Aging clinical and experimental research
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Historical Article
Informed consent for research participation in frail older persons.
Informed consent has been the most scrutinized and controversial aspect of clinical research ethics. Institutional review boards (IRBs), government regulatory agencies, and the threat of litigation have all contributed to increasingly detailed consent documents that hope to ensure that subjects are not misled or coerced. Unfortunately, the growing regulatory burden on researchers has not succeeded in protecting subjects, but has rather made the consent process less effective and has discouraged research on vulnerable populations. ⋯ Two important ethical conflicts should be kept in mind. First, although vulnerable older patients must be protected, protection should not prevent research on this important population. Similarly, because informed consent documents are often written to prevent legal jeopardy, these technical documents, expressed in language sometimes difficult to understand, can prevent comprehension of basic issues, defeating the ethical purpose of human protection.
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The Functional Rating Index (FRI) was developed to provide an assessment instrument which has not only clinical usefulness but also quantifies the patient's current state of pain and dysfunction in a reliable and valid manner for spinal conditions. There is no study on the FRI applied to older people with low back pain (LBP). The primary aim of this study was to evaluate the validity and reliability of the FRI in older people with LBP. ⋯ In this preliminary report, the FRI appears to be easy to administer, seems to have significant validity and reliability, and may be useful in geriatric assessment of older people with LBP.