influencing the probability of infection. Toxoplasmosis increases the reaction time of infected subjects, which can explain the increased probability of traffic accidents in infected subjects reported in three retrospective and one very large prospective case-control study. Latent toxoplasmosis is associated with immunosuppression, which might explain the increased probability of giving birth to a boy in Toxoplasma-infected women and also the extremely high prevalence of toxoplasmosis in mothers of children with Down syndrome. Toxoplasma-infected male students are about 3 cm taller than Toxoplasma-free subjects and their faces are rated by women as more masculine and dominant. These differences may be caused by an increased concentration of testosterone. Toxoplasma also appears to be involved in the initiation of more severe forms of schizophrenia. At least 40 studies confirmed an increased prevalence of toxoplasmosis among schizophrenic patients. Toxoplasma-infected schizophrenic patients differ from Toxoplasma-free schizophrenic patients by brain anatomy and by a higher intensity of the positive symptoms of the disease. Finally, five independent studies performed in blood donors, pregnant women and military personnel showed that RhD blood group positivity, especially in RhD heterozygotes, protects infected subjects against various effects of latent toxoplasmosis, such as the prolongation of reaction times, an increased risk of traffic accidents and excessive pregnancy weight gain. The modern human is not a natural host of Toxoplasma. Therefore, it can only be speculated which of the observed effects of latent toxoplasmosis are the result of the manipulation activity of the Toxoplasma aimed to increase the probability of its transmission from a natural intermediate to the definitive host by predation, and which are just side effects of chronic infection.

Genetic determination of the vascular reactions in humans in response to the diving reflex.

PubMed

Baranova, Tatiana I; Berlov, Dmitrii N; Glotov, Oleg S; Korf, Ekaterina A; Minigalin, Alexey D; Mitrofanova, Alla V; Ahmetov, Ildus I; Glotov, Andrey S

2017-03-01

The purpose of this study was to investigate the genetic mechanisms of the defense vascular reactions in response to the diving reflex in humans with polymorphisms in the genes ADBR2, ACE, AGTR1, BDKRB2 , and REN We hypothesized that protective vascular reactions, in response to the diving reflex, are genetically determined and are distinguished in humans with gene polymorphisms of the renin-angiotensin and kinin-bradykinin system. A total of 80 subjects (19 ± 1.4 yr) participated in the study. The intensity of the vascular response was estimated using photoplethysmogram. The I/D polymorphism (rs4340) of ACE was analyzed by PCR. REN (G/A, rs2368564), AGTR1 (A/C, rs5186), BDKRB2 (T/C, rs1799722), and ADBR2 (A/G, rs1042713) polymorphisms were examined using the two-step multiplex PCR followed by carrying allele hybridization on the biochip. Subjects with the BDKRB2 (C/C), ACE (D/D), and ADBR2 (G/G, G/A) genotypes exhibited the strongest peripheral vasoconstriction in response to diving. In subjects with a combination of the BDKRB2 (C/C) plus ACE (D/D) genotypes, we observed the lowest pulse wave amplitude and pulse transit time values and the highest arterial blood pressure during face immersion compared with the heterozygous individuals, suggesting that these subjects are more susceptible to diving hypoxia. This study observed that humans with gene polymorphisms of the renin-angiotensin and kinin-bradykinin systems demonstrate various expressions of protective vascular reactions in response to the diving reflex. The obtained results might be used in estimation of resistance to hypoxia of any origin in human beings or in a medical practice. NEW & NOTEWORTHY Our study demonstrates that the vascular reactions in response to the diving reflex are genetically determined and depend on gene polymorphisms of the kinin-bradykinin and the renin-angiotensin systems. Copyright © 2017 the American Physiological Society.

32 CFR 219.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 2 2014-07-01 2014-07-01 false Research undertaken without the intention of involving human subjects. 219.119 Section 219.119 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.119 Research...

32 CFR 219.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 2 2014-07-01 2014-07-01 false Applications and proposals lacking definite plans for involvement of human subjects. 219.118 Section 219.118 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219...

34 CFR 97.116 - General requirements for informed consent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... welfare of the subjects; (3) The research could not practicably be carried out without the waiver or... Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research..., no investigator may involve a human being as a subject in research covered by this policy unless the...

34 CFR 97.116 - General requirements for informed consent.

Code of Federal Regulations, 2013 CFR

2013-07-01

... welfare of the subjects; (3) The research could not practicably be carried out without the waiver or... Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research..., no investigator may involve a human being as a subject in research covered by this policy unless the...

34 CFR 97.104-97.106 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false [Reserved] 97.104-97.106 Section 97.104-97.106 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 Subjects) §§ 97.104...

34 CFR 97.122 - Use of Federal funds.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false Use of Federal funds. 97.122 Section 97.122 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 Subjects) § 97.122 Use of...

14 CFR 1230.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Applications and proposals lacking definite plans for involvement of human subjects. 1230.118 Section 1230.118 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.118 Applications and proposals...

14 CFR 1230.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Applications and proposals lacking definite plans for involvement of human subjects. 1230.118 Section 1230.118 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.118 Applications and proposals...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-02

... pregnant women and for children who are the subjects of observational research conducted or supported by... whether human testing is necessary given other methods of research. E. Settlement of the Litigation After... Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides AGENCY...

42 CFR 86.19 - Human subjects; animal welfare.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 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...

42 CFR 86.19 - Human subjects; animal welfare.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 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...

42 CFR 86.19 - Human subjects; animal welfare.

Code of Federal Regulations, 2010 CFR

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...

42 CFR 86.19 - Human subjects; animal welfare.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 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...

42 CFR 86.19 - Human subjects; animal welfare.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 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...

10 CFR 35.404 - Surveys after source implant and removal.

Code of Federal Regulations, 2010 CFR

2010-01-01

... patient or a human research subject, the licensee shall make a survey to locate and account for all... from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have...

10 CFR 35.315 - Safety precautions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Required § 35.315 Safety precautions. (a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall— (1) Quarter the patient or the human research subject either in— (i) A... released under § 35.75; (2) Visibly post the patient's or the human research subject's room with a...

10 CFR 35.404 - Surveys after source implant and removal.

Code of Federal Regulations, 2012 CFR

2012-01-01

... patient or a human research subject, the licensee shall make a survey to locate and account for all... from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have...

10 CFR 35.315 - Safety precautions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Required § 35.315 Safety precautions. (a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall— (1) Quarter the patient or the human research subject either in— (i) A... released under § 35.75; (2) Visibly post the patient's or the human research subject's room with a...

10 CFR 35.315 - Safety precautions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Required § 35.315 Safety precautions. (a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall— (1) Quarter the patient or the human research subject either in— (i) A... released under § 35.75; (2) Visibly post the patient's or the human research subject's room with a...

10 CFR 35.404 - Surveys after source implant and removal.

Code of Federal Regulations, 2013 CFR

2013-01-01

... patient or a human research subject, the licensee shall make a survey to locate and account for all... from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have...

10 CFR 35.404 - Surveys after source implant and removal.

Code of Federal Regulations, 2014 CFR

2014-01-01

... patient or a human research subject, the licensee shall make a survey to locate and account for all... from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have...

