Subject(s)
Mitochondrial Diseases/therapy , Mitochondrial Replacement Therapy/legislation & jurisprudence , DNA, Mitochondrial/genetics , Drug Approval/legislation & jurisprudence , Humans , Legislation, Medical/ethics , Mitochondrial Diseases/genetics , Mitochondrial Replacement Therapy/ethics , Mutation , United Kingdom , United States , United States Food and Drug Administration/legislation & jurisprudenceABSTRACT
OBJECTIVE: Over 70% of women with gestational diabetes mellitus (GDM) will develop diabetes mellitus (DM), but only 30% follow through with the recommended postpartum oral glucose tolerance testing (OGTT). HbA1c is approved to diagnose DM, and combined with a fasting plasma glucose it can identify 93% of patients with dysglycemia. We tested the hypothesis that a single blood draw to assess for dysglycemia at the postpartum visit could improve testing rates compared with those required to obtain an OGTT at an outside laboratory. STUDY DESIGN: Prospective cohort study of all women with GDM who delivered between July 2010 and December 2011. When insurance status required testing at an outside laboratory an OGTT was ordered, when insurance allowed testing at our center a random sugar and HbA1c were drawn at the postpartum visit (SUGAR Protocol). RESULTS: Of the 40 women, 36 attended a postpartum visit. In the SUGAR arm, 19 of 19 (100%) were tested versus 9 of 17 (53%) in the OGTT arm; relative risk of testing was 1.9 (95% confidence interval, 1.2-3.0). 36% were glucose intolerant. CONCLUSION: This pilot study found that an in-office testing model doubled the rate of postpartum testing in this clinic population, and was reasonably sensitive at detecting dysglycemia.
Subject(s)
Blood Glucose/chemistry , Diabetes, Gestational/diagnosis , Glycated Hemoglobin/chemistry , Pregnancy Complications/diagnosis , Adult , Fasting , Female , Glucose Tolerance Test , Humans , Pilot Projects , Postpartum Period , Pregnancy , Prospective Studies , Young AdultABSTRACT
The use of whole-genome sequencing in biomedical research is expected to produce dramatic advances in human health. The increasing use of this powerful, data-rich new technology in research, however, will inevitably give rise to incidental findings (IFs)-findings with individual health or reproductive significance that are beyond the aims of the particular research-and the related questions of whether and to what extent researchers have an ethical obligation to return IFs. Many have concluded that researchers have an ethical obligation to return some findings in some circumstances but have provided vague or context-dependent approaches to determining which IFs must be returned and when. As a result, researchers have started returning IFs inconsistently, giving rise to concerns about legal liability in circumstances in which notification could have potentially prevented injury. Although it is clear that ethical guidance should not be automatically codified as law and that crafting ethical obligations around legal duties can be inappropriate, the ethical debate should not proceed unaware of the potential legal ramifications of advancing and implementing an ethical obligation to return IFs. This Article assesses the legal claims that could be brought for a researcher's failure to return IFs. The potential for researchers to be held liable in tort is still uncertain and turns largely on a number of factors-including customary practice and guidance documents-that are still in flux. Unlike medical care, which has a well-defined duty into which evolving scientific knowledge about genetics and genomics can readily be incorporated, a researcher's duty to return IFs is less well defined, making it difficult to determine at the outset whether and when legal liability will attach. This Article advocates for a clearer, ethically sound standard of requiring that researchers disclose in the informed consent document which approach to offering IFs will be taken. This approach enables participants to know at the outset which findings, if any, will be returned, allows researchers to ascertain when their failure to appropriately return incidental findings will give rise to liability, and enables courts to make determinations that will produce more consistent legal guidance.
