Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

Weide, Marijke C. Jansen-van der; Young, Bridget; Vries, Martine C. de; Willems, Dick L.; Hoff, William van’t; Woolfall, Kerry; Lee, Johanna H. van der; Offringa, Martin

doi:10.1542/peds.2014-3402

Cited by 31 publications

(28 citation statements)

References 39 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Considering children's rights as research and educational subjects in the field of pediatrics, prevention of ethical challenges in this regard was another finding of the present research; findings of other studies have also confirmed this issue (31,32).…”

Section: Referrals or Unnecessary Actions To Obtain Personal And Finasupporting

confidence: 79%

Ethical Challenges in Pediatrics from the Viewpoints of Iranian Pediatric Residents

et al. 2017

View full text Add to dashboard Cite

Background: Some ethical challenges have emerged along with advances within the field of pediatrics. Meanwhile, the residents of pediatrics face particular ethical challenges, since they have different roles in their professional career as educators, students, advocators, and clinicians. Objectives: The aim of the present study was to identify ethical challenges in the field of pediatrics from the viewpoints of Iranian pediatric residents Methods: This cross-sectional study was conducted during 9 months. The studied population consisted of 90 residents of pediatrics studying at Tehran University of Medical Sciences in Tehran, capital of Iran. Sampling was conducted in the form of census counts of a 32-item instrument that evaluated ethical challenges in the field of pediatrics. Validity and reliability of this questionnaire were evaluated by experts in the field of medical ethics and pediatrics. Data were analyzed using the SPSS software using descriptiveanalytic statistic methods. Results: The most serious ethical challenges in the field of pediatrics were providing enough information to obtain informed consent (4.74 ± 0.22), dealing effectively with the conflicts of decision-making by the sick children and their families (4.68 ± 0.14), giving bad news to the sick children or their parents as appropriately as possible (4.64 ± 0.18), and taking necessary actions in dealing with cases of child maltreatment (4.62 ± 0.16), respectively. In addition, based on linear regression analysis, there was a significant correlation (P = 0.03, r = 0.059) between the residents' gender and their views towards ethical conflicts; female residents paid more attention to these challenges than male residents. Conclusions: Paying attention to ethical challenges in the field of pediatrics helps the authorities provide favorable conditions in clinical settings. Therefore, resulting in less ethical challenges in similar situations.

show abstract

Section: Referrals or Unnecessary Actions To Obtain Personal And Finasupporting

confidence: 79%

Ethical Challenges in Pediatrics from the Viewpoints of Iranian Pediatric Residents

et al. 2017

View full text Add to dashboard Cite

show abstract

“…However, these parents would be concerned about not seeking prior consent in trials involving either "new" drug interventions or other potentially significant changes in clinical practice. Last, a report from a European group of pediatric clinical researchers described a new framework for informed consent processes under different time constraints [13], which will be applicable to PICU studies.…”

Section: New Methodologies For Enhancing Patient Recruitment To Rctsmentioning

confidence: 99%

Focus on paediatrics

2016

View full text Add to dashboard Cite

“…Ensuring that parents are fully informed and can actively give permission for infants to participate in research is mandatory, but there is uncertainty and debate about how to best integrate these processes in pragmatic studies [7, 8]. For non-urgent interventions, parents may be approached at a time that suits them and be given sufficient opportunity and support to process information about the study aims, design, requirements, and possible benefits and risks.…”

Section: Consent In the Acute Care Settingmentioning

confidence: 99%

Ethical Issues in Perinatal Clinical Research

2019

View full text Add to dashboard Cite

Background: Perinatal clinical research to improve the quality of care and outcomes for newborn infants relies on transparency, trust, and respect for the autonomy and well-being of study participants and their families. Methods: Here we consider the underpinning principles of ethical research with a focus on perinatal clinical research in the acute care or emergency setting where particular challenges to parental engagement and informed consent exist. Results: Several approaches to improving the validity of the consent process for perinatal research have been proposed and evaluated. These include consent waiver, antenatal consent, deferred consent preceded by verbal assent, and continuous consent. These have strengths and weaknesses and uncertainty remains about their validity and acceptability in certain research contexts. Prior exploration with parents and parent-advocacy groups of approaches to engagement and consent, and independent evaluation and ongoing monitoring of research studies, can enhance adherence to the ethical principles of justice and autonomy, and ensure that benefits to participants and their families exceed harm. Conclusions: High-quality research and ethics are interdependent. Only research that meets ethical standards can be regarded as valid and applicable, and only research designs that are methodologically rigorous and appropriate can be regarded as ethical.

show abstract

Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

Cited by 31 publications

References 39 publications

Ethical Challenges in Pediatrics from the Viewpoints of Iranian Pediatric Residents

Ethical Challenges in Pediatrics from the Viewpoints of Iranian Pediatric Residents

Focus on paediatrics

Ethical Issues in Perinatal Clinical Research

Contact Info

Product

Resources

About