Considerations When Assessing Sex and Gender in Research
The Institutional Review Board for the Protection of Human Subjects (IRB) at the University of Maine encourages researchers to be sensitive to and inclusive of differences when collecting data about identities of participants.
Definitions
- Gender/Gender Identity is a person’s internal held sense of their gender, regardless of biology.
- Sex refers to biological differences between males and females, such as the genitalia and genetic differences. Sex is assigned at birth.
- Sexual Orientation is a term used to describe one’s pattern of emotional, romantic and/or sexual attraction.
Sample Questions
Below are sample questions and response options for gender identity, sex, and sexual orientation.
- What is your current gender identity? (Check all that apply.)
- Male
- Female
- Transgender female / trans woman (or Male-to-Female (MTF) transgender, transsexual, or on the trans female spectrum)
- Transgender male / trans man (or Female-to-Male (FTM) transgender, transsexual, or on the trans male spectrum)
- Non-binary, genderqueer, or genderfluid
- Gender identity not listed:
- Prefer not to reply
- What is your sex assigned at birth?
- Male
- Female
- Intersex
- Not Listed:
- Prefer not to reply
- What is your sexual orientation?
- Heterosexual/Straight
- Gay/lesbian
- Bisexual
- Pansexual
- Not listed:
- Prefer not to reply
- (Note: If investigators will refer to participants directly, it is respectful to ask which pronouns they should use. The Principal Investigator(s) (PIs) may want to consider introducing themselves by name and pronouns to demonstrate what this looks like and to indicate that this is an inclusive space.)
What pronouns would you like study staff to use when referring to you?- He/him/his
- She/her/hers
- They/them/theirs
- Other (please specify):
Tips for Researchers
- Use the term “sex” when reporting biological factors and “gender” when reporting gender identity, psychosocial or cultural factors.
- Consider if it is relevant to the study to include questions regarding sexual health history and/or sexual orientation.
- Sex, gender identity, and sexual orientation are both sensitive and personal characteristics. Therefore, it is important to protect this information, especially when recorded as identifiable. Investigators must ensure that research subjects provide this information in a location where they are comfortable and that ensures their privacy.
- All study documents (including surveys) should use gender-neutral language, avoiding gendered terms (e.g., mailman, chairman) and gendered pronouns (he, she, he/she).
- Gendered terms should be replaced with non-gendered versions (e.g., mail carrier instead of mailman or chairperson instead of chairman).
- Sentences using gendered pronouns should either use gender-neutral pronouns (e.g., singular they as in “Each subject will receive their gift card upon completing the study.”) or be reworded entirely to avoid such pronoun use (e.g., “Subjects will receive their gift card upon completing the study.”).
- Avoid presuming roles whenever possible. For example, say “spouse/partner” instead of “husband/wife”.
Incorporate gender neutral diagrams in research materials.
- Do not assume pronouns when interacting with a subject until they identify a preference.
- Train your research team members to increase their comfort level in asking and answering sensitive questions about gender and sexual orientation from subjects. The National LGBTQIA+ Health Education Center/The Fenway Institute resource Ready, Set, Go! A Guide for Collecting Data on Sexual Orientation and Gender Identity (PDF) (external link) is a good source for training materials.
References and Resources
- Canadian Institutes of Health Research Online Training Modules: Integrating Sex & Gender in Health Research Online Training Module (external link)
- Eastern Michigan University: Use of Gender Inclusive Language (external link)
- The National LGBTQIA+ Health Education Center, The Fenway Institute: Ready, Set, Go! A Guide for Collecting Data on Sexual Orientation and Gender Identity (PDF) (external link)
- Inclusion of sex and gender in biomedical research: Survey of clinical research proposed at the University of Pennsylvania (external link)
- National Institutes of Health (NIH) Reviewer Guidance to Evaluate Sex as a Biological Variable (PDF) (external link)
- Reporting Sex, Gender, or Both in Clinical Research (external link)
- Sex and Gender Equity in Research: rationale for the Sex and Gender Equity in Research (SAGER) guidelines and recommended use (external link)
- Tufts: Sex and Gender Research Considerations (external link)