scholarly journals Ethics in clinical research

2020 ◽  
Vol 5 (2) ◽  
pp. 012-018
Author(s):  
Nagla Hussein Mohamed Khalid
Keyword(s):  
Medical Education ◽  
Clinical Research ◽  
Ethical Issues ◽  
Human Subjects ◽  
Boards Of Trustees ◽  
Independent Research ◽  
Academic Medical ◽  
Research On Human Subjects ◽  
Human Participants ◽  
The University

Ethics in medical education research is associated with any research concerning human participants and including anthropological tissue conducted by supervising and scholars of the University. It is associated with the accountability of the researcher, to be honest, and privacy and confidentially and autonomy and respectfully to all participants who affected by their research studies. Objectives of the review: The motivation behind this report is to look at the ethical issues raised when investigating including human members. In addition, to demonstrate the important ethical consideration with academic medical research. Conclusion: Ethics of restorative research on human subjects should be clinically supported and deductively stable. Educated consent is a compulsory segment of any clinical research. Investigators are committed to configuration look into protocols that build up guidelines of logical respectability, safeguard ethical and authoritative issues of the human subjects, and follow the conventions for forthcoming survey by independent research morals boards of trustees.

University Research Ethics Committees — A Summary of Research into Their Role, Remit and Conduct

2005 ◽  
Vol 1 (1) ◽  
pp. 5-11 ◽  
Author(s):  
Anthea Tinker ◽  
Vera Coomber
Keyword(s):  
Ethical Issues ◽  
Human Subjects ◽  
Ethics Committees ◽  
National Study ◽  
Ethical Review ◽  
The United Kingdom ◽  
Human Volunteers ◽  
Research On Human Subjects ◽  
The University ◽  
Research Councils

As society becomes more aware of the rights of individuals, ethical issues become of increasing importance. Many research funders, including the research councils, increasingly emphasise research governance and ethical review in their consideration of submitted proposals. Little is known, however, about what universities do over ethical scrutiny and in order to find out the authors undertook a national study of all universities in the United Kingdom. The focus of the study was on human volunteers for research outside the remit of the National Health Service. The key questions being: to what extent do universities undertake ethical scrutiny of research and, if so, how? The broad conclusion is that when this survey was carried out in the autumn of 2003, the majority of universities were aware of the need for the ethical scrutiny of research on human subjects although in many of those universities the scrutiny system was being developed at the time of completion of the questionnaire. In some cases practice appeared to lag behind awareness and whilst there were some very good examples there were also some which were below an ‘acceptable’ standard. Recommendations are made concerning structures, coverage and membership for systems of ethical scrutiny within the university sector.

scholarly journals Practice-Based Learning and Improvement for Institutions: A Case Report

2010 ◽  
Vol 2 (4) ◽  
pp. 633-637 ◽  
Author(s):  
Susan E. Kirk ◽  
R. Edward Howell
Keyword(s):  
Medical Education ◽  
Graduate Medical Education ◽  
University Of Virginia ◽  
Review Committee ◽  
New Classification ◽  
Graduate Medical ◽  
Institutional Review ◽  
Medical Institutions ◽  
Academic Medical ◽  
The University

Abstract Background In 2006, the University of Virginia became one of the first academic medical institutions to be placed on probation, after the Accreditation Council for Graduate Medical Education (ACGME) Institutional Review Committee implemented a new classification system for institutional reviews. Intervention After University of Virginia reviewed its practices and implemented needed changes, the institution was able to have probation removed and full accreditation restored. Whereas graduate medical education committees and designated institutional officials are required to conduct internal reviews of each ACGME–accredited program midway through its accreditation cycle, no similar requirement exists for institutions. Learning As we designed corrective measures at the University of Virginia, we realized that regularly scheduled audits of the entire institution would have prevented the accumulation of deficiencies. We suggest that institutional internal reviews be implemented to ensure that the ACGME institutional requirements for graduate medical education are met. This process represents practice-based learning and improvement at the institutional level and may prevent other institutions from receiving unfavorable accreditation decisions.

