Article 5: The Role of Parents in the Proxy Informed Consent Process in Medical Research Involving Children

Abstract Medical research involving child subjects has led to advances in medicine that have dramatically improved the lives, health and well-being of children. Yet, determining when and under what conditions a child should be enrolled in medical research remains an ethically vexing question in research ethics. At the crux of the issue is the free and informed consent of the child participant. A child, who is presumed legally incompetent, or lacks sufficient understanding to exercise autonomous decision-making, will not be able to express free and informed consent in the research setting. Rather than exclude all such children from medical research, a parent (or legal guardian) is designated as a proxy to consent on the child’s behalf. However, the concept of proxy informed consent and the framework for its implementation present practical and ethical challenges for researchers, particularly in navigating the relationship between proxy decision-makers and child subjects in the medical research setting. Article 5 of the uncrc may offer guidance on this point: (1) it places boundaries around how parental authority should be exercised; (2) it offers a model for parent-child decision-making that is participatory, collaborative and linked to the child’s enjoyment of rights under the uncrc; (3) it respects and supports the autonomy of child participants by recognising their evolving capacities to give informed consent. This paper concludes that greater consideration should be given to Article 5 as a complementary framework for researchers engaged in medical research involving children.

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6ER-023 The role of institutional review boards, and hospital pharmacists as members, in the informed consent process in clinical research: a retrospective observational study

10.1136/ejhpharm-2020-eahpconf.458 ◽

2020 ◽

Author(s):

E Villamañán ◽

C Sobrino ◽

M Freire ◽

JN Inmaculada ◽

SR Luis ◽

...

Keyword(s):

Informed Consent ◽

Observational Study ◽

Clinical Research ◽

Informed Consent Process ◽

Consent Process ◽

Retrospective Observational Study ◽

Institutional Review Boards ◽

Hospital Pharmacists ◽

Institutional Review

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Key points of ethic review in the informed consent process and information understanding in medical research

Pharmaceutical Care and Research ◽

10.5428/pcar20140303 ◽

2014 ◽

Vol 14 (3) ◽

pp. 166-169

Author(s):

JinHong HU

Keyword(s):

Informed Consent ◽

Medical Research ◽

Informed Consent Process ◽

Consent Process ◽

Key Points ◽

Ethic Review

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Predictive Genetic Testing,Uncertainty, and Informed Consent

Handbook of Research on Technoethics ◽

10.4018/978-1-60566-022-6.ch031 ◽

2009 ◽

pp. 474-495

Author(s):

Eduardo A. Rueda

Keyword(s):

Genetic Testing ◽

Informed Consent ◽

Informed Consent Process ◽

Predictive Genetic Testing ◽

Three Dimensions ◽

Consent Process ◽

The Public ◽

The Individual

This chapter focuses on showing legitimate ways for coping with uncertainties within the informed consent process of predictive genetic testing. It begins by indicating how uncertainty should be theoretically understood. Then, it describes three dimensions of uncertainty with regard to both the role of genes in pathogenesis and the benefit to patients of undergoing predictive genetic testing. Subsequently, the ways by which institutions tame these uncertainties are explained. Since viewing genes as exceptional informational entities plays an important role in taming uncertainties, it explains why this conception should be abandoned. Then, it discusses how institutional taming of uncertainty becomes a source of paternalism. What is stressed is that in order to avoid paternalism and ensure transparency within the informed consent process, open-to-uncertainty mechanisms should be implemented before the public and the individual. How patients should deal with potential implications of testing for their relatives is also considered.

