What better practice looks like

• Has previous basic science research included both male and female cells or animals?
• Has previous basic science research considered sex differences?
• How are the Variables used and defined in the literature and how does this compare to current standards?
• Are historical gaps and current context understood and acknowledged?
• Are there known health inequities based on any of the Variables?
• Has previous research considered the Variables in its inclusion of research participants?
• Has previous research considered intersectional factors (for example, cultural and linguistic diversity, age, socio-economic status, abilities, geography) alongside the Variables?

• Which population group/s will this research seek to include and benefit? Consider the Variables and other intersectional factors, as appropriate.
• If any population group/s are being excluded, or research is focusing on a specific subgroup, is this justified?

• Has the diversity of the research team been considered?
• Does the research team have expertise to involve the proposed research population group/s effectively, safely and sensitively?
• Are all potential stakeholders being considered? These may include:
  • groups of high unmet need
  • patients
  • consumers
  • community organisations and/or consumer representative groups
  • clinicians and healthcare professionals
  • policy makers
  • industry, including pharmaceutical or medical device manufacturers
  • clinical guideline developers
  • other researchers/stakeholders along the research pipeline.
• Are the voices and priorities of people with lived experience and other relevant stakeholders being valued and included?
• Is this research a priority for the proposed research population group/s?

• Is the potential for sex differences in basic science research being considered in the development of the final research question?

• Are there knowledge gaps about sex differences in basic science research that may impact the research design?
• Are there biases or data gaps related to the Variables that may impact the research design?
• Do any reference values being used in the research design account for the Variables?

• Does the design include realistic timelines and budgets to support effective, safe and sensitive engagement with co-design partners?

• Are male and female cells or animals included in basic science research by default unless appropriately justified?
• Is there appropriate representation of the impacted population/s across the health condition being studied?
• Are there evidence-based and scientifically sound justifications for the groups included and excluded?
• Are eligibility criteria regarding the Variables as inclusive as possible while aligning with the research question?
• Are other eligibility criteria, such as age or pregnancy, that may impact who can be recruited to the study being considered?
• Is a recruitment plan being co-designed with the research population group/s?

• Is the analysis plan being developed with a statistician?
• Is the required sample size of all population or animal groups being determined?
• If the research aims to detect differences between groups, will the study be powered to do so?
• Do any groups need to be oversampled to achieve appropriate study power?

• Could the sex-specific behaviours or housing needs of animals be relevant to the study?
• Are specific sex characteristics, physiological or anatomical features, gender expressions, experience, roles or norms or sexual behaviours relevant to the study?
• Are there any relevant outcomes that may vary based on the Variables that should be measured?
• Are there any intersectional factors that should be considered?

• Are appropriate experimental data collection methods being determined for basic science research?
• Can suppliers of cells or animals provide any relevant data, such as donor sex or chromosomal information?
• Will the ABS 2020 Standard be used to collect data on the Variables?
• If not, is there an appropriate justification, such as that the study includes a global clinical trial that uses a different standard?
• Are the research population group/s being consulted to design best practice data collection for other factors or outcomes of interest?

• How was existing data on the Variables originally collected?
• How can limitations in the existing data, such as only sex being collected, or only binary gender without being able to further identify cisgender and trans men and women, be accounted for?
• Are the implications of using existing data as a proxy for any of the Variables being considered?

• Does the research team have appropriate expertise and capacity to conduct the research?
• Is the research being conducted in effective, safe and respectful partnership with the research population group/s?

• Are the eligibility criteria clearly articulated?
• Do the eligibility criteria allow for all potential participants to be included in the study, for example, allowing inclusion of ‘people with prostate cancer, including cis men, trans women, non-binary people’ rather than only ‘men with prostate cancer’?
• Is the recruitment material designed to target all potential participants? Will this require multiple versions that use different language to communicate effectively to different groups?
• Is the communication to potential participants appropriate and sensitive?
• If there are co-design partner/s, are they involved in participant recruitment, for example, working to overcome recruitment barriers?
• Are individuals being provided the information and support they need to make informed decisions about consenting to participate in research?

Is the ABS 2020 Standard and associated guidance being used to collect data on the Variables? If not, is there an appropriate justification?

• Is respect for the human rights, confidentiality, health and wellbeing of participants demonstrated?
• Is a supportive environment being provided, respectful of the needs and wishes of those with lived experience?
• Is plain language used and relevant training and information provided?
• Are sufficient numbers of participants/stakeholders included to allow for multiple voices and peer support?
• Are roles and responsibilities clearly defined and agreed?

• Are appropriate statistical methods being used?
• Is scientifically sound analysis and interpretation of sex in basic science research being supported?
• Is the ABS 2020 Standard and associated guidance being used to analyse data on the Variables? If not, is there an appropriate justification?
• If powered to do so, are differences between groups or effects based on the Variables being analysed?
• If the sample size of a group was insufficient, are other analysis options and their implications being considered, such as excluding or merging groups?
• Is intra-group variation being analysed?

• Are biases or gaps in previous research being acknowledged?

• Are the approaches to consideration of the Variables in study design, eligibility criteria, recruitment, data collection and analysis being reported?

• Is the sex of cells and animals in basic science research being described using appropriate terminology?
• Are the results on any analyses of sex in basic science research, including null results, being reported?
• Are participant demographics being reported using appropriate terminology, aligned with the ABS 2020 Standard where possible?
• Are actual versus planned recruitment numbers for research population group/s being reported?
• Are the results of any analyses regarding the Variables, including null results, being included?
• Are disaggregated results by the Variables being reported for contribution to larger studies or meta-analyses?
• Is participant confidentiality and anonymity, including that participants from small population groups could be more readily identifiable, being considered in the reporting?

• Is reporting inclusive, safe, appropriate, valid and rigorous?
• Is every effort being made to ensure that interpretation of the results does not perpetuate or create harmful messaging, stereotypes, discriminative practices, or rhetoric?
• Does the discussion acknowledge heterogeneity within groups, including intersectional factors?
• Are results about the Variables being contextualised, including their relevance for translation, clinical practice, health service design or health policy?
• Are any limitations around consideration of the Variables being discussed, such as recruitment targets not being met, gender data only being reported as a cisgender binary, or an animal model only being available in one sex?

• Are stakeholders, including the research population group/s, being updated on relevant outcomes?
• Is the research being shared with institutions and departments that focus on any of the Variables or included research population group/s?

• Can findings be used to inform targeted, fit-for-purpose health interventions, care, services and policies?
• Can findings support improved health outcomes for groups of high unmet need?
• Are relevant policy makers and healthcare professionals being informed of the results?