The quality of parental consent for research with children: A prospective repeated measure self-report survey
International Journal of Nursing StudiesPublished 20 May 2006
Linda S. Franck, Ira Winter, Kate Oulton
Citations33
SJR quartileQ1
SJR score2.82
SNIP3.21
Generate an AI Snapshot to get a quick, structured summary of this paper.
Study Snapshot
ObjectiveStudy objective
MethodsResearch methodology
PopulationPopulation studied
Sample sizeSample sizes
OutcomesStudy outcomes here
ResultsStudy results comes here
LimitationsResearch study limitations comes here
A concise AI-generated summary of the paper will appear here once you click Generate AI Snapshot.
TL;DR
These findings support and extend previous research on parental consent for research with children and suggest areas where further research is indicated, including: the value and use of information and consent documents given to parents, the views and concerns of parents for whom English is not their first language, and further exploration of the concerns of the few dissatisfied parents.
Abstract
These findings support and extend previous research on parental consent for research with children. They suggest areas where further research is indicated, including: the value and use of information and consent documents given to parents, the views and concerns of parents for whom English is not their first language, and further exploration of the concerns of the few dissatisfied parents. Current practices of obtaining informed consent for research lack supporting research evidence and may not be ethically justifiable.
Keywords
Social SciencesMedicine
Oxford University Press eBooksWorld Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects
10,820 Citations2003Rebecca J. Cook, Bernard M. Dickens +1 more
This resolution is to be adopted by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013 on the theme of human rights and democracy.
Social Science & MedicineMaking sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial
296 Citations1997Claire Snowdon, Jo Garcia +1 more
The views of parents who consented that their critically ill newborn baby should be enrolled in a neonatal trial are described to advance understanding of the perceptions of trial participants and raise important issues for those concerned with RCTs.
The LancetObtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study
189 Citations2000Su A Mason, Peter Allmark
Current standards of informed consent to neonatal research projects could be improved and little support was found for the argument that informed consent should be relinquished for the parents' own good.
The Journal of PediatricsParents' attitudes to children's participation in randomized controlled trials
189 Citations2003Patrina Caldwell, Phyllis Butow +1 more
Journal of Pain and Symptom ManagementProbing the Paradox of Patients' Satisfaction with Inadequate Pain Management
144 Citations2002Ree Dawson, Judith A. Spross +4 more
Social Science & MedicineParental perceptions and attitudes about informed consent in clinical research involving children
143 Citations1995S. C. HARTH, Y.H. Thong
There may be significant attitudinal barriers to parental understanding of the informed consent process, and a significant minority offered the view that the strict informed consent procedures followed were unnecessary because they would do what the doctor advised.
Archives of Disease in ChildhoodInformed consent, parental awareness, and reasons for participating in a randomised controlled study
132 Citations1998Margriet van Stuijvenberg, Marja H. Suur +5 more
Parents’ understanding of trial characteristics might be improved by designing less difficult informed consent forms and by the investigator giving extra attention and information to non-west European parents.
AnesthesiologyDo They Understand? (Part I)
128 Citations2003Alan R. Tait, Terri Voepel‐Lewis +1 more
Parents approached for permission to allow their child to participate in a research study had less than optimal understanding of the elements of consent, and investigators must make every effort to enhance understanding.
Archives of Disease in Childhood Fetal & NeonatalConsent for clinical research in the neonatal intensive care unit: a retrospective survey and a prospective study
103 Citations2003Ellen Burgess, N Singhal +3 more
Overall the parents did not support the suggestion that decision making about enrolment for research in the neonatal intensive care unit be taken away from parents and put into the hands of doctors.
Archives of Disease in Childhood Fetal & NeonatalNeonatal research: the parental perspective
91 Citations2004Benjamin J. Stenson, J-C Becher +1 more
A significant proportion of parents who give written consent for a trial in the early neonatal period do not later remember having done so and parents who have had experience of neonatal research would be unhappy for their baby to be enrolled in a study that had ethics committee approval without their consent being obtained.
Critical Care MedicineResearch in children
86 Citations2003Jeffrey P. Burns
These guidelines represent a return of the pendulum to a more moderate position, after an era of restrictive regulations in reaction to past abuses of children as research subjects.
Journal of Clinical OncologyGroups Potentially at Risk for Making Poorly Informed Decisions About Entry into Clinical Trials for Childhood Cancer
84 Citations2003Christian Simon, Stephen J. Zyzanski +4 more
This research hypothesizes that factors such as social and educational status and the role of language interpreters may account for significant differences in the discussion and understanding of an RCT among the three groups of non-English-speaking Latino parents of children with leukemia.
