Healthy Volunteers

2020 ◽  
Author(s):  
Jill A. Fisher
Keyword(s):  
Healthy Volunteers ◽  
Biomedical Research ◽  
Clinical Care ◽  
Research Participation ◽  
Vulnerable Groups ◽  
Biological Processes ◽  
Healthy Individuals ◽  
Ethical Problems ◽  
The Difference ◽  
Healthy Participants

This chapter describes the involvement of healthy volunteers in biomedical research. Healthy individuals are valuable to research because they can offer data about biological processes or investigational products that are not distorted by illness or disease. In addition, healthy individuals are generally much easier to recruit to research than are ill patients. Recruitment of healthy participants is aided by the offer of financial compensation in exchange for their participation. The involvement of healthy individuals in research is meant to resolve ethical problems associated with enrolling patients, such as exposing sick individuals to risk and creating misunderstandings for patients about the difference between research and clinical care. However, as this chapter details, using healthy individuals in biomedical research raises different concerns about risk exposure as well as ethical dilemmas associated with paid research participation, the exploitation of vulnerable groups, and the validity of the data produced.

scholarly journals Therapeutic appropriation: a new concept in the ethics of clinical research

2016 ◽  
Vol 42 (12) ◽  
pp. 805-808 ◽  
Author(s):  
Rosalind McDougall ◽  
Dominique Martin ◽  
Lynn Gillam ◽  
Nina Hallowell ◽  
Alison Brookes ◽  
...  
Keyword(s):  
Primary Care ◽  
Clinical Research ◽  
Clinical Care ◽  
Research Participation ◽  
Therapeutic Benefit ◽  
Therapeutic Misconception ◽  
Ethical Problems ◽  
Ethical Concerns ◽  
Research Participants ◽  
Therapeutic Needs

Ethical concerns about therapeutic misconception have been raised since the early 1980s. This concept was originally described as research participants' assumptions that decisions relating to research interventions are made on the basis of their individual therapeutic needs. The term has since been used to refer to a range of ‘misunderstandings’ that research participants may have. In this paper, we describe a new concept—therapeutic appropriation. Therapeutic appropriation occurs when patients, or clinicians, actively reframe research participation as an opportunity to enhance patients' clinical care, while simultaneously acknowledging the generalised research aims. To illustrate the concept of therapeutic appropriation, we draw on data from an interview study which we conducted to investigate the experiences of patients and general practitioners involved in clinical trials in primary care. We argue that therapeutic appropriation has two key elements: comprehension that the research project is not necessarily aiming to benefit participants and the deliberate use of incidental features of the research for personal therapeutic benefit of various kinds. We conclude that therapeutic appropriation is a useful concept that refines understanding of potential ethical problems in clinical research, and points to strategies to address them.

Relationship between total plasma homocysteine and the risk of aneurysms – a meta-analysis

VASA ◽  
2020 ◽  
pp. 1-6
Author(s):  
Hanji Zhang ◽  
Dexin Yin ◽  
Yue Zhao ◽  
Yezhou Li ◽  
Dejiang Yao ◽  
...  
Keyword(s):  
Large Scale ◽  
Meta Analysis ◽  
Single Species ◽  
Total Plasma ◽  
Control Groups ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
The Difference ◽  
The Relationship ◽  
Healthy Participants

Summary: Our meta-analysis focused on the relationship between homocysteine (Hcy) level and the incidence of aneurysms and looked at the relationship between smoking, hypertension and aneurysms. A systematic literature search of Pubmed, Web of Science, and Embase databases (up to March 31, 2020) resulted in the identification of 19 studies, including 2,629 aneurysm patients and 6,497 healthy participants. Combined analysis of the included studies showed that number of smoking, hypertension and hyperhomocysteinemia (HHcy) in aneurysm patients was higher than that in the control groups, and the total plasma Hcy level in aneurysm patients was also higher. These findings suggest that smoking, hypertension and HHcy may be risk factors for the development and progression of aneurysms. Although the heterogeneity of meta-analysis was significant, it was found that the heterogeneity might come from the difference between race and disease species through subgroup analysis. Large-scale randomized controlled studies of single species and single disease species are needed in the future to supplement the accuracy of the results.

Быстродействующая атомно-силовая и сканирующая капиллярная микроскопия в решении задач материаловедения, биологии и медицины

2020 ◽  
Vol 13 (3-4) ◽  
pp. 222-228
Author(s):  
И.В. Яминский ◽  
А.И. Ахметова
Keyword(s):  
Antibiotic Resistance ◽  
Early Detection ◽  
Biomedical Research ◽  
Drug Screening ◽  
Targeted Delivery ◽  
High Speed ◽  
Scanning Probe ◽  
Biological Processes ◽  
Atomic Force ◽  
Probe Microscope

