title: Gender equality in the work of local research ethics committees in Europe: a study of practice in five countries.
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.
authors.affiliation: Department of General Practice, Room J2-222, Academic Medical Center, University of Amsterdam, Meibergdreef 15, 1105 AZ Amsterdam, The Netherlands. c.j.moerman@amc.uva.nl
authors.forename: C J
authors.initials: CJ
authors.lastname: Moerman
authors.forename: J A
authors.initials: JA
authors.lastname: Haafkens
authors.forename: M
authors.initials: M
authors.lastname: Söderström
authors.forename: E
authors.initials: E
authors.lastname: Rásky
authors.forename: P
authors.initials: P
authors.lastname: Maguire
authors.forename: U
authors.initials: U
authors.lastname: Maschewsky-Schneider
authors.forename: M
authors.initials: M
authors.lastname: Norstedt
authors.forename: D
authors.initials: D
authors.lastname: Hahn
authors.forename: H
authors.initials: H
authors.lastname: Reinerth
authors.forename: N
authors.initials: N
authors.lastname: McKevitt
mesh_terms: D028744:Ethics Committees, Research / Q000458:organization & administration* / Q000592:standards; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D012737:Sex Factors; D014933:Women's Rights