Order:
Disambiguations
Gail Javitt [6]Gail H. Javitt [3]
  1.  7
    How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?Barbara J. Evans, Gail Javitt, Ralph Hall, Megan Robertson, Pilar Ossorio, Susan M. Wolf, Thomas Morgan & Ellen Wright Clayton - 2020 - Journal of Law, Medicine and Ethics 48 (1):44-68.
    Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark   5 citations  
  2.  54
    Take Another Little Piece of My Heart1: Regulating the Research Use of Human Biospecimens.Gail H. Javitt - 2013 - Journal of Law, Medicine and Ethics 41 (2):424-439.
    This article reviews the history of the debate over use of biospecimens in research, the legal and ethical arguments that have been presented both in support of and in opposition to such use, court cases and judicial opinions involving disputes between specimen contributors, researchers, and institutions, and public attitudes regarding the use of biospecimens in research. The paper argues that proposed changes to the Common Rule are inadequate to resolve the legal and ethical concerns that have been raised with respect (...)
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark   4 citations  
  3.  41
    Assessing Mandatory HPV Vaccination: Who Should Call the Shots?Gail Javitt, Deena Berkowitz & Lawrence O. Gostin - 2008 - Journal of Law, Medicine and Ethics 36 (2):384-395.
    In 2007, many legislatures considered, and two enacted, bills mandating HPV vaccination for young girls as a condition of school attendance. Such mandates raise signifcant legal, ethical, and social concerns. This paper argues that mandating HPV vaccination for minor females is premature since long-term safety and efectiveness of the vaccine has not been established, HPV does not pose imminent and signifcant risk of harm to others, a sex specifc mandate raises constitutional concerns, and a mandate will burden fnancially existing government (...)
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark   6 citations  
  4.  8
    Regulation of Next Generation Sequencing.Gail H. Javitt & Katherine Strong Carner - 2014 - Journal of Law, Medicine and Ethics 42 (s1):9-21.
    Since the first draft of the human genome was published in 2001, DNA sequencing technology has advanced at a remarkable pace. Launched in 1990, the Human Genome Project sought to sequence all three billion base pairs of the haploid human genome, an endeavor that took more than a decade and cost nearly three billion dollars. The subsequent development of so-called “next generation” sequencing methods has raised the possibility that real-time, affordable genome sequencing will soon be widely available. Currently, NGS methods (...)
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark   4 citations  
  5.  4
    Take Another Little Piece of My Heart: Regulating the Research Use of Human Biospecimens.Gail H. Javitt - 2013 - Journal of Law, Medicine and Ethics 41 (2):424-439.
    Access to human biospecimens is widely regarded as essential to the progress of medical research, and in particular, to the success of “personalized medicine.” Understanding the influence of genetic variation on human health and disease requires that researchers conduct genetic and other studies on thousands of human specimens. Over the past decade, human “biobanks” — vast collections of human biospecimens — have proliferated both in the United States and internationally. These biobanks are subject to a heterogeneous mix of standards that (...)
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark   5 citations  
  6.  9
    Assessing Mandatory HPV Vaccination: Who Should Call the Shots?Gail Javitt, Deena Berkowitz & Lawrence O. Gostin - 2008 - Journal of Law, Medicine and Ethics 36 (2):384-395.
    The human papillomavirus is the most common sexually transmitted infection worldwide. In the United States, more than six million people are infected each year. Although most HPV infections are benign, two strains of HPV cause 70 percent of cervical cancer cases. Two other strains of HPV are associated with 90 percent of genital warts cases.In June 2006, the Food and Drug Administration approved the first vaccine against HPV. Sold as Gardasil, the quadrivalent vaccine is intended to prevent four strains of (...)
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark   6 citations  
  7.  9
    Capping the Crisis: Medical Malpractice and Tort Reform.Gail Javitt & Elaine Lu - 1992 - Journal of Law, Medicine and Ethics 20 (3):258-261.
    Direct download  
     
    Export citation  
     
    Bookmark  
  8.  3
    Capping the Crisis: Medical Malpractice and Tort Reform.Gail Javitt & Elaine Lu - 1992 - Journal of Law, Medicine and Ethics 20 (3):258-261.
    Direct download  
     
    Export citation  
     
    Bookmark