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persons are vulnerable to coercion and deception. Neonates and children (minors), the mentally impaired, and unconscious patients are legally or mentally incompetent to give informed consent. They should, however, be asked to assent, since their cooperation is essential for high-quality data collection. If an individual is judged incompetent and incapable of consent, the researcher must seek approval from the prospective subject and his or her legally authorized representative.DIF:Cognitive Level: AnalysisREF:Page 16512.In the Jewish Chronic Disease Hospital Study, 22 patients were injected—unknowingly—witha suspension containing live cancer cells that had been generated from human cancer tissue. What ethical principles apply here? (Select all that apply.)a.Beneficenceb.Self-determinationc.Anonymityd.Confidentialitye.Fair treatmentANS:A, B, E
A highly publicized example of unethical research was a study conducted at the Jewish Chronic Disease Hospital in the 1960s. Its purpose was to determine the patients’ rejection responses to live cancer cells. Twenty-two patients were injected with a suspension containinglive cancer cells that had been generated from human cancer tissue. An extensive investigationof this study revealed the patients were not informed that they were taking part in research or that the injections they received were live cancer cells. In addition, the Jewish Chronic Disease Hospital Institutional Review Board never reviewed the study; even the physicians caring for the patients were unaware that the study was being conducted. In addition, the principle of beneficence requires the researcher to do good and “above all, do no harm.”DIF:Cognitive Level: ApplicationREF:Page 16213.Monica is a nurse researcher. She completes her paperwork for an institutional review board (IRB). Her application for approval is returned to her, with comments as to how it should be revised and resubmitted. Which of the following comments are within the scope of the IRB? (Select all that apply.)a.“You have failed to provide a copy of your survey. Please do so.”b.“Your study protocol does not provide information on potential risks to anonymity.Please indicate this in Section 1g.”c.“Because of inexperience in this area, the IRB invites you to meet with us as one of the reviewers of this protocol.”d.“We can only provide provisional approval of your study.”e.“You have not included information about the risk-to-benefit ratio of this research. Please do so.”ANS:A, B, EAn institutional review board (IRB) is a committee that reviews research to ensure that the investigator is conducting the research ethically. Universities, hospital corporations, and manymanaged care centers have IRBs to promote the conduct of ethical research and protect the rights of prospective subjects at these institutions. Each IRB has at least five members of various backgrounds (cultural, economic, educational, gender, racial) to promote a complete, scholarly, and fair review of research that is commonly conducted in an institution. If an