Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11240%2F21%3A10443135" target="_blank" >RIV/00216208:11240/21:10443135 - isvavai.cz</a>

Result on the web

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=2kKzRK7U5U" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=2kKzRK7U5U</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.2478/ebce-2021-0018" target="_blank" >10.2478/ebce-2021-0018</a>

Result language

angličtina

Original language name

Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic

Original language description

The current coronavirus disease 2019 (COVID-19) pandemic has led to essential adjustments in clinical research involving human subjects. The pandemic is substantially affecting most procedures of ongoing, as well as new clinical trials related to diseases other than COVID-19. Procedural changes and study protocol modifications may significantly impact ethically salient fundamentals, such as the risk-benefit profile and safety of clinical trial participants, which raise key ethical challenges the subject-matter experts must face. This article aims to acquaint a wide audience of clinical research professionals, ethicists, as well as the general public interested in this topic with the legal, ethical and practical considerations in the field of clinical trials during the COVID-19 pandemic and to support the clinical researchers and study sponsors to fulfil their responsibilities in conducting clinical trials in a professional way that does not conflict with any legal or ethical obligations.

Czech name

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Czech description

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Type

J_SC - Article in a specialist periodical, which is included in the SCOPUS database

CEP classification

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OECD FORD branch

60301 - Philosophy, History and Philosophy of science and technology

Project

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Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2021

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Ethics &amp; Bioethics

ISSN

2453-7829

e-ISSN

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Volume of the periodical

11

Issue of the periodical within the volume

3-4

Country of publishing house

SK - SLOVAKIA

Number of pages

15

Pages from-to

181-195

UT code for WoS article

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EID of the result in the Scopus database

2-s2.0-85122867789