scholarly journals Ethical issues of randomized controlled trials

2014 ◽  
Vol 5 (1) ◽  
pp. 1-4 ◽  
Author(s):  
Jyotirmoy Sarker
Keyword(s):  
Randomized Controlled Trials ◽  
Ethical Issues ◽  
Human Subjects ◽  
Research Result ◽  
Controlled Trials ◽  
Medical Interventions ◽  
Randomized Controlled ◽  
Institutional Review ◽  
Human Participants ◽  
Selection Of

Clinical trials involve the application of different medical interventions on human participants. Randomized controlled trials involve different groups of human subjects undergoing different clinical interventions. This process ensures bias free subject allocation which leads to a way to statistically establish the research result. Strict ethical guidance is necessary from selection of participants to the analysis of trial results. Without proper guidance the trial participants would be subjected to unethical experiments. Before starting the randomized controlled trials the investigators must meet all ethics issues. The institutional review board (IRB) must check whether all ethical demands are met or not before permitting the research. DOI: http://dx.doi.org/10.3329/bioethics.v5i1.18441 Bangladesh Journal of Bioethics 2014 Vol.5(1): 1-4

scholarly journals Evaluating the prospects for university-based ethical governance in artificial intelligence and data-driven innovation

2021 ◽  
pp. 174701612110227
Author(s):  
Christine Hine
Keyword(s):  
Artificial Intelligence ◽  
Ethical Issues ◽  
Human Subjects ◽  
Research Process ◽  
Data Driven ◽  
Ethical Review ◽  
Effective System ◽  
Human Autonomy ◽  
The University ◽  
Ethical Governance

There has been considerable debate around the ethical issues raised by data-driven technologies such as artificial intelligence. Ethical principles for the field have focused on the need to ensure that such technologies are used for good rather than harm, that they enshrine principles of social justice and fairness, that they protect privacy, respect human autonomy and are open to scrutiny. While development of such principles is well advanced, there is as yet little consensus on the mechanisms appropriate for ethical governance in this field. This paper examines the prospects for the university ethics committee to undertake effective review of research conducted on data-driven technologies in the university context. Challenges identified include: the relatively narrow focus of university-based ethical review on the human subjects research process and lack of capacity to anticipate downstream impacts; the difficulties of accommodating the complex interplay of academic and commercial interests in the field; and the need to ensure appropriate expertise from both specialists and lay voices. Overall, the challenges identified sharpen appreciation of the need to encourage a joined-up and effective system of ethical governance that fosters an ethical culture rather than replacing ethical reflection with bureaucracy.

scholarly journals AAN position statement: Ethical issues in clinical research in neurology

Neurology ◽  
2020 ◽  
Vol 94 (15) ◽  
pp. 661-669
Author(s):  
Benjamin Tolchin ◽  
Robin Conwit ◽  
Leon G. Epstein ◽  
James A. Russell ◽  
Keyword(s):  
Clinical Research ◽  
Ethical Issues ◽  
Research Participant ◽  
Position Statement ◽  
Ethical Framework ◽  
International Studies ◽  
Nuremberg Code ◽  
Institutional Review ◽  
Replication Crisis ◽  
Human Participants

This update to the American Academy of Neurology’s 1998 position statement endeavors to provide guidance for the consistent ethical conduct and review of neurologic research involving human participants. It does so by outlining a widely used ethical framework of 7 principles derived from the foundational documents of modern bioethics, including the Nuremberg Code, the World Medical Association’s Declaration of Helsinki, the Belmont Report, and the US Department of Health and Human Service’s Common Rule. The position statement then applies this principle-based framework to analyze and produce recommendations for the management of common and important ethical issues encountered in neurologic clinical research. These include institutional review board oversight, equitable research participant inclusion, cognitive impairment in research participants, international studies, the replication crisis, and genetic testing and modification.

scholarly journals Standard of Care in Clinical Research Involving Human Subjects: A Perspective from Developing World

2014 ◽  
Vol 5 (2) ◽  
pp. 68-72
Author(s):  
Muhammad Waseem Khan ◽  
Sanam Zeib Khan ◽  
Afrasiab Khan Tareen ◽  
Imrana Niaz Sultan
Keyword(s):  
Developing Countries ◽  
Human Rights ◽  
Clinical Research ◽  
Ethical Issues ◽  
Human Subjects ◽  
Standard Of Care ◽  
Vulnerable Population ◽  
Diagnostic Process ◽  
Ethical Problems ◽  
Conducting Research

