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

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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.

No MeSH data available.


Levels of IRB Oversight and Review
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FIG1: Levels of IRB Oversight and Review

Mentions: Once a PI has supplied an initial assessment, an IRB will verify or correct the level of review needed for a study before rendering a decision and forwarding approval documentation. Figure 1 summarizes various levels of IRB oversight and Figure 2 gives examples of situations which may be presented to an IRB for clarification.


A Framework for Navigating Institutional Review Board (IRB) Oversight in the Complicated Zone of Research
Levels of IRB Oversight and Review
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5120963&req=5

FIG1: Levels of IRB Oversight and Review
Mentions: Once a PI has supplied an initial assessment, an IRB will verify or correct the level of review needed for a study before rendering a decision and forwarding approval documentation. Figure 1 summarizes various levels of IRB oversight and Figure 2 gives examples of situations which may be presented to an IRB for clarification.

View Article: PubMed Central - HTML - PubMed

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.

No MeSH data available.