European Journal of PediatricsEthical principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP)
78 Citations2004Denis Gill
There is a need in paediatrics for better evidence based practice founded on quality research into efficacy and safety of children’s medications and good clinical practice in paediatric research demands that studies comply with the Declaration of Helsinki, ICH topic E11, EU Directives and other relevant international guidelines.
The Journal of PediatricsConventional consent with opting in versus simplified consent with opting out: An exploratory trial for studies that do not increase patient risk
70 Citations1998C.G. Rogers, Jon E. Tyson +3 more
The modified approach may improve communication and facilitate studies judged by the Institutional Review Board to be risk-neutral or risk-reducing and further evaluation of a modified consent procedure for such studies is warranted.
Anesthesia & AnalgesiaFactors That Influence Parents' Decisions to Consent to Their Child's Participation in Clinical Anesthesia Research
61 Citations1998Alan R. Tait, Terri Voepel‐Lewis +2 more
Perceived risk and the importance of the study were the primary factors in the parents' decisions to consent or decline, and only 2.8% of nonconsenters strongly considered a lack of privacy as a deciding factor.
Pediatric AnesthesiaPriorities for disclosure of the elements of informed consent for research: a comparison between parents and investigators
56 Citations2002Alan R. Tait, Terri Voepel‐Lewis +2 more
This study examines and compares the priorities for disclosure of the elements of informed consent between parents of paediatric research subjects and investigators and concludes that disclosure is a key element of the informed consent process.
Guidelines for the ethical conduct of medical research involving children
52 Citations2000Neil McIntosh
IRB Ethics and Human ResearchConducting Empirical Research on Informed Consent: Challenges and Questions
47 Citations2003Greg A. Sachs, Gavin W. Hougham +12 more
The informed consent projects (ICPs) the authors describe here were designed to produce new and improved methods for the informed consent process, methods for confronting the challenges of obtaining consent for special or vulnerable populations, and data to help inform and guide public policy development.
Anesthesia & AnalgesiaFactors That Influence Parents' Decisions to Consent to Their Child's Participation in Clinical Anesthesia Research
42 Citations1998Alan R. Tait, Terri Voepel‐Lewis +2 more
Journal of Family NursingChildren in Research: Informed Consent and Critical Factors Affecting Mothers
35 Citations2001Pamela K. Pletsch, Patricia E. Stevens
Results suggest four critical factors that differentiated and defined mothers’ informed consent experiences: immediacy of the threat to the life of the child, trajectory of illness-related events, opportunities for autonomy, and expertise of mothers in managing their child’s illness and in negotiating the health care system.
Pediatric ResearchPediatric Research Hospitalization: Its Meaning to Parents
33 Citations1969Audrey T. McCollum, A. Herbert Schwartz
It was concluded from this study that if informed parental consent is sought, there are four questions on which the parents and physicians should concentrate: In what ways do the proposed studies constitute research as distinct from diagnosis and treatment?
European Journal of PediatricsResearch in children. A report of the Ethics Working Group of the CESP
29 Citations2001Pieter J.J. Sauer
Research in children is acceptable if it is necessary to promote the health of the population represented and cannot be performed on legally competent persons instead.
AnaesthesiaConsent to clinical trials in anaesthesia
28 Citations1998Jane Montgomery, J. Robert Sneyd
It is concluded that increasing the amount and complexity of information does not alter patient satisfaction and patients were content with the way they were approached when asked for consent for clinical trials.
PubMedBabies and consent: yet another NHS scandal. But it should lead to improvements in research governance within the NHS.
25 Citations2000Richard Smith
PEDIATRICSThe Social Filter Effect of Informed Consent in Clinical Research
16 Citations1991Y.H. Thong, S. C. HARTH
The doctrine of informed consent has four essential components: there must be full disclosure of risks and benefits and the therapeutic alternatives, and the information must be provided in writing in an easily comprehensible form.
The Journal of PediatricsA policy regarding research in healthy children
12 Citations1993Samuel S. Gidding, Diana Camp +5 more
In reviewing pediatric research projects, the institutional review board must take into account developmental changes from birth to adolescence, assent to participation, response to pain or stress, and appropriateness of a proposed intervention in addition to the worth of the proposed research.
Clinical Governance An International JournalConsent for paediatric surgery: what are the risks?
6 Citations2004Suzette Woodward, Linda S. Franck +1 more
Evidence is provided which supports the need for this consistent approach across the NHS which emphasises the effective communication of risks and benefits in relation to proposed treatment.