Why Diversity in Clinical Trials Matters

Research: Some run from it, some run to it. In nursing, we are either creators or consumers of research, whether it is quantitative, qualitative, mixed methodology or a clinical trial. From stem cells and pharmacology to medical devices and vaccines: All patients and providers are affected by research. How we talk about research, especially with patients of diverse backgrounds, is imperative in advancing health outcomes and health equity.

One of the most important pieces of information to share is informed consent for research participation. But, what does informed consent mean?

• It means that imperative parts of the research process, including risks, benefits, outcomes and the purpose of the study, are explained without bias to potential participants, to increase recruitment and retention.
• Similar to procedural consent, a research informed consent form (ICF) is best presented when a potential participant has ample physical and mental space to read and process the information in the form.

Questions Guide Research

Asking a research question is the first step in conducting any study – think of it like programming a GPS. You would not start driving to a destination and then program in the final address halfway through your trip – that would be wildly inefficient! Being clear on the research question/s will determine the participant population, methodology and, ultimately, dissemination of the results. If the researcher or the research team gets lost in the process, the research question acts as a directional compass to maintain focus throughout the research process. Diversity is necessary to ensure the research is representative of the population it wishes to serve. Focusing on one demographic creates a lot of unknowns in efficacy and the barriers that can occur in a clinical trial. It also limits the researcher's awareness and understanding of the trial itself.

Protecting Research Subjects

Volunteer participation in research studies is necessary for the advancement of science. It is the responsibility of researchers to protect the safety, privacy and confidentiality of all research subjects during their participation. In research, privacy and confidentiality are not interchangeable. These words especially matter when studies involve personal information, survey data or data collected from vulnerable populations.

• Privacy applies to the individual or the participant and their desire to control who has access to them and their participation.
• Confidentiality refers to the data and how the participants’ data will be handled, stored and shared.

The history of clinical experimentation is remembered through events such as the Nuremberg and Tuskegee research trials. Increased sensitivity and potential distrust when “research trials” are mentioned can lead to a reluctance to enroll in studies. It is important that we acknowledge feelings of distrust and talk through any hesitations to ensure participants are fully aware of how clinical research trials have changed and why their participation is important. Nationally, organizations such as the Food Drug Administration (FDA) work to protect public health by overseeing food, pharmaceuticals and medical devices, while promoting new advancements to ensure efficacy and affordability, and delivering the most up-to-date scientific information. The FDA is also responsible for protecting patient safety by providing frameworks for research including regulatory guidelines for local institutional review boards (IRBs).

Institutional review boards use a group process to review research protocols and informed consent documents to ensure protection of human subject’s rights and welfare. Important things to know about IRBs include the following:

• They are necessary whether research is being conducted at a university, a hospital or a national clinical trial.
• Periodic review occurs to ensure the safety of human subjects is continuously upheld during the study.
• IRBs are composed of an interdisciplinary panel of experts who provide an objective view about the protocol and how to best protect human subjects.
• The primary investigator (PI) and the research team uphold the standards of good clinical practice.
  • These standards set the bar for how trials should be conducted and define roles and responsibilities to maintain ethical, credible data and the integrity of all involved.
  • It is important to share this information with all study participants to ensure they understand their rights and responsibilities are protected.

The PI and the research team maintain the conditions of the protocol, document adverse events and provide a summative report. It is the combination of these resources that contributes to a successful research study.

Promoting Diversity in Clinical Research

Many groups are underrepresented in clinical research. These groups extend wider than race and ethnicity, and professional research organizations are calling for conscious inclusion of a variety of ages, geographical locations, religions and insurance statuses. Historically, those with Medicaid do not qualify for experimental treatments. This exclusion is a concern because people of different ages, races and ethnicities may react differently to various pharmaceuticals and medical devices, as well as be predisposed to certain medical conditions. Those from underrepresented populations may include people of color, women and children. Limited inclusion in clinical trials can impact the efficacy of treatments and delay research that could lead to groundbreaking discoveries. As healthcare professionals, it is our responsibility to advocate for our patients and each other to change what is impacting health equity outcomes.

Considerations to Promote Diversity Equity, and Inclusion (DEI)

• Review and display the Clinical Diversity Fact Sheet in your practice area.
• Nominate a champion on the team to promote DEI in research.
• Promote appropriate and professional interpretation of informed consent or pediatric assent.
• Include culturally appropriate presentation of the research study, risks and benefits.
• Inquire about complementary, integrative and holistic therapies that the subject may practice while participating.
• Demonstrate full transparency when discussing risks, benefits and potential discoveries.
• Allow ample time to ask and answer questions about the research study in the participant’s or Legal Authorized Representative’s preferred language.

Data Collection Standards

Collecting data in clinical trials is important to understand the study population and the implications of the interventions:

• Following FDA terminology for age, sex, gender, race and ethnicity ensures consistency in data reporting.
• It is recommended to use a two-question format when collecting demographics such as:
  • Question 1 (answer first): Do you consider yourself Hispanic/Latino or not Hispanic/Latino?
  • Question 2 (answer second): Which racial designation(s) best describes you? More than one choice is acceptable.
• Age and developmental level should also be considered in research:
  • Written in developmentally appropriate language, and the participant has the opportunity to ask questions about the research study
• Assents are obtained for potential participants:
  • Who are younger than the legal age of consent, yet are of an age that can understand the implications of research in which they would be participating in?
    • In pediatric research, participants will have a legal adult consent to their participation and validate their assent.
• Language is more than descriptive words:
  • It incorporates nonverbal behaviors, body language, past connotations and experiences that may affect a layperson’s willingness to participate in research trials.
• Medical jargon, unclear definitions and ill-defined processes can lead to research protocols or consents being perceived as complex.
• Differences in behaviors and language among cultures can be a barrier:
  • For example, the use of hand gestures in communication with Turkish cultures is seen as rude and reserved for home communities, while direct eye contact in Asian cultures is seen as a sign of disrespect.
  • Using a targeted cultural assessment parallel to the research process allows for the research nurse and the participant to identify beliefs, values and practices; construct culture-specific interventions to participation barriers; and solidify the participant’s inclusion in the study.
  • Targeted cultural assessments:
    • Increase nurse-patient collaboration.
    • Improve quality of data collection.
    • Allow for health practices/behaviors to be readily shared.
    • Increase the patient's willingness to continue participation.

Stay Informed and Ask

• Educate yourself and others on diversity in research. When in doubt – ask!
• Stay up-to-date on the latest clinical trials for your patient population.
• Use culturally and age-appropriate language when discussing research with enrolled and potential participants.
• Collaborate with DEI unit champions to create a consistent message about research practices.

How do you engage in research?

AACN and Miranda would like to thank Susan Bartos, PhD, RN, CCRN, for her expert guidance, input and knowledge in developing this blog.