Parent Participation and Physician-Parent Communication During Informed Consent in Child Leukemia

PEDIATRICS ◽  
2011 ◽  
Vol 128 (6) ◽  
pp. peds.2010-3542d-peds.2010-3542d
Keyword(s):  
Informed Consent ◽  
Parent Participation ◽  
Parent Communication

scholarly journals Parent Participation and Physician-Parent Communication During Informed Consent in Child Leukemia

PEDIATRICS ◽  
2011 ◽  
Vol 128 (6) ◽  
pp. e1544-e1551 ◽  
Author(s):  
M. Cousino ◽  
R. Hazen ◽  
A. Yamokoski ◽  
V. Miller ◽  
S. Zyzanski ◽  
...  
Keyword(s):  
Informed Consent ◽  
Parent Participation ◽  
Parent Communication

scholarly journals Communicating and Understanding the Purpose of Pediatric Phase I Cancer Trials

2012 ◽  
Vol 30 (35) ◽  
pp. 4367-4372 ◽  
Author(s):  
Melissa K. Cousino ◽  
Stephen J. Zyzanski ◽  
Amy D. Yamokoski ◽  
Rebecca A. Hazen ◽  
Justin N. Baker ◽  
...  
Keyword(s):  
Informed Consent ◽  
Phase I ◽  
Drug Safety ◽  
Dose Escalation ◽  
Dose Finding ◽  
Clear Understanding ◽  
Ethical Challenges ◽  
Parent Communication ◽  
Cancer Trials ◽  
Scientific Purpose

Purpose Quality informed consent should provide a clear understanding of the purpose of the research. Given the ethical challenges of pediatric phase I cancer trials, it is important to investigate physician-parent communication during informed consent conferences (ICCs) and parental understanding of the purpose of these studies. Methods In the multisite Informed Consent in Pediatric Phase I Cancer Trials study, 85 ICCs for phase I research between June 2008 and May 2011 were directly observed, and 60 parents were subsequently interviewed. The scientific purpose was defined as composite understanding of drug safety, dose finding, and dose escalation. We determined the frequency with which physicians explained these and other phase I–related concepts during the ICC. Parent interviews were analyzed to determine understanding. Results The child was present at 83 of 85 ICCs. Only 32% of parents demonstrated substantial understanding of the scientific purpose of phase I cancer trials; 35% demonstrated little or no understanding. Parents of higher socioeconomic status and racial majority status were more likely to understand the scientific purpose. Factors associated with understanding included physician explanation of the goal of the applicable phase I protocol offered (explained in 85% of ICCs) and explanation of the dose cohorts (explained in 43% of ICCs). Physicians explained drug safety in 23% of ICCs, dose finding in 52% of ICCs, and dose escalation in 53% of ICCs. Conclusion Many parents of children participating in phase I trials do not understand the purpose of these trials. Physician-parent communication about the purpose of phase I research is lacking during ICCs.

scholarly journals Clinician–Parent Communication during Informed Consent for Pediatric Leukemia Trials

2005 ◽  
Vol 30 (3) ◽  
pp. 219-229 ◽  
Author(s):  
Victoria A. Miller ◽  
Dennis Drotar ◽  
Christopher Burant ◽  
Eric Kodish
Keyword(s):  
Informed Consent ◽  
Pediatric Leukemia ◽  
Parent Communication

scholarly journals An Observational Study of Children’s Involvement in Informed Consent for Exome Sequencing Research

2016 ◽  
Vol 12 (1) ◽  
pp. 6-13 ◽  
Author(s):  
Victoria A. Miller ◽  
Allison Werner-Lin ◽  
Sarah A. Walser ◽  
Sawona Biswas ◽  
Barbara A. Bernhardt
Keyword(s):  
Informed Consent ◽  
Observational Study ◽  
Exome Sequencing ◽  
Research Participation ◽  
Parent Communication ◽  
Child Participation

The goal of this study was to examine children’s involvement in consent sessions for exome sequencing research and associations of involvement with provider and parent communication. Participants included 44 children (8-17 years) from five cohorts who were offered participation in an exome sequencing study. The consent sessions were audiotaped, transcribed, and coded. Providers attempted to facilitate the child’s involvement in the majority (73%) of sessions, and most (75%) children also verbally participated. Provider facilitation was strongly associated with likelihood of child participation. These findings underscore that strategies such as asking for children’s opinions and soliciting their questions show respect for children and may increase the likelihood that they are engaged and involved in decisions about research participation.

