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

Rebers, Susanne; Aaronson, Neil K.; Leeuwen, Flora E. van; Schmidt, Marjanka K.

doi:10.1186/s12910-016-0092-6

Cited by 48 publications

(44 citation statements)

References 120 publications

(251 reference statements)

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“…However, it is argued that in pragmatic trials with high social value, and with low risk or no risk, a waiver of informed consent should be considered ethically acceptable (43). Another argument is that a waiver of consent might be acceptable in intervention studies, in cases where bias is likely to occur (44).…”

Section: The Data Collectorsmentioning

confidence: 99%

“…The Zelen design involving obtaining consent from participants after randomization has been suggested to minimize these kind of threats in RCTs (45). Only those who had been randomized to the experimental group would then be asked to consent to participation in the trial, while the controls would remain uninformed (44)(45)(46). In a modified two-stage consent design, those assigned to the control group would receive the usual care, and they would know that other people received different care, but without knowing what that care entailed (47).…”

Section: The Data Collectorsmentioning

confidence: 99%

See 1 more Smart Citation

Control Group Design in a Complex Intervention Study: Challenges, Dilemmas and Possible Solutions

Mangset¹,

Kitzmüller²,

Evju³

et al. 2020

Preprint

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Background The use of a control group is one of the most critical components of an RCT. The control conditions may change over time and include assessment interviews and standard stroke treatment. Therefore, the control group should be monitored and described in as much detail as the intervention group. It is important to find ways to reduce the risk of study-induced influence on the members of the control group. The aim of this study was to explore the possible influence of the assessment interviews on the adjustment of the members of a control group in an RCT exploring psychosocial well-being following stroke. Methods Fifteen participants in the control group of the RCT, six women and nine men, aged 29-88 years, were interviewed in narrative semi-structured interviews. Ricoeur’s interpretation theory guided the analysis. Results The perceived influence of the assessment interviews on the control group varied considerably. Two different themes with subthemes were identified, describing the influence of the assessment interviews in the control group. Theme one described how participants emphasized the perceived influence of the assessment interviews that served as a safety net, enhanced their awareness and understanding, facilitated their adjustment after stroke, encouraged them to seek support, and allowed them to vent their disappointment of having been allocated to the control group. Theme two described participants’ experiences of handling their adjustment process on their own without describing any influence of the assessment interviews on their condition. These participants highlighted mild strokes, spontaneous recovery, setting own goals, support from family and friends and supporting research. Conclusions In view of the design challenges in RCTs, it seems important to explore in depth how to design assessment interviews with control group members without introducing risk of bias, and to uphold rigor and stringency in the trials.

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Section: The Data Collectorsmentioning

confidence: 99%

Section: The Data Collectorsmentioning

confidence: 99%

Control Group Design in a Complex Intervention Study: Challenges, Dilemmas and Possible Solutions

Mangset¹,

Kitzmüller²,

Evju³

et al. 2020

Preprint

View full text Add to dashboard Cite

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“…The Ethics Committee of the University Hospital Centre Zagreb approved this research as a non-sponsored prospective epidemiological study. Considering the design of the study and possible exceptions to the rule of informed consent [26], the informed consent was waived for the present study. Pneumonia was the most frequent infection (87 patients, 67.4%), followed by intra-abdominal infections (13 patients, 10%), and urinary tract infections (10 patients, 7.8%), 16 patients (14.8%) had another source of infection (endocarditis, soft tissue, bone).…”

Section: Methodsmentioning

confidence: 99%

Utility of procalcitonin in a medical intensive care unit in Croatia

Brajković

Košuta

Tomek

et al. 2020

Wien Klin Wochenschr

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Aims To investigate the clinical benefit of routine procalcitonin (PCT) measurement in the medical intensive care unit (ICU) of a tertiary referral hospital. Methods Adult patients with suspected infections were included. White blood cells, C-reactive protein (CRP), and PCT were measured. Results In this study 129 patients of median age 64 years (interquartile range 39-89 years) were prospectively included. The Acute Physiology And Chronic Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) scores were 21 ± 14 and 7 ± 6, respectively. Intensive care unit (ICU) mortality was 22.5%. Immunocompromised patients constituted 39.5%. A significant correlation was observed between PCT and APACHE II (Spearman's rho 0.461, p < 0.01), PCT and SOFA (Spearman's rho 0.494, p < 0.01) and PCT and CRP (Spearman's rho 0.403, p < 0.01). Most patients (n = 83, 64.3%) received antibiotics before admission. No difference in PCT (1.56 ± 8 µg/L vs. 1.44 ± 13 µg/L, p = 0.6) was observed with respect to previous antibiotic therapy. Levels of PCT and CRP were significantly increased in patients with positive blood cultures, the

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“…There is public support for recruitment of participants to clinical trials in emergency settings (Furyk et al, ; Rebers, Aaronson, Leeuwen, & Schmidt, ), and changes have been made to research regulations to make the process more straightforward (Medicines for Human Use [Clinical Trials] Regulations 2004—Amendmentsand, , ), including consent exception or waiver in the USA (FDA, ). However, researchers struggle to meet recruitment targets.…”

Section: Introductionmentioning

confidence: 99%

What are research nurses' experiences of obtaining consent from or for patients participating in emergency care research? A qualitative review

Brown

Hewison

Newham

2019

Journal of Clinical Nursing

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Introduction If studies are to be valid, recruitment of representative samples is essential. In 2012, 28% of UK emergency departments met the 80% standard for recruitment to trials set by the National Institute for Health Research. Research nurses play a vital role in the conduct of high‐quality research, and it has been argued that dedicated research nurses are needed if clinical trials are to recruit successfully to target. Review question What are research nurses' experiences of obtaining consent from or for patients participating in emergency care research? A qualitative evidence review. Methods A qualitative integrative literature review with a narrative synthesis of the evidence. PRISMA guidelines for reporting systematic qualitative reviews (Appendix S1) were followed. A search of five electronic databases was performed in December 2018 along with a hand search which yielded 125 citations: 10 papers and one PhD thesis met the review eligibility criteria. Methodological quality of the selected studies was evaluated, and data were extracted and synthesised. Results Three themes were identified: Access, Organisation and Timing. Research nurses encountered both general and specific barriers when seeking to obtain consent for participation in research. In particular, it was found there was lack of experience among staff of working in emergency research and with securing deferred consent. The distinction between nurse researchers with a clinical role and those dedicated to solely to research only is often not clear and warrants further investigation. Conclusion Nurse researchers with and without a clinical role can make a positive difference in recruitment to trials in emergency care. The involvement of dedicated research nurses in the consent process can increase recruitment to emergency care research. Experience of recruiting to clinical trials in nonemergency settings does not seem to help when recruiting for trials in emergency care. Relevance to clinical practice There is a need for greater understanding of the experiences of dedicated research nurses in emergency care settings and in particular with regard to deferred consent.

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

Cited by 48 publications

References 120 publications

Control Group Design in a Complex Intervention Study: Challenges, Dilemmas and Possible Solutions

Control Group Design in a Complex Intervention Study: Challenges, Dilemmas and Possible Solutions

Utility of procalcitonin in a medical intensive care unit in Croatia

What are research nurses' experiences of obtaining consent from or for patients participating in emergency care research? A qualitative review

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