regulation of science

Unjust events such as the St. Louis tragedy or the Tuskegee syphilis experiment 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 and the Department of Health and Human Services 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.{{cite web |url=https://embryo.asu.edu/pages/dickey-wicker-amendment-1996 |title=Dickey-Wicker Amendment, 1996 |last=Kearl |first=Megan |date=August 27, 2010 |publisher=Embryo Project at Arizona State University |access-date=November 25, 2018 }}

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.{{Cite journal|last=Peltzman|first=Sam|date=Sep–Oct 1973|title=An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments|journal=The Journal of Political Economy|volume= 81| issue = 5|pages=1051–91|doi=10.1086/260107|s2cid=154634296}} In 1966, a policy statement by the U.S Surgeon General required that all human subject research go through independent prior review.{{Cite web|url=https://history.nih.gov/about/timelines_laws_human.html|title=Office of History, National Institutes of Health – Timeline of Laws Related to the Protection of Human Subjects|website=history.nih.gov|access-date=2017-06-08}} The National Research Act of 1974 institutionalized this review process by requiring that research centers establish Institutional Review Boards (IRBs).{{Cite journal|last=Silberman, Sam and Katherine Kahn|date=December 2011|title=Burdens on Research Imposed by Institutional Review Boards: The State of the Evidence and Its Implications for Regulatory Reform|jstor=23073390|journal=The Milbank Quarterly|volume= 89| issue = 4|pages=599–627|doi=10.1111/j.1468-0009.2011.00644.x|pmid=22188349|pmc=3250635}}

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.{{Cite journal|first1=Arthur M.|last1=Dula|first2=Marshall J.|last2=Breger|first3=Robert F.|last3=Boruch|first4=Eldon|last4=Sutton|first5=LeRoy |last5=Walters|first6=Gary A.|last6=Ahrens|author-link3=Robert F. Boruch|date=Summer 1979|title=Government Regulation of Scientific Research|jstor=29761683|journal=Jurimetrics|volume= 19| issue = 4|pages= 299, 301–384}}

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.

The Animal Welfare Act of 1966 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.{{Cite web|url=https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/sa_awa/ct_awa_inspections|title=Animal Welfare Act Inspections|website=United States Department of Agriculture|access-date=June 9, 2017}} 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.{{Cite web|url=https://grants.nih.gov/grants/olaw/guidebook.pdf|title=Institutional Animal Care and Use Committee Guidebook}}

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.{{Cite web|url=https://ori.hhs.gov/about-ori|title=About ORI {{!}} The Office of Research Integrity|website=ori.hhs.gov|access-date=2017-06-08}}

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.{{Cite web|url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/default.htm|title=About the Center for Biologics Evaluation and Research (CBER)|last=Research|first=Center for Biologics Evaluation and|website=www.fda.gov|language=en|access-date=2017-06-08}}

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.{{Cite journal|last=Dunlavey|first=Dean C.|date=January 1957|title=Government Regulation of Atomic Industry|jstor=3310313|journal=University of Pennsylvania Law Review|volume= 105| issue = 3|pages= 295–373|doi=10.2307/3310313}}

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.{{Cite book|title=A Short History of Nuclear Regulation, 1946–2009|last=J. Samuel Walker and Thomas R. Wellock|publisher=U.S. Nuclear Regulatory Commission|date=September 2010|location=Washington, D.C.}}

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 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.{{Cite journal|last=Judith V. Grabiner and Peter D. Miller|date=September 1974|title=Effects of the Scopes Trial|jstor=1738991|journal=Science |series=New Series|volume= 185| issue = 4154|pages= 832–837|doi=10.1126/science.185.4154.832|pmid=4602163|bibcode=1974Sci...185..832G|s2cid=159785687}} These bans on teaching evolution were overturned by a Supreme Court ruling in Epperson v. Arkansas in 1968.{{Cite journal|last=Moore|first=Randy|date=Nov–Dec 1998|title=Creationism in the United States: III. The Ban on the Teaching of Evolution Reaches the U.S. Supreme Court|jstor=4450576|journal=The American Biology Teacher|volume= 60| issue = 9|pages= 650–661|doi=10.2307/4450576}} 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.{{Cite news|url=https://arstechnica.com/tech-policy/2008/06/louisiana-passes-first-antievolution-academic-freedom-law/|title=Louisiana passes first antievolution "academic freedom" law|work=Ars Technica|access-date=2017-06-09|language=en-us}}

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.{{Cite encyclopedia|url=https://www.britannica.com/topic/National-Defense-Education-Act|title=National Defense Education Act (NDEA) {{!}} United States [1958]|encyclopedia=Encyclopedia Britannica|access-date=2017-06-09|language=en}} In 2013, 26 state governments worked together to produce the Next Generation Science Standards, which sets expectations for K–12 science education.

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.{{Cite journal|last=Shuster|first=Evelyne|date=1997-11-13|title=Fifty Years Later: The Significance of the Nuremberg Code|journal=New England Journal of Medicine|volume=337|issue=20|pages=1436–1440|doi=10.1056/NEJM199711133372006|issn=0028-4793|pmid=9358142|doi-access=free}} 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.{{Cite web|url=https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/|title=The World Medical Association – Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects|website=www.wma.net|language=en-US|access-date=2017-06-09}}

• Ethics committee
• Intelligent design in politics
• Lysenkoism
• Politicization of science
• Right to science and culture
• Scientific freedom

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{{Science and technology studies}}

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Category:Bioethics

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Category:Regulation

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