10 CFR 35.404 - Surveys after source implant and removal.

Code of Federal Regulations, 2011 CFR

2011-01-01

... patient or a human research subject, the licensee shall make a survey to locate and account for all... from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have...

10 CFR 35.315 - Safety precautions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Required § 35.315 Safety precautions. (a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall— (1) Quarter the patient or the human research subject either in— (i) A... released under § 35.75; (2) Visibly post the patient's or the human research subject's room with a...

10 CFR 35.315 - Safety precautions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Required § 35.315 Safety precautions. (a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall— (1) Quarter the patient or the human research subject either in— (i) A... released under § 35.75; (2) Visibly post the patient's or the human research subject's room with a...

38 CFR 17.85 - Treatment of research-related injuries to human subjects.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2012-07-01 2012-07-01 false Treatment of research-related injuries to human subjects. 17.85 Section 17.85 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... to human subjects. (a) VA medical facilities shall provide necessary medical treatment to a research...

38 CFR 17.85 - Treatment of research-related injuries to human subjects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2014-07-01 2014-07-01 false Treatment of research-related injuries to human subjects. 17.85 Section 17.85 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... to human subjects. (a) VA medical facilities shall provide necessary medical treatment to a research...

38 CFR 17.85 - Treatment of research-related injuries to human subjects.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2013-07-01 2013-07-01 false Treatment of research-related injuries to human subjects. 17.85 Section 17.85 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... to human subjects. (a) VA medical facilities shall provide necessary medical treatment to a research...

45 CFR 46.120 - Evaluation and disposition of applications and proposals for research to be conducted or...

Code of Federal Regulations, 2010 CFR

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 § 46.120 Evaluation and disposition of... will take into consideration the risks to the subjects, the adequacy of protection against these risks...

[How to integrate humanization and technology in nursing training].

PubMed

Meyer, Dagmar Estermann

2002-01-01

This paper discusses the current incorporation of the subject of humanization of care in the current context of Brazilian nursing. The relation between nursing and technology is approached, in this study, from a historical perspective. The study also develops the proposition of "human re-signification", having as reference the concept of Cyborg, considering the way this concept has been employed in the contemporary cultural and feminist theoretical framework.

Posterior Cricoarytenoid Muscle Dynamics in Canines and Humans

PubMed Central

Chhetri, Dinesh K.; Neubauer, Juergen; Sofer, Elazar

2015-01-01

Objective The posterior cricoarytenoid (PCA) muscle is the sole abductor of the glottis and serves important functions during respiration, phonation, cough, and sniff. The present study examines vocal fold abduction dynamics during PCA muscle activation. Study Design Basic science study using an in vivo canine model and human subjects. Methods In four canines and five healthy humans vocal fold abduction time was measured using high speed video recording. In the canines, PCA muscle activation was achieved using graded stimulation of the PCA nerve branch. The human subjects performed coughing and sniffing tasks. High speed video and audio signals were concurrently recorded. Results In the canines the vocal fold moved posteriorly, laterally, and superiorly during abduction. Average time to reach 10%, 50% and 90% abduction was 23, 50, and 100 ms with low stimulation, 24, 58, and 129 ms with medium stimulation, and 21, 49, and 117 ms with high level stimulation. In the humans, 100% abduction times for coughing and sniffing tasks were 79 and 193 ms, respectively. Conclusion The PCA abduction times in canines are within the range in humans. The results also further support the notion that PCA muscles are fully active during cough. Level of Evidence N/A (Animal studies and basic research) PMID:24781959

First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers.

PubMed

Stevens, Misty W; Henry, Ralph L; Owens, S Michael; Schutz, Ralph; Gentry, W Brooks

2014-01-01

This first-in-human study examined the safety and pharmacokinetics of ch-mAb7F9, an anti-methamphetamine monoclonal antibody, in healthy volunteers. Single, escalating doses of ch-mAb7F9 over the range of 0.2 to 20 mg/kg were administered to 42 subjects who were followed for 147 d. Safety was measured by physical examinations, adverse events, vital signs, electrocardiograms, and clinical laboratory testing. Serum ch-mAb7F9 concentration and immunogenicity analyses were performed. There were no serious adverse reactions or discontinuations from the study due to adverse events. No trends emerged in the frequency, relatedness, or severity of adverse events with increased dose or between active and placebo treated subjects. Ch-mAb7F9 displayed expected IgG pharmacokinetic parameters, including a half-life of 17-19 d in the 3 highest dose groups and volume of distribution of 5-6 L, suggesting the antibody is confined primarily to the vascular compartment. Four (12.5%) of the 32 subjects receiving ch-mAb7F9 were confirmed to have developed a human anti-chimeric antibody response by the end of the study; however, this response did not appear to be dose related. Overall, no apparent safety or tolerability concerns were identified; a maximum tolerated dose was not reached in this Phase 1 study. Ch-mAb7F9 therefore appears safe for human administration.

The myth of the normal, average human brain--the ICBM experience: (1) subject screening and eligibility.

PubMed

Mazziotta, John C; Woods, Roger; Iacoboni, Marco; Sicotte, Nancy; Yaden, Kami; Tran, Mary; Bean, Courtney; Kaplan, Jonas; Toga, Arthur W

2009-02-01

In the course of developing an atlas and reference system for the normal human brain throughout the human age span from structural and functional brain imaging data, the International Consortium for Brain Mapping (ICBM) developed a set of "normal" criteria for subject inclusion and the associated exclusion criteria. The approach was to minimize inclusion of subjects with any medical disorders that could affect brain structure or function. In the past two years, a group of 1685 potential subjects responded to solicitation advertisements at one of the consortium sites (UCLA). Subjects were screened by a detailed telephone interview and then had an in-person history and physical examination. Of those who responded to the advertisement and considered themselves to be normal, only 31.6% (532 subjects) passed the telephone screening process. Of the 348 individuals who submitted to in-person history and physical examinations, only 51.7% passed these screening procedures. Thus, only 10.7% of those individuals who responded to the original advertisement qualified for imaging. The most frequent cause for exclusion in the second phase of subject screening was high blood pressure followed by abnormal signs on neurological examination. It is concluded that the majority of individuals who consider themselves normal by self-report are found not to be so by detailed historical interviews about underlying medical conditions and by thorough medical and neurological examinations. Recommendations are made with regard to the inclusion of subjects in brain imaging studies and the criteria used to select them.

Bacterial Diversity in Human Subgingival Plaque

PubMed Central

Paster, Bruce J.; Boches, Susan K.; Galvin, Jamie L.; Ericson, Rebecca E.; Lau, Carol N.; Levanos, Valerie A.; Sahasrabudhe, Ashish; Dewhirst, Floyd E.

