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Review ArticleREVIEWS AND CONTEMPORARY UPDATES
Open Access

Important Considerations for the Institutional Review Board When Granting Health Insurance Portability and Accountability Act Authorization Waivers

Kelsey Williams and Paul Colomb
Ochsner Journal March 2020, 20 (1) 95-97; DOI: https://doi.org/10.31486/toj.19.0083
Kelsey Williams
Department of Compliance and Privacy, Ochsner Clinic Foundation, New Orleans, LA
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  • For correspondence: kelsey.williams@ochsner.org
Paul Colomb
Department of Compliance and Privacy, Ochsner Clinic Foundation, New Orleans, LA
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    The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Office for Human Research Protections. 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 8, 2019.
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    Protection of human subjects. 45 CFR §46. US Department of Health and Human Services. www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html. Accessed July 29, 2019.
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    1. Nurmi SM,
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    . Privacy of clinical research subjects: an integrative literature review. J Empir Res Hum Res Ethics. 2019 Feb;14(1):33-48. doi: 10.1177/1556264618805643.
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    Health Insurance Portability and Accountability Act of 1996. Pub L No. 104-191. www.govinfo.gov/content/pkg/PLAW-104publ191/pdf/PLAW-104publ191.pdf. Effective August 21, 1996. Accessed August 8, 2019.
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    Standards for privacy of individually identifiable health information. final privacy rule preamble.. purpose of the administrative simplification regulations. Office of the Assistant Secretary for Planning and Evaluation. aspe.hhs.gov/report/standards-privacy-individually-identifiable-health-information-final-privacy-rule-preamble/purpose-administrative-simplification-regulations. Published December 28, 2000. Accessed December 1, 2019.
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    Research. US Department of Health and Human Services. www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html. Published December 3, 2002. Updated December 18, 2017. Accessed August 12, 2019.
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    Uses and disclosures for which an authorization or opportunity to agree or object is not required. 45 CFR §164.512. US Department of Health and Human Services. www.govinfo.gov/app/details/CFR-2016-title45-vol1/CFR-2016-title45-vol1-sec164-512. Updated October 1, 2016. Accessed August 12, 2019.
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    Federal policy for the protection of human subjects. Federal Regist. 2017 Jan 19;82(12). www.govinfo.gov/content/pkg/FR-2017-01-19/pdf/2017-01058.pdf. Accessed September 1, 2019.
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    Protection of human subjects. 45 CFR §46.102. US Department of Health and Human Services. www.ecfr.gov/cgi-bin/text-idx?m=07&d=29&y=2019&cd=20190725&submit=GO&SID=83cd09e1c0f5c6937cd9d7513160fc3f&node=pt45.1.46&pd=20180719. Accessed September 1, 2019.
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    Attachment B - recommendations on the interpretation and application of §_.104(d)(4) the “HIPAA Exemption.” Office for Human Research Protections. US Department of Health and Human Services. www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-b-december-12-2017/index.html. Accessed December 4, 2019.
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Ochsner Journal: 20 (1)
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Important Considerations for the Institutional Review Board When Granting Health Insurance Portability and Accountability Act Authorization Waivers
Kelsey Williams, Paul Colomb
Ochsner Journal Mar 2020, 20 (1) 95-97; DOI: 10.31486/toj.19.0083

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Important Considerations for the Institutional Review Board When Granting Health Insurance Portability and Accountability Act Authorization Waivers
Kelsey Williams, Paul Colomb
Ochsner Journal Mar 2020, 20 (1) 95-97; DOI: 10.31486/toj.19.0083
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    • Abstract
    • INTRODUCTION
    • A FUNDAMENTAL NEED FOR PRIVACY
    • CURRENT FRAMEWORK FOR PRIVACY PROTECTION IN CLINICAL RESEARCH
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