ABSTRACT
The recent increased number of conditions for which patients can undergo genetic carrier testing raises the question of how best to obtain pre-test informed consent. Clinical approaches vary from a minimalist model to a model where patients are given detailed information about all conditions to be screened for. Few data exist as to patient preferences, or how information impacts decision-making. Eight high-literacy focus groups were conducted to assess the knowledge and preferences of pregnant patients and their male partners. Most groups indicated that some balance between details and brevity was optimal, recognizing that anxiety can occur when patients are provided with too much information and that the wide range of tests offered during pregnancy often led to confusion. Critical areas for the informed consent process included (1) details about the conditions and risk of being a carrier, (2) logistics of testing, (3) next steps if the test is positive, and (4) prognosis, options and resources if the child were to be affected with a disorder. It will be useful to develop model consent programs and prospectively assess their impact on informed consent and patient satisfaction, both when positive and negative results are received.
Subject(s)
Choice Behavior , Genetic Carrier Screening , Genetic Testing/psychology , Informed Consent/psychology , Awareness , Female , Focus Groups , Genetic Diseases, Inborn/genetics , Genetic Diseases, Inborn/prevention & control , Genetic Diseases, Inborn/psychology , Health Knowledge, Attitudes, Practice , Humans , Infant, Newborn , Maternal Age , Pregnancy , Prenatal Diagnosis/psychologySubject(s)
Embryo, Mammalian , Ethics , Stem Cells , Female , Financing, Government , Humans , Legislation as Topic , Male , Research/standards , United StatesSubject(s)
Confidentiality/legislation & jurisprudence , DNA , Genetic Privacy/legislation & jurisprudence , Genetic Testing/legislation & jurisprudence , Informed Consent/legislation & jurisprudence , Genetic Research , Genotype , Humans , Massachusetts , Prejudice , Privacy/legislation & jurisprudence , Research/legislation & jurisprudence , State GovernmentSubject(s)
Cocaine-Related Disorders/diagnosis , Law Enforcement , Physician-Patient Relations , Pregnancy Complications/diagnosis , Pregnant Women , Substance Abuse Detection/legislation & jurisprudence , Supreme Court Decisions , Child Abuse/legislation & jurisprudence , Female , Humans , Infant, Newborn , Informed Consent/legislation & jurisprudence , Organizational Policy , Poverty , Pregnancy , Schools, Medical/organization & administration , South Carolina , United StatesABSTRACT
This article outlines the arguments for and against new rules to protect genetic privacy. We explain why genetic information is different to other sensitive medical information, why researchers and biotechnology companies have opposed new rules to protect genetic privacy (and favour anti-discrimination laws instead), and discuss what can be done to protect privacy in relation to genetic-sequence information and to DNA samples themselves.
Subject(s)
Ethics, Medical , Genetic Testing , Privacy/legislation & jurisprudence , Employment , Humans , Insurance, Health , PrejudiceSubject(s)
Abortion, Legal , Jurisprudence , Supreme Court Decisions , Abortion, Legal/methods , Abortion, Therapeutic , Female , Humans , Nebraska , Pregnancy , Pregnancy Trimester, Second , United StatesSubject(s)
Judicial Role , Abortion, Induced , Adult , Bioethical Issues , Decision Making , Euthanasia, Passive , Female , Genetic Engineering , Homicide/legislation & jurisprudence , Humans , Infant , Jurisprudence , Medicine , Organ Transplantation , Physician's Role , Suicide, Assisted , Twins, Conjoined , United StatesSubject(s)
Smoking/legislation & jurisprudence , Tobacco Industry/legislation & jurisprudence , United States Food and Drug Administration/legislation & jurisprudence , Government , Government Agencies/organization & administration , Humans , Plants, Toxic , Smoking Prevention , Nicotiana , Tobacco Industry/standards , United States , United States Food and Drug Administration/organization & administrationSubject(s)
Embryo Transfer , Research/legislation & jurisprudence , Contracts , Cryopreservation , Dissent and Disputes , Embryo Disposition/ethics , Embryo Disposition/legislation & jurisprudence , Embryo Disposition/statistics & numerical data , Fertilization in Vitro/legislation & jurisprudence , Guidelines as Topic , Humans , Informed Consent , Massachusetts , National Institutes of Health (U.S.) , Public Policy , Research/standards , Stem Cells , United StatesSubject(s)
Genes , Genome, Human , Patents as Topic/legislation & jurisprudence , Humans , United StatesSubject(s)
Databases as Topic , Databases, Nucleic Acid , Genetic Privacy , Genetic Research , Informed Consent , Medical Records Systems, Computerized , DNA , Delivery of Health Care , Genome, Human , Genotype , Humans , Iceland , Minors , Research , Research Subjects , Risk Assessment , Third-Party ConsentSubject(s)
Genetic Engineering/ethics , Animals , Cloning, Organism , Eugenics , Human Characteristics , Humans , Science/ethicsABSTRACT
Tremendous controversy has surrounded efforts to undertake research on totipotent human stem cells. To date public policy in the United States has attempted to skirt the ethical and social questions raised by this research. Annas et al. argue that research using human embryos as a source of totipotent stem cells can secure broad public support if there is an open and public discussion about the ethical justification for undertaking such research and the assurance of adequate federal regulation and oversight.