2001-01-01

The purpose of this study was to determine the bacterial diversity in the human subgingival plaque by using culture-independent molecular methods as part of an ongoing effort to obtain full 16S rRNA sequences for all cultivable and not-yet-cultivated species of human oral bacteria. Subgingival plaque was analyzed from healthy subjects and subjects with refractory periodontitis, adult periodontitis, human immunodeficiency virus periodontitis, and acute necrotizing ulcerative gingivitis. 16S ribosomal DNA (rDNA) bacterial genes from DNA isolated from subgingival plaque samples were PCR amplified with all-bacterial or selective primers and cloned into Escherichia coli. The sequences of cloned 16S rDNA inserts were used to determine species identity or closest relatives by comparison with sequences of known species. A total of 2,522 clones were analyzed. Nearly complete sequences of approximately 1,500 bases were obtained for putative new species. About 60% of the clones fell into 132 known species, 70 of which were identified from multiple subjects. About 40% of the clones were novel phylotypes. Of the 215 novel phylotypes, 75 were identified from multiple subjects. Known putative periodontal pathogens such as Porphyromonas gingivalis, Bacteroides forsythus, and Treponema denticola were identified from multiple subjects, but typically as a minor component of the plaque as seen in cultivable studies. Several phylotypes fell into two recently described phyla previously associated with extreme natural environments, for which there are no cultivable species. A number of species or phylotypes were found only in subjects with disease, and a few were found only in healthy subjects. The organisms identified only from diseased sites deserve further study as potential pathogens. Based on the sequence data in this study, the predominant subgingival microbial community consisted of 347 species or phylotypes that fall into 9 bacterial phyla. Based on the 347 species seen in our sample of 2,522 clones, we estimate that there are 68 additional unseen species, for a total estimate of 415 species in the subgingival plaque. When organisms found on other oral surfaces such as the cheek, tongue, and teeth are added to this number, the best estimate of the total species diversity in the oral cavity is approximately 500 species, as previously proposed. PMID:11371542

When Art Moves the Eyes: A Behavioral and Eye-Tracking Study

PubMed Central

Massaro, Davide; Savazzi, Federica; Di Dio, Cinzia; Freedberg, David; Gallese, Vittorio; Gilli, Gabriella; Marchetti, Antonella

2012-01-01

The aim of this study was to investigate, using eye-tracking technique, the influence of bottom-up and top-down processes on visual behavior while subjects, naïve to art criticism, were presented with representational paintings. Forty-two subjects viewed color and black and white paintings (Color) categorized as dynamic or static (Dynamism) (bottom-up processes). Half of the images represented natural environments and half human subjects (Content); all stimuli were displayed under aesthetic and movement judgment conditions (Task) (top-down processes). Results on gazing behavior showed that content-related top-down processes prevailed over low-level visually-driven bottom-up processes when a human subject is represented in the painting. On the contrary, bottom-up processes, mediated by low-level visual features, particularly affected gazing behavior when looking at nature-content images. We discuss our results proposing a reconsideration of the definition of content-related top-down processes in accordance with the concept of embodied simulation in art perception. PMID:22624007

When art moves the eyes: a behavioral and eye-tracking study.

PubMed

Massaro, Davide; Savazzi, Federica; Di Dio, Cinzia; Freedberg, David; Gallese, Vittorio; Gilli, Gabriella; Marchetti, Antonella

2012-01-01

The aim of this study was to investigate, using eye-tracking technique, the influence of bottom-up and top-down processes on visual behavior while subjects, naïve to art criticism, were presented with representational paintings. Forty-two subjects viewed color and black and white paintings (Color) categorized as dynamic or static (Dynamism) (bottom-up processes). Half of the images represented natural environments and half human subjects (Content); all stimuli were displayed under aesthetic and movement judgment conditions (Task) (top-down processes). Results on gazing behavior showed that content-related top-down processes prevailed over low-level visually-driven bottom-up processes when a human subject is represented in the painting. On the contrary, bottom-up processes, mediated by low-level visual features, particularly affected gazing behavior when looking at nature-content images. We discuss our results proposing a reconsideration of the definition of content-related top-down processes in accordance with the concept of embodied simulation in art perception.

Screening of Viral Pathogens from Pediatric Ileal Tissue Samples after Vaccination

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hewitson, Laura; Thissen, James B.; Gardner, Shea N.

In 2010, researchers reported that the two US-licensed rotavirus vaccines contained DNA or DNA fragments from porcine circovirus (PCV). Although PCV, a common virus among pigs, is not thought to cause illness in humans, these findings raised several safety concerns. In this study, we sought to determine whether viruses, including PCV, could be detected in ileal tissue samples of children vaccinated with one of the two rotavirus vaccines. A broad spectrum, novel DNA detection technology, the Lawrence Livermore Microbial Detection Array (LLMDA), was utilized, and confirmation of viral pathogens using the polymerase chain reaction (PCR) was conducted. The LLMDA technologymore » was recently used to identify PCV from one rotavirus vaccine. Ileal tissue samples were analyzed from 21 subjects, aged 15–62 months. PCV was not detected in any ileal tissue samples by the LLMDA or PCR. LLMDA identified a human rotavirus A from one of the vaccinated subjects, which is likely due to a recent infection from a wild type rotavirus. LLMDA also identified human parechovirus, a common gastroenteritis viral infection, from two subjects. Additionally, LLMDA detected common gastrointestinal bacterial organisms from the Enterobacteriaceae , Bacteroidaceae , and Streptococcaceae families from several subjects. This study provides a survey of viral and bacterial pathogens from pediatric ileal samples, and may shed light on future studies to identify pathogen associations with pediatric vaccinations.« less

Screening of Viral Pathogens from Pediatric Ileal Tissue Samples after Vaccination

DOE PAGES

Hewitson, Laura; Thissen, James B.; Gardner, Shea N.; ...

2014-01-01

In 2010, researchers reported that the two US-licensed rotavirus vaccines contained DNA or DNA fragments from porcine circovirus (PCV). Although PCV, a common virus among pigs, is not thought to cause illness in humans, these findings raised several safety concerns. In this study, we sought to determine whether viruses, including PCV, could be detected in ileal tissue samples of children vaccinated with one of the two rotavirus vaccines. A broad spectrum, novel DNA detection technology, the Lawrence Livermore Microbial Detection Array (LLMDA), was utilized, and confirmation of viral pathogens using the polymerase chain reaction (PCR) was conducted. The LLMDA technologymore » was recently used to identify PCV from one rotavirus vaccine. Ileal tissue samples were analyzed from 21 subjects, aged 15–62 months. PCV was not detected in any ileal tissue samples by the LLMDA or PCR. LLMDA identified a human rotavirus A from one of the vaccinated subjects, which is likely due to a recent infection from a wild type rotavirus. LLMDA also identified human parechovirus, a common gastroenteritis viral infection, from two subjects. Additionally, LLMDA detected common gastrointestinal bacterial organisms from the Enterobacteriaceae , Bacteroidaceae , and Streptococcaceae families from several subjects. This study provides a survey of viral and bacterial pathogens from pediatric ileal samples, and may shed light on future studies to identify pathogen associations with pediatric vaccinations.« less

Physiologic Pressure and Flow Changes During Parabolic Flight (Pilot Study)

NASA Technical Reports Server (NTRS)

Pantalos, George; Sharp, M. Keith; Mathias, John R.; Hargens, Alan R.; Watenpaugh, Donald E.; Buckey, Jay C.

