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Several months of data from the COVID-19 pandemic showed that African Americans and other people of color were disproportionately dying from the disease. Disparities in how COVID-19 affects minority communities highlight long-standing difficulties in achieving health equity in U.S. society, including clinical trials.
Researchers assessing the demographic statistics of All of Us Research Program participants prioritized enrolling racial, ethnic, and other minorities that, historically, have been underrepresented in clinical trials. The researchers concluded studies need to incorporate more diverse factors as key variables to ensure inclusion and identify barriers that limit research participation.
One barrier to enrolling minorities in research involves resources. For some studies, such as pediatric oncology clinical trials, there might not be enough resources to enroll one or two patients at a single site.
One long-time virtual IRB has learned how to develop camaraderie and rapport among IRB members without ever meeting in person — or seeing each other’s faces.
Social-behavioral-educational research programs have always faced challenges fitting their work into the parameters of human research protection rules and regulations devised with biomedical research in mind. But the revised Common Rule has produced new issues with informed consent.
The Food and Drug Administration recently released updated guidance on conducting clinical trials of medical products during the COVID-19 pandemic. The new version of the guidelines includes a question-and-answer section that clarifies some emergency changes affecting human research protection policies and procedures.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Reviewer Lindsay McNair, MD, MPH, MSB, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, reports she is on the speakers bureau for AORN and Ethicon USA and is a consultant for Mobile Instrument Service and Repair.