Subject(s)
Embryo Research , Ethics, Medical , Stem Cells , Aborted Fetus , Advisory Committees , Animals , Cloning, Organism , Federal Government , Female , Fetus/cytology , Government Regulation , Humans , Moral Obligations , National Institutes of Health (U.S.) , Nuclear Transfer Techniques , Pregnancy , Public Policy , Research Design , Research Embryo Creation , Research Support as Topic , Risk Assessment , United StatesSubject(s)
Behavior Control , Emergencies , Patient Advocacy/legislation & jurisprudence , Restraint, Physical/legislation & jurisprudence , Restraint, Physical/standards , Treatment Refusal/legislation & jurisprudence , Centers for Medicare and Medicaid Services, U.S. , Federal Government , Government Regulation , Humans , Informed Consent/legislation & jurisprudence , Patient Rights , Restraint, Physical/adverse effects , United StatesSubject(s)
Clinical Trials as Topic , Ethics, Medical , Human Experimentation , Needle-Exchange Programs , Alabama , Alaska , Humans , Metaphor , Research Design , SyphilisSubject(s)
Blood Banks/legislation & jurisprudence , Fetal Blood , Biomedical Research , Blood Banks/organization & administration , Blood Banks/standards , Commerce , Commodification , Directed Tissue Donation , Genetic Privacy , Humans , Informed Consent , Ownership , Parental Consent , Placenta/blood supply , Privacy , Tissue and Organ Procurement , United StatesSubject(s)
Evidence-Based Medicine/legislation & jurisprudence , Malpractice/legislation & jurisprudence , Public Health/legislation & jurisprudence , Science/legislation & jurisprudence , Advisory Committees , Causality , Compensation and Redress , Consumer Advocacy/legislation & jurisprudence , Federal Government , Government , Government Regulation , Humans , Judicial Role , Liability, Legal , United StatesABSTRACT
The Titanic has become a metaphor for the disastrous consequences of an unqualified belief in the safety and invincibility of new technology. Similarly, the thalidomide tragedy stands for all of the "monsters" that can be inadvertently or negligently created by modern medicine. Thalidomide, once banned, has returned to the center of controversy with the Food and Drug Administration's (FDA's) announcement that thalidomide will be placed on the market for the treatment of erythema nodosum leprosum, a severe dermatological complication of Hansen's disease. Although this indication is very restricted, thalidomide will be available for off-label uses once it is on the market. New laws regarding abortion and a new technology, ultrasound, make reasonable the approval of thalidomide for patients who suffer from serious conditions it can alleviate. In addition, the FDA and the manufacturer have proposed the most stringent postmarketing monitoring ever used for a prescription drug, including counseling, contraception, and ultrasonography in the event of pregnancy. The Titanic/thalidomide lesson for the FDA and public health is that rules and guidelines alone are not sufficient to guarantee safety. Continuous vigilance will be required to ensure that all reasonable postmarketing monitoring steps are actually taken to avoid predictable and preventable teratogenic disasters.