Project Summary:
Without equitable access to research, the outcomes of research that directly impact health will not be shared across all demographics and groups.
Studies have found that while individual and community-level factors—including medical and research mistrust, socioeconomic circumstances, and health literacy—contribute to lack of participation in research by vulnerable and excluded groups, these are actually misrepresented barriers to participation and are surmountable with the appropriate adaptations to the current research culture and processes. However, these adaptations would require collaboration from shapers of the research enterprise; including sponsors, governmental and regulatory bodies, policy makers, institutions and individuals conducting research, institutional review boards (IRBs), journals, and research subjects themselves. Individual and community-level factors, while considerations in the informed consent process, do not affect willingness to participate among underrepresented and excluded populations. Moreover, the misconception among the research community that underrepresented groups are not willing to participate in research proves to be one of the largest barriers to equitable subject selection and can be mitigated by implementing changes at the individual project and institutional levels. These changes include the creation of accessible and multilingual recruitment and consenting.
According to regulations and ethical principles, individuals must make a fully informed decision regarding their participation in research through a clear and understandable consent process. Multiple factors contribute to informed decision making, and cornerstones in the informed consent process include health literacy, reading level, length, accessibility, and content comprehension. Past studies, however, have found that consent forms are often too complex, lengthy, and hinder the informed consent process. Furthermore, according to Wisconsin Literacy (2024), one in seven Wisconsin adults struggle with low literacy. A study on reading level and length of written consent forms found that most were written at a tenth grade or higher reading level across all medical specialties and including for pediatric studies. High reading levels are fueled by required regulatory language along with pressures from institutional and industry sponsors to include liability-focused terminology rather than language meant to enhance comprehension and inform decision making.
Additionally, due to issues such as budgetary restraints, consent forms are often created in English only, which is not reflective of the U.S. population and therefore does not promote fairness, opportunity, or quality in research. These facts, coupled with the known issues relating to consent form length and complexity, led to the development and evaluation of a shortened consent form in both English and Spanish. The form was created and translated by the MCW Human Research Protection Program (HRPP) Office. All regulatory elements of consent have been incorporated in the shortened form, yet it is rated at a lower reading level and is significantly shorter. However, the HRPP Office lacks the physical and financial resources to evaluate the form. Furthermore, formally evaluating a consent form as part of a research project falls outside of the general duties of an HRPP Office.
As presently composed, consent documents serve as another barrier to just and equitable research participation—ultimately obstructing equitable selection of research subjects and health equity as a whole. This project aims to further explore the impact of accessible informed consent documents on research and health equity by piloting the use of a low literacy shortened informed consent document, in both English and Spanish, with historically underrepresented groups.
The project team will test the hypothesis that a major barrier to research participation is language based. A secondary hypothesis is that removing language-based barriers increases trust in research and researchers, ultimately increasing research subject participation. The goal of this research project is to demonstrate that the removal of language-based barriers in research leads to greater research subject accrual and retention rates among populations that are generally underrepresented.