Разработка высокоэффективных режимов быстродействующего сканирующего зондового микроскопа, в первую очередь атомно-силовой и сканирующей капиллярной микроскопии, представляет особый интерес для успешного проведения биомедицинских исследований: изучения биологических процессов и морфологии биополимеров, определения антибио­тикорезистентности бактерий, адресной доставки биомакромолекул, скринингу лекарств, раннему обнаружению биологических агентов (вирусов и бактерий) и др. The development of highly efficient modes of a high-speed scanning probe microscope, primarily atomic force and scanning capillary microscopy, is of particular interest for successful biomedical research: studying biological processes and the morphology of biopolymers, determining antibiotic resistance of bacteria, targeted delivery of biomacromolecules, drug screening, early detection agents (viruses and bacteria), etc.

scholarly journals Perceptual insensitivity to the modulation of interoceptive signals in depression, anxiety, and substance use disorders

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ryan Smith ◽  
◽  
Justin S. Feinstein ◽  
Rayus Kuplicki ◽  
Katherine L. Forthman ◽  
...  
Keyword(s):  
Machine Learning ◽  
Substance Use ◽  
Individual Differences ◽  
Substance Use Disorders ◽  
Breath Hold ◽  
Healthy Individuals ◽  
Performance Improvements ◽  
Heartbeat Perception ◽  
Minimal Improvement ◽  
Healthy Participants

AbstractThis study employed a series of heartbeat perception tasks to assess the hypothesis that cardiac interoceptive processing in individuals with depression/anxiety (N = 221), and substance use disorders (N = 136) is less flexible than that of healthy individuals (N = 53) in the context of physiological perturbation. Cardiac interoception was assessed via heartbeat tapping when: (1) guessing was allowed; (2) guessing was not allowed; and (3) experiencing an interoceptive perturbation (inspiratory breath hold) expected to amplify cardiac sensation. Healthy participants showed performance improvements across the three conditions, whereas those with depression/anxiety and/or substance use disorder showed minimal improvement. Machine learning analyses suggested that individual differences in these improvements were negatively related to anxiety sensitivity, but explained relatively little variance in performance. These results reveal a perceptual insensitivity to the modulation of interoceptive signals that was evident across several common psychiatric disorders, suggesting that interoceptive deficits in the realm of psychopathology manifest most prominently during states of homeostatic perturbation.

scholarly journals European Biological Variation Study (EuBIVAS): within- and between-subject biological variation estimates for serum thyroid biomarkers based on weekly samplings from 91 healthy participants

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Michela Bottani ◽  
Aasne K. Aarsand ◽  
Giuseppe Banfi ◽  
Massimo Locatelli ◽  
Abdurrahman Coşkun ◽  
...  
Keyword(s):  
Large Scale ◽  
Thyroid Stimulating Hormone ◽  
Biological Variation ◽  
Healthy Individuals ◽  
Serum Samples ◽  
Free Triiodothyronine ◽  
Performance Specifications ◽  
Study Population ◽  
Variance Homogeneity ◽  
Healthy Participants

Abstract Objectives Thyroid biomarkers are fundamental for the diagnosis of thyroid disorders and for the monitoring and treatment of patients with these diseases. The knowledge of biological variation (BV) is important to define analytical performance specifications (APS) and reference change values (RCV). The aim of this study was to deliver BV estimates for thyroid stimulating hormone (TSH), free thyroxine (FT4), free triiodothyronine (FT3), thyroglobulin (TG), and calcitonin (CT). Methods Analyses were performed on serum samples obtained from the European Biological Variation Study population (91 healthy individuals from six European laboratories; 21–69 years) on the Roche Cobas e801 at the San Raffaele Hospital (Milan, Italy). All samples from each individual were evaluated in duplicate within a single run. The BV estimates with 95% CIs were obtained by CV-ANOVA, after analysis of variance homogeneity and outliers. Results The within-subject (CV I ) BV estimates were for TSH 17.7%, FT3 5.0%, FT4 4.8%, TG 10.3, and CT 13.0%, all significantly lower than those reported in the literature. No significant differences were observed for BV estimates between men and women. Conclusions The availability of updated, in the case of CT not previously published, BV estimates for thyroid markers based on the large scale EuBIVAS study allows for refined APS and associated RCV applicable in the diagnosis and management of thyroid and related diseases.

CDH1 germline mutations in healthy individuals from families with the hereditary diffuse gastric cancer syndrome

2021 ◽  
pp. jmedgenet-2021-108226
Author(s):  
Giovanni Corso ◽  
Francesca Magnoni ◽  
Giulia Massari ◽  
Cristina Maria Trovato ◽  
Alessandra Margherita De Scalzi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Healthy Subjects ◽  
Relevant Literature ◽  
Germline Mutations ◽  
Hereditary Diffuse Gastric Cancer ◽  
Diffuse Gastric Cancer ◽  
Missense Mutations ◽  
Healthy Individuals ◽  
Cancer Syndrome ◽  
The Difference

