scholarly journals Co-producing Human and Animal Experimental Subjects: Exploring the Views of UK COVID-19 Vaccine Trial Participants on Animal Testing

2021 ◽  
pp. 016224392110570
Author(s):  
Samantha Vanderslott ◽  
Alexandra Palmer ◽  
Tonia Thomas ◽  
Beth Greenhough ◽  
Arabella Stuart ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Public Opinion ◽  
Public Involvement ◽  
Vaccine Development ◽  
Vaccine Trial ◽  
Animal Research ◽  
Animal Testing ◽  
Experimental Subjects ◽  
Trial Participants

Preclinical (animal) testing and human testing of drugs and vaccines are rarely considered by social scientists side by side. Where this is done, it is typically for theoretically exploring the ethics of the two situations to compare relative treatment. In contrast, we empirically explore how human clinical trial participants understand the role of animal test subjects in vaccine development. Furthermore, social science research has only concentrated on broad public opinion and the views of patients about animal research, whereas we explore the views of a public group particularly implicated in pharmaceutical development: experimental subjects. We surveyed and interviewed COVID-19 vaccine trial participants in Oxford, UK, on their views about taking part in a vaccine trial and the role of animals in trials. We found that trial participants mirrored assumptions about legitimate reasons for animal testing embedded in regulation and provided insight into (i) the nuances of public opinion on animal research; (ii) the co-production of human and animal experimental subjects; (iii) how vaccine and medicine testing, and the motivations and demographics of clinical trial participants, change in an outbreak; and (iv) what public involvement can offer to science.

INTENTION TO OPPOSE ANIMAL RESEARCH: THE ROLE OF INDIVIDUAL DIFFERENCES IN NONCONFORMITY

2006 ◽  
Vol 34 (8) ◽  
pp. 955-964 ◽  
Author(s):  
Ronald E. Goldsmith ◽  
Ronald A. Clark ◽  
Barbara Lafferty
Keyword(s):  
Individual Differences ◽  
Behavioral Intentions ◽  
Animal Research ◽  
The Other ◽  
Cosmetic Products ◽  
Animal Testing ◽  
Intended Action ◽  
Psychological Influences ◽  
Using Data

Using animals to test cosmetic products is controversial, but little research has explored its social and psychological influences. Relationships between two personality constructs related to nonconformity (independence and anticonformity) and attitudes toward animal testing were studied using data from a survey of 418 students. The Independence Orientation and Nonconformity Orientation Scales (Ringness, 1970) were used to measure independence and anticonformity. Results showed that behavioral intentions were unrelated to age, women were more likely to get involved in antitesting behavior than were men, holding antitesting attitudes redicted intended action, and higher levels of anticonformity were associated with opposition as well, even when the effects of the other variables were held constant.

scholarly journals Under consent: participation of people with HIV in an Ebola vaccine trial in Canada

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Pierre-Marie David ◽  
Benjamin Mathiot ◽  
Oumy Thiongane ◽  
Janice E. Graham
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Vaccine Trial ◽  
Study Participant ◽  
Trial Participation ◽  
Structured Interviews ◽  
Contextual Diversity ◽  
Healthcare Needs ◽  
Study Participants ◽  
Trial Participants

Abstract Background Little is known about volunteers from Northern research settings who participate in vaccine trials of highly infectious diseases with no approved treatments. This article explores the motivations of HIV immunocompromised study participants in Canada who volunteered in a Phase II clinical trial that evaluated the safety and immunogenicity of an Ebola vaccine candidate. Methods Observation at the clinical study site and semi-structured interviews employing situational and discursive analysis were conducted with clinical trial participants and staff over one year. Interviews were recorded, transcribed and analysed using critical qualitative interpretivist thematic analytical techniques. Patterns were identified, clustered and sorted to generate distinct and comprehensive themes. We then reassembled events and contexts from the study participants’ stories to develop two ideal portraits based on "composite characters" based on study participants features. These provide ethnographically rich details of participants’ meaningful social worlds while protecting individual identities. Results Ten of the 14 clinical trial participants, and 3 study staff were interviewed. Participant demographics and socio-economic profiles expressed limited contextual diversity. Half were men who have sex with men, half were former injection drug users experiencing homelessness, one was female, none were racialized minorities and there were no people from HIV endemic countries. Fully 90% had previous involvement in other clinical studies. Their stories point to particular socio-economic situations that motivated their participation as clinical labor through trial participation. Conclusions Our findings support Fisher’s argument of “structural coercion” in clinical trial recruitment of vulnerable individuals experiencing precarious living conditions. Clinical trials should provide more detail of the structural socio-economic conditions and healthcare needs which lie “under consent” of study participants. Going well beyond an overly convenient narrative of altruism, ethical deliberation frameworks need to sufficiently address the structural conditions of clinical trials. We offer concrete possibilities for this and acknowledge that further research and clinical data should be made available underlying study participant contexts with regards to recruitment and participation in resource poor settings, in both the South and the North.

