Human subjects, protection

Shamoo, A.E. (2000). Future challenges to human subject protection. Scientist, 14 (13) 35, June 26, 2000. www.the-scientist.eom/yr2000/jun/opin 000626.html Sharp, S.M. (2001). The ethical foundations of clinical trials. Appl. Clinical Trials April, 2001, pp. 48-54. 

Informed consent is in some sense the ethical cornerstone on which human subjects protection rests. It requires that individuals understand their part in a study and the potential consequences, and are free to choose to participate. As Levine has argued, the consent process should include specific elements an invitation to participate a statement of the purpose of the study the basis of participant selection and explanation of procedures, risks, and discomforts how untoward consequences will be handled the benefits of participation alternatives to participation financial consideration confidentiality opportunities for continuing disclosure and measures for ensuring that a person s decision to participate is voluntary (Levine, 1981). 

Attkisson, C.C., Rosenblatt, A., and Hoagwood, K. (1996) Research ethics and human subjects protection in child mental health services research and community studies. In Hoagyvood, K., Jensen, P.S., and Fisher, C.B., eds. Ethical Issues in Mental Health Research with Children and Adolescents. Mahwah, NJ Lawrence Erlbaum Associates, pp. 43-58. 

Gorelick D. A., Pickens R., and Bonkovsky F. (1999) Clinical research in substance abuse human subjects issues, in Ethics in Psychiatric Research A Resource Manual for Human Subject Protection (Pincus, H. A., Lieberman, J. A., and Ferris, S., eds.) American Psychiatric Press, Washington, DC, pp. 177-218. 

In most countries there are offices, institutes, and legal bodies relating to medical research. For example, in the U.S., the Office for Human Research Protections of the Department of Health and Human Services is responsible for the federal policy of human subject protection, and the Food and Drug Administration for research on products. In case of any legal or ethical doubt, it is often worthwhile asking for their advice or approval. 

Malaria Announced 04/12/10 Adenovirus-vectored vaccine Naval Medical Research Center 4/15 human subjects protected Adult volunteers... 

Repellents on Skin. The candidate chemical is dissolved ia ethanol and spread over one forearm of the human subject, as DEET (1) is similarly appHed to the other forearm. Each arm is then exposed to 1500 avidM. aegppti female mosquitoes for 3 min at 30-min iatervals. Effectiveness is based on complete protection, ie, the time until the first confirmed bite (one bite followed by another within 30 min). 

Knockout mice have been reported for several FATPs [1]. As insulin desensitization has been closely linked to excessive fatty acid uptake and intracellular diacylgly-cerol and TG accumulation, these animal models were particularly evaluated in the context of protection from diet-induced type 2 diabetes ( Type 2 Diabetes Mellitus (T2DM)). In addition, studies on human subjects have also established genetic links between polymorphisms in FATP genes and metabolic alterations [1]. 

Sec. 312.50 General responsibibties of sponsors Protection of Human Subjects Financial Disclosure by Clinical Investigators Institutional Review Boards (IRBs)... 

A protocol that described the work to be done and protected the rights of the volunteers in the dosimeter studies was developed for consideration by the Human Subjects Review Committee, University of California, Riverside. Paid volunteers were considered to be at "negligible risk." The approved protocol was designated HS-95-048. The document, including informed consent, was reviewed with participants at an orientation meeting prior to the study. 

No studies have been conducted with silver and avian or mammalian wildlife, and it is unreasonable to extrapolate the results of limited testing with domestic poultry and livestock to wildlife to establish criteria or administratively enforced standards. Research on silver and avian and terrestrial wildlife merits the highest priority in this subject area. No silver criteria are available for the protection of avian and mammalian health, and all criteria now proposed are predicated on human health (Table 7.8). As judged by the results of controlled studies with poultry and small laboratory mammals, safe concentrations of silver ion were less than 250 pg/L in drinking water of mammals, less than 100 mg/L in drinking water of poultry, less than 6 mg/kg in diets of mammals, less than 10 mg/kg in copper-deficient diets of poultry, less than 200 mg/kg in copper-adequate diets of poultry, and less than 1.8 mg/kg in chicken eggs. The proposed short-term (10-day) allowable limit of 1142 pg Ag/L in drinking water for human health protection (Table 7.8) should... 

Subjects were primarily young female adults, undergraduate and graduate students at the University of Nebraska. All were assumed to be in good health and received medical clearance for participation prior to the start of each study from the University of Nebraska Division of Student Health Services. The project was approved by the University of Nebraska Institutional Review Board Involving the Protection of Human Subjects. 

Verify that the rights and well being of human subjects are protected. 

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Department of Health, Education, and Welfare, Washington, DC, April 18, 1979. 

HHS, Public welfare Protection of human subjects. Code of Federal Regulations, Title 45, Part 46 Subtitle A, Department of Health and Human Services, Washington, DC, Rev. October 2000, pp. 107-125. 

Penslar, R.D., Human Research Subjects Institutional Review Board Guidebook, Office of Human Research Protections, Washington, DC, 1993. 

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