44 - Respect for the Reader: Language Sensitivity in Informed Consent Forms

Background:  To demonstrate respect for research participants, informed consent forms (ICFs) must use inclusive and humanizing language. While ICF best practices have shifted over time, there are opportunities for improvement. Gendered terms can be outdated and alienating, and ICFs for cancer research must be sensitive to participants’ potential health outcomes.

Program

Description:  The Protocol Activation & Review and Human Research Protection Program (HRPP) at Memorial Sloan Kettering Cancer Center (MSK) is a centralized unit focused on activation and participant protection. The unit’s Editorial team specializes in developing understandable and accurate ICFs that meet institutional standards for participant protection.

To achieve language sensitivity in ICFs, the unit has incorporated guidance in our resource documents about best practices for language related to mortality and gender. For example:

• Our ICF template does not contain gendered language, including in the reproductive risks/contraception section.

• Our ICF instructions document (which includes standardized language) advises against including study objectives that imply mortality. (Rather than specify an objective related to overall survival, we communicate that the study is looking at whether the investigational treatment is effective.)

• Our ICF Checklist reminds ICF authors and editors not to describe long-term follow-up as occurring until death; alternative phrasing is “throughout your life.”

Program

Assessment:  We analyzed a sample of 40 ICFs to evaluate instances of gendered language. Twenty ICFs were from before the unit incorporated guidance on gendered language into ICF resource documents in 2021, and 20 were from after 2021. We also analyzed 40 ICFs to evaluate mortality-related language. Twenty were from before the unit established guidance in 2018, and 20 were from after 2018. The ICFs were for Phase I/II studies with MSK as the IRB of Record. We chose ICFs likely to include gendered language (breast cancer studies, etc.) or mortality-related language (brain cancer studies, etc.).

We searched for keywords related to:

• Gender (male, female, man, woman, and gendered pronouns).

• Mortality (survive/survival, death, die, pass away, terminal). We omitted studies where it was necessary to discuss mortality directly (for example, psychosocial studies in hospice) and necessary references to mortality in risk sections (for example, mention of a life-threatening allergic reaction).

Our analysis showed a 10-fold decrease in forms with gendered language and a 6-fold decrease in forms with language related to mortality after guidance was established.

Limitations:
The Editorial team doesn't currently remove gendered or mortality-related language from ICFs reviewed by external IRBs. In addition, Editorial reviews only new studies; the team doesn’t review amendment-related ICF revisions after a study starts enrolling. However, MSK does have guidance on gendered language for those working on amendments and external IRB reviews.

Discussion:  

• ICFs that demonstrate respect for participants are vital for successful research studies that advance science. Language that is inclusive and humanizing can engage a greater number of readers, enhance the informed consent process, and aid in participant retention.

• MSK will continue to rely on Editorial for ICF development that demonstrates language sensitivity. MSK may expand the scope of the team.

• When creating participant-facing documents, MSK will strive to use terminology that keeps pace with societal changes and participant needs. MSK will regularly update ICF guidance, search for additional documents that require updates, and provide support for ICF writers and editors.