Human research subjects

Clinical trials shall be conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects... 

Under US regulations, each institution conducting research with human subjects must have its own IRB. These perform the same functions as the Independent Ethics Committees in Europe, and should contain at least five members, one of which should be independent of the institution. There should be available a mixture of scientific and non-scientific expertise capable of assessing research proposals from legal, ethical and scientific perspectives. The IRB must grant written authorisation to the investigator before a study can commence. They are also responsible for on-going reviews of research, and must report to the FDA ... 

Devices intended solely for research on or with laboratory animals should be labelled with CAUTION - Device for investigational use in laboratory animals or other tests that do not involve human subjects. ... 

Assuming that standard codes of conduct, for example, the Nuremburg Code (1947) and the World Medical Association s Declaration of Helsinki, are followed by researchers, the element of consent will already have been satisfied. In fact, as far as the element of consent to the intrusion into privacy goes, the medical community s doctrine of informed consent is a very strict application of the element of consent. We may note that the specific informed consent of an individual human subject of research may not be adequate to the decisions surrounding data mining. 

On the other hand, a topic such as the duty of honesty, although generally stated, holds a lot of interest for the philosopher for the particular manner in which the duty of honesty might appear in research using human subjects. The duty of honesty governs informed consent with regard to health risks, but it could also serve as a springboard to inform human subjects of the potential risks to privacy as well, even if those risks are not well understood. 

Ethical Principles for Medical Research Involving Human Subjects. 

Despite the apparent promise for this line of research to explain caffeine s potential ergogenicity, the doses of caffeine necessary to produce significant calcium shifts are midway between toxic and lethal levels when transposed to in vitro situations.5 These dosage requirements suggest that the mobilization of intracellular calcium is not a viable explanation for caffeine s potential ergogenic effects in live human subjects. 

Regulations governing the use of human subjects in federally funded research projects within the United States include a statement encouraging racial diversity... 

The defendants motion to dismiss the complaint essentially alleges that the duty to disclose is limited to the doctor-patient relationship and was never meant to govern the researcher-subject relationship. As a consequence, the defendants have asked the court to rule on whether physicians/scientists engaging in genetic research have a duty to disclose their intentions to patent their discovery to those who volunteer to be human subjects. The plaintiffs must get past this motion to dismiss to explain to the court what they mean by the "Tay-Sachs model."... 

Although there are several ethical concerns with biobanks and other large-scale research repositories (Rothstein, 2002), the most important issue is informed consent. Participants in research involving human subjects must be advised of the intended research to be performed with their specimens. With biobanks, however, the future research uses of the samples are unknown at the time of collection. It would be infeasible to contact each of the donors to obtain consent every time a new research use is contemplated, yet IRBs are reluctant to approve the use of blanket consent for unspecified uses. One way to avoid this problem is for prospective sample donors to be given a menu of possible uses of their samples. Such a list might include research in mental health, HIV/AIDS, cancer, cardiovascular disease, or other areas. The donors would then have the opportunity to approve the use of their specimens for all or some of the listed uses. Other disclosures necessary to obtain informed consent include the financial interests of the biobank and researchers, whether individuals may elect to be notified of research findings, and whether it is possible for an individual to withdraw his or her sample from the bank (Rothstein, 2002). 

Although there is the potential for some scientific benefit from this research, you may not derive any personal benefit from your participation. However, your participation in this study poses no risk to you whatsoever. By agreeing to this interview, you acknowledge that the questions you have about the research at this time have been answered in a language you understand. If you have any future questions about this research, please contact Professor Mark Rothstein at (502) 852-4980 or the University of Louisville Human Subjects Committee at (502) 852-5188. 

There are several future directions that NIR brain sensing and imaging research can take. In instrumentation, advances in time-resolve spectroscopic equipment may yield less expensive equipment and thus a more prolific use. This will allow for approximation of time of flight parameter providing a possible avenue for inferring path length. Theoretically, there is a need for better theoretical modeling to eliminate crosstalk noise. Possible improvements have already been introduced by Boas, et. al [8]. However, more human subject studies need to be conducted to... 

Review of studies on the effect of oxalic acid on calcium bioavailability in rats and in humans indicates that most of the research was done between 1930 and 1950. Decreased availability of calcium in young rats was reported when spinach containing oxalic acid was fed with low calcium diets. The extent of the effect of oxalic acid on calcium availability was shown to be related to levels of calcium and oxalic acid, as well as the presence of vitamin D in the diet. In human studies there was generally no effect of oxalic acid on calcium balance however, in a few studies decreased calcium balances were reported. There is recent evidence that oxalic acid consumed along with a moderately high level of fiber intake may have adverse effects on calcium balance of human subjects. 

Since the early 1970 s, research has been directed at identifying the mechanism by which the calciuria is induced. Attention was given first to the question of whether the elevated urinary calcium excretion was caused by an increase in the intestinal absorption of calcium. Results of calcium balance studies in human subjects showed that protein ingestion either had no effect on calcium absorption (4) or that the effect was insufficient to account for the calciuria (5j. Consequently, negative calcium balance is a frequent observation in human studies when high protein diets are fed, and this situation is not improved by high calcium intakes (4 ). 

Human subject An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR Code of Federal Regulations) 50.3]. 

While the numbers of animals involved in research is tracked closely and is well known, such is not the case for human subjects involved in clinical trials. We simply do not know how many are involved in such trials in the United States, much less worldwide. Though the NIH does track closely how many dollars and individuals are involved in research it funds ( 12.7 billion and seven million subjects in 1997), the same is not true for privately funded research (where the numbers are greater). And while there is now a Web site where one can examine the numbers and types of efficacy trials open, the same is not true for Phase I tolerance and pharmacokinetic trials, where most potential drugs cease development. 

Clinical drug trials represent research with human subjects (Cato, 1988). All research involving human subjects that is supported by the federal government or... 

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. 

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