ISSN Imprimir: 2151-805X
ISSN En Línea: 2151-8068
Ethical, Legal, and Social Challenges in the Biobanking of Oral Fluid Specimens
SINOPSIS
Biotechnological advances in the rapid diagnostic testing of oral fluids such as saliva and oral transudate have led to the identification of numerous biomarkers and may change the scope of dental care and research policy. However, addressing the ethical, legal, and social challenges is not clear-cut. The United States has no comprehensive regulatory framework governing the use of oral fluid biospecimens and biobanking such as those for blood. Individuals who provide blanket consent do not meet the definition of informed consent because individuals do not have full information about the future use of their oral fluid biospecimens; therefore, alternative forms of consent should include a tiered process. What are the strategies that need to be implemented for minimizing disclosure of confidential information while maximizing the social value of research? Because research with oral fluid biospecimens may lead to therapeutic modalities that have commercial value, what guidelines should be in place regarding proposed legal ownership and property rights? Social repercussions are likely when the public sends salivary samples to direct-to-consumer personal genome companies. A different regulatory framework for the management of oral fluid specimens may thus be needed.