The regulation of science refers to use of law, or other ruling, by

academic An academy (Attic Greek: Ἀκαδήμεια; Koine Greek Ἀκαδημία) is an institution of secondary or tertiary higher learning (and generally also research or honorary membership). The name traces back to Plato's school of philosophy, ...

government A government is the system or group of people governing an organized community, generally a state. In the case of its broad associative definition, government normally consists of legislature, executive, and judiciary. Government is ...

al bodies to allow or restrict

science Science is a systematic endeavor that Scientific method, builds and organizes knowledge in the form of Testability, testable explanations and predictions about the universe. Science may be as old as the human species, and some of the earli ...

from performing certain practices, or researching certain scientific areas. Science could be regulated by

legislation Legislation is the process or result of enrolling, enacting, or promulgating laws by a legislature, parliament, or analogous governing body. Before an item of legislation becomes law it may be known as a bill, and may be broadly referred to ...

if areas are seen as harmful,

immoral Immorality is the violation of moral laws, norms or standards. It refers to an agent doing or thinking something they know or believe to be wrong. Immorality is normally applied to people or actions, or in a broader sense, it can be applied to g ...

, or dangerous. For these reasons science regulation may be closely related to

religion Religion is usually defined as a social- cultural system of designated behaviors and practices, morals, beliefs, worldviews, texts, sanctified places, prophecies, ethics, or organizations, that generally relates humanity to supernatural, ...

culture Culture () is an umbrella term which encompasses the social behavior, institutions, and norms found in human societies, as well as the knowledge, beliefs, arts, laws, customs, capabilities, and habits of the individuals in these groups ...

and

society A society is a group of individuals involved in persistent social interaction, or a large social group sharing the same spatial or social territory, typically subject to the same political authority and dominant cultural expectations. Soci ...

. Science regulation is often a

bioethical Bioethics is both a field of study and professional practice, interested in ethical issues related to health (primarily focused on the human, but also increasingly includes animal ethics), including those emerging from advances in biology, m ...

issue related to practices such as

abortion Abortion is the termination of a pregnancy by removal or expulsion of an embryo or fetus. An abortion that occurs without intervention is known as a miscarriage or "spontaneous abortion"; these occur in approximately 30% to 40% of pre ...

and euthanasia, and areas of research such as

stem-cell research In multicellular organisms, stem cells are undifferentiated or partially differentiated cells that can differentiate into various types of cells and proliferate indefinitely to produce more of the same stem cell. They are the earliest type of ...

and

cloning Cloning is the process of producing individual organisms with identical or virtually identical DNA, either by natural or artificial means. In nature, some organisms produce clones through asexual reproduction. In the field of biotechnology, c ...

synthetic biology.

United States

Biomedical research

Unjust events such as the St. Louis tragedy or the

Tuskegee syphilis experiment The Tuskegee Study of Untreated Syphilis in the Negro Male (informally referred to as the Tuskegee Experiment or Tuskegee Syphilis Study) was a study conducted between 1932 and 1972 by the United States Public Health Service (PHS) and the Cente ...

have prompted regulations in biomedical research. Over the years, regulations have been extended to encompass animal welfare and research misconduct. The federal government also monitors the production and sale of the results of biomedical research such as drugs and biopharmaceuticals. The

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

and the

Department of Health and Human Services The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is ...

oversee the implementation of these regulations. The Dickey–Wicker Amendment prohibits the Department of Health and Human Services (HHS) from using appropriated funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed.

Human subject research

The issue of experimentation on human subjects gained prominence after World War II and the revelation of atrocities committed in the name of science. In the United States, the 1962 Kefauver-Harris amendments to the

included for the first time a requirement for informed consent of participants. In 1966, a policy statement by the U.S Surgeon General required that all human subject research go through independent prior review. The National Research Act of 1974 institutionalized this review process by requiring that research centers establish Institutional Review Boards (IRBs). Universities, hospitals, and other research institutions set up these IRBs to review all the research done at the institution. These boards, generally composed of both scientific peers from the institution and lay persons, are tasked with assessing the risks and benefits associated with the use of human subjects, in addition to the adequacy of the protection and consent of the participants. The IRBs can approve research proposals, make modifications, or disapprove them entirely. Research projects cannot receive federal funding without approval from an IRB. Noncompliance can also induce sanctions from the institution, such as revoked access to facilities and subjects, suspension, and dismissal. The

National Research Act The National Research Act was enacted by the 93rd United States Congress and signed into law by President Richard Nixon on July 12, 1974, after a series of congressional hearings on human-subjects research, directed by Senator Edward Kennedy. The ...

of 1974 also set up the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which produced the Belmont Report (Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research) in 1979. This report established a moral framework for the regulation of research involving human subjects.

