Using Inclusive, Gender-Neutral Language in the IRB Consent Templates.

Institutional Review Board

Human Research Protections (HRP)

Using Inclusive, Gender-Neutral Language in the IRB Consent Templates

Version June 15, 2023

A picture containing person, outdoor, clothing, sky Description automatically generated Effective June 1, 2023, new human research studies that involve an informed consent process will be required to use the latest IRB consent templates. The updated IRB consent templates include the use of gender neutral language.

Why gender neutral language?

In an effort to promote a welcoming of all gender identities and sexual orientations at UCI, the UCI HRP has updated the IRB consent templates to use inclusive, gender-neutral language. If you are interested, you may read more about gender neutral language in the NIH Style Guide.

Will existing consent templates need to be updated to reflect the new language?

No. For existing IRB approved consent forms, updating to include gender-neutral language, while encouraged, it is not required. Should Study Teams wish to update their consent/s and recruitment materials, this may be done at the next amendment or renewal in KRP or as per HRP Policy # 17 for exempt research protocols.

Will new study submissions need to use similar gender-neutral language in other study materials?

Yes. The expectation is that new study submissions will follow the standard of the UCI IRB consent templates, and use inclusive, gender-neutral language. As noted above, refer to the NIH Style guide which encourages inclusivity through not only gender neutral language, but through the use of “person-first and destigmatizing language.”[1]

What are some common examples of gender-neutral language?

It is easier than you may think. Please refer to the following helpful table.

Consent Form: *Exclusive* Gender Specific Language	Consent Form: *Inclusive* Gender Specific Language
Inclusion criteria: male and female adults	Inclusion criteria: adults
Instructional text: All girls who have had their period must complete the assent addendum.	Instructional text: All minors who are able to get pregnant must complete the assent addendum.
General language: Should he/ she meet all inclusion requirements, study procedures may begin.	General language: Should they meet all inclusion requirements, study procedures may begin.

Who can I contact with questions about using inclusive, gender-neutral language in the consent form or recruitment materials?

Please reach out to any member of the HRP Team. While at the Contact Us page, scroll down to review our internal cultural agreement, I-GREAT!

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[1] HRP review is focused on the criteria at 45 CFR 46.111 and 21 CFR 56.111. While the HRP will not review each document to ensure that language is appropriate as per all NIH standards, when recognized, in an effort to be inclusive, HRP will communicate and encourage revisions.

[1] HRP review is focused on the criteria at 45 CFR 46.111 and 21 CFR 56.111. While the HRP will not review each document to ensure that language is appropriate as per all NIH standards, when recognized, in an effort to be inclusive, HRP will communicate and encourage revisions.