Ethical Considerations for Conducting Clinical Research

2011 ◽  
Vol 20 (2) ◽  
pp. 46-52 ◽  
Author(s):  
Debra M. Suiter

The need for evidence-based assessments and treatments for individuals with dysphagia has driven the need for more research in these areas. This article reviews the history of research ethics and the documents that have shaped the public's perception of clinical research, and discusses specific examples of how these ethics affect clinical research of individuals with dysphagia.

1970 ◽  
Vol 8 (1) ◽  
pp. 1-3
Author(s):  
Shamim Ara

DOI: 10.3329/bja.v8i1.6099Bangladesh Journal of Anatomy January 2010, Vol. 8 No. 1 pp. 1-3


Author(s):  
Hiroaki Yanagawa ◽  
Masayuki Chuma ◽  
Kenshi Takechi ◽  
Kenta Yagi ◽  
Yasutaka Sato ◽  
...  

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.


2018 ◽  
Vol 25 (9-10) ◽  
pp. 1056-1064 ◽  
Author(s):  
Sheeva Sabati

This article considers the institutionalization of research ethics as a site of “colonial unknowing” in which the racial colonial entanglements of academic research and institutions are obscured. I examine the origin stories situating Institutional Review Boards (IRBs) as a response to cases of exceptional violence, most notably the Tuskegee syphilis experiment, within an otherwise neutral history of research. I then consider how the 2018 revisions to the Common Rule extend “colonial unknowing” by decontextualizing the forms of risk involved in social and behavioral research. I situate these complicities as necessary starting points toward anticolonial research ethics of “answerability.”


2013 ◽  
Vol 4 (1) ◽  
pp. 20-29 ◽  
Author(s):  
Shamima Parvin Lasker

The aim of clinical research is to congregate useful knowledge about the human biology. Benefits to the participants are not the purpose of research, although it does secondarily. Therefore, exploitation of human subjects occurred in clinical research. Many people were harmed and basic human rights were violated as a result of their unwillingness participation in research. There have been many tragedies throughout the history of research involving human subjects. Every period of research scandals have been followed by attempt to initiate some ethical codes to protect the human from clinical research. First of such codes is the Nuremberg Code. Thereafter, Helsinky Declaration, Belmont Report and lastly Obama Commission on Guatemala syphilis study. To remember history is essential so that it's not repeated again. Knowledge of the history will provide a better understanding to handle the research fairly. Researchers and the healthcare providers have no awareness of the history of ethical requirements for clinical research. Therefore, repetition of scandal is being seen. In addition, there are few sporadic studies on this issue. Formulation of UNIVERSAL rules and regulations is required which will not be limited to a specific tragedy or scandal or the practice of researcher in one country. It will provide common understanding and unique values of the research all over the world, although their application will require adaptation to particular culture, health condition and economic setting. DOI: http://dx.doi.org/10.3329/bioethics.v4i1.14265 Bangladesh Journal of Bioethics 2013; 4(1):20-29


2018 ◽  
Vol 12 (2) ◽  
pp. 223-238
Author(s):  
George Chryssides

In most education institutions, research involving human subjects requires to be scrutinized by an ethics committee. After outlining the history of research ethics and codes of practice, the author draws on his own experience of research on Jehovah’s Witnesses, examining issues of consent, disclosure, respect for informants, and confidentiality. It is argued that institutional ethics committees tend to apply a biomedical model of research, which is inappropriate in the study of religion. Several problems in the operation of research committees are identified, such as their typical adversarial stance, the frequent lack of appropriate qualifications among members, and their failure to recognize the ways in which research in religion is conducted. Ethical considerations are not limited to fieldwork, and the author argues the need to recognize the wider aspects of research, and to note the ways in which other organizations address ethical issues. Such organizations include religious communities themselves, business companies, and a few universities who have developed a concern for their wider social responsibility. Although there remains a place for ethics committees, they can themselves operate in an unethical manner, and need to take a more humane and realistic account of research methods in the study of religion.


2019 ◽  
Vol 23 (3) ◽  
Author(s):  
Eamon Costello ◽  
Enda Donlon ◽  
Mark Brown

This study examined the ethical considerations researchers have made when investigating MOOC learners’ and teachers’ Twitter activity. In so doing, it sought to addresses the lack of an evidence-based understanding of the ethical implications of research into Twitter as a site of teaching and learning. Through an analysis of 31 studies we present a mapping of the ethical practices of researchers in this area. We identified potential ethical issues and concerns that have arisen. Our main contribution is to seek to challenge researchers to engage critically with ethical issues and hence develop their own understanding of ethically- appropriate approaches. To this end, we also reflected and reported on our own evolving practice.


2019 ◽  
Vol 3 (2) ◽  
pp. 84
Author(s):  
Tina Hostetler

Background: The incidence of workplace violence has continued to occupy a significant place in healthcare at a rate nearly double that in other industries. Those providing direct bedside care are among the most vulnerable to violence, including nursing students. Among the evidence-based tools which may be deployed in such circumstances is verbal de-escalation, or the practice of verbal and physical behaviors and actions meant to calm (or at least not exacerbate) the patient. This literature review outlines the history of research on violence against nursing students and identifies the next steps for addressing this problem. Method: A search for relevant studies included using the Cumulative Index to Nursing and Allied Health Literature (CINAHL), ProQuest, Ovid, Science Direct, Medline, and PubMed databases using key terms such as nursing student, verbal de-escalation, aggression, and violence. Results: Search identified 19,000 articles but only 28 focused on violence experienced by nursing students and are covered in this review. Conclusion: Verbal de-escalation training may represent a promising solution for teaching students how to handle workplace violence. Furthur investigation of this and other solutions is necessary.


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