Browsing by Subject "safeguards"
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Item Research With Cognitively Impaired Participants(2009-10) Oruche, Ukamaka M.Illnesses that cause cognitive impairment are a considerable health problem in the United States. These include Alzheimer's disease, Huntington's chorea, cerebrovascular disease, psychiatric disorders, chronic alcoholism, and AIDS dementia complex. Illness associated with cognitive impairment may cause great suffering to the affected patients and their families. Research involving individuals who may be at risk for or have cognitive impairment is necessary to improve our understanding of these illnesses. For example, this may occur during efforts to develop effective therapies to treat them. However, research with participants who have cognitive impairment presents additional ethical concerns because they may be vulnerable to coercion. Therefore, nurse researchers must not only understand the principles of informed consent (i.e., autonomy, beneficence, nonmaleficence, and justice), but also the additional safeguards provided in the common rule to protect cognitively impaired participants in research. These safeguards include advanced informed consent, legal representative, and assent. Gaps exist in federal regulations related to adhering to these safeguards such as how to assess for decision-making capacity and variations on who can be a legal representative. The nurse researchers have potential roles as educators and advocates in research involving participants with cognitive impairment.