Abstract：
:Research on interventions within the standard of care has enormous potential, yet it also raises several ethical and regulatory challenges. Perhaps the most important is determining what consent process is needed for these "pragmatic" clinical trials. Some argue that pragmatic clinical trials need to obtain in-depth research consent. This approach ensures that patients are informed, but may introduce substantial selection bias and disruption of clinical care. Others argue that trials limited to interventions within the standard of care do not need to obtain research consent at all. While this approach avoids the problems with in-depth consent, it results in patients not knowing whether they are in research. The present manuscript proposes a way to avoid both sets of concerns. It argues that consent for research needs to supplement appropriate consent for standard care only to the extent that the research differs from standard care. Hence, pragmatic trials designed to mirror clinical care can obtain consent with only minimal additions to consent for standard care. This conclusion suggests that it may be possible for many pragmatic trials to obtain consent that is ethically appropriate, satisfies research regulations, and does not introduce substantial selection bias or clinical disruption.
journal_name
J Gen Intern Medjournal_title
Journal of general internal medicineauthors
Wendler Ddoi
10.1007/s11606-014-3169-2subject
Has Abstractpub_date
2015-05-01 00:00:00pages
679-82issue
5eissn
0884-8734issn
1525-1497journal_volume
30pub_type
杂志文章,评审abstract：:Increasingly, oncology practitioners are realizing that despite the "success" of cancer therapies, cancer survivors are facing previously unrecognized issues related to survivorship, including physical and psychosocial side-effects of the cancer and its treatment, second cancers, and practical and economic issues rela...
journal_title：Journal of general internal medicine
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更新日期：2009-11-01 00:00:00
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更新日期：2010-07-01 00:00:00
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journal_title：Journal of general internal medicine
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journal_title：Journal of general internal medicine
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doi：
更新日期：2001-12-01 00:00:00
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pub_type： 杂志文章,评审
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更新日期：2015-01-01 00:00:00
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更新日期：2005-11-01 00:00:00
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更新日期：1999-08-01 00:00:00
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更新日期：2020-10-19 00:00:00
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pub_type： 杂志文章,随机对照试验
doi：10.1111/j.1525-1497.2006.00465.x
更新日期：2006-07-01 00:00:00
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journal_title：Journal of general internal medicine
pub_type： 杂志文章,评审
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更新日期：2011-07-01 00:00:00
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pub_type： 杂志文章
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更新日期：2008-01-01 00:00:00
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pub_type： 杂志文章
doi：10.1007/BF02596487
更新日期：1989-01-01 00:00:00
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更新日期：2010-10-01 00:00:00
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更新日期：2020-09-11 00:00:00
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更新日期：1998-12-01 00:00:00
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更新日期：2021-01-26 00:00:00
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更新日期：2011-11-01 00:00:00
