Pediatric Assent: Subject Protection Issues among Adolescent Females Enrolled in Research

2006 ◽  
Vol 34 (2) ◽  
pp. 451-459 ◽  
Author(s):  
Theresa O'Lonergan ◽  
John J. Zodrow
Keyword(s):  
Clinical Research ◽  
Randomized Clinical Trials ◽  
Ethical Issues ◽  
Pediatric Population ◽  
Medical Community ◽  
Research Subjects ◽  
Regulatory Requirements ◽  
Number Of Factors ◽  
Clinical Investigations ◽  
Scientific Attention

Randomized Clinical Trials (RCTs) in the medical community are generally lasting longer due to a number of factors, including an increase in the total volume of biomedical research, expanded federal regulatory requirements, and a rise in patient interest in participating as research subjects. Leading national and international initiatives promote clinical research in children. The primary impetus for these initiatives is the need for adequate data for clinical application of new products and treatment approaches in the pediatric population. Clinical investigations must maintain ethical conduct as an essential component of pediatric research.Ethical issues associated with clinical research in general have received prominent public and scientific attention. Of particular interest is informed consent, or assent, as applied to pediatrics. There is little practical guidance concerning pediatric assent from legal and ethical disciplines; the law has played only a small role in few cases.

The Clinical Investigator as Fiduciary: Discarding a Misguided Idea

2005 ◽  
Vol 33 (3) ◽  
pp. 586-598 ◽  
Author(s):  
E. Haavi Morreim
Keyword(s):  
Clinical Research ◽  
Standard Care ◽  
Standard Treatment ◽  
Medical Community ◽  
Clinical Equipoise ◽  
Medical Patients ◽  
Research Subjects ◽  
Clinical Investigator ◽  
The People ◽  
The Relationship

One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he owes his medical patients, or whether they differ in any fundamental way.Perhaps the most common answer is that the relationship is the same. Investigators, like physicians, are said to be fiduciaries of the volunteers who enroll in research trials. Each owes the best available medical care, which means that a physician can only justify enrolling his patient in research if the study meets the requirements of clinical equipoise, namely, that there is legitimate disagreement within the medical community as to whether the standard treatment or the investigational intervention is superior.

scholarly journals How Community Pharmacists Perceive Ethics in Clinical Research: A Qualitative Study

Healthcare ◽  
2021 ◽  
Vol 9 (11) ◽  
pp. 1496
Author(s):  
Miku Ogura ◽  
Rieko Takehira ◽  
Tatsuya Watanabe ◽  
Etsuko Arita
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Educational Program ◽  
Ethical Issues ◽  
Community Pharmacists ◽  
Opportunities To Learn ◽  
Research Subjects ◽  
Ethical Decisions ◽  
Poor Understanding ◽  
Regular Work

In recent years, the importance of building evidence in clinical practice that is increasingly acknowledged globally has been recognized in Japan as well, and it is expected that clinical research by community pharmacists will grow. In Japan, however, community pharmacists have few opportunities to learn about research ethics and may lack the training to make ethical decisions. We conducted a questionnaire survey of community pharmacists (n = 200) using a free descriptive format to understand how they perceived research ethics. Our qualitative analysis of 170 respondents revealed various perspectives (<A pharmacist’s grounding>, <How pharmacists perceive research>, and <Ethical issues entailed by research>) of Japanese pharmacists on ethics in the context of clinical research. With respect to how to understand research, the following perspectives were found: “research that prioritizes researchers,” “research that prioritizes research subjects (patients),” and “research that enters into regular work.” The perspectives on “research that prioritizes research subjects (patients)” and “research that enters into regular work” may inadvertently lead to ethically inappropriate research due to mismatch in professional values or poor understanding of research. These findings can contribute to the development of an educational program for community pharmacists on research ethics.

scholarly journals Redundant trials can be prevented, if the EU clinical trial regulation is applied duly

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Daria Kim ◽  
Joerg Hasford
Keyword(s):  
Clinical Trials ◽  
Health Risks ◽  
Ethics Committees ◽  
Medical Community ◽  
Significant Extent ◽  
Regulatory Requirements ◽  
Trial Participants ◽  
Clinical Trials Regulation ◽  
Clinical Trial Regulation ◽  
The Eu

Abstract The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.

scholarly journals Effect of childhood overweight on distal metaphyseal radius fractures treated by closed reduction

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Yu Liu ◽  
Chunjie Liu ◽  
Dongmei Guo ◽  
Ning Wang ◽  
Ying Zhao ◽  
...  
Keyword(s):  
Risk Factors ◽  
Surgical Treatment ◽  
Conservative Treatment ◽  
Closed Reduction ◽  
Pediatric Population ◽  
Normal Weight ◽  
Medical Community ◽  
Overweight Children ◽  
Radius Fractures

