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Gender equality in the work of local research ethics committees in Europe: a study of practice in five countries

Moerman, C. J.; Haafkens, J. A.; Söderström, Margareta LU ; Rasky, E.; Maguire, P.; Maschewsky-Schneider, U.; Norstedt, Maria LU ; Hahn, D; Reinerth, H. and McKevitt, N. (2007) In Journal of Medical Ethics 33(2). p.107-112
Abstract
Background: Funding organisations and research ethics committees (RECs) should play a part in strengthening attention to gender equality in clinical research. In the research policy of European Union (EU), funding measures have been taken to realise this, but such measures are lacking in the EU policy regarding RECs. Objective: To explore how RECs in Austria, Germany, Ireland, The Netherlands and Sweden deal with gender equality issues by asking two questions: ( 1) Do existing procedures promote representation of women and gender expertise in the committee? ( 2) How are sex and gender issues dealt with in protocol evaluation? Methods: Two RECs were selected from each country. Data were obtained through interviews with key informants and... (More)
Background: Funding organisations and research ethics committees (RECs) should play a part in strengthening attention to gender equality in clinical research. In the research policy of European Union (EU), funding measures have been taken to realise this, but such measures are lacking in the EU policy regarding RECs. Objective: To explore how RECs in Austria, Germany, Ireland, The Netherlands and Sweden deal with gender equality issues by asking two questions: ( 1) Do existing procedures promote representation of women and gender expertise in the committee? ( 2) How are sex and gender issues dealt with in protocol evaluation? Methods: Two RECs were selected from each country. Data were obtained through interviews with key informants and content analysis of relevant documents ( regulations, guidelines and review tools in use in 2003). Results: All countries have rules ( mostly informal) to ensure the presence of women on RECs; gender expertise is not required. Drug study protocols are carefully evaluated, sometimes on a formal basis, as regards the inclusion of women of childbearing age. The reason for excluding either one of the sexes or including specific groups of women or making a gender-specific risk - benefit analysis are investigated by some RECs. Such measures are, however, neither defined in the regulations nor integrated in review tools. Conclusions: The RECs investigated in five European member states are found to pay limited attention to gender equality in their working methods and, in particular in protocol evaluation. Policy and regulations of EU are needed to strengthen attention to gender equality in the work of RECs. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Journal of Medical Ethics
volume
33
issue
2
pages
107 - 112
publisher
BMJ Publishing Group
external identifiers
  • wos:000244245500011
  • scopus:33846984294
ISSN
1473-4257
DOI
10.1136/jme.2005.015206
language
English
LU publication?
yes
id
515150a8-78b1-4ee5-bd7c-49cab6556fa7 (old id 674574)
date added to LUP
2007-12-18 11:29:14
date last changed
2017-01-01 07:08:48
@article{515150a8-78b1-4ee5-bd7c-49cab6556fa7,
  abstract     = {Background: Funding organisations and research ethics committees (RECs) should play a part in strengthening attention to gender equality in clinical research. In the research policy of European Union (EU), funding measures have been taken to realise this, but such measures are lacking in the EU policy regarding RECs. Objective: To explore how RECs in Austria, Germany, Ireland, The Netherlands and Sweden deal with gender equality issues by asking two questions: ( 1) Do existing procedures promote representation of women and gender expertise in the committee? ( 2) How are sex and gender issues dealt with in protocol evaluation? Methods: Two RECs were selected from each country. Data were obtained through interviews with key informants and content analysis of relevant documents ( regulations, guidelines and review tools in use in 2003). Results: All countries have rules ( mostly informal) to ensure the presence of women on RECs; gender expertise is not required. Drug study protocols are carefully evaluated, sometimes on a formal basis, as regards the inclusion of women of childbearing age. The reason for excluding either one of the sexes or including specific groups of women or making a gender-specific risk - benefit analysis are investigated by some RECs. Such measures are, however, neither defined in the regulations nor integrated in review tools. Conclusions: The RECs investigated in five European member states are found to pay limited attention to gender equality in their working methods and, in particular in protocol evaluation. Policy and regulations of EU are needed to strengthen attention to gender equality in the work of RECs.},
  author       = {Moerman, C. J. and Haafkens, J. A. and Söderström, Margareta and Rasky, E. and Maguire, P. and Maschewsky-Schneider, U. and Norstedt, Maria and Hahn, D and Reinerth, H. and McKevitt, N.},
  issn         = {1473-4257},
  language     = {eng},
  number       = {2},
  pages        = {107--112},
  publisher    = {BMJ Publishing Group},
  series       = {Journal of Medical Ethics},
  title        = {Gender equality in the work of local research ethics committees in Europe: a study of practice in five countries},
  url          = {http://dx.doi.org/10.1136/jme.2005.015206},
  volume       = {33},
  year         = {2007},
}