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Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study

Global Qualitative Nursing Research ◽

10.1177/2333393617732017 ◽

2017 ◽

Vol 4 ◽

pp. 233339361773201 ◽

Cited By ~ 6

Author(s):

Lika Nusbaum ◽

Brenda Douglas ◽

Karla Damus ◽

Michael Paasche-Orlow ◽

Neenah Estrella-Luna

Keyword(s):

Informed Consent ◽

Informed Consent Process ◽

Consent Process ◽

Research Staff ◽

Research Participants ◽

Risks And Benefits ◽

Successful Communication ◽

Communication Practices ◽

And Training

Multiple studies have documented major limitations in the informed consent process for the recruitment of clinical research participants. One challenging aspect of this process is successful communication of risks and benefits to potential research participants. This study explored the opinions and attitudes of informed consent experts about conveying risks and benefits to inform the development of a survey about the perspectives of research nurses who are responsible for obtaining informed consent for clinical trials. The major themes identified were strategies for risks and benefits communication, ensuring comprehension, and preparation for the role of the consent administrator. From the experts’ perspective, inadequate education and training of the research staff responsible for informed consent process contribute to deficiencies in the informed consent process and risks and benefits communication. Inconsistencies in experts’ opinions and critique of certain widely used communication practices require further consideration and additional research.

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Training surgeons and the informed consent discussion in paediatric patients: a qualitative study examining trainee participation disclosure

BMJ Open Quality ◽

10.1136/bmjoq-2018-000559 ◽

2019 ◽

Vol 8 (3) ◽

pp. e000559 ◽

Cited By ~ 1

Author(s):

Kunal Bhanot ◽

Justin Chang ◽

Samuel Grant ◽

Annie Fecteau ◽

Mark Camp

Keyword(s):

Informed Consent ◽

Informed Consent Process ◽

Consent Process ◽

Training Process ◽

Paediatric Hospital ◽

Face To Face ◽

Attitudes And Practices ◽

Surgical Trainees ◽

Trainee Surgeon

BackgroundThe process of obtaining informed consent is an important and complex pursuit, especially within a paediatric setting. Medical governing bodies have stated that the role of the trainee surgeon must be explained to patients and their families during the consent process. Despite this, attitudes and practices of surgeons and their trainees regarding disclosure of the trainee’s participation during the consent process has not been reported in the paediatric setting.MethodsNineteen face-to-face interviews were conducted with surgical trainees and staff surgeons at a tertiary-level paediatric hospital in Toronto, Canada. These were transcribed and subsequently thematically coded by three reviewers.ResultsFive main themes were identified from the interviews. (1) Surgeons do not consistently disclose the role of surgical trainees to parents. (2) Surgical trainees are purposefully vague in disclosing their role during the consent discussion without being misleading. (3) Surgeons and surgical trainees believe parents do not fully understand the specific role of surgical trainees. (4) Graduated responsibility is an important aspect of training surgeons. (5) Surgeons feel a responsibility towards both their patients and their trainees. Surgeons do not explicitly inform patients about trainees, believing there is a lack of understanding of the training process. Trainees believe families likely underestimate their role and keep information purposely vague to reduce anxiety.ConclusionThe majority of surgeons and surgical trainees do not voluntarily disclose the degree of trainee participation in surgery during the informed consent discussion with parents. An open and honest discussion should occur, allowing for parents to make an informed decision regarding their child’s care. Further patient education regarding trainees’ roles would help develop a more thorough and patient-centred informed consent process.

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The Role of Nonverbal and Verbal Communication in a Multimedia Informed Consent Process

Applied Clinical Informatics ◽

10.4338/aci-2011-02-ra-0016 ◽

2011 ◽

Vol 02 (02) ◽

pp. 240-249 ◽

Cited By ~ 3

Author(s):

David Pieczkiewicz ◽

Andrea Mahnke ◽

Catherine McCarty ◽

Justin Starren ◽

Bonnie Westra ◽

...

Keyword(s):

Informed Consent ◽

Interaction Design ◽

Informed Consent Process ◽

Verbal Communication ◽

Consent Process ◽

Communication Styles ◽

Question Asking ◽

Original Process ◽

Content Analyses

SummaryObjective: Nonverbal and verbal communication elements enhance and reinforce the consent form in the informed consent process and need to be transferred appropriately to multimedia formats using interaction design when re-designing the process.Methods: Observational, question asking behavior, and content analyses were used to analyze nonverbal and verbal elements of an informed consent process.Results: A variety of gestures, interruptions, and communication styles were observed. Conclusion: In converting a verbal conversation about a textual document to multimedia formats, all aspects of the original process including verbal and nonverbal variation should be one part of an interaction community-centered design approach.

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