1999-01-01

The objective of this study was to obtain measurement of cutaneous tissue perfusion central and peripheral venous pressure, and esophageal and abdominal pressure in human test subjects during parabolic flight. Hemodynamic data recorded during SLS-I and SLS-2 missions have resulted in the paradoxical finding of increased cardiac stroke volume in the presence of a decreased central venous pressure (CVP) following entry in weightlessness. The investigators have proposed that in the absence of gravity, acceleration-induced peripheral vascular compression is relieved, increasing peripheral vascular capacity and flow while reducing central and peripheral venous pressure, This pilot study seeks to measure blood pressure and flow in human test subjects during parabolic flight for different postures.

Acute Lung Injury: Making Injured Lungs Perform Better and Rebuilding Healthy Lungs

DTIC Science & Technology

2010-07-01

Informed consent will be obtained by the study coordinator/respiratory therapist from legally authorized representatives (defined as a subject’s...will be identified by the primary intensive care unit team, who will notify the study coordinator/respiratory therapist . The study coordinator is a...registered respiratory therapist with human subjects research training and qualifications for obtaining consent, clinical monitoring, arterial blood

Validating Computational Human Behavior Models: Consistency and Accuracy Issues

DTIC Science & Technology

2004-06-01

includes a discussion of SME demographics, content, and organization of the datasets . This research generalizes data from two pilot studies and two base...meet requirements for validating the varied and complex behavioral models. Through a series of empirical studies , this research identifies subject...meet requirements for validating the varied and complex behavioral models. Through a series of empirical studies , this research identifies subject

Pronounced reduction of acquisition of conditioned eyeblink responses in young adults with focal cerebellar lesions impedes conclusions on the role of the cerebellum in extinction and savings.

PubMed

Ernst, T M; Beyer, L; Mueller, O M; Göricke, S; Ladd, M E; Gerwig, M; Timmann, D

2016-05-01

Human cerebellar lesion studies provide good evidence that the cerebellum contributes to the acquisition of classically conditioned eyeblink responses (CRs). As yet, only one study used more advanced methods of lesion-symptom (or lesion-behavior) mapping to investigate which cerebellar areas are involved in CR acquisition in humans. Likewise, comparatively few studies investigated the contribution of the human cerebellum to CR extinction and savings. In this present study, young adults with focal cerebellar disease were tested. A subset of participants was expected to acquire enough conditioned responses to allow the investigation of extinction and saving effects. 19 participants with chronic surgical lesions of the cerebellum and 19 matched control subjects were tested. In all cerebellar subjects benign tumors of the cerebellum had been surgically removed. Eyeblink conditioning was performed using a standard short delay protocol. An initial unpaired control phase was followed by an acquisition phase, an extinction phase and a subsequent reacquisition phase. Structural 3T magnetic resonance images of the brain were acquired on the day of testing. Cerebellar lesions were normalized using methods optimized for the cerebellum. Subtraction analysis and Liebermeister tests were used to perform lesion-symptom mapping. As expected, CR acquisition was significantly reduced in cerebellar subjects compared to controls. Reduced CR acquisition was significantly more likely in participants with lesions of lobule VI and Crus I extending into Crus II (p<0.05, Liebermeister test). Cerebellar subjects could be subdivided into two groups: a smaller group (n=5) which showed acquisition, extinction and savings within the normal range; and a larger group (n=14) which did not show acquisition. In the latter, no conclusions on extinction or savings could be drawn. Previous findings were confirmed that circumscribed areas in lobule VI and Crus I are of major importance in CR acquisition. In addition, the present data suggest that if the critical regions of the cerebellar cortex are lesioned, the ability to acquire CRs is not only reduced but abolished. Subjects with lesions outside these critical areas, on the other hand show preserved acquisition, extinction and saving effects. As a consequence, studies in human subjects with cerebellar lesions do not allow drawing conclusions on CR extinction and savings. In light of the present findings, previous reports of reduced extinction in humans with circumscribed cerebellar disease need to be critically reevaluated. Copyright © 2016 Elsevier Ltd. All rights reserved.

Compensation for injured study subjects in clinical trials: an ethical obligation in human subjects research.

PubMed

Buechner, Bianca

2012-01-01

The Presidential Commission for the Study of Bioethical Issues suggested in its report "Research Across Borders: Proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues" that the United States should implement a system to compensate research subjects for research-related injuries. This article not only analyzes the Commission's recommendation critically, but also discusses if an ethical obligation exists to compensate study subjects for research-related injuries. In addition, the article compares the status quo of the United States to the one in Germany. Germany is one of the countries, which has an established insurance system for research-related injuries based on a non-fault system.

Metabolic Mapping of the Brain's Response to Visual Stimulation: Studies in Humans.

ERIC Educational Resources Information Center

Phelps, Michael E.; Kuhl, David E.

1981-01-01

Studies demonstrate increasing glucose metabolic rates in human primary (PVC) and association (AVC) visual cortex as complexity of visual scenes increase. AVC increased more rapidly with scene complexity than PVC and increased local metabolic activities above control subject with eyes closed; indicates wide range and metabolic reserve of visual…

Human norovirus inactivation in oysters by high hydrostatic pressure processing: A randomized double-blinded study

USDA-ARS?s Scientific Manuscript database

This randomized, double-blinded, clinical trial assessed the effect of high hydrostatic pressure processing (HPP) on genogroup I.1 human norovirus (HuNoV) inactivation in virus-seeded oysters when ingested by subjects. The safety and efficacy of HPP treatments were assessed in three study phases wi...

ASSESSING HUMAN EXPOSURE AND GENOTOXIC EFFECTS IN HUMAN EXFOLIATED EPITHELIA FROM INDIVDUALS IVING IN AN ENDEMIC REGION IN INNER MONGOLAI

EPA Science Inventory

A pilot study was conducted to characterize arsenic exposure and genotoxic effects in Ba Men located in West Central Inner Mongolia in an attempt to identify biomarkers useful for assessing health risk resulting from chronic arsenic exposure. The study subjects included 19 high ...

Acoustic facilities for human factors research at NASA Langley Research Center: Description and operational capabilities

NASA Astrophysics Data System (ADS)

Hubbard, H. H.; Powell, C. A.

1981-06-01

A number of facilities were developed which provide a unique test capability for psychoacoustics and related human factors research. The design philosophy, physical layouts, dimensions, construction features, operating capabilities, and example applications for these facilities are described. In the exterior effects room, human subjects are exposed to the types of noises that are experienced outdoors, and in the interior effects room, subjects are exposed to the types of noises and noise-induced vibrations that are experience indoors. Subjects are also exposed to noises in an echo-free environment in the anechoic listening room. An aircraft noise synthesis system, which simulates aircraft flyover noise at an observer position on the ground, is used in conjunction with these three rooms. The passenger ride quality apparatus, a device for studying passenger response to noise and vibration in aircraft, or in other vehicles, is described.

