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Journal article

Research on medical practices (ROMP): Attitudes of IRB personnel about randomization and informed consent

Abstract:

Activities such as continuous quality improvement, comparative effectiveness research, and electronic medical record review—collectively referred to as research on medical practices (ROMP)—are posing more and more challenges for meeting regulatory requirements governing research with humans. In 2014, the Office for Human Research Protections issued draft guidance to address inconsistent interpretations of how regulatory rules apply to ROMP that uses a randomized approach. That guidance has no...

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Publication status:
Published
Peer review status:
Peer reviewed

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Authors


Porter, KM More by this author
Korngiebel, DM More by this author
Constantine, M More by this author
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Publisher:
Hastings Center Publisher's website
Journal:
IRB: Ethics and Human Research Journal website
Volume:
39
Issue:
1
Pages:
10-16
Publication date:
2017-01-18
Acceptance date:
2016-12-01
EISSN:
2326-2222
ISSN:
0193-7758
Pubs id:
pubs:686594
URN:
uri:7062ae2c-6c4a-4801-9706-b6d2e89fe2bf
UUID:
uuid:7062ae2c-6c4a-4801-9706-b6d2e89fe2bf
Local pid:
pubs:686594

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