Historically, children have been excluded from research for decades to protect them from any risk associated with the drug. In an attempt to protect children, these subjects have been the victims of off-label drug use. Children have been given prescription or over-the-counter medication to treat or cure their illnesses ultimately causing them harm than good. The off-label drugs have little or no data available on children. Since the data is available on adults, assumption is made that the drug is safe on children as well. Children were seen as vulnerable subjects lacking a mature decision-making capability. They were seen as the subject to the authority of others and their interests and rights were not appreciated socially. So, in order to
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Will researchers consider children’s views and opinions valid or reliable? In an adult dominated society, will children be able to express their views freely? Children are defined by the Food and Drug Administration (FDA) (21 CFR 50.3(o)) as “persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted”. There are some inherent differences in children aside from the obvious physical appearance and the amount of knowledge and understanding, making them different from adults. According to Boyden (1997), children have a different understanding of words and vocabulary choices, they have less experience of the world and some may have a shorter attention span”. In order to conduct research with children, researchers must first understand the world from a child’s point of view and understanding. Punch stated (2002), “researchers should use appropriate research methods, such as drawings, photographs, worksheets, participatory rural appraisal (PRA): spider diagrams and activity tables. These research methods have changed over the years due to the changes in rules and regulations in an attempt to improve drugs branded for
Will researchers consider children’s views and opinions valid or reliable? In an adult dominated society, will children be able to express their views freely? Children are defined by the Food and Drug Administration (FDA) (21 CFR 50.3(o)) as “persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted”. There are some inherent differences in children aside from the obvious physical appearance and the amount of knowledge and understanding, making them different from adults. According to Boyden (1997), children have a different understanding of words and vocabulary choices, they have less experience of the world and some may have a shorter attention span”. In order to conduct research with children, researchers must first understand the world from a child’s point of view and understanding. Punch stated (2002), “researchers should use appropriate research methods, such as drawings, photographs, worksheets, participatory rural appraisal (PRA): spider diagrams and activity tables. These research methods have changed over the years due to the changes in rules and regulations in an attempt to improve drugs branded for