Model Ethical Protocol

Greely, H.T., "The Ethics of the Human Genome Diversity Project The North American Regional Committee s Proposal Model Ethical Protocol," in Human DNA Sampling Law and Policy—International and Comparative Perspectives. Kluwer Law Inti, pp. 239-256 (1997b). 

North American Regional Committee, Human Genome Diversity Project, "Proposed Model Ethical Protocol for Collecting DNA Samples," Hous. L. Rev., 33, 1431-1473 (1997). 

A suitable animal model can be used for in vivo pharmacokinetic assessment of a topically applied elastic liposome formulation. Rats and mice are most common but tend to provide an over-estimate compared to human skin as the skin is more permeable. Piglets provide a closer approximation to human skin permeability and have been used for some evaluations of elastic liposomes (9, 34). Appropriate animal ethics committee approval is required. A generalised protocol is outlined in the following section but there can be considerable variation depending on the complexity of information sought, i.e., if the determination of distribution into tissues is required in addition to absorption into the circulation ... 

What little information that is available on the activity of topicals against viruses on mucous membranes comes from experiments using animals [13,14]. Ethical considerations, costs, and the general difficulties of working with animals models severely limit a wider application of such test protocols, especially in the initial development and screening of formulations. The recent introduction of the human umbilical cord as a surrogate for mucous membranes is an attempt at addressing this gap [3], and preliminary experiments with this model show its potential for application in studies on virus survival and inactivation on mucous membranes [72]. 

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