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Case Commentaries

Ancillary Care Obligations of Clinical Trial Investigators in the COVID-19 Pandemic

REFERENCES

  • Belsky, L., and H. S. Richardson. 2004. Medical researchers’ ancillary clinical care responsibilities. BMJ (Clinical Research ed.) 328 (7454):1494–6. doi:10.1136/bmj.328.7454.1494.
  • Danziger-Isakov, L., and D. Kumar. and AST ID Community of Practice. 2019. Vaccination of solid organ transplant candidates and recipients: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clinical Transplantation 33 (9):e13563. doi:10.1111/ctr.13563.
  • Hill, D. R., C. D. Ericsson, R. D. Pearson, J. S. Keystone, D. O. Freedman, P. E. Kozarsky, H. L. DuPont, F. J. Bia, P. R. Fischer, E. T. Ryan, et al. 2006. The practice of travel medicine: Guidelines by the Infectious Diseases Society of America. Clinical Infectious Diseases 43 (12):1499–539. doi:10.1086/508782.
  • Krubiner, C. B., R. H. Syed, and M. W. Merritt. 2015. Health researchers’ ancillary-care responsibilities in low-resource settings: The landscape of institutional guidance. IRB 37 (3):12–9.
  • Murthy, R., G. Rose, C. Liddy, A. Afkham, and E. Keely. 2017. EConsultations to infectious disease specialists: Questions asked and impact on primary care providers’ behavior. Open Forum Infectious Diseases 4 (2):ofx030. doi:10.1093/ofid/ofx030.
  • Oliver, S. E., J. W. Gargano, H. Scobie, M. Wallace, S. C. Hadler, J. Leung, A. E. Blain, N. McClung, D. Campos-Outcalt, R. L. Morgan, et al. 2021. The Advisory Committee on immunization practices’ interim recommendation for use of Janssen COVID-19 vaccine - United States, February 2021. MMWR. Morbidity and Mortality Weekly Report 70 (9):329–32. doi:10.15585/mmwr.mm7009e4.
  • Oster, M. E., D. K. Shay, J. R. Su, J. Gee, C. B. Creech, K. R. Broder, K. Edwards, J. H. Soslow, J. M. Dendy, E. Schlaudecker, et al. 2022. Myocarditis cases reported after MRNA-based COVID-19 vaccination in the US from December 2020 to August 2021. JAMA 327 (4):331–40. doi:10.1001/jama.2021.24110.
  • Richardson, H. S. 2012. Moral entanglements: The ancillary-care obligation of medical researchers. New York: Oxford University Press.
  • Rosenblum, H. G., S. C. Hadler, D. Moulia, T. T. Shimabukuro, J. R. Su, N. K. Tepper, K. C. Ess, E. J. Woo, A. Mba-Jonas, M. Alimchandani, et al. 2021. Use of COVID-19 vaccines after reports of adverse events among adult recipients of Janssen (Johnson & Johnson) and MRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices - United States. MMWR. Morbidity and Mortality Weekly Report 70 (32):1094–9. doi:10.15585/mmwr.mm7032e4.
  • See, Isaac. 2021. “Updates on Thrombosis with Thrombocytopenia Syndrome (TTS).” https://www.Cdc.Gov/Vaccines/Acip/Meetings/Downloads/Slides-2021-12-16/02-COVID-See-508. December 16, 2021.
  • “The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective. US Food and Drug Administration (FDA). 2022.” https://www.Fda.Gov/Drugs/Information-Consumers-and-Patients-Drugs/Fdas-Drug-Review-Process-Ensuring-Drugs-Are-Safe-and-Effective. October 24, 2022.
  • Wilfond, B. S., D. M. Duenas, and L. M. Johnson. 2023. Researcher obligations to participants in novel COVID-19 vaccine research. The American Journal of Bioethics 23 (10):119–120. doi:10.1080/15265161.2023.2250275.

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