Re-thinking Clinical Research Ethics: From Protocol Design to Everyday Practice

2006 ◽  
Author(s):  
Deb DeBruin ◽  
Joan Liaschenko ◽  
A. Fisher
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Protocol Design ◽  
Everyday Practice

scholarly journals A Survey on Clinical Research Training Status and Needs in Public Hospitals from Shenzhen

2017 ◽  
Vol 5 (7) ◽  
pp. 73
Author(s):  
Ping Ji ◽  
Haibo Wang ◽  
Chao Zhang ◽  
Min Liu ◽  
Liping Zhou ◽  
...  
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Research Training ◽  
Training Model ◽  
Protocol Design ◽  
Public Hospitals ◽  
Training Status ◽  
Research Knowledge ◽  
Peking University ◽  
Ethics Course

Objective: To obtain information on the current clinical research training status and evaluate the training needs comprehensively for medical staff in hospitals.Methods: This survey was initiated and conducted by the Health and Family Planning Commission of Shenzhen in conjunction with the Peking University Clinical Research Institute (Shenzhen) from Sep 2016 through Nov 2016. It was planned that no less than 10% of the total staff from each participating hospital were invited to complete the survey. All participants filled out the questionnaire anonymously and voluntarily.Results: A total of 644 subjects from 12 hospitals completed the survey with the response rate of 28.7%. The majority of respondents (80%) have attended training related to clinical research knowledge and skills, however, medical research ethical aspects and statistics knowledge have been provided only for 40% and 27% of respondents, respectively. With regard to preference on training subjects and contents, Protocol design and development (74%) is ranked first, followed by the data analysis and summary (59%) among those researchers from medical professions. Project management and quality control course are mostly demanded for technicians and nurses (53%). Unpredictably, no more than 40% of the respondents consider that it is necessary to receive “Regulation and Research ethics” course even for those Principal investigators.Conclusions: Our survey results indicated that training subjects on protocol design and research ethics are urgently needed and relatively inadequate in China. An appropriate clinical research competency training model should be developed and provided for hospital staffs in China.

scholarly journals State of clinical research ethics in Pakistan

2007 ◽  
Vol 13 (9) ◽  
pp. 1011-1011 ◽  
Author(s):  
Muhammad N Ghayur ◽  
Ayesha Ghayur ◽  
Luke J Janssen
Keyword(s):  
Clinical Research ◽  
Research Ethics

Investigator perception of trial presentation to the clinical research ethics committee

2012 ◽  
Vol 19 (2) ◽  
pp. 241.2-241
Author(s):  
N. Vilardell ◽  
S. Redondo ◽  
N. Giménez ◽  
L. Soriano ◽  
R. Pla ◽  
...  
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Ethics Committee ◽  
Research Ethics Committee

Research Ethics, Clinical Research

2021 ◽  
pp. 897-897
Author(s):  
Henk ten Have ◽  
Maria do Céu Patrão Neves
Keyword(s):  
Clinical Research ◽  
Research Ethics

scholarly journals An educational workshop designed for research ethics consultants to educate investigators on ethical considerations

2020 ◽  
Author(s):  
Hiroaki Yanagawa ◽  
Masayuki Chuma ◽  
Kenshi Takechi ◽  
Kenta Yagi ◽  
Yasutaka Sato ◽  
...  
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Training Methods ◽  
Educational Materials ◽  
Ethical Considerations ◽  
Case Discussion ◽  
Research Institutes ◽  
Anonymous Questionnaire ◽  
Educational Workshop

Abstract The role of research ethics consultants in biomedical research has increased to the point that they have an advisory capacity at all research institutes. For such professionals, we have established an educational system, which includes teaching materials, training methods, and nationwide educational workshops. These workshops have served to examine the developed system’s usefulness and to provide realistic training for consultant candidates. In addition, we have used the current workshop to encourage clinical research investigators (and related personnel) to participate. Subsequently, we examined its usefulness as an opportunity to provide exposure to research ethics. In October 2019, we held a 1-day pilot workshop in Tokushima, Japan, which included a basic lecture in research ethics. During the lecture, two sets of materials were used for case discussion: case 1, covering issues related to a clinical trial, and case 2, covering issues related to human biological specimens. At the end of the workshop, a 30-item self-reporting anonymous questionnaire was provided. Of the 13 total participants, 9 (70%) were clinical research investigators and related personnel, while 6 (46%) had no direct intention to act as consultants. Respondents indicated that case 2 was more difficult than case 1. However, both cases were generally accepted as educational materials; thus, satisfaction was expressed in relation to both. As the evaluations of the cases were generally positive, we will further examine the usefulness of participation in the workshop in the cultivation of research ethics in the investigator community.

Should Research Ethics Committees Be Observing the Law or Working by Ethical Principles?

2005 ◽  
Vol 1 (1) ◽  
pp. 23-26 ◽  
Author(s):  
Charles Warlow
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Public Interest ◽  
Ethics Committees ◽  
Unintended Consequences ◽  
Research Ethics Committees ◽  
Individual Interest ◽  
The Public ◽  
The Law ◽  
The Individual

Recent laws, and their interpretation, have made clinical research more difficult to do, and sometimes impossible. Furthermore the results of that research which can be done may even be unreliable. This is certainly against the public interest, and indeed the individual patient interest as well. But ethics committees have to abide by the law and so even though it is surely unethical to work against the public and individual interest that is exactly what ethics committees now have to endorse. The unintended consequences of the new regulations must be reduced by amending the law.

Clinical Research Ethics in Respiratory Medicine

2006 ◽  
Vol 42 (2) ◽  
pp. 74-80
Author(s):  
E. Fernández de Uzquiano ◽  
R. Álvarez-Sala
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Respiratory Medicine

Research Oversight through New Lenses: The Consortium to Examine Clinical Research Ethics

2003 ◽  
Vol 25 (1) ◽  
pp. 9 ◽  
Author(s):  
Jeremy Sugarman ◽  
Lisa A. Eckenwiler ◽  
Ezekiel J. Emanuel
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Research Oversight
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