Ethical guidelines and regulations in conducting clinical research in children: A critical appraisal

2022 ◽  
Vol 27 (1) ◽  
pp. 14
Author(s):  
FelixN Chukwuneke ◽  
AnthonyC Ezenwugo
Keyword(s):  
Clinical Research ◽  
Critical Appraisal ◽  
Ethical Guidelines

scholarly journals Understanding the nature and scope of clinical research commentaries in PubMed

2019 ◽  
Vol 27 (3) ◽  
pp. 449-456
Author(s):  
James R Rogers ◽  
Hollis Mills ◽  
Lisa V Grossman ◽  
Andrew Goldstein ◽  
Chunhua Weng
Keyword(s):  
Clinical Research ◽  
Sentiment Analysis ◽  
Random Sample ◽  
Full Text ◽  
Topic Modeling ◽  
Critical Appraisal ◽  
Research Articles ◽  
Disease Specific ◽  
Research Studies

Abstract Scientific commentaries are expected to play an important role in evidence appraisal, but it is unknown whether this expectation has been fulfilled. This study aims to better understand the role of scientific commentary in evidence appraisal. We queried PubMed for all clinical research articles with accompanying comments and extracted corresponding metadata. Five percent of clinical research studies (N = 130 629) received postpublication comments (N = 171 556), resulting in 178 882 comment–article pairings, with 90% published in the same journal. We obtained 5197 full-text comments for topic modeling and exploratory sentiment analysis. Topics were generally disease specific with only a few topics relevant to the appraisal of studies, which were highly prevalent in letters. Of a random sample of 518 full-text comments, 67% had a supportive tone. Based on our results, published commentary, with the exception of letters, most often highlight or endorse previous publications rather than serve as a prominent mechanism for critical appraisal.

Crowdsourcing critical appraisal of research evidence (CrowdCARE) was found to be a valid approach to assessing clinical research quality

2018 ◽  
Vol 104 ◽  
pp. 8-14 ◽  
Author(s):  
Michael J. Pianta ◽  
Eve Makrai ◽  
Karin M. Verspoor ◽  
Trevor A. Cohn ◽  
Laura E. Downie
Keyword(s):  
Clinical Research ◽  
Critical Appraisal ◽  
Research Evidence ◽  
Research Quality

Research in anaesthesia

2017 ◽  
Author(s):  
Gary Minto ◽  
J. Robert Sneyd
Keyword(s):  
Clinical Practice ◽  
Clinical Research ◽  
Basic Science ◽  
Critical Appraisal ◽  
Perioperative Medicine ◽  
Limited Information ◽  
Priority Areas ◽  
Number Of Patients ◽  
Critical Appraisal Skills

Clinicians need critical appraisal skills to weigh up the quality of the literature and to decide whether it has implications for their practice. Every belief in medicine is a construct created from the limited information available and carries a degree of uncertainty. A centralized approach to research identifies the highest priority areas of uncertainty so as to bring about the most improvement for the largest number of patients. This patient-centred model classifies studies into basic science, translational, and clinical research. Adequately powered mega-trials are required to bridge the translational gap between efficacy (does a treatment work?) and effectiveness (does a treatment work when applied in ordinary clinical practice?). There is a paucity of these in perioperative medicine.

scholarly journals Islamic concepts in ethics of pediatric clinical research

2020 ◽  
Vol 16 (1-2) ◽  
pp. 1-11
Author(s):  
Areej AG AlFattani ◽  
Hala AlAlem
Keyword(s):  
Decision Making ◽  
Clinical Research ◽  
Medical Research ◽  
Religious Beliefs ◽  
Decision Making Process ◽  
Ethical Guidelines ◽  
Culturally Adapted ◽  
Different Ages ◽  
Islamic Countries ◽  
Muslim Communities

Background: Medical research on children has increased in the last 20 years. International ethical regulations for conducting clinical research on children may not pertain to Muslim communities where religious beliefs play a big role in decision-making process. Methods: The aim of this paper was to illustrate the origins of bioethics principles in Islam, to appraise the existing regulations of Islamic countries, and to systematically review areas of improvements. Conclusion: This review recommends a customized approach for regulators to set culturally adapted ethical guidelines that highlight Islamic traditions in dealing with children of different ages.

scholarly journals Structured abstracts: narrative review

2006 ◽  
Vol 21 (4) ◽  
pp. 263-268 ◽  
Author(s):  
Carlos Alberto Guimarães
Keyword(s):  
Clinical Research ◽  
Working Group ◽  
Critical Appraisal ◽  
Ad Hoc ◽  
Medical Literature ◽  
Narrative Review ◽  
Review Articles ◽  
Discussion Format

PURPOSE: To summarize the main findings from research on structured abstracts. METHODS: A narrative review of all the relevant papers known to the author was conducted. RESULTS: Authors and readers judged the structured abstracts to be more useful than traditional ones. In 1987 the Ad Hoc Working Group for Critical Appraisal of the Medical Literature proposed guidelines for informative seven-headings abstracts. In 1990 Haynes et al. reconsidered the structured abstract of clinical research and review articles and proposed revised guidelines. Nowadays, most abstracts are informative, and the most commonly used structure is IMRAD (Introduction, Methods, Results And Discussion) format. CONCLUSIONS: There are many variations in the structured-abstract formats prescribed by different journals. But even in recent years, not all abstracts of original articles are structured. More research is needed on a number of questions related to the quality and utility of structured abstracts.