Acoustic facilities for human factors research at NASA Langley Research Center: Description and operational capabilities

NASA Technical Reports Server (NTRS)

Hubbard, H. H.; Powell, C. A.

1981-01-01

A number of facilities were developed which provide a unique test capability for psychoacoustics and related human factors research. The design philosophy, physical layouts, dimensions, construction features, operating capabilities, and example applications for these facilities are described. In the exterior effects room, human subjects are exposed to the types of noises that are experienced outdoors, and in the interior effects room, subjects are exposed to the types of noises and noise-induced vibrations that are experience indoors. Subjects are also exposed to noises in an echo-free environment in the anechoic listening room. An aircraft noise synthesis system, which simulates aircraft flyover noise at an observer position on the ground, is used in conjunction with these three rooms. The passenger ride quality apparatus, a device for studying passenger response to noise and vibration in aircraft, or in other vehicles, is described.

Biogeography of the ecosystems of the healthy human body.

PubMed

Zhou, Yanjiao; Gao, Hongyu; Mihindukulasuriya, Kathie A; La Rosa, Patricio S; Wylie, Kristine M; Vishnivetskaya, Tatiana; Podar, Mircea; Warner, Barb; Tarr, Phillip I; Nelson, David E; Fortenberry, J Dennis; Holland, Martin J; Burr, Sarah E; Shannon, William D; Sodergren, Erica; Weinstock, George M

2013-01-14

Characterizing the biogeography of the microbiome of healthy humans is essential for understanding microbial associated diseases. Previous studies mainly focused on a single body habitat from a limited set of subjects. Here, we analyzed one of the largest microbiome datasets to date and generated a biogeographical map that annotates the biodiversity, spatial relationships, and temporal stability of 22 habitats from 279 healthy humans. We identified 929 genera from more than 24 million 16S rRNA gene sequences of 22 habitats, and we provide a baseline of inter-subject variation for healthy adults. The oral habitat has the most stable microbiota with the highest alpha diversity, while the skin and vaginal microbiota are less stable and show lower alpha diversity. The level of biodiversity in one habitat is independent of the biodiversity of other habitats in the same individual. The abundances of a given genus at a body site in which it dominates do not correlate with the abundances at body sites where it is not dominant. Additionally, we observed the human microbiota exhibit both cosmopolitan and endemic features. Finally, comparing datasets of different projects revealed a project-based clustering pattern, emphasizing the significance of standardization of metagenomic studies. The data presented here extend the definition of the human microbiome by providing a more complete and accurate picture of human microbiome biogeography, addressing questions best answered by a large dataset of subjects and body sites that are deeply sampled by sequencing.

Biogeography of the ecosystems of the healthy human body

PubMed Central

2013-01-01

Background Characterizing the biogeography of the microbiome of healthy humans is essential for understanding microbial associated diseases. Previous studies mainly focused on a single body habitat from a limited set of subjects. Here, we analyzed one of the largest microbiome datasets to date and generated a biogeographical map that annotates the biodiversity, spatial relationships, and temporal stability of 22 habitats from 279 healthy humans. Results We identified 929 genera from more than 24 million 16S rRNA gene sequences of 22 habitats, and we provide a baseline of inter-subject variation for healthy adults. The oral habitat has the most stable microbiota with the highest alpha diversity, while the skin and vaginal microbiota are less stable and show lower alpha diversity. The level of biodiversity in one habitat is independent of the biodiversity of other habitats in the same individual. The abundances of a given genus at a body site in which it dominates do not correlate with the abundances at body sites where it is not dominant. Additionally, we observed the human microbiota exhibit both cosmopolitan and endemic features. Finally, comparing datasets of different projects revealed a project-based clustering pattern, emphasizing the significance of standardization of metagenomic studies. Conclusions The data presented here extend the definition of the human microbiome by providing a more complete and accurate picture of human microbiome biogeography, addressing questions best answered by a large dataset of subjects and body sites that are deeply sampled by sequencing. PMID:23316946

Genetic polymorphism of the beta-2 adrenergic receptor in atopic and non-atopic subjects.

PubMed

Potter, P C; Van Wyk, L; Martin, M; Lentes, K U; Dowdle, E B

1993-10-01

To investigate a possible genetic basis for reported differences in beta-2 receptor expression in atopic subjects, DNA from 42 atopic children (22 asthmatics and 22 with allergic rhinitis) and 30 non-atopic subjects was Southern blotted and Ban-1 restriction fragment polymorphisms (RFLPS) were studied using a 2.6 kb probe of the human beta-2 receptor gene. Two alleles 3.1 kb and 2.9 kb were identified. Homozygotes and heterozygotes for the two alleles were found with equal frequency in the atopic patients who had asthma and in those who had allergic rhinitis only. The gene frequencies for the upper and lower alleles were 0.45 and 0.55 respectively. Our studies do not provide evidence for an association between a particular polymorphic form of the human beta-2 receptor gene and atopy.

Cerebral signal intensity abnormalities on T2-weighted MR images in HIV patients with highly active antiretroviral therapy: relationship with clinical parameters and interval changes.

PubMed

Hanning, Uta; Husstedt, Ingo W; Niederstadt, Thomas-Ulrich; Evers, Stefan; Heindel, Walter; Kloska, Stephan P

2011-09-01

The aim of this study was to assess the relationship between immune state and cerebral signal intensity abnormalities (SIAs) on T2-weighted magnetic resonance images in subjects with human immunodeficiency virus type 1 infection and highly active antiretroviral therapy. Thirty-two subjects underwent a total of 109 magnetic resonance studies. The presence of human immunodeficiency virus-associated neurocognitive disorder, categorized CD4(+) T lymphocyte count, and plasma viral load were assessed for relationship with the severity and interval change of SIAs for different anatomic locations of the brain. Subjects with multifocal patterns of SIAs had CD4(+) cell counts < 200 cells/μL in 66.0%, whereas subjects with diffuse patterns of SIAs had CD4(+) cell counts < 200 cells/μL in only 31.4% (P < .001). Subjects without SIAs in the basal ganglia had CD4(+) cell counts < 200 cells/μL in 37.0%, whereas subjects with minor and moderate SIAs in the basal ganglia had CD4(+) cell counts < 200 cells/μL in 78.3% and 80.0%, respectively (P < .005). The percentage of subjects with CD4(+) cell counts < 200 cells/μL was 85.7% when there were progressive periventricular SIA changes and 45.5% when periventricular SIA changes were stable in follow-up (P < .05). The presence and progression of cerebral SIAs on T2-weighted magnetic resonance images reflecting cerebral infection with human immunodeficiency virus are significantly related to impaired immune state as measured by CD4(+) cell count. Copyright © 2011 AUR. Published by Elsevier Inc. All rights reserved.

16 CFR 1702.10 - Human experimental data involving the testing of human subjects.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Human experimental data involving the testing of human subjects. 1702.10 Section 1702.10 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION... PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS § 1702.10 Human experimental data involving...

16 CFR 1702.10 - Human experimental data involving the testing of human subjects.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Human experimental data involving the testing of human subjects. 1702.10 Section 1702.10 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION... PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS § 1702.10 Human experimental data involving...

