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Special Protection Provisions for Children Participating in Research. Children are all persons who are yet to reach or attain the legal age to take part in the research programs, as per the set requirements in research jurisdiction. In most cases, anyone under the age of 18 years is a child. This category of persons needs protection in research, where they are subjects.
It is a responsibility of the office of Human Research Protection, to ensure that these children receive maximum protection from exploitation by the research institutions. The IRBs must also have in mind the likely benefits, dangers and discomforts of the research to the children, and examine if there is adequate justification for these children to take part in the research. The office of Human research protection will ensure that the IRBs, before they commence the research, will have considered the prevailing circumstances of the children before enrolling them in the research. Some of the factors they should consider are the health of the children at that time, their age, and their ability to understand what the research entails, and the likely benefits they may get from the research (Runzheimer, 2010).
One of the conditions that the office of human research protection has enacted to protect the rights of children is the provision that the research should not involve a risk that is way above the minimum risk to children. The research should not present greater risk to the children taking part in it. In addition, the IRBs should make adequate provisions to get consent from the children, and their parents or guardians, as per the set HHS regulations.
Another provision for the protection of the rights of children is the requirement that, if the research presents greater than the minimum risk to the children, it should have the prospect of directly benefiting the children involved in the research (Jastone, 2006).
Therefore, to justify the involvement of the children in the research, we should base our analysis on the benefits, which we expect from the research. In addition, the benefits that we expect from the study should at least equal the benefits from other alternative approaches.
Another provision, which this office has enacted to protect the rights of children in human research, is the requirement that, if the research has more than the minimum risk, and does not have any direct benefits to the children participating in it, must be in a position to provide general knowledge concerning the individual’s condition or ailment. The procedure of the research should, therefore, present experiences that have some degree of similarity with the actual psychological or medical situations, which we expect from the child subjects. The intervention should be able to provide basic information on the child subject’s disorder or condition. This will help in understanding the ailment better, which may yield better ways of containing it. In addition, adequate structures must be in place to ensure the researcher seeks full consent from the child subjects and the parents of these children (Lawton Robert Burns, 2011).
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Protection of the Rights of Prisoners in Human Research
According to the HHS regulations, we define a prisoner as any individual under confinement or detainment without his consent in a penal institution. This includes all individuals who are serving jail terms on a criminal or civil statute and those who are waiting for arraignment in court (Steiner, 2006).
The office of human research protection has enacted a number of regulations to protect the rights of prisoners. This is in cases, where they are human subjects of research. One requirement is that one of the members of the organization conducting the research should be a prisoner, or a representative of a prisoner, who must have adequate experience as a prisoner, to serve in that capacity. In the absence of a prisoner in the IRB, they should choose a representative who has a wide level of experience and knowledge, understanding and appreciation of the conditions of a prison. In fact, he should act, respond, and view things like a prisoner (Marilyn Jane Field, 2004).
Another provision is that in case of any possible benefits to the prisoner because of his participation in research, in terms of general living standards, medical services, or income opportunities within the prison premises, they should not be extremely large to alter or distort the response of the prisoner (Salkind, 2003).
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