IRB safeguards and vulnerable subjects

OA1227 - Come play the worst ever round of the Connections game and figure out what on earth Tuskegee Alabama, the CDC, Southern Denmark University, and the West African country of Guinea-Bissau all have in common, as RFK Jr. continues his campaign of “just asking questions” that we already have the answer to.

• Black men untreated in Tuskegee syphilis study. Heller, J. (July 25, 1972; republished May 10, 2017). Associated Press.

• The untreated syphilis study at Tuskegee timeline. Centers for Disease Control. (September 4, 2024).

• 45 CFR 46 Protection of Human Subjects. (Department of Health and Human Services regulations to implement the National Research Act and create Institutional Review Board policies).

• Hepatitis B. World Health Organization (July 23, 2025).

• Should the U.S. model its vaccine policy on Denmark’s? Experts say we’re nothing alike. Godoy, M. (December 26, 2025). NPR.

• RFK Jr. overhauls childhood vaccine schedule to resemble Denmark’s in unprecedented move. Lovelace Jr., B., Edwards, E., Fattah, M., & Bendix, A. (January 5, 2026). NBC News.

• What is actually the emerging evidence about non-specific vaccine effects in randomized trials from the Bandim Health Project? Støvring, H., Ekstrøm, C.T., Schneider, J.W., & Strøm, C. (2025). Vaccine, 68, 1-4.

• Notice of award of a single source unsolicited grant to fund University of Southern Denmark (SDU). Department of Health and Human Services. (December 15, 2025).

• U.S. plan for $1.6m hepatitis B vaccine study in Africa called ‘highly unethical’. Schreiber, M. & Lay, K. (December 19, 2025). The Guardian.

• CDC awards $1.6 million for hepatitis B vaccine study by controversial Danish researchers. Szabo, L. (December 18, 2025). Center for Infectious Disease Research and Policy.

• CDC funds controversial hepatitis B vaccine trial in African newborns. Offord, C. (December 18, 2025). Science Insider.

• Research ethics and compliance support. Southern Denmark University.

Further reading:

• Qiao, H. (2018). A brief introduction to institutional review boards in the United States. Pediatric Investigation, 2, 46-51.

• U.S. Department of Health and Human Services. International compilation of human research standards. https://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html

• University of North Carolina. Nuremberg Code. https://research.unc.edu/human-research-ethics/resources/ccm3_019064/

• Torrance, R.J., Mormina, M., Sayeed, S., Kessel, A., Yoon, C.H., & Cislaghi, B. (2024). Is the U.N. receiving ethical approval for its research with human participants? Journal of Medical Ethics, 51, 1-4.

• Barchi, F. & Little, M.T. (2016). National ethics guidance in Sub-Saharan Africa on the collection and use of human biological specimens: A systematic review. BMC Medical Ethics, 17, 1-25.

• Salhia, B. & Olaiya, V. (2020). Historical perspectives on ethical and regulatory aspects of human participants research: Implications for oncology clinical trials in Africa. JCO Global Oncology, 6, 959-965.

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