16 CFR 1702.10 - Human experimental data involving the testing of human subjects.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Human experimental data involving the testing of human subjects. 1702.10 Section 1702.10 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION... PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS § 1702.10 Human experimental data involving...

16 CFR 1702.10 - Human experimental data involving the testing of human subjects.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Human experimental data involving the testing of human subjects. 1702.10 Section 1702.10 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION... PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS § 1702.10 Human experimental data involving...

Why humans do not make good vampires. Testing the ability of humans to detect true blood.

PubMed

De Smet, Delphine; Van Speybroeck, Linda; Verplaetse, Jan

2012-01-01

Research indicating the effects of real blood or of its iconic representation on human behaviour has thus far concentrated on phobia and aggressiveness. Little is known about other responses or, more fundamentally, about the biological basis of all such responses. In this study it is examined whether or not humans are able to detect real blood. Human subjects (n = 89) were asked to distinguish different kinds of blood from red control fluids under varying visual and choice conditions. Relevant differences between subjects were tested for through written questionnaires, including standardized scales for disgust sensitivity (DS-R) and blood phobia (MBPI) and performance on two clinical olfactory tests. Analysis of variance shows that humans are excellent detectors of animal blood (in casu pig blood), whereas the ability of detecting human blood is much less developed. Surprisingly, differences in olfactory capacities and personal experience with blood have no effect on blood detection, while blood fear lowers and disgust sensitivity ameliorates this performance. This study allows further mapping of the exact role of disgust sensitivity in human behaviour, as well as a deliberate choice of materials in blood-related experiments. It is imperative for further research on the behavioural and psychological impact 'blood' resorts on humans.

Serum thymulin in human zinc deficiency.

PubMed Central

Prasad, A S; Meftah, S; Abdallah, J; Kaplan, J; Brewer, G J; Bach, J F; Dardenne, M

1988-01-01

The activity of thymulin (a thymic hormone) is dependent on the presence of zinc in the molecule. We assayed serum thymulin activity in three models of mildly zinc-deficient (ZD) human subjects before and after zinc supplementation: (a) two human volunteers in whom a specific and mild zinc deficiency was induced by dietary means; (b) six mildly ZD adult sickle cell anemia (SCA) subjects; and (c) six mildly ZD adult non-SCA subjects. Their plasma zinc levels were normal and they showed no overt clinical manifestations of zinc deficiency. The diagnosis of mild zinc deficiency was based on the assay of zinc in lymphocytes, granulocytes, and platelets. Serum thymulin activity was decreased as a result of mild zinc deficiency and was corrected by in vivo and in vitro zinc supplementation, suggesting that this parameter was a sensitive indicator of zinc deficiency in humans. An increase in T101-, sIg-cells, decrease in T4+/T8+ ratio, and decreased IL 2 activity were observed in the experimental human model during the zinc depletion phase, all of which were corrected after repletion with zinc. Similar changes in lymphocyte subpopulation, correctable with zinc supplementation, were also observed in mildly ZD SCA subjects. Inasmuch as thymulin is known to induce intra- and extrathymic T cell differentiation, our studies provide a possible mechanism for the role of zinc on T cell functions. Images PMID:3262625

21 CFR 320.26 - Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE... test product and the reference material should be administered to subjects in the fasting state, unless...

Posttraumatic Stress Disorder: An Immunological Disorder?

PubMed Central

Wang, Zhewu; Caughron, Blaine; Young, M. Rita I.

2017-01-01

Patients with posttraumatic stress disorder (PTSD) exhibit an increased state of inflammation. Various animal models for PTSD have shown some of the same immune imbalances as have been shown in human subjects with PTSD, and some of these studies are discussed in this review. However, animal studies can only indirectly implicate immune involvement in PTSD in humans. This review of mainly studies with human subjects focuses on dissecting the immunological role in the pathogenesis of PTSD following initial trauma exposure. It addresses both the inflammatory state associated with PTSD and the immune imbalance between stimulatory and inhibitory immune mediators, as well as variables that can lead to discrepancies between analyses. The concept of immunological treatment approaches is proposed for PTSD, as new treatments are needed for this devastating disorder that is affecting unprecedented numbers of Veterans from the long-standing wars in the Middle East and which affects civilians following severe trauma. PMID:29163241

Pumpkin Seed Oil Extracted From Cucurbita maxima Improves Urinary Disorder in Human Overactive Bladder

PubMed Central

Nishimura, Mie; Ohkawara, Tatsuya; Sato, Hiroji; Takeda, Hiroshi; Nishihira, Jun

2014-01-01

The pumpkin seed oil obtained from Cucurbita pepo has been shown to be useful for the treatment of nocturia in patients with urinal disorders in several western countries. In this study, we evaluated the effect of the pumpkin seed oil from Cucurbita maxima on urinary dysfunction in human overactive bladder (OAB). Forty-five subjects were enrolled in this study. An extract of pumpkin seed oil from C. maxima (10 g of oil/day) was orally administrated for 12 weeks. After 6 and 12 weeks, urinary function was evaluated using Overactive Bladder Symptom Score (OABSS). Pumpkin seed oil from C. maxima significantly reduced the degree of OABSS in the subjects. The results from our study suggest that pumpkin seed oil extracts from C. maxima as well as from C. pepo are effective for urinary disorders such as OAB in humans. PMID:24872936

Pumpkin Seed Oil Extracted From Cucurbita maxima Improves Urinary Disorder in Human Overactive Bladder.

PubMed

Nishimura, Mie; Ohkawara, Tatsuya; Sato, Hiroji; Takeda, Hiroshi; Nishihira, Jun

2014-01-01

The pumpkin seed oil obtained from Cucurbita pepo has been shown to be useful for the treatment of nocturia in patients with urinal disorders in several western countries. In this study, we evaluated the effect of the pumpkin seed oil from Cucurbita maxima on urinary dysfunction in human overactive bladder (OAB). Forty-five subjects were enrolled in this study. An extract of pumpkin seed oil from C. maxima (10 g of oil/day) was orally administrated for 12 weeks. After 6 and 12 weeks, urinary function was evaluated using Overactive Bladder Symptom Score (OABSS). Pumpkin seed oil from C. maxima significantly reduced the degree of OABSS in the subjects. The results from our study suggest that pumpkin seed oil extracts from C. maxima as well as from C. pepo are effective for urinary disorders such as OAB in humans.

Researcher liability for negligence in human subject research: informed consent and researcher malpractice actions.

PubMed

Jansson, Roger L

2003-02-01

Two sets of federal regulations, the "Common Rule" and Food and Drug Administration (FDA) regulations, govern human subject research that is either federally-funded or involves FDA regulated products. These regulations require, inter alia, that: (1) researchers obtain informed consent from human subjects, and (2) that an Institutional Review Board (IRB) independently review and approve the research protocol. Although the federal regulations do not provide an express cause of action against researchers, research subjects should be able to bring informed consent and malpractice actions against researchers by establishing a duty of care and standard of care. Researchers owe human subjects a duty of care analogous to the special relationship between physicians and patients. The federal regulations should provide the minimum standard of care for informed consent in human subject research, and complying with them should be a partial defense. In contrast, expert testimony should establish the standard of care for researcher malpractice, and IRB approval should be a partial defense.