Tools and Resources: Web Sites of Interest

2001 ◽  
Vol 6 (2) ◽  
pp. 6-8
Author(s):  
Christopher R. Brigham
Keyword(s):  
Informed Consent ◽  
Physical Examination ◽  
Functional Status ◽  
Web Sites ◽  
Satisfaction Survey ◽  
High Quality ◽  
Diagnostic Studies ◽  
Physician Relationship ◽  
Complete History

Abstract The AMA Guides to the Evaluation of Permanent Impairment (AMA Guides), Fifth Edition, explains that independent medical evaluations (IMEs) are not the same as impairment evaluations, and the evaluation must be designed to provide the data to answer the questions asked by the requesting client. This article continues discussions from the September/October issue of The Guides Newsletter and examines what occurs after the examinee arrives in the physician's office. First are orientation and obtaining informed consent, and the examinee must understand that there is no patient–physician relationship and the physician will not provide treatment bur rather will send a report to the client who requested the IME. Many physicians ask the examinee to complete a questionnaire and a series of pain inventories before the interview. Typical elements of a complete history are shown in a table. An equally detailed physical examination follows a meticulous history, and standardized forms for reporting these findings are useful. Pain and functional status inventories may supplement the evaluation, and the examining physician examines radiographic and diagnostic studies. The physician informs the interviewee when the evaluation is complete and, without discussing the findings, asks the examinee to complete a satisfaction survey and reviews the latter to identify and rectify any issues before the examinee leaves. A future article will discuss high-quality IME reports.

FDA Reviews One Informed Consent Rule

2006 ◽  
Vol 5 (12) ◽  
pp. 62
Author(s):  
ELIZABETH MECHCATIE
Keyword(s):  
Informed Consent

Informed Consent

2011 ◽  
Author(s):  
Deborah Bowman ◽  
John Spicer ◽  
Rehana Iqbal
Keyword(s):  
Informed Consent

Autonomy, Privacy and the Implementation of the Principle of Informed Consent with regard to the Nursing Interventions from the View of elderly People

Pflege ◽  
2001 ◽  
Vol 14 (1) ◽  
pp. 29-37 ◽  
Author(s):  
Anja Schopp ◽  
Theo Dassen ◽  
Maritta Välimäki ◽  
Helena Leino-Kilpi ◽  
Gerd Bansemir ◽  
...  
Keyword(s):  
Informed Consent ◽  
Elderly People ◽  
Ältere Menschen ◽  
Nursing Interventions ◽  
Patient’S Autonomy

Ziel dieser Untersuchung war die Autonomie, Privatheit und die Umsetzung des Prinzips der «informierten Zustimmung» aus der Perspektive des institutionell zu betreuenden, älteren Menschen zu beschreiben. Die Untersuchung ist ein Teil des durch die EU-Kommission unterstützten BIOMED 2 Projektes «Patient’s autonomy and privacy in nursing interventions»1. Interviewdaten (n = 95) wurden in deutschen Kliniken der Geriatrie und Pflegeheimen gesammelt. Ergebnisse zeigten, dass die Teilnehmer in geringem Maß selbstbestimmte Entscheidungen treffen konnten. Das Prinzip der «informierten Zustimmung» wurde wenig umgesetzt. Ihre Privatheit sahen die Teilnehmer in Mehrbettzimmern sowie in Situationen des Ankleidens und bei der Verrichtung der Ausscheidungen nicht respektiert. Es ist anzunehmen, dass ältere Menschen wegen Informationsdefiziten, durch ihren Hilfsbedarf und durch die festgelegten Organisationsstrukturen der Pflegeeinrichtungen eine passive Krankenrolle übernehmen. Es wäre denkbar, dass die Autonomie der älteren Menschen gefördert werden könnte, wenn die Pflegekräfte sie in der Rolle des Fürsprechers bei selbstbestimmten Entscheidungen unterstützen würden. Bei den pflegerischen Interventionen würde die Umsetzung des Prinzips der «informierten Zustimmung» sowohl die Autonomie als auch die Respektierung der Privatheit fördern. Es ist außerdem anzunehmen, dass durch Flexibilisierung der Organisationsstrukturen der Pflegeeinrichtungen die Autonomie und Lebensqualität der älteren Menschen gefördert werden könnte.

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