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Proxy informed consent in pediatric research: a review
1Unit of Epidemiology, Burlo Garofolo Maternal and Child Health Institute, Trieste, Italy. Cuttini@burlo.trieste.it
Insights
Parents prioritize perceived child benefit for medical research consent, alongside contributing to science. Improving the consent process involves clear communication and transparency, viewing it as a partnership.
Area of Science:
- Medical Ethics
- Pediatric Research
Background:
- Informed consent for pediatric medical research presents unique challenges compared to clinical practice.
- Understanding parental motivations and comprehension is crucial for ethical research conduct.
Purpose of the Study:
- To discuss proxy consent for pediatric medical research in developed countries.
- To review informed consent requirements and empirical findings.
- To identify strategies for enhancing the consent process.
Main Methods:
- Review of requirements for valid informed consent.
- Analysis of empirical studies on parental decision-making in research.
- Discussion of factors influencing the consent process.
Main Results:
- Parental consent is primarily driven by perceived benefit for their child.
- Desire to advance medical knowledge and help others also motivates participation.
- Abstract research concepts are harder for parents to grasp than practical aspects.
- The quality of the consent process significantly impacts parental acceptance.
Conclusions:
- Proxy consent for pediatric research requires a nuanced approach.
- Effective consent involves transparent, two-way communication and partnership.
- Optimizing the consent process can improve participation and uphold ethical standards.
Abstract:
This paper is aimed at discussing the issue of proxy consent for medical research with children carried out in the context of developed countries. First, requirements for valid informed consent are reviewed, and differences with clinical practice highlighted. In the second part the findings from empirical studies, and implications for improving the consent process, are discussed. Perceived benefit for their child is the most important factor motivating parents to grant consent, but also a desire to contribute to medical research and benefit others are frequently mentioned. Abstract concepts such as randomization are more difficult to grasp and remember than practical issues. The type and style of the consent-seeking process (quality of the information, physician's attitude, allocated time, readability of consent forms) have an influence on how the invitation to participate is received. Rather than as a one-sided delivery of information, consent should be viewed as a continuous, two-way communication process developing in a context of transparency and partnership between the investigator and potential research subjects.