Animal welfare

The

Animal Welfare Act of 1966 The Animal Welfare Act (Laboratory Animal Welfare Act of 1966, ) was signed into law by President Lyndon B. Johnson on August 24, 1966. It is the main federal law in the United States that regulates the treatment of animals in research and exhibi ...

sets standards of treatment of animals in research experiments. It requires all research facilities to register with the USDA and allows officials to conduct unannounced facility inspections. The Health Research Extension Act of 1985 requires that all research facilities using animals establish

Institutional Animal Care and Use Committee Institutional Animal Care and Use Committees (IACUCs) are centrally important in applying laws about animal research in the United States. Similar systems operate in other countries, but generally under different titles; for example, in Canada a t ...

s (IACUCs) to evaluate twice a year the institutions' activities involving animals. The IACUCs report to the NIH

Office of Laboratory Animal Welfare The Office of Laboratory Animal Welfare (OLAW) oversees the care and use of research animals in any public or private organization, business, or agency (including components of Federal, state, and local governments). The Public Health Service consi ...

annually.

Research misconduct

The Health Research Extension Act of 1985 led to the establishment of the Office of Research Integrity (ORI) within the Department of Health and Human Services. ORI is responsible for reviewing research misconduct allegations and developing policies to improve the responsible conduct of research.

Commercialization

Two divisions of the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA) are in charge of monitoring the production and sale of drugs. The

Center for Drug Evaluation and Research The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also le ...

(CDER) is responsible for reviewing new drug applications and requires clinical trials as proof of effectiveness. The

Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks, ...

(CBER) is responsible for implementing federal regulations of

biopharmaceutical A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, t ...

s such as vaccines, blood components, gene therapies, etc. They approve new drugs on the basis of safety and effectiveness, and issue licenses, which allow companies to market their products.

Nuclear energy research

Nuclear energy is historically linked to issues of national security. From 1942 to 1946, nuclear research was controlled by the military, which conducted research in secrecy. In 1946, the Atomic Energy Act handed over control to civilians, although the government retained a tight monopoly over nuclear energy. The 1954 amendment to this act enabled private industry to pursue non-military applications of nuclear research. The

Energy Reorganization Act of 1974 The Energy Reorganization Act of 1974 (, codified at 42 U.S.C.A. § 5801) is a United States federal law that established the Nuclear Regulatory Commission. Under the Atomic Energy Act of 1954, a single agency, the U.S. Atomic Energy Commission, h ...

established the Nuclear Regulatory Commission (NRC), in charge of licensing and safety. The Chernobyl and Fukushima accidents raised concerns and public apprehension over the safety of nuclear power. As a result, the NRC strengthened safety regulations for nuclear power plants.

Teaching

Science education is a controversial subject in the United States. Several states banned the teaching of evolution in the 20th century, most notably the state of Tennessee with the

Butler Act The Butler Act was a 1925 Tennessee law prohibiting public school teachers from denying the Biblical account of mankind's origin. The law also prevented the teaching of the evolution of man from what it referred to as lower orders of animals ...

of 1925. It was followed by the Scopes Trial, in which the state of Tennessee accused Scopes, a high school teacher, of teaching evolution. Although he was found guilty and fined, the trial showed declining public support for Fundamentalists. The Scopes Trial had an important impact in the larger creation versus evolution debate. In the following decades, the term "evolution" was omitted in many biology textbooks, even when the text discusses it. These bans on teaching evolution were overturned by a Supreme Court ruling in

Epperson v. Arkansas ''Epperson v. Arkansas'', 393 U.S. 97 (1968), was a landmark United States Supreme Court case that invalidated an Arkansas statute prohibiting the teaching of human evolution in the public schools. The Court held that the First Amendment to the Un ...

in 1968. Since 2001, there has been a resurgence of anti-evolution bills, one of which, the Louisiana Science Education Act, was passed. This Act allows public schools to use supplementary material that is critical of the scientific theories such as evolution and global warming in science classrooms. The U.S. government and state legislatures have also enacted regulations promoting science education. The National Defense Education Act of 1958 was passed soon after the Soviet Union's launch of Sputnik 1 and linked education with issues of national security. This law provided funding for scholarships and science programs. In 2013, 26 state governments worked together to produce the

Next Generation Science Standards The Next Generation Science Standards is a multi-state effort in the United States to create new education standards that are "rich in content and practice, arranged in a coherent manner across disciplines and grades to provide all students an inter ...

, which sets expectations for

K–12 K–12, from kindergarten to 12th grade, is an American English expression that indicates the range of years of publicly supported primary and secondary education found in the United States, which is similar to publicly supported school grades ...

science education.

International regulations

The

Nuremberg Code The Nuremberg Code (german: Nürnberger Kodex) is a set of ethical research principles for human experimentation created by the court in '' U.S. v Brandt'', one of the Subsequent Nuremberg trials that were held after the Second World War. Tho ...

was written as part of the trials of Nazi doctors after World War II. It introduced ten ethical principles regarding human experimentation, the first of which requires informed consent from human subjects. It also states that experimentation on humans must be necessary to society, be preceded by studies on animals, and protect subjects from injury, disability and death. The Nuremberg Code was very influential in shaping regulations of scientific research across the world. For example, the Helsinki Declaration of 1964 was developed by the World Medical Association and establishes ethical principles for the medical community.

References

{{DEFAULTSORT:Regulation Of Science Bioethics Politics of science

Science Science is a systematic endeavor that Scientific method, builds and organizes knowledge in the form of Testability, testable explanations and predictions about the universe. Science may be as old as the human species, and some of the earli ...

Science and law