Fitting a routine health-care activity into a randomized trial: An experiment possible without informed consent?

Winkens, Ron; Knottnerus, J. A.; Kester, A.D.M.; Grol, Richard; Pop, P.

doi:10.1016/s0895-4356(96)00422-2

Cited by 20 publications

(19 citation statements)

References 6 publications

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“…Such a design might provide more accurate answers to the problem of the magnitude of the nonspecific effects. Moreover, we did not handle other nonspecific effects, such as the fact that contact between intervention and control physicians can influence outcome, as physicians talk about the quality strategy under study, an effect commonly known as across subject contamination effect or leaking effect [8,25]. We assume that this effect is not particularly great, because GPs normally do not discuss test-ordering performance among themselves and the teams were located in different regions.…”

Section: Discussionmentioning

confidence: 99%

Block design allowed for control of the Hawthorne effect in a randomized controlled trial of test ordering

Verstappen¹,

Weijden²,

Riet³

et al. 2004

Journal of Clinical Epidemiology

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Section: Discussionmentioning

confidence: 99%

Block design allowed for control of the Hawthorne effect in a randomized controlled trial of test ordering

Verstappen¹,

Weijden²,

Riet³

et al. 2004

Journal of Clinical Epidemiology

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“…The first was of feedback to physicians on test ordering behavior; in this case, the rationale for omitting informed consent was not clearly stated, and potential antecedent proposals such as Truog's were not cited. 30 The second was of intercessory prayer; in this case an IRB waiver was granted because of the classification of the study as having no known risk, no additional burden from data collection, and the potential for informed consent process to cause anxiety. 31 After discussion among the co-authors, both of these designs were classified as examples of a low-risk pragmatic RCT without consent (as more explicitly described in the Truog and Faden proposals).…”

Section: Designs That Omit Informed Consent Entirelymentioning

confidence: 99%

“…The first was of feedback to physicians on test ordering behavior; in this case, the rationale for omitting informed consent was not clearly stated, and potential antecedent proposals such as Truog's were not cited. 30 The second was of intercessory prayer; in this case an IRB waiver was granted because of the classification of the study as having no known risk, no Figure 1 Schematic depiction of proposals to randomize prior to obtaining informed consent to randomization from all participants. Rectangles represent consent; shaded rectangles represent discussion specifically of randomization.…”

Section: Designs That Omit Informed Consent Entirelymentioning

confidence: 99%

Proposals to Conduct Randomized Controlled Trials Without Informed Consent: a Narrative Review

2016

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BACKGROUND: Individual informed consent from all participants is required for most randomized clinical trials (RCTs). However, some exceptions-for example, emergency research-are widely accepted. METHODS: The literature on various approaches to randomization without consent (RWOC) has never been systematically reviewed. Our goal was to provide a survey and narrative synthesis of published proposals for RWOC. We focused on proposals to randomize at least some participants in a study without first obtaining consent to randomization. This definition included studies that omitted informed consent entirely, omitted informed consent for selected patients (e.g., the control group), obtained informed consent to research but not to randomization, or only obtained informed consent to randomization after random assignment had already occurred. It omitted oral and staged consent processes that still obtain consent to randomization from all participants before randomization occurs. RESULTS: We identified ten different proposals for RWOC: two variants of cluster randomization, two variants of the Zelen design, consent to postponed information, two-stage randomized consent, cohort multiple RCT, emergency research, prompted optional randomization trials, and low-risk pragmatic RCTs without consent. CONCLUSION: Of all designs discussed here, only cluster randomized designs and emergency research are routinely used, with the justification that informed consent is infeasible in those settings. Other designs have raised concerns that they do not appropriately respect patient autonomy. Recent proposals have emphasized the importance for RWOC of demonstrating such respect through systematic patient engagement, transparency, and accountability, potentially in the context of learning health care systems. INTRODUCTIONRandomized controlled trials (RCTs) are the gold standard for clinical research. 1 Informed consent, including disclosure of randomization, is an ethical requirement for most RCTs. 2 This principle, intended to protect participants' autonomy and dignity, is firmly embedded in guidelines and regulations. [3][4][5][6] But, critics have argued that modern consent processes often fail to convey information well, can confuse or distress participants, and may even hinder legitimate research endeavors to the point where patients are paradoxically harmed by the lack of research on the safety and effectiveness of commonly used therapies. 7,8 These arguments have led to calls to relax or eliminate informed consent requirements in certain circumstances. An example is the exception for emergency medicine studies in which it is deemed impossible to obtain informed consent and still test an emergent intervention. 9 More broadly, US Federal regulations allow a waiver of informed consent requirements for clinical research given that four requirements are met: (1) Bthe research involves no more than minimal risk to the subjects,^(2) Bthe waiver or alteration will not adversely affect the rights and welfare of the subjects,^(3) Bthe researc...

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“…Es ist umstritten, ob bei Studien in der Routineversorgung ohne zusätzliche Datenerfassung auf eine Aufklärung und Einverständnis-erklärung der individuellen Patienten evtl. verzichtet werden kann [9]. Werden zusätzliche Patientendaten erhoben ist auf jeden Fall eine doppelte Einwilligung (Praxis und Patienten) notwendig.…”

Section: Ethische Problemeunclassified

“…Intraclusterkorrelationskoeffizient (ICC oder manchmal auch r) ausgedrückt werden [11]. Die Varianz ist die Streuung oder Verteilung des Studienendpunkts in einem Studienarm oder Cluster [9]. Es gibt mehrere Formeln zur Berechnung des ICC.…”

Section: Der Intraclusterkorrelationskoeffizientunclassified

Cluster-randomisierte Studien: eine wichtige Methode in der allgemeinmedizinischen Forschung

Chenot

2009

Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheit

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Fitting a routine health-care activity into a randomized trial: An experiment possible without informed consent?

Cited by 20 publications

References 6 publications

Block design allowed for control of the Hawthorne effect in a randomized controlled trial of test ordering

Block design allowed for control of the Hawthorne effect in a randomized controlled trial of test ordering

Proposals to Conduct Randomized Controlled Trials Without Informed Consent: a Narrative Review

Cluster-randomisierte Studien: eine wichtige Methode in der allgemeinmedizinischen Forschung

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