Rationale

The Brown IRB requires the use of sexual orientation and gender inclusive language in all study materials, including recruitment material, consent documents, and surveys. This requirement is consistent with The Belmont Report’s principles of Respect for Persons, Beneficence, and Justice, which are the pillars of the human subjects protection regulations. This position statement explains the rationale behind this requirement, how to comply, and examples of acceptable questions.

For the purposes of this document, all uses of the word “surveys” refers to any type of data collection material.

The Brown IRB recognizes that this is a living document and it will be updated as terminology evolves.

Definitions

 “Chosen Name” is the name a person uses and wants others to use in personal communication, even if it is different from the name on that person’s identifying documents (e.g., birth certificate, driver’s license, insurance, etc.). The term “Chosen Name” can be used alongside “Name” (if different) on forms and other legal documents.

“Gender” is a multidimensional construct that has psychological, social, and behavioral dimensions that include gender identity and gender expression. We recognize that gender is not fixed. It is fluid, dynamic, situational, and may change over time or day-to-day.

  • “Gender identity” refers to a person’s internal sense of gender (e.g. being genderqueer, being a man, or being a woman) and potential affiliation with a gender community (e.g., genderqueer, trans women, or women). Gender identity is internal, therefore someone’s gender identity may not necessarily be visible to others.
  • “Gender expression” is how a person displays their identity through appearance and/or behavior. Gender may be reported in terms of an individual’s felt, desired, or intended identity and expression, as well as how an individual believes that they are perceived by others.

“Sex” refers to biological differences among female, intersex, and male people (i.e., hormones, secondary sex characteristics, reproductive anatomy). Sex can be altered over time through the use of hormones and surgical intervention.

  • “Sex Assigned at Birth” is the assignment of individuals to a sex category by medical practitioners at birth and is typically based on the appearance of external genitalia. Sex assigned at birth is then recorded on the birth certificate as female, intersex, or male.
  • “Sexual Orientation” is an individual’s physical and/or emotional attraction to and desire to sexually or emotionally partner with specific genders and/or sexes (e.g., gay, lesbian, heterosexual, bisexual, pansexual, asexual). Sexual orientation should not be confused with gender identity. For example, an individual who identifies as transgender may also identify as straight, lesbian, gay, bisexual, etc.

Principles

  1. The Brown IRB supports a culture of inclusivity. Not being gender conscious is against our mission of protecting human subjects in research.
    1. Sex, gender, sexual orientation, sexuality, etc. are only a few of the many specific terms with unique definitions. These terms may not be used interchangeably.
    2. Investigators are responsible for being precise in their language, in the questions they ask, and the information they collect.
  2. The Belmont Report reinforces this position in its guiding principles:
    1. Respect for Persons instructs that individuals be treated as autonomous agents.
      1. The IRB acknowledges an individual’s right to control their own personal information.
      2. Investigators should respect an individual’s autonomy in all areas, including their identity and how they self-identify.
    2. Beneficence respects an individual’s decisions, directs researchers to do no harm, and protects an individual’s well-being:
      1. The IRB recognizes that a person may suffer emotional harm from feeling excluded or misgendered by recruitment material, a consent document, data collection procedures, and other research material that do not include options that correspond to their identity or forces them to identify in a way that is not consistent with their self-identity.
    3. Justice addresses the fairness and distribution of risk in research.
      1. The IRB feels strongly that by being sexual orientation and gender inclusive, investigators can ensure that the risks and benefits of research may be equitably distributed across all participant populations.

Considerations

  1. Data Collection:
    1. When appropriate, it is respectful to ask participants their chosen name, pronouns, and how they would like to be identified.
    2. Consider the importance of the survey questions and how the information will be used:
      1. Is the information used to confirm eligibility, ensure diversity of the study’s sample, or necessary for the science being conducted?
      2. If the question is not needed for the science of the study, there may be better ways to ensure sample diversity than asking personal or potentially-invasive questions of prospective participants.
    3. Consider the appropriateness of the survey questions:
      1. If the research involves drug administration, sex assigned at birth may be more relevant to ask about than gender identity.
    4. Emphasize the voluntary nature of the process:
      1. Participants must never feel obligated to provide information about sex and gender, and must have the ability to easily skip a question or answer a question by choosing “Skip,” “No response,” or “Prefer not to answer.”
      2. The IRB feels strongly that investigators must not include the term “Other” as an option for participants who wish to skip a question, as this term does not adequately reflect wanting to skip a question and may have negative connotations.
  2. Privacy and Confidentiality:
    1. Consider the nature and location of data collection:
      1. An individual’s sex or gender identity can be sensitive, personal, and not always something they share with others.
      2. It is important to protect this information, especially if research is potentially-identifiable.
      3. If possible, allow participants to choose a location to safely conduct research activities where they feel comfortable sharing confidential information about themselves in private.
  3. Study Documents:
    1. Use non-gendered word order that does not show preference for one gender over another:
      1. Organize variables alphabetically.
      2. Use more common gender neutral terms instead of grouped gendered variables:

Group Gendered Terms

Group Gender Neutral Terms

Men and Women

People

Brothers and Sisters

Siblings

  1. Use non-gendered terms that are equivalent to gendered nouns:

Gendered Nouns

Non-Gendered Nouns

Policeman

Police Officer

Freshman

First-year Student

  1. Use non-gendered pronouns instead of pronouns with specific gender markers or write in 2nd person instead of 3rd person:

Gendered Pronouns

Non-Gendered Pronouns

He, He/She, She

They

3rd: person:

“He/She will be paid $20 for completing the survey.”

2nd person:

“You will be paid $20 for completing the survey.”

Examples of Questions and Response Options

** Starred questions may be required by federally-funded research (i.e., NIH, CDC, NSF, etc.). Please refer to your study sponsor’s specific research design and data reporting requirements to verify if these questions apply to your research.

Chosen Name and Pronouns

When asking about a chosen name and pronouns, investigators could use this question in their survey or reworded for an interview.

What name would you like us to use when we speak with you? / What is your chosen name?

(Please state): _____________________________________________

What are your pronouns?

___He/Him/His

___She/Her/Hers

___They/Them/Their

___Not listed (please state): _____________________

___Prefer not to answer

 

Sex **

When asking about sex, investigators should ask about sex assigned at birth (as listed on a birth certificate) and not exclusively use binary female/male language.

What sex were you assigned at birth (on your original birth certificate)?

___Female

___Intersex

___Male

___Prefer not to answer

 

Gender/Gender Identity **

When asking about gender/gender identity, investigators should not exclusively use binary female/male language.

How do you identify yourself?

___Gender Non-Conforming/Genderqueer

___Man

___Non-Binary

___Transgender Man/Trans Man

___Transgender Woman/Trans Woman

___Woman

___Not listed (please state): _____________________

___Prefer not to answer

 

Sexual Orientation

When asking about sexual orientation, investigators should include all applicable categories for their research and use the current terminology that is acceptable to their study population.

What is your sexual orientation?

___Asexual

___Bisexual

___Gay

___Heterosexual

___Lesbian

___Pansexual

___Not listed (please state): _____________________

___Prefer not to answer

 

Sexual Attraction

When asking about sexual attraction, investigators should include all applicable categories for their research and use the current terminology that is acceptable to their study population.

What is your sexual attraction?

___Both men and women

___Men

___None

___People of any gender

___Women

___Not listed (please state): _____________________

___Prefer not to answer

 

Resources Used For This Document

This document was developed by a subcommittee of the IRB, and was voted on by the Full Board and adopted on April 15, 2021.