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Genomics, ethical issues, and the practice of dentistry

Schloss, A J; Vernillo, A T
Medicine and dental medicine are moving rapidly into a new era of dramatic change. In the practice of medicine, cancer therapy is now targeted to each patient's specific disease based on its genetic make-up (genomics), thereby reducing life-threatening side effects while improving treatment outcomes. Biotechnological advances in salivary diagnostics and rapid oral fluid testing may lead to improved treatments in the management of periodontal disease or susceptibility to certain systemic diseases through the detection of genomic transcripts. Ushering in a new era of personalized health care, dentistry must be at the vanguard to benefit patients. Genomics and its advances present opportunities and ethical challenges to clinical practitioners. Dentistry must adapt to and manage these advances in a manner consistent with our principles of ethics. In this paper, we discuss how dentistry should manage the following issues as these pertain to clinical practice, and include the following: (1) ethical and legal considerations to report test results to patients and potentially their next-of-kin; (2) counseling patients on incidental and actionable findings; (3) direct-to-consumer genetic testing companies and the doctor-patient relationship; and (4) inclusion of the ethics of genetic counseling in the dental school curriculum given advances in salivary diagnostics
EMBASE:20160502125
ISSN: 2151-8068
CID: 2214302

The ethics of corporate social responsibility

Bergman, Stanley M; Vernillo, Anthony T
Corporations as well as individual professionals have an ethical obligation to help those in need. There is a sound tradition in American business for companies including social outreach as part of business strategy. This approach works best when corporations and community and professional experts work in partnership. Henry Schein's Corporate Social Responsibility program contributes expertise, logistics, connections, and funds to these partnerships in the United States and worldwide.
PMID: 25080670
ISSN: 0002-7979
CID: 3118112

Practice-Based Research Network Infrastructure Design for Institutional Review Board Risk Assessment and Generalizability of Clinical Results

Curro, Frederick; Thompson, Van P; Naftolin, Frederick; Grill, Ashley; Vena, Don; Terracio, Louis; Hashimoto, Mariko; Buchholz, Matthew; McKinstry, Andrea; Cannon, Diane; Alfano, Vincent; Gooden, Thalia; Vernillo, Anthony; Czeisler, Elan
Data from clinical studies generated by Practice Based Research Networks should be generalizable to the profession. For nationally representative data a broad recruitment of practitioners may pose added risks to IRB's. Infrastructure must assure data integrity while minimizing risk to assure that the clinical results are generalizable. The PEARL Network is an interdisciplinary dental/medical PBRN conducting a broad range of clinical studies. The infrastructure is designed to support the principles of Good Clinical Practice (GCP) and create a data audit trail to ensure data integrity for generalizability. As the PBRN concept becomes of greater interest, membership may expand beyond the local community, and the issue of geography versus risk management becomes of concern to the IRB. The PEARL Network describes how it resolves many of the issues related to recruiting on a National basis while maintaining study compliance to ensure patient safety and minimize risk to the IRB.
PMCID:4418503
PMID: 25949926
ISSN: 2168-4790
CID: 3154182

Ethical, Legal, and Social Challenges in the Biobanking of Oral Fluid Specimens

Vernillo, Anthony; Naidoo, Sudeshni; Schloss, Alexander
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
ORIGINAL:0008637
ISSN: 2151-805x
CID: 717522

Ethical, legal and social challenges to the biobanking of oral fluid specimens : mini-symposium ethics in dentistry