Clinical Trials Involving Minors: The Role of the Ethics Consultation in Avoiding Therapeutic Misconception

2021 ◽  
Vol 66 (Special Issue) ◽  
pp. 41-41
Author(s):  
Silvia Ceruti ◽  
◽  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Ethics Consultation ◽  
Therapeutic Misconception ◽  
Parental Consent ◽  
Research Subjects ◽  
Course Of Action ◽  
Trial Participants ◽  
Central Purpose

"Therapeutic Misconception (TM) occurs when clinical trial participants believe that the central purpose of the trial is therapeutic and that they will personally benefit from participation. If individuals who are entitled to consent to participation in a specific clinical trial do not understand that the defining purpose of clinical research is to produce generalizable knowledge, regardless of whether the subjects enrolled may potentially benefit from the intervention under study, this false belief may motivate them to participate, and in extreme cases may disqualify their consent. TM is especially frequent in fields in which the patients are highly vulnerable, such as when they are children and require parental consent. The informed consent is an essential ethical prerequisite before enrolling each and every participant in research that should protect patients through a process of dialog about a planned course of action. We argue that Ethics Consultant’s competencies may be crucial in avoiding TM: The Ethics Consultant should be involved in neonatal and paediatric clinical trials in order to face the unique vulnerability of children as research subjects, and to ensure that parental consent procedures are rigorously managed, enhancing recruitment in research trials in the context of fully understood consent. "

scholarly journals Genetic Research Application in the Study of Pharmaceuticals

2021 ◽  
Vol 8 (1) ◽  
pp. 3-35
Author(s):  
A. L. Khokhlov ◽  
Ph. A. Romanov ◽  
A. A. Mokhov ◽  
N. O. Pozdnyakov ◽  
A. E. Miroshnikov ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Gene Polymorphisms ◽  
Genetic Research ◽  
Genetic Material ◽  
Research Application ◽  
Genetic Characteristics ◽  
The One ◽  
Science And Research ◽  
Trial Participants

The current science and research trends, as well as the development of personalized medicine, point to the need to use genetic tests in course of the study of pharmaceuticals. Pharmacogenetic testing has become indispensable when developing new pharmaceuticals in order to study both the peculiarities of pharmacodynamic effects or the prospects of personalized treatment, and the characteristics of metabolism or drug-drug interaction. In addition, the introduction of pharmacogenetics in bioequivalence studies allows limiting, at early stages, the criteria for inclusion or non-inclusion of volunteers based on certain gene polymorphisms determining the metabolic rate.The study of the genetic characteristics of clinical trial participants allows a more detailed analysis of the role of gene polymorphisms in terms of both pharmacokinetics and pharmacodynamics of the studied pharmaceuticals.A separate important issue is genetic material collection from the clinical trial participants. On the one hand, the use of biological material collections is an essential tool for accomplishing the practical tasks in both the pharmaceutical industry and the state-of-the-art medicine. On the other hand, the legal review and ethics review of genetic material collection and use can become formidable barriers to the development of biobanking. The existing legislative differences between Russia and other countries allow identifying the most challenging regulatory aspects, and can contribute to international law harmonization in the sphere of biobanking in the future.

scholarly journals Participants’ perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience

2019 ◽  
Vol 1 ◽  
pp. 14
Author(s):  
Emmy Racine ◽  
Caroline Hurley ◽  
Aoife Cheung ◽  
Carol Sinnott ◽  
Karen Matvienko-Sikar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adult Literacy ◽  
Public Involvement ◽  
Phase 1 ◽  
Hormone Replacement ◽  
Intervention Group ◽  
Control Group ◽  
Questionnaire Response ◽  
Patient Understanding ◽  
Trial Participants

Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this Study Within A Trial (SWAT) is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-based approach to receiving trial results for participants in the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST), a trial of thyroxine versus placebo in people aged 65 years and older. Methods: Mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-based approach using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-based approach) and control group (standard approach developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two groups. Results: Participants want to receive results of clinical trials, with qualitative findings indicating three key themes including ‘acknowledgement of individual contribution’, ‘contributing for a collective benefit’ and ‘receiving accessible and easy to understand results’. Building on these findings, the patient-based approachwas developed. TRUST participants (n=101) were randomised to the intervention (n=51) or control group (n=50). The questionnaire response rate was 74% for the intervention group and 62% for the control group.  There were no differences in patient understanding between the two approaches.  Conclusions: We have demonstrated that it is feasible to involve trial participants in the development of result dissemination materials. Although, in this study PPI did not influence patients’ understanding of results, it documents the process of conducting PPI within the clinical trial setting.

Role of convalescent plasma therapy in new Coronavirus disease (nCOVID-19): A review

2020 ◽  
Vol 11 (SPL1) ◽  
pp. 546-549
Author(s):  
Shweta Dadarao Parwe ◽  
Milind Abhimanyu Nisargandha ◽  
Rishikesh Thakre
Keyword(s):  
Clinical Trial ◽  
Immune Responses ◽  
Indian Population ◽  
Preventive Treatment ◽  
The Body ◽  
Therapeutic Antibodies ◽  
Plasma Therapy ◽  
Host Immune Responses ◽  
Transparent Liquid

Hitherto, there is no proper line of treatment for the new (nCOVID19). The development of unique antiviral drugs has taken precedence. Therapeutic antibodies () will be a significantly beneficial agent against nCOVID-19. Here the host immune responses to new discussed in this review provide strategy and further treatment and understanding of clinical interventions against nCOVID-19. Plasma therapy uses the antibodies found in the blood of people recovering (or convalesced) from an infection to treat infected patients. When an infection occurs, the body begins producing proteins specially made to kill the germ, called antibodies. Those antibodies coat specifically plasma in the blood of survivors, the yellow transparent liquid blood portion for months or even years. research assesses plasma use from Convalescent patients of infected with nCOVID-19 as a possible preventive treatment. But it is not yet recommended as a line of treatment, and it is used as a clinical trial in the new in Indian population.

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