Show Notes for Episode Twenty of seX & whY: Interview With Dr Shirin Heidari Part 2: Gendro – Advancing Sex and Gender Equity in Science Research
Host: Jeannette Wolfe
Guest: Shirin Heidari PhD, virologist and experimental oncologist, founding President of Gendro.
Part 2 of Interview with Dr Shirin Heidari
This podcast focuses on Dr Heidari’s work on systematically integrating the variables of sex and gender into different access points along the research pipeline. She helped start an organization called Gendro which is dedicated to this mission.
The three major gatekeeping posts that Gendro and other organizations are targeting are:
Require the inclusion of both male and female animals or justify an exclusion
2) Ethical Review Boards
These boards review research protocols prior to study enrollment to ensure that the researchers have designed their study to meet national and organization protocols designed to protect participants from being involved with unethical or dangerous practices. Traditionally these boards have been an overlooked area to target.
As many medical publishing house multiple journals, if they modify their standardized template to include query about sex and/or gender analyses, they have the power to rapidly change the expectations of authors and peer reviewers surrounding the inclusion of these factors.
In addition, we talked about the SAGER guidelines
SAGER guidelines a.k.a. Sex and Gender Equity in Research. These guidelines were put together by an international team of researchers in 2015 and geared towards giving researchers, journal editors, peer- reviewers and publishers better tools to include and evaluate the variables of sex and gender in scholarly work. Although the guidelines have increased the awareness and inclusion of these variables, and many journals have now adopted them, there continues to be a significant opportunity for more widespread use. A recent editorial highlights some of the barriers to utilization and possible concerns.
Here is a synopsis of some of the remaining barriers.
|Mandated inclusion will significantly increase overall research costs from enrollment to additional statistical analysis||Underscore that several countries have already been successful in tying initial funding with inclusion criteria which suggests that some of resistance is likely due to ingrained culture rather than significant financial barriers. Highlight that some countries have developed new supplemental funding to enhance adoption. *
|Journal editors may have significant time and resource limitations that prohibit their ability to formally introduce or monitor SAGER guidelines.
|Emphasize that optimizing science requires constant evolution and that as editors they are already well skilled in helping their journal comply with other required updates. Including SAGER guidelines can enhance the quality of research their journal publishes and in turn enhance its reputation.
In additional, engaging publishers to invest in better science by making system wide changes in both editorial expectations and technical support (see below) could rapidly accelerate adoption.
|Peer reviewers may feel ill-equipped to evaluate for the proper inclusion of sex and gender in a review due to knowledge gaps in core principles surrounding sex and gender||Provide access to available online trainingmodules such as those offered by the Canadian Institutes of Health Research.
Enhance diversity training as who is at the table influences policy and priorities.
|Technical challenges. Many publishers use the same templates across multiple journals which may limit an individual journal’s ability to change their own format.||Engage editors to encourage publishers to update digital templated formatting to reflect SAGER principles. The inclusion of a requested digital check off page in submission requirements confirming guideline compliance, could serve both as a reminder cue to the author and a screening tool to journal staff to ensure that it is completed prior to forwarding material to reviewer. This would help minimize any additional time the reviewer would need to spend to ensure SAGER compliance.
* As an aside, identifying important sex-based differences in pre-clinical studies may ultimately be quite cost effective as they may lead to the design of more successful and cost-effective clinical trials
We also discovered the opportunities to include the variables of sex and gender in COVID vaccine research and here are two important papers that Dr Heidari just published in this area.
A Systemic Review of the Sex and Gender Reporting in Covid-19 Clinical Trials.
75 initial published trials- 24% presented data broken down by sex and only 13% included in their discussion any discussion about potential sex differences.
Time for Action: towards an intersectional gender approach to COVID-19 vaccine development and deployment that leaves no one behind.
Take home points from article
- sex and age-based differences in immunology may influence vaccine dosing/side effects
- sex based differences may influence gendered associated acceptance and uptake of vaccines (for example if it is known that women get more side effects with a vaccine it may influence another women’s readiness to get vaccinated.)
- sociocultural associated factors can influence vaccine acceptance and uptake
- it is critical to have meaningful inclusion of gender diverse voices in high level research and policy decisions.
This now becomes very relevant as we now know that there are significant sex differences in side effects in the vaccines including increased risk of myocarditis for males in Pfizer and Moderna (According to a recent Australian study done by their equivalent of the FDA, the Therapeutic Goods Administration (TGA) numbers may occur up to 1 in 10,000 in younger men. Of note, they suggest that chance of getting myocarditis from Covid is likely 8-10x this risk.)
Conversely women are more likely to get increased risk of clotting with the J and J vaccine.