The objective of this study was to determining the frequency of different sub-types of pathogenic CDH1 germline mutations in healthy and asymptomatic individuals from families with the hereditary diffuse gastric cancer (HDGC) syndrome. Relevant literature dating from 1998 to 2019 was systematically searched for data on CDH1 germline mutations. The collected variants were classified according to their subtype into the following classes: missense, non-sense, splicing, insertions and deletions. The χ2 test was used to estimate if the difference observed between patients with gastric cancer (GC) and unaffected individuals was statistically significant. CDH1 genetic screening data were retrieved for 224 patients with GC and 289 healthy individuals. Among the subjects that had tested CDH1 positive, splicing mutations were found in 30.4% of the healthy individuals and in 15.2% of the patients with GC (p=0.0076). Missense mutations were also found to occur in healthy subjects with higher frequency (22.2%) than in GC-affected individuals (18.3%), but the difference was not significant in this case. In families meeting the clinical criteria for the HDGC syndrome, CDH1 splicing and missense germline mutations have been reported to occur with higher frequency in healthy subjects than in patients with cancer. This preliminary observation suggests that not all pathogenic CDH1 germline mutations confer the same risk of developing GC.

Pharmacological Modulation of Cutaneous Reactivity to Histamine: A Double-Blind Acute Comparative Study between Cetirizine, Terfenadine and Astemizole

1989 ◽  
Vol 17 (1) ◽  
pp. 24-27 ◽  
Author(s):  
L. Ghys ◽  
J.-P. Rihoux
Keyword(s):  
Comparative Study ◽  
Healthy Volunteers ◽  
Inhibitory Effect ◽  
Blind Study ◽  
Double Blind Study ◽  
Single Administration ◽  
Double Blind ◽  
Pharmacological Modulation ◽  
The Difference ◽  
Cutaneous Reactivity

In a double-blind study performed in 81 healthy volunteers, 10 mg cetirizine and 60 mg terfenadine given orally in a single administration significantly inhibited skin reactivity to histamine. Astemizole (10 mg) was completely ineffective. The inhibitory effect of cetirizine was potent and regular whereas 6/28 (21%) volunteers did not respond to terfenadine. The difference observed beween cetirizine and terfenadine might be due to differences in the metabolism of the two drugs after administration: terfenadine is rapidly and extensively metabolized whereas cetirizine is directly active without the need for biotransformation and, indeed is poorly metabolized.

scholarly journals A Research Pathway for Experimental Psychopathology: The Role of External Validity Criteria

2017 ◽  
Vol a4 (2) ◽  
pp. 129-140 ◽  
Author(s):  
Graham C L Davey
Keyword(s):  
External Validity ◽  
Healthy Individuals ◽  
Experimental Psychopathology ◽  
Clinical Disorders ◽  
Psychological Models ◽  
Validity Criteria ◽  
Psychological Knowledge ◽  
Healthy Participants

This paper outlines a putative pathway for experimental psychopathology research developing psychological models of clinical disorders. The pathway uses established external validity criteria to define the pathway and clarifies the important role that research conducted on healthy participants can play in our understanding of clinical disorders. Defining a research pathway for experimental psychopathology in this way has a number of benefits It would (1) make explicit the need to address the external validity of developed models, (2) provide a clear set of criteria that would be required to extend research on healthy individuals to diagnostic populations, and (3) recommend using general psychological knowledge when developing models of psychopathology.

Toward a pragmatic migraine model for drug testing: 1. Cilostazol in healthy volunteers

Cephalalgia ◽  
2015 ◽  
Vol 36 (2) ◽  
pp. 172-178 ◽  
Author(s):  
Emma Katrine Hansen ◽  
Song Guo ◽  
Messoud Ashina ◽  
Jes Olesen
Keyword(s):  
Physical Activity ◽  
Healthy Volunteers ◽  
Migraine Headache ◽  
Drug Testing ◽  
Rescue Medication ◽  
No Reduction ◽  
Healthy Individuals ◽  
Double Blind ◽  
Headache Intensity ◽  
Accompanying Symptoms

Background A model for the testing of novel antimigraine drugs should ideally use healthy volunteers for ease of recruiting. Cilostazol provokes headache in healthy volunteers with some migraine features such as pulsating pain quality and aggravation by physical activity. Therefore, this headache might respond to sumatriptan, a requirement for validation. The hypothesis of the present study was that sumatriptan but not placebo is effective in cilostazol-induced headache in healthy individuals. Methods In a double-blind, randomized, cross-over design, 30 healthy volunteers of both sexes received cilostazol 200 mg on two separate days, each day followed by oral self-administered placebo or sumatriptan 50 mg. Headache response and accompanying symptoms were registered in a questionnaire by the participants themselves. Results Cilostazol induced a reproducible headache in 90% of the participants. The headache had several migraine-like features in most individuals. Median peak headache score was 2 on the sumatriptan day and 3 on the placebo day ( p = 0.17). There was no reduction in headache intensity two hours after sumatriptan ( p = 0.97) and difference in AUC 0 to four hours between two experimental days was not significant ( p = 0.18). On the placebo day eight participants took rescue medication compared to 3 on the sumatriptan day ( p = 0.13). Conclusion Despite similarities with migraine headache, cilostazol-induced headache in healthy volunteers does not respond to sumatriptan.

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