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The Institutional Review Board (IRB) was created to protect human rights in research studies. Prior to the creation of ethical standards in research individual rights were frequently violated without consequence for such actions. Extreme examples of ethical violations include the experiments conducted on individuals during the Nazi Concentration Camps and the Tuskegee Syphilis Study. In both cases individuals were inflicted with significant harm without knowledge of the study or willing participation. Currently the Department of Health and Human Services regulates federal guidelines to ensure the safety and protection of participants in research studies. Following ethical guidelines ensures protection of human beings' rights and the integrity of research. In the case study of Lucy, several ethical violations occurred including: lacking of formal IRB approval for her research study, issues with informed consent, and misrepresentation of the research authorship.
Lucy, a special education teacher, sought IRB approval for her proposed research study to take place in a special education classroom. According to the case, Lucy submitted the proposal to the scientific review committee and IRB. Following submission of the proposal Lucy began to seek parental informed consent. Thus, the first ethical violation that occurred is that Lucy did not wait for her proposal to be approved. She began her research before meeting with the IRB. According to the Department of Health and Human Services (2009) approval must be granted prior to initiation of research. In Lucy's case due to the minimal risk of her study she would have been able to seek expedited review procedure. However, by submitting a proposal and not waiting for approval, Lucy violated standard research ethics.
The next issue of concern is in regards to obtaining proper informed consent. Informed consent involves multiple factors including: purpose of the study, right to decline or withdrawal, consequence of declining or withdrawing, potential risk or adverse effects, potential benefits, limit of confidentiality, incentives, and contact when questions about the research or one's rights come up (Department of Health and Human Services, 2009). In Lucy's case she sought informed consent for the study by sending informational letters to the parents of students. Considering these are high school students learning functional word recognition it is assumed that these are students have low cognitive abilities. Research has shown that a majority of individuals with moderate to severe intellectual disabilities are unable to give informed consent and parent consent is frequently sought out (Wiles, Heath, Crow, & Charles, 2005). Thus, parental approval was appropriate. However, careful analysis of each individual's ability to provide informed consent should take place (Adams & Boyd, 2010). It is unclear whether or not Lucy took steps to assess each student's ability to provide informed consent. Additionally following consent from the parents, the study should have been described to the student at his or her level to obtain assent from the student (Society for Research in Child Development, 2007). Although consent is sought out from the parents, the participant should also be included in this process in order to protect his or her individual rights. Thus, Lucy could have taken additional steps in her research to protect the rights of this vulnerable population including assessing each student's ability to provide consent and informing the students about the proposed study to seek his or her assent.
Another area of concern in regards to informed consent is how the information was presented to the parents. According to the case, informational letters were sent home and written consent was returned. However, it is unclear if the parents understood the proposed study, whether written information was in their home language, and if follow up was made to answer questions. It is important that informed consent involves truly understanding the study that will be conducted. It is recommended that Lucy sought informed consent not only through written information but also by speaking directly with parents and answering questions and explaining in further detail about the study.
Another area of concern is the possibility of coercion in this case. Parents may have felt inadvertently pressured to participate due to fears that there would be consequences for non-participation or because of a prior relationship with the teacher. According to the Department of Health and Human Services (2009) when research…[continue]
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[09 September 2006]. http://www.bartleby.com/63/28/228.html. A www.questia.com/PM.qst?a=o&d=103972372 Shamoo, Adil E., and David B. Resnik. Responsible Conduct of Research. New York: Oxford University Press, 2003. Stanford Human Research Protection Program Wins Highest Rating from Accrediting Group.," Business Wire, March 23, 2006. UNIVERSITY POLICY." University of Medicine & Dentistry of New Jersey, 2006. http://www.umdnj.edu/oppmweb/Policies/HTML/AcademicAff/00-01-2085_00.html. Yoder, Linda H.. "The basics of human subjects protection.(Cancer: Caring and Conquering)," MedSurg Nursing, April 1, 2006. Wechsler, Jill. "FDA to modernize BIMO activities:
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