Clinical research has not always been a safe space for racially and ethnically marginalized communities. Historical abuse and racism, demonstrated in the Tuskegee Study and coerced sterilization, throughout the 20th century has built a foundation of medical mistrust and uncertainty about participation in clinical trials.
According to KFF public polling on diversity in clinical trials, between 2000 to 2020, the median enrollment of Hispanic (6%), Asian (1%), and American Indian and Alaska Native (AIAN) (0%) participants in clinical trials was lower than their percentage of representation in the U.S. population, while white participants were overrepresented in clinical trials, with a median enrollment of 80%. Black participants are also consistently underrepresented in clinical research.
Due to lack of accessibility and medical mistrust in health institutions, clinical trials commonly lack racially and ethnically diverse participants, but racial and ethnic disparities in health outcomes are persistent. Diversity in clinical trials is important to ensure that treatments have a positive impact across the board, and to ensure that all patients get access to innovative treatments that can improve health outcomes.
But this raises the question of why clinical trials should be trusted now? And what protocols are in place to ensure the safety of all participants?
Due to historical abuses, laws have been put in place to provide research participants with multiple levels of protection. According to the National Institute Aging (NIA), the following protocols have been put in place to protect wellbeing and patient safety:
The Institutional Review Board (IRB)
IRB approval is mandatory for all clinical trials, including humans, to protect participants. The board is made up of experts like doctors and scientists but also includes members of the public to ensure that study participants are not exposed to any unnecessary risks. They make sure that the potentials risks, or harm, don’t outweigh the potential benefits of the study.
Informed Consent
Before signing up for a clinical trial, it is important that you know everything you can about that specific study. Informed consent is another protocol that helps protect participants by ensuring the patient is aware of important facts about a study. Once the patient is aware, they can make an informed decision about whether or not to participate. An informed consent document is provided and typically includes the following information:
- The purpose of the study
- How long the study will last
- The required procedures involved
- Who to contact for questions or concerns
- Risks and potential benefits of the study
Members of the research team will explain the research process before the study begins and throughout different parts of the study.
Research Monitoring Boards
Clinical trials and studies also have committees or experts that monitor the safety of the research as it occurs. Clinical trials that test an intervention, like treatment, are closely monitored by a Data and Safety Monitoring Review Board. If the members find that the treatment is not working or is causing harm, they will stop the trial early.
Safety protocols may differ depending on the type of clinical trial and the age of the participants, among other factors. To learn more about safety protocols for a specific clinical trial, contact a trusted healthcare provider or member of your care team.
Resources
Kaiser Family Foundation. (2024, February 22). Racial and ethnic disparities in access to medical advancements and technologies. https://www.kff.org/racial-equity-and-health-policy/racial-and-ethnic-disparities-in-access-to-medical-advancements-and-technologies/
National Institute on Aging. (n.d.). Clinical research: Benefits, risks, and safety. National Institutes of Health. https://www.nia.nih.gov/health/clinical-trials-and-studies/clinical-research-benefits-risks-and-safety\