Scientific research has resulted in notable advances in cancer treatment for children. Conducting research, involving children, requires adhering to numerous ethical challenges whether it involves human subjects or human tissues from biobanks. One major ethical issue is obtaining informed consent. Parents of critically ill children are under tremendous stress, compromising their ability to provide voluntary consent without the intervention of duress.
Approaching parents with an appeal for the child to participate in biomedical research may create more anxiety. Consent procedure guidelines are relatively straightforward, however, every research study presents its own discrete set of circumstances. Special protection and consideration must be provided when children are involved, whether the research study presents minimal risk, or a higher degree of risk.
Who May Give Consent?
Biomedical research requires higher standards of informed consent than medical treatment. First, and foremost, of the regulations established in the Nuremberg Code  is that "the voluntary consent of the human subject is essential." When children are involved in research, parents, or guardians, are legally responsible and can give authorization to proceed on the minor's behalf. For most research studies, children over the age of six are asked to give their assent to the procedure.
Key Elements of Informed Consent
The consent process includes the discussion between the researcher and the parents, or guardians, and a consent form detailing the particular research process. Key information elements that must be incorporated in the form include:
- Purpose of research
- Procedures involved
- Risks and benefits
- If permission can be withdrawn
- Participation options
- Contact information
- Many research studies involve drugs or procedures that may or may not have any therapeutic benefit over the existing standard of care. Parents may consent to the research, in the hope that the research drug or procedure may offer the best chance of recovery for their child, or because their child will receive better medical care. The informed consent given, is often done under pressure.
- Research is investigative, without demonstrable risks and outcomes. Parents tend to feel excessive guilt, whether they agree to the research study, or not. When they give their permission for the research project, their child may be subjected to risks from the drug or procedures, without any guarantee of benefit. If they refuse to give consent, they may be denying their child valuable treatment.
Informed Consent Preferences
There have been several studies conducted at the highly advanced labs involving the preferences of parents, and children, when weighing informed consent matters. A study in pediatric oncology determined that participants preferred:
- More information, rather than less
- Information presented in organized steps
- Adequate time to process the information
- Audio and visual learning aids
Research is key to advancing medical understanding. More important, is the Nuremberg Code, the most significant control in the United States regulating human medical research.
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