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Advances in oral fluid testing: Proposed property rights, violation of privacy, and revising informed consent

Vernillo, A; Naidoo, S; Wolpe, P R
Biotechnological advances in rapid diagnostic testing of oral fluids such as saliva or oral transudate have led to the identification of a wide array of pathogens, enzymes, gene products and mutations, and other biomarkers. A new paradigm related to property rights likely will emerge with more information obtained from testing an individual patient or research participant; oral fluids may be a counterpart to blood. Traditionally, blood has been subjected to a large variety of diagnostic testing for both medical and legal purposes. Should oral fluid, like blood, also be granted comparable legal and ethical protections? Concerns about violation of privacy, including genetic discrimination, have emerged with rapid testing of saliva. The management of salivary biospecimens must include considerations of property rights and financial compensation; the right to privacy; and re-evaluation of informed consent. The challenges of obtaining informed consent for rapid oral diagnostic testing from culturally diverse populations must be addressed to promote overall public health and research. Testing must also be affordable and accessible. Strategies that incorporate rapid oral diagnostic testing into oral health care should reshape and align dentistry with medicine, promote public health, and advance research investigations. 2011 by Begell House, Inc
EMBASE:2013305433
ISSN: 2151-805x
CID: 369532

Property and privacy paradigms of 'Marketable Spit" : an ethical and legal counterpart to blood?

Vernillo, AT; Wolpe, PR
ORIGINAL:0008646
ISSN: 1555-9254
CID: 742622

Blood is a precious resource-does it really matter who donates it?

Vernillo, Anthony
PMID: 20131173
ISSN: 1526-5161
CID: 154997

Property and privacy paradigms of "marketable spit": an ethical and legal counterpart to blood?

Vernillo, Anthony Thomas; Wolpe, Paul Root
Major advances in the testing of oral fluid (e.g., saliva) may lead to the diagnosis and treatment of previously undiagnosed conditions and may enable dentists to manage oral disease more effectively. Such use of another body fluid, blood, is already well established. Blood is a complex tissue that has been extensively researched and is now used for a wide variety of diagnostic tests. It is also regarded as a form of property with ethical and legal dimensions. If saliva is to fulfill a similar role, it should perhaps be granted those same protections. This paper advances the concept that saliva should be considered a form of property, possibly within personal biological materials law. The emerging potential for the development of marketable products from oral fluids raises the issue of protecting the research participant's ethical and legal rights. In particular, violation of privacy and genetic discrimination may arise from the testing of salivary DNA. Respect for autonomy requires that the clinician inform a patient or research participant about his or her rights to property and privacy as these may pertain to oral fluid
PMID: 20719097
ISSN: 1488-2159
CID: 155206

An ethical, legal and social implications (ELSI) program for neuroscience : heuristics and the lay public

Vernillo, AT
ORIGINAL:0008645
ISSN: 2150-7740
CID: 742612

Placebos in clinical practice and the power of suggestion

Vernillo, Anthony
PMID: 20013496
ISSN: 1536-0075
CID: 154982

Disclosure of adverse clinical trial results-should legal immunity be granted to drug companies?

Vernillo, Anthony
PMID: 19998162
ISSN: 1536-0075
CID: 154976

Effect of HAART on salivary gland function in the Women's Interagency HIV Study (WIHS)

Navazesh, M; Mulligan, R; Karim, R; Mack, W J; Ram, S; Seirawan, H; Greenspan, J; Greenspan, D; Phelan, J; Alves, M; Vernillo, A
OBJECTIVE: To determine the impact of highly active antiretroviral therapy (HAART) on salivary gland function in human immunodeficiency virus (HIV) positive women from the Women's Interagency HIV Study (WIHS). DESIGN: Longitudinal cohort study. SUBJECTS AND METHODS: A total of 668 HIV positive women from the WIHS cohort with an initial and at least one follow-up oral sub-study visit contributed 5358 visits. Salivary gland function was assessed based on a dry mouth questionnaire, whole unstimulated and stimulated salivary flow rates, salivary gland enlargement or tenderness and lack of saliva on palpation of the major salivary glands. MAIN OUTCOME MEASURES: Changes in unstimulated and stimulated flow rates at any given visit from that of the immediate prior visit (continuous variables). The development of self-reported dry mouth (present/absent), enlargement or tenderness of salivary glands (present/absent), and absence of secretion on palpation of the salivary glands were binary outcomes (yes/no). RESULTS: Protease Inhibitor (PI) based HAART was a significant risk factor for developing decreased unstimulated (P = 0.01) and stimulated (P = 0.0004) salivary flow rates as well as salivary gland enlargement (P = 0.006) as compared with non-PI based HAART. CONCLUSIONS: PI-based HAART therapy is a significant risk factor for developing reduced salivary flow rates and salivary gland enlargement in HIV positive patients
PMCID:2644059
PMID: 19017280
ISSN: 1601-0825
CID: 1425012

Oral manifestations of systemic diseases

Chapter by: Ibsen OAC; Phelan JA; Vernillo AT
in: Oral pathology for the dental hygienist by Ibsen OAC; Phelan JA [Eds]
St. Louis, MO : Saunders, 2009
pp. 290-293
ISBN: 9781416049913
CID: 151794

Pragmatism as a complementary approach to legislation: closing regulatory gaps in human subject research

Vernillo, Anthony
PMID: 19061099
ISSN: 1536-0075
CID: 154270