Common Rule


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Common Rule

Any of the U.S. policies designed to protect the rights and interests of citizens who choose to participate in government-funded biomedical research. Those who choose to participate in biomedical research often suffer from life-altering or life-threatening illnesses. As a result they may be more psychologically vulnerable than others and may agree to become investigative subjects because of fear or desperation. The protections provided by the Common Rule are designed to ensure that agencies that perform federally funded human research respect the rights of experimental subjects. Included are the rights of confidentiality and full disclosure (informed consent). Research performed on children or prisoners is given special protections.
See also: rule
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The right to withdraw and mandatory re-consent are widespread practices based on the Common Rule and online biobank consent forms.
Commentators have noted the "lack of harmony in regulations" between studies that are and are not subject to the Common Rule with respect to gathering and storing data.
or under the regulatory regime provided by the Common Rule and HIPAA
Second, the Common Rule specifically states that studies undertaken in an established educational setting using normal educational practices (including tests) are "exempted" from the policies.
The Common Rule codifies this principle: "Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result" [Common Rule (DHHS 2001)].
4697), which is designed to address many of the criticisms of the NBAC and others by extending Common Rule compliance to all institutions, both private and public.
institutions receiving funding from the Common Rule agencies.
The Newborn Screening Saves Lives Act of 2015 (Public Law 114-240) requires HHS to publish final revisions to the Common Rule by the end of 2016.
Groups of ranchers combined to form "conservancies" of five to 25 properties, each with common rules and objectives, and each with sufficient land base to reintroduce far-roaming yet economically valuable species such as elephant and cape buffalo.
The Common Rule signatories group includes the Departments of Agriculture, Energy, Commerce, Defense, Education, HHS, Housing and Urban Development, Justice, Transportation, Veterans Affairs, the Agency for International Development, the Central Intelligence Agency, the Consumer Products Safety Commission, the Environmental Protection Agency, the National Aeronautics and Space Administration and the National Science Foundation.
Food and Drug Administration (FDA) have rules governing the ethics and scientific quality of studies submitted for research purposes--the so-called Common Rule (Office of Science and Technology Policy 1991)--but that the U.
There were some cases for which we could not verify compliance with certain Common Rule elements because the documentation was unavailable; however, based on our evaluation, it is apparent that the studies we reviewed were conducted in a manner substantially consistent with the fundamental protections of the Common Rule: voluntary participation, informed consent, and review by an ethical committee or institutional review board (which would have considered and discussed any potentially "scientifically misleading" protocols).