Law & Bioethics Introduction: The Relationship Between Law and Bioethics Statutory Law Case Law Ethical IssuesStatutory Laws Influencing BioethicsCase Law Influencing BioethicsWeb ResourcesSuggested ReadingsGlossary of Legal TermsIntroduction The Relationship Between Law and BioethicsThe Encyclopedia of Bioethics (Simon & Schuster Macmillan, 1995) defines bioethics as: "thebroad terrain of the moral problems of life sciences, ordinarily taken to encompass medicine,biology, and some important aspects of the environmental, population, and social sciences." Laws often provide guidance to those confronted with bioethical problems because they establish restrictions and requirements for behavior, and may represent a general consensusof what is or is not ethical. For example, Title 21, a federal law, establishes when and under what conditions it is acceptable to conduct biomedical research on human subjects and is generally regarded as a set of rules arising out of ethical concerns and reflecting something of an ethical consensus. However, laws cannot always offer definitive answers. In some cases the law may even conflict with an individual's belief of what is ethical in a particular situation. Thus, laws affecting bioethical issues often create conflict and raise important questions. How Laws Affect Bioethical DecisionsMost individuals will have to make a choice involving bioethics at some point in their lives. The study of bioethics is concerned with identifying all of the available options and considering the implications of each option. In some cases, laws limit the available choices. For example, a Pennsylvania law requires minors to obtain parental consent in order to have an abortion. Thus, in Pennsylvania, a physician has limited legal options when confronted with a minor patient who requests an abortion but does not wish to inform her parents (discussed in Planned Parenthood v. Casey). The physician's choices are limited regardless of his or her beliefs regarding the validity of the patient's reasons for wishing to maintain her privacy. In this way, certain bioethical standards may be imposed on all members of society, based on legislative or judicial actions that may, or may not, represent societal consensus. Bioethicists often disagree about whether or not this is appropriate. At the same time, the creation and form of such laws may be influenced by those working in the field of bioethics who actively engage in the legislative or judicial process. Because laws can affect bioethics by limiting choices and bioethics can affect the creation oflaws, the two fields are inseparable in many situations. Laws can be created either through legislation which is called statutory law, or by opinions written by judges in court cases which is called case law. Below is an explanation of thesetwo types of law. You can also access examples of statutory laws or case laws influencing bioethics further down on this page.Statutory law is comprised of written laws enacted by either a state legislature or the Federal Congress. Statutory laws are either civil, including such things as licensing professions, building codes, and the establishment of holidays, or criminal. Civil laws represent the government's general power to influence or control activity, but do not involvecriminal penalties. Violation of a criminal statutory law is considered a crime and may resultin a fine and/or jail time.Congress, the President, and various state officials often review reports or presentations by bioethicists while considering new legislation. (For an example of this, see the President's Council on Bioethics). The legal options available to a person making a bioethical decision may be the same throughout the country, or may depend on the state in which that person is located. The Constitution defines specific areas in which the federal government may make laws, preserving all other areas of law for the individual states. Once the federal government makes a law concerning a certain issue, that law is superior to any conflicting state law. Thus, if federal law addresses a specific issue, the legal options are the same in all states. If there is no federal law that applies, options are determined by state law and may differ among states. In addition to specific laws, the federal government, and individual state governments, may also establish regulatory bodies with the power to regulate certain well-defined areas and practices. One example of a regulatory body affecting bioethics is the Office for Human Research Protections (OHRP), part of the U.S. Department of Health and Human Services (HHS). The OHRP regulates research involving human subjects. Click here for a list of links to several federal and Minnesota state statutory laws. Case law, often referred to as judge-made law, is comprised of decisions, in the form of written opinions, which determine the outcome of individual court cases by providing an interpretation of statutory laws, and often an interpretation of the U.S. Constitution. Many of the legal rules affecting bioethics are the result of case law.Appellate courts may consider outside information in the form of amicus briefs, including those written by, or submitted on behalf of bioethicists, when ruling on cases and creating case law. Statutory law as amplified and interpreted by case law establishes principles and guidelines of behavior that must be followed at the risk of legal consequences in the form of civil lawsuits, enforcement actions by the government or its agencies, or criminal prosecution. An individual or agency that violates an established law may be susceptible to a lawsuit. As a result, a court may order the individual or agency to stop a particular activity and/or require them to pay monetary damages to the other party. If the actions of the individual or agency also violate a criminal law, the individual may be susceptible to criminal penalties, including jail time and/or fines. A government agency may also bring an action to suspend alicense or stop an activity conducted in violation of the law. If a person feels that her rights have been violated in some way, she can, in many cases, suethe individual or corporation responsible for that violation. In addition, an individual orentity can sue a state, a government agency, or even the federal government, if he or she believes that a particular law violates his or her rights. Once a case is
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