Food and Drug Administration Public Hearing on the Draft Guidance for Exception from Informed Consent Requirements for Emergency Research: Testimony of Novo Nordisk

Weiskopf, Richard B.

doi:10.1197/j.aem.2006.12.001

Cited by 2 publications

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“…Many of the reviewed articles refer to conditions in official regulations [ 1 , 5 , 6 , 23 , 32 , 34 , 36 , 37 , 39 , 45 , 49 , 52 , 53 , 55 – 57 , 60 , 61 , 64 , 65 , 68 – 70 , 73 , 74 , 76 , 77 , 80 – 83 , 85 , 86 , 88 , 95 , 101 , 103 , 107 – 112 ], such as the ‘Final Rule’ of the U.S. Food and Drug Administration (FDA). The FDA amended its informed consent regulations in 1996 in order to ensure that emergency research could be carried out without informed consent in certain situations.…”

Section: Resultsmentioning

confidence: 99%

“…The practical problems with informed consent, especially those in emergency research [ 1 , 34 , 39 , 49 , 63 , 84 , 85 , 99 , 108 , 117 ], are thought to lead to ethical problems as well. For instance, it is considered to be unethical to delay treatment initiation because of an informed consent procedure when it is expected that this delay will adversely affect treatment outcome.…”

Section: Resultsmentioning

confidence: 99%

“…Risk-benefit analyses sometimes also include benefits on the broader societal level. Some then argue that not asking informed consent may be the most ethically correct thing to do, because it is beneficial for future patients or for society as a whole [ 3 , 35 , 39 , 41 , 54 , 57 , 63 , 76 , 84 , 85 , 108 , 118 – 121 ]. Informed consent might, for example, prevent or delay progress being made in critical clinical situations which, in turn, could lead to increased mortality or disability, such as in traumatic brain injury [ 34 , 40 , 41 , 55 , 57 , 61 , 68 , 71 , 108 ].…”

Section: Resultsmentioning

confidence: 99%

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Exceptions to the rule of informed consent for research with an intervention

et al. 2016

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BackgroundIn specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent.MethodsHere, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy.ResultsWe identified three main categories of arguments for the acceptability of a consent waiver: data validity and quality, major practical problems, and distress or confusion of participants. Approval by a medical ethical review board always needs to be obtained. Further, we provide examples of specific conditions under which consent waiving might be allowed, such as additional privacy protection measures.ConclusionsThe reasons legitimized by the authors of the papers in this overview can be used by researchers to form their own opinion about requesting an exception to the rule of informed consent for their own study. Importantly, rules and guidelines applicable in their country, institute and research field should be followed. Moreover, researchers should also take the conditions under which they feel an exception is legitimized under consideration. After discussions with relevant stakeholders, a formal request should be sent to an IRB.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Exceptions to the rule of informed consent for research with an intervention

et al. 2016

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Getting the Ethics Right Regarding Research in the Emergency Setting: Lessons from the PolyHeme Study

Dickert¹,

Sugarman²

2007

ken

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Research in emergency settings (RES) has become a major public issue with urgent policy implications. Significant attention has focused recently on RES in response to the trial of PolyHeme, a synthetic blood substitute, in trauma victims in hemorrhagic shock. Unfortunately, the discussion of the PolyHeme trial in the popular and scholarly press leaves important questions unanswered. This paper articulates three important lessons from the PolyHeme trial that have significant policy implications. First, the RES regulations should be re-visited, particularly the requirement that existing treatments be unproven or unsatisfactory in order for research to be acceptable without consent. Second, further conceptual and empirical scholarship is needed to accomplish the goal of effectively involving communities. Third, a more subtle analysis is needed regarding how to balance the needs of maintaining public trust and protecting confidential trade information in the context of RES.

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Food and Drug Administration Public Hearing on the Draft Guidance for Exception from Informed Consent Requirements for Emergency Research: Testimony of Novo Nordisk

Cited by 2 publications

References 0 publications

Exceptions to the rule of informed consent for research with an intervention

Exceptions to the rule of informed consent for research with an intervention

Getting the Ethics Right Regarding Research in the Emergency Setting: Lessons from the PolyHeme Study

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