Standard of care is an ordinary, reasonable formal treatment and diagnostic process that a physician should follow for his/her patient with specific disease. Standard of care followed in one country may not suit to other country; the reason may involve economic conditions, certain norms, beliefs, tradition and culture of that society. It may be considered ethical if it does not exploit human rights and poor vulnerable population, once it exploits the human rights it creates ethical dilemmas that need to be sort out to protect vulnerable population and to make the research more ethical. Patients attending medicine department of Bolan Medical Complex (BMC) Quetta, Balochistan, Pakistan were selected randomly interviewed and requested to fill the questionnaire. The ethical issues in clinical research conducted on human population have been perplexing and remains to be the same in clinical research settings. Exploitive use of research participants in resource poor developing countries has intensified the debate on the ethics of international research and led to increasing attention to exploitation of vulnerable study subjects. The issues of conducting research in developing countries will remain and need to be focused and debated where and whenever require. One has to try sincerely to sort out the ethical problems while conducting a research study, he might fail to solve all the issues but the situation may improve by the time if tried sincerely.DOI: http://dx.doi.org/10.3329/bioethics.v5i2.19617 Bangladesh Journal of Bioethics 2014 Vol.5(2):68-72 

A University Wide Model for the Ethical Review of Human Subjects Research

2005 ◽  
Vol 1 (2) ◽  
pp. 39-44 ◽  
Author(s):  
Bryn Williams-Jones ◽  
Søren Holm
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Ethics Committees ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Ethics Review ◽  
Wide System ◽  
Tiered System ◽  
The University

In the United Kingdom (and elsewhere), there are moves to extend formal ethical review of research involving human subjects beyond the traditional oversight by NHS local or multi-centre research ethics committees of medical or clinical research, to also encompass all ‘non-clinical’ research involving human subjects. This paper describes and analyses the development and implementation of a model for ethical review within the university sector. At Cardiff University, a devolved or two-tiered system of ethics review has been created in which a top-level university research ethics committee provides policy advice to and oversight of school-based research ethics committees that engage in formal ethics review of research conducted in their respective schools. We describe the system and reflect on the challenges and benefits of implementing such a coordinated and comprehensive university-wide system of ethics review.

User Evaluation of an Integrated Medical Workstation for Clinical Data Analysis

1993 ◽  
Vol 32 (05) ◽  
pp. 365-372 ◽  
Author(s):  
T. Timmeis ◽  
J. H. van Bemmel ◽  
E. M. van Mulligen
Keyword(s):  
Data Analysis ◽  
Clinical Research ◽  
Clinical Data ◽  
University Hospital ◽  
User Evaluation ◽  
Scientific Staff ◽  
Medical Institutions ◽  
Clinical Data Analysis ◽  
Research Problems ◽  
The University

AbstractResults are presented of the user evaluation of an integrated medical workstation for support of clinical research. Twenty-seven users were recruited from medical and scientific staff of the University Hospital Dijkzigt, the Faculty of Medicine of the Erasmus University Rotterdam, and from other Dutch medical institutions; and all were given a written, self-contained tutorial. Subsequently, an experiment was done in which six clinical data analysis problems had to be solved and an evaluation form was filled out. The aim of this user evaluation was to obtain insight in the benefits of integration for support of clinical data analysis for clinicians and biomedical researchers. The problems were divided into two sets, with gradually more complex problems. In the first set users were guided in a stepwise fashion to solve the problems. In the second set each stepwise problem had an open counterpart. During the evaluation, the workstation continuously recorded the user’s actions. From these results significant differences became apparent between clinicians and non-clinicians for the correctness (means 54% and 81%, respectively, p = 0.04), completeness (means 64% and 88%, respectively, p = 0.01), and number of problems solved (means 67% and 90%, respectively, p = 0.02). These differences were absent for the stepwise problems. Physicians tend to skip more problems than biomedical researchers. No statistically significant differences were found between users with and without clinical data analysis experience, for correctness (means 74% and 72%, respectively, p = 0.95), and completeness (means 82% and 79%, respectively, p = 0.40). It appeared that various clinical research problems can be solved easily with support of the workstation; the results of this experiment can be used as guidance for the development of the successor of this prototype workstation and serve as a reference for the assessment of next versions.

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