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Human Subjects Research in Bioemergencies

  • Lauren M. Sauer
  • Jared D. Evans
  • Kathryn Shaw-Saliba
  • Bruce Gordon
  • Christopher J. Kratochvil
Chapter

Abstract

Bioemergencies present unique ethical and operational challenges to performing clinical research with human subjects. Patient care, public health protection, and responder safety are paramount in these situations, which often involve high biosafety level pathogens and containment conditions. While working to halt the spread of disease, research is necessary to understand the ongoing outbreak as well as increase response capabilities in the face of future threats. Research in bioemergencies has novel and unexpected challenges that vary greatly depending on the type of studies being conducted and data being collected. This chapter will provide an understanding of basic principles, challenges, and regulatory components of human subjects research during bioemergencies, as well as ongoing practical components of these studies.

Keywords

Research Ethics Novel pathogen Clinical trial Biorepository Institutional review board Human subjects research Publication Data Public health Confidentiality 

References

  1. 1.
    Otto JL, Holodniy M, DeFraites RF. Public health practice is not research. Am J Public Health. 2014;104(4):596–602.CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Human Subject Regulations Decision Charts [Internet]. HHS.gov. 2017 [cited 29 October 2017]. Available from: https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html. eCFR — Code of Federal Regulations [Internet]. Ecfr.gov. 2017 [cited 29 October 2017]. Available from: https://www.ecfr.gov/cgi-bin/ECFR?page=browse
  3. 3.
    Protection of Human Subjects, 45 C.F.R. §46 (2009). [regulation on the Internet]. [cited 29 October 2017]. Available from: https://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title45/45cfr46_main_02.tpl.
  4. 4.
    Mack A, Choffnes ER, Sparling PF, Hamburg MA, Lemon SM, editors. Ethical and legal considerations in mitigating pandemic disease: workshop summary. In: National Academies Press. Washington, DC; 2007.Google Scholar
  5. 5.
    Protection of Human Subjects, 21 C.F.R. §50.23 (2017). [regulation on the Internet]. [cited 29 October 2017]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.23.
  6. 6.
    Protection of Human Subjects, 21 C.F.R. §50.24 (2017). [regulation on the Internet]. [cited 29 October 2017]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.
  7. 7.
    Investigational New Drug (IND) Application [Internet]. Fda.gov. 2017 [cited 29 November 2017]. Available from: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm.
  8. 8.
    Protection of Human Subjects, 21 C.F.R. §56.104c (2017). [regulation on the Internet]. [cited 29 October 2017]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.104.
  9. 9.
    Emergency Use Authorization of Medical Products and Related Authorities Guidance for Industry and Other Stakeholders [Internet]. Fda.gov. 2017 [cited 29 November 2017]. Available from: https://www.fda.gov/downloads/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/UCM493627.pdf.
  10. 10.
    Schopper D, Dawson A, Upshur R, Ahmad A, Jesani A, Ravinetto R, Segelid MJ, Sheel S, Singh J. Innovations in research ethics governance in humanitarian settings. BMC Med Ethics 2015;16(1):10.Google Scholar
  11. 11.
    Altevogt B, Wizemann T, Reeve M, editors. Enabling Rapid and Sustainable Public Health Research During Disasters: Summary of a Joint Workshop by the Institute of Medicine and the US Department of Health and Human Services. Chapter 4: Addressing Institutional Review Board Barriers to Health Research Implementation.Washington, DC: National Academies Press; 2015.Google Scholar
  12. 12.
    National Ebola Training and Education Center [Internet]. NETEC. 2017 [cited 29 October 2017]. Available from: https://netec.org
  13. 13.
    NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Reliance Platform. National Center for Advancing Translational Sciences (NCATS). October 14, 2016. (Retrieved from: https://ncats.nih.gov/expertise/clinical/smartirb).
  14. 14.
    Lane HC, Marston HD, Fauci AS. Conducting clinical trials in outbreak settings: points to consider. Clin Trials. 2016;13(1):92–5.CrossRefPubMedPubMedCentralGoogle Scholar
  15. 15.
    Woodcock J, LaVange LM. Master protocols to study multiple therapies, multiple diseases, or both. N Engl J Med. 2017;377(1):62–70.CrossRefPubMedGoogle Scholar
  16. 16.
    Coded Private Information or Specimens Use in Research, Guidance (2008) [Internet]. HHS.gov. 2008 [cited 29 October 2017]. Available from: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/research-involving-coded-private-information/index.html.
  17. 17.
    Allen MJ, Powers ML, Gronowski KS, Gronowski AM. Human tissue ownership and use in research: what laboratorians and researchers should know. Clin Chem. 2010;56(11):1675–82.CrossRefPubMedGoogle Scholar
  18. 18.
    Guidelines and Policies for the Conduct of Research in the Intramural Research Programs at the NIH [Internet]. oir.nih.gov. 2015 [cited 29 October 2017]. Available from: https://oir.nih.gov/sites/default/files/uploads/sourcebook/documents/ethical_conduct/guidelines-conduct_research.pdf.
  19. 19.
    Horn EJ, Moore HM. Overcoming challenges in the acquisition of biospecimens for rare diseases. Expert Opin Orphan Drugs. 2013;2(1):1–4.Google Scholar
  20. 20.
    Schopper D, Ravinetto R, Schwartz L, Kamaara E, Sheel S, Segelid MJ, Ahmad A, Dawson A, Singh J, Jesani A, Upshur R. Research ethics governance in times of Ebola. Public Health Ethics. 2017;10(1):49–61.PubMedGoogle Scholar
  21. 21.
    Dye C, Bartolomeos K, Moorthy V, Kieny MP. Data sharing in public health emergencies: a call to researchers. Bull World Health Organ. 2016;94(3):158.CrossRefPubMedPubMedCentralGoogle Scholar
  22. 22.
    Developing global norms for sharing data and results during public health emergencies [Internet]. World Health Organization. 2015 [cited 29 October 2017]. Available from: http://www.who.int/medicines/ebola-treatment/blueprint_phe_data-share-results/en/.

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Lauren M. Sauer
    • 2
    • 1
  • Jared D. Evans
    • 2
    • 3
  • Kathryn Shaw-Saliba
    • 2
  • Bruce Gordon
    • 4
  • Christopher J. Kratochvil
    • 4
  1. 1.Johns Hopkins Biocontainment Unit, Johns Hopkins HospitalBaltimoreUSA
  2. 2.Department of Emergency Medicine, Johns Hopkins UniversityBaltimoreUSA
  3. 3.Research and Exploratory Development DepartmentJohns Hopkins University Applied Physics LaboratoryLaurelUSA
  4. 4.University of Nebraska Medical CenterOmahaUSA

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