Ethical considerations

Before a drug is put forward for a clinical trial, there are ethical and regulatory constraints for the design and conduct of a clinical trial that have to be considered. 

The United States National Institutes of Health (NIH) has stipulated seven ethical requirements to ensure that, before the trial begins, there is proper consideration of ethical issues and the trial subjects are protected. The essential tenet is that the potential exploitation of human subjects must be minimized and the risk-benefit ratio must be favorable. These seven ethical requirements are  

This requirement is to ensure that the clinical trial is justified based on scientific research, and will result in improvements in health or advancement of scientific knowledge. In this way, resources are not directed at non-meaningful clinical research and human subjects are not being exploited. 

The clinical trial should be conducted methodically with clear objectives and outcomes that are statistically verifiable. The pre-clinical and toxicological data should have been carefully analyzed and should confirm the scientific finding. The trial should not be biased, and should be able to be executed without unreasonable caveats and conditions. 

Selection of subjects is based on scientific objectives and not on whether the subject is privileged or vulnerable, or because of convenience. Inclusion and exclusion criteria are well thought out and designed solely to satisfy the scientific basis being put forward. There must be documented evidence to support the choice of selection criteria (Exhibit 6.2). 

Ethics n. The concept of human duty, of doing the right thing the body of rules of duty a particular system of principles and rules concerting duty rules of practice in respect to a single class of human actions as, political or social ethics. 

Stewardship. The archaeological record is irreplaceable and it is the responsibility of all archaeologists to practice and promote stewardship of the archaeological record 

Accountability. Responsible archaeological research requires a commitment to consult with affected group(s) to establish a working relationship that can be beneficial to aU parties involved 

Commercialization. The buying and selling of objects contributes to the destruction of the archaeological record on the American continents and around the world. Archaeologists should discourage and avoid activities that enhance the commercial value of archaeological objects 

Public education and outreach. Archaeologists should work with the public to improve the preservation, protection, and interpretation of the record 

FIGURE 5-10. Jetties, Portage Lake Harbor, Onekama, Michigan. Courtesy of US. Army Corps of Engineers. 

FIGURE 5-11. Jetties, Entrance to Umpqua River, Oregon. Courtesy ofU.S. Army Corps of Engineers. 

Consider, for example, the jetty criteria of Section 5.6. Criteria (d) and (e) can limit littoral transport of sediment into the navigation channel, making the channel more reliable and reducing maintenance costs. However, in many sandy coast situations those criteria may produce structures that effectively block longshore sand transport and cause downcoast beach erosion, violating criteria for preserving beaches and protecting coastal property (principles of safety, social values, and sustainability). 

This review argues that, as of now, the preferred type of monitoring involves surveillance of a series of human proteins present in blood and metabolites in urine, for evidences of mutational change. No insurmountable obstacles exist to mass genetic monitoring, although a very large amount of research, development, and optimization remains to be done. 

Abrams, M. E. (1970), Medical Computing, American Elsevier Publishing Co., New York. 

Anderson, N. G., and Caton, J. E. (1973), High resolution electrophoresis Immuno-subtraction. In preparation. 

(1964), in Plant Virology (M. K. Corbett and H. D. Siler, eds.). University of Florida Press, Gainesville. 

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C. S. Stewart, T. Acamovic, FI. Gurung and A. S. Abdullah, in Manipulation of Rumen Microorganisms , Faculty of Agriculture, Alexandria University, Alexandria, Egypt, 1992, p. 150. T. Acamovic, in Developments and Ethical Considerations in Toxicology, ed. M.I. Weitzner, The Royal Society of Chemistry, 1993, p. 129. 

Developments and Ethical Considerations in Toxicology, ed. M. I. Weitzner, The Royal Society of... 

Hecdth effects data come from three types of studies clinical, epidemiological, and toxicological. Clinical and epidemiological studies focus on human subjects, whereas toxicological studies are conducted on animals or simpler cellular systems. Ethical considerations limit human exposure to low levels of air poUutants which do not have irreversible effects. Table 7-1 lists the advantages and disadvantages of each type of experimental informahon. 

While there is no FDA involvement in such investigations, ethical considerations and institutional regulations would generally dictate that informed consent and the approval of the local institutional review board be obtained. However, due to the negligible risks involved these are likely to be a formality and will not involve extensive review or scrutiny. 

Unfortunately transplants require 6-7 foetal brains to obtain enough transplantable material for one patient, which itself raises ethical considerations, and as the tissue cannot diffuse its influence is restricted, even with multiple injection sites, and only a fraction (approx. 20%) of the neurons survive. Also without knowledge of the cause of PD the transplant could meet the same fate as the original neurons. The concept, however, demands perseverance and a number of variants are being tried. 

Issa AM Ethical considerations in clinical pharmacogenomics research. TIPS 2000 21 247-249. 

Licinio J, Hannestad J, Wong M-L. Pharmacogenomics of antidepressants Drug discovery, treatment, and ethical considerations. TEN Trends in Evidence-Based Neuropsychiatry 2002 (in press). 

One of the most obvious benefits of plants is the potential for production scale up, leading to the production of virtually limitless amounts of recombinant antibody at minimal cost Plants are easy to grow, and unlike bacteria or animal cells their cultivation is straightforward and does not require specialist media, equipment or toxic chemicals. It has been estimated that plantibodies could be produced at a yield of 10-20 kg per acre at a fraction of the cost associated with production in mammalian cells [2,18] The use of plants also avoids many of the potential safety issues associated with other expression systems, such as contaminating mammalian viruses or prions, as well as ethical considerations involving the use of animals. 

Non-immune libraries are produced in a similar fashion, but using B-lymphocytes fromnon-im-munized donors as a source of antibody genes. This approach becomes necessary if initial immunization with the antigen of interest is not possible (e.g. due to ethical considerations). Although such... 

The initial strategy for Phase I is to conduct a single-dose safety study in normal volunteers. The first trial demands close 24-hour supervision in a clinical setting. Ethical considerations may, however, demand that only patients be used, for example, when evaluating an anticancer agent with predictable toxicity. A repeat dose tolerance and pharmacokinetic study in normal or patient volunteers is then conducted for chronically administered drugs. These studies will provide the necessary safety information to support efficacy testing. 

In in vivo studies, an important issue is the quality of ECG recordings and the methods used for the analysis. A few years ago, a survey reported on the practice in the pharmaceutical industry to assess the potential for QT prolongation and concluded that the majority view in the industry is not necessarily best practice [153]. After this publication, a lot of work has been done to improve the performance of in vivo models, although it should be acknowledged that their cost (together with some ethical considerations on the rational use of animals) makes them unsuitable for large-scale screening. 

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