Cargando…

Participant Informed Consent in Cluster Randomized Trials: Review

BACKGROUND: The Nuremberg code defines the general ethical framework of medical research with participant consent as its cornerstone. In cluster randomized trials (CRT), obtaining participant informed consent raises logistic and methodologic concerns. First, with randomization of large clusters such...

Descripción completa

Detalles Bibliográficos
Autores principales:	Giraudeau, Bruno, Caille, Agnès, Le Gouge, Amélie, Ravaud, Philippe
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Public Library of Science 2012
Materias:	Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3391275/ https://www.ncbi.nlm.nih.gov/pubmed/22792319 http://dx.doi.org/10.1371/journal.pone.0040436

Ejemplares similares

Peer Review of Grant Applications: A Simple Method to Identify Proposals with Discordant Reviews
por: Giraudeau, Bruno, et al.
Publicado: (2011)

Propensity score to detect baseline imbalance in cluster randomized trials: the role of the c-statistic
por: Leyrat, Clémence, et al.
Publicado: (2016)

Planning a cluster randomized trial with unequal cluster sizes: practical issues involving continuous outcomes
por: Guittet, Lydia, et al.
Publicado: (2006)

A priori postulated and real power in cluster randomized trials: mind the gap
por: Guittet, Lydia, et al.
Publicado: (2005)

Preventing Bias in Cluster Randomised Trials
por: Giraudeau, Bruno, et al.
Publicado: (2009)

Intervention effect estimates in cluster randomized versus individually randomized trials: a meta-epidemiological study
por: Leyrat, Clémence, et al.
Publicado: (2019)

Heterogeneous perception of the ethical legitimacy of unbalanced randomization by institutional review board members: a clinical vignette-based survey
por: Dibao-Dina, Clarisse, et al.
Publicado: (2018)

Reporting of sample size calculation in randomised controlled trials: review
por: Charles, Pierre, et al.
Publicado: (2009)

Mechanical cervicAl ripeninG for women with PrOlongedPregnancies (MAGPOP): protocol for a randomised controlled trial of a silicone double balloon catheter versus the Propess system for the slow release of dinoprostone for cervical ripening of prolonged pregnancies
por: Diguisto, Caroline, et al.
Publicado: (2017)

Mixing Nulliparous and Multiparous Women in Randomised Controlled Trials of Preeclampsia Prevention Is Debatable: Evidence from a Systematic Review
por: Simon, Emmanuel, et al.
Publicado: (2013)

Informed consent in critically ill adults participating to a randomized trial
por: Guinchard, Milène, et al.
Publicado: (2020)

When is informed consent required in cluster randomized trials in health research?
por: McRae, Andrew D, et al.
Publicado: (2011)

Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial
por: Barnes, Caroline, et al.
Publicado: (2015)

Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials
por: Taljaard, Monica, et al.
Publicado: (2011)

Blockchain protocols in clinical trials: Transparency and traceability of consent
por: Benchoufi, Mehdi, et al.
Publicado: (2018)

Written Informed Consent for Participation in a Study and Reduction in Consent Rate
por: Tamakoshi, Akiko, et al.
Publicado: (2008)

Heterogeneity in pragmatic randomised trials: sources and management
por: Giraudeau, Bruno, et al.
Publicado: (2022)

Motivation to participate and experiences of the informed consent process for randomized clinical trials in emergency obstetric care in Uganda
por: Kaye, Dan Kabonge
Publicado: (2021)

Interactive Informed Consent: Randomized Comparison with Paper Consents
por: Rowbotham, Michael C., et al.
Publicado: (2013)

Intervention effect estimates in randomised controlled trials conducted in primary care versus secondary or tertiary care settings: a meta-epidemiological study
por: Dugard, Amandine, et al.
Publicado: (2022)

Informed consent in cluster randomised trials: a guide for the perplexed
por: Nix, Hayden P, et al.
Publicado: (2021)

Participants’ understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis
por: Tam, Nguyen Thanh, et al.
Publicado: (2015)

Quality of Reporting of Bioequivalence Trials Comparing Generic to Brand Name Drugs: A Methodological Systematic Review
por: van der Meersch, Amélie, et al.
Publicado: (2011)

A survey of study participants’ understanding of informed consent to participate in a randomised controlled trial of acupuncture
por: Smith, Caroline A., et al.
Publicado: (2016)

Blockchain, consent and prosent for medical research
por: Porsdam Mann, Sebastian, et al.
Publicado: (2021)

Co-creation with research participants to inform the design of electronic informed consent
por: De Sutter, Evelien, et al.
Publicado: (2022)

Women’s experiences of receiving information about and consenting or declining to participate in a randomized controlled trial involving episiotomy in vacuum-assisted delivery: a qualitative study
por: Ericson, Jenny, et al.
Publicado: (2021)

Visualising the risks of clinical trials for fair treatment and appropriate informed consent of participants
por: Harris, Alexander R., et al.
Publicado: (2022)

Dead space closure with quilting suture versus conventional closure with drainage for the prevention of seroma after mastectomy for breast cancer (QUISERMAS): protocol for a multicentre randomised controlled trial
por: Ouldamer, Lobna, et al.
Publicado: (2016)

Informed Consent Process: Foundation of the Researcher-participant Bond
por: Sil, Amrita, et al.
Publicado: (2017)

The Open Brain Consent: Informing research participants and obtaining consent to share brain imaging data
por: Bannier, Elise, et al.
Publicado: (2021)

Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting
por: Addissie, Adamu, et al.
Publicado: (2016)

A multimedia consent tool for research participants in the Gambia: a randomized controlled trial
por: Afolabi, Muhammed Olanrewaju, et al.
Publicado: (2015)

Could the Decision of Trial Participation Precede the Informed Consent Process? Evidence From Burkina Faso
por: Paré Toe, Lea, et al.
Publicado: (2013)

Patient and Proxy Recall After Providing Written or Oral Informed Consent to Participate in an Interventional Trial
por: Huttner, Angela, et al.
Publicado: (2022)

Using an informed consent in mammography screening: a randomized trial
por: Baena‐Cañada, José M., et al.
Publicado: (2015)

A randomized trial of multimedia-facilitated informed consent for cataract surgery
por: Vo, Thomas A, et al.
Publicado: (2018)

Taking part in a pharmacogenetic clinical trial: assessment of trial participants understanding of information disclosed during the informed consent process
por: Rose, Diana, et al.
Publicado: (2013)

An evaluation of the process of informed consent: views from research participants and staff
por: O’ Sullivan, Lydia, et al.
Publicado: (2021)

A Booklet on Participants’ Rights to Improve Consent for Clinical Research: A Randomized Trial
por: Benatar, Jocelyne R., et al.
Publicado: (2012)

Cannot write session to /tmp/vufind_sessions/sess_vvhmnq9a9htsm63m61fpl7ii6p