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Regulation of science

United States of America

Biomedical Research

Tragic events such as the St. Louis tragedy or the Tuskegee syphilis experiment have prompted regulations in biomedical research. Over the years, regulations have extended to 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 and the Department of Health and Human Services oversee the implementation of these regulations.

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 FDA 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 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 set 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 Committees (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 (FDA) are in charge of monitoring the production and sale of drugs. The Center for Drug Evaluation and Research (CDER) is responsible for reviewing new drug applications and requires clinical trials as proof of effectiveness. The Center for Biologics Evaluation and Research (CBER) is responsible for implementing federal regulations of biopharmaceuticals 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 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 20^th century, most notably the state of Tennessee with the Butler Act 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 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, which sets expectations for K–12 science education.

International Regulations

The Nuremberg Code 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.

Biologics Control Act of 1902

The Biologics Control Act of 1902, also known as the Virus-Toxin Law, was the first law that implemented federal regulations of biological products such as vaccines in the United States. It was enacted in response to two incidents involving the deaths of 22 children who had contracted tetanus from contaminated vaccines. This law paved the way for further regulation of drug products under the Pure Food and Drug Act of 1906 and the Federal Food, Drug, and Cosmetic Act of 1938. Biologics control is now under the supervision of the U.S. Food and Drug Administration (FDA).

History

When the large scale production of vaccines began in the late 19^th century, the United States had no government regulations on biological products. In 1901, a 5-year-old girl died of tetanus in St. Louis, Missouri after being given a diphtheria anti-toxin. Investigations found that the St. Louis Board of Health produced the contaminated vaccine using the blood of a horse infected with tetanus. While the infected horse, Jim, was killed, the Board of Health continued to use the serum to treat diphtheria. It was later discovered that 12 other children had died from the same contaminated vaccines in St. Louis. That same year, 9 children in Camden, New Jersey died from contaminated smallpox vaccines. These incidents led the Hygienic Laboratory and the Medical Society of the District of Columbia to propose a law regulating the production of biological products. On July 1, 1902, Congress passed the Biologics Control Act.

Contents of the Act

The Biologics Control Act established a board to oversee the implementation of regulations of biological products. The board consisted of the Surgeon-General of the Army, the Surgeon-General of the Navy, and the Surgeon-General of the Marine Hospital Service, and was to be overseen by the Secretary of the Treasury. This board was given the power to issue, suspend, and revoke licenses to produce and sell biological products. The Biologics Control Act also mandated that all products be labeled accurately with the name of the product and the address and license number of the manufacturer. Laboratories could be subjected to unannounced inspections by the Treasury Department. The punishment for the violation of this law was a fine of up to $500 or up to a year in prison.

Institutions

The Laboratory of Hygiene of the Marine Health Service, established on Staten Island, NY, in 1887, was in charge of testing biologics before the Biologics Control Act. It was moved to Washington, D.C. in 1891, and renamed the Hygienic Laboratory of the Public Health and Marine Hospital Service in 1902. The Hygienic Laboratory was responsible for renewing licenses annually, testing products, and performing inspections. In 1930, the Ransdell Act transformed the Hygienic Laboratory into the National Institute of Health and gave it a larger role in public health research. In 1948, the name was changed again to the National Institutes of Health, as it encompassed many institutes and centers dedicated to biomedical research. In 1972, biologics regulation was moved to the Food and Drug Administration and later became known as the Center for Biologics Evaluation and Research (CBER).

Impact

The Biologics Control Act set a precedent for the federal regulation of biologics such as vaccines and blood components. With the development of biotechnology, the FDA’s Center for Biologics Evaluation and Research (CBER) has taken a larger role in reviewing and approving new biological products intended for medical purposes, including probiotics, xenotransplantation and gene therapy.