Regulation of science

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The regulation of science refers to use of law, or other ruling, by academic or governmental bodies to allow or restrict science from performing certain practices, or researching certain scientific areas.

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Science could be regulated by legislation if areas are seen as harmful, immoral, or dangerous. For these reasons science regulation may be closely related to religion, culture and society.

Science regulation is often a bioethical issue related to practices such as abortion and euthanasia, and areas of research such as stem-cell research and cloning synthetic biology.

United States

Biomedical research

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. [1]

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. [2] In 1966, a policy statement by the U.S Surgeon General required that all human subject research go through independent prior review. [3] The National Research Act of 1974 institutionalized this review process by requiring that research centers establish Institutional Review Boards (IRBs). [4]

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. [5]

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. [3]

Animal welfare

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. [6] 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. [7]

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. [8]

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. [9]

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. [10]

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. [11]

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 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. [12] These bans on teaching evolution were overturned by a Supreme Court ruling in Epperson v. Arkansas in 1968. [13] 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. [14]

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. [15] 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. [16] 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. [17]

See also

Related Research Articles

<span class="mw-page-title-main">Food and Drug Administration</span> United States federal agency

The United States Food and Drug Administration 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 safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

<span class="mw-page-title-main">Clinical trial</span> Phase of clinical research in medicine

Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.

<span class="mw-page-title-main">Federal Food, Drug, and Cosmetic Act</span> Acts of the United States Congress

The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.

<span class="mw-page-title-main">Investigational New Drug</span> USFDA permission to test

The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines before a marketing application for the drug has been approved. Regulations are primarily at 21 CFR 312. Similar procedures are followed in the European Union, Japan, and Canada.

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 for research done at that institution to ensure that the projects are ethical. Such boards are formally designated to approve, monitor, and review biomedical and behavioral research involving humans, and they are legally required in some countries under certain specified circumstances. Most countries use some form of IRB to safeguard ethical conduct of research so that it complies with national and international norms, regulations or codes.

<span class="mw-page-title-main">Medical research</span> Wide array of research

Medical research, also known as experimental medicine, encompasses a wide array of research, extending from "basic research", – involving fundamental scientific principles that may apply to a preclinical understanding – to clinical research, which involves studies of people who may be subjects in clinical trials. Within this spectrum is applied research, or translational research, conducted to expand knowledge in the field of medicine.

Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.

<span class="mw-page-title-main">Institutional Animal Care and Use Committee</span>

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 typical title would be the University Animal Care Committee (UACC), while in the United Kingdom it would be the Animal Welfare and Ethical Review Body (AWERB).

Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.

An ethics committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law.

A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a Principal Investigator (PI).

<span class="mw-page-title-main">Animal testing regulations</span> Guidelines with regard to animal testing

Animal testing regulations are guidelines that permit and control the use of non-human animals for scientific experimentation. They vary greatly around the world, but most governments aim to control the number of times individual animals may be used; the overall numbers used; and the degree of pain that may be inflicted without anesthetic.

<span class="mw-page-title-main">Public Responsibility in Medicine and Research</span> Nonprofit organisation

Public Responsibility in Medicine and Research (PRIM&R) is a 501(c)(3) nonprofit organization based in Boston, Massachusetts. The organization was formed in 1974 by a group of researchers who sought to ensure that the concerns and experiences of those working in biomedical research would be reflected in the growing body of federal regulations governing the field.

<span class="mw-page-title-main">Children in clinical research</span>

In health care, a clinical trial is a comparison test of a medication or other medical treatment, versus a placebo, other medications or devices, or the standard medical treatment for a patient's condition.

The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH).

A glossary of terms used in clinical research.

The following outline is provided as an overview of and topical guide to clinical research:

Human subject research legislation in the United States can be traced to the early 20th century. Human subject research in the United States was mostly unregulated until the 20th century, as it was throughout the world, until the establishment of various governmental and professional regulations and codes of ethics. Notable – and in some cases, notorious – human subject experiments performed in the US include the Tuskegee syphilis experiment, human radiation experiments, the Milgram obedience experiment and Stanford prison experiments and Project MKULTRA. With growing public awareness of such experimentation, and the evolution of professional ethical standards, such research became regulated by various legislation, most notably, those that introduced and then empowered the institutional review boards.

