Reviewer's report
Title:Twenty years and still counting: including women as participants and
studying sex and gender in biomedical research
Version:1Date:31 March 2015
Reviewer: Gillian Einstein
Reviewer's report:
Mazur manuscript
This is a timely manuscript on the history of the inclusion of sex and gender
analyses in biomedical research in the US. It contains helpful information on past
efforts as well as recommendations for going forward toward actualizing these
policies. Some of what is recommended echoes what is currently espoused by a
number of journal editorial policies, including the European Association of
Science Editors, the Institute of Gender and Health (Canadian Institutes of Health
Research), and the a number of other publications such as, “Better Science with
Sex and Gender” as well as the Stanford Gendered Innovations web site. This
manuscript is focused on policy advances in the US so while the
Recommendations do not refer to what has been recommended and put into
effect in other countries and organizations, it is nice to have all these
recommendations in one place and in the context of the history of inclusion of
sex and gender in the US.
MINOR ESSENTIAL REVISION
Conflation of sex and gender in the manuscript:
One issue that needs clarification, especially for a manuscript on sex and gender
research milestones, is the interchangeable use of the term gender with the term
sex in the manuscript. It is of utmost importance that the authors go through the
manuscript and clarify when they are referring to sex differences and when
gender.
Further, it would also add depth and clarity to the manuscript if, when a milestone
is cited in which the word ‘gender’ has been used incorrectly instead of using
sex, for this to be pointed out. A brief discussion about the conflation of these
terms and the problems that it raises would be helpful. Ultimately, it would be
beneficial to biomedical research and policy, in general, if there were clear use of
these terms: i.e., when researchers are studying sex differences, gender, and/or
the intersection of the two.
DISCRETIONARY REVISIONS
Other countries’ contributions to policy in sex and gender:
Research including sex and gender is currently a hot topic. Policy and science
around it are being developed simultaneously internationally. While it is explicitly
stated that this is about policy changes in the US, it might be nice to give a 'nod'
to other countries that are working on this as well. Even one sentence in the
introduction would suffice.
Organizational/Conceptual issues:
1) The listing starts off primarily with government reports and mandates and then
switches to clinical studies and literature reviews on sex differences in different
conditions – CVD and aspirin, Pain, Workshop summary on orthopedic medicine.
There is also a mix of clinical studies with once in awhile, animal studies.
All of these are different types and different levels of understanding and of action.
It would clarify the manuscript if there were an explicit acknowledgement of a
move from one type to the other. For example, it is interesting that we’ve moved
from legal and funding mandates (with the exception of the newly put forward
ORWH mandate to look at sex differences in pre-clinical studies) to policy
documents coming from within professional organizations to review papers.
Synthesizing this progression from the timeline is a very interesting history of
science progression and useful to note.
2) It is unfortunate that in the literature, the inclusion of women and female
animals is continually discussed in terms of adding complexity, with the
conclusion that complexity makes a study more expensive (Pg 28, ln 621).
First, this makes complexity sound like a bad thing when it is not – perhaps if we
had had been studying women and female animals exclusively all these years
rather than XY creatures, we might have determined that male models don’t have
the nuance to yield a full picture of the biology of the action of a drug…etc.
Second, with respect to the additional costs, a well-designed study to include
females and males from the outset might not actually cost more. There are many
scientists doing sex difference research who don’t ask for more money than
those who use only males. So extra cost is only if one is treating the study of
another sex as a simple ‘add on’ which is not really weaving sex and gender into
the research question and design. Furthermore, even if it is treated as an add on
to already designed experiments, the largest cost to research in general is
infrastructure which presumably is already established for a funded study. So
what is being considered is the addition of animals/persons, which has
associated costs but not of the type that would not be surmountable.
Rather than pointing out the perceived difficulties, it would be helpful to
emphasize how it can be done and that it is not only feasible, but a matter of
good science.
3) Finally, our lack of knowledge about women’s biologies beyond the
reproductive system is sorely lacking. One colleague pointed out at the poster
session of an international meeting that if we studied women and female models
exclusively for the next 50 years, we might still not catch up with what we know
about male biologies. Thus, to call our lack of knowledge, “a gap” seems like an
understatement. Actually, it could and should be described as an area of
profound ignorance.
Points to consider re the Timeline:
1. The Society for Women’s Health Research has been a player in this
movement since at least 1995 when they were lobbying congress for inclusion of
women in research. They were important in the original IOM report (2001) and in
generating and supporting other reports – their contributions probably should be
acknowledged prior to 2014. Further, they have always supported sex
differences research, not gender – in fact they say so in what’s quoted so the text
should reflect that focus.
2. The BIRCWH Awards were started in 2000. Why not list them as a year 2000
milestone?
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I declare that I have no competing interests.