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Review ArticleREVIEWS AND CONTEMPORARY UPDATES
Open Access

Exemptions and Limited Institutional Review Board Review: A Practical Look at the 2018 Common Rule Requirements for Exempt Research

Amelia Walch-Patterson
Ochsner Journal March 2020, 20 (1) 87-94; DOI: https://doi.org/10.31486/toj.19.0095
Amelia Walch-Patterson
Human Research Protection Program, Ochsner Clinic Foundation, New Orleans, LA
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REFERENCES

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    About HHS. US Department of Health and Human Services. www.hhs.gov/about/index.html. Accessed August 23, 2019.
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    Final rule. Fed Regist. 2017 Jan;82(12). www.govinfo.gov/content/pkg/FR-2017-01-19/pdf/2017-01058.pdf. Accessed August 29, 2019.
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    . NPRM: escape for many, scant relief for those left behind. Institutional Review Blog. www.institutionalreviewblog.com/2015/09/nprm-escape-for-many-scant-relief-for.html. Published September 11, 2015. Accessed August 29, 2019.
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    . Historians love the NPRM. www.institutionalreviewblog.com/2015/11/historians-love-nprm.html. Published November 4, 2015. Accessed August 29, 2019.
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    Criteria for IRB approval of research. 45 CFR §46.111. 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#se45.1.46_1111. Accessed August 22, 2019.
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    Pre-2018 requirements. Protection of human subjects. 45 CFR §46. US Department of Health and Human Services. www.govinfo.gov/content/pkg/CFR-2016-title45-vol1/pdf/CFR-2016-title45-vol1-part46.pdf. Accessed August 2, 2019.
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    The Belmont Report. US Department of Health and Human Services. www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html. Published April 18, 1979. Accessed August 2, 2019.
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Exemptions and Limited Institutional Review Board Review: A Practical Look at the 2018 Common Rule Requirements for Exempt Research
Amelia Walch-Patterson
Ochsner Journal Mar 2020, 20 (1) 87-94; DOI: 10.31486/toj.19.0095

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Exemptions and Limited Institutional Review Board Review: A Practical Look at the 2018 Common Rule Requirements for Exempt Research
Amelia Walch-Patterson
Ochsner Journal Mar 2020, 20 (1) 87-94; DOI: 10.31486/toj.19.0095
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  • Article
    • Abstract
    • INTRODUCTION
    • NOTICE OF PROPOSED RULEMAKING: INTRODUCTION OF EXCLUSIONS
    • NOTICE OF PROPOSED RULEMAKING: EXEMPTION CHANGES
    • THE FINAL RULE
    • LIMITED INSTITUTIONAL REVIEW BOARD REVIEW
    • EXEMPTION CATEGORIES: PRE-2018 REQUIREMENTS VS 2018 REQUIREMENTS12,13
    • LOOKING FORWARD
    • CONCLUSION
    • ACKNOWLEDGMENTS
    • REFERENCES
  • Figures & Data
  • Info & Metrics
  • References
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