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The Health Insurance Portability and Accountability Act of 1996 is a United States federal statute enacted by the 104th United States Congress and signed into law by President Bill Clinton on August 21, 1996. It modernized the flow of healthcare information, stipulates how personally identifiable information maintained by the healthcare and healthcare insurance industries should be protected from fraud and theft, and addressed some limitations on healthcare insurance coverage. It generally prohibits healthcare providers and healthcare businesses, called covered entities, from disclosing protected information to anyone other than a patient and the patient's authorized representatives without their consent. With limited exceptions, it does not restrict patients from receiving information about themselves. It does not prohibit patients from voluntarily sharing their health information however they choose, nor – if they disclose medical information to family members, friends, or other individuals not a part of a covered entity – legally require them to maintain confidentiality.
Human subject research is systematic, scientific investigation that can be either interventional or observational and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, and focus groups.
The Code of Federal Regulations (CFR) is the codification of the general and permanent regulations published in the Federal Register by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent broad areas subject to federal regulation.
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.
The Dickey–Wicker Amendment is the name of an appropriation bill rider attached to a bill passed by United States Congress in 1995, and signed by former President Bill Clinton, which 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. HHS funding includes the funding for the National Institutes of Health (NIH). Technically the Dickey Amendment is a "rider" to other legislation, which amends the original legislation. The rider receives its name from the name of the Congressman that originally introduced the amendment, Representative Jay Dickey. The Dickey amendment language has been added to each of the Labor, HHS, and Education appropriations acts for fiscal years 1997 through 2009. The original rider can be found in Section 128 of P.L. 104-99. The wording of the rider is generally the same year after year. For fiscal year 2009, the wording in Division F, Section 509 of the Omnibus Appropriations Act, 2009, prohibits HHS, including NIH, from using fiscal year 2009 appropriated funds as follows:
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 that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. Such boards are formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be conducted. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. Along with developed countries, many developing countries have established national, regional or local Institutional Review Boards in order to safeguard ethical conduct of research concerning both national and international norms, regulations or codes.
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.
The Belmont Report is a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics.
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).
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 National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to develop guidelines for human subject research and to oversee and regulate the use of human experimentation in medicine. The National Research Act issued Title 45, Part 46 of the Code of Federal Regulations: Protection of Human Subjects. The National Research Act is overseen by the Office of Human Research Protections. The Act also formalized a regulated IRB process through local institutional review boards, also overseen by the Office of Human Research Protections.
In the United States, public drinking water is governed by the laws and regulations enacted by the federal and state governments. Certain ordinances may also be created at a more local level. The Safe Drinking Water Act (SDWA) is the principal federal law. The SDWA authorizes the United States Environmental Protection Agency (EPA) to create and enforce regulations to achieve the SDWA goals.
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.
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.
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.
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).
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.
Various organizations have created guidelines for human subject research for various kinds of research involving human subjects and for various situations.
Respect for persons is the concept that all people deserve the right to fully exercise their autonomy. Showing respect for persons is a system for interaction in which one entity ensures that another has agency to be able to make a choice.
References
- ↑ "Regulations". 16 February 2016.
- ↑ U.S. Department of Health and Human Services. "Code of Federal Regulations - Title 45 Public Welfare CFR 46" . Retrieved 2014-07-25.
- ↑ Korenman, S.G., Teaching the Responsible conduct of Research in humans (RCRH) Common Rule, Office of Research Integrity, US Department of Health and Human Services