Despite the European Union’s commitment to gender equality, women are still underrepresented on the committees that sanction research while the impact of gender differences// continues to be ignored in clinical trials, suggests a study in the Journal of Medical Ethics.
The authors assessed the composition and procedures of two major research ethics committees in European member states, including Ireland, Germany, Sweden, Austria and The Netherlands in 2003.
Before research can be carried out, it must be submitted to a research ethics committee to ensure that it complies with good ethical practice and is of sufficient quality.
The authors found a great deal of variation in the regulations governing the committees they assessed. Some were governed locally; others nationally.
As to the gender make-up of the committees, all of them had informal rules requiring the inclusion of at least some women, and took sex into account when recruiting new members.
But few had any formal rules.
And while every committee had formal requirements to ensure that certain types of expertise were represented, these did not include experts on sex and gender issues.
All committees had protocols for research involving drugs and women of childbearing age, to ensure that unborn children are protected from harm.
But none was required to ensure that sufficient numbers of both sexes were included in any piece of research, or that any potential benefits or harms did not unfairly affect either sex.
Only Sweden had clear national guidelines on these issues.
The authors conclude that despite the existence of a European Union policy on gender equality in health research funded by the EU, the research ethics committees “paid only limited attention” to it.
They also point out that gender equality has also been left out of the recent EU clinical trials directive, which was int
ended to harmonise practice across member states.
More education of the importance of gender differences in health is needed, say the authors to ensure that research is properly designed and evaluated for the benefit of patients and doctors.
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