Research Ethics in Clinical Trials

2021 ◽  
pp. 301-313
Author(s):  
Stephen Honeybul ◽  
Kwok M. Ho
1987 ◽  
Vol 42 (12) ◽  
pp. 1132-1133
Author(s):  
Stanley D. Imber ◽  
Lawrence M. Glanz ◽  
Irene Elkin ◽  
Stuart M. Sotsky ◽  
Jenny L. Boyer ◽  
...  

2021 ◽  
Vol 44 (4) ◽  
pp. 549-561
Author(s):  
Michelle Hume ◽  
Melissa Abraham

Author(s):  
Ike Valentine Iyioke

This chapter aims to prominently position the African philosophical notion of the self within the clinical trials context (and the larger bioethics project). As opposed to autonomy-based principlism, this other-regarding or communalist perspective is proposed as the preferred alternative model. The intent is to draw further attention to the inadequacy of the principlist approach particularly in multicultural settings. It also engenders a rethink, stimulates interest, and re-assesses the failed assumptions of universal ethical principles. As a novel attempt that runs against much of the prevailing (Euro-American) intellectual mood, this approach strives to introduce the African viewpoint by making explicit the import of the self in a re-contextualized (nay, globalized) arena. Viewed as such, research ethics is guided to go beyond autonomy-based considerations for the individual with absolute right to self-determination; to embrace more holistic-based approach, recognizing that the individual is embedded in his/her family, community, and the environment.


2019 ◽  
Vol 9 (2) ◽  
pp. 22-25
Author(s):  
Zoheb Rafique

This article talks about both clinical research ethics and public health research ethics. Clinical research ethics are defined as set of relevant ethics considered necessary for the conduct of clinical trials in field of the clinical research. While public health research ethics is mainly aimed at finding out what is best for the communities and the populations rather than the individuals. Research ethics is mainly focused on the protection of individual participants and some of the research norms and accepted principles may be challenging when applying in some of the research contexts.  


2020 ◽  
pp. medethics-2020-106757
Author(s):  
Vilma Lukaseviciene ◽  
Joerg Hasford ◽  
Dirk Lanzerath ◽  
Eugenijus Gefenas

The upcoming Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Regulation), which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will weaken in at least some of the Member States because the new Regulation allows narrowing down the scope of ethics review as compared with the currently valid Clinical Trial Directive. Although the new Regulation may lead to faster approval procedures for clinical trials, which is especially relevant in the context of pandemics, high-quality ethics reviews integrating methodological aspects of a clinical trial should nevertheless be ensured. To maintain high research ethics standards as well as to foster measures to mitigate potential negative consequences of the reform, it is therefore of vital importance to start debating and sharing the reflections about the potential consequences of these transformations and trends as soon as possible.


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