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MADRID, Spain, July 17 /U.S. Newswire/ -- Two researchers presented new methods for assessing the ability of people with Alzheimer's to give informed consent to participate in clinical trials, including the first study of this type done during an actual clinical trial, today in Madrid at the 10th International Conference on Alzheimer's Disease and Related Disorders, presented by the Alzheimer's Association. Informed consent is the process of ensuring that people understand all of the benefits and risks involved in a clinical trial before deciding whether or not to participate.
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 understand not on...
...'s ability to provide his or her personal consent to participate in research. The purpose of this ar... is enhanced by a closer look at informed consent in general, the core elements and principl...
... of protected health information, informed consent of the individual to participate in resear... authorization for purposes other than research. Notwithstanding any provisions in ? 164.508, a co...
Health care policies are often legislated and implemented without empirical research to support them. Informed consent policy is a frequently debated topic in health care and research arenas. In some jurisdictions, minors are afforded the right to consent to specific health care treatments without the permission of their parents. Specifically, adolescents may independently consent to psychiatric mental health treatment in most states. However, these minor consent policies have been implemented without fully understanding how adolescents decide in real life health care situations. The purpose of this article is to present the theoretical model, therapeutic jurisprudence (TJ), which served as the framework for a study that examined how adolescents decide to consent in outpatient psychiatr...
Introduction. II. A Historical Overview of Research Abuses and the Development of Research Regulations. III. The Federal Regulations that Govern IRBs and Informed Consent. A. What Is Regulated?. B. IRBs. C. Informed Consent. D. Research Involving Only Existing Medical Records Or Tissue Samples. IV. Deficiencies in the Regulatory System. A. IRB Workloads. B. Flaws In The Informed Consent Process. C. Informed Consent Is Particularly Difficult To Obtain From Gravely Ill Patients. V. Recommendations. A. IRBs. B. Informed Consent Procedures. C. Storage Of Blood And Tissue Samples For Future Genetic Testing. VI. Conclusion.
PRESIDENT Obama and the National Institutes of Health should be complimented for their plan to expand stem cell research initiatives. The newly endorsed approach is a significant improvement over the restrictive 2001 funding policy for embryonic stem cell research. There are, however, a number of changes that might serve to enhance the new administration's stated intent, since the NIH draft guidelines for this research pose a number of impediments. NIH should, for example, amend references to acceptable stem cell lines in order to acknowledge donors' informed consent to contribute their unused embryos for research. This suggestion has particular relevance to the many stem cell lines that are already being utilized and that under the newly prepared guidelines would not currently qualify ...
Managed care promises to contain the cost of medical care while maintaining quality of care. Some studies have indicated that managed care can lead to improvements in utilization, costs and access. However, many sectors remain skeptical about managed care. For social workers and the people they serve, managed care raises several issues: confidentiality, duty to aid, self-determination, freedom of choice, access, quality of care, research protocols, informed consent, participation in treatment decisions and client rights.
... information given to subjects as part of informed consent is in accordance with ? 50.25. The IRB may...
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