The regulations found at 45 CFR part 46 are based in large part on the Belmont Report and were written to offer basic protections to human subjects involved in both biomedical and behavioral research conducted or supported by HHS. HHS regulations at 45 CFR part 46 stipulate substantive and procedural requirements for investigators and institutions engaged in HHS-supported or -conducted research.
Specifically, in addition to providing definitions and information about application of the regulations, specific sections of the regulations address the following topics:. Additional protections for specific populations have been adopted by HHS and other departments and agencies to a lesser extent , as follows:.
The assurance identifies policies and procedures for the institution and describes the activities to which the regulations apply. HHS employs many approaches to facilitate compliance with the regulations. First, through a system of IRB registration and assurances , HHS regulations require institutions to commit to compliance with 45 CFR part 46 before initiating participation in HHS-conducted or -supported research involving human subjects.
OHRP also promotes compliance through its Division of Policy and Assurances, which provides policy and guidance documents pertaining to the regulatory requirements in 45 CFR In addition, through its Division of Education and Development, OHRP provides a multifaceted education program -- including national conferences, research community forums, and a quality improvement program -- all of which enhance understanding of the regulations and what is necessary for compliance.
Yes, whenever non-U. The current US system of protection for human research subjects is heavily influenced by the Belmont Report , written in by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
The Belmont Report outlines the basic ethical principles in research involving human subjects. In , with this report as foundational background, HHS and the Food and Drug Administration revised, and made as compatible as possible under their respective statutory authorities, their existing human subjects regulations.
For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance.
Missouri 20 CSR Code Admin. Ins Ohio Ohio Admin. Code - - Protection of human subjects. Ohio Admin. Code - - Policy on human subjects research. Code - - Conduct and ethics: ethical conduct in research involving human subjects. Code - - Provisions for the protection of human research subjects. Code - - Medical screening and research. Oklahoma Okla Admin. Part 46 Okla Admin. Part 46 Oregon OR Admin.
If the neonate is viable , then it will be protected by the protections allotted to normal research subjects and the additional protections of children. The additional protections for prisoners are necessary since their incarceration limits their ability to make a truly voluntary decision to participate in the research. These protections ensure that any danger faced by the prisoners from participating in the research will be of minimal risk and equal to that of non-prisoner volunteers. The research must also treat all of the prisoner subjects fairly and present information about the research in plain language.
The additional protections for children are that the research must be of minimal risk and provide a direct benefit to the participant. The research performed must also be of great value in understanding, preventing, or alleviating a serious problem affecting health or welfare of the children.
Informed consent must be obtained from both children and their parents or legal guardians. For children who do not have a parent or legal guardian, the research is restricted to research related to their status as wards of the state or in general facilities like schools or camps where most of the other participants are not wards of the state.
As of , the most recent version of this code was revised and made effective on 23 June Keywords: Government , Fetus.
Sources United States Congress.
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