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Technical report
peer-reviewed

A Framework for Navigating Institutional Review Board (IRB) Oversight in the Complicated Zone of Research



Abstract

The treatment therapies and technologies currently emerging from the rapidly evolving health care industry must undergo full examination in a clinical setting if they are to be marketed to the public. All elements of clinical studies involving human subjects must undergo thorough IRB review before study activities can commence. Regulations regarding IRB oversight apply to all clinical studies—including retrospective examinations of private medical data and identifiable biological samples. It is not uncommon for researchers to be unsure whether, or on what level, IRB review and oversight are required for a particular project. Yet, if human subjects or their private medical data are utilized in a study, peer-reviewed journals will require relevant IRB approval information be provided as a requirement for publication. This article examines IRB processes and review types, offers insight into the IRB decision-making process, and emphasizes the importance of engaging an IRB consultant early in the clinical study design process.



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Technical report
peer-reviewed

A Framework for Navigating Institutional Review Board (IRB) Oversight in the Complicated Zone of Research


Author Information

Gretchen E. Parker Corresponding Author

Ethics Review, Pearl IRB LLC


Ethics Statement and Conflict of Interest Disclosures

Human subjects: This study did not involve human participants or tissue. Animal subjects: This study did not involve animal subjects or tissue. Conflicts of interest: The authors have declared that no conflicts of interest exist.

Acknowledgements

Gretchen Parker, PhD, RAC, CIP, serves as a co-chair at Pearl IRB. Pearl IRB is an AAHRPP-accredited, independent IRB that provides comprehensive IRB services. She can be reached at www.pearlirb.com, 317.899.9341, or info@pearlirb.com.


Technical report
peer-reviewed

A Framework for Navigating Institutional Review Board (IRB) Oversight in the Complicated Zone of Research


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Technical report
peer-reviewed

A Framework for Navigating Institutional Review Board (IRB) Oversight in the Complicated Zone of Research

  • Author Information
    Gretchen E. Parker Corresponding Author

    Ethics Review, Pearl IRB LLC


    Ethics Statement and Conflict of Interest Disclosures

    Human subjects: This study did not involve human participants or tissue. Animal subjects: This study did not involve animal subjects or tissue. Conflicts of interest: The authors have declared that no conflicts of interest exist.

    Acknowledgements

    Gretchen Parker, PhD, RAC, CIP, serves as a co-chair at Pearl IRB. Pearl IRB is an AAHRPP-accredited, independent IRB that provides comprehensive IRB services. She can be reached at www.pearlirb.com, 317.899.9341, or info@pearlirb.com.


    Article Information

    Published: October 25, 2016

    DOI

    10.7759/cureus.844

    Cite this article as:

    Parker G E (October 25, 2016) A Framework for Navigating Institutional Review Board (IRB) Oversight in the Complicated Zone of Research. Cureus 8(10): e844. doi:10.7759/cureus.844

    Publication history

    Received by Cureus: September 23, 2016
    Peer review began: September 28, 2016
    Peer review concluded: October 17, 2016
    Published: October 25, 2016

    Copyright

    © Copyright 2016
    Parker. This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 3.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

    License

    This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

The treatment therapies and technologies currently emerging from the rapidly evolving health care industry must undergo full examination in a clinical setting if they are to be marketed to the public. All elements of clinical studies involving human subjects must undergo thorough IRB review before study activities can commence. Regulations regarding IRB oversight apply to all clinical studies—including retrospective examinations of private medical data and identifiable biological samples. It is not uncommon for researchers to be unsure whether, or on what level, IRB review and oversight are required for a particular project. Yet, if human subjects or their private medical data are utilized in a study, peer-reviewed journals will require relevant IRB approval information be provided as a requirement for publication. This article examines IRB processes and review types, offers insight into the IRB decision-making process, and emphasizes the importance of engaging an IRB consultant early in the clinical study design process.



Want to read more?

Create a free account to continue reading this article.

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Gretchen E. Parker, Ph.D.

Ethics Review, Pearl IRB LLC

For correspondence:
gparker@pearlpathways.com

Gretchen E. Parker, Ph.D.

Ethics Review, Pearl IRB LLC

For correspondence:
gparker@pearlpathways.com