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Clinical trials, informed consent, &...

Petty, Courtney.

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Clinical trials, informed consent, & emergency medicine: A systematic literature review.

Record Type:	Language materials, printed : Monograph/item
Title/Author:	Clinical trials, informed consent, & emergency medicine: A systematic literature review./
Author:	Petty, Courtney.
Description:	52 p.
Notes:	Source: Masters Abstracts International, Volume: 52-02.
Contained By:	Masters Abstracts International52-02(E).
Subject:	Health Sciences, Public Health. -
Online resource:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=1543283
ISBN:	9781303294389

Clinical trials, informed consent, & emergency medicine: A systematic literature review.
Petty, Courtney.

Clinical trials, informed consent, & emergency medicine: A systematic literature review. - 52 p.

Source: Masters Abstracts International, Volume: 52-02.

Thesis (M.P.H.)--The University of Texas School of Public Health, 2013.

Background: In the United States, the Food and Drug Administration (FDA) regulates clinical trials. These regulations address good clinical practices as well as human subject protection (FDA, 2012). One of the most important legal and ethical concerns in clinical trials is informed consent. 21 CFR 50 governs human subjects research. Part 50.24 provides an emergency research exception to the informed consent requirement. Research was conducted to determine the appropriateness of this exception, whether the benefit justifies the exception, and its public health significance.

ISBN: 9781303294389Subjects--Topical Terms:

1017659
Health Sciences, Public Health.

Clinical trials, informed consent, & emergency medicine: A systematic literature review.
LDR:02013nam a2200337 4500 001 1966894
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100 1 $a Petty, Courtney. $3 2103789
245 1 0 $a Clinical trials, informed consent, & emergency medicine: A systematic literature review.
300 $a 52 p.
500 $a Source: Masters Abstracts International, Volume: 52-02.
500 $a Adviser: Carl Hacker.
502 $a Thesis (M.P.H.)--The University of Texas School of Public Health, 2013.
520 $a Background: In the United States, the Food and Drug Administration (FDA) regulates clinical trials. These regulations address good clinical practices as well as human subject protection (FDA, 2012). One of the most important legal and ethical concerns in clinical trials is informed consent. 21 CFR 50 governs human subjects research. Part 50.24 provides an emergency research exception to the informed consent requirement. Research was conducted to determine the appropriateness of this exception, whether the benefit justifies the exception, and its public health significance.
520 $a Methods: A systematic literature review was conducted and articles were identified from peer-reviewed journals.
520 $a Results: There is some variance in opinions regarding the appropriateness of the exception, but the literature reviewed found the study results of these trials justified the waiver.
520 $a Conclusion: The exception to the informed consent requirement is likely appropriate and justified in emergency research when implemented within the specified guidelines.
590 $a School code: 0219.
650 4 $a Health Sciences, Public Health. $3 1017659
650 4 $a Health Sciences, Health Care Management. $3 1017922
650 4 $a Law. $3 600858
650 4 $a Health Sciences, Medical Ethics. $3 1669715
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710 2 $a The University of Texas School of Public Health. $b Policy and Community Health. $3 2094324
773 0 $t Masters Abstracts International $g 52-02(E).
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792 $a 2013
793 $a English
856 4 0 $u http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=1543283