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The role of oversight in the protection of research subjects

Johansson, Mats LU orcid and Broström, Linus LU (2016)
Abstract
During a five-year period, the Regional Ethical Review Boards (cf. IRB) in Sweden handled applications regarding more than 13 000 studies. This may seem to offer significant protection, but the question is to what extent this review procedure really protects research subjects, if the way in which research is actually conducted is not monitored as well. For instance, do researchers really apply for ethical approval whenever this is required by the law, and do those who get an ethical approval proceed as described in their experimental treatment on
dying patients – implanting an artificial trachea – was conducted without any approval from the Regional Ethical Review Board. It is reasonable to assume that there is a need for an effective... (More)
During a five-year period, the Regional Ethical Review Boards (cf. IRB) in Sweden handled applications regarding more than 13 000 studies. This may seem to offer significant protection, but the question is to what extent this review procedure really protects research subjects, if the way in which research is actually conducted is not monitored as well. For instance, do researchers really apply for ethical approval whenever this is required by the law, and do those who get an ethical approval proceed as described in their experimental treatment on
dying patients – implanting an artificial trachea – was conducted without any approval from the Regional Ethical Review Board. It is reasonable to assume that there is a need for an effective and efficient system of oversight. Indeed, The
Ethical Review Act and the preparatory work on which it is based explicitly acknowledges the need for oversight. Moreover, there are authorities responsible for conducting it. In this presentation, however, we will provide empirical data that reveals an almost total lack of actual oversight in Sweden. We shall also discuss the significance of oversight in more general terms. (Less)
Please use this url to cite or link to this publication:
author
and
organization
publishing date
type
Contribution to conference
publication status
published
subject
keywords
research objects, protection, oversight
DOI
10.13140/RG.2.1.3826.6480
project
Research on decisionally incapacitated individuals. A legal study of the Act concerning the Ethical Review of Research Involving Humans, and its application
language
English
LU publication?
yes
id
41756564-92cf-46d8-8656-8005e6d39835
date added to LUP
2016-06-07 21:24:49
date last changed
2025-04-04 14:54:40
@misc{41756564-92cf-46d8-8656-8005e6d39835,
  abstract     = {{During a five-year period, the Regional Ethical Review Boards (cf. IRB) in Sweden handled applications regarding more than 13 000 studies. This may seem to offer significant protection, but the question is to what extent this review procedure really protects research subjects, if the way in which research is actually conducted is not monitored as well. For instance, do researchers really apply for ethical approval whenever this is required by the law, and do those who get an ethical approval proceed as described in their experimental treatment on<br/>dying patients – implanting an artificial trachea – was conducted without any approval from the Regional Ethical Review Board. It is reasonable to assume that there is a need for an effective and efficient system of oversight. Indeed, The<br/>Ethical Review Act and the preparatory work on which it is based explicitly acknowledges the need for oversight. Moreover, there are authorities responsible for conducting it. In this presentation, however, we will provide empirical data that reveals an almost total lack of actual oversight in Sweden. We shall also discuss the significance of oversight in more general terms.}},
  author       = {{Johansson, Mats and Broström, Linus}},
  keywords     = {{research objects; protection; oversight}},
  language     = {{eng}},
  title        = {{The role of oversight in the protection of research subjects}},
  url          = {{http://dx.doi.org/10.13140/RG.2.1.3826.6480}},
  doi          = {{10.13140/RG.2.1.3826.6480}},
  year         = {{2016}},
}