Stitzel, K. The use of clinical data to confirm the safety of consumer products for use on the skin.  ATLA 1999.  27:  108.

 

Clinical testing is an essential tool for the development of drugs and for basic research.  The volunteers are protected by the Declaration of Helsinki, which states that there must always be careful assessment of inherent risk, in comparison to foreseeable benefits to the subject or to others.  In both medicine and basic research, the risk to the participant is often weighed against benefit to the population.  This is true in drug development where the first human exposure to new drugs often involves healthy volunteers who derive no benefit, but are at low risk.  It is also true in basic research performed to increase our knowledge of biology and other sciences.  Sometimes, basic research, such as nutritional studies, can be uncomfortable or cause biological changes in the human subjects, but again the benefits to the population are weighed against the risks to the individual.  Clinical evaluation to confirm the safety of new products is also a valuable tool.  This is only done when the risk is no greater than the risk of using similar products in everyday situations.  This testing is again justified by balancing the very small risk to the subject against the benefits for the larger population.  As industry moves toward non-animal methods, regulatory agencies will need to understand how non-animal safety information, including results from alternative methods, (quantitative) structure-activity relationship information, and human experience, is to be integrated into the evaluation of the safety of new products.