Researchers gathered June 10th for a Research Town Hall to discuss why language matters when discussing issues of equity and inclusion in research. This was the second in a collaborative series between the Duke Office of Scientific Integrity (DOSI), Center for Equity in Research (EIR), and Community Engaged Research Initiative (CERI) teams that centers on issues of equity. You can find the recording and slides for the previous Town Halls here.
Raquel Ruiz, MBA, MA Ed, Senior Director of Equity and Learning Health Communities with the Clinical & Translational Science Institute (CTSI) kicked off our discussion with an overview of why language matters for inclusion in research. “Words have power,” she says, “the way in which we do our work as research professionals relies greatly on how we can communicate and engage with our audiences.” She highlights that about 22% of people in the US speak a language other than English and 8% have limited English proficiency. These populations are particularly vulnerable when attempting to find resources to meet their healthcare needs and experience a disproportionate number of negative health outcomes. These inequalities demonstrate the drastic need for language access services, such as translation and interpretation for written, verbal, and signed communication. Researchers should work with formats that are easy to comprehend for their intended audience and use clear, easy to understand language that has been reviewed by members of the community that they are trying to reach. Spending the time to truly get the know the intended communities and building in accessibility at the start of a project is vital to increasing equity in the work that we do. More information on CTSI and available resources can be found here. You can also access the FDA’s new Language Access plan for 2024 here.
Dane Whicker, PhD, the Director for Gender and Sexual Diversity Initiatives with the Center for Equity in Research (EIR), next spoke on best practices for using gender-inclusive language. One of the foundations of this conversation is understanding the difference between sex and gender. Sex refers to “sex traits” based on an individual’s physiology and anatomy. In contrast, gender encompasses an individual’s identity, such as their gender expression and how they express their gender to others. Gender expression is influenced by societal and cultural norms, and how a person identifies can change over time and in different situations. Dr. Whicker also spoke on SO/GI data, which encompasses both an individual’s sexual orientation (SO) and gender identity (GI). SO/GI language is crucial to improving inclusivity as it conveys respect to the participant and allows them the autonomy to self-identify. Some tips for improving inclusivity include moving away from binary language (e.g., instead of ‘men and women’ use ‘individuals’ or ‘people’) and simply asking individuals to self-identify by asking their name and pronouns. “People are the experts in their own identity,” Dr. Whicker emphasizes. Acknowledging someone’s identity and using inclusive language that reflects that identity is a visible way of conveying acceptance and safety to participants, especially those with significant mistrust of the research community.
Evan Myers, MD, MPH, Walter L. Thomas Professor of Obstetrics and Gynecology, spoke on language and inclusion around reproduction and the historical exclusion of individuals who are pregnant, lactating, or have the potential to become pregnant from participation in research. While based in good intentions, excluding individuals who are pregnant or could become pregnant from research also excludes them from the potential benefits and limits our understanding of clinical outcomes. Dr. Myers highlights some ethical considerations when developing protocols and consent for studies that keep individuals capable of pregnancy in mind. Protocols should be respectful of diversity, such as gender identity and sexual orientation, and allow potential participants to make their own informed choices about research participation. Informed consent should contain accurate information about the study, including reasons why pregnant people may be excluded, any contraception requirements, and what would happen in the event of an unplanned pregnancy. Excluding those who may become pregnant is not a justifiable exclusion criterion except in extremely rare circumstances. Studies should show respect for participants when ruling out pregnancy, such as considering participant’s age and/or sexual orientation and avoid requiring ongoing pregnancy testing for those who are highly unlikely to become pregnant. In cases where these requirements must be included, such as sponsor requirements, care should be taken to clearly explain why to those who participate. Clear explanations and considerations for how and why there is a need to minimize the risks of an unintended pregnancy during a study can help foster inclusion and reduce barriers to participation.
Denise Snyder, MS, RD, LDN, Associate Dean for Clinical Research, next shared information about language services available through the Duke Office of Clinical Research (DOCR). The DOCR Service center provides Spanish language services through a core group of bilingual clinical research professionals who are either native or heritage Spanish speakers. They offer translation for written research documents such as informed consent and recruitment flyers along with interpretation of verbal communication for the research team and/or participants during the study. Requests for language services should be submitted via the DOCR Services Request form and a written estimate will be provided within 48 hours in most cases. Translated documents come with a certification of the translation. For more information, please reach out to DOCR at docr.help@dm.duke.edu.
Ronna Zimmer, MS, RD, LDN, CCRP, Director for the Institutional Review Board (IRB) Compliance, provided updates on the new IRB translation policy. This new translation policy replaces two previous policies (“Research Involving Non-English Speaking Participants” and the “Use of Short Form Consent”) in order to simplify the IRB submission process and the process of consenting participants. The new policy includes details on when the short form consent can be used, such as when there is minimal risk to participants or when researchers expect a very small number of participants enrolled (~1-2) who do not speak English. Short form consent forms for both adults and minors that have been already translated to a number of languages are accessible on the IRB website. Long consent forms and documents that may impact participants safety, such as a drug information page with instructions, do still require a forward and back translation or certificate of translation. More information can be found here.
Hayden Bosworth, PhD, Vice Chair of Research & Professor of Population Health Sciences, spoke on the importance of health literacy and its impact on health disparities and inclusion in research. Health literacy is an individual’s ability to access, process, and understand basic health information such as medication instructions or treatment options. According to the CDC, 90 million US adults have low health literacy and these individuals are more likely to experience negative health outcomes and even increased mortality rates. Limited health literacy can impact wide-ranging health behaviors such as medication adherence, communicating with healthcare providers, and engaging in self-management of chronic illnesses. Dr. Bosworth emphasizes that “health literacy is not something you can visualize,” – researchers and clinicians should not make assumptions about who may or may not have a high degree of health literacy. Low health literacy can be strongly associated with feelings of shame, making it important to try and assess health literacy in a respectful, kind, and compassionate manner. Best practices when communicating with patients include presenting information as clearly as possible, avoiding medical jargon or complex terms, using visual aids to assist in comprehension, encouraging questions, and tailoring the communication to the individual. He also encourages doctors to regularly follow up with patients and participants to ensure their understanding and adherence to treatment plans. He provides a number of options to assess health literacy, such as the Rapid Estimate of Adult Literacy in Medicine (REALM) and the Test of Functional Health Literacy in Adults (TOFHLA). More Health Literacy resources can be found here.
Christina Kline, Executive Director of Duke’s Disability Management System (DMS) wrapped up the Town Hall with a discussion on including individuals with disabilities in research. DMS provides guidance and assistance to all of Duke for responsibilities under the Americans with Disabilities Act (ADA) and the Pregnant Workers Fairness Act (PWFA). The ADA specifies that individuals with a disability shall not, on the basis of disability, be denied participation in or excluded from the benefits of programs and services such as research. It also affirms the responsibility of researchers to provide reasonable accommodations to ensure equitable access to research participation and benefits. Approximately 1 in 4 Americans have a disability according the CDC. Disabilities are not always apparent or easily identified. Language around disability can be very charged, and negative language around disability can perpetuate stereotypes and biases. When speaking on disability, researchers should strive to use language that is respectful of the individual and their preferences and avoids words such as “handicap” in favor of terms such as “accessible”. More equitable research should strive for universal design, which allows as many people as possible to have access without requiring accommodations or modifications. Research design should also include clear opportunities for participants to request reasonable accommodations should they need them. Make sure to reach out to DMS to arrange any requested accommodations ahead of time to ensure everyone can participate. You can contact DMS via DMSOffice@duke.edu or contact Christina directly at Christina.d.kline@duke.edu.