ABSTRACT
For more than 20 years, the Ethical, Legal, and Social Implications (ELSI) Program of the National Human Genome Research Institute has supported empirical and conceptual research to anticipate and address the ethical, legal, and social implications of genomics. As a component of the agency that funds much of the underlying science, the program has always been an experiment. The ever-expanding number of issues the program addresses and the relatively low level of commitment on the part of other funding agencies to support such research make setting priorities especially challenging. Program-supported studies have had a significant impact on the conduct of genomics research, the implementation of genomic medicine, and broader public policies. The program's influence is likely to grow as ELSI research, genomics research, and policy development activities become increasingly integrated. Achieving the benefits of increased integration while preserving the autonomy, objectivity, and intellectual independence of ELSI investigators presents ongoing challenges and new opportunities.
Subject(s)
Genome, Human/genetics , National Human Genome Research Institute (U.S.)/ethics , National Human Genome Research Institute (U.S.)/legislation & jurisprudence , Public Policy , Genetic Testing , Humans , National Human Genome Research Institute (U.S.)/trends , United StatesABSTRACT
The cost of whole genome sequencing is dropping rapidly. There has been a great deal of enthusiasm about the potential for this technological advance to transform clinical care. Given the interest and significant investment in genomics, this seems an ideal time to consider what the evidence tells us about potential benefits and harms, particularly in the context of health care policy. The scale and pace of adoption of this powerful new technology should be driven by clinical need, clinical evidence, and a commitment to put patients at the centre of health care policy.
Subject(s)
Genomics/economics , Health Policy , High-Throughput Nucleotide Sequencing/economics , Sequence Analysis, DNA/economics , Genome, Human , Genomics/legislation & jurisprudence , Humans , Public Opinion , United StatesSubject(s)
Genetic Research , Genomics/ethics , Incidental Findings , Disclosure/ethics , Games, Experimental , HumansABSTRACT
Ethical complexities surround the promise of genomic technology and the power of genetic information as they alter conceptions of identity and dynamics within personal and professional relationships. Creative approaches such as dramatic vignettes offer a unique analytical stage for imagining the bioethical past and future. Dramatic narratives can bring to life images of differing perspectives and values when experiencing innovations in medicine. Although the scientific landscape shifts, concerns expressed in theatre from 50 years ago parallel many contemporary ELSI (ethical, legal, and social implications) issues, highlighting the ongoing struggle to appreciate the impact of emerging genetic technologies on relationships. To illuminate these enduring concerns, we explore how perceptions and relationships have influenced-and been influenced by-genetics as portrayed through dramatic vignettes. We build on the legacy of using case vignettes as a clinical teaching modality, and believe similar value exists within the research ethics domain. The selection of dialogue discussed encompasses abbreviated excerpts from two existing and one original vignette that we staged at the ELSI 2011 Congress and various academic and health institutions.
Subject(s)
Drama , Genetic Research/ethics , Research Personnel/psychology , Ethics, Research , Genetic Research/legislation & jurisprudence , Genetic Techniques/ethics , Humans , Informed Consent , Research Personnel/ethics , Social ValuesABSTRACT
During the past two decades, the use of DNA tests has revolutionized court proceedings in criminal and paternity cases. On the horizon is a new challenge for judges--whether to admit or compel genetic tests to confirm or predict genetic diseases and conditions in many more judicial contexts, e.g., decisions regarding culpability, sentencing, liability, causation, and damages. This Policy Forum reports on an empirical study of how judges would analyze these issues. The authors discuss the challenges these types of cases will bring to the court-room and suggest a series of questions that judges should consider in evaluating the need for genetic information in legal cases.
