Fair inclusion of men and women in Australian clinical research: views from ethics committee chairs.
OBJECTIVE
To explore the role played by human research ethics committees (HRECs) with regard to the fair inclusion of men and women in Australian clinical research.


METHODS
Semi-structured face-to-face and telephone interviews with 25 chairs (or their nominees) of Australian HRECs between 9 June 2006 and 24 January 2007.


METHODS
Chairs' views about the role of HRECs in identifying sex discrimination, monitoring the inclusion of men and women in clinical research, and interpreting and applying National Health and Medical Research Council (NHMRC) guidelines relating to fair inclusion in research.


RESULTS
In general, HRECs do not take an active role in monitoring the sex of research participants. They do not ask for or often receive information about the sex of participants. Most HREC chairs did not believe that sex discrimination in research is currently a significant or widespread problem, and were confident that their committees would be able to identify arbitrary exclusion of either men or women from research. However, many chairs expressed a lack of familiarity with debates about sex equity in research. Most chairs were unaware that anti-sex-discrimination legislation could apply to research. "Fair inclusion" was interpreted in a number of ways by chairs, but most frequently that the sex balance among research participants should reflect the sex distribution in the community of the condition under investigation. Chairs said their committees would be reluctant to reject a research protocol on the grounds that the sex balance among participants was perceived to be unfair.


CONCLUSIONS
Views about, and expertise on, sex equity in research vary among chairs of HRECs. Many HRECs require further guidance about the appropriate standards for fair inclusion of men and women in Australian clinical research.
Department of Medical Education, Flinders University, Adelaide, SA, Australia.
Angela J
AJ
Ballantyne
Wendy A
WA
Rogers
D001291:Attitude of Health Personnel; D001315:Australia; D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research; D005260:Female; D006801:Humans; D008297:Male; D018579:Patient Selection / Q000941:ethics*; D017410:Practice Guidelines as Topic; D011287:Prejudice; D011361:Professional Competence; D024382:Professional Role; D015983:Selection Bias