Regulatory science is the scientific and technical foundations upon which regulations are based in various industries – particularly those involving health or safety. Regulatory bodies employing such principles in the United States include, for example, the FDA for food and medical products, the EPA for the environment, and the OSHA for work safety.

A Designated Member Review (DMR) or Designated Subcommittee Review (DSR), also known as Designated Review, is a review of a protocol where a committee designates one or more members of the committee to review a decisionmaking process or a protocol or procedure, a review which would ordinarily require the full committee's review. Typically this pertains to IACUCs.

References

  1. ↑ Kearl, Megan (August 27, 2010). "Dickey-Wicker Amendment, 1996". Embryo Project at Arizona State University. Retrieved November 25, 2018.
  2. ↑ Peltzman, Sam (Sep–Oct 1973). "An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments". The Journal of Political Economy. 81 (5): 1051–91. doi:10.1086/260107. S2CID   154634296.
  3. 1 2 "Office of History, National Institutes of Health – Timeline of Laws Related to the Protection of Human Subjects". history.nih.gov. Retrieved 2017-06-08.
  4. ↑ Silberman, Sam and Katherine Kahn (December 2011). "Burdens on Research Imposed by Institutional Review Boards: The State of the Evidence and Its Implications for Regulatory Reform". The Milbank Quarterly. 89 (4): 599–627. doi:10.1111/j.1468-0009.2011.00644.x. JSTOR   23073390. PMC   3250635 . PMID   22188349.
  5. ↑ Dula, Arthur M.; Breger, Marshall J.; Boruch, Robert F.; Sutton, Eldon; Walters, LeRoy; Ahrens, Gary A. (Summer 1979). "Government Regulation of Scientific Research". Jurimetrics. 19 (4): 299, 301–384. JSTOR   29761683.
  6. ↑ "Animal Welfare Act Inspections". United States Department of Agriculture. Retrieved June 9, 2017.
  7. ↑ "Institutional Animal Care and Use Committee Guidebook" (PDF).
  8. ↑ "About ORI | The Office of Research Integrity". ori.hhs.gov. Retrieved 2017-06-08.
  9. ↑ Research, Center for Biologics Evaluation and. "About the Center for Biologics Evaluation and Research (CBER)". www.fda.gov. Retrieved 2017-06-08.
  10. ↑ Dunlavey, Dean C. (January 1957). "Government Regulation of Atomic Industry". University of Pennsylvania Law Review. 105 (3): 295–373. doi:10.2307/3310313. JSTOR   3310313.
  11. ↑ J. Samuel Walker and Thomas R. Wellock (September 2010). A Short History of Nuclear Regulation, 1946–2009. Washington, D.C.: U.S. Nuclear Regulatory Commission.
  12. ↑ Judith V. Grabiner and Peter D. Miller (September 1974). "Effects of the Scopes Trial". Science. New Series. 185 (4154): 832–837. Bibcode:1974Sci...185..832G. doi:10.1126/science.185.4154.832. JSTOR   1738991. PMID   4602163. S2CID   159785687.
  13. ↑ Moore, Randy (Nov–Dec 1998). "Creationism in the United States: III. The Ban on the Teaching of Evolution Reaches the U.S. Supreme Court". The American Biology Teacher. 60 (9): 650–661. doi:10.2307/4450576. JSTOR   4450576.
  14. ↑ "Louisiana passes first antievolution "academic freedom" law". Ars Technica. Retrieved 2017-06-09.
  15. ↑ "National Defense Education Act (NDEA) | United States [1958]". Encyclopedia Britannica. Retrieved 2017-06-09.
  16. ↑ Shuster, Evelyne (1997-11-13). "Fifty Years Later: The Significance of the Nuremberg Code". New England Journal of Medicine. 337 (20): 1436–1440. doi: 10.1056/NEJM199711133372006 . ISSN   0028-4793. PMID   9358142.
  17. ↑ "The World Medical Association – Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects". www.wma.net. Retrieved 2017-06-09.
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