Professional paper

Ethics of biomedical research with children

Josip Grbac ; Theology in Rijeka, Dislocated Studies of Catholic Faculty of Theology, University of Zagreb, Rijeka, Croatia
Iva Štajduhar ; Theology in Rijeka, Dislocated Studies of Catholic Faculty of Theology, University of Zagreb, Rijeka, Croatia

Abstract

This essay explores some of the fundamental ethical issues and concepts that arise in research involving children. After introducing basic concepts and definitions, we reconsider the fact that children should not be viewed exclusively as objects of protection but as individuals who have rights, and as active participants in society. This is one of the basic ethical challenges in research involving children.
The development of lifesaving treatment for lethal childhood diseases depends on advances in pediatric research, yet child-subjects can be at risk of harm even when intentions are good. Worse yet, children may be exploited or abused in the course of unethical studies. Often, children are both vulnerable subjects who need to be protected from potential research risks and “therapeutic orphans” who
have been denied access to the benefits of research.In recent times some governments have promoted the inclusion of children in clinical research and have provided researchers and the pharmaceutical
industry with new financial incentives, a move which has potential benefits and drawbacks. Despite years of debate and controversy, fundamental ethical questions about pediatric research persist. The twin goals of access and protection are not easily reconciled. Arguments for and against the participation of children in research are compelling, and the stakes are high.For decades, research policy protected children but failed to provide incentives for the conduct of pediatric research. Coupled with the disincentives associated with the additional protection required by regulation and the lack of a substantial market for pediatric drugs (relative to adults), children were categorically denied access to research and its benefits. Only in the last ten years has the pendulum begun to swing in the other direction.The development of a pediatric ethics that is based on genuine respect for children and their best interests requires that justification for pediatric research go beyond pure utilitarian motivation. Pediatric ethics is premised on this respect,even if it requires that such respect come at the expense of progress against childhood diseases. Individual benefit must take precedence over collective benefit, and the pediatric research community must remember that our responsibilities to individual children outweigh more speculative concerns regarding potential benefits to future generations of children. The balance must never tip in favor of science that benefits others over the best interests of the child-subject.Knowledge gained from research is part of our commitment to the benefit of our future but must be acquired in a way that recognizes the vulnerability of children and respects their inherent worth. Many children have not yet matured sufficiently to understand the risks and benefits of participating in a study, and
they are not yet fully able to weigh the pros and cons of participation for themselves or to contribute to new knowledge that may help future generations of children. Yet there is a consensus that children’s participation in research may be ethically justifiable under certain conditions. There is ample reason for caution, because the history of research with children reveals that the interests of child participants
have not always been protected and that in some cases researchers have exploited children. To hold all pediatric research to an unachievable standard, however, would be to paralyze efforts to improve health care for children. In the past 40 years, guidelines and regulations have been developed to protect children from serious and unnecessary risks and to safeguard their best interests. The current regulations, designed to provide explicit “additional protections” for children in research, are a result of the perceived need to categorize children as vulnerable research subjects but to allow limited pediatric research to proceed. These regulations areboth “carefully restrictive and sensibly permissive”.

Keywords

pediatric biomedical research; subjects of research procedure; pediatric informed consent; best interest standard; no-harm principle; ethical and legal regulation of pediatric research

Hrčak ID:

272216

URI

https://hrcak.srce.hr/272216

Publication date:

20.12.2012.

Article data in other languages: croatian

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