Integrating the gender aspects in research and promoting the participation of women in Life Sciences, Genomics and Biotechnology for Health

What happened so far? The Women and Science approach Action plan adopted by the Commission in 1999: measures to take gender into account into all areas of research policy The Gender Impact Assessment studies of FP5 programmes ( ): problems were identified such as inadequate address of sex differences or missed gender aspects in various elements of the projects The Science and Society Action Plan (2001) producing gender equality in science is an objective The European Research Area and one of its objective: to reinforce and increase the role of women in research

Why a specific approach?  Particular relevance for the priority: There is scientific evidence of sex and gender differences in the incidence, prevalence and severity of a broad range of diseases, disorders and conditions Genomic research will address the biological mechanisms of disease that underlie many disorders that affect women and men differently How was it designed? An external expert group has been asked to reflect and contribute to the set up of the approach and drafting of the documents The approach is integrated in the different steps: Work Programme, guidelines for applicants and application form, evaluation guidelines and evaluation form

Guidelines to applicants Description of general principles: a) The scope of gender aspects in research b) The use of language and concepts c) The implementation in FP6 Application form  Set of questions to be addressed by the proposers

Guidelines to applicants a) Scope of gender aspects in research: The possibility of gender/sex differences must be considered in all areas of health research: in the formulation of research hypotheses, in the development of research protocols, choice of research methodologies and in the analysis of results, in biological, pre-clinical, clinical and epidemiological, behavioural research/studies on both human and animal subjects, in the use of cells, tissues and other specimens, when appropriate, in the choice for a particular study population that should be thoroughly justified and the sex of the participants described in full, unless it can be demonstrated that gender/sex is inappropriate, with respect to the health of the subjects or the objective of the research. This may be established by reference to previous, not gender/sex biased research in published scientific communications subject to peer review, or during the evaluation by the evaluation panel on the basis of substantiated justification duly included in the application.

Guidelines to applicants b) Language and concepts: Gender is not a woman's issue but gender is a process that impacts on both women and men. Male and female differ not only in their basic biology but also in ways they interact with and are treated by society. In the research on human subjects, the term sex refers to differences attributed to biological origins. In the research on human subjects, the term gender refers to social influences that lead to differences. In most research on non-human animals the term sex should normally be used. The use of language and concepts can determine the direction of the research, the questions asked, the results obtained and the interpretation of the results. The use of generic terms for gender specific situations must be avoided (e.g. human subject instead of female/male subject).

Guidelines to applicants c) Implementation in FP6:  Gender aspects in research will have to be considered and integrated in the projects, whenever appropriate.  This refers to all project modalities of FP6: Networks of Excellence, Integrated projects, Article 169, specific targeted research projects, co-ordination actions and specific support actions.  Furthermore, although these aspects have to be part of the research plan, they have also to be considered in the linked activities, whenever addressed, such as training, ethic/legal/social/regulatory issues, infrastructures, exploitation, dissemination, communication activities and science/society issues.  Proposers will be asked to complete a section in the application form, describing how gender aspects have been addressed in the proposal.  Gender aspects in the research will be included as part of the evaluation criteria for selection for funding, by the evaluation panel.

Guidelines to applicants Application form: questions to answer 1) Gender/sex aspect(s) in a proposal if YES to any of the questions: Does the project involve human subjects? Does the project use human cells / tissues / other specimens? If human subjects are not involved or human materials not used, does the research involve animal subjects or animal tissues / cells / other specimens (as models of human biology/physiology) in such a way that it is expected that it may have implications for humans? Does the project use collection of data related to human subjects, human materials, animal subjects or animal materials? 2) Are gender/sex differences with respect to the research documented in the literature? Yes/No If yes please give details. A negative answer to this question may imply some innovation in the proposal towards this issue that will be taken into account in the evaluation process.

Guidelines to applicants Application form: questions to answer 3) Applicants with gender/sex aspects in their project will have to: Detail the questions addressed in their proposal related to gender/sex aspects in research. Comment on the expected outcome. Describe how the gender/sex aspects will be taken into account in the research, methodology and interpretation of their results. 4) Applicants who do not consider gender/sex differences should provide justification. The evaluation panel will assess the relevance of the justifications provided. Neither additional costs, nor difficulties in obtaining female cells, female tissues, female specimens, or recruiting female subjects, would normally be considered as a valid reason for excluding gender/sex aspects ("female" includes both animal and human subjects).

Evaluation form and evaluation guidelines Gender aspects of research proposals will be considered unless applicants can demonstrate that gender/sex aspect is inappropriate with respect to the health of the subjects or the objective of the research. This may be established by reference to previous, not gender/sex biased research in published scientific communications subject to peer review, or during the evaluation by the evaluation panel on the basis of substantiated justification duly included in the application as sub-criterion of the evaluation criterion associated with the scientific and technological excellence of the proposal (for Network of excellence the evaluation criterion will be Relevance to the objectives of the programme and for Specific support actions it will be Support to the objectives of the programme)

Evaluation form and evaluation guidelines Evaluation form: questions to answer Gender/sex Scientifically Scientifically aspects in the proposal acceptable (1)unacceptable (1) not relevant  female only  male only  both included  absent/unknown  Innovation in the approach: Excellent  Good  Poor  (1) Examples will be provided Figures will have to be taken into account for the final assessment of the criterion “scientific and technological excellence” of the proposal. In other terms, an overall mark for this criterion of 4 or 5 would normally not be possible for a proposal with scientifically unacceptable consideration of gender/sex aspects in research.

Why encourage an increased participation of women scientists?  to more accurately reflect their existence in the scientific population, that should also be the mirror of their place in the society.  to increase the role of women in research [Participation rules] Furthermore, article 10 of these rules on "Evaluation and selection of proposals for indirect actions" section 2a clearly mentions that the following additional criterion "Activities to increase the role of women in research" may be taken into account.

Implementation in FP6 The participation and role of women scientists will be promoted in the projects, as much as possible and taking into account the specificity of the scientific fields and disciplines. This refers to all project modalities of FP6: Networks of Excellence, Integrated projects, Article 169, specific targeted research projects, co-ordination actions and specific support actions. Proposers will be asked to complete a section in the application form regarding the participation/role of women in their project. The evaluation panel will consider these issues.

Application form: questions to answer  Women directly involved  in the scientific management of the project? yes/no  in the scientific partnership as scientific team leader in the project?yes/no  % of women scientists involved in the project ( Definitions according to the FP6 mobility & Marie Curie activities)  Early researchers (less than 4 years after graduate) ?  Experienced researchers (minimum 4 years after graduate or having a PhD) ?  Please comment and justify if necessary?  Do you plan specific measure(s) regarding women role/participation in your project? Which? How? When?

Evaluation form:  Participation/role of women in research proposals will be considered as sub-criterion of the evaluation criterion associated with the quality of the consortium (for Network of excellence the evaluation criterion will be Organisation and management and for Specific support actions it will be Mobilisation of resources) Questions to answer  Is the level of participation of women acceptable in the proposal, taking into account the recruitment potential in this area of research ?  Will this project facilitate the participation of women in science? In case of equal ranking proposals, the sub-criterion “participation of women" may be taken into account to separate them.