scholarly journals Ethics in clinical research

2012 ◽  
Vol 3 (3) ◽  
pp. 16-20 ◽  
Author(s):  
Md Fakruddin ◽  
Abhijit Chowdhury ◽  
Md Nur Hossain ◽  
Khanjada Shahnewaj Bin Mannan
Keyword(s):  
Clinical Research ◽  
Human Subjects ◽  
Second World War ◽  
Ethical Review ◽  
Ethical Guidelines ◽  
Nuremberg Code ◽  
The World ◽  
Long Time ◽  
History Of ◽  
Second World

History of unethical clinical research practice date back to a very long time, though the most remarkable unethical clinical research was those by the Nazis during second world war, which eventually shaken the scientific community and gives birth to the first guideline of ethics in clinical research, the Nuremberg Code. Following Nuremberg code, a number of ethical guidelines has been formulated most important of which are the declaration of Helsinski. To make any research involving human subjects or samples ethically acceptable, a number of key features have to be considered by the scientists. These guidelines are internationally accepted and without following these guidelines, no clinical research is acceptable in the world. Though, there are many countries in the world like Bangladesh, which don’t have any ethical guidelines of their own and thus scientists in those countries do not adhere the any ethical guideline while conducting their research. Each country should have their own ethical guidelines and each clinical research institutes should have own ethical review committee to ensure ethical clinical research. DOI: http://dx.doi.org/10.3329/bioethics.v3i3.12560 Bangladesh Journal of Bioethics 2012; 3(3):16-20

scholarly journals The Current Status and Future Direction of Clinical Research in Japan From a Regulatory Perspective

2022 ◽  
Vol 8 ◽  
Author(s):  
Hideki Maeda
Keyword(s):  
Clinical Trials ◽  
Clinical Study ◽  
Clinical Research ◽  
Personal Information ◽  
Human Subjects ◽  
Legal Framework ◽  
Current Status ◽  
Biological Research ◽  
Marketing Approval ◽  
Ethical Guidelines

In Japan, a law called the Clinical Trials Act went into being effective on April 1, 2018, and clinical research on human subjects conducted in Japan has been undergone major changes. Those other than clinical trials for marketing approval of drugs or medical devices are broadly classified into “specific clinical trials” and others, and regulations have been tightened for each. As a result, clinical interventional study was drastically reduced, and observational clinical study increased. For the observational clinical study, the two previous ethical guidelines were merged into the “Ethical Guidelines for Medical and Biological Research Involving Human Subjects,” which was enacted in March 2021. The observational clinical study is now subjected to these ethical guidelines. In addition, changes are planned for the Act on the Protection of Personal Information, which greatly affects data collection in clinical research. Clinical research in Japan must be conducted appropriately while adapting to these various changes in the external environment and legal framework. Adapting to these changes is not an easy task, as it requires increased financial and human resources for all stakeholders.

Getting ahead

2019 ◽  
pp. 1009-1046
Keyword(s):  
Medical Student ◽  
Clinical Research ◽  
Medical School ◽  
Reflective Practice ◽  
Time Management ◽  
Critical Appraisal ◽  
Laboratory Research ◽  
Academic Training ◽  
Special Study ◽  
Research Papers

Chapter 54 outlines the approaches to capitalize on opportunities to strengthen your CV while at medical school. Most of your colleagues will quality with a medical degree, and therefore, there remains an element of competition to make yourself stand out from the crowd when applying for intercalated degrees, electives, foundation jobs, and beyond. This chapter provides tips on making contacts from various spheres, time management, surgical logbooks, reflective practice, finding projects, involvement in clinical audit, and clinical research. Opportunities for higher degrees, academic training pathways, laboratory research, and funding are outlined, including the challenges associated with such roles. Generic research skills are summarized, as well as the ethical principles that underpin them. Tips are offered for getting involved in research as a medical student, and for writing up research with a detailed summary of the structure of research papers. Systematic critical appraisal of papers is an important skill for every doctor and an approach to this task is outlined. Special study modules may offer opportunities for indulging interests: advice how to choose one is provided.

The Connection and Disconnection Between Microbiome and Metabolome: A Critical Appraisal in Clinical Research

2020 ◽  
Vol 22 (4) ◽  
pp. 561-576
Author(s):  
Biswapriya B. Misra
Keyword(s):  
Big Data ◽  
Clinical Research ◽  
Current Literature ◽  
Critical Appraisal ◽  
Well Being ◽  
The Other ◽  
Present Review ◽  
Data Driven ◽  
Nursing Research ◽  
Challenges And Opportunities

Big data-driven omics research has led to a steep rise in investigations involving two of the most functional omes, the metabolome and microbiome. The former is touted as the closest to the phenotype, and the latter is implicated in general well-being and a plethora of human diseases. Although some research publications have integrated the concepts of the two domains, most focus their analyses on evidence solely originating from one or the other. With a growing interest in connecting the microbiome and metabolome in the context of disease, researchers must also appreciate the disconnect between the two domains. In the present review, drawing examples from the current literature, tools, and resources, I discuss the connections between the microbiome and metabolome and highlight challenges and opportunities in linking them together for the basic, translational, clinical, and nursing research communities.

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