Abstract Background The medical community has recognized overweight as an epidemic negatively affecting a large proportion of the pediatric population, but few studies have been performed to investigate the relationship between overweight and failure of conservative treatment for distal radius fractures (DRFs). This study was performed to investigate the effect of overweight on the outcome of conservative treatment for DRFs in children. Methods We performed a retrospective study of children with closed displaced distal metaphyseal radius fractures in our hospital from January 2015 to May 2020. Closed reduction was initially performed; if closed reduction failed, surgical treatment was performed. Patients were followed up regularly after treatment, and redisplacement was diagnosed on the basis of imaging findings. Potential risk factors for redisplacement were collected and analyzed. Results In total, 142 children were included in this study. The final reduction procedure failed in 21 patients, all of whom finally underwent surgical treatment. The incidences of failed final reduction and fair reduction were significantly higher in the overweight/obesity group than in the normal-weight group (P = 0.046 and P = 0.041, respectively). During follow-up, 32 (26.4%) patients developed redisplacement after closed reduction and cast immobilization. The three risk factors associated with the incidence of redisplacement were overweight/obesity [odds ratio (OR), 2.149; 95% confidence interval (CI), 1.320–3.498], an associated ulnar fracture (OR, 2.127; 95% CI, 1.169–3.870), and a three-point index of ≥ 0.40 (OR, 3.272; 95% CI, 1.975–5.421). Conclusions Overweight increases the risk of reduction failure and decreases the reduction effect. Overweight children were two times more likely to develop redisplacement than normal-weight children in the present study. Thus, overweight children may benefit from stricter clinical follow-up and perhaps a lower threshold for surgical intervention.

scholarly journals Scientific Attention to Sustainability and SDGs: Meta-Analysis of Academic Papers

Energies ◽  
2020 ◽  
Vol 13 (4) ◽  
pp. 975 ◽  
Author(s):  
Kimitaka Asatani ◽  
Haruo Takeda ◽  
Hiroko Yamano ◽  
Ichiro Sakata
Keyword(s):  
Language Processing ◽  
Early Childhood Development ◽  
Meta Analysis ◽  
Citation Network ◽  
Childhood Development ◽  
Research Subjects ◽  
Research Attention ◽  
Research Activities ◽  
Sustainability Research ◽  
Scientific Attention

Scientific research plays an important role in the achievement of a sustainable society. However, grasping the trends in sustainability research is difficult because studies are not devised and conducted in a top-down manner with Sustainable Development Goals (SDGs). To understand the bottom-up research activities, we analyzed over 300,000 publications concerned with sustainability by using citation network analysis and natural language processing. The results suggest that sustainability science’s diverse and dynamic changes have been occurring over the last few years; several new topics, such as nanocellulose and global health, have begun to attract widespread scientific attention. We further examined the relationship between sustainability research subjects and SDGs and found significant correspondence between the two. Moreover, we extracted SDG topics that were discussed following a convergent approach in academic studies, such as “inclusive society” and “early childhood development”, by observing the convergence of terms in the citation network. These results are valuable for government officials, private companies, and academic researchers, empowering them to understand current academic progress along with research attention devoted to SDGs.

Ethical Issues in Immigrant Health Care and Clinical Research

1998 ◽  
pp. 203-226 ◽  
Author(s):  
Patricia A. Marshall ◽  
Barbara A. Koenig ◽  
Paul Grifhorst ◽  
Mirjam van Ewijk
Keyword(s):  
Health Care ◽  
Clinical Research ◽  
Immigrant Health ◽  
Ethical Issues

scholarly journals Privacy of Clinical Research Subjects: An Integrative Literature Review

2018 ◽  
Vol 14 (1) ◽  
pp. 33-48 ◽  
Author(s):  
Sanna-Maria Nurmi ◽  
Mari Kangasniemi ◽  
Arja Halkoaho ◽  
Anna-Maija Pietilä
Keyword(s):  
Clinical Research ◽  
Privacy Protection ◽  
Personal Data ◽  
Comparison Method ◽  
Health Data ◽  
The Body ◽  
Social Benefits ◽  
Theoretical Studies ◽  
Research Practice ◽  
Research Subjects

With changes in clinical research practice, the importance of a study-subject’s privacy and the confidentiality of their personal data is growing. However, the body of research is fragmented, and a synthesis of work in this area is lacking. Accordingly, an integrative review was performed, guided by Whittemore and Knafl’s work. Data from PubMed, Scopus, and CINAHL searches from January 2012 to February 2017 were analyzed via the constant comparison method. From 16 empirical and theoretical studies, six topical aspects were identified: the evolving nature of health data in clinical research, sharing of health data, the challenges of anonymizing data, collaboration among stakeholders, the complexity of regulation, and ethics-related tension between social benefits and privacy. Study subjects’ privacy is an increasingly important ethics principle for clinical research, and privacy protection is rendered even more challenging by changing research practice.

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