Differential Use of Attentional and Visual Communicative Signaling by Orangutans (Pongo pygmaeus) and Gorillas (Gorilla gorilla) in Response to the Attentional Status of a Human

PubMed Central

POSS, SARAH R.; KUHAR, CHRIS; STOINSKI, TARA S.; HOPKINS, WILLIAM D.

2007-01-01

In this study we investigated the communicative abilities of 10 orangutans (Pongo pygmaeus) and seven western lowland gorillas (Gorilla gorilla gorilla), and particularly focused on their sensitivity to the attentional state of a human experimenter when choosing from a repertoire of both auditory and visual communication strategies. In experiment 1 a banana was placed in front of the subject's cage and a human experimenter was either present or absent. The subject's behavior was recorded for 60 sec. Both gorillas and orangutans gestured (t(16)= −3.58, P<.005) and vocalized (t(16) = −2.47, P<.05) more when the experimenter was present. In experiment 2 a human experimenter held a banana in front of the subject's cage and was oriented either toward or away from the subject. Again the subject's behavior was recorded for 60 sec. In this experiment both gorillas and orangutans gestured significantly more frequently (t(16) = 3.40, P<.005) when the experimenter was oriented toward them. In addition, gorillas and orangutans used other forms of visual communication signals, such as lip pout (t(16) = 3.66, P<.005), barter/trade (t(16) = 2.31, P<.05), and body present (t(16) = 2.31, P<.05) significantly more when an experimenter was facing them. The overall results indicate that both gorillas and orangutans are sensitive to the attentional state of a human experimenter and use appropriate communicative signals to gain that individual's attention. These results are also similar to previous findings on communicative behaviors in chimpanzees. PMID:16967515

Differential use of attentional and visual communicative signaling by orangutans (Pongo pygmaeus) and gorillas (Gorilla gorilla) in response to the attentional status of a human.

PubMed

Poss, Sarah R; Kuhar, Chris; Stoinski, Tara S; Hopkins, William D

2006-10-01

In this study we investigated the communicative abilities of 10 orangutans (Pongo pygmaeus) and seven western lowland gorillas (Gorilla gorilla gorilla), and particularly focused on their sensitivity to the attentional state of a human experimenter when choosing from a repertoire of both auditory and visual communication strategies. In experiment 1 a banana was placed in front of the subject's cage and a human experimenter was either present or absent. The subject's behavior was recorded for 60 sec. Both gorillas and orangutans gestured (t(16)=-3.58, P<.005) and vocalized (t(16)=-2.47, P<.05) more when the experimenter was present. In experiment 2 a human experimenter held a banana in front of the subject's cage and was oriented either toward or away from the subject. Again the subject's behavior was recorded for 60 sec. In this experiment both gorillas and orangutans gestured significantly more frequently (t(16)=3.40, P<.005) when the experimenter was oriented toward them. In addition, gorillas and orangutans used other forms of visual communication signals, such as lip pout (t(16)=3.66, P<.005), barter/trade (t(16)=2.31, P<.05), and body present (t(16)=2.31, P<.05) significantly more when an experimenter was facing them. The overall results indicate that both gorillas and orangutans are sensitive to the attentional state of a human experimenter and use appropriate communicative signals to gain that individual's attention. These results are also similar to previous findings on communicative behaviors in chimpanzees.

A Four-Dimensional Computed Tomography Comparison of Healthy vs. Asthmatic Human Lungs

PubMed Central

Jahani, Nariman; Choi, Sanghun; Choi, Jiwoong; Haghighi, Babak; Hoffman, Eric A.; Comellas, Alejandro P.; Kline, Joel N.; Lin, Ching-Long

2017-01-01

The purpose of this study was to explore new insights in non-linearity, hysteresis and ventilation heterogeneity of asthmatic human lungs using four-dimensional computed tomography (4D-CT) image data acquired during tidal breathing. Volumetric image data were acquired for 5 non-severe and one severe asthmatic volunteers. Besides 4D-CT image data, function residual capacity and total lung capacity image data during breath-hold were acquired for comparison with dynamic scans. Quantitative results were compared with the previously reported analysis of five healthy human lungs. Using an image registration technique, local variables such as regional ventilation and anisotropic deformation index (ADI) were estimated. Regional ventilation characteristics of non-severe asthmatic subjects were similar to those of healthy subjects, but different from the severe asthmatic subject. Lobar airflow fractions were also well correlated between static and dynamic scans (R2 > 0.84). However, local ventilation heterogeneity significantly increased during tidal breathing in both healthy and asthmatic subjects relative to that of breath-hold perhaps because of airway resistance present only in dynamic breathing. ADI was used to quantify non-linearity and hysteresis of lung motion during tidal breathing. Nonlinearity was greater on inhalation than exhalation among all subjects. However, exhalation nonlinearity among asthmatic subjects was greater than healthy subjects and the difference diminished during inhalation. An increase of non-linearity during exhalation in asthmatic subjects accounted for lower hysteresis relative to that of healthy ones. Thus, assessment of nonlinearity differences between healthy and asthmatic lungs during exhalation may provide quantitative metrics for subject identification and outcome assessment of new interventions. PMID:28372795

Contextual conditioning enhances the psychostimulant and incentive properties of d-amphetamine in humans

PubMed Central

Childs, Emma; de Wit, Harriet

2014-01-01

Learned associations between drugs and the places they are used are critical to the development of drug addiction. Contextual conditioning has long been studied in animals as an indirect measure of drug reward, but little is known about the process in humans. Here, we investigated de novo contextual conditioning with d-amphetamine in healthy humans (n = 34). Volunteers underwent four conditioning sessions conducted in two testing rooms with double-blind, alternating d-amphetamine (20 mg) and placebo administration. Before conditioning procedures began, they rated the two rooms to examine pre-existing preferences. One group (Paired, n = 19) always received d-amphetamine in their least preferred room and placebo in the other during conditioning sessions. Another group (Unpaired, n = 15) received d-amphetamine and placebo in both rooms. Subjective drug effects were monitored at repeated times. At a separate re-exposure test, preference ratings for the drug-associated room were increased among the Paired group only, and more subjects in the Paired than the Unpaired group switched their preference to their initially least preferred room. Also, ratings of d-amphetamine drug liking independently predicted room liking at test among the Paired group only. Further, Paired group subjects reported greater stimulation and drug craving after d-amphetamine on the second administration, relative to the first. This study supports preliminary findings that humans, like animals, develop a preference for a place associated with d-amphetamine that is related to its subjective effects. These findings also suggest that experiencing d-amphetamine in a consistent environment produces context-dependent changes in its subjective effects, including an enhanced rewarding efficacy and abuse potential. PMID:22129527

Exome-wide Association Study Identifies GREB1L Mutations in Congenital Kidney Malformations.