Vernillo, AT; Naidoo, S
ORIGINAL:0008647
ISSN: 1555-9254
CID: 742632

Ethical and legal issues on HIV testing, policy and the practice of dentistry

Naidoo, Sudeshni; Vernillo, Anthony
This paper is structured around the following: autonomy and consent, confidentiality, disclosure, knowledge of patient and provider HIV status, the right to choose whom to treat, testing for HIV and the importance of HIV policies in the workplace to guard against discrimination. The emergence of the HIV/AIDS pandemic has challenged traditional ethical values of the health care profession. These include the infectious nature of HIV, the social stigma of the disease and its ethical and legal dilemmas. This paper addresses some of the pertinent questions related to HIV infection and AIDS. The three broad principles of ethics, namely, autonomy, beneficence and justice, provide the basic framework on which this paper is based. Advances in the biotechnology of rapid oral fluid testing particularly in the detection of HIV antibodies from patients in the dental setting have raised additional ethical and legal considerations in the subsequent management of HIV infected patients to include disclosure of test results to the patient and proper referral to physicians or nurse practitioners. The oral health care worker must thus have a solid foundation in the application of bioethical principles. A clinical case scenario related to HIV testing in the dental setting is presented to illustrate how a lack of understanding and the wrongful application of ethical principles may lead to patient harm and legal liability. Given the increasing infection rate of HIV worldwide, polices must be upheld and revised as needed to protect healthcare providers, patients, and society generally against discrimination.
PMID: 23474504
ISSN: 0258-414x
CID: 627032

Feasibility of implementing rapid oral fluid HIV testing in an urban University Dental Clinic: a qualitative study

Hutchinson, M Katherine; VanDevanter, Nancy; Phelan, Joan; Malamud, Daniel; Vernillo, Anthony; Combellick, Joan; Shelley, Donna
BACKGROUND: More than 1 million individuals in the U.S. are infected with HIV; approximately 20% of whom do not know they are infected. Early diagnosis of HIV infection results in earlier access to treatment and reductions in HIV transmission. In 2006, the CDC recommended that health care providers offer routine HIV screening to all adolescent and adult patients, regardless of community seroprevalence or patient lifestyle. Dental providers are uniquely positioned to implement these recommendations using rapid oral fluid HIV screening technology. However, thus far, uptake into dental practice has been very limited. METHODS: The study utilized a qualitative descriptive approach with convenience samples of dental faculty and students. Six in-depth one-on-one interviews were conducted with dental faculty and three focus groups were conducted with fifteen dental students. RESULTS: Results were fairly consistent and indicated relatively high levels of acceptability. Barriers and facilitators of oral fluid HIV screening were identified in four primary areas: scope of practice/practice enhancement, skills/knowledge/training, patient service/patient reactions and logistical issues. CONCLUSIONS: Oral fluid HIV screening was described as having benefits for patients, dental practitioners and the public good. Many of the barriers to implementation that were identified in the study could be addressed through training and interdisciplinary collaborations.
PMCID:3436777
PMID: 22571324
ISSN: 1472-6831
CID: 215142

Different labs

Peltier, Bruce; Vernillo, Anthony; Giusti, Lola; Jenson, Larry E
In this case a young dentist has signed onto a managed care plan that has several attractive features. Eventually, however, he notices that he makes little or no net revenue for some of the work that he does. A colleague recommends that he use different labs for different patients, with labs matched to each patient's dental plan and coverage. Offshore labs are used for managed care patients. Three knowledgeable experts comment on the case, two with many years of private practice experience, two who are dental educators holding master's degrees in philosophy and bioethics.
PMID: 23654165
ISSN: 0002-7979
CID: 627042

Routine Opt-Out HIV Testing in Dental Health Care-Its Implementation and the Advancement of Public Health

Vernillo, Anthony
PMID: 21480076
ISSN: 1536-0075
CID: 155270

The challenges of oral-based diagnostics in extending the role of dentistry as a health care profession: property rights, privacy, and informed consent

Vernillo, Anthony; Welie, Jos V M; Naidoo, Sudeshni; Malamud, Daniel
Saliva may be a legal and ethical counterpart of other bodily fluids in diagnostic testing to blood and urine, with regard to its role in diagnostic testing. Two paradigms that have been proposed in the literature to address these challenges are reviewed in this paper. The first is centered on ownership and property rights to saliva, including financial compensation from commercially developed products using saliva. The commodification of saliva as property is also discussed. The second paradigm is related to privacy and the potential for genetic discrimination, given the unwarranted disclosure of confidential information. The management of saliva specimens from dental patients and research participants will also require the implementation of innovative approaches to obtain informed consent
PMID: 22263370
ISSN: 0002-7979
CID: 155494