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Review ArticleREVIEWS AND CONTEMPORARY UPDATES
Open Access

Vulnerability in Research: Basic Ethical Concepts and General Approach to Review

Bruce G. Gordon
Ochsner Journal March 2020, 20 (1) 34-38; DOI: https://doi.org/10.31486/toj.19.0079
Bruce G. Gordon
Assistant Vice-Chancellor for Regulatory Affairs, Executive Chairman, Institutional Review Boards, and Professor, Department of Pediatrics, University of Nebraska Medical Center, Omaha, NE
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  • For correspondence: bgordon@unmc.edu
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REFERENCES

  1. 1.↵
    Protection of Human Subjects. 45 CFR §46. US Department of Health and Human Services. www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML. Accessed August 30, 2019.
  2. 2.↵
    The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html. Published April 18, 1979. Accessed January 22, 2020.
  3. 3.↵
    Ethical and policy issues in research involving human participants: report and recommendations of the National Bioethics Advisory Commission. National Bioethics Advisory Commission. bioethicsarchive.georgetown.edu/nbac/human/overvol1.pdf. Published August 2001. Accessed March 4, 2020.
  4. 4.↵
    Declaration of Helsinki – ethical principles for medical research involving human subjects. World Medical Association. www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/. Updated July 9, 2018. Accessed August 30, 2019.
  5. 5.↵
    1. Bracken-Roche D,
    2. Bell E,
    3. Macdonald ME,
    4. Racine E
    . The concept of ‘vulnerability’ in research ethics: an in-depth analysis of policies and guidelines. Health Res Policy Syst. 2017 Feb 7;15(1):8. doi: 10.1186/s12961-016-0164-6.
    OpenUrlCrossRef
  6. 6.↵
    International ethical guidelines for health-related research involving humans. Council for International Organizations of Medical Sciences. cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf. Published 2016. Accessed January 22, 2020.
  7. 7.↵
    1. Levine C,
    2. Faden R,
    3. Grady C,
    4. Hammerschmidt D,
    5. Eckenwiler L,
    6. Sugarman J
    ; Consortium to Examine Clinical Research Ethics. The limitations of ‘vulnerability’ as a protection for human research participants. Am J Bioeth. 2004 Summer;4(3):44-49. doi: 10.1080/15265160490497083.
    OpenUrlCrossRefPubMed
  8. 8.↵
    1. Leavitt FJ
    . Is any medical research population not vulnerable? Camb Q Healthc Ethics. 2006 Winter;15(1):81-88. doi: 10.1017/s0963180106060099.
    OpenUrlCrossRefPubMed
  9. 9.↵
    1. Hurst SA
    . Vulnerability in research and health care; describing the elephant in the room? Bioethics. 2008 May;22(4):191-202. doi: 10.1111/j.1467-8519.2008.00631.x.
    OpenUrlCrossRefPubMedWeb of Science
  10. 10.↵
    1. Coleman CH
    . Vulnerability as a regulatory category in human subject research. J Law Med Ethics. 2009 Spring;37(1):12-18. doi: 10.1111/j.1748-720X.2009.00346.x.
    OpenUrlCrossRef
  11. 11.↵
    Efficacy guidelines: E6(R2) good clinical practice. International Council for Harmonisation. www.ich.org/page/efficacy-guidelines. Published November 9, 2016. Accessed August 20, 2019.
  12. 12.↵
    Vulnerable populations background: learning objectives. Presidential Commission for the Study of Bioethical Issues. bioethicsarchive.georgetown.edu/pcsbi/node/4031.html. Accessed July 9, 2019.
  13. 13.↵
    1. Kipnis K
    . Vulnerability in research subjects: a bioethical taxonomy. In: Ethical and Policy Issues in Research Involving Human Participants. Volume II: Commissioned Papers. National Bioethics Advisory Commission. www.aapcho.org/wp/wp-content/uploads/2012/02/Kipnis-VulnerabilityinResearchSubjects.pdf. Published 2001. Accessed March 4, 2020.
  14. 14.↵
    1. Brown JS,
    2. Schonfeld TL,
    3. Gordon BG
    . “You may have already won…”: an examination of the use of lottery payments in research. IRB. 2006 Jan-Feb;28(1):12-16.
    OpenUrlPubMed
  15. 15.↵
    1. Kahneman D,
    2. Tversky A
    . Choices, values, and frames. Am Psychol. 1984;39(4):341-350. doi: 10.1037/0003-066X.39.4.341.
    OpenUrlCrossRefPubMedWeb of Science
  16. 16.↵
    Research involving children: report and recommendations. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. ideocast.nih.gov/pdf/ohrp_research_involving_children.pdf. Published September 6, 1977. Accessed March 4, 2020.
  17. 17.↵
    1. Hiller JL,
    2. Benda GI,
    3. Rahatzad M,
    4. et al.
    Benzyl alcohol toxicity: impact on mortality and intraventricular hemorrhage among very low birth weight infants. Pediatrics. 1986 Apr;77(4):500-506.
    OpenUrlAbstract/FREE Full Text
  18. 18.↵
    1. Christensen ML,
    2. Helms RA,
    3. Chesney RW
    . Is pediatric labelling really necessary? Pediatrics. 1999 Sep;104(3 Pt 2):593-597.
    OpenUrlPubMedWeb of Science
  19. 19.↵
    1. Beecher HK
    . Ethics and clinical research. N Engl J Med. 1966 Jun 16;274(24):1354-1360. doi: 10.1056/NEJM196606162742405.
    OpenUrlCrossRefPubMedWeb of Science
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Ochsner Journal: 20 (1)
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Vulnerability in Research: Basic Ethical Concepts and General Approach to Review
Bruce G. Gordon
Ochsner Journal Mar 2020, 20 (1) 34-38; DOI: 10.31486/toj.19.0079

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Vulnerability in Research: Basic Ethical Concepts and General Approach to Review
Bruce G. Gordon
Ochsner Journal Mar 2020, 20 (1) 34-38; DOI: 10.31486/toj.19.0079
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  • Article
    • Abstract
    • INTRODUCTION
    • ETHICAL AND CONCEPTUAL BASIS OF VULNERABILITY
    • CATEGORICAL VULNERABILITY
    • CONTEXTUAL VULNERABILITY
    • BASIC APPROACH TO INSTITUTIONAL REVIEW BOARD REVIEW
    • CONCLUSION
    • ACKNOWLEDGMENTS
    • REFERENCES
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