After the enactment of the Children Act of 2002, there was a increased incentive for pharmaceutical companies to perform studies where they test their drugs on children in order to determine the safest doses of medication that has already been approved as effective and safe in adults. Part of this legislation also required the Institute of Medicine to research into the desirable practices regarding ethical research when children are involved, hence this report. This report delves into several ethical issues regarding studies on children, some of which include payments that are related to the participation of children in clinical research, issues on regulatory compliance, quality improvement and accreditation, the challenges and the necessity of involving children in clinical research, the regulatory mechanisms that protect the children who participate in clinical research and building consensus on the participation of children in clinical research (Field & Behrman, 2004).
The contents of this report have implications on advance practice nursing. In using their advanced knowledge, skills in problem solving and critical analysis to improve patient outcomes, the actions of an advance practice nurses are governed by the code of ethics developed by the American Nurses Association.
Particularly, provision 3 of the code of ethics entails the protection of individuals participating in research. With regards to children, it is important for nurses to avail to their legal guardians or parents all the requisite material to making the decision on whether or not to enroll their children into pharmaceutical studies. Such information should also entail the potentials harms that can emanate from participating in such studies and any alternatives to participating in such studies (American Nurses Association, 2010). The inclusion of this provision in the code of ethics in the report by the Institute of Medicine, especially with the increased incentive for pharmaceutical companies to perform studies involving children, highlights the importance of the issue.
Field, M. Behrman, R. (2004). Ethical conduct of research involving children. Institute of Medicine of the National Academies. Washington D.C. The National Academies Press.
American Nurses Association. (2010). Code of ethics for nurses with interpretive statements. Retrieved 21 Dec. 2014. From http://www.nursingworld.org/MainMenuCategories/ EthicsStandards/CodeofEthicsforNurses/Code-of-Ethics.pdf