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 tertiary education. The name traces back to Plato's school of philosophy, founded approximately 386 BC at Akademia, a sanctuary of Athena, the go ...

government A government is the system or group of people governing an organized community, generally a State (polity), state. In the case of its broad associative definition, government normally consists of legislature, executive (government), execu ...

al bodies to allow or restrict

science Science is a systematic discipline that builds and organises knowledge in the form of testable hypotheses and predictions about the universe. Modern science is typically divided into twoor threemajor branches: the natural sciences, which stu ...

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 ...

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 gr ...

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

religion Religion is a range of social system, social-cultural systems, including designated religious behaviour, behaviors and practices, morals, beliefs, worldviews, religious text, texts, sanctified places, prophecies, ethics in religion, ethics, or ...

culture Culture ( ) is a concept that encompasses the social behavior, institutions, and Social norm, norms found in human societies, as well as the knowledge, beliefs, arts, laws, Social norm, customs, capabilities, Attitude (psychology), attitudes ...

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. ...

. 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, me ...

issue related to practices such as

abortion Abortion is the early termination of a pregnancy by removal or expulsion of an embryo or fetus. Abortions that occur without intervention are known as miscarriages or "spontaneous abortions", and occur in roughly 30–40% of all pregnan ...

and

euthanasia Euthanasia (from : + ) is the practice of intentionally ending life to eliminate pain and suffering. Different countries have different Legality of euthanasia, euthanasia laws. The British House of Lords Select committee (United Kingdom), se ...

, and areas of research such as

stem-cell research In multicellular organisms, stem cells are Cellular differentiation, undifferentiated or partially differentiated Cell (biology), cells that can change into various types of cells and Cell proliferation, proliferate indefinitely to produce more ...

and

cloning Cloning is the process of producing individual organisms with identical genomes, either by natural or artificial means. In nature, some organisms produce clones through asexual reproduction; this reproduction of an organism by itself without ...

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 Cent ...

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 US federal government created to protect the health of the US people 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 An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed ...

(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 is an American law enacted by the 93rd United States Congress and signed into law by President Richard Nixon on July 12, 1974. The law was passed following a series of congressional hearings on human-subjects research, d ...

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 ...

s (IACUCs) to evaluate twice a year the institutions' activities involving animals. The IACUCs report to the NIH Office of Laboratory Animal Welfare 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 respo ...

(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 Food and Drug Administration (United States), U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmet ...

(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 Vinay Pras ...

(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, ...

established the

Nuclear Regulatory Commission The United States Nuclear Regulatory Commission (NRC) is an independent agency of the United States government tasked with protecting public health and safety related to nuclear energy. Established by the Energy Reorganization Act of 1974, the ...

(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 book of Genesis account of humankind's origin. The law also prevented the teaching of the evolution of humans from what it referred to as lower orders ...

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 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 The National Defense Education Act (NDEA) was signed into law on September 2, 1958, providing funding to United States education institutions at all levels.Schwegler 1 NDEA was among many science initiatives implemented by President Dwight ...

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 int ...

, which sets expectations for

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

science education.

International regulations

The

Nuremberg Code The Nuremberg Code () is a set of research ethics, ethical research principles for human experimentation created by the court in ''Doctors' trial, U.S. v Brandt'', one of the Subsequent Nuremberg trials that were held after the World War II, Seco ...

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 Regulation Science and law