Subject(s)
Genetic Testing/legislation & jurisprudence , Data Collection , Humans , JurisprudenceSubject(s)
Genetic Predisposition to Disease , Genetic Privacy , Genetic Testing , Insurance, Health , Employment/legislation & jurisprudence , Fear , Genetic Privacy/legislation & jurisprudence , Human Genome Project , Humans , Insurance Selection Bias , Insurance, Health/legislation & jurisprudence , Prejudice , Public Opinion , Public Policy , United StatesSubject(s)
Child , Disclosure/legislation & jurisprudence , Lead Poisoning/prevention & control , Liability, Legal , Nontherapeutic Human Experimentation/legislation & jurisprudence , Research Personnel/legislation & jurisprudence , Risk , Baltimore , Duty to Warn , Environmental Exposure , Housing/standards , Humans , Judicial Role , Nontherapeutic Human Experimentation/ethics , Parental Consent/legislation & jurisprudence , Public Health , Researcher-Subject RelationsSubject(s)
Genetic Predisposition to Disease , Genetic Research , Genetics , Jews , Prejudice , Breast Neoplasms , Employment , Female , Genetic Testing , Human Experimentation , Humans , Informed Consent , Insurance , Neoplasms , Research Subjects , Risk , Risk Assessment , Stereotyping , Tay-Sachs Disease , Trust , United States , WomenSubject(s)
Ethics Committees, Research , Ethics Committees , Human Experimentation , Minority Groups , National Institutes of Health (U.S.) , Patient Selection , Research Subjects , Women , Community Participation , Federal Government , Female , Government , Government Regulation , Guidelines as Topic , Humans , Pregnancy , Pregnant Women , Social Control, Formal , Statistics as Topic , United StatesSubject(s)
Human Experimentation , Patient Selection , Pregnancy , Pregnant Women , Research Subjects , Women , Age Factors , Disclosure , Ethics Committees , Ethics Committees, Research , Federal Government , Female , Government , Government Regulation , Guidelines as Topic , Humans , Informed Consent , Mental Competency , National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division , National Institutes of Health (U.S.) , Paternalism , Persons , Social Control, Formal , Social Justice , Spouses , Third-Party Consent , United States , United States Dept. of Health and Human Services , Vulnerable Populations , Women's HealthSubject(s)
Guidelines as Topic , Human Experimentation , Liability, Legal , National Institutes of Health (U.S.) , Patient Selection , Prenatal Exposure Delayed Effects , Public Policy , Research Subjects , Women's Health , Women , Age Factors , Behavioral Research , Child , Disclosure , Female , Fetus , Humans , Informed Consent , Minority Groups , Peer Review , Pregnancy , Pregnant Women , Research , Research Design , Research Personnel , Risk , Therapeutic Human Experimentation , United StatesSubject(s)
Government Regulation , Human Experimentation , Patient Selection , Prejudice , Public Policy , Research Subjects , Social Control, Formal , Women , Biomedical Research , Civil Rights , Communication , Confidentiality , Decision Making , Federal Government , Female , Fetus , Financing, Government , Freedom , Government , Humans , Jurisprudence , Liability, Legal , Men , National Institutes of Health (U.S.) , Personal Autonomy , Pharmaceutical Preparations , Physician-Patient Relations , Pregnancy , Pregnant Women , Prenatal Exposure Delayed Effects , Reproduction , Research , Social Justice , Spouses , State Government , Supreme Court Decisions , Third-Party Consent , United States , United States Food and Drug Administration , Women's HealthSubject(s)
Coercion , Communicable Diseases , Jurisprudence , Mandatory Programs , Patient Compliance , Public Health , Public Policy , Quarantine , Tuberculosis , Civil Rights , Commitment of Mentally Ill , Disabled Persons , Economics , Federal Government , Government , HIV Seropositivity , Health Care Rationing , Ill-Housed Persons , Humans , Minority Groups , Motivation , Patient Care , Pharmaceutical Preparations , Prejudice , Prevalence , Resource Allocation , Socioeconomic Factors , State Government , Treatment Refusal , United States , Vulnerable PopulationsABSTRACT
The law's response to reproductive genetic testing depends on a number of assumptions about choice, causation and control which need to be questioned. From the preconception stage forward, the illusion of choice may raise such fundamental questions as the woman's choice not to be tested, limits on genetic information, and the availability of reproductive options. In turn, assumptions about choice raise questions about the responsibility for results and the connection between choice and causation in the context of wrongful birth and life actions. Assumptions made about control over reproductive choice and over causing 'harm', will impact on the development of future law.