PubMed

Sanna-Cherchi, Simone; Khan, Kamal; Westland, Rik; Krithivasan, Priya; Fievet, Lorraine; Rasouly, Hila Milo; Ionita-Laza, Iuliana; Capone, Valentina P; Fasel, David A; Kiryluk, Krzysztof; Kamalakaran, Sitharthan; Bodria, Monica; Otto, Edgar A; Sampson, Matthew G; Gillies, Christopher E; Vega-Warner, Virginia; Vukojevic, Katarina; Pediaditakis, Igor; Makar, Gabriel S; Mitrotti, Adele; Verbitsky, Miguel; Martino, Jeremiah; Liu, Qingxue; Na, Young-Ji; Goj, Vinicio; Ardissino, Gianluigi; Gigante, Maddalena; Gesualdo, Loreto; Janezcko, Magdalena; Zaniew, Marcin; Mendelsohn, Cathy Lee; Shril, Shirlee; Hildebrandt, Friedhelm; van Wijk, Joanna A E; Arapovic, Adela; Saraga, Marijan; Allegri, Landino; Izzi, Claudia; Scolari, Francesco; Tasic, Velibor; Ghiggeri, Gian Marco; Latos-Bielenska, Anna; Materna-Kiryluk, Anna; Mane, Shrikant; Goldstein, David B; Lifton, Richard P; Katsanis, Nicholas; Davis, Erica E; Gharavi, Ali G

2017-11-02

Renal agenesis and hypodysplasia (RHD) are major causes of pediatric chronic kidney disease and are highly genetically heterogeneous. We conducted whole-exome sequencing in 202 case subjects with RHD and identified diagnostic mutations in genes known to be associated with RHD in 7/202 case subjects. In an additional affected individual with RHD and a congenital heart defect, we found a homozygous loss-of-function (LOF) variant in SLIT3, recapitulating phenotypes reported with Slit3 inactivation in the mouse. To identify genes associated with RHD, we performed an exome-wide association study with 195 unresolved case subjects and 6,905 control subjects. The top signal resided in GREB1L, a gene implicated previously in Hoxb1 and Shha signaling in zebrafish. The significance of the association, which was p = 2.0 × 10 -5 for novel LOF, increased to p = 4.1 × 10 -6 for LOF and deleterious missense variants combined, and augmented further after accounting for segregation and de novo inheritance of rare variants (joint p = 2.3 × 10 -7 ). Finally, CRISPR/Cas9 disruption or knockdown of greb1l in zebrafish caused specific pronephric defects, which were rescued by wild-type human GREB1L mRNA, but not mRNA containing alleles identified in case subjects. Together, our study provides insight into the genetic landscape of kidney malformations in humans, presents multiple candidates, and identifies SLIT3 and GREB1L as genes implicated in the pathogenesis of RHD. Copyright © 2017 American Society of Human Genetics. Published by Elsevier Inc. All rights reserved.

Altered metabolism of orally administered loxoprofen in human subjects after an oral administration of loxoprofen for three consecutive days followed by a seven-day washout.

PubMed

Kim, In-Wha; Chung, Suk-Jae; Shim, Chang-Koo

2002-04-01

The effect of pretreatment (i.e., oral administration of loxoprofen for 3 consecutive days followed by a 7-day washout) on the pharmacokinetics and metabolism of the drug was studied in humans. In a control study, a Loxonin tablet (60 mg as loxoprofen anhydrous) was administered orally to 6 healthy male Korean subjects. In a pretreatment study, a Loxonin tablet was administered orally to the subjects once daily for 3 consecutive days. On the 10(th) day, a Loxonin tablet was administered orally to the subjects, and the concentrations of loxoprofen and the trans- and cis-alcohol metabolites in the plasma and urine were measured as a function of time. Using this pretreatment, the area under the curve (AUC) of the trans-alcohol metabolite of loxoprofen in the plasma, but not those of loxoprofen and the cis-alcohol metabolite, was increased (1.5-fold, p < 0.05), leading to increased contribution of the trans-alcohol metabolite to the total urinary recovery of loxoprofen (1.3-fold, p < 0.05). The urinary recovery of total metabolites, which was largely (> 90%) comprised of conjugate metabolites, was also increased as a result of the pretreatment (1.5-fold, p < 0.05). These results indicate that stereoselective reduction to trans-alcohol metabolites as well as the phase II metabolism of loxoprofen may be increased by such a pretreatment in human subjects. Copyright 2002 Wiley-Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 91:973-979, 2002

How Students View the Boundaries between Their Science and Religious Education Concerning the Origins of Life and the Universe

ERIC Educational Resources Information Center

Billingsley, Berry; Brock, Richard; Taber, Keith S.; Riga, Fran

2016-01-01

Internationally in secondary schools, lessons are typically taught by subject specialists, raising the question of how to accommodate teaching which bridges the sciences and humanities. This is the first study to look at how students make sense of the teaching they receive in two subjects (science and religious education [RE]) when one subject's…

Randomized, double-blinded clinical trial for human norovirus inactivation in oysters by high hydrostatic pressure processing.

PubMed

Leon, Juan S; Kingsley, David H; Montes, Julia S; Richards, Gary P; Lyon, G Marshall; Abdulhafid, Gwen M; Seitz, Scot R; Fernandez, Marina L; Teunis, Peter F; Flick, George J; Moe, Christine L

2011-08-01

Contamination of oysters with human noroviruses (HuNoV) constitutes a human health risk and may lead to severe economic losses in the shellfish industry. There is a need to identify a technology that can inactivate HuNoV in oysters. In this study, we conducted a randomized, double-blinded clinical trial to assess the effect of high hydrostatic pressure processing (HPP) on Norwalk virus (HuNoV genogroup I.1) inactivation in virus-seeded oysters ingested by subjects. Forty-four healthy, positive-secretor adults were divided into three study phases. Subjects in each phase were randomized into control and intervention groups. Subjects received Norwalk virus (8FIIb, 1.0 × 10(4) genomic equivalent copies) in artificially seeded oysters with or without HPP treatment (400 MPa at 25°C, 600 MPa at 6°C, or 400 MPa at 6°C for 5 min). HPP at 600 MPa, but not 400 MPa (at 6° or 25°C), completely inactivated HuNoV in seeded oysters and resulted in no HuNoV infection among these subjects, as determined by reverse transcription-PCR detection of HuNoV RNA in subjects' stool or vomitus samples. Interestingly, a white blood cell (granulocyte) shift was identified in 92% of the infected subjects and was significantly associated with infection (P = 0.0014). In summary, these data suggest that HPP is effective at inactivating HuNoV in contaminated whole oysters and suggest a potential intervention to inactivate infectious HuNoV in oysters for the commercial shellfish industry.

Protecting the Teaching and Learning Environment: A Hybrid Model for Human Subject Research Public Policy Implementation

ERIC Educational Resources Information Center

Hottenstein, Kristi N.

2017-01-01

Regulations for research involving human subjects have long been a critical issue in higher education. Federal public policy for research involving human subjects impacts institutions of higher education by requiring all federally funded research to be passed by an Institutional Review Board (IRB). Undergraduate research is no exception. Given the…